Finished product reference

Reteplase

Injection, Powder, for Solution · Parenteral · 10.4 IU

List code
50033
Pharmacologic class
Thrombolytic (recombinant plasminogen activator)

What it is and how it works

Reteplase is a recombinant, non-glycosylated deletion variant of tissue plasminogen activator. It converts plasminogen to plasmin, which degrades the fibrin matrix of thrombi; its longer half-life allows administration as two bolus injections.

Indications

Thrombolytic treatment of suspected acute myocardial infarction with persistent ST elevation or recent left bundle branch block, within 12 hours of symptom onset.

Dosage and administration (summary)

Given as two intravenous bolus injections of 10 units each, 30 minutes apart, each injected over not more than 2 minutes, with concomitant heparin and antiplatelet therapy.

Contraindications

Active or recent significant bleeding, history of haemorrhagic stroke or stroke of unknown origin, recent ischaemic stroke, recent major surgery or trauma, intracranial neoplasm or vascular malformation, severe uncontrolled hypertension, aortic dissection and bleeding diathesis.

Warnings and precautions

Bleeding, including intracranial haemorrhage, is the main risk; avoid non-compressible punctures and intramuscular injections, and monitor for reperfusion arrhythmias. Do not give with other medicines in the same intravenous line, particularly heparin, without flushing.

Pregnancy

Use in pregnancy only if the benefit outweighs the risk of bleeding.

Storage and supply

Store below 25 °C in the original package, protected 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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