REPLENINE - VF 1000

Страна: Израиль

Язык: английский

Источник: Ministry of Health

Активный ингредиент:

FACTOR IX

Доступна с:

KAMADA LTD, ISRAEL

код АТС:

B02BD01

Фармацевтическая форма:

POWDER FOR SOLUTION FOR INJECTION

состав:

FACTOR IX 1000 IU/VIAL

Администрация маршрут:

I.V

Тип рецепта:

Required

Производитель:

BIO PRODUCTS LABORATORY LIMITED, UK

Терапевтическая группа:

COAGULATION FACTOR IX, II, VII AND X IN COMBINATION

Терапевтические области:

COAGULATION FACTOR IX, II, VII AND X IN COMBINATION

Терапевтические показания :

Treatment and prophylaxis of bleeding in patients with haemophilia B ( congenital factor IX deficiency).

Дата Авторизация:

2021-07-31

Характеристики продукта

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R
R
E
E
P
P
L
L
E
E
N
N
I
I
N
N
E
E
-
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V
V
F
F
1.
NAME OF THE MEDICINAL PRODUCT
Replenine-VF 500, powder for solution for injection
Replenine-VF 1000, powder 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment
should
be
under
the
supervision
of
a
physician
experienced
in
the
treatment
of
haemophilia.
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2
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_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 repeated infusions.
Individual patients may vary in their
response to factor IX, demonstrating different half-lives and
recoveries. Dose based