Mingfule Recombinant Human TNK Tissue-Type Plasminogen Activator for Injection

1. Indications and Usage
Acute Myocardial Infarction (AMI):
Treatment of patients with acute myocardial infarction within 6 hours of symptom onset.
Goal: To limit myocardial damage and preserve left ventricular function by rapidly restoring coronary blood flow .
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Injection ONLY.
Recommended Dosage:
Standard Dose: 16 mg (1.0 x 10⁷ IU).
Frequency: Single bolus dose.
Critical Administration Instructions:
Reconstitution: Reconstitute one vial (16 mg) with 3 mL of Sterile Water for Injection. Gently swirl until dissolved; do not shake vigorously to avoid foaming and loss of activity .
Injection Speed: Administer as a single IV bolus over 5 to 10 seconds.
Timing: Should be administered as early as possible after the onset of symptoms .
3. Mechanism of Action
Fibrin-Specific Activation:
TNK-tPA is a genetically modified variant of tissue-type plasminogen activator (t-PA). It binds to fibrin in the thrombus and converts plasminogen to plasmin.
Therapeutic Result: Plasmin degrades fibrin, dissolving the clot and restoring blood flow.
Enhanced Properties: Compared to native t-PA, TNK-tPA has a higher affinity for fibrin and is more resistant to inhibition by plasminogen activator inhibitor-1 (PAI-1), allowing for a single-bolus administration rather than an infusion .
4. Safety and Warnings
Bleeding (Hemorrhage):
The most common and serious adverse reaction is bleeding, including intracranial hemorrhage (ICH) and gastrointestinal bleeding.
Action: If severe bleeding or ICH occurs, discontinue therapy immediately.
Contraindications:
Active internal bleeding.
History of cerebrovascular accident (CVA) or recent intracranial/intraspinal surgery/trauma (within 2 months).
Intracranial neoplasm, arteriovenous malformation, or aneurysm.
Known bleeding diathesis or uncontrolled severe hypertension .
Hypersensitivity:
Although rare, allergic reactions may occur.
5.Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Bleeding (major and minor), nausea, vomiting, and transient hypotension.
Clinical Research Highlights:
Clinical trials have demonstrated that TNK-tPA is non-inferior to Streptokinase and other t-PA formulations in terms of efficacy for AMI, with the added benefit of single-bolus administration .
6.Drug Interactions
Anticoagulants and Antiplatelets:
Concomitant use of heparin, aspirin, or clopidogrel may increase the risk of bleeding.
Action: Monitor coagulation parameters (APTT, PT) and bleeding signs closely when used in combination .
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Recombinant Human TNK Tissue-Type Plasminogen Activator.
Appearance: White loose solid; reconstituted solution is colorless and clear.
Packaging: Single-use vial (16 mg/1.0 x 10⁷ IU).
Storage: Store at 2°C to 8°C, protected from light. Reconstituted solution should be used immediately or stored at 2-8°C for up to 24 hours .