Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherland
Colobreathe 1,662,500 IU inhalation powder, hard capsules.
| Pharmaceutical Form |
|---|
|
Inhalation powder, hard capsule (inhalation powder). Hard transparent PEG-gelatin capsules containing a fine white powder |
Each capsule contains 1,662,500 IU, which is approximately equal to 125 mg of colistimethate sodium.
| Active Ingredient | Description | |
|---|---|---|
| Colistimethate |
Colistimethate is a cyclic polypeptide antibacterial active substance that is derived from Bacillus polymyxa var colistinus and belongs to the polymyxin group. Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium. Polymyxins are selective for Gram-negative bacteria that have a hydrophobic outer membrane. |
| List of Excipients |
|---|
|
Components of the PEG-gelatin hard capsules: Gelatin |
The capsules are contained in oPA/aluminium/pvc blisters with a peelable lidding foil composed of polyester/aluminium of either 8 or 14 hard capsules in each blister.
Colobreathe is available in packs containing either 8 or 56 hard capsules.
Each 56 capsule pack contains one Turbospin powder inhaler device and 7 blisters of 8 capsules or one Turbospin powder inhaler device and 4 blisters of 14 capsules (56 hard capsules) sufficient for 4 weeks use.
Each 8 capsule pack contains one Turbospin powder inhaler device and 1 blister of 8 hard capsules sufficient for 4 days use.
Not all pack sizes may be marketed.
Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherland
EU/1/11/747/001 56 hard capsules (4 blisters of 14 capsules)
EU/1/11/747/002 8 hard capsules (1 blister of 8 capsules)
EU/1/11/747/003 56 hard capsules (7 blisters of 8 capsules)
Date of first authorisation: 13/02/2012
Date of latest renewal: 26/09/2016
| Drug | Countries | |
|---|---|---|
| COLOBREATHE | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
