Prothrombin Complex (Concentrated)

What it is and how it works

Prothrombin complex concentrate contains the vitamin K-dependent coagulation factors II, VII, IX and X (four-factor products), usually with proteins C and S, purified from human plasma. It rapidly restores these factors and normalises coagulation.

Indications

Urgent reversal of vitamin K antagonist anticoagulation (e.g. warfarin) in major bleeding or before urgent surgery; treatment and prophylaxis of bleeding in congenital or acquired deficiency of vitamin K-dependent factors when specific concentrates are unavailable.

Dosage and administration (summary)

Dosing is individualised by the specialist according to INR, body weight and clinical situation, given by slow intravenous injection; vitamin K is given concurrently for warfarin reversal.

Contraindications

Hypersensitivity to the product or heparin (if heparin-containing); history of heparin-induced thrombocytopenia for heparin-containing products; disseminated intravascular coagulation (relative).

Warnings and precautions

Risk of thromboembolic events, including in patients with coronary disease, liver disease or recent thrombosis; monitor clinically and with coagulation tests. As a plasma-derived product, transmission of infectious agents cannot be totally excluded.

Pregnancy

Use in pregnancy only if clearly needed.

Storage and supply

Store according to the manufacturer, usually at 2–25 °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.