Replenine-VF 50 IU/ml powder and solvent for solution for injection

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

FACTOR IX, HUMAN

זמין מ:

BPL Bioproducts Laboratory GmbH Dornhofstraße 34, 63263 Neu-Isenburg,, Germany

קוד ATC:

B02BD04

INN (שם בינלאומי):

FACTOR IX, HUMAN 50 IU/ml

טופס פרצבטיות:

POWDER FOR SOLUTION FOR INJECTION

הרכב:

FACTOR IX, HUMAN 50 IU/ml

סוג מרשם:

POM

איזור תרפויטי:

ANTIHEMORRHAGICS

מצב אישור:

Withdrawn

תאריך אישור:

2005-10-12

עלון מידע

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
REPLENINE-VF 50 IU/ML
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
high purity factor IX
PLEASE 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Replenine-VF is and what it is used for
2.
What you need to know before you use Replenine-VF
3.
How to use Replenine-VF
4.
Possible side effects
5.
How to store Replenine-VF
6.
Contents of the pack and other information
1.
WHAT REPLENINE-VF IS AND WHAT IT IS USED FOR
Replenine-VF contains a high purity factor IX concentrate, a protein
that is used to prevent and treat
bleeding in patients with haemophilia B (an inherited shortage of
factor IX in the blood). Your doctor
will explain further why this medicine has been given to you.
Replenine-VF can be used in patients of all age groups.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REPLENINE-VF
DO NOT USE REPLENINE-VF
-
if you are allergic (hypersensitive) to human coagulation factor IX or
any of the other
ingredients of this medicine (listed in section 6).
Talk to your doctor if you think this applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Replenine-VF if
you:
-
have heart or liver disease
-
have a risk of blood clotting
-
have had surgery recently
-
have a high level of antibodies to factor IX (Your doctor may give you
an alternative treatment).
Your doctor or nurse will check the level of factor IX and antibodies
in your blood before and after
treatment, especially for your first injectio

מאפייני מוצר

1
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Replenine-VF 50 IU/ml powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Replenine-VF contains high purity human coagulation factor IX.
500 IU
Each vial contains nominally 500 IU human coagulation factor IX.
Replenine-VF contains approximately 50 IU/ml of human coagulation
factor IX after reconstitution at
full volume.
1000 IU
Each vial contains nominally 1000 IU human coagulation factor IX.
Replenine-VF contains approximately 50 IU/ml of human coagulation
factor IX after reconstitution at
full volume.
One ml of Replenine-VF contains approximately 100 IU human coagulation
factor IX after
reconstitution at half volume (see section 6.6).
The potency (IU) is determined using the European Pharmacopoeia one
stage clotting test. The
specific activity of Replenine-VF is approximately 100 IU/mg protein.
Produced from the plasma of human donors.
Excipient with known effect:
This medicinal product contains up to 83 mg sodium per vial,
equivalent to 4% of the WHO
recommended maximum daily intake of 2 g sodium for an adult.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: White or slightly coloured powder.
Solvent: Clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia B
(congenital factor IX
deficiency).
Replenine-VF can be used for all age groups.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a physician experienced
in the treatment of haemophilia.
_Treatment monitoring _
During the course of treatment, appropriate determination of factor IX
levels is advised to guide the
3
_ _
dose to be administered and the frequency of repeated infusions.
Individual patients may vary in their
response to factor IX, demonstrating different half-lives and
recoveries. Dose based on body weight
may require adjustment i