Trixeo Aerosphere 5 micrograms/7.2 micrograms/160 micrograms pressurised inhalation, suspension

6.3 SHELF LIFE

2 3 years

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10.DATE OF REVISION OF THE TEXT

01 October 2021 31 August 2023

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6.      Contents of the pack and other information

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Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca Dunkerque Production

224 Avenue de la Dordogne

Dunkerque

59640

France

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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This corresponds to a metered dose of 5.38 micrograms of formoterol fumarate dihydrate, glycopyrronium bromide 10.4 9.6 micrograms, equivalent to 8.2 7.7 micrograms of glycopyrronium, and budesonide 182 170 micrograms.

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4.2         Posology and method of administration

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Patients who find it difficult to coordinate actuation with inhalation may use Trixeo Aerosphere with a spacer to ensure proper administration of the medicinal product. Trixeo Aerosphere can be used with spacer devices including the Aerochamber Plus Flow-Vu (see section 5.2). Compatibility with the Aerochamber Plus Flow Vu spacer device has been demonstrated.

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6.3         Shelf life

To be used within 6 weeks of opening the pouch (56 actuations)

To be used within 3 months of opening the pouch. (120 actuations)

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6.5         Nature and contents of container

Trixeo Aerosphere is a pressurised metered dose inhaler, comprising an aluminium pressurised container with an attached dose indicator, supplied with a white plastic actuator body and mouthpiece with a grey dust cap. Trixeo Aerosphere is a pressurised metered dose inhaler, comprising a coated aluminium canister, a yellow plastic actuator and white mouthpiece with an attached grey plastic dust cap, and a dose indicator. Each inhaler is individually packaged in a foil laminate pouch containing a desiccant sachet and packed in to a carton.

Pack sizes of 1 container of 56 or 120 actuations.

Multipacks of 360 (3 containers of 120) actuations.

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8.           MARKETING AUTHORISATION NUMBER(S)

EU/1/20/1498/001 56 actuations

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10.         DATE OF REVISION OF THE TEXT

9th December 2020 01 October 2021

5.How to store Trixeo Aerosphere

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After opening the pouch, the inhaler must be used within:

6 weeks – for an inhaler that contains 56 puffs

3 months – for an inhaler that contains 120 puffs.

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6.Contents of the pack and other information

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What Trixeo Aerosphere looks like and contents of the pack

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Trixeo Aerosphere comes as a pressurised container with a dose indicator, supplied with a white plastic actuator body and mouthpiece (see Figure 1 of the instructions for Use at the end of this leaflet). Trixeo Aerosphere comes as a canister with a dose indicator, supplied with a yellow plastic actuator body and white mouthpiece. The mouthpiece is covered with a removable grey protective cap.

Trixeo Aerosphere is supplied in a foil pouch that contains a drying packing (desiccant) and packed into a carton.

Each inhaler contains 56 or 120 puffs. Additionally, there are multipacks containing 3 pressurised containers with 120 puffs, each.

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This leaflet was last revised in 02/2021 10/2021.