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

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Feiba

Commercializzato da:

Baxalta Innovations GmbH

Codice ATC:

B02BD; B02BD03

INN (Nome Internazionale):

Feiba

Dosaggio:

25 unit(s)/millilitre

Forma farmaceutica:

Powder and solvent for solution for infusion

Via di somministrazione:

slow infusion via the intravenous route

Confezione:

1 vial with 500 U FEIBA powder for solution for infusion

Tipo di ricetta:

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

Gruppo terapeutico:

coagulation factors

Area terapeutica:

Blood coagulation factors; factor VIII inhibitor bypassing activity

Indicazioni terapeutiche:

It is used for: 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

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2010-05-28

Foglio illustrativo

1
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 haemophilia
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
haemophilia 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-haemophilic patients who
have acquired inhibitors to factor VIII.
2
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 expected.

if you are al

Scheda tecnica

Health Products Regulatory Authority
02 December 2020
CRN00C00H
Page 1 of 11
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 haemophilia A patients with inhibitors.

Treatment of bleeding in haemophilia B patients with inhibitors, if no
other specific treatment is available (see
section 5.1).

Treatment of bleeding in non-haemophiliacs with acquired inhibitors to
factor VIII.

Prophylaxis of bleeding in haemophilia A patients with inhibitors who
have experienced a significant bleed or are
at high risk of significant bleeding.
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 we