Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
HEPARIN SODIUM
PROPHARM LTD
C05BA03
SOLUTION FOR INJECTION / INFUSION
HEPARIN SODIUM 5000 IU/ML
I.V
Required
FISIOPHARMA S.R.L, ITALY
HEPARIN
•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)
2020-08-25
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _PHAREPA 25,000 IU/5 ML _ Solution for injection or infusion. For intravenous injection or intravenous infusion after dilution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 5 ml solution for injection or infusion contains 25,000 IU of heparin sodium. Excipient with known effect: sodium, methyl p-hydroxybenzoate and propyl p- hydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection or infusion. Clear solution, visible particles free. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • 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 nature and course of the disease, patient’s response, adverse reactions, 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. TREATMENT OF VENOUS OR ARTERIAL THROMBOEMBOLIC DISORDERS Continuous intravenous administration is recommended if there are clots in blood vessels. Dosage in adults Generally start with 5000 IU heparin sodium as an intravenous bolus, followed by a continuous infusion of 1000 IU heparin sodium per hour using an infusion pump. Dosage in children Initially 50 IU/kg body weight, then 20 IU/kg body weight per hour. If a continuous intravenous infusion is not possible, other heparin product may be used as subcutaneously alternative. THERAPY MONITORING Close monitoring of therapy accompanied by assay of coagulation parameters is absolutely essential in all cases. Monitoring of therapy and dose adjustment are generally based on activated partial thromboplastin Đọc toàn bộ tài liệu