actilyse alteplase injection 50mg per vial per carton

Description

Indication & Scope

Actilyse® is a recombinant tissue plasminogen activator (rt-PA) indicated for intravenous thrombolytic therapy in eligible patients with acute ischemic stroke, acute myocardial infarction, and hemodynamically unstable acute pulmonary embolism.

Mechanism: Alteplase selectively binds to fibrin within thrombi and converts plasminogen into plasmin, promoting fibrin degradation and dissolution of pathological blood clots to restore vascular blood flow.
Drug class: Recombinant tissue plasminogen activator (rt-PA) / Thrombolytic agent.
Clinical use: Intravenous thrombolysis within 4.5 hours after onset of acute ischemic stroke symptoms, thrombolytic treatment for acute myocardial infarction according to approved time-window protocols, and emergency thrombolysis for hemodynamically unstable massive pulmonary embolism under specialist monitoring.

Specification

Generic Name	Alteplase for Injection
Brand Name	Actilyse®
Ingredient	Alteplase
Dosage Form	Injection (Lyophilized Powder for Intravenous Infusion)
Package	50 mg/vial/carton (with matching sterile diluent and transfer device)
Conditions Treated	Acute ischemic stroke, acute myocardial infarction, and hemodynamically unstable acute pulmonary embolism requiring thrombolysis
Taboos	Hypersensitivity to alteplase or any component of the product; active bleeding; history of intracranial hemorrhage; intracranial neoplasm, arteriovenous malformation or aneurysm; recent major surgery, trauma, or stroke; severe uncontrolled hypertension; coagulation disorders; pregnancy (unless benefits outweigh risks).
Place of origin	Germany
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store at 2–8°C, protect from light. Do not freeze. Reconstituted solution should be used promptly according to approved labeling.
Manufacturer	Boehringer Ingelheim Pharma GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG
Registration Authority	National Medical Products Administration (NMPA), China
Approval Number	SJ20160055
Approval Date	May 8, 2026
Shelf Life	24 months

How to use ?

Recommended Dose: For acute ischemic stroke, the recommended dose is 0.9 mg/kg administered by intravenous infusion (maximum dose 90 mg). Administer 10% of the total dose as an initial intravenous bolus over 1 minute, followed by the remaining dose over 60 minutes. Treatment should be initiated within 4.5 hours after symptom onset. For acute myocardial infarction, dosing depends on body weight and the approved thrombolysis regimen, including an accelerated 90-minute infusion protocol for eligible patients. For hemodynamically unstable massive pulmonary embolism, the recommended dose is 100 mg administered by intravenous infusion over 2 hours.

Time: Administer according to the indication-specific thrombolysis protocol under hospital monitoring.

Instructions for use: Reconstitute only with the supplied diluent. Administer by intravenous infusion only. Monitor bleeding, blood pressure, neurological status, and coagulation parameters during treatment.

Interaction: Concurrent use with anticoagulants, antiplatelet agents, or NSAIDs may increase bleeding risk. Alteplase has no clinically significant CYP450-mediated drug interactions.

Side effects: Common adverse reactions include bleeding, bruising, nausea, vomiting, hypotension, and fever. Serious reactions include intracranial hemorrhage, major bleeding, allergic reactions, angioedema, and reperfusion arrhythmias.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is Actilyse®?

Actilyse® is a recombinant thrombolytic medicine containing alteplase, used to dissolve blood clots blocking blood vessels.

How does alteplase work?

It activates plasminogen into plasmin, which breaks down fibrin structures within blood clots and restores blood flow.

Who may receive Actilyse® treatment?

Eligible patients with acute ischemic stroke, acute myocardial infarction, or unstable massive pulmonary embolism may receive treatment after specialist evaluation.

Why must it be administered in a hospital?

Because alteplase can cause severe bleeding, including life-threatening intracranial hemorrhage, requiring emergency monitoring and management.