Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS

6.1      List of excipients
Monosodium phosphate dihydrate
Sodium chloride
Dibasic sodium phosphate anhydrous
Polysorbate 20
Sorbitan laurate
Water for injection

6.2      Incompatibilities

None reported.
6.3      Shelf life

The expiry date of the product is indicated on the packaging materials.
In-use shelf-life:

The flow wrap pack should be opened immediately before use. Once Flixotide Nebules have been removed from their flow wrap pack they should be protected from light and used within 28 days.

Once opened, nebules should be used immediately.

6.4      Special precautions for storage

Flixotide Nebules should not be stored above 30oC. Keep the container in the outer carton in order to protect from light. Do not freeze. Store upright.
For storage conditions after first opening of the medicinal product, see section 6.3

6.5      Nature and contents of container

2.5ml low density polyethylene ampoules provided as a strip of Nebules in a foil flow wrap, in boxes of 10.
Each card of five Flixotide Nebules is wrapped and sealed with a flow wrap foil. The foil is composed of polyester on the outer surface, aluminium as the middle layer and low density polyethylene on the inner surface.

6.6      Special precautions for disposal and other handling

It is important to ensure that the contents of the Nebule are well mixed before use. While holding the Nebule horizontally by the labelled tab, ‘flick’ the other end a few times and shake. Repeat this process several times until the entire contents of the Nebule are completely mixed. To open the Nebule, twist off the tab.

Dilution: Flixotide Nebules may be diluted with Sodium Chloride Injection BP if required, to aid administration of small volumes or if a prolonged delivery time is desirable. Any unused suspension remaining in the nebuliser should be discarded.

For detailed instructions please refer to the Patient Information Leaflet in every pack.
The nebuliser must be used according to the manufacturer’s instructions. It is advisable to administer Flixotide Nebules via a mouthpiece (see Posology and method of administration).

As many nebulisers operate on a continuous flow basis, it is likely that some nebulised drug will be released into the local environment. Flixotide Nebules should therefore be administered in a well-ventilated room, particularly in hospitals where several patients may be using nebulisers at the same time.