Instruction for use: Troparin

Dosage form: solution for injections

Active substance: Certoparinum natrium

ATX

B01AB01 Heparin

Pharmacological group

Anticoagulants

Nosological classification (ICD-10)

I74 Embolism and arterial thrombosis: Thrombosis of effort (stress); Arterial thrombosis; Arteriothrombosis; Subacute and chronic arterial thrombosis; Subacute thrombosis of peripheral arteries; Postoperative thrombosis; Vascular thrombosis; Vascular embolism; Thrombosis of aortocoronary shunt; Arterial thrombosis; Thrombosis of arteries; Coronary artery thrombosis; Coronary thrombosis; Thrombosis of blood vessels; Thrombosis with ischemic stroke; Thrombosis with general surgical operations; Thrombosis in Oncology Operations; Vascular thrombosis; Thrombus formation in the postoperative period; Thrombotic complications; Thromboembolic diseases; Thromboembolic syndrome; Thromboembolic complication in the postoperative period; Thromboembolism of arteries; Partial vascular thrombosis; Embolism; Embolism of arteries

I82 Embolism and thrombosis of other veins: Recurrent venous thrombosis; Postoperative thrombosis; Venous thrombosis; Acute venous thromboembolism; Recurrent vein thrombosis; Venous thrombosis; Thrombosis of veins of internal organs; Venous thrombosis; Deep vein thrombosis; Thrombosis of blood vessels; Vascular thrombosis; Thrombosis of veins; Deep vein thrombosis; Thromboembolic diseases; Thromboembolism of veins; Severe venous thrombosis; Embolism; Embolism of veins; Thromboembolic complications

Composition and release form

1 ampoule with 0.5 ml or 1 syringe-ampoule with 0.3 ml of solution for injection contains sodium certoparin (low molecular weight heparin of sodium) 3000 I antifactor Ha (approximately 1500 IU APTT) from pig intestinal mucosa with an average molecular weight of 4000-6000 , Sodium chloride 1.69 mg (in amp.), Water for injection to 0.5 or 0.3 ml, respectively; In cartons 20 ampoules or 5 syringes-ampoules.

Pharmachologic effect

Mode of action - Anticoagulant.

Pharmacokinetics

Quickly and almost completely absorbed after SC administration, Cmax (inhibition of factor Xa) is achieved after 2-4 hours at a dose of 1000 IU APTTV. T1 / 2 - 4 h.

Clinical Pharmacology

Preventive action of Troparin in a dose of 1500 IU APTTV with a single administration corresponds to 5000 IU of conventional heparin 3 times a day. Unlike non-unfractionated standard heparin (characterized by the ratio of antifactor Xa / APTTV 1: 1), the inhibitory effect of Troparin on factor Xa is more pronounced than the effect on APTT, which improves the efficiency / tolerance ratio, i.e. Antithrombotic activity / risk of bleeding.

Indications of Troparin

Thromboembolic diseases (prophylaxis).

Contraindications

Hypersensitivity, allergic reaction to heparin, thrombocytopenia of immune genesis, caused by heparin (including in the anamnesis), hemophilia, thrombocytopenic purpura, increased permeability of capillaries, stroke, acute intracranial bleeding, surgical interventions on the brain and spinal cord, including . Ophthalmic, proliferative diabetic retinopathy, peptic ulcer and duodenal ulcer, gastrointestinal bleeding, abdominal cavity cancer, pulmonary hemorrhage, active pulmonary tuberculosis, liver and pancreas diseases, kidney, renal bleeding, severe arterial hypertension, bacterial endocarditis, threatening abortion .

Pregnancy and breast-feeding

With caution (you cannot rule out the risk of termination of pregnancy).

Side effects

From the cardiovascular system and blood (hematopoiesis, hemostasis): bleeding, hemorrhages in the skin and mucous membranes, hematomas at the site of injection, increased blood pressure, eosinophilia, thrombocytopenia, severe arterial thrombosis, venous thromboembolism, lowering of fibrinogen level.

Allergic reactions: erythema, urticaria, rhinitis, lacrimation, bronchospasm, anaphylactic shock, collapse.

Other: headache, nausea, vomiting, arthralgia, fever, osteoporosis, alopecia.

Interaction

The effect is reduced ascorbic acid, antihistamines, cardiac glycosides, nicotinic acid and tetracycline antibiotics, intensify - dextran, phenylbutazone, indomethacin, sulfinpyrazone, probenecid, ethacrynic acid (iv), penicillin, cytostatics. It displaces from the connection with plasma proteins phenytoin, quinidine, propranolol and bilirubin. Incompatible with solutions containing dihydroergotamine (possible precipitation of the active substance).

Dosing and Administration

Subcutaneously, in the fold of the abdominal skin (in some cases - in the upper region of the shoulder or thigh), 0.5 ml (the contents of 1 ampoule) or 0.3 ml (contents of a disposable syringe) with an interval of 24 hours. For postoperative thromboembolism prevention, the first The injection should be performed 1-2 hours before the operation; In the postoperative period - to enter within 7-10 days, if necessary - for a longer time.

Overdose

Symptoms: bleeding of varying severity.

Treatment: administration of protamine sulfate (IV dose 1,500 IU per dose) under the control of the blood coagulation system.

Precautionary measures

Before the onset of the first day and during treatment, control of the blood coagulation system, the number of platelets (especially between 6 and 14 in the afternoon), monitoring of blood pressure is necessary. With a marked decrease in the number of platelets, therapy is canceled. If you suspect a possible development of hypersensitivity reactions, it is recommended to inject a test dose (500 IU) slowly in / in, and after a few minutes - the rest. Caution should be given in cases of puncture or surgery, spinal anesthesia, cerebral thrombosis, diabetes mellitus, concomitant oral anticoagulant intake, during the first 36 hours after birth, for women over 60 years of age.

Special instructions

It is only intended for SC administration.

Storage conditions of the drug Troparin

In a cool, dark place.

Keep out of the reach of children.

The shelf life of the drug Troparin

Injection for 3000 IU aXa - 2 years.

Do not use beyond the expiration date printed on the package.