PERFAN Concentrate for solution for injection or infusion Ref.[27497] Active ingredients: Enoximone

Source: Health Products Regulatory Authority (IE) Revision Year: 2011 Publisher: Carinopharm GmbH, Bahnhofstraße 18, 31008 Elze, Germany

Product name and form

Perfan 5mg/ml Concentrate for Solution for Injection or Infusion.

Pharmaceutical Form
Concentrate for solution for injection or infusion. Clear, yellow solution.

Qualitative and quantitative composition

Each ml of the concentrate contains 5 mg enoximone.

Each 20ml ampoule contains 100 mg enoximone.

When diluted as recommended, the resulting diluted solution contains 2.5 mg of enoximone per ml.

Also includes: ethanol sodium and propylene glycol.

For a full list of excipeint, see section 6.1.

Active Ingredient	Description
Enoximone	Enoximone, an imidazolone, has both positive inotropic and vasolidator properties, inhibiting cardiac phosphodiesterase III with an increase in cAMP.

List of Excipients
Ethanol, anhydrous Sodium hydroxide Propylene glycol Water for injections

Pack sizes and marketing

Glass ampoules (TypeI Ph.Eur.) of 20ml in cartons containing 10 ampoules.

Marketing authorization holder

Carinopharm GmbH, Bahnhofstraße 18, 31008 Elze, Germany

Marketing authorization dates and numbers

PA1682/1/1

Date of first authorization: 10 October 1988
Date of last renewal: 10 October 2008

Drugs

Drug	Countries
PERFAN	Malta, Netherlands, United Kingdom

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