FEIBA Powder and solvent for solution for infusion Ref.[4259] Active ingredients: Factor VIII inhibitor bypass activity

Source: Health Products Regulatory Authority (IE)  Revision Year: 2011  Publisher: Baxter Healthcare Limited, Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom

Product name and form

FEIBA 1000 U powder and solvent for solution for infusion.

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.

Qualitative and quantitative composition

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
List of Excipients

Powder:

Sodium chloride
Sodium citrate

Solvent:

Sterilized Water for Injections

Pack sizes and marketing

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:

  • 1 vial with FEIBA 1000 U
  • 1 vial with 20 ml sterilized Water for Injections
  • 1 disposable syringe
  • 1 disposable needle
  • 1 butterfly needle with clamp
  • 1 filter needle
  • 1 transfer needle
  • 1 aeration needle

or

  • 1 vial with FEIB A 1000 U
  • 1 vial with 20 ml sterilized Water for Injections
  • 1 BAXJECT II Hi-Flow
  • 1 disposable syringe
  • 1 disposable needle
  • 1 butterfly needle with clamp

Not all pack sizes may be marketed.

Marketing authorization holder

Baxter Healthcare Limited, Caxton Way, Thetford, IP243 SE, Norfolk, United Kingdom

Marketing authorization dates and numbers

PA 167/138/2

Date of first authorisation: 28th May 2010

Drugs

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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