Гепарин-Ферейн®

General characteristics. Structure:

Active ingredient: 5000 PIECES of heparin.

Excipients: benzyl alcohol, sodium chloride, water for injections.

Pharmacological properties:

Pharmacodynamics. Blocks thrombin biosynthesis, reduces aggregation of thrombocytes. Activity of hyaluronidase oppresses, somewhat activates fibrinolitic properties of blood.

After intravenous administration of drug the maximum concentration in plasma is reached almost at once. After hypodermic introduction the maximum concentration in plasma is observed in 2-4 hours. Biotransformation generally occurs in a liver, mononuklearno-macrophagic and endothelial cells.

Plasma elimination half-life makes 30-60 minutes. A small part in not changed look is allocated with kidneys in the form of metabolites. Heparin does not get through a placenta and into breast milk.

Indications to use:

- Prevention and treatment of venous thromboses (including thrombosis of superficial and deep veins of the lower extremities; thrombosis of renal veins) and thromboembolisms of a pulmonary artery.

- Prevention and treatment of the tromboembolic episodes associated with fibrillation of auricles.

- Prevention and treatment of peripheral arterial embolisms (including associated with mitral heart diseases).

- Treatment of acute and chronic consumption coagulopathies (including the I stage of the IDCS).

- An acute coronary syndrome without permanent raising of a segment of ST on an ECG (unstable stenocardia, a myocardial infarction, without raising of a segment of ST on an ECG).

- A myocardial infarction, with raising of a segment of ST: at thrombolytic therapy, at primary transdermal coronary revascularization (balloon angioplasty with stenting or without it) and at high risk of arterial or venous thromboses and thromboembolisms.

- Prevention and treatment of a microthrombogenesis and disturbances of microcirculation, including at гемолитико - an uraemic syndrome; a glomerulonephritis (including lupoid nephrite) and at an artificial diuresis.

- Prevention of a blood coagulation at a hemotransfusion, in systems of extracorporal circulation (extracorporal blood circulation at heart operation, hemosorption, a cytapheresis) and at a hemodialysis.

- Processing of peripheral venous catheters.

Route of administration and doses:

Adults. Heparin in the medical purposes whenever possible should be entered in the form of drop infusion in a dose of 15 ME/kg of body weight in an hour. Before infusion 1 ml (5 000 ME) for bystry ensuring required anticoagulating action is intravenously struyno entered. The anticoagulating effect of heparin is considered optimum if the blood clotting time is extended by 2-3 times in comparison with a normal indicator, the activated partial tromboplastinovy time (APTT) increases by 1,5-2 times (at a possibility of continuous control of AChTV).

In order to avoid overdose it is necessary to watch the clinical symptoms indicating possible bleeding (bleeding of mucous membranes, a hamaturia, etc.) constantly. At impossibility of infusional introduction it is possible to administer the drug subcutaneously fractionally 4 times a day (the adult on 2 ml = 10 000 ME). The blood clotting time needs to be controlled in 30-60 minutes prior to the following introduction for the purpose of correction of the subsequent dose. The daily dose of heparin should not exceed 60 000 - 80 000 ME and more than 10 days can be only in exceptional cases applied.

Heparin sodium can be appointed with the preventive purpose. For the prevention of thrombosis heparin is entered subcutaneously in a stomach on 1 ml (5 000 ME) 2 times a day. At a cardiomyopathy, heart failure and a myocardial infarction heparin is entered on 2 ml (10 000 ME) 2 times a day.

Children. The initial dose makes 50 ME/kg of body weight a day for intravenous administration with the subsequent maintenance dose of 20 000 ME/sq.m of a body surface in days or is fractional at the rate of 100 ME/kg of body weight intravenously each 4 hours.

Features of use:

Preventions: carrying out the corresponding control laboratory researches (a blood clotting time and the activated partial tromboplastinovy time) is necessary. Therefore treatment by high doses is recommended to be carried out in the conditions of a hospital. In the preventive purposes heparin can is entered and is out-patient.

At appointment pregnant women and patients in a serious condition need extra care. The heparin molecule because of a negative charge creates in vitro complexes with many medicines therefore heparin cannot be mixed with other medicines.

Side effects:

Allergic reactions: urticaria, rhinitis, dacryagogue, fever, bronchospasm, pain.

From the hemopoietic system: a hemorrhagic syndrome, development of thrombocytopenia, eosinophilia is possible.

Local reactions: an erythema, a hematoma, a necrosis in the place of an injection.

Interaction with other medicines:

Efficiency amplifies at simultaneous use with anticoagulants of indirect action, antiagregant (acetylsalicylic acid, non-steroidal anti-inflammatory drugs).

Upon transition to peroral anticoagulants it is necessary to reduce a dose of heparin and at careful laboratory control it is possible to combine with atsenokumaroly. Efficiency decreases cardiac glycosides, tetracyclines, nicotine, antihistaminic drugs.

Contraindications:

Hypersensitivity to drug; cankers, tumors and polyps of a GIT; subacute bacterial endocarditis; the expressed abnormal liver functions and kidneys, brain and backbone operation, operation in the eyes; the diseases which are followed by decrease in a blood clotting time; the menacing abortion; in the absence of a possibility of laboratory control; thrombocytopenia; hyperpermeability of vessels.

Overdose:

Symptoms - bleeding of various localization and severity. An antidote - protamin sulfate.

Treatment: At not heavy bleeding it is enough to reduce a dose of heparin or to temporarily stop a geparinization. At heavier hemorrhagic syndrome introduction of an antidote is required. One ml of protamin of sulfate neutralizes 1 000 ME heparins. If it is unknown how many heparin is in a circulatory bed, the single dose of protamin of sulfate should not exceed 1 ml intravenously (to enter slowly). This dose as necessary can be applied repeatedly before normalization of time of coagulation - blood (even more reasonablly - thrombin time).

Repeated definition of a blood clotting time (thrombin time) in 1-2 hours as partially from the place of hypodermic introduction heparin can come further to a blood stream is recommended, it can chastino be exempted from communication with an antidote (so-called "heparin rebound"). In such cases repeated introduction of 1 ml protamin is necessary; sulfate.

Storage conditions:

In the dry, protected from light place, at a temperature from 0 to 25 °C. A drug period of storage after opening of a bottle of 14 days. To store in the place, unavailable to children. A period of validity - 4 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Solution for injections of 5000 PIECES in 1 ml in bottles on 5 ml and ampoules on 1 ml or 5 ml. Packaging. On 5 ml in bottles from neutral glass or on 1 ml, 5 ml in ampoules from neutral glass. 1 bottle with the application instruction is placed in a pack from a cardboard. 5 bottles or 5 ampoules place in a blister strip packaging from a film polyvinyl chloride or in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1 blister strip packaging with bottles together with the application instruction place in a pack from a cardboard. On 1 blister strip packaging with ampoules together with the application instruction place in a pack from a cardboard.

Packaging for hospitals. On 10 blister strip packagings with bottles together with the equal number of application instructions place in a box from a cardboard.