ISOPTIN Solution for injection / infusion Ref.[51033] Active ingredients: Verapamil

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Product name and form

Isoptin 2.5mg/ml Solution for Injection or Infusion.

Pharmaceutical Form

Solution for injection or infusion.

A clear, colourless, sterile, aqueous solution.

Qualitative and quantitative composition

1ml of solution contains 2.5mg of Verapamil Hydrochloride.

Each ampoule contains 2ml of solution containing 5mg of verapamil hydrochloride.

Excipients: contains 17 mg of sodium under the sodium chloride form.

For a full list of excipients, see section 6.1

Active Ingredient Description
Verapamil

Verapamil inhibits the transmembrane influx of calcium ions into the heart and vascular smooth muscle cell. The myocardial oxygen demand is lowered directly as a result of the effect on the energy consuming metabolic processes of the myocardial cell and indirectly due to a reduction of the afterload. Due to its effect on coronary vascular smooth muscle, verapamil enhances myocardial blood flow, even in postโ€stenotic areas, and relieves coronary spasms. These properties contribute to the antiโ€ischaemic and antianginal efficacy of verapamil in all types of coronary artery disease.

List of Excipients

Sodium chloride
Hydrochloric acid 10% (as pH adjuster)
Water for Injections

Pack sizes and marketing

2ml ampoules of Ph. Eur. type I glass.

Each pack contains: 5 × 2ml ampoules.

Marketing authorization holder

Mylan IRE Healthcare Limited, Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

Marketing authorization dates and numbers

PA2010/003/004

Date of first authorisation: 01 April 1980
Date of last renewal: 01 April 2010

Drugs

Drug Countries
ISOPTIN Austria, Australia, Canada, Cyprus, Germany, Estonia, Finland, Hong Kong, Croatia, Ireland, Italy, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, South Africa

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