Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
FEIBA
Baxter Healthcare Limited
FEIBA
50 Units/ml
Pdr+Solv for soln for Inf
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
b 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 50 U/ml is and what it is used for. 2. What you need to know before you use FEIBA 50 U/ml. 3. How to use FEIBA 50 U/ml. 4. Possible side effects. 5. How to store FEIBA 50 U/ml. 6. Content of the pack and other information. 1. WHAT FEIBA 50 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FEIBA 50 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 titer – no response to treatment with the appropriate coagulation factor concentrate can be expected. • if you are allergic (hypersensitive) to any of the components of FEIBA. • Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FEIBA 50 U/ml powder and solvent for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Factor VIII Inhibitor Bypassing Activity 1 ml contains 50 U* factor VIII inhibitor bypassing activity. FEIBA 50 U/ml is available in two different presentations: - The presentation 1000 U FEIBA contains 1000 U factor VIII inhibitor bypassing activity in 400 – 1,200 mg human plasma protein - The presentation 2500 U FEIBA contains 2500 U factor VIII inhibitor bypassing activity in 1,000 – 3,000 mg human plasma protein. FEIBA also contains the factors II, IX and X, mainly in non-activated form, as well as activated factor VIII. 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). For a 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. 4.2 POSOLOGY AND METHOD Aqra d-dokument sħiħ