Replenine-VF, 50 IU/mL human factor IX, a powder for solution.
Country: Малта
Језик: Енглески
Извор: Medicines Authority
Информативни летак
(PIL)
29-05-2024
Карактеристике производа
(SPC)
29-05-2024
Активни састојак:
FACTOR IX, HUMAN
Доступно од:
Bio Products Laboratory Limited
АТЦ код:
B02BD04
INN (Међународно име):
FACTOR IX, HUMAN
Фармацеутски облик:
POWDER FOR SOLUTION FOR INJECTION
Састав:
FACTOR IX, HUMAN 50 international unit(s)/millilitre
Тип рецептора:
POM
Терапеутска област:
ANTIHEMORRHAGICS
Статус ауторизације:
Authorised
Датум одобрења:
2005-10-12
Информативни летак
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REPLENINE
®
-VF 250 IU, 500 IU, 1000 IU
POWDER FOR SOLUTION FOR INJECTION
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Карактеристике производа
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
REPLENINE
®
-VF
High Purity Factor IX
1.
NAME OF MEDICINAL PRODUCT
Replenine
®
-VF, 50 IU/mL human factor IX, a powder for solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Replenine-VF is a high purity factor IX. This product is prepared from plasma from
screened donors. Donors are selected from the USA.
Replenine-VF is presented as a sterile powder for solution, containing nominally 250 IU,
500 IU or 1000 IU human coagulation factor IX per vial. The product contains
approximately 50 IU/mL when reconstituted with either 5 mL (250 IU vial), 10 mL (500 IU
vial) or 20 mL (1000 IU vial) of Sterilised Water for Injections, Ph.Eur..
One mL of Replenine-VF contains approximately 100 IU of human coagulation factor IX
after reconstitution at half volume (see 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 per mg of protein.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Replenine-VF is a powder for solution; it is a freeze-dried concentrate of factor IX for
reconstitution with Sterilised Water for Injections, Ph.Eur.. After reconstitution with the
supplied sterile water diluent, the product is administered intravenously.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis in patients with haemophilia B (congenital factor IX deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physic
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