MIDAZOLAM Solution for injection or infusion Ref.[7761]
Active ingredients: Midazolam

Source: Medicines & Healthcare Products Regulatory Agency (GB) |  Revision Year: 2019 |  Publisher: Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Midazolam 5mg/ml Solution for Injection/Infusion.

Pharmaceutical Form

Solution for Injection / Infusion.

Qualitative and quantitative composition

Each 1ml solution contains 5mg midazolam presented in 2ml and 10ml ampoules.

Excipient(s) with known effect: Each 1ml contains 1.97 mg of Sodium.

For the full list of excipients, see section 6.1.

Active Ingredient
Description
Midazolam

Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of midazolam to form water-soluble salts with acids.

List of Excipients

Sodium chloride
Hydrochloric acid
Sodium hydroxide
Water for injections

Pack sizes and marketing

Clear One Point Cut (OPC) 2ml & 10ml glass ampoules, glass type I, Ph. Eur.

Pack sizes: 5 × 2ml ampoules; 10 × 2ml ampoules. 5 × 10ml ampoules; 10 × 10ml ampoules

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 12762/0591

20/12/2005

 
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