País: Malta
Idioma: inglés
Fuente: Medicines Authority
FACTOR VIII, INHIBITOR BYPASSING, FRACTION
Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria
B02BD03
FACTOR VIII INHIBITOR BYPASSING FRACTION 25 U/ml
POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
FACTOR VIII INHIBITOR BYPASSING FRACTION 25 U/ml
POM
ANTIHEMORRHAGICS
Authorised
2006-12-21
Page 1 of 16 PACKAGE LEAFLET: INFORMATION FOR THE USER FEIBA 25 U/ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION ACTIVE SUBSTANCE: Factor VIII Inhibitor Bypassing Activity 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, please ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. IN THIS LEAFLET: 1. What FEIBA 25 U/ml is and what it is used for. 2. What you need to know before you use FEIBA 25 U/ml. 3. How to use FEIBA 25 U/ml. 4. Possible side effects. 5. How to store FEIBA 25 U/ml. 6. Content of the pack and other information. 1. WHAT FEIBA 25 U/ML IS AND WHAT IT IS USED FOR FEIBA is a preparation made from human plasma which allows hemostasis, even when individual coagulation factors are reduced or absent. FEIBA is used for the treatment of bleedings in inhibitor hemophilia A patients. FEIBA is used for the treatment of bleedings in inhibitor haemophilia B patients, if no other specific treatment is available. FEIBA is also used for prophylaxis of bleeding in inhibitor hemophilia A patients who have experienced a _ _ significant bleed or are at high risk of significant bleeding. Furthermore, FEIBA may be used for the treatment of bleedings in non-hemophilic patients who have acquired inhibitors to factor VIII. Page 2 of 16 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FEIBA 25 U/ML. Please inform your doctor if you have a known allergy. Please inform your doctor if you are on a low-sodium diet. DO NOT USE FEIBA In the following situations FEIBA should only be used if - for example due to a very high inhibitor titre - no response to treatment with the appropriate coagulation factor concentrate can be expec Leer el documento completo
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FEIBA 25 U/ml powder and solvent for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Factor VIII Inhibitor Bypassing Activity 1 ml contains 25 U* factor VIII inhibitor bypassing activity. 1 vial FEIBA 25 U/ml contains 500 U factor VIII inhibitor bypassing activity in 200 – 600 mg human plasma protein. FEIBA also contains the factors II, IX and X, mainly in non-activated form, as well as activated factor VII. Factor VIII coagulation antigen (F VIII C:Ag) is present at a concentration of up to 0.1 U./1 U. FEIBA. The factors of the kallikrein-kinin system are present in trace amounts only, if at all. * 1 unit of FEIBA shortens the activated partial thromboplastin time (aPTT) of a factor VIII inhibitor plasma by 50% of the buffer value (blank value). Excipients with known effect: FEIBA contains approximately 80 mg sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for infusion. White, off-white or pale green powder. The pH value of the ready-to-use solution is between 6.8 and 7.6. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of bleeding in hemophilia A patients with inhibitors. - Treatment of bleeding in hemophilia B patients with inhibitors, if no other specific treatment is available (see section 5.1). - Treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor VIII. - Prophylaxis of bleeding in hemophilia A patients with inhibitors who have experienced a significant bleed or are at high risk of significant bleeding. Page 2 of 18 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment is to be initiated and monitored by a physician experienced in the treatment of coagulation disorders. _Posology _ Dosage and duration of treatment depend on the severity of the haemostatic disorder, the localization and the extent of the bleeding, as well as the clinical condition of the patient. Dosage and f Leer el documento completo