FEIBA 25 U/ml powder and solvent for solution for infusion

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

FACTOR VIII, INHIBITOR BYPASSING, FRACTION

Tilgjengelig fra:

Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria

ATC-kode:

B02BD03

INN (International Name):

FACTOR VIII INHIBITOR BYPASSING FRACTION 25 U/ml

Legemiddelform:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Sammensetning:

FACTOR VIII INHIBITOR BYPASSING FRACTION 25 U/ml

Resept typen:

POM

Terapeutisk område:

ANTIHEMORRHAGICS

Autorisasjon status:

Authorised

Autorisasjon dato:

2006-12-21

Informasjon til brukeren

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FEIBA 25 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 25 U/ml is and what it is used for.
2. What you need to know before you use FEIBA 25 U/ml.
3. How to use FEIBA 25 U/ml.
4. Possible side effects.
5. How to store FEIBA 25 U/ml.
6. Content of the pack and other information.
1. WHAT FEIBA 25 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 25 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

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
FEIBA 25 U/ml powder and solvent for solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Factor VIII Inhibitor Bypassing Activity
1 ml contains 25 U* factor VIII inhibitor bypassing activity.
1 vial FEIBA 25 U/ml contains 500 U factor VIII inhibitor bypassing
activity in 200 – 600 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:
FEIBA contains approximately 80 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 6.8
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.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The treatment is to be initiated and monitored by a physician
experienced in the treatment of
coagulation disorders.
_Posology _
Dosage and duration of treatment depend on the severity of the
haemostatic disorder, the
localization and the extent of the bleeding, as well as the clinical
condition of the patient.
Dosage and f