Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Incline Therapeutics Europe Ltd
21 St. Thomas Street
Bristol
BS1 6JS
United Kingdom
Do not store above 25°C.
Do not refrigerate or freeze.
Each IONSYS system is packaged in a sealed thermoform tray. The tray contains one Controller and one sachet containing a Drug Unit. The sachet foil is comprised of a lamination of nylon, aluminium foil and a heat seal layer of a copolymer of polyethylene and polymethacrylic acid.
Each tray is packaged in a folding cardboard carton. There are 6 systems per carton.
EU/1/15/1050/001
Contact with the hydrogel can be harmful to humans. If the fentanyl hydrogel contacts the skin during application or removal, the area should be washed with copious amounts of water. Soap, alcohol, or other solvents should not be used to remove the hydrogel because they may enhance the active substances' ability to penetrate the skin.
Disposal
The used IONSYS system contains a dangerous amount of fentanyl within the red hydrogel housing. Gloves must be worn when removing IONSYS from the patient's skin and during disposal. The used system should be handled carefully by the sides and top. Contact with the hydrogel should be avoided.
The design of the system allows separate disposal of the hydrogel housing and the Controller.
To dispose of a used IONSYS system:
1. Hold the Controller in one hand and pull the red tab with the other hand to separate the hydrogel housing from the system.
2. Fold the hydrogel housing in half with the sticky side facing in.
3. Dispose of the folded hydrogel housing in accordance with local requirements for opioid medicinal products.
4. Dispose of remainder of the system, containing electronics, according to hospital procedures for battery waste.
Local arrangements should be in place to ensure that used systems are returned appropriately (e.g., to hospital pharmacies) for disposal of the residual fentanyl in the hydrogel. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation: 11/2015
