SERETIDE Inhaler Ref.[50859] Active ingredients: Fluticasone Salmeterol

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2021  Publisher: GlaxoSmithKline NZ Limited, Private Bag 106600, Downtown, Auckland, New Zealand

Product name and form

SERETIDE Inhaler (with counter), 25 mcg/50 mcg, aerosol inhaler, metered dose.

SERETIDE Inhaler (with counter), 25 mcg/125 mcg, aerosol inhaler, metered dose.

SERETIDE Inhaler (with counter), 25 mcg/250 mcg, aerosol inhaler, metered dose.

Pharmaceutical Form

Aerosol inhaler, metered dose.

The canisters are fitted into plastic actuators incorporating an atomising orifice and fitted with dustcaps.

Qualitative and quantitative composition

SERETIDE Inhaler 25 mcg/50 mcg: Each single actuation provides salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 50 micrograms of fluticasone propionate.

SERETIDE Inhaler 25 mcg/125 mcg: Each single actuation provides salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 125 micrograms of fluticasone propionate.

SERETIDE Inhaler 25 mcg/250 mcg: Each single actuation provides salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 250 micrograms of fluticasone propionate.

For the full list of excipients, see Section 6.1 List of excipients.

Active Ingredient Description
Fluticasone

Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

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

Norflurane HFA 134a (a CFC-Free propellant)

Pack sizes and marketing

SERETIDE Inhaler comprises a suspension of salmeterol xinafoate and fluticasone propionate in the non-CFC propellant HFA 134a. The suspension is contained in an aluminium alloy can sealed with a metering valve. The canisters are fitted into plastic actuators incorporating an atomising orifice and fitted with dustcaps. The canister has a counter attached to it, which shows how many actuations of medicine are left. The number of actuations left will show through a window in the back of the plastic actuator. SERETIDE Inhaler has been formulated in three strengths and one pack size, delivering 120 actuations per inhaler.

Marketing authorization holder

GlaxoSmithKline NZ Limited, Private Bag 106600, Downtown, Auckland, New Zealand

Marketing authorization dates and numbers

25 January 2001

Drugs

Drug Countries
SERETIDE Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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