FrancophonIA/ELRC3.0 huggingface dataset:
English: However, more patients in the sitagliptin group discontinued due to lack of efficacy than in the glipizide group.
Danish: Imidlertid ophørte flere patienter i sitagliptingruppen med behandling på grund af manglende effekt end i glipizidgruppen.
English: Sitagliptin was not carcinogenic in mice.
Danish: Sitagliptin var ikke karcinogent hos mus.
English: Patients with an eGFR < 30 mL/min/1.73 m2 were not to be enrolled in the study.
Danish: Patienter med eGFR < 30 ml/min/1,73 m2 blev ikke inkluderet i studiet.
English: Two studies were conducted to evaluate the efficacy and safety of sitagliptin monotherapy.
Danish: Der er udført to undersøgelser, der vurderede effekt og sikkerhed af sitagliptin-monoterapi.
English: - The active substance is sitagliptin.
Danish: - Aktivt stof: Sitagliptin.
English: Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
Danish: Resolution af pankreatitis er set efter seponering af sitagliptin (med eller uden understøttende behandling), men der er indberettet meget sjældne tilfælde af nekrotiserende eller hæmoragisk pankreatitis og/eller død.
English: C]sitagliptin oral dose, approximately 16 % of the radioactivity was excreted as metabolites of sitagliptin.
Danish: C] oral sitagliptin-dosis udskiltes ca. 16% af radioaktiviteten som sitagliptin-metabolitter.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas
Danish: • Svære og vedvarende smerter i maven, som kan stråle ud i ryggen, med eller uden kvalme og opkastning, da det kan være tegn på betændelse i bugspytkirtlen (pankreatitis).
English: Sitagliptin is modestly dialysable.
Danish: Sitagliptin er kun moderat dialyserbart.
English: Common: swelling of the hands or legs
Danish: Almindelige: Hævede hænder eller ben.
English: Plasma AUC of sitagliptin increased in a dose-proportional manner.
Danish: Plasma-AUC for sitagliptin øgedes proportionalt med dosis.
English: If a dose of Ristaben is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis Ristaben glemmes, bør den tages, så snart patienten kommer i tanke om det.
English: as dual oral therapy in combination with
Danish: som dual oral behandling sammen med
English: You should not take this medicine if you are breast-feeding or plan to breast-feed.
Danish: De bør ikke tage dette lægemiddel, hvis De ammer eller planlægger at amme.
English: The safety and efficacy of sitagliptin in children and adolescents under 18 years of age have not yet been established.
Danish: Sitagliptins sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: This medicine does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige opbevaringsforhold.
English: If you miss a dose, take it as soon as you remember.
Danish: Hvis De glemmer en dosis, så tag den, så snart De kommer i tanke om det.
English: If you forget to take Ristaben
Danish: Hvis De har glemt at tage Ristaben
English: Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal impairment or end-stage renal disease (ESRD).
Danish: Metabolisme kan derimod spille en mere betydningsfuld rolle ved eliminationen af sitagliptin ved svær nyreinsufficiens eller nyresygdom i slutstadiet (ESRD).
English: The difference was mainly due to a higher percentage of patients in the placebo group experiencing 3 or more episodes of hypoglycaemia (9.4 vs. 19.1 %).
Danish: Forskellen skyldtes hovedsageligt en højere procentdel af patienter i placebogruppen, som oplevede 3 eller flere episoder med hypoglykæmi (9,4 versus 19,1%).
English: There is no experience with doses above 800 mg in clinical studies.
Danish: Der er ingen erfaring med doser over 800 mg i kliniske studier.
English: Analysis in the Intention-to-Treat Population
Danish: Analyse i Intention to treat-populationen
English: The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Danish: Den kliniske relevans af hOAT-3 i sitagliptin-transport er ikke fastslået.
English: If pancreatitis is suspected, Ristaben and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Ristaben should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør Ristaben og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med Ristaben ikke genoptages.
English: For this reason, it is possible that potent CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the pharmacokinetics of sitagliptin in patients with severe renal impairment or ESRD.
Danish: Derfor kan potente CYP3A4-hæmmere (dvs. ketoconazol, itraconazol, ritonavir, clarithromycin) muligvis ændre sitagliptins farmakokinetik hos patienter med svær nyreinsufficiens eller ESRD.
English: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required.
Danish: I tilfælde af overdosering er det hensigtsmæssigt at benytte de sædvanlige understøttende forholdsregler, f.eks. fjerne uabsorberet materiale fra mave- og tarmkanalen, sørge for klinisk monitorering (inklusive elektrokardiogram) og igangsætte understøttende behandling om nødvendigt.
English: The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones.
Danish: Den forbedring i den glykæmiske kontrol, som blev observeret med dette lægemiddel, medieres via en stigning i de aktive inkretinhormoners niveauer.
English: Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Ristaben may be administered with or without food.
Danish: Eftersom samtidig administration af et fedtrigt måltid sammen med Ristaben ikke havde nogen effekt på farmakokinetikken, kan sitagliptin administreres med eller uden mad.
English: These changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful.
Danish: Disse ændringer i sitagliptins farmakokinetik blev ikke vurderet til at have klinisk relevans.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Danish: Patienterne bør informeres om det karakteristiske symptom på akut pankreatitis: vedvarende svære mavesmerter.
English: OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
Danish: OAT3-medieret transport af sitagliptin hæmmes in vitro af probenecid, selvom risikoen for klinisk relevante interaktioner anses for at være lav.
English: Secondary Outcome
Danish: Sekundære endepunkter
English: C]sitagliptin dose to healthy subjects, approximately 100 % of the administered radioactivity was eliminated in faeces (13 %) or urine (87 %) within one week of dosing.
Danish: C] sitagliptin-dosis til raske personer elimineredes ca. 100% af den administrerede radioaktivitet i fæces (13%) eller urin (87%) inden for en uge efter dosering.
English: as monotherapy
Danish: som monoterapi
English: Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumours in rats was likely secondary to chronic hepatic toxicity at this high dose.
Danish: Eftersom hepatotoksicitet har vist sig at korrelere med induktion af hepatisk neoplasi hos rotter, var denne øgede forekomst af hepatiske tumorer sandsynligvis sekundær til kronisk hepatisk toksicitet ved denne høje dosis.
English: The dose is 100 mg sitagliptin once daily.
Danish: Dosis er 100 mg sitagliptin en gang dagligt.
English: Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Danish: Sitagliptin er en potent og høj-selektiv hæmmer af enzymet DPP-4 og hæmmer ikke de nært beslægtede enzymer DPP-8 eller DPP-9 ved terapeutiske koncentrationer.
English: The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
Danish: Sitagliptins farmakokinetik var generelt den samme hos raske personer og hos patienter med type 2diabetes.
English: Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal.
Danish: Inkretinhormoner, inklusive glucagonlignende peptid 1 (GLP-1) og glucoseafhængigt insulinotropt polypeptid (GIP), frigives i tarmene i løbet af dagen, og niveauerne øges som reaktion på et måltid.
English: The mean dose of metformin was approximately 1,900 mg per day.
Danish: Den gennemsnitlige metformindosis var ca. 1.900 mg/dag.
English: Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
Danish: Seks metabolitter blev påvist på sporstofniveau og forventes ikke at bidrage til sitagliptins DPP-4hæmmende aktivitet i plasma.
English: Treatment by stratum (metformin and insulin use) interactions were not significant (p > 0.10).
Danish: Behandling baseret på stratum- (anvendelse af metformin og insulin), interaktioner var ikke signifikant (p > 0,10).
English: Sitagliptin is a substrate for human organic anion transporter-3 (hOAT-3), which may be involved in the renal elimination of sitagliptin.
Danish: Sitagliptin er et substrat for humant organisk aniontransporter-3 (hOAT-3), som kan være involveret i den renale elimination af sitagliptin.
English: Prolonged haemodialysis may be considered if clinically appropriate.
Danish: Forlænget dialyse kan overvejes, hvis det er klinisk hensigtsmæssigt.
English: When considering the use of sitagliptin in combination with another anti-diabetic medicinal product, its conditions for use in patients with renal impairment should be checked.
Danish: Når anvendelse af sitagliptin sammen med et andet antidiabetikum påtænkes, bør betingelserne for anvendelse til patienter med nyreinsufficiens undersøges.
English: Further, GLP-1 does not impair the normal glucagon response to hypoglycaemia.
Danish: Desuden nedsætter GLP-1 ikke det normale glucagonrespons på hypoglykæmi.
English: In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Danish: Hos patienter med normal nyrefunktion spiller metabolisme, inklusive metabolismen via CYP3A4, kun en lille rolle i sitagliptin-clearance.
English: If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule.
Danish: Hvis De ikke kommer i tanke om det, før det er tid til næste dosis, skal De springe den glemte dosis over og tage den næste dosis som normalt.
English: What you need to know before you take Ristaben
Danish: Det skal De vide, før De begynder at tage Ristaben
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and Ristaben administered concomitantly.
Danish: Ved anvendelse sammen med metformin og/eller en PPAR-agonist bør dosis af metformin og/eller PPAR-agonisten opretholdes, og Ristaben administreres samtidigt.
English: The renal clearance of sitagliptin was not meaningfully altered.
Danish: Sitagliptins renale clearance ændredes ikke signifikant.
English: Packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Danish: Pakninger med 14, 28, 30, 56, 84, 90 eller 98 filmovertrukne tabletter og 50 x 1 filmovertrukne tabletter i perforerede enkeltdosisblistre.
English: In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents.
Danish: I en to-dages undersøgelse med raske forsøgspersoner øgede sitagliptin alene den aktive GLP-1koncentration, hvorimod metformin alene øgede den aktive og totale GLP-1-koncentration i tilsvarende grad.
English: Co-administration of sitagliptin and metformin had an additive effect on active GLP-1 concentrations.
Danish: Samtidig administration af sitagliptin og metformin havde en additiv effekt på den aktive GLP-1-koncentration.
English: The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Danish: Aktiviteten af GLP-1 og GIP begrænses af DPP-4-enzymet, som hurtigt hydrolyserer inkretinhormonerne til inaktive produkter.
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Danish: Brug af DPP-4-hæmmere er sat i forbindelse med en risiko for udvikling af akut pankreatitis.
English: Overall, sitagliptin improved glycaemic control when used as monotherapy or in combination treatment (see Table 2).
Danish: Sitagliptin forbedrede totalt set den glykæmiske kontrol, når det blev givet som monoterapi eller som kombinationsbehandling (se tabel 2).
English: Reproductive toxicity studies showed a slight treatment-related increased incidence of foetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Danish: Reproduktive toksicitetsundersøgelser viste en let behandlingsrelateret øget forekomst af føtale ribbensdefekter (manglende, hypoplastiske og takkede ribben) hos rotteafkom ved en systemisk eksponering på mere end 29 gange eksponeringen for mennesker.
English: In vitro, sitagliptin did not inhibit OAT3 (IC50=160 M) or p-glycoprotein (up to 250 M) mediated transport at therapeutically relevant plasma concentrations.
Danish: In vitro hæmmede sitagliptin ikke OAT3 (IC50=160 µM) eller p-glykoprotein (op til 250 µM) medieret transport ved terapeutisk relevante plasmakoncentrationer.
English: It is not known if this medicine passes into breast milk.
Danish: Det vides ikke, om lægemidlet går over i modermælken.
English: In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes.
Danish: In vitro-data tyder på, at sitagliptin hverken hæmmer eller inducerer CYP450-isoenzymer.
English: These medical conditions can increase your chance of getting pancreatitis (see section 4).
Danish: Disse sygdomme kan forøge risikoen for at få pankreatitis (se punkt 4).
English: In addition, GLP-1 lowers glucagon secretion from pancreatic alpha cells.
Danish: Desuden sænker GLP-1 glucagonsekretionen fra pankreatiske alfaceller.
English: Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported.
Danish: Alvorlige bivirkninger herunder pankreatitis og overfølsomhed er blevet rapporteret.
English: During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered.
Danish: I kontrollerede kliniske studier med raske personer blev enkeltdoser på op til 800 mg sitagliptin administreret.
English: Improvement of surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Danish: Forbedring i surrogatmarkører for betacellefunktionen, inklusive HOMA-β (homøostatisk modelvurdering-β), proinsulin/insulin-ratio samt resultater for betacellereaktioner fra en frequently sampled meal tolerance test blev observeret.
English: These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Danish: Disse reaktioner er anafylaksi, angioødem og eksfoliative hudreaktioner, herunder Stevens-Johnsons syndrom.
English: In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and organic anion transporter-3 (OAT3).
Danish: In vitro-transportundersøgelser har vist, at sitagliptin er et substrat for p-glykoprotein og organisk aniontransporter-3 (OAT3).
English: This study involved 423 patients with chronic renal impairment (estimated glomerular filtration rate < 50 ml/min).
Danish: Denne undersøgelse omfattede 423 patienter med kronisk nyreinsufficiens (estimeret glomerulær filtrationshastighed <50 ml/min).
English: Hypoglycaemia has been reported in combination with sulphonylurea (4.7 %-13.8 %) and insulin (9.6 %) (see section 4.4).
Danish: Hypoglykæmi er blevet rapporteret sammen med sulfonylurinstof (4,7%-13,8%) og insulin (9,6%) (se pkt.
English: Digoxin: Sitagliptin had a small effect on plasma digoxin concentrations.
Danish: Digoxin: Sitagliptin havde en lille effekt på digoxinkoncentrationen i plasma.
English: In this study, the proinsulin to insulin ratio, a marker of efficiency of insulin synthesis and release, improved with sitagliptin and deteriorated with glipizide treatment.
Danish: I denne undersøgelse forbedredes proinsulin/insulinratioen, der er en markør for effektiviteten af insulinsyntese og -sekretion, med sitagliptin og forværredes med glipizidbehandling.
English: Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
Danish: Der forventes derfor ingen klinisk betydende interaktioner med andre p-glykoproteinhæmmere.
English: It is not known if sitagliptin is dialysable by peritoneal dialysis.
Danish: Det vides ikke, om sitagliptin er dialyserbart ved peritonealdialyse.
English: Uncommon: dry mouth
Danish: Ikke almindelig: Tør mund
English: The glucose-dependent mechanism of sitagliptin is distinct from the mechanism of sulphonylureas, which increase insulin secretion even when glucose levels are low and can lead to hypoglycaemia in patients with type 2 diabetes and in normal subjects.
Danish: Sitagliptins glucoseafhængige mekanisme er forskellig fra sulfonylurinstoffers mekanisme, som øger insulinsekretionen, selv når glucosekoncentrationerne er lave og kan føre til hypoglykæmi hos patienter med type 2-diabetes og hos normale forsøgspersoner.
English: Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Danish: Samtidig administration af OAT3-hæmmere er ikke vurderet in vivo.
English: Elderly No dose adjustment is necessary based on age.
Danish: Ældre Dosisjustering er ikke nødvendig på basis af alder.
English: In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
Danish: I fase I-studier med multiple doser sås ingen dosisrelaterede kliniske bivirkninger, når sitagliptin blev givet i doser på op til 600 mg dagligt i perioder på op til 10 dage og 400 mg dagligt i perioder på op til 28 dage.
English: These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza (common with insulin (with or without metformin)), nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth (uncommon with insulin (with or without metformin)).
Danish: Disse omfattede hypoglykæmi (frekvens: meget almindelig ved kombinationsbehandling med sulfonylurinstof og metformin), influenza (almindelig med insulin (med eller uden metformin)), kvalme og opkastning (almindelig med metformin), flatulens (almindelig med metformin eller pioglitazon), obstipation (almindelig ved kombinationsbehandling med sulfonylurinstof og metformin), perifert ødem (almindelig med pioglitazon eller ved kombinationsbehandling med pioglitazon og metformin), døsighed og diarré (ikke almindelig med metformin) og mundtørhed (ikke almindelig med insulin (med eller uden metformin)).
English: In vitro data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Danish: In vitro-data viste, at sitagliptin ikke er en hæmmer af CYP-isozymerne CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 eller 2B6, og det inducerer ikke CYP3A4 og CYP1A2.
English: Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
Danish: Sitagliptin forhindrer DPP-4s hydrolyse af inkretinhormoner, og øger dermed plasmakoncentrationerne af de aktive former af GLP-1 og GIP.
English: Nervous system disorders headache
Danish: Nervesystemet Hovedpine
English: The study included patients with mild, moderate, and severe renal impairment, as well as patients with ESRD on haemodialysis.
Danish: Undersøgelsen omfattede patienter med let, moderat og svær nyreinsufficiens samt patienter med ESRD i hæmodialyse.
English: TECOS Cardiovascular Safety Study
Danish: Kardiovaskulært sikkerhedsstudie TECOS
English: The frequency of adverse reactions identified from placebo-controlled clinical studies of sitagliptin monotherapy and post-marketing experience
Danish: Bivirkningsfrekvens identificeret i placebo-kontrollerede kliniske undersøgelser med sitagliptin-monoterapi og efter markedsføring
English: Metabolism and nutrition disorders hypoglycaemia
Danish: Metabolisme og ernæring Hypoglykæmi
English: This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.
Danish: Lægemidlet kan bruges alene eller sammen med visse andre lægemidler (insulin, metformin, sulfonylurinstof eller glitazoner), som sænker blodsukkeret, og som De måske allerede tager for Deres diabetes, samtidig med at De følger en diæt- og motionsplan.
English: Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma Cmax on average by 18 %.
Danish: Efter administration af 0,25 mg digoxin samtidig med 100 mg sitagliptin dagligt i 10 dage øgedes plasma AUC for digoxin gennemsnitligt med 11% og plasma Cmax med gennemsnitligt 18%.
English: The effects of GLP-1 and GIP are glucose-dependent such that when blood glucose concentrations are low, stimulation of insulin release and suppression of glucagon secretion by GLP-1 are not observed.
Danish: Effekten af GLP-1 og GIP er glucoseafhængig, således at når blodglucosekoncentrationen er lav, ses der ikke en stimulering af insulinfrigørelse og hæmning af glucagonsekretion af GLP-1.
English: Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/plasma ratio: 4:1).
Danish: Sitagliptin udskilles i betydelige mængder i modermælken hos diegivende rotter (mælk/plasma-ratio:
English: The apparent terminal t1/2 following a 100-mg oral dose of sitagliptin was approximately 12.4 hours.
Danish: Den tilsyneladende terminale halveringstid (t½) efter indgift af en 100 mg oral dosis sitagliptin var ca. 12,4 timer.
English: Caution should be exercised in patients with a history of pancreatitis.
Danish: Der skal udvises forsigtighed hos patienter med pankreatitis i anamnesen.
English: HbA1c results in placebo-controlled monotherapy and combination therapy studies*
Danish: HbA1c resultater i placebo-kontrollerede monoterapi-og kombinationsterapiundersøgelser*
English: Baseline HbA1c was 8.74 % and baseline insulin dose was 37 IU/day.
Danish: HbA1c ved baseline var 8,74%, og insulindosis ved baseline var 37 IE/dag.
English: The analysis of hospitalization for heart failure was adjusted for a history of heart failure at baseline.
Danish: Analysen af hospitalsindlæggelser pga. hjertesvigt blev justeret for hjertesvigt i anamnesen ved baseline.