MILNIRONE Solution for injection / infusion Ref.[8124] Active ingredients: Milrinone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom

Product name and form

Milrinone 1mg/ml Solution for injection/infusion.

Pharmaceutical Form

Solution for injection/infusion.

Clear, colourless to pale yellow solution, practically free from particles.

The pH of the solution is 3.2-4.0 and the osmolality is 261–319 mOsm/Kg.

Qualitative and quantitative composition

Each 10 ml ampoule contains 10 mg milrinone. Each ml of solution contains 1 mg milrinone.

Excipient with known effect: Sodium (this medicinal product contains less than 1 mmol sodium (23 mg) per dose).

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

(S)-Lactic acid
Anhydrous glucose
Water for injections
Sodium hydroxide (for pH adjustment)
Lactic acid (for pH adjustment)

Pack sizes and marketing

Milrinone 1mg/ml Solution for Injection is presented in 10ml clear, neutral glass (PhEur, Type I) ampoules. The ampoules are packed in a PVC tray and cardboard box in packs of 10.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, United Kingdom

Marketing authorization dates and numbers

PL 29831/0619

01/08/2016

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