SOLTEL Pressurised inhalation, suspension Ref.[7089] Active ingredients: Salmeterol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Cipla (EU) Limited, Dixcart House, Addlestone Road, Bourne Business Park, Addlestone, Surrey, KT15 2LE, United Kingdom

Product name and form

Soltel CFC-free Inhaler 25 micrograms per actuation pressurised inhalation, suspension.

Pharmaceutical Form

Pressurised inhalation, suspension.

Pressurised aluminium canister containing a white suspension sealed with a metering valve, with a mid-green polypropylene actuator and a pale green polypropylene dust cap.

Qualitative and quantitative composition

Each metered dose (ex-valve) contains 25 micrograms salmeterol (as xinafoate). This is equivalent to a delivered dose (ex-actuator) of 21 micrograms salmeterol (as xinafoate).

Excipient with known effect: Each metered dose contains 0.007 micrograms of soya lecithin (see section 4.3)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Salmeterol

Salmeterol is a selective long-acting (12 hour) β2 adrenoceptor agonist. These pharmacological properties of salmeterol offer more effective protection against histamine-induced bronchoconstriction and produce a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting β2 agonists.

List of Excipients

Anhydrous ethanol
Soya lecithin (E322)
Norflurane (HFA 134a), a hydrofluoroalkane (non-chlorofluorocarbon) propellant.
This product does not contain any chlorofluorocarbon propellants.

Pack sizes and marketing

Pressurised aluminium canister containing a white suspension sealed with a metering valve, with a mid-green polypropylene actuator and a pale green polypropylene dust cap.

Each canister provides 120 actuations, each actuation containing 25 micrograms of salmeterol (as xinafoate) corresponding to a delivered dose (ex-actuator) of 21 micrograms salmeterol (as xinafoate).

Marketing authorization holder

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

Marketing authorization dates and numbers

PLGB 36390/0361

04/11/2011

Drugs

Drug Countries
SOLTEL Germany, Spain, United Kingdom

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