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
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
12-01-2021
अनुरोध भेजा।
सक्रिय संघटक:
simoctocog alfa, Quantity: 4000 IU
थमां उपलब्ध:
Octapharma Australia Pty Ltd
फार्मास्यूटिकल फॉर्म:
Injection, powder for
रचना:
Excipient Ingredients: poloxamer; arginine hydrochloride; sucrose; sodium chloride; sodium citrate dihydrate; calcium chloride dihydrate
प्रशासन का मार्ग:
Intravenous
पैकेज में यूनिट:
1 vial
प्रिस्क्रिप्शन प्रकार:
exempt from scheduling - Appendix A; prescription medicine
चिकित्सीय संकेत:
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.
उत्पाद समीक्षा:
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
प्राधिकरण का दर्जा:
Registered
प्राधिकरण की तारीख:
2020-11-12
