The drug Fraxiparine: release forms and price. Fraxiparine - indications for the use of injections, reviews Reviews of Fraxiparine

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medside.ru

Fraxiparine:: Instructions:: Price:: Description of the drug

Fraxiparin (Nadroparin calcium) Manufacturer: Glaxo Smiith Kline (Belgium)

In stock UAH.

Release forms:

Buy These products are located on the website of the pharmacy chain "Thetida" Active ingredient: nadroparin calcium; 1 ml of injection solution contains 9500 IU of anti-Xa nadroparin calcium; excipients: calcium hydroxide or hydrochloric acid, water for injection. Nadroparin calcium ( active substance Fraxiparin) is a low molecular weight heparin obtained from standard heparin by depolymerization in special conditions. The drug is characterized by pronounced activity against blood clotting factor Xa and weak activity against factor Pa. The Angi-Ha activity (i.e., antiplatelet/anti-platelet adhesion activity) of the drug is more pronounced than its effect on activated partial thromboplastin time (an indicator of blood clotting rate), which distinguishes nadroparin calcium from unfractionated standard heparin. Thus, the drug has antithrombotic activity (preventing the formation of a blood clot), has a rapid and long-lasting effect. The use of Fraxiparine is recommended for: prevention of thromboembolic complications (formation blood clots in the veins) after surgical interventions, both in general and orthopedic surgery; in non-surgical patients with a high risk of developing thromboembolic complications (acute respiratory failure and/or respiratory infection, acute heart failure), in patients undergoing treatment in intensive care units; prevention of blood clotting during hemodialysis; treatment of thromboembolic complications; on ECG. Fraxiparin is intended for subcutaneous and intravenous administration. Do not use Fraxiparine intramuscularly. When Fraxiparine is administered, it should not be mixed with other drugs.

Prevention of thromboembolic complicationsGeneral surgery. The usual recommended dose is 0.3 ml of Fraxiparine once a day subcutaneously for at least 7 days. In any case, prophylaxis should be carried out during the period of risk. The first dose is administered 2 to 4 hours before surgery. Orthopedic surgery. The initial dose of Fraxiparine is administered 12 hours before surgery and 12 hours after it. The use of the drug is continued for at least 10 days. In any case, prophylaxis should be carried out during the period of risk. The dose depends on the patient’s body weight and is determined according to the table below:

Treatment of thromboembolic complications Fraxiparin is administered subcutaneously twice a day (every 12 hours), usually for 10 days. The dose depends on the patient’s body weight and is determined according to the table below:

Prevention of blood clotting during hemodialysis Doses of the drug are selected individually, taking into account the technical conditions of dialysis. Fraxiparine is usually administered as a single injection into the arterial circuit at the beginning of each procedure. Recommended starting doses for patients without an increased risk of bleeding are shown in the table below:

In patients with an increased risk of bleeding, it is recommended to administer half the dose.

Treatment of unstable angina and myocardial infarction without a Q wave on the ECG. It is recommended to use Fraxiparine in combination with aspirin (up to 325 mg per day). The usual duration of treatment is 6 days. The initial dose of Fraxiparine is administered intravenously into a pre-installed venous catheter at a dose of 86 IU anti-Xa/kg, and then the same dose subcutaneously every 12 hours. Recommended doses of Fraxiparine are indicated in the table below:

When using Fraxiparine, allergic reactions, bleeding in different places, a reversible increase in liver enzyme levels, small hematomas or hard painful nodules at the injection sites, which usually disappear after a few days, may occur. For skin redness and formation painful lump at the injection site, the use of Fraxiparine should be stopped immediately and consult a doctor. IN in some cases Thrombocytopenia, eosinophilia and hyperkalemia (reversible after cessation of treatment) may occur. If any unusual reactions occur, be sure to consult your doctor about the possibility of further use of the drug. Fraxiparin is not recommended for use in the following cases: if you are allergic to nadroparin calcium; if thrombocytopenia has developed in the past when using nadroparin calcium; with bleeding or increased risk of bleeding; at peptic ulcer stomach or duodenum in the acute stage; with hemorrhagic cerebrovascular injury; for acute infective endocarditis. Use of Fraxiparine during pregnancy, except in cases where the therapeutic benefit outweighs the possible risk. The use of Fraxiparine during breastfeeding is not recommended. During treatment with Fraxiparine, you should not take any other medications (including those available without a prescription) without first consulting your doctor. The simultaneous use of Fraxiparin with aspirin (except for the treatment of unstable angina and myocardial infarction without a Q wave) and other salicylates, non-steroidal anti-inflammatory drugs without prior consultation with a doctor is not recommended. You should inform your doctor if you are taking oral anticoagulants, glucocorticosteroids or dextrans. In case of an overdose of the drug, bleeding of varying severity occurs. Minor bleeding requires a reduction in dose or an increase in the interval between drug administration. For significant bleeding, the use of protamine sulfate is recommended. 0.6 ml of protamine sulfate neutralizes about 0.1 ml of Fraxiparine. 1 pre-filled syringe in a blister, 2 or 10 blisters in a cardboard box. Injection solutions in pre-filled syringes contain: Store out of the reach of children, at room temperature (up to 30°C), away from heating devices. Conditions for dispensing from pharmacies - by prescription. Nadroparin calcium (Nadropariri calcium) See also the list of analogues of the drug Fraxiparin. Nadroparin calcium Fraxiparin should not be used intramuscularly. Treatment with Fraxiparine should be carried out under the supervision of a physician. The use of Fraxiparine can lead to hyperkalemia, which is usually reversible, especially in patients with elevated plasma potassium levels and in patients at risk of increased plasma potassium levels.

The description of the drug "Fraxiparin" on this page is a simplified and expanded version official instructions by application. Before purchasing or using the drug, you should consult your doctor and read the instructions approved by the manufacturer. Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

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instructions for use, analogues, composition, indications

Compound

1 ml of solution contains fragmented elements of heparin glycosaminoglycan in an amount of 25000 U antiXaIC, which corresponds to 10250 UI antiXa (international units). Solution for subcutaneous administration: in pre-filled syringes with a single dose of 0.2 ml, 10 pieces per package; in pre-filled syringes with a single dose of 0.3 ml, 2 and 10 pieces per package; in pre-filled syringes with a single dose of 0.4 ml, 10 pieces per package: in pre-filled syringes (graduated) with a dose of 0.6 ml or 0.8 ml, 2 and 10 pieces per package; in pre-filled syringes - (graduated) with a dose of 1 ml, 10 pieces per package.

pharmachologic effect

Fraxiparin is a low molecular weight heparin obtained from standard heparin by depolymerization under special conditions. The drug is characterized by pronounced activity against factor Xa and weak activity against factor Na. The anti-Xa activity (i.e., antiplatelet activity) of Fraxiparine is more pronounced than its effect on activated partial thromboplastin time (aPTT), which distinguishes Fraxiparine from unfractionated standard heparin. Thus, Fraxiparine has antithrombotic activity and has a rapid and long-lasting effect.

Pharmacokinetics

The maximum concentration is reached 3 hours after administration of the drug. The half-life is 3.5 hours. Anti-Xa activity appears within 18 hours after administration of the drug. Activity against factor Ha is negligible and reaches its maximum after approximately 3 hours. 98% of the drug is present in the blood in a biologically active form.

Indications for use

Prevention of thromboembolic disease, primarily in orthopedic and surgical practice, treatment of already formed deep venous thrombosis. Prevention of coagulation in extracorporeal circulation during hemodialysis.

Contraindications

Hypersensitivity, acute bacterial endocarditis, thrombocytopenia (in persons with positive test aggregation in vitro in the presence of the drug), bleeding (except for DIC syndrome), hemorrhagic stroke, pericarditis, vasculitis, arterial hypertension, orthostatic hypotension, fainting conditions, chorioretinopathy, exacerbation of gastric and duodenal ulcers, severe renal/liver failure, severe diabetes mellitus, central nervous system injuries, condition after spinal puncture, radiation therapy, use of IUDs, pregnancy, lactation, postpartum period.

Directions for use and doses

The injection is carried out into the subcutaneous tissue of the abdomen. The needle is inserted perpendicularly into the thickness of the skin fold formed between the thumb and index finger. The fold should be maintained throughout the entire insertion period. 1 unit (V) of antiXa fraxiparine corresponds to 0.41 international unit (VI) of antiXa;

Preventative treatment thromboembolic disease. General surgery: prevention is based on a single daily dose of Fraxiparine 0.3 ml. A dose of 0.3 ml is administered 2-4 hours before the start of surgery. The total duration of treatment is at least 7 days. It is recommended to carry out prophylaxis during the entire period of risk, until the patient’s motor activity is completely restored. Orthopedic surgery: the dose of the drug is selected depending on the patient’s body weight. The drug is administered once a day daily in the following doses: For patients weighing less than 50 kg: in the preoperative period and for 3 days after surgery - 0.2 ml; in the postoperative period (starting from the 4th day) - 0.3 ml. For patients weighing from 51 to 70 kg: in the preoperative period and within 3 days after surgery - 0.3 ml; in the postoperative period (starting from the 4th day) - 0.4 ml. For patients weighing from 71 to 95 kg: in the preoperative period and within 3 days after surgery - 0.4 ml; in the postoperative period (starting from the 4th day) - 0.6 ml. The course is at least 10 days.

Medicinal use: Prevention of coagulation during hemodialysis: in patients without the risk of bleeding and for a session not exceeding 4 hours, at the beginning of the session, inject a single dose into the arterial line: - Patients weighing less than 50 kg: 0.3 ml - Patients weighing from 51 to 70 kg: 0.4 ml - Patients with body weight above 71 kg: 0.6 ml If necessary, the dose will be more accurately selected depending on each individual case and the technical conditions of dialysis. In patients with hemorrhagic risk, it will be possible to conduct a dialysis session using doses reduced by half. Fraxiparine replaces traditional heparin therapy, carried out while awaiting the results of venography. Fraxiparine is administered every 12 hours for 10 days. The dose of the drug depends on the patient’s body weight: with a body weight of 45 kg - 0.4 ml; 55 kg-0.5 ml; 70 kg-0.6 ml; 80 kg-0.7 ml; 90 kg-0.8 ml; 100 kg or more - 0.9 ml.

Side effect

Hemorrhages, allergic reactions; rarely - thrombocytopenia, small hematomas and skin necrosis at the injection site.

Overdose

Symptoms: increased bleeding. Treatment: slow intravenous administration of protamine sulfate or hydrochloride is indicated (0.6 ml of protamine is neutralized by about 0.1 ml of Fraxiparine).

Interaction with other drugs

Fraxiparine may potentiate the effects of the following: medicines non-steroidal anti-inflammatory drugs; acetylsalicylic acid and preparations containing it; platelet antiplatelet agents, dextran, indirect anticoagulants.

Features of application

If skin necrosis occurs at the injection site, you should immediately stop using Fraxiparine. Particular caution is recommended in cases of renal or hepatic failure, a history of gastric ulcers, or any other organic lesion that may bleed, or vascular disease retina and choroid. It is necessary before starting treatment, and then 2 times a week quantitative analysis platelets.

Release form

Solution for subcutaneous administration of 9500 IU anti-Xa/ml in multi-dose vials.

5 ml or 15 ml of solution in a type I flint glass bottle, sealed with a chlorobutyl rubber stopper, crimped with a tear-off aluminum cap with a protective plastic cap.

10 bottles along with instructions for medical use are placed in a cardboard box.

Storage conditions

At temperatures below 30 °C. Do not freeze.

The opened bottle should be stored at a temperature below Keep out of the reach of children.

Best before date

The shelf life of the drug after opening the bottle is 28 days.

Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies

On prescription.

Fraxiparine analogues, synonyms and group drugs

Self-medication may be harmful to your health. You should consult your doctor and also read the instructions before use.

apteka.103.by

Name: Fraxiparine

Indications for use: The use of Fraxiparine is recommended for: prevention of thromboembolic complications (formation of blood clots in the veins) after surgical interventions, both in general and orthopedic surgery; in non-surgical patients with an increased risk of developing thromboembolic complications (acute respiratory failure and/or respiratory infection, acute heart failure), in patients undergoing treatment in intensive care units; prevention of blood clotting during hemodialysis; treatment of thromboembolic complications; treatment of unstable angina and myocardial infarction without a Q wave on the ECG.

Pharmacological action: Nadroparin calcium (the active ingredient of Fraxiparin) is a low-molecular-weight heparin obtained from standard heparin by depolymerization under special conditions. The drug is characterized by pronounced activity against blood clotting factor Xa and weak activity against factor Pa. The Angi-Ha activity (i.e., antiplatelet/anti-platelet adhesion activity) of the product is more pronounced than its effect on activated partial thromboplastin time (an indicator of blood clotting rate), which distinguishes nadroparin calcium from unfractionated standard heparin. Thus, the product has antithrombotic activity (preventing the formation of a blood clot) and has a quick and long-lasting effect.

Fraxiparine method of administration and dosage: Fraxiparine is intended for subcutaneous and intravenous administration. Do not use Fraxiparine intramuscularly. When Fraxiparine is administered, it should not be mixed with other products.

Prevention of thromboembolic complicationsGeneral surgery. The usual recommended dose is 0.3 ml of Fraxiparine once a day subcutaneously for at least 7 days. In any case, prevention must be carried out throughout the period of risk. The first dose is administered 2 to 4 hours before surgery. Orthopedic surgery. The initial dose of Fraxiparine is administered 12 hours before surgery and 12 hours afterwards. Use of the product is continued for at least 10 days. In any case, prevention must be carried out throughout the period of risk. The dose depends on the body weight of the patient and is determined according to the table below:

Non-surgical intensive care unit patients

Treatment of thromboembolic complications Fraxiparin is administered subcutaneously twice a day (every 12 hours), usually for 10 days. The dose depends on the body weight of the patient and is determined according to the table below:

Prevention of blood clotting during hemodialysis Doses of the product are selected individually, taking into account the technical conditions of dialysis. Fraxiparine is usually administered as a single injection into the arterial circuit at the beginning of each procedure. Recommended starting doses for patients without an increased risk of bleeding are shown in the table below:

In patients with an increased risk of bleeding, it is recommended to administer half the dose.

Treatment of unstable angina and myocardial infarction without a Q wave on the ECG. It is recommended to use Fraxiparine in combination with aspirin (up to 325 mg per day). The usual duration of treatment is 6 days. The initial dose of Fraxiparine is administered intravenously into a pre-installed venous catheter at a dose of 86 IU anti-Xa/kg, and then the same dose subcutaneously 12 hours later. Recommended doses of Fraxiparine are indicated in the table below:

Fraxiparine contraindications: Fraxiparine is not recommended for use in the following cases: if you are allergic to nadroparin calcium; if thrombocytopenia has developed in the past when using nadroparin calcium; with bleeding or increased risk of bleeding; with peptic ulcer of the stomach or duodenum in the acute stage; with hemorrhagic cerebrovascular injury; in acute infective endocarditis.

Fraxiparine side effects: When using Fraxiparine, allergic reactions, bleeding in different places, a reversible increase in the level of liver enzymes, small hematomas or dense painful nodules at the injection sites may be observed, which usually disappear after a few days. With redness of the skin and the formation of a painful lump at the injection site product, use of Fraxiparine should be stopped immediately and consult a doctor. In some cases, thrombocytopenia, eosinophilia and hyperkalemia (reversible after discontinuation of treatment) may occur. If any unusual reactions occur, be sure to consult a doctor about the possibility of further use of the product.

Pregnancy: The use of Fraxiparine during pregnancy, except in cases where the therapeutic benefit outweighs the possible risk. The use of Fraxiparine during breastfeeding is not recommended.

Overdose: In case of an overdose of the product, bleeding of varying severity appears. Minor bleeding requires reducing doses or increasing the interval between administration of the product. For significant bleeding, the use of protamine sulfate is recommended. 0.6 ml of protamine sulfate neutralizes within 0.1 ml of Fraxiparine.

Use with other medicinal products: During treatment with Fraxiparin, you should not take any other medications (including those sold without a prescription) without first consulting your doctor. The simultaneous use of Fraxiparin with aspirin is not recommended (except for the treatment of unstable angina and non-Q wave myocardial infarction) and other salicylates, non-steroidal anti-inflammatory products without prior consultation with your doctor. You should inform your doctor if you are taking oral anticoagulants, glucocorticosteroids or dextrans.

Release form: 1 pre-filled syringe in a blister, 2 or 10 blisters in a cardboard box. Injection solutions in pre-filled syringes contain:

Storage conditions: Store out of the reach of children, at room temperature (up to 30°C), away from heating devices. Dispensing conditions from pharmacies - by prescription.

Synonyms: Nadroparin calcium (Nadropariri calcium)

Fraxiparine composition: Active ingredient: nadroparin calcium; 1 ml of solution for injection contains 9500 IU of anti-Xa nadroparin calcium; excipients: calcium hydroxide or hydrochloric acid, water for injection.

Additionally: Fraxiparin should not be used intramuscularly. Treatment with Fraxiparine should be carried out under the supervision of a physician. The use of Fraxiparine can lead to hyperkalemia, which is usually reversible, especially in patients with elevated plasma potassium levels and in patients at risk of increased plasma potassium levels.

Attention! Before using the drug "Fraxiparin", you must consult a doctor. The instructions are provided solely for information about "Fraxiparin".

Group affiliation:

medprep.info

Fraxiparine Solution for injection (syringes): instructions, description PharmPrice

Instructions for medical use

medicine

Tradename

International generic name

Nadroparin calcium

Dosage form

Solution for injection, 3800 IU anti-Xa/0.4 ml No. 10

1 syringe contains

active substance – nadroparin calcium 3800 IU anti-Xa,

excipients: calcium hydroxide solution or hydrochloric acid diluted to pH 5-7.5, water for injection up to 0.4 ml

Description

Transparent or slightly opalescent, colorless or light yellow solution

Pharmacotherapeutic group

Anticoagulants. Direct anticoagulants (heparin and its derivatives). Nadroparin.

ATX code B01AB06

Pharmacological properties

Pharmacokinetics

The pharmacokinetic properties of nadroparin are based on biological activity, that is, on changes in anti-Xa factor activity.

The maximum level of anti-Xa activity (Cmax) is achieved 3-4 hours after subcutaneous administration 2 times a day, when using Fraxiparine 1 time a day - after 4-6 hours. Bioavailability is almost complete (about 88%).

After intravenous administration, the maximum level of anti-Xa activity in plasma is achieved within 10 minutes, and the half-life is about 2 hours. Metabolism occurs mainly in the liver (desulfation, depolymerization). It is excreted primarily by the kidneys.

Anti-Xa activity persists for 18 hours after administration of the drug.

Special groups patients

Due to possible reduction renal function, in elderly patients the excretion of nadroparin slows down. Before prescribing the drug, it is necessary to assess renal function and adjust the prescribed dose accordingly.

Patients with impaired renal function

IN clinical studies The pharmacokinetics of nadroparin in patients with varying degrees of renal failure revealed a correlation between the clearance of nadroparin and creatinine clearance. In patients with average degree renal failure (creatinine clearance 36-43 ml/min), AUC and T1\2 increased by 52 and 39%, respectively, with a decrease in plasma clearance of nadroparin by 63%. In patients with severe renal failure (creatinine clearance 10-20 ml/min), AUC and T1/2 increased by 95 and 112%, respectively, with a decrease in plasma clearance of nadroparin by 50%. In patients with a creatinine clearance of 3-6 ml/min or on hemodialysis, AUC and T1/2 increased by 62 and 65%, respectively, with a decrease in plasma clearance of nadroparin by 67%.

Pharmacodynamics

The active substance of the drug is nadroparin calcium - low molecular weight heparin, obtained by depolymerization of standard heparin under special conditions. It is a glycosaminoglycan with an average molecular weight of approximately 4300 daltons. Fraxiparine exhibits high similarity with plasma protein antithrombin. This leads to accelerated suppression of factor Xa, which stimulates the high antithrombic potential of Fraxiparine.

Other mechanisms for enhancing antithrombotic activity include stimulation of the inhibitor tissue factor, activation of fibrinolysis by direct release of tissue plasmogenic activator from endothelial cells and modification of hemorheological parameters (decreasing blood viscosity and increasing the number of platelets, variability of the granulocyte membrane).

The drug is characterized by more pronounced anti-Xa factor activity compared to anti-IIa factor activity. The ratios between the two activities for Fraxiparine are in the range of 2.5-4. It has both immediate and prolonged antithrombic effects.

Compared with unfractionated heparins, Fraxiparine has less effect on platelet function and aggregation and a negligible effect on overall hemostasis.

Indications for use

prevention of thromboembolic complications (associated with general or orthopedic surgery, in non-surgical patients - with acute respiratory failure, respiratory infection and/or acute heart failure in an intensive care unit)

prevention of blood clotting during hemodialysis

treatment of thromboembolism

treatment of unstable angina and myocardial infarction without Q wave

Directions for use and doses

Instructions for administering the drug

For subcutaneous administration. Do not use intramuscularly.

1. Wash your hands with soap and dry them with a towel.

Sit or lie down in a comfortable position. Fraxiparine is injected subcutaneously into the abdominal area 1.5-2 cm below the navel. Select the left or right area as shown in the picture. Alternatively, the drug may be injected into the thigh.

2. Clean the intended injection site with an alcohol swab.

3.Remove the protective cap from the needle. If the amount of solution in the syringe exceeds the dose recommended by your doctor, remove the excess amount. Gently press the plunger of the syringe to bring the amount of solution to the level recommended by your doctor. Avoid contact of the needle with other surfaces until insertion. A small amount of bubbles in the solution is normal and there is no need to remove them.

4.Carefully grab the skin in the fold between the large and index fingers.

5. The needle should be inserted perpendicularly, not at an angle, into the pinched fold of skin, which should be held between the thumb and forefinger during the entire insertion period.

6. Inject the entire amount of solution that is in the syringe.

Remove the needle from the injection site. The injection site should not be rubbed.

7.For safety reasons, put the protective cap on the needle after the injection. Dispose of the used syringe as directed by your doctor.

Fraxiparine should not be used interchangeably with other low molecular weight heparins during the course of therapy.

Platelet counts should be monitored throughout treatment.

Prevention of thromboembolic disorders

general surgery

IN general surgery a dose of Fraxiparine 0.3 ml (2850 IU anti-Xa) is administered subcutaneously 2-4 hours before surgery, and then, in the following days, 1 time per day. The total duration of treatment is at least 7 days. It is recommended to carry out prevention during the entire period of risk.

Orthopedics

In orthopedic practice, the dose is selected depending on the patient’s body weight and is administered subcutaneously in accordance with Table 1. The first dose is administered 12 hours before surgery, the second – 12 hours after surgery. The drug is administered once a day, the minimum duration of treatment is 10 days.

Table 1

For patients with a high thromboembolic risk in the intensive care unit (acute respiratory failure, respiratory infection, acute heart failure), treatment is continued throughout the entire period of risk of thromboembolism. The dose is selected depending on the patient’s body weight, according to Table 2.

table 2

Treatment of thromboembolic disorders

When treating thromboembolic complications, therapy with oral anticoagulants, in the absence of contraindications, should be started as soon as possible.

Fraxiparine is administered subcutaneously every 12 hours.

The dose is selected depending on the patient’s body weight, according to Table 3.

Table 3

Prevention of blood clotting during hemodialysis Fraxiparine is usually used as a single dose in the intra-arterial infusion system at the beginning of each procedure.

For patients without an increased risk of bleeding, initial doses are determined based on the patient's body weight, according to Table 4.

Table 4

Patients with an increased risk of bleeding should be given half the dose. An additional, smaller dose may be administered during dialysis lasting more than 4 hours. The dosage for sequential dialysis should be adjusted according to the observed effect. Patients should be closely monitored during each dialysis procedure for signs of bleeding or clotting.

Treatment of unstable angina and non-Q wave myocardial infarction

Fraxiparine is administered subcutaneously 2 times a day (every 12 hours) in combination with acetylsalicylic acid(up to 325 mg per day). The duration of treatment is 6 days. The initial dose is determined at 86 IU anti-Xa/kg and should be administered as an intravenous bolus. Then the same dose is administered subcutaneously. Doses are determined depending on body weight in accordance with Table 5.

Table 5

In elderly patients, the dose is adjusted if necessary, except in cases of renal impairment.

Kidney failure

There is no need to adjust the dose if creatinine clearance is greater than or equal to 50 ml/min. In moderate to severe renal failure, increased exposure to nadroparin may occur, leading to an increased risk of thromboembolism and hemorrhage. In such patients (creatinine clearance less than 30 ml/min or 30 ml/min - 50 ml/min), the dose of Fraxiparine should be reduced by 25-33%.

Liver failure

No studies have been conducted.

Use in pediatrics

Side effects

Increased bleeding, mild thrombocytopenia (including heparin-induced thrombocytopenia), thrombocytosis, reversible eosinophilia

Allergic reactions, urticaria, rash, erythema, including angioedema, skin necrosis (at the injection site), anaphylactic reactions

Reversible hyperkalemia

Temporary increase in liver enzyme levels

Small hematomas, hard nodules or calcinosis at the injection site that disappear after a few days

Priapism

Hypersensitivity to the latex contained in the needle guard

Contraindications

Hypersensitivity to nadroparin or excipients

Severe thrombocytopenia associated with the use of heparin or nadroparin

Intraocular hemorrhage and other bleeding or increased risk of bleeding associated with impaired hemostasis, excluding disseminated intravascular coagulation (DIC) not caused by heparin

Organic diseases with the potential for bleeding (for example, stomach ulcers or duodenum, cerebral bleeding, cerebral aneurysm)

Hemorrhagic cerebrovascular injury

Acute infective endocarditis

Severe uncontrolled hypertension

Severe renal failure (creatinine clearance less than 30 ml/min) except time on hemodialysis

Injuries and surgeries to the central nervous system, eye or ear

Retinopathy, hemorrhages in vitreous eyes

Threatened abortion

Children and teenagers up to 18 years of age

Drug interactions

The drug Fraxiparine is prescribed with caution when used simultaneously with oral anticoagulants, systemic glucocorticosteroids and dextrans. When prescribing oral anticoagulants to patients already receiving Fraxiparine, Fraxiparine is used until the INR normalizes.

With simultaneous use of Fraxiparine with potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II inhibitors, non-steroidal anti-inflammatory drugs, heparins, cyclosporine, the development of hyperkalemia is observed.

Fraxiparine can enhance the anticoagulant effect of the following drugs: non-steroidal anti-inflammatory drugs, acetylsalicylic acid and preparations containing it, platelet antiplatelet agents, glucocorticosteroids, and therefore their combined use with Fraxiparine is not recommended. In cases where the use of these combinations cannot be avoided, caution should be exercised in the ongoing assessment of the blood coagulation system and the general clinical condition.

special instructions

Heparin-induced thrombocytopenia

Due to the possibility of heparin-induced thrombocytopenia, the platelet count should be monitored throughout the course of treatment with Fraxiparine.

Rare cases of thrombocytopenia, some severe, that have been associated with arterial or venous thrombosis have been identified. The diagnosis of heparin-induced thrombocytopenia should be considered in the following conditions:

Thrombocytopenia

Any significant decrease in platelet count (30-50% from baseline)

Vascular thrombosis or worsening of existing thrombosis during ongoing therapy

DIC syndrome

If any of the above conditions develop, treatment with nadroparin should be discontinued.

These symptoms may be of an immuno-allergic nature and, during the first use of the drug, their occurrence is described between 5 and 21 days, but may appear earlier in the case of thrombocytopenia that occurs during the use of heparin.

If there are known cases of heparin-induced thrombocytopenia (when using standard or low molecular weight heparins), the use of nadroparin should be considered by the attending physician. If positive, the platelet count and assessment should be monitored daily throughout the course of treatment with nadroparin. If heparin-induced thrombocytopenia develops, treatment with nadroparin should be discontinued immediately and replaced with another class of antithrombotic drugs. If this is not possible, another low molecular weight heparin can be used, but platelet counts and assessments should be monitored at least daily and the drug should be discontinued as soon as possible, as thrombocytopenia has been reported with other classes of antithrombotic drugs.

In vitro platelet aggregation tests are of limited value in the diagnosis of heparin-induced thrombocytopenia.

Nadroparin should be prescribed with caution in following situations which may be associated with an increased risk of bleeding:

Liver failure

Severe degree arterial hypertension

History of peptic ulcer and other diseases with an increased risk of bleeding

Circulatory disorders in choroid and retina

Postoperative period after surgical interventions on the brain, spinal cord, eyes

Hyperkalemia

Heparin may suppress adrenal secretion of aldosterone leading to hyperkalemia, especially in patients at risk for elevated plasma potassium levels, in patients with diabetes mellitus, chronic renal failure, previous metabolic acidosis or when taking drugs that cause hyperkalemia (for example, ACE inhibitors, non-steroidal anti-inflammatory drugs).

The risk of developing hyperkalemia increases with increasing duration of therapy, but is usually reversible.

In patients at risk of hyperkalemia, plasma potassium levels should be monitored.

Spinal and epidural anesthesia/lumbar puncture and combined use with other drugs

If spinal or epidural anesthesia is necessary while using the drug Fraxiparine, rare cases of intraspinal hematoma, even the development of long-term paralysis, have been observed. The risk of developing intraspinal hematoma increases with the use of an epidural catheter or with the concomitant use of other drugs that can cause hemostasis, such as nonsteroidal anti-inflammatory drugs, platelet inhibitors or other anticoagulants, as well as with traumatic, repeated epidural or spinal puncture.

Therefore, it is necessary to carefully evaluate the benefits and risks of combined use of nerve blockade and anticoagulants in the following cases:

In patients already on anticoagulant treatment, the benefits of nerve blockade should be assessed against the possible risks.

In patients planning surgery using nerve blockade, it is necessary to evaluate the benefits of anticoagulants in relation to the possible risks.

If it is necessary to combine such anesthesia and the prescription of nadroparin, it should be taken into account that in the case of spinal/epidural anesthesia or lumbar puncture, an interval of at least 12 hours must be maintained between the injection of Fraxiparin and the insertion/removal of a needle or catheter in the case of its prophylactic administration, or 24 hours in the case of its prescribed in therapeutic doses. For patients with renal impairment, lengthening the suggested interval should be considered.

Patients require careful neurological monitoring in case of signs and symptoms of neurological disorders and, if necessary, emergency treatment measures.

Salicylates, non-steroidal anti-inflammatory drugs and platelet inhibitors

In preventive or medicinal purposes to eliminate thromboembolic disorders and prevent blood clotting during hemodialysis, the concomitant use of aspirin, NSAIDs or platelet inhibitors is not recommended, as this may increase the risk of bleeding. When this combination cannot be avoided, monitoring of the patient's clinical and biological parameters is necessary.

In clinical studies in the treatment of unstable angina and non-Q wave myocardial infarction, Fraxiparine was prescribed in combination with acetylsalicylic acid (up to 325 mg per day).

Kidney failure

Nadroparin is excreted primarily by the kidneys, therefore, if renal function is impaired, the exposure of nadroparin may increase, and therefore the risk of bleeding increases in such patients, and the drug should be used with caution.

With a creatinine clearance of 30-50 mg/ml, the attending physician should consider reducing the dose of Fraxiparine based on an assessment of the risk between possible bleeding and the development of thromboembolism.

Before prescribing the drug, it is necessary to monitor renal function.

Skin necrosis

In very rare cases, cases of skin necrosis have been identified, the prerequisites of which were purpura, infiltration or painful erythematous plaques, with associated general symptoms or without. If these symptoms develop, treatment with Fraxiparine should be stopped immediately.

The needle sheath may contain latex, which can lead to allergic reactions in patients with latex allergies.

Fertility

Clinical studies on the effect of nadroparin on fertility have not been conducted.

Pregnancy and lactation

Data on the use of nadroparin during pregnancy and lactation are limited.

The use of the drug during pregnancy is not recommended, unless the therapeutic benefit does not outweigh the possible risk.

There is no information on the penetration of nadroparin into breast milk However, the use of Fraxiparine during feeding is not recommended.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

There are no data on the effect of Fraxiparine on the ability to drive vehicles and other mechanisms.

Overdose

Symptoms: bleeding. In such cases, platelet count and other coagulation parameters should be determined. Minor bleeding rarely requires special intervention.

Treatment: slow intravenous administration of protamine sulfate is indicated. 0.6 ml of protamine sulfate neutralizes about 1.0 ml of Fraxiparine. It should be taken into account that it is impossible to completely neutralize the anti-Xa factor activity of Fraxiparine. If necessary, it may be necessary to administer the calculated dose in several doses (2-4) during the day.

Release form and packaging

0.4 ml is placed in glass, graduated, siliconized syringes with a capacity of 1 ml, equipped with a stainless steel injection needle attached to the syringe barrel and protected by a rubber cap. 2 pre-filled syringes are placed in PVC blister packs, covered with transparent plastic film. 5 contour packages together with instructions for use in the state and Russian languages ​​are placed in a cardboard box.

Storage conditions

At a temperature not higher than +30 °C. Do not freeze.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Conditions for dispensing from pharmacies

On prescription

Manufacturer

Aspen Notre Dame de Bondeville

1 rue de l'Abbaye, 76960 Notre Dame de Bondeville, France

Registration Certificate Holder

Aspen Pharma Trading Limited

3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

LifeMed LLP

st. Popova, 9/57 –9, 050040, Almaty, Republic of Kazakhstan.

Phone/fax number: +7 727 328 41 01

pharmaceuticalprice.kz

Fraxiparine - instructions for use, doses, side effects, contraindications

Subcutaneous injection technique

It is preferable to inject with the patient lying down, into the subcutaneous tissue of the anterolateral or posterolateral surface of the abdomen, alternately from the right and left sides. Injection into the thigh is allowed.

To avoid loss of the drug when using syringes, do not remove air bubbles before injection.

The needle should be inserted perpendicularly, and not at an angle, into the pinched fold of skin, which must be held between the thumb and forefinger until the end of the solution. Do not rub the injection site after injection.

Prevention of thromboembolism

general surgery

The recommended dose of Fraxiparine is 0.3 ml (2850 anti-Xa ME) subcutaneously, 2-4 hours before surgery, then Fraxiparine is administered once a day. Treatment is continued for at least 7 days and during the period of risk of thrombosis, until the patient is transferred to an outpatient regimen.

Orthopedic surgeries

Fraxiparine is prescribed subcutaneously, the dosage depends on the patient’s body weight, and is indicated in the table below, at the rate of 38 anti-Xa IU/kg body weight, which can be increased to 50% on the 4th postoperative day. The initial dose is prescribed 12 hours before surgery, the 2nd dose - 12 hours after the end of the operation. Further, Fraxiparine continues to be used once a day during the period of risk of thrombosis until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.

Patients at high risk of thrombosis, usually in intensive care units (respiratory failure and/or infection) respiratory tract and/or heart failure)

Fraxiparine is prescribed subcutaneously, 1 time per day. The dose depends on the patient’s body weight and is indicated in the table below. Fraxiparine is used throughout the entire period of risk of thrombosis.

Treatment of unstable angina and non-Q wave myocardial infarction

Fraxiparine is administered subcutaneously 2 times a day (every 12 hours). The duration of treatment is usually 6 days. In clinical studies, patients with unstable angina/non-Q wave myocardial infarction were prescribed Fraxiparine in combination with aspirin at a dose of 325 mg per day.

The initial dose is administered as a single intravenous bolus injection and subsequent doses are administered subcutaneously. The dose depends on the patient’s body weight and is indicated in the table below, at the rate of 86 anti-Xa IU/kg body weight.

Patient's body weight (kg)	Initial dose, for intravenous administration (bolus)	Subcutaneous injection (every 12 hours)	Anti-Ha ME

Treatment of thromboembolism

When treating thromboembolism, therapy with oral anticoagulants, in the absence of contraindications, should be started as early as possible. Fraxiparine therapy should not be discontinued until the target values ​​of prothrombin time are achieved.

Fraxiparine is prescribed subcutaneously 2 times a day (every 12 hours), the usual course duration is 10 days. The dose depends on the patient’s body weight and is indicated in the table below, at the rate of 86 anti-Xa IU/kg body weight.

Prevention of blood coagulation in the extracorporeal circulation system during hemodialysis

The dose of Fraxiparine should be set individually for each patient, taking into account the technical conditions of dialysis.

Fraxiparine is administered once into the arterial line of the dialysis loop at the beginning of each session. For patients who do not have an increased risk of bleeding, the following initial doses are recommended, depending on body weight, sufficient for a 4-hour dialysis session:

In patients with an increased risk of bleeding, dialysis sessions can be performed using half the dose of the drug.

If the dialysis session lasts longer than 4 hours, additional small doses of Fraxiparine may be administered.

During subsequent dialysis sessions, the dose should be adjusted depending on the observed effects. The patient should be monitored during the dialysis procedure for possible bleeding or signs of thrombus formation in the dialysis system.

Elderly patients

In elderly patients, no dose adjustment is required, with the exception of patients with impaired renal function. Before starting treatment with Fraxiparine, it is recommended to assess renal function.

Kidney failure

Prevention of thromboembolism

In patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min and less than 60 ml/min), no dose reduction is required if Fraxiparine is used to prevent thrombosis. In patients with severe renal failure (creatinine clearance less than 30 ml/min), the dose should be reduced by 25%. In patients with severe renal impairment (creatinine clearance less than 30 ml/min), the dose should be reduced by 25%.

Treatment of thromboembolism, prevention of thromboembolism in patients at high risk of thrombus formation (unstable angina and myocardial infarction without a Q wave)

In patients with mild to moderate renal impairment receiving Fraxiparine for the treatment of these diseases, the dose should be reduced by 25%. Fraxiparine is contraindicated in patients with severe renal impairment.

Patients with liver dysfunction

Not carried out special research for this group of patients.

www.lsgeotar.ru

instructions for use, description of the drug and indications for use.

Name: Fraxiparin (Nadroparin calcium)

Pharmacological effects: Nadroparin calcium (the active ingredient of Fraxiparin) is considered a low molecular weight heparin, obtained from standard heparin by depolymerization under special conditions. The drug is characterized by pronounced activity against blood clotting factor Xa and weak activity against factor Pa. The Angi-Ha activity (i.e., antiplatelet/anti-platelet adhesion activity) of the drug is more pronounced than its effect on activated partial thromboplastin time (an indicator of blood clotting rate), which distinguishes nadroparin calcium from unfractionated standard heparin. Thus, the drug has antithrombotic activity (preventing the formation of a blood clot) and has a rapid and long-lasting effect.

Fraxiparine - indications for use:

The use of Fraxiparine is suggested for: prevention of thromboembolic complications (formation of blood clots in the veins) after surgical interventions, both in general and orthopedic surgery; in non-surgical patients with a high risk of developing thromboembolic complications (acute respiratory failure and/or respiratory infection, acute heart failure), in patients undergoing treatment in intensive care units; prevention of blood clotting during hemodialysis; treatment of thromboembolic complications; treatment of unstable angina and myocardial infarction without a Q wave on the ECG.

Fraxiparine - method of application:

Fraxiparine is intended for subcutaneous and intravenous administration. Do not use Fraxiparine intramuscularly. When Fraxiparine is administered, it must not be mixed with other medications.

Prevention of thromboembolic complicationsGeneral surgery. The usual recommended dosage is 0.3 ml of Fraxiparine once a day subcutaneously for at least 7 days. In any case, prophylaxis should be carried out during the period of risk. The first dose is administered 2 to 4 hours before surgery. Orthopedic surgery. The initial dose of Fraxiparine is administered 12 hours before surgery and 12 hours after it. The use of the medicine is continued for at least 10 days. In any case, prophylaxis should be carried out during the period of risk. The dosage depends on the patient’s body weight and is determined according to the table below:

Non-surgical intensive care unit patients

Treatment of thromboembolic complications Fraxiparin is administered subcutaneously twice a day (every 12 hours), often for 10 days. The dosage depends on the patient’s body weight and is determined according to the table below:

Prevention of blood clotting during hemodialysis. Drug dosages are selected individually, taking into account the technical conditions of dialysis. Fraxiparine is often used as a one-time injection into the arterial circuit at the beginning of each procedure. Recommended starting dosages for patients without an increased risk of bleeding are shown in the table below:

Patients with an increased risk of bleeding are advised to administer half the dose.

Treatment of unstable angina and myocardial infarction without a Q wave on the ECG. It is suggested to use Fraxiparine in combination with aspirin (up to 325 mg per day). The usual duration of treatment is 6 days. The initial dose of Fraxiparine is administered intravenously into a pre-installed venous catheter at a dose of 86 IU anti-Xa/kg, and then the same dose subcutaneously every 12 hours. Recommended dosages of Fraxiparine are shown in the table below:

Fraxiparine - side effects:

When using Fraxiparine, allergic reactions, bleeding in different places, a reversible increase in the level of liver enzymes, small hematomas or dense painful nodules at the injection sites, which often disappear after a few days, may be observed. If the skin becomes red and a painful lump forms at the injection site, Fraxiparine should be used stop immediately and consult a doctor. In some cases, thrombocytopenia, eosinophilia and hyperkalemia (reversible after stopping treatment) may occur. If any unusual reactions occur, be sure to consult your doctor about the possibility of further use of the medicine.

Fraxiparine - contraindications:

Fraxiparine is not recommended for use in the following cases: if you are allergic to nadroparin calcium; if thrombocytopenia has developed in the past when using nadroparin calcium; with bleeding or increased risk of bleeding; with peptic ulcer of the stomach or duodenum in the acute stage; with hemorrhagic cerebrovascular injury; in acute infective endocarditis.

Fraxiparine - pregnancy:

Use of Fraxiparine during pregnancy, except in cases where the therapeutic benefit outweighs the possible risk. Use of Fraxiparine during breastfeeding is not recommended.

Interaction with other drugs: During treatment with Fraxiparin, you should not take any other medications (including those sold without a prescription) without first consulting your doctor. The simultaneous use of Fraxiparin with aspirin is not recommended (except for the treatment of unstable angina and non-Q wave myocardial infarction) and other salicylates, non-steroidal anti-inflammatory drugs without prior consultation with your doctor. You should inform your doctor if you are taking oral anticoagulants, glucocorticosteroids or dextrans.

Fraxiparine - overdose:

An overdose of the drug causes bleeding of varying severity. Minor bleeding requires a reduction in dose or an increase in the interval between drug administration. In case of significant bleeding, the use of protamine sulfate is suggested. 0.6 ml of protamine sulfate neutralizes about 0.1 ml of Fraxiparine.

Fraxiparine - release form:

1 initially filled syringe in a blister, 2 or 10 blisters in a cardboard box. Injection solutions in initially filled syringes contain:

Fraxiparine - storage conditions:

Store out of the reach of children, at room temperature (up to 30°C), away from heating devices. Dispensing conditions from pharmacies - according to prescription.

Fraxiparine - synonyms:

Nadroparin calcium

Fraxiparine - composition:

Active ingredient: nadroparin calcium; 1 ml of solution for injection contains 9500 IU of anti-Xa nadroparin calcium; excipients: calcium hydroxide or hydrochloric acid, water for injection.

Fraxiparine - additionally:

Fraxiparine should not be used intramuscularly. Treatment with Fraxiparine should be carried out under the supervision of a physician. The use of Fraxiparine can lead to hyperkalemia, which is mainly reversible, especially in patients with elevated plasma potassium levels and in patients at risk of increased plasma potassium levels.

Important! Before using Fraxiparine, you should consult your doctor. This instruction is intended for informational purposes only.

dxline.ru

Fraxiparine is a direct-acting anticoagulant that has an antithrombotic effect. Active ingredient: Nadroparin calcium.

The main active ingredient is low molecular weight heparin (LMWH). It is obtained by depolymerization from standard heparin and is a glycosaminoglycan with an average molecular weight of 4,300 daltons.

Fraxiparine exhibits high ability to binding to the blood plasma protein antithrombin III (AT III). This binding leads to accelerated inhibition of factor Xa, which accounts for the high antithrombotic potential of nadroparin.

Nadroparin calcium is characterized by higher anti-Xa factor activity compared to anti-IIa factor or antithrombotic activity and has both immediate and prolonged antithrombotic activity.

In prophylactic doses, nadroparin does not cause a significant decrease in aPTT.

During a course of treatment during the period of maximum activity, it is possible to increase the aPTT to a value 1.4 times higher than the standard one. This prolongation reflects a residual antithrombotic effect.

Indications for use

What does Fraxiparine help with? According to the instructions, the drug is prescribed in the following cases:

• prevention of thromboembolic complications during general or orthopedic surgical interventions;
• in patients at high risk of thromboembolic complications (respiratory failure and/or infectious diseases of the respiratory tract, and/or heart failure) hospitalized in the intensive care unit; treatment of thromboembolic complications;
• prevention of blood clotting during hemodialysis; treatment of unstable angina and myocardial infarction without a pathological Q wave on the ECG.

Instructions for use Fraxiparine, dosage

When administered subcutaneously, the drug is preferably administered with the patient lying down, into the subcutaneous tissue of the anterolateral or posterolateral surface of the abdomen, alternately from the right and left sides. Injection into the thigh is allowed.

To avoid loss of the drug when using syringes, do not remove air bubbles before injection.

The needle should be inserted perpendicularly, not at an angle, into the pinched fold of skin formed between the thumb and index finger. The fold should be maintained throughout the entire period of drug administration. Do not rub the injection site after injection.

• For the prevention of thromboembolism in general surgical practice, the recommended dose of Fraxiparine is 0.3 ml (2850 anti-Xa ME) s.c. The drug is administered 2-4 hours before surgery, then once a day. Treatment is continued for at least 7 days or for the entire period of increased risk of thrombosis, until the patient is transferred to an outpatient regimen.
• To prevent thromboembolism during orthopedic operations, Fraxiparine is administered subcutaneously at a dose determined depending on the patient’s body weight at the rate of 38 anti-Xa IU/kg, which can be increased to 50% on the 4th postoperative day. The initial dose is prescribed 12 hours before surgery, the 2nd dose – 12 hours after the end of the operation. Further, Fraxiparine continues to be used once a day throughout the entire period of increased risk of thrombosis until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.
• For patients with a high risk of thrombosis (usually those in intensive care units / respiratory failure and / or respiratory tract infection and / or heart failure /), Fraxiparine is prescribed subcutaneously 1 time per day at a dose determined depending on body weight patient. Used throughout the entire period of risk of thrombosis.
• In the treatment of unstable angina and myocardial infarction without a Q wave, subcutaneous injection is prescribed 2 times a day (every 12 hours). The duration of treatment is usually 6 days. In clinical studies, patients with unstable angina/non-Q wave myocardial infarction were prescribed Fraxiparine in combination with acetylsalicylic acid at a dose of 325 mg/day. The instructions for use recommend that the initial dose be administered as a single intravenous bolus injection, subsequent doses should be administered subcutaneously. The dose is set depending on body weight at the rate of 86 anti-Xa IU/kg.
• When treating thromboembolism, oral anticoagulants (in the absence of contraindications) should be prescribed as early as possible. Therapy is not stopped until the target values ​​of prothrombin time are achieved. The drug is prescribed subcutaneously 2 times a day (every 12 hours), the usual course duration is 10 days. The dose depends on the patient’s body weight at the rate of 86 anti-Xa IU/kg body weight.

special instructions

Do not administer the drug intramuscularly!

In patients with an increased risk of bleeding, half the recommended dose of the drug can be used.

If the dialysis session lasts longer than 4 hours, additional small dosages of the drug may be administered.

In elderly patients, no dose adjustment is required (except for patients with impaired renal function). Before starting treatment with Fraxiparine, it is recommended to monitor renal function indicators.

In patients with mild to moderate renal failure (creatinine clearance ≥ 30 ml/min and< 60 мл/мин) для профилактики тромбообразования снижения дозы не требуется, у пациентов с почечной недостаточностью тяжелой степени (КК < 30 мл/мин) дозу следует снизить на 25%.

In patients with mild to moderate renal failure, for the treatment of thromboembolism or for the prevention of thromboembolism in patients with a high risk of thrombus formation (with unstable angina and non-Q wave myocardial infarction), the dose should be reduced by 25%; in patients with severe renal failure, the drug is contraindicated.

Signs of the development of necrosis in the area of ​​injection of the solution are usually purpura, a painful erythematous or infiltrated spot (including general symptoms). If they appear, you should stop using Fraxiparine immediately.

Side effects

The instruction warns about the possibility of developing the following side effects when prescribing Fraxiparine:

• Hematopoietic system: thrombocytopenia, eosinophilia, reversible after cessation of therapy.
• Immune system: hypersensitivity reactions (skin reactions, Quincke's edema).
• Hepatobiliary system: transient increase in the level of activity of liver transaminases.
• Blood coagulation system: bleeding various localizations.
• Local reactions: dense nodules, subcutaneous hematoma or skin necrosis at the injection site. The development of necrosis is usually preceded by purpura or a painful or infiltrated erythematous patch.
• Other: reversible hyperglycemia, priapism.

Contraindications

It is contraindicated to prescribe Fraxiparine in the following cases:

• thrombocytopenia (including in cases where it was observed previously);
• organic lesion internal organs with an increased risk of bleeding (for example, stomach ulcers or ulcerative colitis);
• increased risk of bleeding in various conditions;
• signs of starting bleeding;
• intracranial hemorrhage;
• head injuries;
• surgery performed on the brain;
• some major eye surgeries;
• endocarditis;
• severe renal and liver failure;
• intolerance to nadroparin calcium.

The drug can be prescribed with caution for the following diseases:

• mild and moderate forms of liver and kidney failure;
• severe arterial hypertension;
• peptic ulcer;
• risk of bleeding;
• circulatory disorders in the choroid of the eyes or retina;
• rehabilitation period after head surgery;
• rehabilitation period after eye surgery;
• lack of weight, dystrophy (less than 40 kg);
• simultaneous use of drugs that increase the risk of bleeding;

special instructions

Due to the existing risk of heparin-induced thrombocytopenia, the platelet count should be monitored during the entire course of treatment with nadroparin.

Isolated cases of severe thrombocytopenia accompanied by arterial or venous thrombosis have been reported. Such a diagnosis can be assumed in the following situations: thrombocytopenia; any significant decrease in platelet count (30 to 50% compared to baseline); negative dynamics of thrombosis for which treatment was prescribed; the appearance of thrombosis during treatment; ICE.

If these conditions occur, treatment with nadroparin should be discontinued.

The above-mentioned effects are of an immunoallergic nature, if treatment is carried out for the first time, and occur between the 5th and 21st day of treatment, but may occur much earlier if the patient has a history of thrombocytopenia associated with heparin treatment.

In patients with a history of thrombocytopenia that occurred during treatment with heparin (both standard and low molecular weight), treatment with nadroparin can be prescribed if necessary. In this case, careful clinical observation and determination of the platelet count daily are necessary. If thrombocytopenia occurs, treatment with nadroparin should be discontinued immediately.

If thrombocytopenia occurs during treatment with heparin (both standard and low molecular weight), it must be discontinued and treatment with a drug of another class of antithrombotic agents must be continued. If such a drug is not available, another low molecular weight heparin drug can be used if the use of heparin is necessary.

The platelet count should be monitored at least once a day and treatment should be stopped as soon as possible if the initial thrombocytopenia persists even after changing the drug.

An in vitro platelet aggregation test is of limited value in establishing the diagnosis of heparin-induced thrombocytopenia.

Overdose

Symptoms of overdose are bleeding, abnormal platelet counts and other parameters of the blood coagulation system.

In case of minor bleeding, it is sufficient to reduce the next dose of Fraxiparine or delay its administration. Special therapy is required in severe cases.

Protamine sulfate has a pronounced neutralizing effect on the anticoagulant effect of heparin. When calculating the dose of the antidote, it should be taken into account that to neutralize 950 IU of anti-Xa nadroparin, 0.6 ml of protamine sulfate is needed.

It is possible to reduce the dose of the antidote if a long period has passed since the overdose.

Drug interactions

The drug is not recommended to be prescribed simultaneously with other anticoagulants, as this increases the risk of bleeding. For the same reason, the drug is not prescribed to the patient simultaneously with NSAIDs and acetylsalicylic acid (aspirin).

Particular care should be taken when prescribing Fraxiparine to a patient simultaneously with antiplatelet agents and antipyretics - drug interactions increases the risk of side effects and bleeding.

During treatment with drugs from the group of glucocorticosteroids, care should be taken when prescribing, as there is a high risk of developing severe side effects.

Analogues of Fraxiparine, price in pharmacies

If necessary, you can replace Fraxiparine with an analogue according to active substance- these are drugs:

1. Fraxiparine Forte,
2. Athenative,
3. Fragmin,
4. Heparin,
5. Enoxarin,
6. Flenox.

When choosing analogues, it is important to understand that the instructions for use of Fraxiparine, price and reviews of the drugs similar action do not apply. It is important to consult a doctor and not change the drug yourself.

Price in Russian pharmacies: Fraxiparine solution 0.4 ml - from 278 rubles, 9500 ANTI-HA IU/ml 0.3 ml 10 single-dose syringes - from 2437 to 2621 rubles, solution 0.4 ml 10 pcs. – from 2792 to 3127 rubles.

Store at temperatures up to 30 °C, do not allow freezing. Shelf life – 3 years. Dispensing conditions from pharmacies are by prescription.

1 syringe of Fraxiparine may contain 9500, 7600, 5700, 3800 or 2850 IU of anti-Xa nadroparin calcium .

Additional components: hydrochloric acid or solution calcium hydroxide , water.

Release form

The syringes contain a slightly opalescent, colorless, transparent solution for subcutaneous injection.

Two such disposable syringes in a blister, five or one blisters in a pack of paper.

pharmachologic effect

Anticoagulant And antithrombotic.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Combined use with , indirect anticoagulants, NSAIDs, fibrinolytics or mutually enhances the effects of drugs.

Terms of sale

On prescription.

Storage conditions

• Do not freeze.
• Store at temperatures up to 30 degrees.
• Keep away from children.

Best before date

Three years.

special instructions

Fraxiparine should not be administered intramuscularly.

Does not affect the ability to drive a car.

Analogs

Level 4 ATX code matches:

Analogues of Fraxiparine: Atenativ, Heparin-Biolek, Heparin-Darnitsa, Heparin-Indar, Heparin-Novopharm, Heparin-Pharmex, Novoparin, Flenox, Enoxarin.

For children

Age under 18 years is a contraindication for prescribing the drug.

Fraxiparine during pregnancy (and lactation)

Nadroparin calcium penetrates the placenta and is excreted into breast milk. Therefore, it is not recommended to prescribe Fraxiparine injections during and during pregnancy, except in extreme cases.

Fraxiparine for IVF

It is prescribed to improve the rheological properties of blood, since the use of hormones causes the opposite effect, and to facilitate implantation.

Reviews about Fraxiparine

Patient reviews of the drug are quite different, but you should not rely on them if you are offered treatment with Fraxiparine. The validity of prescribing the drug, its effectiveness and all the risks associated with it can only be assessed by a specialist.

None bad reviews about Fraxiparine during pregnancy from those who have undergone treatment. As practice shows, the drug does not affect the health of children. In the Latin recipe, the name of the product sounds like Fraxiparini.

Fraxiparine price, where to buy

In Russia, the price of Fraxiparine No. 10 0.3 ml is 2177-4020 rubles (buying in Moscow will cost about the same amount). In Ukraine, the price of the drug in this form of release is 510 hryvnia. The price of analogues, also used during pregnancy, is almost always noticeably lower.

• Online pharmacies in Russia Russia
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Fraxiparine solution for subcutaneous treatment 9500 anti-Xa IU/ml syringe 0.6 ml (5700 IU) 10 pcs.

Fraxiparine solution for subcutaneous injection. 9500 anti-Ha IU/ml syringe 0.3 ml (2850 IU) 10 pcs.Aspen Notre Dame de Bondeville/Nanolek LLC

Fraxiparine solution for subcutaneous treatment 9500 anti-Xa IU/ml syringe 0.8 ml (7600 IU) 10 pcs.Aspen Notre Dame de Bondeville/Nanolek LLC

Fraxiparine: instructions for use and reviews

Fraxiparine is a direct-acting anticoagulant.

Release form and composition

Fraxiparine is available as a solution for subcutaneous (s/c) administration: a clear or slightly opalescent liquid, colorless or light yellow (in a dose of 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml or 1 ml in glass disposable syringes, 2 syringes in a blister, 1 or 5 blisters in a cardboard box).

1 ml of solution contains:

• active ingredient: calcium nadroparin – 9500 ME (international unit) anti-Xa;
• auxiliary components: calcium hydroxide solution (or diluted hydrochloric acid), water for injection.

In 1 syringe the calcium content of nadroparin depends on its volume and corresponds to the following amount:

• volume 0.3 ml – 2850 IU anti-Xa;
• volume 0.4 ml – 3800 IU anti-Xa;
• volume 0.6 ml – 5700 IU anti-Xa;
• volume 0.8 ml – 7600 IU anti-Xa;
• volume 1 ml – 9500 IU anti-Xa.

Pharmacological properties

Pharmacodynamics

Fraxiparine is a direct anticoagulant. Its active ingredient is calcium nadroparin. It is a low molecular weight heparin obtained from standard heparin by depolymerization. It is a glycosaminoglycan with an average molecular weight of 4300 daltons.

The high ability of nadroparin calcium to bind to the blood plasma protein antithrombin III (AT III) causes accelerated inhibition of blood coagulation factor (Xa), causing the manifestation of its high antithrombotic potential.

In addition, the antithrombotic effect of nadroparin is due to mechanisms such as activation of tissue factor conversion inhibitor (TFPI), activation of fibrinolysis by direct release of tissue plasminogen activator from endothelial cells, and modification of the rheological properties of blood. The change in blood properties consists of a decrease in its viscosity and an increase in the permeability of platelet and granulocyte membranes.

Nadroparin calcium is characterized by higher anti-Xa factor activity when compared with anti-IIa factor or antithrombotic activity. It has both immediate and prolonged antithrombotic effects.

Nadroparin has a slight effect on primary hemostasis.

Prophylactic doses of Fraxiparine do not cause a significant decrease in activated partial thromboplastin time (aPTT). During course therapy, the aPTT value may increase 1.4 times compared to the standard value during the period of maximum activity of the drug. This is a reflection of the residual antithrombotic effect of nadroparin calcium.

Pharmacokinetics

Pharmacokinetic properties are determined based on changes in anti-Xa factor activity of plasma.

After subcutaneous administration, up to 88% of nadroparin is absorbed, maximum anti-Xa activity (Cmax) is achieved after 3–5 hours. With intravenous administration, Cmax occurs in less than 1/6 hour.

In the liver it is metabolized to a greater extent by depolymerization and desulfation.

T1/2 (half-life) with intravenous administration is approximately 2 hours, with subcutaneous administration - about 3.5 hours. In this case, anti-Xa activity after subcutaneous administration at a dose of 1900 IU of anti-Xa persists for at least 18 hours.

In elderly patients, dose adjustment is made in accordance with age-related physiological deterioration of renal function.

When prescribing Fraxiparine for the treatment of unstable angina, non-Q wave myocardial infarction or thromboembolism in patients with mild or moderate renal failure with a creatinine clearance (CL) of 30 ml/min to 60 ml/min, it is recommended to reduce the dose of the drug by 25%. The use is contraindicated in patients with severe renal failure.

To prevent thromboembolism in patients with mild or moderate renal failure, a dose reduction of nadroparin is not required; in patients with severe renal failure, the dose must be reduced by 25%.

Injecting high doses of low molecular weight heparin into the arterial line of the dialysis loop prevents blood clotting in the dialysis loop. In case of overdose, the entry of Fraxiparine into the systemic circulation may cause an increase in anti-Xa factor activity associated with the final phase of renal failure.

Indications for use

• thromboembolism;
• unstable angina;
• myocardial infarction without Q wave;
• prevention of thromboembolic complications during surgical operations and orthopedic interventions;
• prevention of thrombus formation in the intensive care unit in patients with acute respiratory and/or heart failure;
• prevention of blood clotting during a hemodialysis session.

Contraindications

• thrombocytopenia due to a history of nadroparin use;
• intracranial hemorrhage;
• signs of bleeding, increased risk of bleeding due to impaired hemostasis (except for disseminated intravascular coagulation syndrome not caused by heparin);
• acute ulcer of the stomach and/or duodenum and other organic lesions of organs prone to bleeding;
• acute septic endocarditis;
• surgery or injury to the eyes, spinal cord or brain;
• breast-feeding;
• age under 18 years;
• hypersensitivity to the components of Fraxiparine.

In addition, the use of the solution is contraindicated for the treatment of thromboembolism, unstable angina or myocardial infarction without a Q wave in patients with severe renal failure (creatinine clearance less than 30 ml/min).

According to the instructions, Fraxiparine should be used with caution if there is a history of peptic ulcers or other diseases with an increased risk of bleeding, liver and/or renal failure, severe arterial hypertension, circulatory disorders in the retina and choroid, in combination with drugs that increase the risk of bleeding , use of the drug in the period after surgery on the head and spinal cord or on the eyes, the patient’s body weight is less than 40 kg, in situations where treatment must be continued for more than 10 days, in case of violation of the recommendations for use, especially if they are related to the duration and discrepancy between the dose and the patient’s body weight.

Instructions for use of Fraxiparine: method and dosage

The solution is injected subcutaneously into the abdominal tissue (anterolateral or posterolateral surface area) from the right and left sides alternately. It is advisable to perform the procedure with the patient in a horizontal position. Fraxiparine can be administered into the thigh.

Do not remove air bubbles from the syringe before injection to prevent loss of the drug.

To administer Fraxiparine, you need to form a fold of skin with your thumb and forefinger and hold it during the entire period of administration of the solution. The needle is inserted perpendicular (not at an angle) to the surface. After the injection, do not rub the injection site.

• prevention of thromboembolism during surgical interventions: Fraxiparine 0.3 ml (2850 IU anti-Xa) 2–4 hours before surgery, then once a day during the entire period of increased risk of thrombosis. Course duration – at least 7 days;
• prevention of thromboembolism during orthopedic operations: at the rate of 38 IU of anti-Xa per 1 kg of patient weight. The first dose is administered 12 hours before surgery, the second dose 12 hours after it. Next, injections are performed once a day during the entire period of increased risk of thrombosis and until the patient switches to ambulatory treatment. On the fourth day after surgery, the dose can be increased, but not more than 50%. The minimum course of therapy is 10 days;
• prevention of thrombus formation in the intensive care unit in patients with respiratory tract infections, acute respiratory and/or heart failure: in a dose of 0.4 ml for a patient weighing up to 70 kg, 0.6 ml for a patient weighing more than 70 kg. Fraxiparine is prescribed once a day. The duration of the course is determined by the doctor individually.

In the treatment of non-Q wave myocardial infarction and unstable angina, the first dose is administered intravenously (IV) as a bolus, subsequent doses are administered subcutaneously at 12-hour intervals for 6 days. A combination of Fraxiparine with 325 mg of acetylsalicylic acid per day is indicated. A single dose for intravenous and subcutaneous administration is determined at the rate of 86 IU of anti-Xa per 1 kg of patient weight.

• less than 50 kg: 0.4 ml;
• 50–59 kg: 0.5 ml;
• 60–69 kg: 0.6 ml;
• 70–79 kg: 0.7 ml;
• 80–89 kg: 0.8 ml;
• 90–99 kg: 0.9 ml;
• 100 kg and above: 1 ml.

When treating thromboembolism, the recommended dosage is 86 IU anti-Xa per 1 kg of body weight 2 times a day. The duration of the course is 10 days. In the absence of contraindications, oral anticoagulants should be prescribed as early as possible. The use of Fraxiparine is continued until the target prothrombin time is achieved.

The dose of the drug in the treatment of thromboembolism should be in the following accordance with the patient’s body weight:

• less than 50 kg: 0.4 ml;
• 50–59 kg: 0.5 ml;
• 60–69 kg: 0.6 ml;
• 70–79 kg: 0.7 ml;
• 80–89 kg: 0.8 ml;
• 90 kg and above: 0.9 ml.

The dose of Fraxiparine for the purpose of preventing blood clotting during hemodialysis in the extracorporeal circulation system is set individually, taking into account the technical conditions of dialysis. The solution is injected into the arterial line of the dialysis loop at the beginning of the session once.

• less than 50 kg: 0.3 ml;
• 50–69 kg: 0.4 ml;
• 70 kg and above: 0.6 ml.

For patients with a high risk of bleeding, half the recommended dose should be used, but sufficient for a dialysis session.

If the duration of the session is more than 4 hours, an additional small dose of Fraxiparine may be administered. The procedure should be accompanied by careful monitoring of the patient's condition due to possible thrombus formation in the dialysis system or bleeding.

Taking into account the observed effects during the first dialysis session, the dose of the drug for subsequent procedures can be adjusted.

When using Fraxiparine to prevent thrombus formation in patients with renal failure, a dose reduction is not required when the CC is 30–60 ml/min; when the CC is less than 30 ml/min, the dose should be reduced by 25%.

For the treatment of thromboembolism, unstable angina and myocardial infarction without a Q wave in patients with creatinine clearance 30–60 ml/min, the dose is reduced by 25%; patients with creatinine clearance less than 30 ml/min should not be prescribed Fraxiparine.

Side effects

• from the blood coagulation system: very often - bleeding of various locations (more often in the presence of other risk factors);
• from the hematopoietic system: rarely – thrombocytopenia; very rarely – transient eosinophilia;
• from the outside immune system: very rarely - hypersensitivity reactions in the form of skin rashes, Quincke's edema;
• from the hepatobiliary system: often - increased activity of liver transaminases (usually transient);
• local reactions: very often - small hematomas at the injection site; very rarely - skin necrosis at the injection site; in some cases - the appearance of dense nodules (not encapsulating heparin), which disappear after a few days;
• others: very rarely - priapism, reversible hyperkalemia (more often in patients at risk).

Overdose

Symptoms: bleeding, abnormal platelet count and other parameters of the blood coagulation system.

Treatment: for minor bleeding, it is sufficient to reduce the next dose of Fraxiparine or delay its administration. Special therapy is required in severe cases. Protamine sulfate has a pronounced neutralizing effect on the anticoagulant effect of heparin. When calculating the dose of the antidote, it should be taken into account that to neutralize 950 IU of anti-Xa nadroparin, 0.6 ml of protamine sulfate is needed. It is possible to reduce the dose of the antidote if a long period has passed since the overdose.

special instructions

Do not administer the drug intramuscularly!

During treatment with Fraxiparin, its alternation with other drugs belonging to the class of low molecular weight heparin is unacceptable. This is due to the possible violation of the prescribed dosage regimen due to the use of dosage units different from the drug.

Graduated syringes allow you to accurately select an individual dose, taking into account the patient’s body weight.

Signs of the development of necrosis in the area of ​​injection of the solution are usually purpura, a painful erythematous or infiltrated spot (including general symptoms). If they appear, you should stop using Fraxiparine immediately.

Heparins increase the risk of thrombocytopenia, so treatment must be accompanied by careful monitoring of platelet counts. Particular caution should be exercised, and if the following conditions occur, immediately discontinue treatment: thrombocytopenia, a marked decrease (by 30–50% of the initial value) in the platelet count, negative dynamics of thrombosis for which therapy is being carried out, thrombosis that developed during the administration of the drug , disseminated intravascular coagulation syndrome.

If necessary, it is possible to prescribe Fraxiparine to patients with a history of heparin-induced thrombocytopenia that occurred during the use of unfractionated or low molecular weight heparins. In this case, a daily platelet count is indicated. If thrombocytopenia occurs, you should immediately stop using the drug and consider prescribing anticoagulants of other groups.

Fraxiparine should be prescribed only taking into account the results of an assessment of renal function.

During the use of heparin in patients with increased level potassium in the blood or the risk of increasing the concentration of potassium in the blood increases the likelihood of hyperkalemia. In this regard, during a long course of therapy or treatment of patients with chronic renal failure, diabetes mellitus, metabolic acidosis or those on concomitant therapy Angiotensin-converting enzyme (ACE) inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs) and other drugs that contribute to the development of hyperkalemia, it is necessary to carefully monitor the level of potassium in the blood.

The decision on the possibility of combining anticoagulants with neuraxial blockade is made individually based on an assessment of the benefit-risk ratio of this combination.

When performing spinal and epidural anesthesia or lumbar puncture, an interval is required between the administration of the drug and the insertion or removal of the spinal or epidural needle or catheter. When using Fraxiparine for the purpose of preventing thromboembolism, it is at least 12 hours, for the purpose of treatment - 24 hours. In case of renal failure, the interval may be increased.

Use during pregnancy and lactation

It is not recommended to prescribe Fraxiparine during pregnancy and lactation. The use of the drug during pregnancy is possible only in cases where the expected effect of therapy for the mother exceeds the potential threat to the fetus.

Use in childhood

Fraxiparine is contraindicated for the treatment of children under 18 years of age.

For impaired renal function

For the treatment of thromboembolism, unstable angina or myocardial infarction without a Q wave, the administration of nadroparin calcium solution is contraindicated in patients with severe renal failure (creatinine clearance less than 30 ml/min). With CC 30–60 ml/min, the dose is reduced by 25%.

When using Fraxiparine for the prevention of thrombus formation in patients with renal failure, a dose reduction is not required when the creatinine clearance is 30–60 ml/min; when the creatinine clearance is less than 30 ml/min, it should be reduced by 25%.

Use in old age

No special dose adjustment is required for elderly patients.

Drug interactions

With simultaneous use of Fraxiparine:

• unfractionated or low molecular weight heparins, potassium-sparing diuretics, potassium salts, angiotensin II receptor blockers, cyclosporine, tacrolimus, trimethoprim, ACE inhibitors, NSAIDs: increase the risk of hyperkalemia;
• drugs affecting hemostasis (indirect anticoagulants, dextran, fibrinolytics, acetylsalicylic acid, NSAIDs): cause mutual enhancement of action;
• acetylsalicylic acid (at a dose of 50–300 mg for cardiac or neurological indications), abciximab, clopidogrel, beraprost, iloprost, eptifibatide, tirofiban, ticlopidine: have an effect on increasing the risk of bleeding;
• indirect anticoagulants, dextrans, systemic glucocorticosteroids: should be used with caution. After prescribing indirect anticoagulants, the use of Fraxiparine should be continued until the required INR (international normalized ratio) is achieved.

Analogs

Analogues of Fraxiparin are: Fraxiparin Forte, Atenativ, Fragmin, Wessel Due F, Clexane, Heparin, Heparin-Darnitsa, Heparin-Biolek, Heparin-Indar, Heparin-Pharmex, Heparin-Novopharm, Novoparin, Tsibor, Enoxarin, Flenox.

Terms and conditions of storage

Keep away from children.

Store at temperatures up to 30 °C, do not allow freezing.

Shelf life – 3 years.

Instructions for medical use

medicine

Fraxiparine

Tradename

Fraxiparine

International nonproprietary name

Nadroparin calcium

Dosage form

Solution for injection, 3800 IU anti-Xa/0.4 ml No. 10

Compound

1 syringe contains

active substance- nadroparin calcium 3800 IU anti-Xa,

Excipients: calcium hydroxide solution or hydrochloric acid diluted to pH 5-7.5, water for injection up to 0.4 ml

Description

Transparent or slightly opalescent, colorless or light yellow solution

Pharmacotherapeutic group

Anticoagulants. Direct anticoagulants (heparin and its derivatives). Nadroparin.

ATX code B01AB06

Pharmacological properties

F armakokinetics

The pharmacokinetic properties of nadroparin are based on biological activity, that is, on changes in anti-Xa factor activity.

The maximum level of anti-Xa activity (Cmax) is achieved 3-4 hours after subcutaneous administration 2 times a day, when using Fraxiparine 1 time a day - after 4-6 hours. Bioavailability is almost complete (about 88%).

After intravenous administration, the maximum level of anti-Xa activity in plasma is achieved within 10 minutes, and the half-life is about 2 hours. Metabolism occurs mainly in the liver (desulfation, depolymerization). It is excreted primarily by the kidneys.

Anti-Xa activity persists for 18 hours after administration of the drug.

Special patient groups

Elderly

Due to a possible decrease in renal function, the elimination of nadroparin is slowed down in elderly patients. Before prescribing the drug, it is necessary to assess renal function and adjust the prescribed dose accordingly.

Patients with impaired renal function

In clinical studies of the pharmacokinetics of nadroparin in patients with varying degrees of renal failure, a correlation was found between the clearance of nadroparin and creatinine clearance. In patients with moderate renal failure (creatinine clearance 36-43 ml/min), AUC and T1/2 increased by 52 and 39%, respectively, with a decrease in plasma clearance of nadroparin by 63%. In patients with severe renal failure (creatinine clearance 10-20 ml/min), AUC and T1/2 increased by 95 and 112%, respectively, with a decrease in plasma clearance of nadroparin by 50%. In patients with a creatinine clearance of 3-6 ml/min or on hemodialysis, AUC and T1/2 increased by 62 and 65%, respectively, with a decrease in plasma clearance of nadroparin by 67%.

Pharmacodynamics

The active substance of the drug is nadroparin calcium - low molecular weight heparin, obtained by depolymerization of standard heparin under special conditions. It is a glycosaminoglycan with an average molecular weight of approximately 4300 daltons. Fraxiparine exhibits high similarity to plasma protein antithrombin. This leads to accelerated suppression of factor Xa, which stimulates the high antithrombic potential of Fraxiparine.

Other mechanisms for enhancing antithrombotic activity include stimulation of tissue factor inhibitor, activation of fibrinolysis by direct release of tissue plasmogenic activator from endothelial cells and modification of hemorheological parameters (decreasing blood viscosity and increasing platelet count, granulocyte membrane variability).

The drug is characterized by more pronounced anti-Xa factor activity compared to anti-IIa factor activity. The ratios between the two activities for Fraxiparine are in the range of 2.5-4. It has both immediate and prolonged antithrombic effects.

Compared with unfractionated heparins, Fraxiparine has less effect on platelet function and aggregation and a negligible effect on overall hemostasis.

Indications for use

prevention of thromboembolic complications (associated with general or orthopedic surgery, in non-surgical patients - with acute respiratory failure, respiratory infection and/or acute heart failure in an intensive care unit)

prevention of blood clotting during hemodialysis

treatment of thromboembolism

treatment of unstable angina and myocardial infarction without Q wave

Directions for use and doses

Instructions for administering the drug

For subcutaneous administration. Do not use intramuscularly.

1. Wash your hands with soap and dry them with a towel.

Sit or lie down in a comfortable position. Fraxiparine is injected subcutaneously into the abdominal area 1.5-2 cm below the navel. Select the left or right area as shown in the picture. Alternatively, the drug may be injected into the thigh.

2. Clean the intended injection site with an alcohol swab.

3.Remove the protective cap from the needle. If the amount of solution in the syringe exceeds the dose recommended by your doctor, remove the excess amount. Gently press the plunger of the syringe to bring the amount of solution to the level recommended by your doctor. Avoid contact of the needle with other surfaces until insertion. A small amount of bubbles in the solution is normal and there is no need to remove them.

4.Gently grab the skin in the fold between your thumb and forefinger.

5. The needle should be inserted perpendicularly, not at an angle, into the pinched fold of skin, which should be held between the thumb and forefinger during the entire insertion period.

6. Enter All the amount of solution that is in the syringe.

Remove the needle from the injection site. The injection site should not be rubbed.

7.For safety reasons, put the protective cap on the needle after the injection. Dispose of the used syringe as directed by your doctor.

Fraxiparine should not be used interchangeably with other low molecular weight heparins during the course of therapy.

Platelet counts should be monitored throughout treatment.

Prevention of thromboembolic disorders

general surgery

In general surgery, a dose of Fraxiparine 0.3 ml (2850 IU anti-Xa) is administered subcutaneously 2-4 hours before surgery, and then, in the following days, 1 time per day. The total duration of treatment is at least 7 days. It is recommended to carry out prevention during the entire period of risk.

Orthopedics

In orthopedic practice, the dose is selected depending on the patient’s body weight and administered subcutaneously in accordance with Table 1. The first dose is administered 12 hours before surgery, the second dose 12 hours after surgery. The drug is administered once a day, the minimum duration of treatment is 10 days.

Table 1

Body weight (kg)	12 hours before and 12 hours after surgery, then once a day for 3 days after surgery		Starting from the 4th day after surgery
	Injection volume (ml)	IU anti-Xa	Injection volume (ml)	IU anti-Xa
70 or more

For patients with a high thromboembolic risk in the intensive care unit (acute respiratory failure, respiratory infection, acute heart failure), treatment is continued throughout the entire period of risk of thromboembolism. The dose is selected depending on the patient’s body weight, according to Table 2.

table 2

Treatment of thromboembolic disorders

When treating thromboembolic complications, therapy with oral anticoagulants, in the absence of contraindications, should be started as soon as possible.

Fraxiparine is administered subcutaneously every 12 hours.

The dose is selected depending on the patient’s body weight, according to Table 3.

Table 3

Body weight (kg)	2 times a day for 10 days
	Injection volume (ml)	IU anti-Xa
90 or more kg

Prevention of blood clotting during hemodialysis Fraxiparine is usually administered as a single dose via intra-arterial infusion at the beginning of each procedure.

For patients without an increased risk of bleeding, initial doses are determined based on the patient's body weight, according to Table 4.

Table 4

Patients with an increased risk of bleeding should be given half the dose. An additional, smaller dose may be administered during dialysis lasting more than 4 hours. The dosage for sequential dialysis should be adjusted according to the observed effect. Patients should be closely monitored during each dialysis procedure for signs of bleeding or clotting.

Treatment of unstable angina and non-Q wave myocardial infarction

Fraxiparine is administered subcutaneously 2 times a day (every 12 hours) in combination with acetylsalicylic acid (up to 325 mg per day). The duration of treatment is 6 days. The initial dose is determined at 86 IU anti-Xa/kg and should be administered as an intravenous bolus. Then the same dose is administered subcutaneously. Doses are determined depending on body weight in accordance with Table 5.

Table 5

Body weight (kg)	Initial dose intravenously, bolus	Subcutaneous injection	IU anti-Xa
100 kg or more

In elderly patients, the dose is adjusted if necessary, except in cases of renal impairment.

Kidney failure

There is no need to adjust the dose if creatinine clearance is greater than or equal to 50 ml/min. In moderate to severe renal failure, increased exposure to nadroparin may occur, leading to an increased risk of thromboembolism and hemorrhage. In such patients (creatinine clearance less than 30 ml/min or 30 ml/min - 50 ml/min), the dose of Fraxiparine should be reduced by 25-33%.

Liver failure

No studies have been conducted.

Use in pediatrics

Side effects

Increased bleeding, mild thrombocytopenia (including heparin-induced thrombocytopenia), thrombocytosis, reversible eosinophilia

Allergic reactions, urticaria, rash, erythema, including angioedema, skin necrosis (at the injection site), anaphylactic reactions

Reversible hyperkalemia

Temporary increase in liver enzyme levels

Small hematomas, hard nodules or calcinosis at the injection site that disappear after a few days

Priapism

Hypersensitivity to the latex contained in the needle guard

Contraindications

Hypersensitivity to nadroparin or excipients

Severe thrombocytopenia associated with the use of heparin or nadroparin

Intraocular hemorrhage and other bleeding or increased risk of bleeding associated with impaired hemostasis, excluding disseminated intravascular coagulation (DIC) not caused by heparin

Organic diseases with the potential for bleeding (for example, gastric or duodenal ulcers, cerebral bleeding, cerebral aneurysm)

Hemorrhagic cerebrovascular injury

Acute infective endocarditis

Severe uncontrolled hypertension

Severe renal failure (creatinine clearance less than 30 ml/min) except time on hemodialysis

Injuries and surgeries to the central nervous system, eye or ear

Retinopathy, hemorrhage into the vitreous body of the eye

Threatened abortion

Children and teenagers up to 18 years of age

Drug interactions

The drug Fraxiparine is prescribed with caution when used simultaneously with oral anticoagulants, systemic glucocorticosteroids and dextrans. When prescribing oral anticoagulants to patients already receiving Fraxiparine, Fraxiparine is used until the INR normalizes.

With simultaneous use of Fraxiparine with potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II inhibitors, non-steroidal anti-inflammatory drugs, heparins, cyclosporine, the development of hyperkalemia is observed.

Fraxiparine can enhance the anticoagulant effect of the following drugs: non-steroidal anti-inflammatory drugs, acetylsalicylic acid and preparations containing it, platelet antiplatelet agents, glucocorticosteroids, and therefore their combined use with Fraxiparine is not recommended. In cases where the use of these combinations cannot be avoided, caution should be exercised in the ongoing assessment of the blood coagulation system and the general clinical condition.

special instructions

Heparin-induced thrombocytopenia

Due to the possibility of heparin-induced thrombocytopenia, The platelet count should be monitored throughout the course of treatment with Fraxiparine..

Rare cases of thrombocytopenia, some severe, that have been associated with arterial or venous thrombosis have been identified. The diagnosis of heparin-induced thrombocytopenia should be considered in the following conditions:

Thrombocytopenia

Any significant decrease in platelet count (30-50% from baseline)

Vascular thrombosis or worsening of existing thrombosis during ongoing therapy

DIC syndrome

If any of the above conditions develop, treatment with nadroparin should be discontinued.

These symptoms may be of an immuno-allergic nature and, during the first use of the drug, their occurrence is described between 5 and 21 days, but may appear earlier in the case of thrombocytopenia that occurs during the use of heparin.

If there are known cases of heparin-induced thrombocytopenia (when using standard or low molecular weight heparins), the use of nadroparin should be considered by the attending physician. If positive, the platelet count and assessment should be monitored daily throughout the course of treatment with nadroparin. If heparin-induced thrombocytopenia develops, treatment with nadroparin should be discontinued immediately and replaced with another class of antithrombotic drugs. If this is not possible, another low molecular weight heparin can be used, but platelet counts and assessments should be monitored at least daily and the drug should be discontinued as soon as possible, as thrombocytopenia has been reported with other classes of antithrombotic drugs.

In vitro Platelet aggregation tests are of limited value in the diagnosis of heparin-induced thrombocytopenia.

Nadroparin should be used with caution in the following situations, which may be associated with an increased risk of bleeding:

Liver failure

Severe arterial hypertension

History of peptic ulcer and other diseases with an increased risk of bleeding

Circulatory disorders in the choroid and retina of the eye

Postoperative period after surgical interventions on the brain, spinal cord, eyes

Hyperkalemia

Heparin may suppress adrenal secretion of aldosterone leading to hyperkalemia, especially in patients at risk of elevated plasma potassium levels, in patients with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, or when taking drugs that cause hyperkalemia (eg, ACE inhibitors, nonsteroidal anti-inflammatory drugs). facilities).

The risk of developing hyperkalemia increases with increasing duration of therapy, but is usually reversible.

In patients at risk of hyperkalemia, plasma potassium levels should be monitored.

Spinal and epidural anesthesia/lumbar puncture and combined use with other drugs

If spinal or epidural anesthesia is necessary while using the drug Fraxiparine, rare cases of intraspinal hematoma, even the development of long-term paralysis, have been observed. The risk of developing intraspinal hematoma increases with the use of an epidural catheter or with the concomitant use of other drugs that can cause hemostasis, such as nonsteroidal anti-inflammatory drugs, platelet inhibitors or other anticoagulants, as well as with traumatic, repeated epidural or spinal puncture.

Therefore, it is necessary to carefully evaluate the benefits and risks of combined use of nerve blockade and anticoagulants in the following cases:

In patients already on anticoagulant treatment, the benefits of nerve blockade should be assessed against the possible risks.

In patients planning surgery using nerve blockade, it is necessary to evaluate the benefits of anticoagulants in relation to the possible risks.

If it is necessary to combine such anesthesia and the prescription of nadroparin, it should be taken into account that in the case of spinal/epidural anesthesia or lumbar puncture, an interval of at least 12 hours must be maintained between the injection of Fraxiparin and the insertion/removal of a needle or catheter in the case of its prophylactic administration, or 24 hours in the case of its prescribed in therapeutic doses. For patients with renal impairment, lengthening the suggested interval should be considered.

Patients require careful neurological monitoring in case of signs and symptoms of neurological disorders and, if necessary, emergency treatment measures.

Salicylates, non-steroidal anti-inflammatory drugs and platelet inhibitors

For prophylactic or therapeutic purposes to eliminate thromboembolic disorders and prevent blood clotting during hemodialysis, the concomitant use of aspirin, NSAIDs or platelet inhibitors is not recommended, as this may increase the risk of bleeding. When this combination cannot be avoided, monitoring of the patient's clinical and biological parameters is necessary.

In clinical studies in the treatment of unstable angina and non-Q wave myocardial infarction, Fraxiparine was prescribed in combination with acetylsalicylic acid (up to 325 mg per day).

Kidney failure

Nadroparin is excreted primarily by the kidneys, therefore, if renal function is impaired, the exposure of nadroparin may increase, and therefore the risk of bleeding increases in such patients, and the drug should be used with caution.

With a creatinine clearance of 30-50 mg/ml, the attending physician should consider reducing the dose of Fraxiparine based on an assessment of the risk between possible bleeding and the development of thromboembolism.

Elderly

Before prescribing the drug, it is necessary to monitor renal function.

Skin necrosis

In very rare cases, cases of skin necrosis have been identified, the prerequisites of which were purpura, infiltration or painful erythematous plaques, with or without associated general symptoms. If these symptoms develop, treatment with Fraxiparine should be stopped immediately.

Latex

The needle sheath may contain latex, which can lead to the development of allergic reactions in patients with latex allergies.

Fertility

Clinical studies on the effect of nadroparin on fertility have not been conducted.

Pregnancy and lactation

Data on the use of nadroparin during pregnancy and lactation are limited.

The use of the drug during pregnancy is not recommended, unless the therapeutic benefit does not outweigh the possible risk.

There is no information on the penetration of nadroparin into breast milk; however, the use of Fraxiparine during feeding is not recommended.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

There is no data on the effect of Fraxiparine on the ability to drive vehicles and other mechanisms.

Overdose

Symptoms: bleeding. In such cases, platelet count and other coagulation parameters should be determined. Minor bleeding rarely requires special intervention.

Treatment: slow intravenous administration of protamine sulfate is indicated. 0.6 ml of protamine sulfate neutralizes about 1.0 ml of Fraxiparine. It should be taken into account that it is impossible to completely neutralize the anti-Xa factor activity of Fraxiparine. If necessary, it may be necessary to administer the calculated dose in several doses (2-4) during the day.

Release form and packaging

0.4 ml is placed in glass, graduated, siliconized syringes with a capacity of 1 ml, equipped with a stainless steel injection needle attached to the syringe barrel and protected by a rubber cap. 2 pre-filled syringes are placed in PVC blister packs, covered with transparent plastic film. 5 contour packages together with instructions for use in the state and Russian languages ​​are placed in a cardboard box.

Storage conditions

At a temperature not higher than +30 °C. Do not freeze.

Keep out of the reach of children!

Termstorage

Do not use after the expiration date.

Conditions for dispensing from pharmacies

On prescription

Manufacturer

Aspen Notre Dame de Bondeville

1 rue de l'Abbaye, 76960 Notre Dame de Bondeville, France

Registration Certificate Holder

Aspen Pharma Trading Limited

3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

LifeMed LLP

st. Popova, 9/57 -9, 050040, Almaty, Republic of Kazakhstan.

Phone/fax number: +7 727 328 41 01

Address Email: [email protected]

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