Država: Izrael
Jezik: angleščina
Source: Ministry of Health
HEPARIN SODIUM
MBI PHARMA LTD., ISRAEL
B01AB01
SOLUTION FOR INJECTION
HEPARIN SODIUM 1000 IU / 1 ML
I.V, S.C
Required
LABORATORIUM DR. G. BICHSEL AG
HEPARIN
Prevention of thromboembolic disorders• As part of the treatment of venous or arterial thromboembolic disorders (including the early treatment of heart attacks as well as unstable angina pectoris)• For anticoagulation during treatment or operation with an extracorporeal circulation (e.g. heart/lung machine, hemodialysis)
2020-10-11
1. NAME OF THE MEDICINAL PRODUCT Heparin Bichsel 1000 IU/ml _ _ Heparin Bichsel 5000 IU/ml _ _ _ _ Solution for injection. For subcutaneous and intravenous injection. or intravenous infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ampoule of 1 ml Heparin Bichsel 1000 IU/ml _ _contains 1,000 I.U. heparin sodium. 1 ampoule of 1 ml Heparin Bichsel 5000 IU/ml _ _contains 5,000 I.U. heparin sodium. 1 ampoule of 5 ml Heparin Bichsel 5000 IU/ml _ _contains 25,000 I.U. heparin sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Prevention of thromboembolic disorders - As part of the treatment of venous or arterial thromboembolic disorders (including the early treatment of heart attacks as well as unstable angina pectoris) - For anticoagulation during treatment or operation with an extracorporeal circulation (e.g. heart/lung machine, haemodialysis) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Dosage _ Heparin sodium must be individually dosed. The dosage depends on the coagulation parameters, nature and course of the disease, patient’s response, adverse reactions, and the patient’s weight and age. Differences in sensitivity to heparin and a possible change in heparin tolerance during the course of treatment need to be considered. PROPHYLAXIS OF THROMBOEMBOLISM (LOW-DOSE TREATMENT) Subcutaneous injection is recommended for the prophylaxis of thromboembolism - _Pre- and postoperative prophylaxis of thromboembolism _ Preoperatively 5000-7500 IU subcutaneously approximately 2 hours before the operation. Postoperatively, depending on the risk of thrombosis, usually 5000 IU subcutaneously every 8 ‑ 12 hours or 7500 IU subcutaneously every 12 hours until the patient is mobilised or until vitamin K antagonists have an adequate effect. Laboratory monitoring (coagulation parameters) for dose adjustment may be required in individual cases. _- Prophylaxis in non-surgical medicine _ (e.g. prolonged bed rest, increased t Preberite celoten dokument