Frauxiparin 9,500 anti-Xa IU/ml /5700 IU anti-Xa /0.6 ml 0.6 ml syringes, 10 pcs.

Fraxiparin is a low molecular weight heparin (LMWH) obtained by depolymerization from standard heparin and is a glycosoaminoglycan with an average molecular weight of 4300 daltons.

It exhibits a high ability to bind to the plasma protein antithrombin III (AT III). This binding leads to accelerated inhibition of factor Xa, which explains the high antithrombotic potential of nadroparin. Other mechanisms providing antithrombotic effect of nadroparin include activation of tissue factor conversion inhibitor (TFPI), activation of fibrinolysis by direct release of tissue plasminogen activator from endothelial cells and modification of blood rheological properties (decrease of blood viscosity and increase of membrane permeability of platelets and granulocytes).

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. Compared with unfractionated heparin, nadroparin has less effect on platelet function and aggregation and little effect on primary hemostasis. In prophylactic doses, nadroparin does not cause a pronounced decrease in the BHRT.

In case of course treatment during the period of maximum activity it is possible to increase Frequency Deviation Time Values up to 1.4 times the standard value. This prolongation reflects the residual antithrombotic effect of calcium nadroparin.

Indications

– Prevention of thromboembolic complications during surgical and orthopedic interventions in patients with high risk of thrombosis (in acute respiratory and/or cardiac failure in the ICU, unstable angina, myocardial infarction without pathological Q tooth on the ECG).
– Treatment of thromboemboli.
– Prevention of blood clotting during hemodialysis.

Active ingredient

Composition

1 syringe contains 5,700 IU of anti-Xa calcium nadroparin.

How to take, the dosage

If injected by injection, the drug is preferably administered in the supine position, into the pelvic or posterolateral surface of the abdominal region, alternately on the right and left side. It is allowed to be injected into the thigh. To avoid loss of drug when using syringes, air bubbles should not be removed before injection.

The needle should be inserted perpendicularly, not at an angle, into the pinched skin fold formed between the thumb and forefinger. The fold should be maintained throughout the insertion period. The injection site should not be rubbed after injection.

For the prevention of thromboembolism in general surgical practice the recommended dose of Fraxiparin is 0.3 ml (2850 anti-Ha ME) by injection. The drug is administered 2-4 hours before surgery, then once a day. Treatment is continued for at least 7 days or throughout the period of increased risk of thrombosis, before the patient is transferred to an outpatient regimen.

For prevention of thromboembolism in orthopedic surgeries Fraxiparin is administered p/k in a dose set according to the body weight of the patient at the rate of 38 anti-Ha IU/kg, which may be increased up to 50% on the 4th postoperative day. The initial dose is administered 12 hours before surgery, the 2nd dose 12 hours after the end of surgery. Then, Fraxiparin is continued once daily during the whole period of increased 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 (with unstable angina, myocardial infarction without Q-wave) Fraxiparin is administered p/q 2 times/day (every 12 hours). The duration of treatment is usually 6 days. In clinical trials, patients with unstable angina/ 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 v/v bolus injection, subsequent doses are administered by p/v. The dose is set depending on body weight at a rate of 86 anti-Xa IU/kg.

In the treatment of thromboembolism, oral anticoagulants (if there are no contraindications) should be administered as early as possible. Therapy with Fraxiparin is not stopped until the target values of prothrombin time are achieved. The drug is administered by p/c 2 times / day (every 12 hours), the normal course length is 10 days. The dose depends on the patient’s body weight at the rate of 86 anti-Xa IU/kg of body weight.

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

In patients at increased risk of bleeding, half the recommended dose of the drug may be used. If the dialysis session lasts longer than 4 hours, additional small doses of Fraxiparin may be administered. For subsequent dialysis sessions the dose should be adjusted according to the observed effects. The patient should be monitored during the dialysis procedure for possible bleeding or signs of thrombosis in the dialysis system.

In elderly patients dosage adjustment is not required (except in patients with impaired renal function). Prior to treatment with Fracyparin it is recommended to monitor renal function parameters.

In patients with mild to moderate renal insufficiency (creatinine clearance ≥ 30 ml/min and less than 60 ml/min): no dose reduction is required for thrombosis prevention, in patients with severe renal insufficiency (creatinine clearance less than 30 ml/min) the dose should be reduced by 25%.

In patients with mild to moderate renal insufficiency: For treatment of thromboembolism or for prevention of thromboembolism in patients at high risk of thrombosis (in unstable angina and myocardial infarction without Q-wave), the dose should be reduced by 25%; in patients with severe renal impairment the drug is contraindicated.

Interaction

Risk of hyperkalemia with concomitant use of Fraxiparin:The risk of hyperkalemia is increased with Fraxiparin in patients receiving potassium salts, potassium-saving diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine and tacrolimus, trimethoprim.

Potentiation of action when using Fraxiparin: Fraxiparin may potentiate the effects of drugs that affect hemostasis, such as acetylsalicylic acid and other NSAIDs, vitamin K antagonists, fibrinolytics and dextran, platelet aggregation inhibitors (except acetylsalicylic acid as an analgesic and antipyretic medication, ie.i.e., in doses over 500 mg; NSAIDs): abciximab, acetylsalicylic acid as an antiaggregant (i.e., in doses of 50-300 mg) in cardiac and neurological indications, beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban increase the risk of bleeding.

Contraindications

– Thrombocytopenia with a history of nadroparin use.
– Signs of bleeding or increased risk of bleeding associated with impaired hemostasis (except for DIC syndrome not caused by heparin).
– Organic diseases with a tendency to bleeding (e.g., acute gastric or duodenal ulcer).
– Trauma or surgical interventions on the brain, spinal cord or eyes.
– Intracranial hemorrhage.
– Acute septic endocarditis.
– Severe renal failure (CKR less than 30 ml/min) in patients receiving Fraxiparin for treatment of thromboembolism, unstable angina and myocardial infarction without Q-wave.
– Child and adolescent age (under 18 years).
– Hypersensitivity to nadroparin or any other components of the drug.

Fraxiparin should be administered with caution in situations associated with an increased risk of bleeding: in hepatic failure, renal failure, severe arterial hypertension, a history of peptic ulcers or other conditions with increased risk of bleeding, circulatory disorders in the vasculature and retina, in the postoperative period after operations on the brain and spinal cord or eyes, in patients with a body weight less than 40 kg, the duration of therapy exceeding the recommended (10 days), if the recommended treatment conditions are not followed (especially increasing the duration and to

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, which do not indicate heparin encapsulation, which disappear after a few days.

High doses of Fraxiparin may provoke bleeding of various localizations and mild thrombocytopenia (type I), which usually disappears during further therapy. Temporary moderate increase of liver enzymes (ALT, AST) is possible.

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.

Overdose

Symptoms:The main sign of overdose is bleeding; the platelet count and other parameters of the clotting system should be monitored.

Treatment:Significant bleeding does not require special therapy (usually it is sufficient to reduce the dose or delay the subsequent administration). Protamine sulfate has a pronounced neutralizing effect with respect to the anticoagulant effects of heparin, but in some cases anti-Xa activity may be partially restored.

The use of protamine sulfate is necessary only in severe cases. Note that 0.6 ml of protamine sulfate neutralizes about 950 anti-Xa ME of 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.

Pregnancy use

There are currently only limited data on penetration of nadroparin through the placental barrier in humans.

Therefore, the use of Fracyparin in pregnancy is not recommended unless the potential benefit to the mother outweighs the risk to the fetus.

There are currently only limited data on the excretion of nadroparin with breast milk.

In this regard, the use of nadroparin during lactation (breastfeeding) is not recommended.

The teratogenic effect of calcium nadroparin has not been found in experimental studies on animals.