Country: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Dalteparin sodium 10000 IU/mL
Pharmacia Limited Company trading as Pharmacia
Dalteparin sodium 10000 IU/mL
10000 IU/mL
Solution for injection
Active: Dalteparin sodium 10000 IU/mL Excipient: Sodium chloride Water for injection
Ampoule, 10 x 1mL, 10 mL
Prescription
Prescription
Recipharm Stockholm AB
Package - Contents - Shelf Life: Ampoule, 10 x 1mL - 10 mL - 36 months from date of manufacture stored at or below 30°C
1988-03-24
Version: pfdfragi10320 Supersedes: pfdfragi10219 Page 1 of 21 NEW ZEALAND DATA SHEET 1. PRODUCT NAME FRAGMIN® 10,000 IU/mL, 12,500 IU/mL, 25,000 IU/mL Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FRAGMIN solution for injection contains 10,000 IU/mL, 12,500 IU/mL, 25,000 IU/mL dalteparin sodium. The active substance of FRAGMIN is the sodium salt of low molecular weight heparin extracted from the intestinal mucosa of pig and is manufactured by controlled depolymerisation of heparin to produce sulphated polysaccharide chains having an average molecular weight of 5,000 Da with 90% between 2,000 – 9,000 Da. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Dalteparin sodium (low molecular weight heparin), sodium chloride q.s. (in the 2,500 IU/0.2 mL, 7,500 IU/0.75 mL and 10,000 IU/1 mL syringe presentations only), Water for Injections. One unit anti-Xa of FRAGMIN is equivalent in effect to the activity of one unit of the 1st international standard for Low Molecular Weight Heparin with regard to inhibition of coagulation factor Xa in plasma. The 10,000 IU (anti-Xa)/1 mL syringe, 7,500 IU (anti-Xa)/0.75 mL syringe, 5,000 IU (anti-Xa)/0.2 mL syringe and 2,500 IU (anti-Xa)/0.2 mL syringe have the following anti-IIa factor potencies 3,900, 2,940, 1,960 and 980 respectively. The 0.5, 0.6 and 0.72 mL single dose syringe presentations have the same anti-IIa factor potency per mL as the 5,000 IU (anti-Xa)/0.2 mL single dose syringe, corresponding to 4,900, 5,880 and 7,060 IU anti-IIa respectively per syringe. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of clotting in the extracorporeal system during haemodialysis and haemofiltration in connection with acute renal failure or chronic renal insufficiency. Treatment of acute deep venous thrombosis (DVT) and pulmonary embolism (PE). Version: pfdfragi10320 Supersedes: pfdfragi10219 Page 2 of 21 Extended treatment of symptomatic venous thromboembolism (VTE) (proximal deep vein thrombosis and/or Прочитајте комплетан документ