Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland
Bronchitol 40 mg inhalation powder, hard capsules.
| Pharmaceutical Form |
|---|
|
Inhalation powder, hard capsule. Clear colourless hard capsules marked with ‘PXS 40 mg’ and containing white or almost white powder. |
Each hard capsule contains 40 mg mannitol.
Mean delivered dose per capsule is 32.2 mg.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mannitol |
Mannitol is a naturally occurring sugar alcohol used clinically primarily for its osmotic diuretic properties. |
| List of Excipients |
|---|
|
None. |
Aluminium/polyamide/PVC/aluminium blisters. Cartons containing 10 or 280 capsules for initial dose and treatment use respectively.
The initiation dose carton contains 1 blister (of 10 capsules) and one inhaler device.
The 2-week carton contains 28 blisters (of 10 capsules each) and two inhaler devices.
Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland
EU/1/12/760/001-002
Date of first authorisation: 13 April 2012
Date of latest renewal: 11 January 2017
| Drug | Countries | |
|---|---|---|
| BRONCHITOL | Austria, Australia, Estonia, Spain, Ireland, Lithuania, Poland, United Kingdom |
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