GENTAMICIN Eye / Ear drops Ref.[6851] Active ingredients: Gentamicin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hants, PO15 7FE

Product name and form

Gentamicin Eye/Ear Drops 0.3% W/V.

Pharmaceutical Form
Eye/Ear Drops.

Qualitative and quantitative composition

Active Ingredient: Gentamicin sulphate equivalent to 30mg gentamicin base in 10ml of solution.

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 chloride Disodium edetate Sodium metabisulphite Borax Benzalkonium chloride solution Purified water Sodium hydroxide soluion (pH adjuster) Hydrochloric acid (pH adjuster)

Pack sizes and marketing

10ml low density polyethylene bottle with polystyrene spiked cap.

Marketing authorization holder

FDC International Ltd, Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hants, PO15 7FE

Marketing authorization dates and numbers

PL 15872/0004

22 January 1998 / 18 March 2003

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