Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FEIBA
Baxter Healthcare Limited
500
Pdr+Solv for soln for Inf
2010-05-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT FEIBA 500 U powder and solvent for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Factor VIII Inhibitor Bypassing Activity As the active ingredient, FEIBA 500 U* 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 (empty 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 episodes in patients with hemophilia A and factor VIII inhibitors. - Treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor VIII. - Prophylaxis of bleeding in inhibitor hemophilia A patients who have experienced a significant musculoskeletal bleed requiring the use of a bypassing agent or with significant impairment of quality of life due to bleeding and/or who have experienced a single life-threatening bleed (e.g. intracranial, intra-abdominal, intrathoracic bleed). 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 t Read the complete document