Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Fentanyl
Rowex Ltd
N02AB; N02AB03
Fentanyl
100 Microgram per hour
Transdermal patch
Product subject to prescription which may not be renewed (A)
Phenylpiperidine derivatives; fentanyl
Marketed
2007-04-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FENTAL MATRIX 25 MICROGRAMS/HOUR TRANSDERMAL PATCH FENTAL MATRIX 50 MICROGRAMS/HOUR TRANSDERMAL PATCH FENTAL MATRIX 75 MICROGRAMS/HOUR TRANSDERMAL PATCH FENTAL MATRIX 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 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 any 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 Fental Matrix is and what it is used for 2. What you need to know before you use Fental Matrix 3. How to use Fental Matrix 4. Possible side effects 5. How to store Fental Matrix 6. Contents of the pack and other information 1. WHAT FENTAL MATRIX IS AND WHAT IT IS USED FOR The name of your medicine is Fental Matrix. 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 medicines and who need continuous pain treatment. Fental Matrix contains an active substance called fentanyl. It belongs to a group of strong painkillers called opioids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENTAL MATRIX DO NOT USE FENTAL MATRIX IF: • You are allergic to fentanyl, colophonium resin (hydrogenated), soya, peanuts 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 sure, talk to your doct Đọc toàn bộ tài liệu
Health Products Regulatory Authority 01 September 2023 CRN00DHMY Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fental Matrix 100 micrograms/hour transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch (42 cm 2 absorption surface area) contains 23.12 mg fentanyl equivalent to a release rate of the active substance of 100 microgram/hour. Excipient with known effect: Each transdermal patch contains 23.12 mg of refined Soya-bean oil. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch Transparent rounded oblong transdermal patch, consisting of a protective film (to be removed prior to application of the patch) and two functional layers: one self-adhesive matrix layer containing fentanyl and a carrier film impermeable to water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Fental Matrix 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 Doses of fentanyl transdermal patches 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 12.5, 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 dose selection_ The appropriate initiating dose of fentanyl patches should be based on the patient's current opioid use. It is recommended that fentanyl patches 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 conver Đọc toàn bộ tài liệu