Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Polyethylene glycol 400, Ethanol 96%, Essence of banana (contains propylene glycol), Saccharin, Purified water, Levomenthol.

6.2. Incompatibilities
Not applicable.
6.3. Shelf-life
The expiry date of the product is indicated on the packaging materials.
Shelf life after first opening: Until the end of shelf life.

6.4. Special precautions for storage
Do not store above 25°C. Do not freeze. During storage at temperatures below 8°C precipitation may occur. This prescription is dissolved when warming up in room temperature.

6.5. Nature and content of container
50 ml glass spray bottles (approx. 500 spray doses) with a metering spray pump.
The package includes a single-use spray nozzle approximately 120mm long.
Additional short spray nozzles are available separately.
Each depression of the metered spray pump delivers 10 mg lidocaine base. The contents of the spray bottles are sufficient to provide approximately 500 sprays.

6.6. Special precautions for disposal and other handling
The spray nozzle is bent to ensure correct spray function. Do not try to alter the shape as this could affect its performance.
The nozzle must not be shortened, as it will affect the spray function.
Nozzles are non-sterile single patient single use and national/local procedures should be adhered to in order to prevent cross contamination. The nozzles should be handled using gloves and the box of 50 should be kept closed between procedures.
Nozzles should not be reused, and should be discarded after use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Registration holder
Padagis Israel Agencies Ltd.
1 Rakefet St., Shoham, Israel.