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

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
26-11-2017

Aktivna sestavina:

simoctocog alfa, Quantity: 250 IU

Dostopno od:

Octapharma Australia Pty Ltd

INN (mednarodno ime):

simoctocog alfa

Farmacevtska oblika:

Injection, powder for

Sestava:

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

Pot uporabe:

Intravenous

Enote v paketu:

1 vial

Tip zastaranja:

exempt from scheduling - Appendix A; prescription medicine

Terapevtske indikacije:

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.

Povzetek izdelek:

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

Status dovoljenje:

Licence status A

Datum dovoljenje:

2014-11-10