FEIBA 25units/ml (500unit) powder and 20ml solvent for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Factor VIII inhibitor bypassing fraction

Available from:

500unit) powder and 20ml solvent for solution for infusion vials (Takeda UK Ltd

ATC code:

B02BD03

INN (International Name):

Factor VIII inhibitor bypassing fraction

Dosage:

500unit

Pharmaceutical form:

Powder and solvent for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: ; GTIN: 00642621015119

Summary of Product characteristics

OBJECT 1
FEIBA 500 U POWDER AND SOLVENT FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 14-Jan-2016 | Shire
Pharmaceuticals Limited
1. Name of the medicinal product
FEIBA 500 U powder and solvent for solution for infusion
2. Qualitative and quantitative composition
FEIBA is presented as powder and solvent to prepare a solution for
infusion containing 200-600 mg
human plasma protein with a Factor Eight Inhibitor Bypassing Activity
of 500 U* per vial.
The final solution has an activity of approximately 25 U/ml when
reconstituted with 20 ml of Sterilised
Water for Injections.
FEIBA contains factors II, IX and X mainly in non-activated form as
well as activated factor VII; factor
VIII coagulant antigen (FVIII C:Ag) is present in a concentration of
up to 0.1 U/l U FEIBA. The factors
of the kallikrein-kinin system are present only in trace amounts, if
at all.
*A solution containing 1 unit of FEIBA shortens the activated partial
thromboplastin time (aPTT) of a
factor VIII inhibitor plasma to 50% of the buffer value (blank).
For excipients, see 6.1.
3. Pharmaceutical form
Powder and solvent for solution for infusion.
The product is presented as freeze-dried powder or friable solid of
white to off-white or pale green colour.
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of spontaneous bleeding and cover of surgical
interventions in haemophilia A patients with
Factor VIII inhibitors
• Treatment of spontaneous bleeding and cover of surgical
interventions in non haemophiliacs with
acquired inhibitors to Factor VIII
• Prophylaxis in haemophilia A patients with high-responding
inhibitors and frequent joint bleeding
4.2 Posology and method of administration
Treatment should be initiated and supervised by a physician
experienced in the management of
haemophilia.
POSOLOGY
The dosage and duration of the therapy is dependent upon the severity
of the disorder, the location and
extent of the bleeding and the patient's clinical condition.
Dosage and frequency of administration should always