FEIBA 50 Units/ml Pdr+Solv for soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FEIBA

Available from:

Baxter Healthcare Limited

INN (International Name):

FEIBA

Dosage:

50 Units/ml

Pharmaceutical form:

Pdr+Solv for soln for Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

b
Read all of this leaflet carefully before you start using 
this medicine because it contains important information 
for you.
–  Keep this leaflet. You may need to read it again.
–  If you have any further questions, please ask your 
doctor or pharmacist.
–  This medicine has been prescribed for you only. 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 or 
pharmacist. This includes any possible side effects not 
listed in this leaflet.
In this leaflet:
1. What FEIBA 50 U/ml is and what it is used for.
2.  What you need to know before you use FEIBA 50 U/ml.
3. How to use FEIBA 50 U/ml.
4. Possible side effects.
5. How to store FEIBA 50 U/ml.
6. Content of the pack and other information.
1. WHAT FEIBA 50 U/ml IS AND WHAT IT IS USED FOR
FEIBA is a preparation made from human plasma which 
allows hemostasis, even when individual coagulation 
factors are reduced or absent.
FEIBA is used for the treatment of bleedings in inhibitor 
hemophilia A patients.
FEIBA is used for the treatment of bleedings in inhibitor 
haemophilia B patients, if no other specific treatment is 
available.  
FEIBA is also used for prophylaxis of bleeding in inhibitor 
hemophilia A patients who have experienced a significant 
bleed or are at high risk of significant bleeding.
Furthermore, FEIBA may be used for the treatment of 
bleedings in non-hemophilic patients who have acquired 
inhibitors to factor VIII.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE 
FEIBA 50 U/ml.
Please inform your doctor if you have a known allergy. 
Please inform your doctor if you are on a low-sodium diet.
Do not use FEIBA
In the following situations FEIBA should only be used if – 
for example due to a very high inhibitor titer – no response 
to treatment with the appropriate coagulation factor 
concentrate can be expected. 
•  if you are allergic (hypersensitive) to any of the 
components of FEIBA.
• �

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FEIBA 50 U/ml powder and solvent for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Factor VIII Inhibitor Bypassing Activity
1 ml contains 50 U* factor VIII inhibitor bypassing activity.
FEIBA 50 U/ml is available in two different presentations:
-
The presentation 1000 U FEIBA contains 1000 U factor VIII inhibitor bypassing activity in 400 – 1,200 mg human
plasma protein
-
The presentation 2500 U FEIBA contains 2500 U factor VIII inhibitor bypassing activity in 1,000 – 3,000 mg human
plasma protein.
FEIBA also contains the factors II, IX and X, mainly in non-activated form, as well as activated factor VIII. Factor VIII
coagulation antigen (F VIII C:Ag) is present at a concentration of up to 0.1 U./1 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 (blank value).
For a full list of excipients, see Section 6.1.
3 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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Treatment of bleeding in hemophilia A patients with inhibitors.
-
Treatment of bleeding in hemophilia B patients with inhibitors, if no other specific treatment is available (see
section 5.1).
-
Treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor VIII.
-
Prophylaxis of bleeding in hemophilia A patients with inhibitors who have experienced a significant bleed or are at
high risk of significant bleeding.
4.2 POSOLOGY AND METHOD�