Nuwiq, Human cell line recombinant human factor VIII (Human-cl rhFVIII) 4000 IU powder and solvent for solution for injection. Vial of powder and prefilled WFI syringe

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
12-01-2021

有效成分:

simoctocog alfa, Quantity: 4000 IU

可用日期:

Octapharma Australia Pty Ltd

药物剂型:

Injection, powder for

组成:

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

给药途径:

Intravenous

每包单位数:

1 vial

处方类型:

exempt from scheduling - Appendix A; prescription medicine

疗效迹象:

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.

產品總結:

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

授权状态:

Registered

授权日期:

2020-11-12