FLUMAZENIL Solution for injection or infusion Ref.[9518] Active ingredients: Flumazenil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: hameln pharma gmbh, InselstraรŸe 1, 31787, Hameln, Germany

Product name and form

Flumazenil 100 micrograms/ml solution for injection/infusion.

Pharmaceutical Form

Solution for injection/infusion.

Clear colourless solution.

Qualitative and quantitative composition

Each ml contains 100 micrograms flumazenil.

1 ampoule with 5 ml contains 500 micrograms flumazenil.
1 ampoule with 10 ml contains 1000 micrograms flumazenil.

Excipient with known effect: This medicinal product contains approximately 3.7 mg sodium per ml of flumazenil solution for injection/infusion (see section 4.4).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Flumazenil

Flumazenil, an imidazobenzodiazepine, is a benzodiazepine antagonist which, by competitive interaction, blocks the effects of substances acting via the benzodiazepine-receptor. Neutralisation of paradoxal reactions of benzodiazepines has been reported.

List of Excipients

Disodium edetate
Glacial acetic acid
Sodium chloride
Sodium hydroxide for pH adjustment
Water for injections

Pack sizes and marketing

Carton boxes with 5 or 10 ampoules (glass Type I) containing 5 ml solution for injection/infusion.

Carton boxes with 5 or 10 ampoules (glass Type I) containing 10 ml solution for injection/infusion.

Not all pack sizes may be marketed.

Marketing authorization holder

hameln pharma gmbh, InselstraรŸe 1, 31787, Hameln, Germany

Marketing authorization dates and numbers

PL 25215/0001

20/09/2010

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