Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Fentanyl
Janssen Sciences Ireland UC
N02AB; N02AB03
Fentanyl
25 micrograms/hour
Transdermal patch
Phenylpiperidine derivatives; fentanyl
Marketed
1995-10-31
PACKAGE LEAFLET: INFORMATION FOR THE USER DUROGESIC ® _DTRANS_ ® 12 MICROGRAMS /HOUR TRANSDERMAL PATCH 25 MICROGRAMS /HOUR TRANSDERMAL PATCH 50 MICROGRAMS /HOUR TRANSDERMAL PATCH 75 MICROGRAMS /HOUR TRANSDERMAL PATCH 100 MICROGRAMS /HOUR TRANSDERMAL PATCH fentanyl Durogesic is a registered trademark and DTrans is a trademark 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 already using opioid medication and who need continuous pain treatment. Durogesic DTrans contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE DUROGESIC DTRANS DO NOT USE DUROGESIC DTRANS IF • You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6) • You have pain which lasts only for a short period, such as sudden pain or pain after having an operation • You have breathing difficulties, with slow or shallow breathing Do not use this medicine if any of the above apply to you or your child. Baca dokumen lengkap
Health Products Regulatory Authority 22 September 2023 CRN00DHMV Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Durogesic DTrans 25 micrograms/hour transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DUROGESIC DOSE (MICROGRAMS/HOUR) PATCH SIZE (CM 2 ) QUANTITY OF FENTANYL PER PATCH (MG) DUROGESIC 25 micrograms/hour 25 10.5 4.2 For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Durogesic DTrans is a translucent, rectangular transdermal patch with rounded corners. Each patch is marked in coloured printing ink as follows: Each patch is 10.5 cm 2 , and is marked with a border and "DUROGESIC 25 µg fentanyl/h" in red 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 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 should be based on the patient's current opioid use. It is recommended that DUROGESIC 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 refer to Equianalgesic potency conversion below. The dosage may subsequently Baca dokumen lengkap