SALBUTAMOL Nebuliser solution Ref.[7086] Active ingredients: Salbutamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Product name and form

Salbutamol 2mg/ml nebuliser solution.

Pharmaceutical Form

Nebuliser solution (for use via a nebuliser).

Plastic ampoule containing 2.5 ml of a clear sterile solution containing 5mg salbutamol (as sulphate) in normal saline.

Qualitative and quantitative composition

Each nebule contains 5mg/2.5ml salbutamol (as sulphate).

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 chloride
Sulphuric acid to adjust pH
Water for injection

Pack sizes and marketing

Plastic polyethylene ampoules in strips of 5 ampoules, with a protective foil over-wrap. Available in boxes containing 20 ampoules.

Marketing authorization holder

Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Marketing authorization dates and numbers

PL 36390/0036

06/06/2011

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