Finished product reference
Factor Xiii
Injection, Powder, Lyophilized, for Solution · Parenteral · 1250 IU
- List code
- 53749
- Pharmacologic class
- Blood coagulation factor; factor XIII concentrate (plasma-derived or recombinant)
What it is and how it works
Factor XIII (fibrin-stabilising factor) is a transglutaminase that, once activated by thrombin, cross-links fibrin monomers and incorporates α2-antiplasmin into the clot, making it mechanically stable and resistant to fibrinolysis. Replacement restores clot stability in factor XIII deficiency.
Indications
Prophylaxis and treatment of bleeding in congenital factor XIII deficiency, including perioperative use; the recombinant A-subunit product is only for factor XIII A-subunit deficiency.
Dosage and administration (summary)
Dosing is individualised by the haemostasis specialist; routine prophylaxis is usually given by slow intravenous injection about every 4 weeks, with the dose based on body weight and adjusted to maintain an adequate trough factor XIII activity.
Contraindications
Known hypersensitivity to the active substance or excipients.
Warnings and precautions
Hypersensitivity reactions and inhibitor development may occur; an inadequate response should prompt testing for inhibitors. Thrombosis may occur in patients with risk factors, and plasma-derived products carry a theoretical risk of transmitting infectious agents.
Pregnancy
Factor XIII deficiency is associated with recurrent miscarriage, and replacement is used during pregnancy under specialist supervision.
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.
Other presentations of the same active ingredient
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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