SALBULIN Inhalation powder Ref.[50248] Active ingredients: Salbutamol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Salbulin MDPI Novolizer.

100 micrograms/dose inhalation powder.

Pharmaceutical Form

Inhalation powder.

White powder.

Qualitative and quantitative composition

One delivered dose contains 100 micrograms of salbutamol equivalent to 120 micrograms of salbutamol sulphate.

The delivered dose is the dose which is available for the patient after passing the mouthpiece.

Excipient: 11.42 milligrams mg of lactose monohydrate/delivered dose.

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

Lactose monohydrate

Pack sizes and marketing

Original sales packs and samples: 1 cartridge containing 200 metered doses filled with not less than 2.308 g of powder packed in a container sealed by aluminium foil and 1 Novolizer device

Refill packs: 1 or 2 cartridges each containing 200 metered doses packed in a container sealed by aluminium foil

Hospital pack: Pack of 10 of original sales packs

All components are made of plastic materials (the cartridge is made of acrylonitrile butadiene styrene (ABS) / polypropylene, the Novolizer device is made of acrylnitrilbutadienestyrol copolymer / polyoxymethylene and the mouthpiece of polycarbonate).

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0191

01/11/2009
31/12/2011

Drugs

Drug Countries
SALBULIN United Kingdom, South Africa

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