Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
fentanyl hydrochloride
Incline Therapeutics Europe Ltd
N02AB03
fentanyl
Analgesics
Pain, Postoperative
Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Revision: 2
Withdrawn
2015-11-18
28 B. PACKAGE LEAFLET Medicinal product no longer authorised 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IONSYS 40 MICROGRAMS PER DOSE TRANSDERMAL SYSTEM FENTANYL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or your nurse. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What IONSYS is and what it is used for 2. Before you use IONSYS 3. How to use IONSYS 4. Possible side effects 5. How to store IONSYS 6. Contents of the pack and other information 1. WHAT IONSYS IS AND WHAT IT IS USED FOR What IONSYS is IONSYS is a transdermal system (to be applied on intact skin) that contains a strong analgesic (pain reliever) medicine called fentanyl. What IONSYS is used for IONSYS is used to treat short-term moderate to severe pain in adults after an operation. IONSYS is used in hospital only. How IONSYS works IONSYS is a small device applied to the skin of your upper arm or chest. It works by delivering fentanyl through your skin to relieve your pain. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IONSYS DO NOT USE IONSYS: • if you are allergic (hypersensitive) _ _ to fentanyl, or any of the other ingredients of IONSYS (listed in section 6). • if you suffer from severe breathing problems or cystic fibrosis. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using IONSYS if: • you have a severe or persistent lung disease, or any breathing problems • you have a very slow heart rate, low blood pressure, or other serious heart problem • you have problems with your liver or kidneys • you ha Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT IONSYS 40 micrograms per dose transdermal system 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each IONSYS system contains fentanyl hydrochloride equivalent to 9.7 mg of fentanyl and delivers 40 micrograms fentanyl per dose, to a maximum of 80 doses (3.2 mg/24 hours). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal system IONSYS is composed of an electronic controller and a drug unit with two hydrogels. The controller is white with the identifier ‘IONSYS ®’ and has a digital display, a light window, and a recessed dose activation button. The drug unit is blue on the side that connects to the controller and has a red bottom housing containing the hydrogels, one of which contains the fentanyl. The assembled IONSYS product measures 47 mm x 75 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IONSYS is indicated for the management of acute moderate to severe post-operative pain in adult patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ IONSYS is restricted to hospital use only. Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy. Due to the well-known potential of abuse of fentanyl, physicians should evaluate patients for a history of drug abuse (see section 4.4). Posology Patients should be titrated to an acceptable level of analgesia prior to initiating use of IONSYS (see section 5.1). IONSYS should only be activated by the patient. Each dose of IONSYS delivers 40 micrograms of fentanyl over a 10 minute period, to a maximum of 240 micrograms per hour (6 doses each of 10 minutes duration). IONSYS will operate for 24 hours after the system is assembled or for 80 doses, whichever comes first, and then becomes inoperative. After 24 hours or 80 doses, a new system should be applied if necessary. Each new system should be placed on a new skin site. With each new IONSYS application Lesen Sie das vollständige Dokument