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

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

simoctocog alfa, Quantity: 250 IU

Disponibbli minn:

Octapharma Australia Pty Ltd

INN (Isem Internazzjonali):

simoctocog alfa

Għamla farmaċewtika:

Injection, powder for

Kompożizzjoni:

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

Rotta amministrattiva:

Intravenous

Unitajiet fil-pakkett:

1 vial

Tip ta 'preskrizzjoni:

exempt from scheduling - Appendix A; prescription medicine

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2014-11-10