Finished product reference
Activated Prothrombin Complex (Concentrated)
Injection, Powder, Lyophilized, for Solution · Parenteral · 500 IU
- List code
- 19
- Pharmacologic class
- Blood product; factor VIII inhibitor bypassing agent (activated prothrombin complex concentrate, aPCC)
What it is and how it works
Plasma-derived concentrate containing factors II, IX and X mainly in non-activated form and factor VII mainly in activated form. It generates thrombin independently of factor VIII and IX activity, bypassing inhibitors to restore haemostasis.
Indications
Treatment and prophylaxis of bleeding in haemophilia A or B patients with inhibitors, and in acquired haemophilia due to factor VIII inhibitors.
Dosage and administration (summary)
Dosing is individualised by the haematologist according to the bleeding episode and protocol; given by slow intravenous infusion with a maximum single dose and daily dose limit to avoid thrombosis.
Contraindications
Disseminated intravascular coagulation; acute thrombosis or embolism including myocardial infarction, unless life-threatening bleeding.
Warnings and precautions
Risk of thromboembolic events and DIC, particularly at high doses or with concomitant emicizumab, tranexamic acid or recombinant factor VIIa. As a plasma-derived product, transmission of infectious agents cannot be totally excluded. Monitor for hypersensitivity reactions.
Pregnancy
Use only if clearly needed because experience in pregnancy is limited.
Storage and supply
Store at 2–25 °C as specified by the product, do not freeze, protect from light; use promptly after reconstitution.
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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