Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Fentanyl citrate
Takeda Pharma A/S
N02AB03
fentanyl
Analgesics
Pain; Cancer
Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Revision: 36
Authorised
2009-07-20
89 B. PACKAGE LEAFLET 90 PACKAGE LEAFLET: INFORMATION FOR THE USER INSTANYL 50 MICROGRAMS/DOSE NASAL SPRAY, SOLUTION INSTANYL 100 MICROGRAMS/DOSE NASAL SPRAY, SOLUTION INSTANYL 200 MICROGRAMS/DOSE NASAL SPRAY, SOLUTION 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Instanyl is and what it is used for 2. What you need to know before you use Instanyl 3. How to use Instanyl 4. Possible side effects 5. How to store Instanyl 6. Contents of the pack and other information 1. WHAT INSTANYL IS AND WHAT IT IS USED FOR Instanyl contains the active substance fentanyl and belongs to a group of strong painkillers called opioids. Opioids act by blocking the pain signals to the brain. Instanyl acts rapidly and is used for relieving breakthrough pain in adult cancer patients already treated with opioids for their usual pain. Breakthrough pain is an additional sudden pain that occurs despite you having taken your usual opioid pain relieving medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE INSTANYL DO NOT USE INSTANYL - if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6). - if you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain. If you have not been using these medicines you must not use Instanyl, because it may increase the risk that breathing could become dangerously slow and/or shall Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms/dose nasal spray, solution Instanyl 100 micrograms/dose nasal spray, solution Instanyl 200 micrograms/dose nasal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Instanyl 50 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 500 micrograms fentanyl. 1 dose (100 microlitres) contains 50 micrograms fentanyl. Instanyl 100 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 1,000 micrograms fentanyl. 1 dose (100 microlitres) contains 100 micrograms fentanyl. Instanyl 200 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 2,000 micrograms fentanyl. 1 dose (100 microlitres) contains 200 micrograms fentanyl. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution (nasal spray) Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients. Physicians should keep in mind the potential of abuse, misuse, addiction and overdose of fentanyl (see section 4.4). Posology Patients should be individually titrated to a dose that provides adequate analgesia with tolerable adverse Pročitajte cijeli dokument