VENTOLIN Syrup Ref.[28325] Active ingredients: Salbutamol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Ventolin Syrup.

Pharmaceutical Form

Syrup.

A clear, colourless to pale yellow viscous liquid with an odour of orange.

Qualitative and quantitative composition

Each 5 ml contains 2 mg Salbutamol (as Salbutamol Sulfate BP).

Excipient with known effect: Sodium.

For the full list of excipients, see section 6.1.

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 citrate
Citric acid monohydrate
Hydroxypropyl methylcellulose
Sodium benzoate
Saccharin sodium
Sodium chloride
Orange flavour IFF 17.42.8187
Purified water

Pack sizes and marketing

Type III amber glass bottle with plastic, child resistant, pilfer-proof caps with low density polyethylene polyvinylidene chloride low density polyethylene (LDPE-PVDC-LDPE) faced liners.

Pack size: 150 ml.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

19628

Date of first authorisation: 29 April 2004
Date of latest renewal: 17 July 2009

Drugs

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