Biostate

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Dried factor VIII fraction 500 [iU]; von Willebrand's factor : Ristocetin cofactor 1000 [iU]

Commercializzato da:

CSL Behring (NZ) Ltd

INN (Nome Internazionale):

Dried factor VIII fraction 500 IU

Dosaggio:

500 IU

Forma farmaceutica:

Injection with diluent

Composizione:

Active: Dried factor VIII fraction 500 [iU] von Willebrand's factor : Ristocetin cofactor 1000 [iU] Excipient: Albumin Calcium chloride dihydrate Plasma protein Sodium chloride Sodium citrate dihydrate Sucrose Trometamol Water for injection

Confezione:

Combination pack, Powder + Diluent + Reconstitution device, 1 dose unit

Classe:

General sale

Tipo di ricetta:

General sale

Prodotto da:

CSL Behring (Australia) Pty Ltd

Indicazioni terapeutiche:

Biostate® is indicated for: · the prophylaxis and treatment of non-surgical and surgical bleeding in patients with von Willebrand disease when desmopressin (DDAVP) treatment is ineffective or contraindicated

Dettagli prodotto:

Package - Contents - Shelf Life: Combination pack, Powder + Diluent + Reconstitution device - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. one excursion of up to 6 months at 25°C allowed - Vial, glass, Lyophilised powder, 500/1000 IU of FVIII/VWF - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. one excursion of up to 6 months at 25°C allowed - Vial, glass, Diluent - 5 mL - 60 months from date of manufacture stored at or below 25°C

Data dell'autorizzazione:

2009-09-21

Scheda tecnica

NEW ZEALAND DATA SHEET
Biostate NZ DS 20.00
Page 1 of 20
1 PRODUCT NAME
Biostate
®
250 IU FVIII/500 IU VWF powder and diluent (5 mL) for solution for
injection
Biostate
®
500 IU FVIII/1000 IU VWF powder and diluent (5 mL) for solution for
injection
Biostate
®
500 IU FVIII/1000 IU VWF powder and diluent (10 mL) for solution for
injection
Biostate
®
1000 IU FVIII/2000 IU VWF powder and diluent (10 mL) for solution for
injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Biostate
®
is a high purity, sterile, powder for injection containing a human
coagulation factor VIII
(FVIII) and human von Willebrand factor (VWF) complex.
Biostate
®
is manufactured from human plasma donated by New Zealand’s voluntary
non-remunerated
donors. The FVIII/VWF complex in Biostate
®
is purified from cryoprecipitate using selective
precipitation and size exclusion chromatography steps. It contains
other proteins such as fibrinogen,
fibronectin, immunoglobulins (IgA, IgM, IgG) and transforming growth
factor-β (TGF-β) all of which
are present at significantly lower levels than in normal plasma.
Biostate
®
250 IU FVIII/500 IU VWF powder and diluent for solution for injection
One vial of powder contains nominally:
-
250 IU human coagulation factor VIII (FVIII).
-
500 IU human von Willebrand factor (VWF).
After reconstitution with the 5 mL water for injections provided, the
solution contains 50 IU/mL of
FVIII and 100 IU/mL of VWF.
Biostate
®
500 IU FVIII/1000 IU VWF powder and diluent for solution for injection
One vial of powder contains nominally:
-
500 IU human coagulation factor VIII (FVIII).
-
1000 IU human von Willebrand factor (VWF).
After reconstitution with the 10 mL water for injections provided, the
solution contains 50 IU/mL of
FVIII and 100 IU/mL of VWF.
Biostate
®
500 IU FVIII/1000 IU VWF powder and diluent for solution for injection
One vial of powder contains nominally:
-
500 IU human coagulation factor VIII (FVIII).
-
1000 IU human von Willebrand factor (VWF).
After reconstitution with the 5 mL water for injecti