País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
fentanyl
Kyowa Kirin Holdings B.V.
N02AB03
fentanyl
Analgesics
Pain; Cancer
PecFent is indicated for the management of breakthrough pain in adults who are 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 of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.
Revision: 23
Authorised
2010-08-31
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE USER PECFENT 100 MICROGRAMS/SPRAY NASAL SPRAY, SOLUTION PECFENT 400 MICROGRAMS/SPRAY 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 doctoror 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. WHAT IS IN THIS LEAFLET 1. What PecFent is and what it is used for 2. What you need to know before you use PecFent 3. How to use PecFent 4. Possible side effects 5. How to store PecFent 6. Contents of the pack and other information 1. WHAT PECFENT IS AND WHAT IT IS USED FOR WHAT PECFENT IS PecFent contains fentanyl, which is a strong pain-relieving medicine known as an opioid pain killer. WHAT PECFENT IS USED FOR PecFent is used in adults with cancer for a type of pain called ‘breakthrough’ pain. • Breakthrough pain comes on suddenly. • It comes on even though you have taken your usual opioid pain killer (such as morphine, fentanyl, oxycodone or hydromorphone) to control your constant background pain. PecFent is only to be used by adults who are already taking other opioid medicines daily for their constant cancer pain. HOW PECFENT WORKS PecFent is a nasal spray, solution • When you spray PecFent into your nose the very small spray droplets form a thin gel. • Fentanyl is absorbed quickly through the lining of your nose and into the blood stream. • This means the medicine gets into your system quickly to relieve your breakthrough pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PECFENT DO NOT USE PECFENT IF: • you are allergic to fentanyl or any of the other ingredients of this medicine ( Llegiu el document complet
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT PecFent 100 micrograms/spray nasal spray, solution PecFent 400 micrograms/spray nasal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PecFent 100 micrograms/spray nasal spray, solution Each ml of solution contains 1,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate) Bottles contain: 0.95 ml (950 micrograms fentanyl) - 2 spray bottle or 1.55 ml (1,550 micrograms fentanyl) - 8 spray bottle PecFent 400 micrograms/spray nasal spray, solution Each ml of solution contains 4,000 micrograms fentanyl (as citrate) 1 spray (100 microlitres) contains 400 micrograms fentanyl (as citrate) Each bottle contains 1.55 ml (6,200 micrograms fentanyl) Excipients with known effect: _ _ Each spray contains 0.02 mg propylparahydroxybenzoate (E216). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, solution (nasal spray). A clear to practically clear colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PecFent is indicated for the management of breakthrough pain (BTP) in adults who are 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 of 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 for abuse of fentanyl. 3 Posology PecFent should be titrated to an “effective” dose that provides adequate anal Llegiu el document complet