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 is a phenylalkylamine calcium antagonist which blocks the inward movement of calcium ions in cardiac muscle cells, in smooth muscle cells of the coronary and systemic arteries and in cells of the intracardiac conduction system. It lowers heart rate, increases myocardial perfusion and reduces coronary spasm. Because of its effect on the movement of calcium in the intracardiac conduction system, verapamil reduces automaticity, decreases conduction velocity and increases the refractory period.

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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