NIMOTOP 0.02% Solution for infusion Ref.[7830] Active ingredients: Nimodipine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Nimotop 0.02% Solution for Infusion.

Pharmaceutical Form

Clear yellow sterile solution for intravenous use.

Qualitative and quantitative composition

A sterile solution containing 10 mg nimodipine in 50 ml vials of aqueous alcoholic solvent (0.02%).

Excipients with known effect: Ethanol and sodium citrate.

For the full list of excipients see section 6.1.

Active Ingredient Description
Nimodipine

Nimodipine is a dihydropyridine calcium channel blocker with particular cerebrovascular effect. Nimodipine increases cerebral perfusion, particularly in poorly perfused areas, by arterial dilatation, an effect which is proportionately greater in smaller than in larger vessels.

List of Excipients

Nimodipine 0.02% solution contains the following excipients:

Ethanol 96%
Macrogol 400
Sodium citrate
Citric acid
Water for Injections Ph. Eur.

Pack sizes and marketing

Brown glass type II infusion vials containing 50 ml of solution; with grey chlorobutyl stopper laminated with fluoropolymer.

150 cm of colorless transparent polyethylene tubing with conus connector for each vial of 50 ml of Nimotop 0.02% Solution for Infusion.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization dates and numbers

PL 00010/0138

21 January 1988/23 November 2003

Drugs

Drug Countries
NIMOTOP Austria, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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