NICARDIPINE Solution for injection Ref.[8184] Active ingredients: Nicardipine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL, UK

Product name and form

Nicardipine 10 mg/10 ml solution for injection.

Pharmaceutical Form

Clear, pale yellow colour solution for injection.

Qualitative and quantitative composition

Each mL of solution contains 1mg of Nicardipine hydrochloride.

Each 10mL ampoule contains 10mg of Nicardipine hydrochloride

Excipient with known effect:

This medicinal product contains sodium.

Each mL of solution for injection contains 0.039 mg equivalent to 0.0017 mmol of sodium.

Each 10 mL ampoule contains 0.39 mg equivalent to 0.017 mmol of sodium.

Each mL of solution for injection contains 50mg sorbitol.

Each 10mL ampoule contains 500 mg sorbitol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nicardipine

Nicardipine is a second generation slow calcium channel inhibitor, and belongs to the phenyl-dihydropyridine group. Nicardipine has a greater selectivity for L-type calcium channels in vascular smooth muscle than cardiac myocytes. Nicardipine produces smooth muscle relaxation and marked peripheral vasodilatation.

List of Excipients

Sorbitol
Citric acid monohydrate
Sodium citrate
Hydrochloric acid
Sodium hydroxide
Water for injections

Pack sizes and marketing

10 ml in a type I brown glass ampoule with an OPC (One Point Cut) break system. Boxes of 5, 10 or 50 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL, UK

Marketing authorization dates and numbers

PL 12762/0450

24/04/2014

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