Feiba Description

Active substance: Factor VIII Inhibitor Bypassing Activity.
25 U/mL: 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.
50 U/mL: 1 ml contains 50 U* factor VIII inhibitor bypassing activity.
FEIBA 50 U/ml is available in the following presentation: The presentation 500 U FEIBA contains 500 U factor VIII inhibitor bypassing activity in 200 - 600 mg human plasma protein; The presentation 1000 U FEIBA contains 1000 U factor VIII inhibitor bypassing activity in 400 - 1,200 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).
The pH value of the ready-to-use solution is between 6.8 and 7.6.
Excipients with known effect: 25 U/mL: 3.6 mmol sodium (80 mg) per vial.
50 U/mL: 1.8 mmol sodium (40 mg) per vial with 500 U FEIBA; 3.6 mmol sodium (80 mg) per vial with 1000 U FEIBA.
Excipients/Inactive Ingredients: Powder: Sodium chloride, Sodium citrate.
Solvent: Water for Injections.