VENTOLIN Solution for inhalation via a nebuliser Ref.[28324] Active ingredients: Salbutamol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Ventolin Nebules 2.5mg.

Pharmaceutical Form

Solution for inhalation via a nebuliser.

Qualitative and quantitative composition

Plastic ampoule containing 2.5 ml of a sterile 0.1% w/v solution of salbutamol (as Salbutamol Sulfate BP) in normal saline.

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
Sulfuric acid if required to adjust pH
Purified water

Pack sizes and marketing

Low density polyethylene ampoules available in boxes of 20 in strips of 5.

Marketing authorization holder

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

Marketing authorization dates and numbers

17101

Date of first authorisation: 27 January 1998
Date of latest renewal: 12 March 2010

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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