CAYSTON Powder and solvent for nebuliser solution Ref.[6351] Active ingredients: Aztreonam

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

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 powder.

Qualitative and quantitative composition

Each vial contains aztreonam lysine equivalent to 75 mg aztreonam. After reconstitution the nebuliser solution contains 75 mg aztreonam.

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:

L-Lysine

Solvent:

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 with a blue cap.

Solvent: 1 ml low density polyethylene ampoule.

Each 28-day pack of Cayston contains 84 vials of lyophilised aztreonam 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

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Marketing authorization dates and numbers

EU/1/09/543/001
EU/1/09/543/002

Date of first authorisation: 21 September 2009
Date of latest renewal: 26 May 2016

Drugs

Drug Countries
CAYSTON Austria, Canada, Cyprus, Estonia, Spain, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom

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