FrancophonIA/ELRC3.0 huggingface dataset:
English: Metformin may exert its glucose-lowering effect via three mechanisms: - by reduction of hepatic glucose production through inhibition of gluconeogenesis and glycogenolysis; - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation; - by delaying intestinal glucose absorption.
Danish: Metformin kan udøve den glucosesænkende effekt via tre mekanismer: - ved reduktion af glucoseproduktionen i leveren gennem hæmning af glukoneogenesen og glykogenolysen; - i musklerne ved i beskeden grad at øge insulinfølsomheden og derved forbedre den perifere glucoseoptagelse og -udnyttelse; - ved at forsinke glucoseabsorption i tarmsystemet.
English: A fertility and early embryonic development study in rats revealed no evidence of impaired fertility, reproductive performance or early embryonic development due to vildagliptin.
Danish: Et studie af fertilitet og tidlig fosterudvikling hos rotter viste ingen dokumentation for nedsat fertilitet, nedsat reproduktionsevne eller forsinket tidlig fosterudvikling på grund af vildagliptin.
English: Clinical trials of up to more than 2 years' duration did not show any additional safety signals or unforeseen risks when vildagliptin was added on to metformin.
Danish: Kliniske forsøg af op til over 2 års varighed viste ingen yderligere sikkerhedssignaler eller uforudsete risici, når vildagliptin blev føjet til metformin.
English: Another two-year carcinogenicity study was conducted in mice at oral doses up to 1000 mg/kg.
Danish: Der blev udført endnu et toårigt karcinogenicitetsstudie med mus med orale doser på op til 1000 mg/kg.
English: Results from clinical trials conducted with the oral antidiabetics pioglitazone, metformin and glyburide in combination with vildagliptin have shown no clinically relevant pharmacokinetic interactions in the target population.
Danish: Resultaterne fra kliniske forsøg udført med de orale antidiabetika, pioglitazon, metformin og glyburid i kombination med vildagliptin har ikke vist nogen klinisk relevante farmakokinetiske interaktioner hos målpopulationen.
English: Vildagliptin was not mutagenic in conventional in vitro and in vivo tests for genotoxicity.
Danish: Vildagliptin var ikke mutagent i konventionelle in vitro- og in vivo-test for genotoksicitet.
English: Administration of iodinated contrast agents
Danish: Administration af iodholdige kontrastmidler
English: Renal impairment: In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (Cmax 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Danish: Nedsat nyrefunktion: Hos forsøgspersoner med let, moderat eller svært nedsat nyrefunktion var den systemiske eksponering for vildagliptin øget (Cmax 8-66 %, AUC 32-134 %), og den totale bodyclearance var reduceret sammenlignet med forsøgspersoner med normal nyrefunktion.
English: Stop taking Zomarist and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Danish: Stop med at tage Zomarist og kontakt omgående læge eller nærmeste hospital, hvis du får et eller flere af nedenstående symptomer på laktatacidose, da denne tilstand kan føre til koma.
English: Hepatic impairment (see sections 4.2, 4.4 and 4.8) Acute alcohol intoxication, alcoholism Breast-feeding (see section 4.6)
Danish: 4.2, 4.4 og 4.8) - Akut alkoholforgiftning, alkoholisme - Amning (se pkt.
English: You may need more frequent blood glucose and kidney function tests or your doctor may need to adjust the dosage of Zomarist.
Danish: Du skal eventuelt have kontrollere dit blodsukker eller din nyrefunktion hyppigere, eller lægen kan ændre din dosis af Zomarist.
English: What you need to know before you take Zomarist
Danish: Det skal du vide, før du begynder at tage Zomarist
English: Do not store above 30C.
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: Table 6 Post-marketing adverse reactions
Danish: Tabel 6 Bivirkninger fra post-marketing
English: Vildagliptin Information regarding overdose with vildagliptin is limited.
Danish: Data vedrørende overdosering af vildagliptin er begrænsede.
English: Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Zomarist.
Danish: Patienter, der udvikler gulsot eller andre symptomer, som tyder på leverdysfunktion, bør ophøre behandling med Zomarist.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Danish: Hos mennesker har metformin, uafhængig af stoffets virkning på glykæmi, en gunstig virkning på lipidmetabolismen.
English: Metformin acts primarily by decreasing endogenous hepatic glucose production.
Danish: Metformin virker primært ved at reducere den endogene glucoseproduktion i leveren.
English: Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.
Danish: Vildagliptin er ikke et cytokrom P (CYP) 450-enzymsubstrat og hæmmer eller inducerer ikke CYP 450-enzymer, og der vil derfor være lav risiko for interaktion med aktive stoffer, som er substrater, hæmmere eller induktorer af disse enzymer.
English: • Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.
Danish: • Betændelse i bugspytkirtlen (pankreatitis) (hyppighed ikke kendt): Symptomerne inkluderer stærke og vedvarende smerter i maven, der eventuelt breder sig til ryggen, samt kvalme og opkastning.
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Zomarist should have their renal function monitored regularly (see sections 4.4 and 5.2).
Danish: Da metformin udskilles via nyrerne, og ældre patienter har en tendens til nedsat nyrefunktion, skal ældre patienter, der tager Zomarist, have overvåget deres nyrefunktion regelmæssigt (se pkt.
English: Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Danish: Vildagliptin, der tilhører klassen af ø-celle-forstærkere, er en potent og selektiv dipeptidyl-peptidase-4 (DPP-4)-hæmmer.
English: The substance vildagliptin works by making the pancreas produce more insulin and less glucagon.
Danish: Stoffet vildagliptin virker ved at få bugspytkirtlen til at producere mere insulin og mindre glucagon.
English: Patients receiving vildagliptin in combination with a sulphonylurea may be at risk for hypoglycaemia.
Danish: Patienter i behandling med vildagliptin i kombination med et sulfonylurinstof kan være i risiko for at udvikle hypoglykæmi.
English: No severe hypoglycaemic events were reported in the vildagliptin arms.
Danish: Ingen alvorlige hypoglykæmihændelser blev rapporteret i vildagliptin-armene.
English: If necessary, the dosage of Zomarist may need to be adjusted during concomitant therapy and on its discontinuation.
Danish: Om nødvendigt skal dosis af Zomarist eventuelt justeres under samtidig behandling og ved seponering.
English: Gender: No clinically relevant differences in the pharmacokinetics of vildagliptin were observed between male and female healthy subjects within a wide range of age and body mass index (BMI).
Danish: Køn: Der blev ikke observeret nogen klinisk relevante forskelle i vildagliptins farmakokinetik hos mandlige og kvindelige forsøgspersoner inden for et bredt interval af alder og BMI.
English: Talk to your doctor, pharmacist or nurse before taking Zomarist if you have or have had a disease of the pancreas.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet før du tager Zomarist, hvis du har eller har haft en sygdom i bugspytkirtlen.
English: When Zomarist is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Danish: Når Zomarist anvendes i kombination med et sulfonylurinstof, kan en lavere dosis sulfonylurinstof overvejes for at nedsætte risikoen for hypoglykæmi.
English: 60 film-coated tablets.Component of a multipack.
Danish: 60 filmovertrukne tabletter Del af multipakning.
English: 10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 360 film-coated tablets
Danish: 10 filmovertrukne tabletter 30 filmovertrukne tabletter 60 filmovertrukne tabletter 120 filmovertrukne tabletter 180 filmovertrukne tabletter 360 filmovertrukne tabletter
English: Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
Danish: ACE-hæmmere (angiotensin converting enzyme hæmmere) kan reducere blodsukkerniveauet.
English: Vildagliptin acts primarily by inhibiting DPP-4, the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide).
Danish: Vildagliptin virker primært ved at hæmme DPP-4, det enzym, der er ansvarligt for nedbrydningen af inkretin-hormonerne GLP-1 (glucagonlignende peptid 1) og GIP (glucoseafhængigt insulinotropt polypeptid).
English: GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Danish: GFR skal bestemmes inden behandlingsstart og regelmæssigt derefter, se pkt.
English: Clinical trials of up to 2 years' duration did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy.
Danish: Kliniske forsøg af op til 2 års varighed viste ingen yderligere sikkerhedssignaler eller uforudsete risici med vildaglitptin monoterapi.
English: A meta-analysis of independently and prospectively adjudicated cardiovascular events from 37 phase III and IV monotherapy and combination therapy clinical studies of up to more than 2 years duration (mean exposure 50 weeks for vildagliptin and 49 weeks for comparators) was performed and showed that vildagliptin treatment was not associated with an increase in cardiovascular risk versus comparators.
Danish: En metaanalyse af uafhængige og prospektivt bekræftede kardiovaskulære hændelser fra 37 kliniske fase III og IV monoterapi- og kombinationsbehandlingsstudier af en varighed på op til mere end 2 år (gennemsnitlig eksponering var 50 uger for vildagliptin og 49 uger for komparatorer) blev udført og viste, at vildagliptin-behandling ikke var forbundet med en øget kardiovaskulær risiko i forhold til komparatorer.
English: Decreased blood glucose
Danish: Nedsat blodsukker
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin.
Danish: Der er rapporteret sjældne tilfælde af leverdysfunktion (inklusive hepatitis) med vildagliptin.
English: Drug-drug interaction studies with digoxin (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after coadministration with vildagliptin.
Danish: Studier af lægemiddel-lægemiddel interaktioner med digoxin (P-glycoproteinsubstrat) og warfarin (CYP2C9-substrat) hos raske forsøgspersoner har ikke vist nogen klinisk relevante farmakokinetiske interaktioner efter samtidig administration med vildagliptin.
English: Zomarist should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
Danish: Zomarist bør ikke anvendes til patienter med nedsat leverfunktion, inklusive dem der før behandlingstidspunktet har alanin-aminotransferase (ALAT) eller aspartat-aminotransferase (ASAT) > 3x den øvre normale grænseværdi (ULN) (se pkt.
English: Cationic active substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems and hence delay the elimination of metformin, which may increase the risk of lactic acidosis.
Danish: Kationiske lægemidler, der elimineres ved tubulær sekretion (f.eks. cimetidin) kan interagere med metformin ved at konkurrere om fælles tubulære transportsystemer og dermed forsinke eliminationen af metformin, hvilket kan forhøje risikoen for laktatacidose.
English: One severe hypoglycaemic event was reported in the vildagliptin group.
Danish: Et alvorligt hypoglykæmisk tilfælde blev rapporteret i vildagliptin-gruppen.
English: - For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
Danish: - Patienter, der er utilstrækkeligt kontrolleret med en kombination af insulin og den maksimalt tolererede dosis metformin:
English: A no-effect level was not established.
Danish: Der blev ikke fastslået et niveau for NOEL.
English: Patients receiving vildagliptin experienced no weight gain (+0.2 kg) while those receiving placebo experienced weight reduction (-0.7 kg).
Danish: Patienter, der fik vildagliptin, oplevede ingen vægtøgning (+0,2 kg), mens de patienter, der fik placebo, oplevede en vægtreduktion (-0,7 kg).
English: If this happens you must stop taking Zomarist and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Danish: Hvis dette sker for dig, skal du omgående stoppe med at tage Zomarist og kontakte læge eller nærmeste hospital, da laktatacidose kan føre til koma.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmiske virkninger, der sænker både det basale og postprandiale blodsukker.
English: Zomarist is indicated in the treatment of type 2 diabetes mellitus: - Zomarist is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Danish: Zomarist er indiceret til behandling af type 2-diabetes mellitus: - Zomarist er indiceret til behandling af voksne patienter, der ikke opnår tilstrækkelig glykæmisk kontrol på monoterapi med den maksimalt tolererede dosis oral metformin, eller som allerede behandles med kombinationen af vildagliptin og metformin i form af separate tabletter.
English: Children and adolescents The use of Zomarist in children and adolescents up to 18 years of age is not recommended.
Danish: Børn og unge Zomarist anbefales ikke til børn og unge under 18 år.
English: In the subgroups treated with insulin with or without concomitant metformin the placebo-adjusted mean reduction in HbA1c was -0.63% and -0.84%, respectively.
Danish: I undergrupperne, som blev behandlet med insulin med eller uden samtidig administration af metformin, var den gennemsnitlige placebo-korrigerede reduktion i HbA1c henholdsvis -0,63 % og -0,84 %.
English: Skin lesions, including blistering and ulceration have been reported with vildagliptin in extremities of monkeys in non-clinical toxicology studies (see section 5.3).
Danish: Hudlæsioner, herunder blære- og sårdannelse, er rapporteret for vildagliptin på abers ekstremiteter i non-kliniske toksikologi-undersøgelser (se pkt.
English: A mean weight gain of +1.9 kg was observed in patients receiving pioglitazone added to metformin compared to +0.3 kg in those receiving vildagliptin added to metformin.
Danish: Der blev observeret en gennemsnitlig vægtøgning på +1,9 kg hos patienter, der fik pioglitazon lagt til metformin sammenlignet med +0,3 kg hos dem, der fik vildagliptin lagt til metformin.
English: Vildagliptin/metformin 50 mg/1000 mg twice daily reduced HbA1c by -1.82%, vildagliptin/metformin 50 mg/500 mg twice daily by -1.61%, metformin 1000 mg twice daily by -1.36% and vildagliptin 50 mg twice daily by -1.09% from a mean baseline HbA1c of 8.6%.
Danish: Vildagliptin/metformin 50 mg/1.000 mg to gange daglig reducerede HbA1c med -1,82 %, vildagliptin/metformin 50 mg/500 mg to gange daglig med -1,61 %, metformin 1.000 mg to gange daglig med -1,36 % og vildagliptin 50 mg to gange daglig med -1,09 % i forhold til en gennemsnitlig baseline-HbA1c på 8,6 %.
English: Maximal daily dose is 50 mg.
Danish: Maksimal daglig dosis er 50 mg.
English: • Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever; signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing; redness of the skin, itching; decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or memory disturbances).
Danish: • Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer): ondt i halsen, løbende næse, feber, tegn på et højt niveau af mælkesyre i blodet (kaldes laktatacidose), som f.eks. sløvhed eller svimmelhed, svær kvalme eller opkastning, mavesmerter, uregelmæssig hjerterytme eller dyb, hurtig vejrtrækning, rødme i huden, kløe, nedsat niveau af B12-vitamin (bleghed, træthed, mentale symptomer såsom forvirring eller problemer med hukommelsen).
English: Talk to your doctor, pharmacist or nurse before taking Zomarist if you are taking an anti-diabetic medicine known as a sulphonylurea.
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før du tager Zomarist, hvis du tager medicin mod diabetes, kaldet sulfonylurinstof.
English: Age: In healthy elderly subjects (≥ 70 years), the overall exposure of vildagliptin (100 mg once daily) was increased by 32%, with an 18% increase in peak plasma concentration as compared to young healthy subjects (18-40 years).
Danish: Alder: Hos raske ældre forsøgspersoner (≥ 70 år) steg den samlede eksponering for vildagliptin (100 mg en gang daglig) med 32 %, og den maksimale plasmakoncentration steg med 18 % sammenlignet med unge raske forsøgspersoner (18-40 år).
English: Store in the original package (blister) in order to protect from moisture.
Danish: Opbevares i den originale pakning (blister) for at beskytte mod fugt.
English: The noeffect dose in rats was 25 mg/kg (5-fold human exposure based on AUC) and in mice 750 mg/kg (142fold human exposure).
Danish: Dosis uden effekt hos rotter var 25 mg/kg (5 gange den humane eksponering baseret på AUC) og hos mus 750 mg/kg (142 gange den humane eksponering).
English: • Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
Danish: • Leversygdom (hepatitis) (sjælden): symptomer inkluderer gul hud og øjne, kvalme, nedsat appetit eller mørk urin, hvilket kan tyde på en leversygdom (hepatitis).
English: Driving and using machines If you feel dizzy while taking Zomarist, do not drive or use any tools or machines.
Danish: Hvis du føler dig svimmel, når du tager Zomarist, må du ikke køre bil, arbejde med værktøj eller maskiner.
English: - Store in the original package (blister) in order to protect from moisture.
Danish: - Opbevares i den originale pakning (blister) for at beskytte mod fugt.
English: There may be an increased risk of angioedema in patients concomitantly taking ACE inhibitors.
Danish: Der kan være en øget risiko for angioødem hos patienter, som samtidig tager ACE-hæmmere (se pkt.
English: There have been no studies of metformin added to vildagliptin.
Danish: Der har ikke været foretaget studier af metformin som tillægsbehandling til vildagliptin.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction in the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patientyears), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction in the absolute risk of diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction in the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patientyears (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years (p=0.01).
Danish: Analyse af resultaterne for overvægtige patienter, der blev behandlet med metformin, efter at diæt alene havde slået fejl, viste: - en signifikant reduktion i den absolutte risiko for diabetesrelaterede komplikationer i metformin-gruppen (29,8 hændelser/1.000 patientår) i forhold til diæt alene (43,3 hændelser/1.000 patientår), p=0,0023, og i forhold til grupperne med kombineret sulfonylurinstof- og insulin-monoterapi (40,1 hændelser/1.000 patientår), p=0,0034; - en signifikant reduktion i den absolutte risiko for diabetesrelateret dødelighed; metformin 7,5 hændelser/1.000 patientår, diæt alene 12,7 hændelser/1.000 patientår, p=0,017; - en signifikant reduktion i den absolutte risiko for generel dødelighed; metformin 13,5 hændelser/1.000 patientår i forhold til diæt alene 20,6 hændelser/1.000 patientår (p=0,011) og i forhold til de kombinerede sulfonylurinstof- og insulin-monoterapigrupper 18,9 hændelser/1.000 patientår (p=0,021); - en signifikant reduktion i den absolutte risiko for myokardieinfarkt: metformin 11 hændelser/1.000 patientår, diæt alene 18 hændelser/1.000 patientår, (p=0,01).
English: The data presented here relate to the co-administration of vildagliptin and metformin, where vildagliptin has been added to metformin.
Danish: De data, der præsenteres her, vedrører samtidig administration af vildagliptin og metformin, hvor vildagliptin er tillægsbehandling til metformin.
English: Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA- (Homeostasis Model Assessment-), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Danish: Behandling med vildagliptin 50-100 mg daglig til patienter med type 2-diabetes forbedrede signifikant markørerne for betacellefunktionen, herunder HOMA- (Homeostasis Model Assessment-), proinsulin-insulinratioen og målinger af betacellerespons fra den hyppigt afprøvede måltidstolerancetest.
English: Intravascular administration of iodinated contrast agents lead to contrast-induced nephropathy, resulting in metformin accumulation and increased risk of lactic acidosis.
Danish: Intravaskulær administration af iodholdige kontrastmidler kan medføre kontrastinduceret nefropati, resulterende i akkumulation af metformin og en øget risiko for laktatacidose.
English: In these cases, the patients were generally asymptomatic without clinical sequelae and liver function tests (LFTs) returned to normal after discontinuation of treatment.
Danish: I disse tilfælde var patienterne generelt asymptomatiske uden kliniske følgetilstande, og leverfunktionstests (LFTs) blev normale efter behandlingsophør.
English: In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.
Danish: I sammenlignende kontrollerede monoterapistudier var hypoglykæmi ikke almindelig, rapporteret hos 0,4 % (7 ud af 1.855) af de patienter, som blev behandlet med vildagliptin 100 mg daglig, sammenlignet med 0,2 % (2 ud af 1.082) af patienterne i de grupper, der blev behandlet med et aktivt sammenligningsstof eller placebo, og der blev ikke rapporteret nogen alvorlige eller svære bivirkninger.