Leaflet TRANDATE 5mg / ml solution for injection


Indicated for: hypertension

Substance: labetalol (beta blocker)

ATC: C07AG01 (Cardiovascular system | Beta blocking agents | Alpha and beta blocking agents)

Labetalol is an antihypertensive medication used to treat high blood pressure, including hypertensive emergencies and pregnancy-induced hypertension. It is a non-selective beta-blocker with additional alpha-blocking properties, lowering blood pressure by reducing peripheral vascular resistance and heart rate.

It is administered orally for chronic treatment or intravenously in emergencies. Compared to other beta-blockers, labetalol provides a more balanced effect on blood pressure without excessively lowering heart rate.

Side effects may include dizziness, fatigue, nausea, orthostatic hypotension, and, rarely, heart failure or bronchospasm in asthmatic patients. Careful monitoring is recommended, especially for patients with pre-existing cardiac or respiratory conditions.

General data about TRANDATE 5mg / ml

  • Substance: labetalol
  • Date of last drug list: 01-11-2025
  • Commercial code: W69804001
  • Concentration: 5mg / ml
  • Pharmaceutical form: solution for injection
  • Quantity: 5
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: CENEXI SAS - FRANTA
  • Holder: ALLIANCE HEALTHCARE ROMANIA SRL - ROMANIA
  • Number: 831/2023/01
  • Shelf life: 2 years;after opening/dilutie-trebuie utilizat imediat