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

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
12-01-2021

Bahan aktif:

simoctocog alfa, Quantity: 4000 IU

Boleh didapati daripada:

Octapharma Australia Pty Ltd

Borang farmaseutikal:

Injection, powder for

Komposisi:

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

Laluan pentadbiran:

Intravenous

Unit dalam pakej:

1 vial

Jenis preskripsi:

exempt from scheduling - Appendix A; prescription medicine

Tanda-tanda terapeutik:

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.

Ringkasan produk:

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 kebenaran:

Registered

Tarikh kebenaran:

2020-11-12