国家: 马耳他
语言: 英文
来源: Medicines Authority
octocog alfa 500 iu
Baxter Healthcare Limited
B02BD02
octocog alfa
powder and solvent for solution for injection
Authorised
2011-07-29
PACKAGE LEAFLET: INFORMATION FOR THE USER RECOMBINATE 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION. Octocog alfa (recombinant coagulation factor VIII) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Recombinate is and what it is used for 2. Before you use Recombinate 3. How to use Recombinate 4. Possible side effects 5. How to store Recombinate 6. Further information 1. WHAT RECOMBINATE IS AND WHAT IT IS USED FOR _RECOMBINATE BELONGS TO A PHARMACOTHERAPEUTIC GROUP CALLED BLOOD COAGULATION FACTOR VIII._ Recombinate is used in patients with haemophilia A (congenital factor VIII deficiency) for • prevention of bleeding • treatment of bleeding (e.g. muscle bleeding, oral bleeding, bleeding at the site of surgery). The product does not contain von Willebrand factor and is therefore not to be used in von Willebrand’s disease (a special blood coagulation disorder). 2. BEFORE YOU USE RECOMBINATE DO NOT USE RECOMBINATE • If you are hypersensitive (allergic) to octocog alfa, to mouse, bovine or hamster proteins or to any of the other ingredients of Recombinate. If you are unsure about this, ask your doctor. TAKE SPECIAL CARE WITH RECOMBINATE _WHEN ALLERGIC REACTIONS OCCUR:_ • There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Recombinate. You should be aware of the early signs of allergic reactions such as rash, hives, 阅读完整的文件
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Recombinate 500 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Octocog alfa 50 IU per ml of reconstituted solution After reconstitution: One vial of 10 ml contains 500 IU octocog alfa Recombinate 500 IU, contains nominally 500 IU octocog alfa, recombinant, coagulation factor VIII per vial. The product contains approximately 50 IU/ml octocog alfa, recombinant coagulation factor VIII when reconstituted with 10 ml of sterile water for injections. The potency is determined using the European Pharmacopoeia chromogenic assay against the FDA Mega Standard calibrated to the WHO Standard. The specific activity of Recombinate is approximately 4000 - 8000 IU/mg protein. Recombinate contains recombinant coagulation factor VIII (INN: octocog alfa). Octocog alfa (recombinant coagulation factor VIII) is a purified protein consisting of 2332 amino acids. It has an amino acid sequence that is comparable to factor VIII, and post-translational modifications that are similar to the plasma derived molecule. Recombinant coagulation factor VIII is a glycoprotein that is expressed by genetically engineered mammalian cells derived from a Chinese Hamster Ovary cell line. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White to off-white friable powder. The solvent (sterilised water for injections) is a clear and colorless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleed 阅读完整的文件