Država: Nizozemska
Jezik: nizozemščina
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
FENTANYLDIWATERSTOFCITRAAT SAMENSTELLING overeenkomend met ; FENTANYL
Generics (UK) Ltd. Station Close EN6 1TL POTTERS BAR, HERTFORDSHIRE (VERENIGD KONINKRIJK)
N02AB03
FENTANYLDIWATERSTOFCITRAAT COMPOSITION corresponding to ; FENTANYL
Zuigtablet
AARDAPPELZETMEEL ; AMMONIA (E 527) ; ARABISCHE GOM (E 414) ; ASCORBINEZUUR (L-) (E 300) ; AZIJNZUUR (E 260) ; BLAUWE INKT ; BRILJANTBLAUW FCF (E 133) ; CITROENZUUR 0-WATER (E 330) ; DEXTRATEN ; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339) ; EETBARE LIJM ; GLYCEROLTRIACETAAT (E 1518) ; KUNSTMATIGE BESSENSMAAKSTOF ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904)
Oromucosaal gebruik
Fentanyl
2019-06-03
1 de 11 PACKAGE LEAFLET 2 de 11 PACKAGE LEAFLET: INFORMATION FOR THE USER FENTANYL GENERICS 200 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR VOOR OROMUCOSAAL GEBRUIK FENTANYL GENERICS 400 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR VOOR OROMUCOSAAL GEBRUIK FENTANYL GENERICS 600 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR VOOR OROMUCOSAAL GEBRUIK FENTANYL GENERICS 800 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR VOOR OROMUCOSAAL GEBRUIK FENTANYL GENERICS 1200 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR VOOR OROMUCOSAAL GEBRUIK FENTANYL GENERICS 1600 MICROGRAM ZUIGTABLETTEN MET INTEGRALE APPLICATOR VOOR OROMUCOSAAL GEBRUIK fentanyl READ ALL OFTHIS 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. WHAT IS IN THIS LEAFLET 1. What Fentanyl Generics is and what it is used for. 2. What you need to know before you take Fentanyl Generics 3. How to take Fentanyl Generics 4. Possible side effects 5. How to store Fentanyl Generics 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR Fentanyl Generics contains the active substance fentanyl which is a strong pain-relieving medicine known as an opioid. The Fentanyl Generics unit comes as a lozenge on a stick. It is used to treat breakthrough pain in adults and adolescents aged 16 years and above with cancer who are already taking other opioid pain medicines for their persistent (around-the-clock) cancer pain. Breakthrough pain is additional sudden pain that occurs suddenly in spite of your having taken your usual opioid pain-relieving medicine Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fentanyl Generics 200 microgram zuigtabletten met integrale applicator voor oromucosaal gebruik Fentanyl Generics 400 microgram zuigtabletten met integrale applicator voor oromucosaal gebruik Fentanyl Generics 600 microgram zuigtabletten met integrale applicator voor oromucosaal gebruik Fentanyl Generics 800 microgram zuigtabletten met integrale applicator voor oromucosaal gebruik Fentanyl Generics 1200 microgram zuigtabletten met integrale applicator voor oromucosaal gebruik Fentanyl Generics 1600 microgram zuigtabletten met integrale applicator voor oromucosaal gebruik 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fentanyl Generics 200 microgram compressed lozenges One compressed lozenge contains 200 micrograms fentanyl (as citrate) Fentanyl Generics 400 microgram compressed lozenges One compressed lozenge contains 400 micrograms fentanyl (as citrate) Fentanyl Generics 600 microgram compressed lozenges One compressed lozenge contains 600 micrograms fentanyl (as citrate) Fentanyl Generics 800 microgram compressed lozenges One compressed lozenge contains 800 micrograms fentanyl (as citrate) Fentanyl Generics 1200 microgram compressed lozenges One compressed lozenge contains 1200 micrograms fentanyl (as citrate) Fentanyl Generics 1600 microgram compressed lozenges One compressed lozenge contains 1600 micrograms fentanyl (as citrate) Excipients with known effect One compressed lozenge contains 1.89g of glucose (as hydrated dextrates) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Compressed lozenge. Fentanyl Generics is a white or slightly yellowish cylindrical lozenge of 17 – 20 mm of thickness and 11 – 12 mm of diameter, on which its respective dosage strength is printed, attached to a plastic handle at the opposite end also labelled with the dosage strength. The lozenges may develop brownish spots during storage. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fentanyl Generics is indicated for management of break Preberite celoten dokument