Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl
Accord-UK Ltd
N02AB03
Fentanyl
12microgram/1hour
Transdermal patch
Transdermal
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5012617025777
BBBA1117 _continued..._ VICTANYL 12MICROGRAMS/HOUR TRANSDERMAL PATCH Fentanyl 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 or pharmacist. • 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 or pharmacist. 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 Transdermal Patch. It is called ‘Victanyl patch’ or just ‘patch’ in this leaflet. 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 patch contains a medicine called fentanyl. It belongs to a group of strong painkillers called opioids. 2 _ _WHAT YOU NEED TO K Przeczytaj cały dokument
OBJECT 1 VICTANYL 12MICROGRAMS/HOUR TRANSDERMAL PATCH Summary of Product Characteristics Updated 07-Apr-2017 | Accord-UK Ltd 1. Name of the medicinal product Victanyl 12micrograms/hour Transdermal Patch 2. Qualitative and quantitative composition Victanyl 12 micrograms/h transdermal patch Each patch releases 12.5 micrograms fentanyl per hour. Each patch of 4.25 cm 2 contains 2.55 mg fentanyl. Excipient with known effect Aloe vera leaf extract oil (on the basis of soya oil tocopherol acetate) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal patch Each patch: Opaque and colourless rectangular shaped patch with round corners and imprint on the backing foil: “Fentanyl 12µg/h”. 4. Clinical particulars 4.1 Therapeutic indications Adults Victanyl 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 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 patch is designed to deliver approximately 12 mcg/h fentanyl to the systemic circulation, which represent about 0.3 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, i Przeczytaj cały dokument