Nuwiq, Human cell line recombinant human factor VIII (Human-cl rhFVIII), 250IU, powder and solvent for solution for injection. Vial of powder and prefilled WFI syringe

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
26-11-2017

Toimeaine:

simoctocog alfa, Quantity: 250 IU

Saadav alates:

Octapharma Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

simoctocog alfa

Ravimvorm:

Injection, powder for

Koostis:

Excipient Ingredients: sucrose; sodium chloride; sodium citrate dihydrate; poloxamer; calcium chloride dihydrate; arginine hydrochloride

Manustamisviis:

Intravenous

Ühikuid pakis:

1 vial

Retsepti tüüp:

exempt from scheduling - Appendix A; prescription medicine

Näidustused:

Treatment and prophylaxis of bleeding (also during and after surgery) in previously treated paediatric (>= 2 years) and adult patients with haemophilia A (congenital factor VIII deficiency). Nuwiq does not contain von Willebrand Factor and is thus not indicated to treat von Willebrand?s Disease.

Toote kokkuvõte:

Visual Identification: Nuwiq - white to off-white lyophilised powder,WFI - clear, colourless liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2014-11-10