BAMBEC Tablet Ref.[7691] Active ingredients: Bambuterol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK

Product name and form

Bambec Tablets 10 mg.

Pharmaceutical Form

Tablet.

Qualitative and quantitative composition

Each tablet contains 10 mg Bambuterol hydrochloride.

Excipient(s) with known effect: Each tablet contains 63 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bambuterol

Bambuterol is an active precursor of the selective β2-adrenergic agonist terbutaline. Bambuterol is the bis-N,N-dimethyl-carbamate of terbutaline. Bambuterol is a remarkably selective and potent inhibitor of cholinesterase. Bambuterol is indicated for the management of asthma, bronchospasm and/or reversible airways obstruction.

List of Excipients

Lactose monohydrate
Maize starch
Povidone
Microcrystalline cellulose
Magnesium stearate
Water, purified

Pack sizes and marketing

Amber glass bottle with LD-polyethene cap: 7, 14, 28, 30, 56 or 100 tablets.
HDPE container with LD-polyethene cap: 7, 14, 28, 30, 56 or 100 tablets.
HDPE container with polypropylene cap: 7, 14, 28, 30, 56 or 100 tablets.
PVC blisters: 7, 14, 28, 30, 56 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK

Marketing authorization dates and numbers

PL 17901/0103

Date of first authorisation: 4th August 1992
Date of latest renewal: 21st May 2002

Drugs

Drug Countries
BAMBEC Austria, Brazil, Germany, Spain, Singapore, United Kingdom

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