Alphanate 1,000unit powder and solvent for solution for injection vials

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Factor VIII high purity; von Willebrand factor

Предлага се от:

Grifols UK Ltd

АТС код:

B02BD06

INN (Международно Name):

Factor VIII high purity; von Willebrand factor

дозиране:

1000unit ; 1200unit

Лекарствена форма:

Powder and solvent for solution for injection

Начин на приложение:

Intravenous

Клас:

No Controlled Drug Status

Вид предписание :

Never Valid To Prescribe As A VMP

Каталог на резюме:

BNF: 02110000; GTIN: 00368516792223

Данни за продукта

OBJECT 1
ALPHANATE
Summary of Product Characteristics Updated 25-May-2016 | Grifols UK
Ltd
1. Name of the medicinal product
Alphanate
®
, powder for injection.
2. Qualitative and quantitative composition
Alphanate
®
is a high purity solvent detergent and heat treated preparation of
human coagulation factor
VIII, freeze-dried, Ph. Eur. Alphanate
®
also contains human von Willebrand factor at pharmacologically
effective levels.
Alphanate
®
is presented as a powder and solvent for solution for injection
containing nominally 250 IU,
500 IU, 1000 IU or 1500 IU human coagulation factor VIII and 300, 600,
1200 or 1800 IU of human von
Willebrand factor per vial.
Alphanate
®
250 IU contains approximately 50 IU/ml human coagulation factor VIII
and 60 IU/ml human
von Willebrand factor when reconstituted with 5 ml sterile Water for
Injections, Ph. Eur.
Alphanate
®
500 IU contains approximately 100 IU/ml human coagulation factor VIII
and 120 IU/ml
human von Willebrand factor activity when reconstituted with 5 ml
sterile Water for Injections, Ph. Eur.
Alphanate
®
1000 IU contains approximately 100 IU/ml human coagulation factor VIII
and 120 IU/ml
human von Willebrand factor activity when reconstituted with 10 ml
sterile Water for Injections, Ph. Eur.
Alphanate
®
1500 IU contains approximately 150 IU/ml human coagulation factor VIII
and 180 IU/ml
human von Willebrand factor activity when reconstituted with 10 ml
sterile Water for Injections, Ph. Eur.
Each container is labelled with the number of International Units of
factor VIII and von Willebrand factor
activity.
The factor VIII potency is determined using the Activated Partial
Thromboplastin Time method, which
gives results comparable to the European Pharmacopoeia chromogenic
assay, and a reference standard
calibrated against the WHO International Standard (FVIII:C IU).
The von Willebrand factor potency is determined by measuring the
ristocetin cofactor activity using a
reference standard calibrated against the WHO International Standard
(VWF:RCo IU).
The specific ac