देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Octocog alfa 1000 [iU]
Takeda New Zealand Limited
Octocog alfa 1000 IU
1000 IU
Injection with diluent
Active: Octocog alfa 1000 [iU] Excipient: Albumin Calcium chloride dihydrate Histidine Hydrochloric acid Macrogol 3350 Sodium chloride Sodium hydroxide Water for injection
Combination pack, 1 x ( powder + diluent, ex-Baxter), 1000 IU
General sale
General sale
Baxalta U.S. Inc
in haemophilia A (classical haemophilia) for the prevention and control of haemorrhagic episodes. · in the perioperative management of patients with haemophilia A (classical haemophilia).
Package - Contents - Shelf Life: Combination pack, 1 x ( powder + diluent, ex-Baxter) - 1000 IU - 36 months from date of manufacture stored at or below 25°C. expiry date is earliest for 2 components 3 hours reconstituted stored at or below 25°C - Combination pack, 1 x ( powder + diluent, ex-Ben Venue) - 1000 IU - 24 months from date of manufacture stored at or below 25°C. expiry is earliest of 2 components 3 hours reconstituted stored at or below 25°C - Vial, glass, single dose, 1 x 10 ml, ex-Baxter - 10 mL - 48 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, 1 x 10 ml, ex-Ben Venue - 10 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, 1 x 1000IU - 1000 IU - 36 months from date of manufacture stored at or below 30°C
1993-03-05
NEW ZEALAND DATA SHEET RECOMBINATE Data Sheet 18 October 2017 Page 1 of 10 Shire New Zealand Ltd 1 RECOMBINATE (injection with diluent) RECOMBINATE is available in the following strengths: 250IU 500IU 1000IU. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Octocog alfa [rAHF, Factor VIII (rch)]. _Biological origin of active substance _ The active ingredient in RECOMBINATE, octocog alfa [Antihaemophilic Factor (Recombinant)], is a glycoprotein synthesized using genetically engineered Chinese Hamster Ovary Cells (CHO). The CHO cells secrete recombinant Factor VIII (rFVIII) into a cell culture medium, which is then purified by a series of chromatography columns. The rFVIII is selectively isolated in a purification matrix prepared by immobilisation of a monoclonal antibody directed to Factor VIII. The rFVIII produced has the same biological effects as natural human Factor VIII. Recombinant von Willebrand Factor (rVWF) is co‐ expressed with the rFVIII and helps to stabilize it. RECOMBINATE is available in single dose vials containing 250, 500 and 1000IU (International Units) octocog alfa, nominally per vial. When RECOMBINATE (dry factor concentrate) is reconstituted with the appropriate volume of diluent (10mL Sterile Water for Injection, USP) prior to administration; each vial contains 250IU/10mL, 500IU/10mL and 1000IU/10mL octocog alfa respectively. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Injection with diluent. RECOMBINATE is a sterile, non‐pyrogenic, off‐white to faint yellow lyophilised powder preparation of concentrated recombinant factor VIII (rAHF) for intravenous injection. The reconstituted solution is colourless to faint yellow in appearance, and substantially free from foreign particles. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications The use of RECOMBINATE [Antihemophilic Factor (Recombinant)] is indicated in haemophilia A (classical haemophilia) for the prevention and control of haemorrhagic episodes. RECOMBINATE is also indicated in the perioperative पूरा दस्तावेज़ पढ़ें