Products information : HEPARINE MEDIS

HEPARINE MEDIS 25000 UI Sodium heparin
 
Products technical sheet

Pharmaceutical form

 Forme
Injectable solution 
Présentation
Box of 10 vials
M.A number: 923 318 1H

Pharmacotherapeutic class

 This drug is an anticoagulant

Composition

Sodium heparin ……...................………25000 UI
Chlorocresol……………........................………s.q.
W.F.I……………………..........…………s.q.f.5ml

Therapeutic indications

 -Prophylaxis and treatment of thromboembolic diseases (phlebitis, thrombophlebitis and embolisms).
-Adjuvant for early treatment of myocardial infarction.
-Blood heparinization during extracorporeal circulation and dialysis.

Contra-indications

-Hypersensitivity to heparin or to relative substances.
-Hypersensitivity to one of the components
-Hemorrhagic manifestations or tendencies related to hemostasis disorders: hemophilia, purpura, icterus, severe hepatitis and thrombocytopenia.
-Organic hemorrhagic lesions
-Acute infectious endocarditis excepting those occurring over mechanical prosthesis.
-Post-operative period after brain and spinal cord surgery.
-Hemorrhagic cerebro-vascular accident
-Non controlled hypertension.

Warnings and precautions of use

 -A platelets count must be done before initiating treatment and once or twice a week thereafter. Imperative heparin discontinuation when a thrombocytopenia appears.
-Precautions are required on case of hepatic or renal impairment, hypertension, digestive ulcers or organic hemorrhagic lesions history or chorioretinal vascular diseases
Pregnancy and breastfeeding Pregnancy
-Heparin does not pass through the placenta. It can be used throughout all the pregnancy duration.
-Special precautions are required when approaching delivery because of the hemorrhagic risk.
Breastfeeding
-Heparin does not pass in mother’s milk.

Drugs Interactions

 Not recommended combinations
-acetyl salicylic acid and salicylated products
-NSAI (general route)
-Ticlopidin
Combinations to be monitored
-Combinations with oral anticoagulants, corticoids and dextran because of the hemorrhagic risk.

Undesirable effects

-hemorrhagic manifestations
-Severe immuno-allergic thrombocytopenia requiring immediate heparin discontinuation.
-Rare cutaneous or general allergic manifestations.
-Rare cutaneous necrosis in the injection site.
-Small hematomas in the injection site which will disappear spontaneously.
-Osteoporosis in extended and high doses treatments.
-Increases in transaminases and eosinophilia.
-Other rare disorders: alopecia, priapism, aldosterone deficiency with hyperkaliemia and/or metabolic acidosis in risky patients.

Dosage and mode of administration

 -Curative treatment: 400 to 600 UI/kg/24h in continuous infusion with electric syringe or when not available in intravenous injection every 2 hours.
-The dose should be reduced by the half in the elderly.
-Treatment monitoring: curative treatment, the dose should be adjusted according to global coagulation measurements: activated partial thromboplastin time: 2 to 3 times the control.
-Prophylactic therapy: 100 UI/kg/24h in continuous infusion with electric syringe or when not available in intravenous injection every 2 hours.
-Treatment monitoring: prophylactic therapy: the dose should be adjusted according to global coagulation measurements: activated partial thromboplastin time: 1 to 1 and 1/2 times the control.

Overdose

 -the hemorrhagic risk is partial concerning the hypo-coagulability
-In case of hemorrhagic accident, it is urgent to administer 1mg of protamin sulphate to neutralize about 100 UI of heparin.

Storage

 Keep away from light and heat.

Delivery conditions

 LIST I (table A)