FEIBA 50units/ml (1,000unit) 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:

1,000unit) powder and 20ml solvent for solution for infusion vials (Takeda UK Ltd

ATC code:

B02BD03

INN (International Name):

Factor VIII inhibitor bypassing fraction

Dosage:

1000unit

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: 02110000; GTIN: 00642621015102

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FEIBA 500 U AND 1000 U POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
ACTIVE SUBSTANCE: Factor VIII Inhibitor Bypassing Activity
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, nurse or
pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
•
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
Throughout this leaflet FEIBA 500 U and 1000 U Powder and Solvent for
Solution for Infusion
will be called FEIBA.
IN THIS LEAFLET:
1.
What FEIBA is and what it is used for
2.
What you need to know before you use FEIBA
3.
How to use FEIBA
4.
Possible side effects
5.
How to store FEIBA
6.
Contents of the pack and other information
1.
WHAT FEIBA IS AND WHAT IT IS USED FOR
FEIBA is a concentrate of blood factors normally present in your blood
that help it to clot. It is used to
help clotting in patients who have developed inhibitors (antibodies)
to factor VIII (factor 8). Haemophilia
A patients have lower Factor VIII levels than normal. So, if anything
stops the factor from working your
blood will not clot properly. FEIBA makes sure that your blood clots
properly.
FEIBA is used:
•
To treat spontaneous bleeding episodes in haemophilia A patients with
inhibitors (haemophilia is
when your blood does not clot properly)
•
In haemophilia A patients with inhibitors if they need surgery
•
In haemophilia A patients with inhibitors to prevent frequent bleeding
•
To treat non-haemophiliacs who have developed antibodies in their
blood that prevent factor VIII from
working
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FEIBA
DO NOT USE FEIBA IF:
•
You are allergic (hypersensitive) to the active ingredients or any of
the other ingredients (listed in
section 6). The signs

Summary of Product characteristics

OBJECT 1
FEIBA 1000 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 1000 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 400-1200 mg
human plasma protein with a Factor Eight Inhibitor Bypassing Activity
of 1000 U* per vial.
The final solution has an activity of approximately 50 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 al