Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
FACTOR VIII, HUMAN RECOMBINANT
Baxter Healthcare Limited
FACTOR VIII, HUMAN RECOMBINANT
250 IU International Unit
Pdr+Solv for Soln for Inj
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER Recombinate 250 IU powder and solvent for solution for injection. Recombinate 500 IU powder and solvent for solution for injection. Recombinate 1000 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. 2 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 rea Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Recombinate 250 IU, powder and solvent for solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Octocog alfa 25 IU per ml of reconstituted solution After reconstitution: One vial of 10ml contains 250 IU octocog alfa Recombinate 250 IU, contains nominally 250 IU octocog alfa, recombinant, coagulation factor VIII per vial. The product contains approximately 25 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. _Excipients: _For a full list of excipients see 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 colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with Haemophilia A (congenital Factor VIII deficiency). This product does not contain von Willebrand factor and is therefore not indicated in von Willebrand’s disease. Recombinate is indicated fo Læs hele dokumentet