Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: Gilead Sciences International Limited Granta Park Abington Cambridge CB21 6GT United Kingdom
Cayston 75 mg powder and solvent for nebuliser solution.
| Pharmaceutical Form |
|---|
|
Powder and solvent for nebuliser solution. White to off-white, lyophilised powder. |
Cayston contains aztreonam lysine (formed in situ from 75 mg aztreonam) as a sterile lyophilised powder in a vial and a 1 ml ampoule of sterile solvent (0.17% w/v sodium chloride). After reconstitution of the powder in the solvent, the nebuliser solution contains 75 mg aztreonam (as lysine).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Aztreonam |
Aztreonam exhibits activity in vitro against gram-negative aerobic pathogens, including P. aeruginosa. Aztreonam binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition of bacterial cell wall synthesis, followed by filamentation and cell lysis. |
| List of Excipients |
|---|
|
Powder vial |
Powder vial: Type I amber glass vial with siliconised grey rubber stopper and aluminium tear off overseal.
Solvent: 1 ml low density polyethylene ampoule.
Each 28-day pack of Cayston contains 84 vials of lyophilised Cayston and 88 solvent ampoules. The four additional solvent ampoules are provided in case of spillage.
The following pack sizes are available:
Not all pack sizes may be marketed.
Gilead Sciences International Limited
Granta Park
Abington
Cambridge
CB21 6GT
United Kingdom
EU/1/09/543/001
EU/1/09/543/002
Date of first authorisation: 21 September 2009
Date of latest renewal: 21 September 2010
| Drug | Countries | |
|---|---|---|
| CAYSTON | Austria, Canada, Cyprus, Estonia, Spain, France, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom |
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