ACTILYSE 50mg (Alteplase) INJ

When it comes to emergency medical situations such as stroke, myocardial infarction, or pulmonary embolism, rapid and effective thrombolytic therapy is essential. Actilyse Powder (Alteplase 50 mg) is a trusted solution in such critical care scenarios, offering healthcare professionals a potent and targeted approach to dissolving life-threatening blood clots.

What is Actilyse Powder?

Actilyse Powder contains Alteplase, a recombinant tissue plasminogen activator (t-PA) produced using advanced recombinant DNA technology in Chinese hamster ovary cell lines. Each vial contains 50 mg of Alteplase (equivalent to 29,000,000 International Units [IU]), ensuring high potency and reliability.

Key Features and Composition

Dosage Form: Powder for injection (lyophilizate cake)

Route of Administration: Intravenous (IV)

Composition: Alteplase 50 mg per vial (29,000,000 IU)

Production: Recombinant DNA technique; activity verified against WHO standards

Specific Activity: 522,000 to 696,000 IU/mg

Regulatory and Product Information

Product Category: Drugs

Marketing Category: Prescription-only Medicine (POM)

Packaging

Actilyse Powder is supplied as a single vial (1 x 1’s) containing the powder and a solvent for reconstitution, suitable for both injection and infusion. The powder presents as a colourless to pale yellow lyophilizate cake, while the reconstituted solution remains clear and colourless to pale yellow.

Manufacturer Details

Manufacturer Name: Boehringer Ingelheim Pharma GmbH & Co. KG

Manufacturer Country: Germany

Clinical Applications

Alteplase is a thrombolytic agent used for the treatment of acute ischemic stroke, acute myocardial infarction (heart attack), and pulmonary embolism. By catalyzing the conversion of plasminogen to plasmin, it rapidly dissolves fibrin clots, restoring blood flow and minimizing tissue damage in emergency settings.