Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1      List of excipients
Norflurane (HFA-134a)
Ethanol anhydrous
Hydrochloric acid 1 M
6.2     Incompatibilities
Not applicable.

6.3     Shelf life
The expiry date of the product is indicted on the packaging materials.

6.4      Special precautions for storage
Prior to dispensing to the patient:
At the pharmacy store in a refrigerator (temperature 2-8°C) for a maximum of 18 months.
After dispensing:
Once the product is dispensed to a patient, it should be stored at room temperature (below 25°C) for a maximum of 3 months.
See section 6.6.
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.

6.5      Nature and contents of container
The inhalation solution is contained in a pressurised aluminium container sealed with a metering valve and fitted into a polypropylene plastic actuator which incorporates a dose counter and a mouthpiece and is provided with a polypropylene plastic cap.
Each pack contains:
1 pressurised container which provides 120 actuations
6.6      Special precautions for disposal and other handling
For pharmacies:
Enter the date of dispensing to the patient on the pack.
Ensure that there is a period of at least 3 months between the date of dispensing and the expiry date printed on the pack.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.