Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl
Accord-UK Ltd
N02AB03
Fentanyl
75microgram/1hour
Transdermal patch
Transdermal
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5012617018052
IMPORTANT THINGS YOU NEED TO KNOW ABOUT VICTANYL TRANSDERMAL PATCHES • 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). • Do not soak in a hot bath or take a hot shower whilst wearing a patch. • If you develop a fever tell your doctor immediately. • Follow the dosage instructions carefully and only change your patch at the SAME TIME of day every 3 DAYS (72 HOURS). • If your breathing becomes shallow and weak take the patch off and seek medical help. 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 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 VICTANYL_ _IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU USE VICTANYL 3 HOW TO USE VICTANYL 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE VICTANYL 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT VICTANYL_ _IS AND WHAT IT IS USED FOR The name of your medicine is Victanyl. 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 Victanyl contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE VICTANYL DO NOT USE VICTANYL IF: • You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6). • Y Přečtěte si celý dokument
OBJECT 1 VICTANYL 75 MICROGRAMS/HOUR TRANSDERMAL PATCH Summary of Product Characteristics Updated 08-Mar-2018 | Accord-UK Ltd 1. Name of the medicinal product Victanyl 75 micrograms/hour Transdermal Patch fentanyl 2. Qualitative and quantitative composition Each patch releases 75 micrograms fentanyl per hour. Each patch of 22.5 cm2 contains 12.375 mg fentanyl. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch Each patch: Transparent and colourless patch with blue imprint on the backing foil “fentanyl 75 µg/h“ 4. Clinical particulars 4.1 Therapeutic indications Adults: Victanyl is indicatedfor 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 Victanyl 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 25, 50, 75, and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.6, 1.2, 1.8, and 2.4 mg per day respectively. _Initial dosage selection _ The appropriate initiating dose of Victanyl should be based on the patient's current opioid use. It is recommended that Victanyl 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 Victanyl refer to Equianalgesic potency conversion below. The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12 or 25 mcg/h to achieve the lowest appropriate dosage of Victanyl depending on the response and s Přečtěte si celý dokument