CORDARONE X Solution for injection

Active ingredients: Amiodarone

Product name and form

Cordarone X 150mg/3ml Solution for Injection.

Pharmaceutical Form

Solution for injection.

Qualitative and quantitative composition

Each 3ml ampoule contains 150mg amiodarone hydrochloride.

For excipients, see 6.1.

Active Ingredient
Description

Amiodarone is an antiarrhythmic medication used to treat and prevent a number of types of irregular heartbeats. This includes ventricular tachycardia (VT), ventricular fibrillation (VF), and wide complex tachycardia, as well as atrial fibrillation and paroxysmal supraventricular tachycardia.

List of Excipients

Benzyl alcohol
Polysorbate
Water for injections

Pack sizes and marketing

Cordarone X 150mg/3ml Solution for Injection is supplied in boxes containing 6 or 10 glass ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

or trading as:

Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 04425/0643

Date of first authorisation: 31 July 2010

Drugs

Drug
Countries
Australia, Germany, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, South Africa