Kraj: Kanada
Język: angielski
Źródło: Health Canada
HEPARIN SODIUM; DEXTROSE
B. BRAUN MEDICAL INC
B01AB51
HEPARIN, COMBINATIONS
10000UNIT; 5G
SOLUTION
HEPARIN SODIUM 10000UNIT; DEXTROSE 5G
INTRAVENOUS
250ML
Ethical
HEPARINS
Active ingredient group (AIG) number: 0220064003; AHFS:
APPROVED
1998-06-16
Heparin Sodium B. Braun INJECTABLE DRUGS Heparin has been used as an anticoagulant in clinical medicine for more than 80 years. 1 In fact, it still remains one of the most commonly used parenteral anticoagulants to treat or prevent thromboembolism until today. 2 Its importance in clinical medicine is also reflected by being listed in the 21 st WHO Model List of Essential Medicines. 3 USER BENEFITS WITH HEPARIN SODIUM · Effective and safe in prevention and treatment of thrombosis when appropriate dosing is given 4 · Safe profile due to its short half-life and reversibility with protamine 2 · Preferred option for patients with renal dysfunction since it is not excreted through the kidney 2 HEPARIN SODIUM B. BRAUN IS USED IN ADULTS AND PEDIATRICS FOR THE FOLLOWING INDICATIONS · Therapy of acute venous and arterial thromboembolism in- cluding early treatment of myocardial infarction and unstable angina pectoris (i.v. or s.c.) · Prophylaxis of thromboembolism (s.c.) · Prevention of blood clotting during use of extracorporeal circulation (e.g. cardiopulmonary bypass, hemodialysis) METHOD OF ADMINISTRATION · Continuous intravenous infusion * · Intravenous bolus injection · Subcutaneous injection PRODUCT CONTAINER TYPE TOTAL VOLUME SALES UNIT HEPARIN SODIUM B. BRAUN 5000 I.U / ML Glass Vial 5 ml 10 x 5 ml * For continuous intravenous infusion Heparin Sodium B. Braun may be diluted with Sodium chloride 9 mg / ml solution for infusion, Glucose 50 mg / ml or 100 mg / ml solution for infusion or Ringer‘s solution for infusion. FIG. 1 | Glass Vial – Heparin Sodium B. Braun 5000 I.U / ml LITERATURE 1. Oduah EI et al.; Pharmaceuticals 2016, 9 (3), 38. 2. Malloy RJ et al.; Unfractionated Heparin and Low-Molecular-Weight Heparin. In: Lau J, Barnes G, Streiff M (eds) Anticoagulation Therapy. Springer, Cham. 3. World Health Organization Model List of Essential Medicines, 21st List, 2019. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. 4. Hirsh J et al., Circulation 2001;103:2994-3018. B. Braun Me Przeczytaj cały dokument
1d1d0d1d0d1d1d0d1d1 126/12606671/0210 COMPOSITION 1 ml of solution contains Heparin Sodium (mucosa) 5000 I.U. _Excipients:_ Benzyl alcohol (antimicrobial preservative), sodium chloride, water for injections PHARMACEUTICAL FORM Solution for injection in glass vials of 5 ml PHARMACO-THERAPEUTIC GROUP Anticoagulant INDICATIONS - Prophylaxis of thrombo-embolism in surgical and non-surgical medicine; - Use as anticoagulant in the therapy of acute venous and arterial thrombo- embolism; - Therapy of consumption coagulopathy in the hypercoagulative phase, - Prevention of blood clotting during use of extracorporal circulation (heart-lung machine). CONTRAINDICATIONS _Heparin Sodium Injection 5000 I.U./ml must not be used in the following conditions:_ - Hypersensitivity to heparin; - Diseases associated with an increased tendency to bleeding, such as: haemorrhagic diathesis, deficiency of coagulation factors with the exception of consumption coagulopathy in the hypercoagulative phase, severe diseases of liver, kidneys, and pancreas, severe thrombocytopenia; - Diseases where there is a suspicion of vascular damage, e.g. ulcers in the gastro-intestinal tract, hypertension with a diastolic blood pressure higher than 105 mm Hg, brain haemorrhage, injuries or surgical procedures on the central nervous system, cerebral arterial aneurysm, retinopathias, bleeding into the vitreum, ophthalmic surgical procedures, subacute bacterial endocarditis; - Imminent abortion; - Spinal or epidural anaesthesia, lumbar puncture; - Case history or acute cases of thrombocytopenia (type II) caused by an allergic reaction to heparin; Because Heparin Sodium Injection 5000 I.U./ml contains benzyl alcohol, it must not be administered to new-borns, esp. to immature pre-term infants. _Administration of Heparin Sodium Injection 5000 I.U./ml should also be avoided in the_ _following conditions:_ - Suspected malignant tumour with risk of bleeding; - Nephro- and ureterolithiasis; - Chronic alcohol abuse. SPECIAL WARNINGS AND PRECAUTIONS FOR USE During therap Przeczytaj cały dokument