FEIBA 100 U/ml powder and solvent for solution for infusion (1000 U/10 ml)

Land: Malta

Taal: Engels

Bron: Medicines Authority

Beschikbaar vanaf:

Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria

ATC-code:

B02BD03

INN (Algemene Internationale Benaming):

FACTOR VIII INHIBITOR BYPASSING FRACTION 100 U/ml

farmaceutische vorm:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Samenstelling:

FACTOR VIII INHIBITOR BYPASSING FRACTION 100 U/ml

Prescription-type:

POM

Therapeutisch gebied:

ANTIHEMORRHAGICS

Product samenvatting:

Licence number in the source country: N/A

Autorisatie-status:

Authorised

Autorisatie datum:

2024-01-11

Bijsluiter

Page
1
of
14
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEIBA 100
U/ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Factor VIII Inhibitor Bypassing Activity
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. See section 4.
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. Content of the pack and other information
1. WHAT FEIBA 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.
FEIBA can be used for all age groups.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FEIBA
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
titre - no response to treatment with the appropriate coagulation
factor concentrate can be expected.
Page
2
of
14
•
if you are

Productkenmerken

Page
1
of
15
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
FEIBA 100 U/ml powder and solvent for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Factor VIII Inhibitor Bypassing Activity
1 ml contains 100 U* factor VIII inhibitor bypassing activity.
FEIBA 100 U/ml is available in three different presentations:
-
The presentation 500 U FEIBA contains 500 U factor VIII inhibitor
bypassing activity in
200 – 600 mg human plasma protein,
-
The presentation 1 000 U FEIBA contains 1 000 U factor VIII inhibitor
bypassing activity in
400 – 1 200 mg human plasma protein,
-
The presentation 2 500 U FEIBA contains 2 500 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
VII. Factor VIII coagulation antigen (FVIII 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).
Excipients with known effect:
500 U
FEIBA contains approximately 40 mg sodium per vial.
1 000 U
FEIBA contains approximately 80 mg sodium per vial.
2 500 U
FEIBA contains approximately 200 mg sodium per vial.
For the 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 6.5 and
7.3.
Page
2
of
15
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