TOBRAMYCIN Solution for injection Ref.[7710] Active ingredients: Tobramycin

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

Product name and form

Tobramycin 40 mg/ml Solution for injection.

Pharmaceutical Form

Solution for injection.

Clear colourless solution.

Qualitative and quantitative composition

Each ml of solution for injection contains 40 mg tobramycin.

Each 1 ml vial contains 40 mg of tobramycin.

Each 2 ml vial contains 80 mg of tobramycin.

Each 6 ml vial contains 240 mg of tobramycin.

Excipient(s) with known effect:

For a full list of excipients, see section 6.1.

Active Ingredient Description
Tobramycin

Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death. It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.

List of Excipients

Sodium metabisulphite
Disodium edetate
Sulphuric acid
Water for injections

Pack sizes and marketing

40 mg/1 ml and 80 mg/2 ml presentation – clear Type I glass vials with elastomeric stoppers in packs of 5 vials.

240 mg/6 ml presentation – clear Type I glass vials with elastomeric stoppers in packs of 1 or 5 vials.

Not all presentations above may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 04515/0066

Date of first authorisation: 22/09/1993

Date of latest renewal: 26/02/2009

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