| HEPARIN LEOŽ |
|Heparin Sodium |
|Action And Clinical Pharmacology: Heparin is an anticoagulant which prevents the formation of thrombin by accelerating the neutralization of activated coagulation factors by naturally occurring inhibitors. tag_IndicationsIndications
Indications And Clinical Uses: For the prophylaxis and management of intravascular clotting and embolism in susceptible patients.
It is also used in extra-corporeal circulation, i.e. heart-lung and renal dialysis machines and blood transfusions.
Contra-Indications: Hemorrhagic disorders and patients with an actual or potential bleeding site, e.g. peptic ulcer.
Low doses of heparin, administered as recommended, do not cause alterations in clotting times in most patients, but occasionally local hematomata may occur at injection sites.
Pregnancy and Lactation: Menstruation and pregnancy are not contraindications to heparin therapy since heparin does not cross placenta or appear in breast milk.
Manufacturers' Warnings In Clinical States: Patients with hemorrhagic disorders may experience bleeding, especially from surgical wounds. The relative risks and benefits of heparin administration in these patients should be assessed carefully.
Oral anticoagulants or drugs which interfere with platelet function, e.g. ASA and dextran solutions, should be administered with caution.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: If bleeding should occur, the effect of heparin can be reversed immediately by i.v. administration of a 1% protamine sulfate solution (1 mg for every 100 I.U. of heparin to be neutralized). The precise dose of protamine sulfate required for neutralization should be determined accurately by titrating with the patient's plasma. tag_DosageDosage
Dosage And Administration: Low dose for prophylaxis (by s.c. injection only): Patients undergoing surgery: 5 000 IU should be given 2 to 6 hours pre-operatively and every 8 to 12 hours post-operatively for 10 to 14 days or until ambulation, whichever is the longer.
Other Patients: 5 000 units every 8 to 12 hours.
Therapeutic dose (by i.v. or s.c. injection): Average daily dose: 20 000 to 40 000 IU daily. However, the dose should be monitored with coagulation tests and varied according to individual response. The treatment period varies and can be as long as 6 weeks in patients with established thrombosis.
Stability in Infusion Fluids: Heparin Leo is stable for 24 hours at room temperature in the following infusion fluids: sodium chloride 0.9%, dextrose solutions (55 and 100 g/L), invertose (100 mg/L), Ringer solution, Ringer glucose, Ringer acetate, sodium bicarbonate 8.4%, Vamin with glucose. Stability tests were carried out using heparin concentrations of 10 and 20 units/mL.
Availability And Storage: 100 IU/mL: Nonmedicinal ingredients: chlorobutanol hemihydrate, sodium chloride, sodium citrate and water for injection. Ampuls of 2 mL, vials of 10 mL.
1 000 IU/mL: Nonmedicinal ingredients: sodium chloride, sodium citrate and water for injection. Ampuls of 1 mL*.
Nonmedicinal ingredients: benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium chloride, sodium citrate and water for injection. Vials of 10 and 20 mL.
10 000 IU/mL: Nonmedicinal ingredients: water for injection. Ampuls of 1 mL*.
Nonmedicinal ingredients: benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium chloride, sodium citrate and water for injection. Vials of 5 mL.
25 000 IU/mL: Nonmedicinal ingredients: water for injection. Ampuls of 0.2 mL*.
Nonmedicinal ingredients: benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium chloride, sodium citrate and water for injection. Vials of 2 mL.
Store below 25°C. Admixture of heparin with solutions of other medicinal products may result in precipitation or loss of potency.