Feiba 500 U, powder and solvent for solution for injection. Factor VIII Inhibitor Bypassing Activity.

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

factor viii inhibitor bypassing fraction 500 u

Saatavilla:

Baxter Healthcare Limited

ATC-koodi:

B02BD03

INN (Kansainvälinen yleisnimi):

factor viii inhibitor bypassing fraction

Lääkemuoto:

powder and solvent for solution for injection

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-12-21

Pakkausseloste

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
b
0726458
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 allergi

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS 

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 

Page 1 of 12 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Treatment should be initiated and supervised
by a physician experienced in the management 
of haemophilia