Registered Rwanda · Rwanda FDA

METALYSE 10,000 IU

Tenecteplase 1,000units (5mg) per ml

Rwanda FDA-HMP-MA-1339 Powder for injection 1,000units (5mg) per ml INN generic

What it does

Tenecteplase is a medication used to dissolve blood clots in certain medical emergencies.

Commonly used for: heart attack (myocardial infarction), pulmonary embolism

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1339
Registration date
18/05/2024
Expiry date
17/05/2029
Status
Registered
Active ingredient
Tenecteplase 1,000units (5mg) per ml
Dosage form
Powder for injection
Strength
1,000units (5mg) per ml
Pack size
Vial Pre-filled syringe
Therapeutic class
-
Manufacturer / MAH
Boehringer Ingelheim
Country of origin
GERMANY
Manufacturer location
Binger Str. 173, 55218 Ingelheim am Rhein, Germany

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:13 · updated 2026-09-21 02:30:20

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Tenecteplase is a medication used to dissolve blood clots in certain medical emergencies.

What it treats

  • heart attack (myocardial infarction)
  • pulmonary embolism

How it works

It helps break down clots that block blood flow to the heart or lungs.

Who it's for

It is for adults experiencing a heart attack or certain types of severe blood clots.

Cautions

  • • Avoid use with other medications that thin the blood.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Tenecteplase

BNF-referenced

Tenecteplase is a recombinant tissue plasminogen activator (tPA) used primarily in the treatment of acute myocardial infarction. It works by promoting the conversion of plasminogen to plasmin, leading to the breakdown of fibrin clots in the blood vessels, thereby restoring blood flow to the heart muscle. It is administered via intravenous injection and is indicated for use in emergency settings where rapid thrombolysis is required.

Indications

  • Acute myocardial infarction
  • Acute coronary syndromes

Dosage

Adults: 30–50 mg (maximum per dose 50 mg), administered intravenously over 10 seconds, initiated within 6 hours of symptom onset.

Mechanism of action

Tenecteplase is a genetically engineered variant of tissue plasminogen activator (tPA) that binds to fibrin in a thrombus (blood clot) and activates plasminogen, converting it to plasmin. This process leads to the degradation of fibrin, thus facilitating the dissolution of the clot and restoration of normal blood flow.

Pharmacodynamics

The pharmacodynamic effects of tenecteplase include rapid thrombolysis in patients with acute myocardial infarction. The drug's fibrin specificity and longer half-life compared to alteplase contribute to its efficiency in dissolving clots. It enhances the body's ability to recanalize occluded coronary arteries, resulting in improved myocardial perfusion.

Pharmacokinetics

Tenecteplase is administered intravenously, with a bioavailability approaching 100%. The drug has a half-life of approximately 20 to 25 minutes, allowing for rapid action. Its clearance is primarily through the liver, and plasma levels can be affected by factors such as age, weight, and renal function. Monitoring is essential to ensure effective dosing and minimize the risk of bleeding complications.

Contra-indications

  • Aortic stenosis
  • Cardiac tamponade
  • Head trauma
  • Toxic pulmonary oedema
  • Recent history of myocardial infarction
  • Susceptibility to angle-closure glaucoma
  • Ventilation and perfusion abnormalities

Adverse effects

  • Drowsiness
  • Hemiparesis
  • Venous thrombosis
  • Arrhythmias
  • Asthenia
  • Cerebral ischaemia
  • Dizziness
  • Flushing
  • Headache
  • Hypotension
  • Nausea
  • Vomiting
  • Circulatory collapse
  • Diarrhoea
  • Skin reactions

Interactions

  • Nitrates may develop tolerance leading to reduced therapeutic effects
  • Care should be taken when used with other anticoagulants or antiplatelet agents

Precautions

  • Caution in elderly patients due to potential for postural hypotension and falls
  • Patients on long-acting nitrates should have doses adjusted to avoid tolerance
  • Monitor for signs of bleeding

Pregnancy

Manufacturer advises caution, as risk cannot be ruled out.

Breast-feeding

Manufacturer advises avoiding breastfeeding for 24 hours after dose; express and discard milk during this time.

Storage

Store in a cool, dry place. Protect from light. Store vials in the original package until use.

Formulations

  • Powder for solution for infusion
BNF 85 (British National Formulary) p.258 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.