Actilyse Injection 50 mg/50 ml contains Alteplase, a recombinant tissue plasminogen activator (rt-PA) used as a thrombolytic agent. It is designed to dissolve blood clots in emergency, life-threatening conditions such as acute myocardial infarction, acute ischemic stroke, and massive pulmonary embolism. Alteplase works by activating plasminogen to plasmin, the enzyme responsible for breaking down fibrin clots.

Actilyse is administered intravenously in hospital settings under strict medical supervision. Rapid administration in appropriate patients can restore blood flow, minimize tissue damage, and significantly improve clinical outcomes.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Composition

Each vial contains:

• Alteplase 50 mg (as sterile lyophilized powder for reconstitution)

After reconstitution, the solution delivers 50 mg Alteplase in 50 ml for intravenous use.

Indications

Actilyse Injection 50 mg/50 ml is indicated for:

• Acute ST-elevation myocardial infarction (STEMI) to reduce mortality and preserve cardiac function

• Acute ischemic stroke (within the recommended therapeutic window) to improve neurological recovery

• Acute massive pulmonary embolism with hemodynamic instability

Early treatment is critical to achieving optimal outcomes.

Mechanism of Action

Alteplase is a genetically engineered form of human tissue plasminogen activator. It binds to fibrin within a thrombus and converts entrapped plasminogen into plasmin. Plasmin then breaks down fibrin strands, leading to clot dissolution.

Unlike non-specific thrombolytics, Alteplase has relative fibrin specificity, meaning it primarily acts at the site of the clot. This targeted action helps restore blood flow while minimizing systemic fibrinolysis, although bleeding risk remains a major consideration.

Dosage and Administration

Actilyse must be administered by healthcare professionals experienced in thrombolytic therapy.

Dosage varies depending on the indication:

• Acute Myocardial Infarction: Administered as accelerated infusion regimen or 3-hour infusion regimen, depending on clinical protocol.

• Acute Ischemic Stroke: Recommended total dose is 0.9 mg/kg (maximum 90 mg). Ten percent is given as an initial IV bolus, followed by the remainder infused over 60 minutes.

• Pulmonary Embolism: Typically 100 mg over 2 hours (based on protocol and patient weight).

Strict adherence to approved dosing guidelines and patient eligibility criteria is essential.

Contraindications

Actilyse is contraindicated in patients with:

• Active internal bleeding

• History of hemorrhagic stroke

• Recent major surgery or significant trauma

• Severe uncontrolled hypertension

• Known bleeding disorders

Careful risk assessment is mandatory before administration.

Side Effects

The most significant adverse effect is bleeding, including:

• Intracranial hemorrhage

• Gastrointestinal bleeding

• Injection site bleeding

Other possible reactions include hypotension, allergic reactions, and reperfusion arrhythmias in myocardial infarction patients.

Immediate medical intervention is required if serious bleeding occurs.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Precautions and Warnings

• Treatment should only be initiated after confirming diagnosis and eligibility.

• Blood pressure must be controlled before and during therapy.

• Patients must be closely monitored for signs of bleeding and neurological changes.

• Concomitant use of anticoagulants increases bleeding risk.

Storage Conditions

Store refrigerated at 2°C to 8°C. Protect from light. Do not freeze. Keep out of reach of children.