Aimafix 500IU/10ml, powder and solvent for solution for infusion

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

FACTOR IX, HUMAN

متاح من:

Kedrion S.p.A Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga - Lucca, Italy

ATC رمز:

B02BD04

INN (الاسم الدولي):

FACTOR IX, HUMAN 500 IU

الشكل الصيدلاني:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

تركيب:

FACTOR IX, HUMAN 500 IU

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTIHEMORRHAGICS

الوضع إذن:

Authorised

تاريخ الترخيص:

2007-04-16

نشرة المعلومات

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AIMAFIX 500 IU/10 ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
HUMAN PLASMA COAGULATION FACTOR IX
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, 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 signs of illness 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.
WHAT IS IN THIS LEAFLET
1. What AIMAFIX is and what it is used for
2. What you need to know before you use AIMAFIX
3. How to use AIMAFIX
4. Possible side effects
5. How to store AIMAFIX
6. Contents of the pack and other information
1
. WHAT AIMAFIX IS AND WHAT IT IS USED FOR
AIMAFIX is a solution containing coagulation factor IX derived from
human blood. Factor IX is a
protein with an antihemmorrhagic action.
AIMAFIX is used in the following therapies:
-
Treatment
and
prophylaxis
(prevention)
of
bleeding
in
patients
with
haemophilia
B
(congenital factor IX deficiency).
-
management of acquired factor IX deficiency.
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2. WHAT YOU NEED TO KNOW BEFORE YOU USE AIMAFIX
DO NOT USE AIMAFIX
If you are allergic to Factor IX or any of the other ingredients of
this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using AIMAFIX.
As with any intravenous protein product, allergic type
hypersensitivity reactions are possible.
AIMAFIX contains traces of human proteins other than factor IX.
IF DURING THE ADMINISTRATION OF THIS MEDICINE YOU NOTICE SOME OF THE
SYMPTOMS LISTED BELOW, YOU
SHOULD DISCONTINUE IMMEDIATELY THE USE OF THIS MEDICINE AND CONTACT
YOUR PHYSICIAN
since these
symptoms could be the early signs of an allergic re

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
AIMAFIX 500 IU/10 ml, powder and solvent for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human plasma coagulation factor IX.
Each vial contains nominally 500 IU human coagulation factor IX.
AIMAFIX contains approximately 50 IU/ml (500 IU/10 ml) of human
coagulation factor IX after
reconstitution.
AIMAFIX
500 IU/10 ML
Human plasma coagulation factor
IX
500 IU/vial
Human plasma coagulation factor
IX reconstituted with water for
injections
50 IU/ ml
(500 IU/10 ml)
solvent volume
10 ml
The potency (IU) is determined using the European Pharmacopoeia
coagulation method “one stage”..
The specific activity of AIMAFIX is approximately 100 IU/mg protein.
Produced from the plasma of human donors.
Excipients with known effect:
This medicinal product contains up to 41 mg sodium per vial of 10 ml.
This medicine contains up to 10 IU/ml heparin.
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For a full list of excipients, see paragraph 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
The medicinal product is a white or pale yellow powder, or friable
solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia B
(congenital factor IX deficiency).
This product may be used in the management of acquired factor IX
deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be carried out under the supervision of a physician
experienced in the treatment of
haemophilia.
Previously untreated patients
The safety and efficacy of AIMAFIX in previously untreated patients
have not yet been established. No data
are available.
Treatment monitoring
During the course of treatment, appropriate determination of factor IX
levels is advised to guide the dose to
be administered and the frequency of infusions. Factor IX responses
may vary in individual patients,
reaching different levels of in vivo rec