Երկիր: Մալթա
Լեզու: անգլերեն
Աղբյուրը: Medicines Authority
FACTOR VIII, HUMAN; VON WILLEBRAND FACTOR, HUMAN
Bio Products Laboratory Limited
B02BD02
FACTOR VIII, HUMAN; VON WILLEBRAND FACTOR, HUMAN
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FACTOR VIII, HUMAN 1000 IU; VON WILLEBRAND FACTOR, HUMAN 1720 IU
POM
ANTIHEMORRHAGICS
Authorised
2012-07-11
1 OPTLE5 PACKAGE LEAFLET: INFORMATION FOR THE USER OPTIVATE 250 IU, 500 IU, 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION HUMAN COAGULATION FACTOR VIII READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours, • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Optivate is and what it is used for 2 What you need to know before you use Optivate 3. How to use Optivate 4. Possible side effects 5. How to store Optivate 6. Contents of the pack and other information 1. WHAT OPTIVATE IS AND WHAT IT IS USED FOR Optivate is a high purity factor VIII concentrate from human blood plasma obtained from screened donors. It is a white or pale yellow sterile powder, supplied with sterilised water for injections. Optivate is given by injection into a vein (intravenously) and is used to prevent and treat bleeding in patients with haemophilia A (congenital factor VIII deficiency in the blood). Your doctor will explain further why this medicine has been given to you. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTIVATE DO NOT USE OPTIVATE : - if you are allergic (hypersensitive) to the human coagulation factor VIII or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS - If you have a larger or longer bleed than usual and the bleeding does not stop after an injection of Optivate , speak to your doctor. Some patients with a shortage of factor VIII may develop inhibitors (ant Կարդացեք ամբողջական փաստաթուղթը
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Optivate 250 IU, 500 IU, 1000 IU, powder and solvent for solution for injection Human coagulation factor VIII _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Optivate is presented as a powder and solvent for solution for injection containing nominally 250 IU, 500 IU or 1000 IU human coagulation factor VIII per vial. Optivate contains approximately 100 IU/mL human coagulation factor VIII when reconstituted with 2.5 mL (250 IU), 5 mL (500 IU) or 10 mL (1000 IU) sterilised water for injections. The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Optivate is approximately 43 IU/mg of protein. Optivate also contains human von Willebrand factor (VWF by ristocetin cofactor activity) at a concentration of approximately 430 IU, 860 IU or 1720 IU per vial respectively for the 250 IU, 500 IU and 1000 IU presentations. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. Product vial containing white or pale yellow powder. Solvent vial containing clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia. Posology The dosage and duration of the substitution therapy depend on the severity of the FVIII deficiency, on the location and extent of the bleeding and the patient’s clinical condition. _On demand treatment _ Page 2 of 9 The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO stan Կարդացեք ամբողջական փաստաթուղթը