Source: European Medicines Agency (EU) Revision Year: 2016 Publisher: Mylan IRE Healthcare Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
TOBI Podhaler 28 mg inhalation powder, hard capsules.
| Pharmaceutical Form |
|---|
|
Inhalation powder, hard capsule. Clear colourless capsules containing a white to almost white powder, with “NVR AVCI” printed in blue on one part of the capsule and Novartis logo printed in blue on the other part of the capsule. |
Each hard capsule contains 28 mg tobramycin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tobramycin |
Tobramycin is an aminoglycoside antibiotic produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis leading to altered cell membrane permeability, progressive disruption of the cell envelope and eventual cell death. It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. |
| List of Excipients |
|---|
|
Capsule content: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) |
The hard capsules are supplied in PVC/PA/Alu/PVC- PET/Alu blisters.
The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene).
TOBI Podhaler is supplied in monthly packs containing 4 weekly cartons and a reserve Podhaler device in its storage case. Each weekly carton contains 56 × 28mg capsules (7 blisters with 8 capsules per blister), and a Podhaler device in its storage case.
Pack sizes:
56 capsules and 1 inhaler
224 (4 × 56) capsules and 5 inhalers (monthly multipack)
448 (8 × 56) capsules and 10 inhalers (2 x monthly multipack wrapped in foil)
Not all pack sizes may be marketed.
Mylan IRE Healthcare Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
EU/1/10/652/001-003
Date of first authorisation: 20 July 2011
Date of latest renewal: 18 February 2016
| Drug | Countries | |
|---|---|---|
| TOBI | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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