Nuwiq, Human cell line recombinant human factor VIII (Human-cl rhFVIII), 2000IU, powder and solvent for solution for injection. Vial of powder and prefilled WFI syringe

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

simoctocog alfa, Quantity: 2000 IU

Disponibil de la:

Octapharma Australia Pty Ltd

INN (nume internaţional):

simoctocog alfa

Forma farmaceutică:

Injection, powder for

Compoziție:

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

Calea de administrare:

Intravenous

Unități în pachet:

1 vial

Tip de prescriptie medicala:

exempt from scheduling - Appendix A; prescription medicine

Indicații terapeutice:

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.

Rezumat produs:

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

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2014-11-10