Finished product reference
Factor Vii
Injection, Powder, for Solution · Parenteral · 600 IU
- List code
- 21121
- Pharmacologic class
- Blood coagulation factor; plasma-derived human factor VII concentrate
What it is and how it works
Factor VII is a vitamin K-dependent coagulation factor that, after activation and binding to tissue factor at the site of injury, activates factors IX and X and initiates thrombin generation through the extrinsic pathway. The concentrate replaces deficient factor VII.
Indications
Treatment and prophylaxis of bleeding in patients with congenital factor VII deficiency, including surgical prophylaxis.
Dosage and administration (summary)
Dosing is individualised by the specialist according to body weight, baseline factor VII level, type of bleeding or surgery and clinical response, with factor VII activity monitoring; it is given by slow intravenous injection.
Contraindications
Known hypersensitivity to the product or its components, and, for products containing heparin, history of heparin-induced thrombocytopenia.
Warnings and precautions
There is a risk of thrombosis or disseminated intravascular coagulation, particularly with high or repeated doses and in patients with liver disease, after major surgery or with thrombotic risk factors. Inhibitor development and hypersensitivity reactions may occur, and plasma-derived products carry a theoretical risk of infectious agent transmission.
Pregnancy
Use only if clearly needed, as experience is limited.
Storage and supply
Store refrigerated at 2–8 °C; do not freeze; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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