Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder
Lysine monohydrate

Solvent
Water for injection
Sodium chloride

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of Cayston and solvent are indicated on the packaging materials.
After reconstitution, immediate use of Cayston is recommended. If not used immediately, the reconstituted solution must be stored at 2°C - 8°C and used within 8 hours. In-use storage times and conditions prior to use are the responsibility of the user.

6.4   Special precautions for storage

Powder vial and solvent ampoule: Store in a refrigerator (2°C - 8°C). May be stored outside a refrigerator but below 25°C for up to 28 days.

For storage conditions of the reconstitued medicinal product, see section 6.3.

6.5   Nature and contents of container
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:
•     Pack containing one 28-day pack of Cayston plus one Altera Nebuliser Handset 

6.6   Special precautions for disposal and other handling
Reconstitution

Cayston should only be reconstituted with the solvent provided. Following reconstitution, Cayston is a clear, colourless to slightly coloured solution.

It is recommended that Cayston be administered immediately after reconstitution with solvent.
Cayston should not be reconstituted until a dose is ready to be administered. One glass vial containing Cayston is opened by carefully removing the blue cap and the metal ring, and then the grey rubber stopper. The liquid is squeezed out of one solvent ampoule into the glass vial. The vial is then gently swirled until contents have completely dissolved. The reconstituted Cayston is then poured into the Altera Nebuliser Handset and the dose administered.

Cayston is administered by inhalation over a 2 to 3 minute period, using a Cayston specific Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit. Cayston should not be used with any other type of handset or aerosol head. Cayston should not be mixed with any other medicinal products in the Altera Nebuliser Handset. Do not put other medicinal products in the Altera Nebuliser Handset.

Do not reconstitute or mix Cayston with any other solvent or medicinal product. Do not reconstitute more than one dose at a time. Any unused product or waste material should be disposed of in accordance with local requirements.