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Cayston 75 mg powder and solvent for nebuliser solution (2012)

Active ingredients: Aztreonam

Product Name and Form

Cayston 75 mg powder and solvent for nebuliser solution.

Pharmaceutical form

Powder and solvent for nebuliser solution.

White to off-white, lyophilised powder.

Qualitative and Quantitative Composition

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.

Chemical substance
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
L-Lysine
Solvent ampoule
Sodium chloride
Water for injections

Pack sizes and Marketing

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:

  • 28-day pack of Cayston
  • Pack containing one 28-day pack of Cayston plus one Altera Nebuliser Handset

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Gilead Sciences International Limited
Granta Park
Abington
Cambridge
CB21 6GT
United Kingdom

Date of first authorisation: 21 September 2009

Date of latest renewal: 21 September 2010

Marketing authorization number:

EU/1/09/543/001

EU/1/09/543/002