FrancophonIA/ELRC3.0 huggingface dataset:
English: Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
Danish: Maternel toksicitet sås hos kaniner ved eksponeringsniveauer på mere end 29 gange eksponeringen hos mennesker.
English: Co-administration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of ciclosporin increased the AUC and Cmax of sitagliptin by approximately 29 % and 68 %, respectively.
Danish: Samtidig administration af en enkelt oral 100 mg dosis sitagliptin og en enkelt oral 600 mg-dosis ciclosporin øgede sitagliptins AUC og Cmax med henholdsvis ca. 29% og 68%.
English: No dose adjustment is required based on age.
Danish: Dosisjustering er ikke nødvendig på basis af alder.
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet ved høje doser (se pkt.
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP.
Danish: Når blodglucosekoncentrationen er normal eller forhøjet, bevirker GLP-1 og GIP en øget insulinsyntese og frigørelsen af insulin fra de pankreatiske betaceller via intracellulære signalleringsveje, som inddrager cyklisk AMP.
English: If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Danish: Hvis De får blærer på huden, kan det være et tegn på en hudsygdom kaldet bulløs pemfigoid.
English: If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away.
Danish: Hvis De får en alvorlig allergisk reaktion (hyppighed ikke kendt), herunder udslæt, nældefeber, blærer på huden/hudafskalning og hævelse af ansigt, læber, tunge og svælg, som kan medføre vejrtrækningsog synkebesvær, skal De stoppe med at tage dette lægemiddel og kontakte lægen omgående.
English: Animal data do not suggest an effect of treatment with sitagliptin on male and female fertility.
Danish: Data fra dyreforsøg viser ingen behandlingseffekt med sitagliptin på fertiliteten hos mænd og kvinder.
English: In clinical studies, approximately 13.5 % of the dose was removed over a 3- to 4-hour haemodialysis session.
Danish: I kliniske studier blev ca. 13,5% af dosis fjernet i løbet af en hæmodialysesession på 3-4 timer.
English: In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Danish: Hos rotter var der en øget forekomst af hepatiske adenomer og carcinomer ved en systemisk eksponering, der var 58 gange højere end eksponeringen for mennesker.
English: as triple oral therapy in combination with
Danish: som tripel oral behandling sammen med
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Ristaben (see section 4).
Danish: Der er indberettet tilfælde af betændelse i bugspytkirtlen (pankreatitis) hos patienter, der får Ristaben (se punkt 4).
English: If a hypersensitivity reaction is suspected, Ristaben should be discontinued.
Danish: Hvis der er mistanke om en overfølsomhedsreaktion, skal Ristaben seponeres.
English: Hospitalization for heart failure
Danish: Hospitalsindlæggelse pga. hjertesvigt
English: In addition, the effects of renal impairment on sitagliptin pharmacokinetics in patients with type 2 diabetes and mild, moderate, or severe renal impairment (including ESRD) were assessed using population pharmacokinetic analyses.
Danish: Derudover blev indvirkningen af nyreinsufficiens på sitagliptins farmakokinetik vurderet hos patienter med type 2-diabetes og let, moderat eller svær nyreinsufficiens (inklusive ESRD) ved hjælp af farmakokinetiske populationsanalyser.
English: However, ciclosporin, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
Danish: Ciclosporin, en p-glykoproteinhæmmer, reducerede dog ikke sitagliptins renale clearance.
English: The incidence of hypoglycaemia was similar across treatment groups.
Danish: Incidensen af hypoglykæmi var den samme på tværs af behandlingsgrupperne.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Ristaben is used in combination with a sulphonylurea or with insulin.
Danish: Desuden bør patienterne være opmærksomme på risikoen for hypoglykæmi, når Ristaben anvendes sammen med et sulfonylurinstof eller sammen med insulin.
English: Some adverse reactions were observed more frequently in studies of combination use of sitagliptin with other anti-diabetic medicinal products than in studies of sitagliptin monotherapy.
Danish: Nogle bivirkninger blev observeret hyppigere i undersøgelser med sitagliptin i kombination med andre antidiabetika end i undersøgelser med sitagliptin som monoterapi.
English: In patients with type 2 diabetes with hyperglycaemia, these changes in insulin and glucagon levels lead to lower haemoglobin A1c (HbA1c) and lower fasting and postprandial glucose concentrations.
Danish: Hos patienter med type 2-diabetes med hyperglykæmi fører disse ændringer i insulin- og glucagonniveauer til lavere hæmoglobin A1c (HbA1c) samt lavere koncentration af faste plasmaglucose (FPG) og postprandial glucose (PPG).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: At Week 24, the increase in daily insulin dose was 19 IU/day in patients treated with sitagliptin and 24 IU/day in patients treated with placebo.
Danish: I uge 24 var stigningen i daglig insulindosis 19 IE/dag hos de patienter, der blev behandlet med sitagliptin, og 24 IE/dag hos de patienter, der blev behandlet med placebo.
English: In patients taking pre-mixed insulin, the mean daily dose was 70.9 U/day.
Danish: Hos patienter, der tog forblandet insulin, var den gennemsnitlige daglige dosis 70,9 E/dag.
English: Very common (may affect more than 1 in 10 people): low blood sugar Common: constipation
Danish: Meget almindelig (kan berøre flere end 1 ud af 10): Lavt blodsukker.
English: Animal studies have shown excretion of sitagliptin in breast milk.
Danish: Dyreforsøg har vist udskillelse af sitagliptin i modermælk.
English: In another study involving 91 patients with type 2 diabetes and chronic renal impairment (creatinine clearance < 50 ml/min), the safety and tolerability of treatment with sitagliptin at 25 or 50 mg once daily were generally similar to placebo.
Danish: I en anden undersøgelse med 91 patienter med type 2-diabetes og kronisk nyreinsufficiens (kreatininclearance <50 ml/min) var sikkerhed og tolerabilitet for sitagliptinbehandling med 25 eller 50 mg en gang dagligt generelt den samme som for placebo.
English: Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU United Kingdom
Danish: Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU Storbritannien
English: Ristaben is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Danish: Ristaben er også indiceret som tillægsbehandling til insulin (med eller uden metformin), når diæt og motion plus stabil dosering af insulin ikke giver tilstrækkelig glykæmisk kontrol.
English: However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.
Danish: Der har dog været rapporter om svimmelhed og døsighed, som kan påvirke Deres evne til at køre bil eller betjene maskiner.
English: Children and adolescents below 18 years should not use this medicine.
Danish: Dette lægemiddel bør ikke anvendes til børn og unge under 18 år.
English: There was also a significant difference between groups with respect to change from baseline body weight (sitagliptin -0.6 kg; glipizide +1.2 kg).
Danish: Der var også signifikant forskel mellem grupperne med hensyn til ændring i kropsvægt ved baseline (sitagliptin -0,6 kg; glipizid +1,2 kg).
English: Your doctor may reduce the dose of your sulphonylurea or insulin medicine.
Danish: Lægen vil måske nedsætte dosis af sulfonylurinstof eller insulin.
English: In patients taking non-pre-mixed (intermediate/long-acting) insulin, the mean daily dose was 44.3 U/day.
Danish: Hos patienter, der tog ikke-forblandet insulin (middellangt/langtidsvirkende), var den gennemsnitlige daglige dosis 44,3 E/dag.
English: Do not take Ristaben - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Ristaben - hvis De er allergisk over for sitagliptin eller et af de øvrige indholdsstoffer i lægemidlet
English: Skin and subcutaneous tissue disorders pruritus
Danish: Hud og subkutane væv Pruritus
English: If you get any side effects, talk to your doctor, pharmacist, or nurse.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: Metformin: Co-administration of multiple twice-daily doses of 1,000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
Danish: Metformin: Samtidig administration af multiple doser af 1.000 mg metformin to gange om dagen og 50 mg sitagliptin ændrede ikke sitagliptins farmakokinetik betydeligt hos patienter med type 2diabetes.
English: The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 mL/min/1.73 m
Danish: Studiepopulationen bestod af 2.004 patienter ≥ 75 år og 3.324 patienter med nedsat nyrefunktion (eGFR < 60 ml/min/1,73 m
English: Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Danish: Hypoglykæmi er blevet observeret, når sitagliptin blev anvendt i kombination med insulin eller et sulfonylurinstof.
English: There was no meaningful change from baseline in body weight in either group.
Danish: Med hensyn til kropsvægt var der ingen ændring af betydning i forhold til baseline i nogen af grupperne.
English: Least squares mean adjusted for metformin use at Visit 1 (yes/no), insulin use at Visit 1 (pre-mixed vs. non-pre-mixed [intermediate- or long-acting]), and baseline value.
Danish: Gennemsnit ved mindste kvadraters metode justeret for anvendelse af metformin ved besøg 1 (ja/nej), anvendelse af insulin ved besøg 1 (forblandet versus ikke-forblandet [middellangt- eller langtidsvirkende]) samt baseline-værdi.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ristaben in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Ristaben hos en eller flere undergrupper af den pædiatriske population ved type 2diabetes mellitus (se pkt.
English: Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported.
Danish: Efter markedsføring er der rapporteret om alvorlige overfølsomhedsreaktioner hos patienter, der er blevet behandlet med sitagliptin.
English: Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
Danish: Behandling med GLP-1 eller DPP-4-hæmmere i dyremodeller af type 2diabetes har vist sig at forbedre betacellernes reaktion på glucose og at stimulere syntesen samt frigivelsen af insulin.
English: Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glipizide (-1.5 vs. +1.1 kg).
Danish: De patienter, der blev behandlet med sitagliptin, udviste et signifikant gennemsnitligt fald i kropsvægt i forhold til baseline sammenlignet med en signifikant vægtøgning hos patientgruppen, der fik glipizid (-1,5 versus +1,1 kg).
English: Decreased glucagon concentrations, along with higher insulin levels, lead to reduced hepatic glucose production, resulting in a decrease in blood glucose levels.
Danish: Reducerede glucagonkoncentrationer fører, sammen med højere insulinniveauer, til reduceret hepatisk glucoseproduktion, hvilket resulterer i fald i blodglucoseniveauerne.
English: Ristaben should not be used during breast-feeding.
Danish: Ristaben bør ikke anvendes under amning.
English: Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Danish: Alder havde ingen klinisk relevant indflydelse på sitagliptins farmakokinetik baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data.
English: These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Danish: Disse karakteristika havde ingen klinisk relevant virkning på sitagliptins farmakokinetik på basis af en sammensat analyse af fase I farmakokinetiske data og en farmakokinetisk populationsanalyse af fase I- og fase II-data.
English: The incidence of hypoglycaemia was 25.2 % in patients treated with sitagliptin and insulin (with or without metformin) and 36.8 % in patients treated with placebo and insulin (with or without metformin).
Danish: Incidensen af hypoglykæmi var 25,2% hos de patienter, der blev behandlet med sitagliptin og insulin (med eller uden metformin), og 36,8% hos de patienter, der blev behandlet med placebo og insulin (med eller uden metformin).
English: Ciclosporin: A study was conducted to assess the effect of ciclosporin, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
Danish: Ciclosporin: Der er udført en undersøgelse til vurdering af ciclosporins (en potent hæmmer af pglykoprotein) effekt på sitagliptins farmakokinetik.
English: Patients were instructed to titrate their insulin glargine dose based on fingerstick fasting glucose values.
Danish: Patienterne blev instrueret i at titrere deres dosis af insulin glargin på basis af fasteglucose fra fingerprikmålinger.
English: Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common).
Danish: Nogle patienter har oplevet forskellige typer mavegener, når de er startet med at kombinere sitagliptin og metformin (hyppighed: almindelig).
English: For both GLP-1 and GIP, stimulation of insulin release is enhanced as glucose rises above normal concentrations.
Danish: Både mht. GLP-1 og GIP øges insulinstimulationen, når glucose stiger over de normale koncentrationer.
English: What Ristaben contains
Danish: Ristaben indeholder:
English: The incidence of hypoglycaemia was not significantly different between the treatment groups (sitagliptin, 1.3 %; metformin, 1.9 %).
Danish: Incidensen af hypoglykæmi var ikke signifikant forskellig mellem behandlingsgrupperne (sitagliptin 1,3%; metformin 1,9%).
English: • a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e. a thiazolidinedione) when use of a PPAR agonist is appropriate and when diet and exercise plus the PPAR agonist alone do not provide adequate glycaemic control.
Danish: • en peroxisom proliferator-aktiveret receptor-gamma (PPAR)-agonist (dvs. et glitazon), når anvendelse af en PPAR-agonist er hensigtsmæssig, og når diæt og motion plus PPARagonisten alene ikke giver tilstrækkelig glykæmisk kontrol.
English: Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin.
Danish: Sitagliptin er også et substrat for p-glykoprotein, som også kan være involveret i sitagliptins renale elimination.
English: Body weight decreased from baseline in both groups (sitagliptin, -0.6 kg; metformin -1.9 kg).
Danish: Kropsvægten faldt i forhold til baseline i begge grupper (sitagliptin -0,6 kg; metformin -1,9 kg).
English: The overall incidence of gastrointestinal adverse reactions considered as drug-related in patients treated with sitagliptin was 2.7 % compared with 12.6 % in patients treated with metformin.
Danish: Overordnet var incidensen for gastrointestinale bivirkninger, som blev anset for at være lægemiddelrelaterede, 2,7% hos patienter, der fik sitagliptin, sammenlignet med 12,6% hos de patienter, der fik metformin.
English: If you take more Ristaben than you should If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Danish: Hvis De har taget for meget Ristaben Kontakt straks Deres læge, hvis De har taget mere end den foreskrevne dosis af dette lægemiddel.
English: However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.
Danish: Da sitagliptin primært udskilles via nyrerne, forventes det imidlertid ikke, at svær leverinsufficiens vil påvirke sitagliptins farmakokinetik.
English: Film-coated tablet (tablet).
Danish: Filmovertrukken tablet.
English: There have been post-marketing reports of bullous pemphigoid in patients taking DPP-4 inhibitors including sitagliptin.
Danish: Efter markedsføring er der rapporteret om bulløs pemfigoid hos patienter, der tog DPP-4-hæmmere inklusive sitagliptin.
English: Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Danish: Der blev observeret nyre- og levertoksicitet hos gnavere ved systemiske eksponeringsniveauer, der var 58 gange højere end eksponeringsniveauet for mennesker, mens no-effect-niveauet fandtes ved niveauet 19 gange højere end eksponeringsniveauet for mennesker.
English: OUTER CARTON
Danish: YDRE KARTON
English: Placebo-corrected mean change in HbA1c (%) (95 % CI)
Danish: Placebokorrigeret gennemsnitlig ændring i HbA1c (%) (95% CI)
English: In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Danish: Histologisk blev der desuden observeret en meget let til let degeneration af skeletmuskulaturen ved doser svarende til en systemisk eksponering, der var ca. 23 gange højere end i mennesker.
English: The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40 % of patients requiring a glipizide dose of  5 mg/day throughout the study.
Danish: Den gennemsnitligt anvendte glipiziddosis var 10 mg dagligt, og ca. 40% af patienterne havde behov for en glipiziddosis på 5 mg/dag i hele undersøgelsesperioden.
English: After a median follow up of 3 years, sitagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or the risk of hospitalization for heart failure compared to usual care without sitagliptin in patients with type 2 diabetes (Table 3).
Danish: Med en median opfølgningstid på 3 år øgede sitagliptin som supplement til standardbehandling ikke risikoen for alvorlige kardiovaskulære bivirkninger (major adverse cardiovascular events - MACE) eller hospitalsindlæggelse på grund af hjertesvigt sammenlignet med standardbehandling uden sitagliptin hos patienter med type 2-diabetes (tabel 3).
English: The effect of potent CYP3A4 inhibitors in the setting of renal impairment has not been assessed in a clinical study.
Danish: Virkningen af potente CYP3A4-hæmmere hos patienter med nyreinsufficiens har ikke været genstand for klinisk undersøgelse.
English: It is unknown whether sitagliptin is excreted in human breast milk.
Danish: Det vides ikke, om sitagliptin udskilles i human mælk.
English: The addition of sitagliptin to insulin provided significant improvements in glycaemic parameters.
Danish: Tillæg af sitagliptin til insulin gav signifikante forbedringer i de glykæmiske parametre.
English: The incidence of hypoglycaemia was not significantly different between the treatment groups (sitagliptin, 6.3 %; glipizide, 10.8 %).
Danish: Incidensen af hypoglykæmi var ikke signifikant forskellig mellem behandlingsgrupperne (sitagliptin 6,3%; glipizid 10,8%).
English: Adverse reactions were identified through postmarketing surveillance.
Danish: Bivirkninger identificeret ved bivirkningsovervågning efter markedsføring.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 50 x 1 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter 50 x 1 filmovertrukne tabletter
English: Over the course of the study, the overall estimated mean (SD) difference in HbA1c between the sitagliptin and placebo groups was 0.29 % (0.01), 95 % CI (-0.32, -0.27); p < 0.001.
Danish: I løbet af studiet var den samlede estimerede gennemsnitlige forskel (standardafvigelse (SD)) i HbA1c mellem sitagliptingruppen og placebogruppen 0,29% (0,01), 95% CI (-0,32; -0,27); p < 0,001.
English: Sitagliptin may be a mild inhibitor of p-glycoprotein in vivo.
Danish: Sitagliptin kan være en svag hæmmer af p-glykoprotein in vivo.
English: • in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
Danish: • hos patienter, der ikke er tilstrækkeligt kontrolleret ved diæt og motion alene, og når metformin ikke er hensigtsmæssigt pga. kontraindikationer eller intolerance.
English: All myocardial infarction (fatal and non-fatal)
Danish: Alle tilfælde af myokardieinfarkt (letale og ikke-letale)
English: Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.
Danish: Hvis De tager dette lægemiddel sammen med medicin, der kaldes sulfonylurinstof eller sammen med insulin, kan det medføre for lavt blodsukker (hypoglykæmi), som kan påvirke Deres evne til at køre bil og betjene maskiner, eller hvis De arbejder uden sikkert fodfæste.
English: Ristaben has no or negligible influence on the ability to drive and use machines.
Danish: Ristaben påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The incidence of hypoglycaemia in the sitagliptin group (6.2 %) was significantly lower than that in the glipizide group (17.0 %).
Danish: Incidensen af hypoglykæmi i sitagliptingruppen (6,2%) var signifikant lavere end i glipizidgruppen (17,0%).
English: Another study comparing sitagliptin at 25 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in 129 patients with ESRD who were on dialysis.
Danish: Der er udført endnu en undersøgelse, hvor sitagliptin 25 mg en gang dagligt blev sammenlignet med glipizid 2,5 mg til 20 mg/dag hos 129 patienter med ESRD, som var i dialyse.
English: In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
Danish: I en klinisk undersøgelse havde sitagliptin en lille effekt på digoxinkoncentrationerne i plasma, som tyder på, at sitagliptin kan være en mild hæmmer af p-glykoprotein.
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50 mg) in patients with varying degrees of chronic renal impairment compared to normal healthy control subjects.
Danish: I en åben undersøgelse med enkeltdosis blev farmakokinetikken for en reduceret dosis sitagliptin (50 mg) vurderet hos patienter med varierende grader af kronisk nyreinsufficiens sammenlignet med normale raske kontrolpersoner.