Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
FENTANYL
Imbat Limited
FENTANYL
50 Microgram per hour
Transdermal Patch
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER DUROGESIC ® DTRANS ® 25 MICROGRAMS/HOUR TRANSDERMAL PATCH 50 MICROGRAMS/HOUR TRANSDERMAL PATCH 75 MICROGRAMS/HOUR TRANSDERMAL PATCH 100 MICROGRAMS/HOUR TRANSDERMAL PATCH (fentanyl) Your medicine is available using the above names but will be referred to as ‘Durogesic DTrans patch’ or just ‘patch’ throughout this leaflet. 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, ask your doctor, nurse or pharmacist This medicine has been prescribed for you or your child. 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, nurse or pharmacist IN THIS LEAFLET 1. WHAT DUROGESIC DTRANS PATCHES ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU USE DUROGESIC DTRANS PATCHES 3. HOW TO USE DUROGESIC DTRANS PATCHES 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DUROGESIC DTRANS PATCHES 6. FURTHER INFORMATION 1. WHAT DUROGESIC DTRANS PATCHES ARE AND WHAT THEY ARE USED FOR The name of your medicine is Durogesic DTrans transdermal patch. It is called ‘Durogesic DTrans patch’ or just ‘patch’ in this leaflet. Durogesic DTrans patch contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. The patches come in five strengths (see section 6 overleaf). The medicine passes slowly into your body through your skin. WHAT DUROGESIC DTRANS PATCHES ARE USED FOR The patches help relieve pain that is very b Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Durogesic DTrans 50 micrograms/hour Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Durogesic DTrans 50 patch contains fentanyl 8.4 mg. Release rate of approximately 50 micrograms per hour; active surface area 21.0 cm2. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. _Product imported from the Netherlands:_ A rectangular shaped, clear patch with a sticky back so that it can be stuck onto the skin. Each Durogesic DTrans patch is marked: Fentanyl 50 µg fentanyl/h in green printing ink 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Durogesic DTrans is indicated in the management of chronic intractable pain in patients requiring opioid analgesia. Children: long term management of severe chronic pain in children receiving opioid therapy from 2 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For transdermal use. Durogesic DTrans should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arm. In young children, the upper back is the preferred location to apply the patch, to minimise the potential of the child removing the patch. Hair at the application site (a non-hairy area is preferable) should be clipped (not shaved) prior to application. If the site of Durogesic DTrans application requires to be cleansed prior to application of the patch, this should be done with water. Soaps, oils, lotions or any other agent that might irritate the skin or alter its characteristics should not be used. The skin should be completely dry before the patch is applied. Patches should be inspected prior to use. Patches that are cut, divided, or damaged in any way should not be used. The Durogesic DTrans Прочитайте повний документ