ARQUIST Pressurised inhalation suspension Ref.[50947] Active ingredients: Fluticasone

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium

Product name and form

Arquist 125 microgram per actuation pressurised inhalation, suspension.

Pharmaceutical Form

Pressurised inhalation suspension (pressurised inhalation).

Arquist is a white homogeneous suspension, filled in an aluminum container fitted with a suitable metering valve and a plastic actuator. White coloured body with yellow cap.

Qualitative and quantitative composition

One metered dose (ex-valve) contains 125 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex-actuator) of 110 micrograms fluticasone propionate.

For the full list of excipients, see section 6.1.

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.

List of Excipients

Norflurane (HFA 134a)

Pack sizes and marketing

An inhaler comprising an aluminium alloy canister sealed with a metering valve, actuator and cap. Each canister contains 120 metered actuations.

Pack sizes: 1 or 2 canisters. Each canister contains 120 metered actuations.

Not all pack sizes may be marketed.

Marketing authorization holder

Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium

Marketing authorization dates and numbers

PA1963/012/001

Date of first authorisation: 2nd October 2015
Date of last renewal: 17th July 2019

Drugs

Drug Countries
ARQUIST Croatia, Ireland, Romania

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