FEIBA 50 U/ml powder and solvent for solution for infusion

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Dostopno od:

Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria

Koda artikla:

B02BD03

INN (mednarodno ime):

FACTOR VIII INHIBITOR BYPASSING FRACTION 50 U/ml

Farmacevtska oblika:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Sestava:

FACTOR VIII INHIBITOR BYPASSING FRACTION 50 U/ml

Tip zastaranja:

POM

Terapevtsko območje:

ANTIHEMORRHAGICS

Povzetek izdelek:

Licence number in the source country: NOT APPLICAPABLE

Status dovoljenje:

Authorised

Datum dovoljenje:

2023-03-15

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FEIBA 50 U/ML
POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
ACTIVE SUBSTANCE:
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.
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.
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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 titre - no response to treatment with the appropriate
coagulation factor concentrate can
be expec

Lastnosti izdelka

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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 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 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 VII. 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).
Excipients with known effect:
500 U
FEIBA contains approximately 40 mg sodium per vial.
1000 U
FEIBA contains approximately 80 mg sodium per vial.
2500 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.
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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 inhi