MILDRONATS Solution for injection Ref.[28005] Active ingredients: Meldonium

Revision Year: 2015  Publisher: AS GRINDEKS, Krustpils iela 53, RÄ«ga, LV-1057, Latvia Tel.: +371 67083205 Fax: +371 67083505 E-mail: grindeks@grindeks.lv

Product name and form

MILDRONÄ€TS 0.5 g/5 ml solution for injection.

Pharmaceutical Form

Solution for injection.

A clear, colourless liquid.

Qualitative and quantitative composition

1 ml of solution contains 100 mg meldonium dihydrate (Meldonium dihydricum).

One ampoule (5 ml) contains 500 mg meldonium dihydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Meldonium

Meldonium is a structural analogue of a precursor of carnitine, gamma-butyrobetaine (GBB), which has one carbon atom replaced by nitrogen atom. Meldonium, by reversibly inhibiting the activity of gamma butyrobetainhydroxylase, causes a decrease of carnitine biosynthesis and thus prevents long-chain fatty acid transport through the cell membranes. Accordingly, it prevents the accumulation of strong detergents, activated forms of un-oxidised fatty acids, in cells thus diminishing damage of the cells membranes.

List of Excipients

Water for injections

Pack sizes and marketing

5 ml of solution in clear glass ampoule.
5 ampoules in a PVC liner.
2 liners (10 ampoules) in a cardboard box.

Marketing authorization holder

AS GRINDEKS, Krustpils iela 53, RÄ«ga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: grindeks@grindeks.lv

Marketing authorization dates and numbers

98-0259

Date of authorisation: 09 November 1992
Date of latest renewal: 20 June 2008

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