Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
fentanyl hydrochloride
Janssen-Cilag International NV
N02AB03
fentanyl
Analgesics
Pain, Postoperative
Management of acute moderate to severe post-operative pain for use in a hospital setting only
Revision: 3
Withdrawn
2006-01-24
Medicinal product no longer authorised B. PACKAGE LEAFLET 22 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER IONSYS 40 MICROGRAMS PER DOSE IONTOPHORETIC TRANSDERMAL SYSTEM fentanyl Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or your nurse. - This product 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 any of the side-effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. 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. Further Information 1. WHAT IONSYS IS AND WHAT IT IS USED FOR IONSYS is a system that you can operate to control your pain. IONSYS IS USED IN HOSPITAL ONLY , to treat pain after an operation. You control your own treatment, under the guidance of medical staff. 2. BEFORE YOU USE IONSYS DO NOT USE IONSYS: - IF YOU ARE ALLERGIC _(hypersensitive) _ to fentanyl, adhesive bandages or tapes, or any of the ingredients listed below. TAKE SPECIAL CARE WITH IONSYS Tell your doctor or nurse - If you already have problems with your lungs or trouble breathing - If you have problems with your heart, liver or kidneys - If you get headaches or have had a head injury - If you have any difficulty hearing - If you have abnormally slow bowel movements TAKING OTHER MEDICINES Some medicines can affect the way IONSYS works, or make it more likely that you’ll have side effects. CHECK WITH YOUR DOCTOR if you’re taking: - any medicine which makes you sleepy or drowsy (such as other morphine-related painkillers, antihistamines or tranquillisers) - muscle relaxants (these may be prescribed for back pain) - ritonavir or other CYP3A4 inhibitors (medicines that help control HIV infection) - antidepressants call Aqra d-dokument sħiħ
Medicinal product no longer authorised _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT IONSYS 40 micrograms per dose iontophoretic transdermal system. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each IONSYS system contains 10.8 mg fentanyl hydrochloride equivalent to 9.7 mg of fentanyl and delivers 40 micrograms fentanyl per dose, to a maximum of 3.2 mg (80 doses). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Iontophoretic transdermal system (ITS). IONSYS is composed of a compact electronic controller and two hydrogel reservoirs, one of which contains fentanyl hydrochloride in a gel formulation for needle free, on-demand delivery. The upper part of the product is white and contains the identifier ‘IONSYS ™ ’. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS IONSYS is indicated for the management of acute moderate to severe post-operative pain for use in a hospital setting only. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION IONSYS should be restricted to hospital use only. Due to the well known potential of abuse of fentanyl physicians should evaluate patients for a history of drug abuse (see section 4.4). Special precautions for disposal should be followed (see section 6.6). IONSYS should only be activated by the patient. Before any surgery, the healthcare professional should ensure that the patient has been properly informed on how to use IONSYS post-operatively. IONSYS delivers 40 micrograms per on-demand dose up to a maximum of 240 micrograms (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period. Patients should be titrated to an acceptable level of analgesia prior to initiating use of IONSYS. _ _ The system should only be activated by the patient in response to pain. IONSYS will operate for 24 hours following completion of the first dose or for 80 doses, whichever comes first, and then becomes inoperative. If the patient attempts to initiate a dose Aqra d-dokument sħiħ