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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

Chemical substance
Description
Coagulation factor II
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.

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.

Coagulation factor VII
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
Authorization dates

Baxter Healthcare Limited
Caxton Way
Thetford
IP243 SE
Norfolk
United Kingdom

Date of first authorisation: 28th May 2010

Marketing authorization number:

PA 167/138/2