Registered Tanzania · TMDA

Elaxim

Tenecteplase 52.5 mcg/actuation

TZ 20 H 0059 Solution for injection 52.5 INN generic

What it does

Actuation is a medication that may be used for various health conditions.

Read more in plain English ↓

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

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Registration & product details

Registration no.
TZ 20 H 0059
Registration date
2025-03-16
Expiry date
2030-03-15
Status
Registered/Compliant
Active ingredient
Tenecteplase 52.5 mcg/actuation
Strength
52.5
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Gennova Biopharmaceuticals
Country of origin
INDIA
Manufacturer location
Block 1, Plot No. P-1 & P-2, ITBT Park, Hinjawadi Phase 2 Rd, Hinjawadi Phase II, Hinjawadi Rajiv Gandhi Infotech Park, Hinjawadi, Pune, Man, Maharashtra 411057, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:47:37 · updated 2026-10-19 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About actuation

Actuation is a medication that may be used for various health conditions.

How it works

The specific mechanism of how actuation works is not provided.

Who it's for

Actuation is intended for patients with certain health conditions, but specific conditions are not listed.

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

About tenecteplase

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: actuation

Actuation refers to the process through which a drug is delivered from a device, such as an inhaler or nebulizer, allowing for the administration of medication directly to the site of action. This method is commonly used in the treatment of respiratory conditions, ensuring rapid absorption and effect.

Indications

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Acute bronchospasm
  • Respiratory distress

Dosage

Children: Refer to specific drug guidelines in the BNF for Children for accurate dosing information.

Adults: Refer to specific drug guidelines in the BNF for accurate dosing information.

Mechanism of action

The mechanism of action varies depending on the specific drug being actuated, but generally involves the rapid dispersal of drug particles into the airways. For inhaled bronchodilators, they typically work by binding to adrenergic receptors in the bronchial smooth muscle leading to relaxation and dilation of the airways.

Pharmacodynamics

Pharmacodynamics of actuation primarily involves the drug's effects on the respiratory system, with the intention of relieving bronchoconstriction and improving airflow. The duration of action and peak effect can vary widely based on the specific medication used and the delivery technique.

Pharmacokinetics

Pharmacokinetics of inhaled medications generally indicates a rapid onset of action due to the direct delivery to the lungs, with peak plasma concentrations occurring within minutes. The distribution is localized, and the elimination half-life will depend on the specific pharmacological properties of the drug being actuated.

Pregnancy

Limited data on the safety of actuation during pregnancy. Consult a healthcare provider for individualized assessment.

Breast-feeding

Consult a healthcare provider as the effects on breastfed infants are not well-studied.

Storage

Store in a cool, dry place, away from light and moisture.

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

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.