Leaflet TRANDATE 5mg / ml solution for injection

Indicated for: hypertension

Route of administration: injectable

Substance: labetalol (beta blocker)

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

Precautions:
Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Hypotension / fall risk
Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

Elderly warning
Elderly warning

Older people may have an increased risk of side effects.

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 latest medicines list: 01-11-2025
  • Product code: W69804001
  • Concentration: 5mg / ml
  • Pharmaceutical form: solution for injection
  • Quantity: 5
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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