Source: Health Products Regulatory Authority (IE) Revision Year: 2011 Publisher: Baxter Healthcare Limited, Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom
FEIBA 1000 U powder and solvent for solution for infusion.
| Pharmaceutical Form |
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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.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor IX |
Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. |
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| Coagulation factor VII |
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| Coagulation factor X |
Coagulation factor X is derived from human plasma and used as a replacement for the naturally existing coagulation factor X in patients with hereditary factor X deficiency. |
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| Factor VIII inhibitor bypass activity |
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| Thrombin |
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| List of Excipients |
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Powder: Sodium chloride Solvent: 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:
or
Not all pack sizes may be marketed.
Baxter Healthcare Limited, Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom
PA 167/138/2
Date of first authorisation: 28th May 2010
| Drug | Countries | |
|---|---|---|
| FEIBA | Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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