BRICANYL TURBOHALER Inhalation powder Ref.[7932] Active ingredients: Terbutaline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK

Product name and form

Bricanyl Turbohaler, 0.5 mg/dose, inhalation powder.

Pharmaceutical Form

Inhalation powder.

A white inhaler comprising a blue turning grip, an integral dose indicator and a white cover.

Qualitative and quantitative composition

Each delivered dose contains: Terbutaline sulfate 0.4 mg (which corresponds to 0.5 mg metered dose).

Excipients with known effect: Bricanyl Turbohaler 0.5mg/dose: each delivered dose contains approximately 0.4 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Terbutaline

Terbutaline is a selective beta2-adrenoceptor agonist, thus producing relaxation of bronchial smooth muscle, inhibition of the release of endogenous spasmogens, inhibitions of oedema caused by endogenous mediators, increased mucociliary clearance and relaxation of the uterine muscle.

List of Excipients

Lactose monohydrate (which may contain milk protein residue)

Pack sizes and marketing

Bricanyl Turbohaler consists of a number of assembled plastic details, the main parts being the dosing mechanism, the drug substance store, the desiccant store and the mouthpiece. The inhaler is protected by an outer tubular cover screwed onto a bottom plate.

Each inhaler contains 120 doses.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca UK Limited, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK

Marketing authorization dates and numbers

PL 17901/0117

Date of first authorisation: 2nd November 1987
Date of latest renewal: 12th May 2007

Drugs

Drug Countries
BRICANYL Austria, Australia, Brazil, Canada, Estonia, Finland, France, Hong Kong, Ireland, Japan, Malta, Netherlands, New Zealand, Tunisia, Turkey, United Kingdom

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