Nuwiq, Human cell line recombinant human factor VIII (Human-cl rhFVIII) 3000 IU powder and solvent for solution for injection. Vial of powder and prefilled WFI syringe

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

simoctocog alfa, Quantity: 3000 IU

Διαθέσιμο από:

Octapharma Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, powder for

Σύνθεση:

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

Οδός χορήγησης:

Intravenous

Μονάδες σε πακέτο:

1 vial

Τρόπος διάθεσης:

exempt from scheduling - Appendix A; prescription medicine

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-11-12