GENTAMICIN Solution for injection Ref.[6852] Active ingredients: Gentamicin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

Product name and form

Gentamicin 40 mg/ml Injection.

Pharmaceutical Form

Solution for injection.

Vials containing a clear colourless solution.

Qualitative and quantitative composition

1 ml of solution for injection contains 40 mg of gentamicin (as sulphate).

1 vial of 2 ml solution for injection contains 80 mg of gentamicin (as sulphate).

For excipients, see 6.1.

Active Ingredient Description
Gentamicin

Gentamicin is usually bactericidal in action. Although the exact mechanism of action has not been fully elucidated, the drug appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.
List of Excipients

Sodium metabisulphite
Disodium edetate
Methyl hydroxybenzoate
Propyl hydroxybenzoate
Water for Injections
Sulphuric acid (2.5N)
Sodium hydroxide (2.5N)

Pack sizes and marketing

80 mg/2 ml: Clear, Type I glass vials in packs of 5 vials.

Marketing authorization holder

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

Marketing authorization dates and numbers

PL 04515/0037

5th February 1998

 
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