Finished product reference

Fibrinogen

Injection, Powder, for Solution · Parenteral · 1 g

List code
532
Pharmacologic class
Blood coagulation factor; human fibrinogen concentrate (factor I)

What it is and how it works

Fibrinogen is a soluble plasma glycoprotein that thrombin converts to fibrin monomers, which polymerise and, after cross-linking by factor XIIIa, form the structural meshwork of the haemostatic clot. Fibrinogen also supports platelet aggregation via glycoprotein IIb/IIIa. Concentrate restores plasma fibrinogen levels.

Indications

Treatment and prophylaxis of bleeding in congenital hypo- or afibrinogenaemia; in some regions also as complementary therapy for uncontrolled severe bleeding with acquired hypofibrinogenaemia (e.g. in surgery, trauma or obstetric haemorrhage).

Dosage and administration (summary)

Dosing is individualised by the specialist according to the target plasma fibrinogen level, measured baseline level, body weight and clinical situation; it is given by slow intravenous injection or infusion with laboratory monitoring of fibrinogen.

Contraindications

Known hypersensitivity to the active substance or excipients.

Warnings and precautions

There is a risk of thrombosis, particularly with high or repeated doses and in patients with risk factors for thromboembolism, and of hypersensitivity or anaphylactic reactions. As a plasma-derived product, it carries a theoretical risk of transmitting infectious agents.

Pregnancy

Use only if clearly needed; it is used in the management of congenital fibrinogen deficiency and obstetric bleeding under specialist supervision.

Storage and supply

Store at 2–25 °C according to the product information; 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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