VENTOLIN Solution for injection Ref.[7087] Active ingredients: Salbutamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Product name and form

Ventolin Injection 500 micrograms (0.5mg) in 1ml.

Pharmaceutical Form

A colourless or faintly straw coloured solution for injection.

Qualitative and quantitative composition

Ventolin Injection 500 micrograms (0.5mg) in 1ml (500 micrograms/ml) is presented as ampoules of 1ml, each containing 500 micrograms salbutamol as salbutamol sulfate BP in a sterile isotonic solution.

Active Ingredient Description
Salbutamol

Salbutamol is a selective β2-agonist providing short-acting (4-6 hour) bronchodilation with a fast onset (within 5 minutes) in reversible airways obstruction. At therapeutic doses it acts on the β2-adrenoceptors of bronchial muscle. Salbutamol is administered for the symptomatic relief of bronchospasm associated with chronic or acute asthma, bronchitis or other obstructive pulmonary diseases.

List of Excipients

Sodium chloride
Sodium hydroxide pellets
Dilute sulfuric acid
Water for injections
Nitrogen (oxygen free)

Pack sizes and marketing

Clear, neutral glass ampoules, packed in plastic trays with a cardboard sleeve over the trays.

Pack size: 1ml ampoules in plastic trays of 5.

Marketing authorization holder

Glaxo Wellcome UK Ltd, trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Marketing authorization dates and numbers

PL 10949/0084

6 September 2000

Drugs

Drug Countries
VENTOLIN Australia, Canada, Cyprus, Estonia, Spain, Hong Kong, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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