Heparin-Ferein - instructions for use, dose, side effects, contraindications

Pharmacodynamics:It blocks the biosynthesis of thrombin, reduces the aggregation of platelets. Inhibits the activity of hyaluronidase, to some extent activates the fibrinolytic properties of the blood. After intravenous administration of the drug, the maximum concentration in the plasma is achieved almost immediately. After subcutaneous administration, the maximum plasma concentration is observed after 2-4 hours. Biotransformation mainly occurs in the liver, mononuclear-macrophage and endothelial cells.The half-life of the plasma is 30-60 minutes. It is allocated by the kidneys in the form of metabolites, a small part in unchanged form. Heparin does not penetrate the placenta and into breast milk.

Indications:

- Prevention and treatment of venous thrombosis (including thrombosis of superficial and deep veins of the lower extremities, thrombosis of the renal veins) and pulmonary embolism.

- Prevention and treatment of thromboembolic complications associated with atrial fibrillation.

- Prevention and treatment of peripheral arterial embolism (including associated with mitral heart defects).

- Treatment of acute and chronic coagulopathy of consumption (including the first stage of DIC syndrome).

- Acute coronary syndrome without stable rise of the ST segment on the ECG (unstable angina, myocardial infarction, without ST segment elevation on the ECG).

- Myocardial infarction, with ST segment elevation: with thrombolytic therapy, with primary percutaneous coronary revascularization (balloon angioplasty with or without stenting) and with a high risk of arterial or venous thrombosis and thromboembolism.

- Prevention and treatment of microthrombogenesis and microcirculatory disorders, incl.with hemolytic - uremic syndrome; glomerulonephritis (including lupus nephritis) and with forced diuresis.

- Prevention of blood coagulation during blood transfusion, extracorporeal circulation systems (extracorporeal circulation in heart surgery, hemosorption, cytarapheresis) and hemodialysis.

- Treatment of peripheral venous catheters.

Contraindications:Hypersensitivity to the drug; ulcerative lesions, tumors and polyps of the gastrointestinal tract; subacute bacterial endocarditis; expressed violations of the liver and kidneys, operations on the brain and spine, eye surgery; diseases accompanied by a decrease in clotting time; threatening abortion; in the absence of the possibility of laboratory monitoring; thrombocytopenia; increased vascular permeability.

Dosing and Administration:

Adults

Heparin for therapeutic purposes should, if possible, be administered as a drip infusion at a dose of 15 IU / kg body weight per hour. Before intravenous injection, 1 ml (5 000 IU) is injected rapidly to provide the required anticoagulant action. Anticoagulant effect of heparin is considered optimal,if clotting time is 2-3 times longer than normal, activated partial thromboplastin time (APTT) is increased by 1.5-2 times (with the possibility of continuous monitoring of APTT). To avoid overdose, it is necessary to constantly monitor clinical symptoms indicating possible bleeding (bleeding of the mucous membranes, hematuria, etc.). If infusion is not possible, the drug can be administered subcutaneously fractional 4 times a day (adults 2 ml = 10 000 ME). Clotting time should be monitored 30-60 minutes before the next administration in order to correct the subsequent dose. The daily dose of heparin should not exceed 60 000 - 80 000 ME and only in exceptional cases can be applied more than 10 days.

Sodium Heparin can be prescribed with a preventive purpose. To prevent thrombosis, heparin is injected subcutaneously in the abdomen 1 ml (5 000 ME) 2 times a day. With cardiomyopathy, heart failure and myocardial infarction, heparin is administered 2 ml (10 000 IU) 2 times a day.

Children

The initial dose is 50 IU / kg body weight per day for intravenous administration followed by a maintenance dose of 20,000 IU / m²body surface per day or fractional at a rate of 100 IU / kg body weight intravenously every 4 hours.

Side effects:

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

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

Local reactions: erythema, hematoma, necrosis at the injection site.

Overdose:

Symptoms - bleeding of different localization and severity.

Antidote - Protamine sulfate.

Treatment: With mild bleeding it is enough to reduce the dose of heparin or temporarily stop heparinization. With a more severe hemorrhagic syndrome, an antidote is required. One ml of protamine sulfate neutralizes 1,000 IU of heparin. If it is not known how much heparin is in the bloodstream, a single dose of protamine sulfate should not exceed 1 ml intravenously (inject slowly). This dose, if necessary, can be applied repeatedly until the clotting time of blood is normalized (even more advantageously, thrombin time). It is recommended to re-determine the blood clotting time (thrombin time) in 1-2 hours, since partially from the place of subcutaneous injection, heparin can enter further into the bloodstream,partially can be released from the connection with the antidote (the so-called "heparin rebound"). In such cases, repeated administration of 1 ml of protamine is necessary; sulfate.

Interaction:Efficacy is enhanced by simultaneous use with indirect anticoagulants, antiplatelet agents (acetylsalicylic acid, non-steroidal anti-inflammatory drugs). When switching to oral anticoagulants, it is necessary to reduce the dose of heparin and, with careful laboratory monitoring, can be combined with acenocoumarol. Efficacy is reduced by cardiac glycosides, tetracyclines, nicotine, antihistamines.

Special instructions:

Warnings:

It is necessary to conduct appropriate control laboratory tests (clotting time and activated partial thromboplastin time). Therefore, treatment with large doses is recommended in a hospital. For preventive purposes, heparin can be administered and outpatient.

When appointing pregnant women and patients in serious condition requires special care. The heparin molecule, because of the negative charge, creates in vitro complexes with many drugs,so heparin should not be mixed with other drugs.

Form release / dosage:Solution for injection 5000 units in 1 ml.

Packaging:

In vials of 5 ml and ampoules of 1 ml or 5 ml.

To 5 ml in bottles of neutral glass or 1 ml, 5 ml in ampoules of neutral glass.

1 bottle with instruction for use is placed in a pack of cardboard.

5 vials or 5 ampoules are placed in a contoured cell pack of a polyvinyl chloride film or in a contoured cell pack of a polyvinylchloride film and aluminum foil printed lacquered.

1 contour pack with vials together with instructions for use is placed in a pack of cardboard.

1 contour pack with ampoules together with instructions for use is placed in a pack of cardboard.

Packing for hospitals.

For 10, 20, 30, 40, 50 contour cell packs with vials, together with an equal number of instructions for use, are placed in a cardboard box.

Storage conditions:In a dry, the dark place at a temperature of 0 to 25 ° C. Keep out of the reach of children.

Shelf life:

4 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002043 / 01-2002

Date of registration:20.11.2008 / 18.03.2013

Expiration Date:Unlimited

The owner of the registration certificate:BRYNTSALOV-A, CJSC BRYNTSALOV-A, CJSC Russia

Manufacturer: & nbsp

BRYNTSALOV-A, CJSC Russia

Information update date: & nbsp27.03.2017

Illustrated instructions

Instructions

Heparin-Ferein® (Heparin-Ferein)