TRANDATE 5mg / ml solution for injection medication leaflet

C07AG01 labetalol • 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

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