TYMBRINEB Nebuliser solution Ref.[49977] Active ingredients: Tobramycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, UNITED KINGDOM

Product name and form

Tymbrineb 300 mg/5 mL Nebuliser Solution.

Pharmaceutical Form

Nebuliser solution.

Clear to slightly yellow solution.

Qualitative and quantitative composition

Each ampoule of 5 ml contains 300 mg tobramycin as a single dose.

For the 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 chloride
Water for injections
Sulfuric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

Pack sizes and marketing

Tymbrineb Nebuliser Solution is supplied in 5 mL single-dose low density polyethylene ampoules.

4 ampoules are packed and sealed in a foil pouch. Each carton comprises 14 (56 ampoules), 28 (112 ampoules) or 42 (168 ampoules) foil pouches.

Not all pack sizes may be marketed.

Marketing authorization holder

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, UNITED KINGDOM

Marketing authorization dates and numbers

PL 00289/1437

22/12/2011

Drugs

Drug Countries
TYMBRINEB Ireland, United Kingdom

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