Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Fentanyl
PCO Manufacturing Ltd.
N02AB03
Fentanyl
75 micrograms/hour
Transdermal patch
Product subject to prescription which may not be renewed (A)
fentanyl
Authorised
2014-07-25
_ _ _ _ _ _ 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 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 TM is and what it is used for 2. What you need to know before you use Durogesic DTrans TM 3. How to use Durogesic DTrans TM 4. Possible side effects 5. How to store Durogesic DTrans TM 6. Contents of the pack and other information 1. WHAT DUROGESIC DTRANS TM IS AND WHAT IT IS USED FOR The name of your medicine is Durogesic DTrans TM 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 TM 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 TM DO NOT USE DUROGESIC DTRANS TM 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. If you are not Lugege kogu dokumenti
Health Products Regulatory Authority 15 January 2024 CRN00F172 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Durogesic DTrans 75 micrograms/hour Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Durogesic DTrans 75 patch contains fentanyl 12.6 mg. Release rate of approximately 75 micrograms per hour; active surface area 31.5 cm 2 . For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. _Product imported from Italy, Greece and Poland_ Durogesic is a translucent, rectangular transdermal patch with rounded corners, marked with the product name, strength and a border in coloured ink. The patch has a sticky back so that it can be stuck onto the skin. Each patch is 31.5 cm 2 and is marked with a border and "Durogesic 75 µg fentanyl/h " in blue printing ink. 4 CLINICAL PARTICULARS As per PA22612/004/003 5 PHARMACOLOGICAL PROPERTIES As per PA22612/004/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Polyacrylate adhesive Polyethylene terephthalate/ethyl vinyl acetate film Blue printing ink Silconised polyester film 6.2 INCOMPATIBILITIES To prevent interference with the adhesive properties of Durogesic DTrans, no creams, oils, lotions or powder should be applied to the skin area when the Durogesic DTrans transdermal patch is applied. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 15 January 2024 CRN00F172 Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special temperature storage conditions. Store in the original pouch in order to protect from light. 6.5 NATURE AND CONTENTS OF CONTAINER Each patch is packed in a heat-sealed pouch made of acrylonitrate film, polyethylene terephthalate (PET), low density polyethylene/aluminium foil and adhesive. Pouches are packed into cardboard cartons (five pouches per carton). 6.6 SPECIAL PRECA Lugege kogu dokumenti