PRIMACOR Solution for injection Ref.[27628] Active ingredients: Milrinone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK

Product name and form

Primacor 1 mg/ml Solution for Injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless to pale yellow liquid.

Qualitative and quantitative composition

Each ampoule contains 1 mg/ml of the active substance Milrinone.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Milrinone

Milrinone is a positive inotrope and vasodilator, with little chronotropic activity. It also improves left ventricular diastolic relaxation. It is a selective inhibitor of peak III phosphodiesterase isoenzyme in cardiac and vascular muscle. It produces slight enhancement of A-V node conduction, but no other significant electrophysiological effects.

List of Excipients

Lactic acid
Glucose anhydrous
Water for injection
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Type 1 colourless, glass ampoules 10ml or 20ml packed in lots of 10.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK

Marketing authorization dates and numbers

PL 04425/0646

Date of first authorisation: 11 October 1989
Date of latest renewal: 7 April 2004

Drugs

Drug Countries
PRIMACOR Brazil, Hong Kong, Malta, Mexico, New Zealand, Singapore, United Kingdom

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