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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