BETALOC Solution for injection Ref.[7777] Active ingredients: Metoprolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Recordati Ireland Ltd., Raheens East, Ringaskiddy, Co. Cork, Ireland

Product name and form

Betaloc I.V. Injection.

Pharmaceutical Form

Solution for Injection.

Qualitative and quantitative composition

Each ampoule of 5 ml contains 5 mg Metoprolol tartrate Ph. Eur.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Metoprolol

Metoprolol is a cardioselective beta-adrenergic blocking agent. It has a relatively greater blocking effect on beta1-receptors (ie those mediating adrenergic stimulation of heart rate and contractility and release of free fatty acids from fat stores) than on beta2-receptors, which are chiefly involved in broncho and vasodilation.
List of Excipients

Sodium chloride
Water for injections

Pack sizes and marketing

5 ml glass ampoule.

Marketing authorization holder

Recordati Ireland Ltd., Raheens East, Ringaskiddy, Co. Cork, Ireland

Marketing authorization dates and numbers

PL 30883/0007

Date of first authorisation: 28th May 2002
Date of renewal of authorisation: 16th July 2005

Drugs

Drug Countries
BETALOC Australia, Cyprus, Ecuador, Estonia, Hong Kong, Croatia, Ireland, Lithuania, Malta, Nigeria, New Zealand, Poland, Romania, United Kingdom
 
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