Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Microcrystalline cellulose and Carmellose sodium (Avicel RC-591) sodium phosphate Dibasic heptahydrate Carmellose sodium (E 466)
Sodium chloride
Benzalkonium chloride solution, 50%
Disodium edetate
Polysorbate 80
Hydrochloric acid
Sodium hydroxide
Water for injections



6.2   Incompatibilities
Not applicable.


6.3   Shelf life
The expiry date of the product is indicated on the packaging materials In-use shelf life (after first use): 2 months
Store below 25oC



6.4   Special precautions for storage
Store below 25oC
Do not freeze.
For shelf live after first opening, see section 6.3


6.5   Nature and contents of container
The nasal spray is contained in a 20 ml white opaque , high density polyethylene (HDPE) bottle supplied with a metered-dose, manual polypropylene spray pump actuator. The actuator is fitted with a HDPE purple cap.
Pack sizes:
1 bottle of 20 ml with 9 g suspension (56 actuations),
1 bottle of 20 ml with 18 g suspension (120 actuations)
1 bottle of 30 ml with 29 g suspension (240 actuations).
Not all pack sizes may be marketed.



6.6   Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements