국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
FENTANYL
Pfizer Healthcare Ireland
FENTANYL
25 Microgram per hour
Transdermal Patch
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FENTADUR 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 or pharmacist. - This medicine has been prescribed for you. 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 any side effects talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Fentadur is and what it is used for 2. What you need to know before you use Fentadur 3. How to use Fentadur 4. Possible side effects 5. How to store Fentadur 6. Contents of the pack and other information 1. WHAT FENTADUR IS AND WHAT IT IS USED FOR Fentanyl is one of a group of strong painkillers called opioids. The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body. ADULTS Fentadur is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers (opioids). CHILDREN Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENTADUR DO NOT USE FENTADUR: - if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6). - if you suffer from pain which lasts only for a short period e.g. after a surgical procedure - if your central 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fentadur 25 micrograms/hour Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fentadur 25 micrograms/ hour transdermal patch contains 2.75 mg of fentanyl in a patch size of 10m 2 , releasing 25 micrograms of fentanyl per hour. Excipients(s) with known effect: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal Patch Fentadur transdermal patch is a rectangular, tan coloured patch placed between two oversized, transparent protective layers which must be removed prior to the patch application. The patches will be imprinted: “Fentadur 25 µg/h” in red ink 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS The product is indicated in severe chronic pain which can be adequately managed only with opioid analgesics. 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 It is not possible to ensure the interchangeability of different fentanyl containing transdermal patch product in individual patients. Therefore, it should be emphasised that patients should not be changed from one fentanyl containing product to another without specific counselling on the change from their healthcare professionals. Initial dose selection The appropriate initiating dose of fentanyl should be based on the patient’s current opioid use. It is recommended that fentanyl 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 전체 문서 읽기