Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Heparin sodium 25000 IU/mL
Pfizer New Zealand Limited
Heparin sodium 25000 IU/mL
25000 IU/mL
Solution for injection
Active: Heparin sodium 25000 IU/mL Excipient: Hydrochloric acid Sodium hydroxide Water for injection
Ampoule, glass, 5 x 0.2mL, 5 dose units
Prescription
Prescription
New Zealand Pharmaceuticals Ltd
Package - Contents - Shelf Life: Ampoule, glass, 5 x 0.2mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 50 x 0.2mL - 50 dose units - 36 months from date of manufacture stored at or below 25°C
1980-03-06
Version: pfdhephi11221 Supersedes: pfdhephi11119 Page 1 of 12 NEW ZEALAND DATA SHEET 1. PRODUCT NAME _ _ DBL™ Heparin Sodium Injection BP Solution for Injection, 1,000 IU/mL, 5,000 IU/mL and 25,000 IU/mL. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Heparin Sodium Injection 1,000 IU/mL, 5,000 IU/mL and 25,000 IU/mL is prepared from porcine intestinal mucosa and is free from pyrogenic substances. EXCIPIENT(S) WITH KNOWN EFFECT • Benzyl alcohol (vials only) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL Heparin Sodium Injection is a colourless or straw coloured sterile solution for injection: available as ampoules (1,000 IU/mL, 5,000 IU/mL and 25,000 IU/mL) or vials (1,000 IU/mL only). The pH of the injection ranges between 5.0 and 8.0. 4. CLINICAL PARTICULARS 4.1THERAPEUTIC INDICATIONS Heparin is indicated for the prophylaxis and treatment of thromboembolic disorders such as thrombophlebitis, pulmonary embolism and occlusive vascular disease. It is also used to prevent thromboembolic complications arising from cardiac and vascular surgery, frostbite, dialysis and other perfusion procedures. Heparin is also used as an anticoagulant in blood transfusions. 4.2 DOSE AND METHOD OF ADMINISTRATION Heparin may be given by intermittent intravenous injection, intravenous infusion or deep subcutaneous injection. It should not be given intramuscularly because of the danger of haematoma formation. Low dose prophylaxis against postoperative venous thromboembolism: The usual dose is 5,000 units by deep subcutaneous injection 2 hours before surgery and repeated every 8 to 12 hours for 7 days or longer until the patient is fully ambulatory. Version: pfdhephi11221 Supersedes: pfdhephi11119 Page 2 of 12 ADULTS Treatment of established venous thrombosis or pulmonary embolism. Treatment may be given by the following routes: 1. Continuous intravenous infusion: a bolus dose of 5,000 units may be given initially followed by an infusion of 20,000 to 40,000 units over 24 hours. 2. Intermittent intravenous i Baca dokumen lengkap