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▼Detta läkemedel är föremål för utökad övervakning Trulicity 0,75 mg, 1,5 mg injektionsvätska, lösning i förfylld injektionspenna (dulaglutid). ATC-kod: A10BX14 Indikationer: Trulicity är avsett för vuxna med typ 2-diabetes mellitus för att förbättra glykemisk kontroll som: Monoterapi När behandling med enbart kost och motion inte ger tillräcklig glykemisk kontroll hos patienter för vilka behandling med metformin inte anses lämplig på grund av intolerans eller kontraindikationer. Tilläggsbehandling I kombination med andra glukossänkande läkemedel inklusive insulin, när dessa tillsammans med kost och motion inte ger tillräcklig glykemisk kontroll (se avsnitt 5.1 för data gällande olika kombinationsbehandlingar). Kontraindikationer: Överkänslighet mot den aktiva substansen eller mot något hjälpämne. Varning: Dulaglutid ska inte användas av patienter med typ 1-diabetes mellitus eller för behandling av diabetesketoacidos. Användning av GLP-1-receptoragonister kan sättas i samband med gastrointestinala biverkningar. Detta skall tas under övervägande då patienter med nedsatt njurfunktion behandlas eftersom dessa biverkningar, t ex illamående, kräkningar och/eller diarré, kan orsaka dehydrering vilket kan leda till en försämrad njurfunktion. Dulaglutid har inte studerats hos patienter med allvarlig gastrointestinal sjukdom, däribland allvarlig gastropares, och rekommenderas därför inte till dessa patienter. Användning av GLP-1- receptoragonister har satts i samband med en risk att utveckla akut pankreatit. Patienterna ska informeras om de karakteristiska symtomen på akut pankreatit. Om pankreatit misstänkts ska behandlingen med dulaglutid avbrytas. Om pankreatit bekräftas ska dulaglutid inte återinsättas. Utan andra tecken och symtom på akut pankreatit är förhöjda pankreasenzymer inte prediktivt för akut pankreatit. Patienter som får dulaglutid i kombination med en sulfonureid eller insulin kan löpa ökad risk för hypoglykemi. Risken för hypoglykemi kan minskas genom att dosen av sulfonureid eller insulin sänks. Datum för översyn av produktresumén: 2016-10-13 Läs bipacksedeln före användning. För ytterligare information och priser se Rx, F Subventioneras för patienter som först har prövat metformin, sulfonureider eller insulin, eller när metformin eller sulfonureider inte är lämpliga. Subventioneras endast för patienter som inte behandlas i kombination med basinsulin. Eli Lilly Sweden AB, Box 721, 169 27 Solna. 08-737 88 00, Referens: Produktresumé (SPC) Trulicity (dulaglutid), | PP-DG-SE-0010