FEIBA 1000 U powder and solvent for solution for infusion.
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.
Active substance: Factor VIII Inhibitor Bypassing Activity.
As the active ingredient, FEIBA 1000 U* contains 1000 U factor VIII inhibitor bypassing activity in 400-1200 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 CAg) is present at a concentration of up to 0.1 U./l 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.
Sterilized Water for Injections
The powder is supplied in a vial made of surface treated, colorless glass (hydrolytic class II). The solvent is supplied in a vial made of surface treated, colorless glass (hydrolytic class I). The vials are closed by a stopper made of butyl rubber.
The package contains either:
Not all pack sizes may be marketed.
Baxter Healthcare Limited, Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom
Date of first authorisation: 28th May 2010