International reference: 1 US FDA recall for this ingredient

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. (alteplase)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Botswana.

Registered Botswana · BoMRA

ACTILYSE 50MG; ACTILYSE SOLVENT

Alteplase 50mg

BOT2500007 POWDER FOR SOLUTION FOR INJECTION/ INFUSION 50mg blood and blood forming organs INN generic

What it does

Alteplase is a medication used to dissolve blood clots in the body.

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

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.
BOT2500007
Registration date
2023-02-20
Expiry date
2029-08-08
Status
Registered/Compliant
Active ingredient
Alteplase 50mg
Dosage form
POWDER FOR SOLUTION FOR INJECTION/ INFUSION
Strength
50mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
B01AD - Enzymes
Drug group
BLOOD AND BLOOD FORMING ORGANS
RxNorm RxCUI
8410
Manufacturer / MAH
Boehringer Ingelheim
Applicant / LTR
INGELHEIM PHARMACEUTICALS (PTY) LTD Suite 1, Building 4, 2nd Floor Waterfall Corporate Campus, 74 Waterfall Drive Midrand, 2066, South Africa
Country of origin
Germany

Source: Botswana Medicines Regulatory Authority · fetched 2026-04-15 20:42:56 · updated 2026-10-20 04:32:03

Disclaimer: This information is sourced from Botswana Medicines Regulatory Authority (Botswana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Alteplase is a medication used to dissolve blood clots in the body.

What it treats

  • heart attack (myocardial infarction)
  • stroke
  • pulmonary embolism

How it works

Alteplase works by breaking down the clots that block blood vessels, helping to restore normal blood flow.

Who it's for

Alteplase is for adults experiencing severe blood clots that can cause serious health issues.

Cautions

  • • Should be used with caution if you are taking 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: Alteplase

BNF-referenced

Alteplase is a thrombolytic medication used to dissolve intravascular thrombi and unblock occluded central venous access devices, including those used for haemodialysis.

Indications

  • Intravascular thrombosis
  • Blocked catheters and lines
  • Blood clots

Dosage

Children: Neonate: 100–500 micrograms/kg/hour for 3–6 hours; consult local protocol for further dosing guidance.

Adults: For intravenous administration, the typical dose is 100 mg total, infused over 2 hours. Adjustments may be needed based on clinical response and specific conditions.

Mechanism of action

Alteplase acts as a fibrinolytic agent by activating plasminogen to form plasmin, which degrades fibrin and breaks up thrombi.

Pharmacodynamics

Alteplase increases the rate of fibrinolysis by converting plasminogen to plasmin, leading to the breakdown of fibrin clots. It is particularly effective in the treatment of acute thromboembolic events.

Pharmacokinetics

Alteplase is administered intravenously and has a short half-life. It is rapidly distributed in the bloodstream, with effects generally observed within minutes. Metabolism occurs in the liver and clearance is mainly via the reticuloendothelial system. Specific pharmacokinetic parameters in children may vary and should be monitored during therapy.

Contra-indications

  • Recent delivery
  • Recent ulcerative gastrointestinal disease
  • Acute pancreatitis
  • Aneurysm
  • Bacterial endocarditis
  • Bleeding diatheses
  • Coagulation defects
  • Neoplasm with risk of haemorrhage
  • Pericarditis
  • Recent haemorrhage
  • Recent surgery (including dental extraction)
  • Recent trauma
  • Severe hypertension
  • Oesophageal varices
  • Recent stroke

Adverse effects

  • Serious bleeding
  • Haemothorax
  • Agitation
  • Confusion
  • Delirium
  • Depression
  • Epilepsy
  • Psychosis
  • Speech disorder
  • Brain oedema (caused by reperfusion)

Precautions

  • The safety and efficacy of treatment remains uncertain, especially in neonates.
  • A fibrinolytic drug is probably only appropriate where arterial occlusion threatens ischaemic damage.
  • An anticoagulant may stop the clot from enlarging.

Pregnancy

Thrombolytic drugs can possibly lead to premature separation of the placenta in the first 18 weeks of pregnancy. There is also a risk of maternal haemorrhage throughout pregnancy and post-partum, and a theoretical risk of fetal haemorrhage throughout pregnancy.

Breast-feeding

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Storage

Protect infusion from light. Use polyethylene, polypropylene, or glass apparatus.

Formulations

  • Intravenous infusion solution
BNF for Children 2019-2020 p.111 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.

Kenya 4 products