NADROPARINUM calcium | Fraksiparin solution d / subcutaneous injection. 9,500 anti-XA ME / ml / 7600 IU anti-Xa / 0.8 ml 0.8 ml syringes 10 pcs.

Release form

Solution for sc administration.

Packaging

In a single-dose syringe, 0.8 ml of solution. There are 10 syringes in the package.

Pharmacological action of

Fraxiparin, a low molecular weight heparin (NMH) obtained by depolymerization from standard heparin, is a glycosaminoglycan with an average molecular weight of 4300 daltons. It exhibits high ability to bind to a plasma protein with antithrombin III (AT III). This binding leads to accelerated inhibition of factor Xa, which is due to the high antithrombotic potential of nadroparin. Other mechanisms that provide the antithrombotic effect of nadroparin include activation of a tissue factor conversion inhibitor (TFPI), activation of fibrinolysis by direct release of a tissue plasminogen activator from endothelial cells, and modification of blood rheological properties (lowering blood viscosity and increasing permeability of platelet and granulocyte membranes).

Nadroparin calcium has a higher anti-Xa factor activity than anti-IIa factor or antithrombotic activity and has both immediate and prolonged antithrombotic activity. Compared to unfractionated heparin, nadroparin has a lesser effect on platelet function and aggregation, and a less pronounced effect on primary hemostasis. In prophylactic doses, nadroparin does not cause a pronounced decrease in APTT. With the course of treatment during the period of maximum activity, an increase in APTT to a value 1.4 times higher than the standard is possible. Such prolongation reflects the residual antithrombotic effect of calcium nadroparin.

Indications

- Prevention of thromboembolic complications in surgical and orthopedic interventions in patients with a high risk of thrombosis (in acute respiratory and / or heart failure in conditions of ICU, unstable angina pectoris, myocardial infarction without pathological Q wave on ECG).

- Treatment of thromboembolism.

- Prevention of blood coagulation during hemodialysis.

Contraindications

- Thrombocytopenia with a history of nadroparin.

- Signs of bleeding or an increased risk of bleeding associated with impaired hemostasis (with the exception of DIC, not caused by heparin).

- Organic bleeding disorder (e.g., acute gastric or duodenal ulcer).

- Injuries or surgical interventions on the brain, spinal cord, or eyes.

- Intracranial hemorrhage.

- Acute septic endocarditis.

- Severe renal failure (CC less than 30 ml / min) in patients receiving Fraxiparin for the treatment of thromboembolism, unstable angina and myocardial infarction without Q wave.

- Children and adolescents (under 18 years).

- Hypersensitivity to nadroparin or any other components of the drug.

With caution, Fraxiparin should be prescribed in situations associated with an increased risk of bleeding: with liver failure, with kidney failure, with severe arterial hypertension, with a history of peptic ulcers or other diseases with an increased risk of bleeding, in case of circulatory disturbance in the choroid and retina, in the postoperative period after operations on the brain and spinal cord or in the eyes, in patients weighing less than 40 kg, with a duration of therapy exceeding the recommended (10 days), in case of non-compliance with the recommended treatment conditions (especially increasing the duration and dose for course use), when combined with drugs that increase the risk of bleeding.

Use during pregnancy and lactation

Currently, there is only limited data on the penetration of nadroparin through the placental barrier in humans. Therefore, the use of Fraxiparin during pregnancy is not recommended, unless the potential benefit to the mother outweighs the risk to the fetus. Currently, there is only limited data on the allocation of nadroparin with breast milk. In this regard, the use of nadroparin during lactation (breastfeeding) is not recommended. In experimental animal studies, no teratogenic effect of calcium nadroparin was found.

Composition

1 dose of solution for sc administration contains: nadroparin calcium 7600 IU anti-Xa in 1 syringe.

Excipients: calcium hydroxide solution or dilute hydrochloric acid to pH 5.0-7.5, d / i water - up to 0.8 ml.

Dosage and administration of

In case of SC administration, it is preferable to administer the drug in the patient lying position, SC tissue of the anterolateral or posterolateral surface of the abdomen, alternately on the right and left sides. Allowed to enter the thigh. In order to avoid drug loss 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 formed between the thumb and forefinger. The fold should be maintained during the entire period of administration of the drug. Do not rub the injection site after injection.

For the prevention of thromboembolism in general surgical practice, the recommended dose of Fraxiparin is 0.3 ml (2850 anti-Xa ME) s / c. The drug is administered 2-4 hours before surgery, then - 1 time / day. Treatment is continued for at least 7 days or during the entire period of increased risk of thrombosis, until the patient is transferred to an outpatient setting.

For the prevention of thromboembolism during orthopedic operations, Fraxiparin is administered subcutaneously in a dose set 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 the operation, the 2nd dose - 12 hours after the end of the operation. Further, Fraxiparin continues to be used 1 time / day for the entire period of increased risk of thrombus formation until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.

Patients with a high risk of thrombosis (with unstable angina, myocardial infarction without Q wave) Fraxiparin is prescribed sc 2 times / day (every 12 hours). The duration of treatment is usually 6 days. In clinical studies, patients with unstable angina pectoris / myocardial infarction without Q wave Fraxiparin was prescribed in combination with acetylsalicylic acid at a dose of 325 mg / day. The initial dose is administered as a single intravenous bolus injection, the subsequent doses are administered sc. The dose is set depending on body weight at the rate of 86 anti-XA IU / kg.

In the treatment of thromboembolism, oral anticoagulants (in the absence of contraindications) should be prescribed as soon as possible. Therapy with Fraxiparin is not stopped until the target values ​​of the prothrombin time indicator are reached. The drug is prescribed s / c 2 times / day (every 12 hours), the usual duration of the course is 10 days. The dose depends on the patient's body weight at the rate of 86 anti-XA ME / kg body weight.

Prevention of blood coagulation in the extracorporeal circulation system during hemodialysis: the dose of Fraxiparin should be set individually for each patient, taking into account the technical conditions of dialysis. Fraxiparin is injected once into the arterial line of the dialysis loop at the beginning of each session. For patients without an increased risk of bleeding, the recommended initial doses are set depending on body weight, but sufficient for a 4-hour dialysis session.

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 doses of Fraxiparin may be administered. In subsequent dialysis sessions, the dose should be selected depending on the observed effects. The patient should be monitored during the dialysis procedure due to the possible occurrence of bleeding or signs of thrombosis in the dialysis system.

In elderly patients, dose adjustment is not required (except in patients with impaired renal function). Before starting treatment with Fraxiparin, it is recommended to monitor renal function indicators.

In patients with mild to moderate renal failure (creatinine clearance? 30 ml / min and less than 60 ml / min): for the prevention of thrombosis, a dose reduction is not required, in patients with severe renal failure (creatinine clearance less than 30 ml / min), the dose should be reduced by 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 thrombosis (with unstable angina and myocardial infarction without Q wave), the dose should be reduced by 25%, in patients with severe renal failure, the drug is contraindicated.

Side effects

The most common side effect is the formation of a subcutaneous hematoma at the injection site. In some cases, there is the appearance of dense nodules that do not mean heparin encapsulation, which disappear after a few days.

Large doses of Fraxiparin can cause bleeding in various locations and mild thrombocytopenia (type I), which usually disappears during further therapy. Perhaps a temporary moderate increase in the level of liver enzymes (ALT, AST).

Skin necrosis and allergic reactions are rare. Several cases of anaphylactic reactions and immune thrombocytopenia (type II), combined with arterial and / or venous thrombosis or thromboembolism, have been reported.

Drug Interaction

Increases the effectiveness of other types of drug therapy: the use of immunophane helps overcome glucocorticosteroid resistance.

The drug can be given in combination with anti-inflammatory steroid and non-steroidal anti-inflammatory drugs. ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine and tacrolimus, trimethoprim.

Potentiation of action when using fraksiparin: Fraksiparin may potentiate the effects of drugs affecting hemostasis, such as acetylsalicylic acid and other NSAIDs, vitamin K antagonists, fibrinolytics and dextran, inhibitors of platelet aggregation ie at a dose of more than 500 mg NSAIDs): abciximab, acetylsalicylic acid as an antiaggregant (ie at a dose of 50-300 mg) in cardiac and neurological indications, simple, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban increase the risk of bleeding.

Overdose

Symptoms: The main sign of an overdose is bleeding, you need to monitor your platelet count and other parameters of the blood coagulation system.

Treatment: Minor bleeding does not require special therapy (it is usually sufficient to reduce the dose or delay the subsequent administration). Protamine sulfate has a pronounced neutralizing effect against the anticoagulant effects of heparin, however, in some cases, anti-Xa activity may partially recover. The use of protamine sulfate is only necessary in severe cases. It should be noted that 0.6 ml of protamine sulfate neutralizes about 950 anti-HA ME nadroparin. The dose of protamine sulfate is calculated taking into account the time elapsed after heparin administration, with a possible reduction in the dose of the antidote.

Storage conditions

The drug should be stored out of the reach of children, away from heaters at a temperature not exceeding 30 РC and do not freeze.

Expiration

3 years.

Deystvuyuschee substances

NADROPARINUM calcium

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Aspen Pharma Trading Limited, Ireland