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CAYSTON Powder and solvent for nebuliser solution (2018)

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 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.

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:

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 or without 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
Authorization dates

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

Date of first authorisation: 21 September 2009

Date of latest renewal: 26 May 2016

Marketing authorization number:

EU/1/09/543/001

EU/1/09/543/002