Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl
Janssen-Cilag Ltd
N02AB03
Fentanyl
50microgram/1hour
Transdermal patch
Transdermal
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5012674901113
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DUROGESIC ® _DTRANS_ ® 12 MICROGRAMS/HOUR TRANSDERMAL PATCH DUROGESIC ® _DTRANS_ ® 25 MICROGRAMS/HOUR TRANSDERMAL PATCH DUROGESIC ® _DTRANS_ ® 50 MICROGRAMS/HOUR TRANSDERMAL PATCH DUROGESIC ® _DTRANS_ ® 75 MICROGRAMS/HOUR TRANSDERMAL PATCH DUROGESIC ® _DTRANS_ ® 100 MICROGRAMS/HOUR TRANSDERMAL PATCH Fentanyl Durogesic and DTrans are registered trademarks IMPORTANT THINGS YOU NEED TO KNOW ABOUT DUROGESIC DTRANS TRANSDERMAL PATCHES These patches contain a strong pain killer Ensure that old patches are removed before applying a new one Patches must not be cut Do not expose the patches to a heat source (such as a hot water bottle) If you develop a fever tell your doctor immediately Follow the dosage instructions carefully and only change your patch every 3 DAYS (72 HOURS) If your breathing becomes shallow and weak take the patch off and seek medical help 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, ask your doctor, pharmacist or nurse This medicine has been prescribed for you (or your child) only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours If you get side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Durogesic DTrans is and what it is used for 2. What you need to know before you use Durogesic DTrans 3. How to use Durogesic DTrans 4. Possible side effects 5. How to store Durogesic DTrans 6. Contents of the pack and other information 1. WHAT DUROGESIC DTRANS IS AND WHAT IT IS USED FOR The name of your medicine is Durogesic DTrans The patches help relieve pain that is very bad and long-lasting: in adults who need continuous pain treatment in children above 2 years of age who are alrea Olvassa el a teljes dokumentumot
OBJECT 1 DUROGESIC DTRANS 50 MCG/HR TRANSDERMAL PATCH Summary of Product Characteristics Updated 08-Jun-2018 | Janssen-Cilag Ltd 1. Name of the medicinal product Durogesic ® DTrans ® 50 mcg/hr Transdermal Patch 2. Qualitative and quantitative composition Each Durogesic DTrans 50 patch contains fentanyl 8.4 mg. Release rate approximately 50 µg/h; active surface area 21.0 cm 2 . For excipients, see 6.1 3. Pharmaceutical form Transdermal patch. Durogesic is a translucent, rectangular transdermal patch with rounded corners, marked with the product name, strength and a border in coloured ink. Each patch is marked: Durogesic 50 µg fentanyl/h Green printing ink 4. Clinical particulars 4.1 Therapeutic indications Adults Durogesic DTrans is indicated for management of severe chronic pain that requires continuous long term opioid administration. Children Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy. 4.2 Posology and method of administration Posology Durogesic DTrans doses should be individualised based upon the status of the patient and should be assessed at regular intervals after application. The lowest effective dose should be used. The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively. Initial dosage selection The appropriate initiating dose of Durogesic DTrans should be based on the patient's current opioid use. It is recommended that Durogesic DTrans be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance. Adults _Opioid-tolerant patients _ To convert opioid-tolerant patients from oral or parenteral opioids to Durogesic DTrans refer to Equianalgesic potency conversion below. The dosage may subsequently be titrated upwards o Olvassa el a teljes dokumentumot