Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl
Viatris UK Healthcare Ltd
N02AB03
Fentanyl
75microgram/1hour
Transdermal patch
Transdermal
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5016695001678
PAGE 1 OF 13 PACKAGE LEAFLET PAGE 2 OF 13 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT M YLAFENT ® 12 MICROGRAM / HOUR T RANSDERMAL P ATCH M YLAFENT ® 25 MICROGRAM / HOUR T RANSDERMAL P ATCH M YLAFENT ® 50 MICROGRAM / HOUR T RANSDERMAL P ATCH M YLAFENT ® 75 MICROGRAM / HOUR T RANSDERMAL P ATCH M YLAFENT ® 100 MICROGRAM/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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - 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 72 hours. - If your breathing becomes shallow and weak take the patch off and seek medical help. WHAT IS IN THIS LEAFLET 1. What Mylafent is and what it is used for 2. What you need to know before you use Mylafent. 3. How to use Mylafent. 4. Possible side effects 5. How to store Mylafent. 6. Contents of the pack and other information 1. WHAT M YLAFENT IS AND WHAT IT IS USED FOR Mylafent contains fentanyl, which belongs to a group of strong painkillers called opioids. The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body. Adults: Mylafent is indicated in severe chronic pain which can be adequately managed only with opioid analgesics. Children and adolescents: Mylafent is used for the long term treatment of severe and long lasting pain in children and adole Preberite celoten dokument
OBJECT 1 MYLAFENT 75 MICROGRAM/HOUR TRANSDERMAL PATCH Summary of Product Characteristics Updated 30-Jun-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Mylafent 75 microgram/hour Transdermal Patch 2. Qualitative and quantitative composition Each Mylafent 75 microgram/hour transdermal patch contains 12.6 mg of fentanyl in a patch size 31.5 cm 2 , releasing 75 micrograms of fentanyl per hour. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch A translucent rectangular patch printed with white ink on a removable liner. The following is printed on each patch: Fentanyl 75 µg/h 4. Clinical particulars 4.1 Therapeutic indications Adults: Mylafent is indicated in severe chronic pain which can be adequately managed only with opioid analgesics. Children and adolescents: Long term management of severe chronic pain in children and adolescents receiving opioid therapy from 2 years of age. 4.2 Posology and method of administration Posology Adults: _Initial dose selection_ The dosing is individual and based on the patient's opioid history and takes in to account: • possible development of tolerance • the current general condition, the medical status of the patient, and • the degree of severity of the disorder The required fentanyl dosage is adjusted individually and should be assessed regularly after each administration. _Patients receiving opioid treatment for the first time_ Patches with a release rate of 12 micrograms/hour are available and should be used for initial dosing. In very elderly or weak patients, it is not recommended to initiate a treatment with Mylafent, due to their known susceptibility to opioid treatments. In these cases, it would be preferable to initiate a treatment with low doses of immediate release morphine and to prescribe Mylafent after determination of the optimal dosage. _Switching from other opioids_ When changing over from oral or parenteral opioids to fentanyl treatment, the initial dosage should be calculated as follows: 1. The quantit Preberite celoten dokument