FrancophonIA/ELRC3.0 huggingface dataset:
English: The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed.
Danish: Den øgede incidens af disse tumorer hos mus anses ikke for at udgøre en signifikant risiko for mennesker på grund af vildagliptins og dets hovedmetabolits manglende genotoksicitet, forekomsten af tumorer hos kun én art og de høje systemiske eksponeringsratioer, som tumorerne blev observeret ved.
English: Use of vildagliptin has beenassociated with a risk of developing of acute pancreatitis.
Danish: Anvendelse af vildagliptin er blevet forbundet med en risiko for udvikling af akut pankreatitis.
English: Zomarist is used to treat adult patients with type 2 diabetes.
Danish: Zomarist bruges til at behandle voksne patienter med type 2-diabetes (sukkersyge).
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid dette lægemidlet nøjagtigt efter lægens anvisning.
English: Not all pack sizes and tablet strengths may be marketed.
Danish: Ikke alle pakningsstørrelser og tabletstyrker er nødvendigvis markedsført.
English: Following administration of a dose of 850 mg, the plasma peak concentration was 40% lower, AUC was decreased by 25% and time to peak plasma concentration was prolonged by 35 minutes.
Danish: Efter administration af en dosis på 850 mg var den maksimale plasmakoncentration 40 % lavere, AUC blev reduceret med 25 % og tiden til maksimal plasmakoncentration blev forøget med 35 minutter.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apoteket til råds, før du bruger nogen form for medicin.
English: The substance metformin works by helping the body to make better use of insulin.
Danish: Stoffet metformin virker ved at hjælpe kroppen til at udnytte insulinet bedre.
English: Skin lesions were not reversible in the monkeys treated at 160 mg/kg/day during a 4-week recovery period.
Danish: Hudlæsionerne var ikke reversible hos aber, som blev behandlet med 160 mg/kg daglig i en 4-ugers restitutionsperiode.
English: These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice.
Danish: Disse transaminaseforhøjelser var generelt asymptomatiske, ikke-progredierende og ikke associeret med kolestase eller gulsot.
English: Urticaria Exfoliative and bullous skin lesions, including bullous pemphigoid
Danish: Urticaria Eksfoliative og bulløse hudlæsioner, herunder bulløs pemfigoid
English: Non-clinical data on metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Danish: Prækliniske data vedrørende metformin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktionstoksicitet.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD08
Danish: Farmakoterapeutisk klassifikation: Lægemidler til diabetes, kombinationer af orale lægemidler til reduktion af blodsukkeret, ATC-kode: A10BD08
English: If you stop taking Zomarist
Danish: Hvis du holder op med at tage Zomarist
English: - if you are going to have a contrast x-ray (a specific type of x-ray involving an injectable dye).
Danish: - hvis du skal have udført en røntgenundersøgelse med kontraststof (en speciel type røntgen, der involverer indsprøjtning af et farvestof).
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Zomarist.
Danish: Du bør også være særlig opmærksom på nye frembrud af blærer eller sår, mens du tager Zomarist.
English: Zomarist with alcohol
Danish: Brug af Zomarist sammen med alkohol
English: The majority of events were mild in severity and resolved with ongoing vildagliptin treatment.
Danish: De fleste hændelser var milde og forsvandt ved fortsat vildagliptin-behandling.
English: The most effective method of removing metformin is haemodialysis.
Danish: Den mest effektive metode til at fjerne metformin er hæmodialyse.
English: Both active substances, vildagliptin and metformin, help to control the level of sugar in the blood.
Danish: De to aktive stoffer, vildagliptin og metformin, hjælper med at kontrollere blodsukkeret.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/l) and an increased anion gap and lactate/pyruvate ratio.
Danish: Diagnostiske laboratoriefund er nedsat pH i blodet (< 7,35), forhøjet laktatniveau i blodet (> 5 mmol/l) samt øget anion-gap og laktat/pyruvat-ratio.
English: Your doctor will tell you exactly the dose of Zomarist to take.
Danish: Din læge vil fortælle dig helt nøjagtigt, hvor mange tabletter du skal tage.
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Danish: Det anbefales derfor - i overensstemmelse med rutinekontrol af diabetespatienten - at monitorere for hudlæsioner, såsom blære- eller sårdannelse.
English: The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Danish: Vildagliptins plasmaproteinbinding er lav (9,3 %), og vildagliptin fordeles ligeligt mellem plasma og erytrocytter.
English: Hepatitis (reversible upon discontinuation of the medicinal product) Abnormal liver function tests (reversible upon discontinuation of the medicinal product)
Danish: Hepatitis (reversibel ved seponering af lægemidlet) Unormale leverfunktionsværdier (reversibel ved seponering af lægemidlet)
English: Avoid excessive alcohol intake while taking Zomarist since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Danish: Undgå at indtage store mængder alkohol, mens du tager Zomarist, da det kan øge risikoen for laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Your doctor will decide when you must stop and when to restart your treatment with Zomarist.
Danish: Lægen vil beslutte, hvornår du skal stoppe behandlingen med Zomarist, og hvornår du kan genoptage den igen.
English: Findings were only observed in association with maternal toxicity at ≥ 150 mg/kg and included a transient decrease in body weight and reduced motor activity in the F1 generation.
Danish: Der blev kun observeret fund i forbindelse med maternel toksicitet ved ≥ 150 mg/kg, og de omfattede et forbigående fald i legemsvægten og nedsat motorisk aktivitet i F1-generationen.
English: The safety and efficacy of Zomarist in children and adolescents (< 18 years) have not been established.
Danish: Zomarists sikkerhed og virkning hos børn og unge (<18 år) er ikke klarlagt.
English: The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the amide hydrolysis product (4% of dose).
Danish: Hovedmetabolitten (LAY 151), som er farmakologisk inaktiv og hydrolyseproduktet af cyanodelen, gør rede for 57 % af dosis, efterfulgt af amidhydrolyseproduktet (4 % af dosis).
English: DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats.
Danish: DPP-4 bidrager delvist til hydrolysen af vildagliptin på basis af et in vivo-studie af rotter med DPP-4-mangel.
English: In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels.
Danish: Hos personer uden diabetes (normal glykæmi) stimulerer vildagliptin ikke insulinsekretionen eller reducerer glucoseniveauerne.
English: A study in healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50%.
Danish: Et studie med raske frivillige forsøgspersoner viste, at cimetidin, administreret som 400 mg daglig, øgede den systemiske eksponering af metformin (AUC) med 50 %.
English: Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which can lead to diabetic pre-coma.
Danish: Ketoacidose er en tilstand, hvor såkaldte ketonstoffer ophobes i blodet, hvilket kan føre til diabetisk prækoma.
English: After intravenous administration to healthy subjects, the total plasma and renal clearances of vildagliptin are 41 and 13 l/h, respectively.
Danish: Efter intravenøs administration til raske forsøgspersoner er den totale plasma- og renale clearance af vildagliptin henholdsvis 41 og 13 l/t.
English: The mean elimination half-life after intravenous administration is approximately 2 hours.
Danish: Den gennemsnitlige eliminationshalveringstid efter intravenøs administration er ca. 2 timer.
English: There are no adequate data from the use of Zomarist in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af Zomarist til gravide kvinder.
English: You should stop taking Zomarist and see your doctor immediately if you experience the following side effects:
Danish: Du skal stoppe med at tage Zomarist og kontakte din læge omgående, hvis du oplever en eller flere af følgende bivirkninger:
English: There have been no formal interaction studies for Zomarist.
Danish: Der er ikke udført nogen formelle interaktionsstudier med Zomarist.
English: Patients should be informed of the characteristic symptom of acute pancreatitis.
Danish: Patienter bør informeres om de karakteristiske symptomer ved akut pankreatitis.
English: The Cmax for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.
Danish: Cmax for vildagliptin og arealet under plasmakoncentrations- mod tidskurven (AUC) steg omtrent dosisproportionalt over det terapeutiske dosisinterval.
English: Food does not affect the extent and rate of absorption of vildagliptin from Zomarist.
Danish: Mad påvirker ikke absorptionsomfang og -hastighed for vildagliptin fra Zomarist.
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Zomarist should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin.
Danish: Voksne med normal nyrefunktion (GFR ≥ 90 ml/min) Doseringen af antihyperglykæmisk behandling med Zomarist bør individualiseres på basis af patientens aktuelle regime, effektivitet og tolerabilitet, uden at overskride den maksimalt anbefalede daglige dosis på 100 mg vildagliptin.
English: At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), AST, C-reactive protein (CRP) and myoglobin levels.
Danish: Ved 600 mg oplevede en forsøgsperson ødem i hænder og fødder og en stigning i kretininfosfokinase (CPK), ASAT, C-reaktivt protein (CRP) og myoglobinniveauer.
English: Hyperhidrosis General disorders and administration site conditions Common
Danish: Hyperhidrose Almene symptomer og reaktioner på administrationsstedet Almindelig
English: The decrease in HbA1c observed in patients with a baseline ≥10.0% was greater.
Danish: Reduktionen i HbA1c observeret hos patienter med en baseline-HbA1c på ≥10,0 % var større.
English: Nervous system disorders Common
Danish: Nervesystemet Almindelig
English: Some patients have experienced the following side effects while taking Zomarist and a sulphonylurea: • Common: dizziness, tremor, weakness, low blood glucose, excessive sweating.
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de har taget Zomarist og et sulfonylurinstof: • Almindelige: svimmelhed, rysten, svaghed, lavt blodsukker, øget svedtendens.
English: No studies on the effect on human fertility have been conducted for Zomarist (see section 5.3).
Danish: Der er ikke udført studier vedrørende Zomarist virkning på human fertilitet (se pkt.
English: If you forget to take Zomarist
Danish: Hvis du har glemt at tage Zomarist
English: Patients who may experience dizziness as an adverse reaction should avoid driving vehicles or using machines.
Danish: Patienter, der oplever svimmelhed som en bivirkning, skal undgå at føre motorkøretøj eller betjene maskiner.
English: Taking Zomarist with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Danish: Indtagelse af Zomarist sammen med eller umiddelbart efter mad kan reducere de gastrointestinale symptomer, der sættes i forbindelse med metformin (se også pkt.
English: Skin reactions such as erythema, pruritus and urticaria *A decrease in vitamin B12 absorption with decrease in serum levels has been very rarely observed in patients treated long-term with metformin.
Danish: Meget sjælden Hudreaktioner som erytem, pruritus og urticaria *En reduktion af vitamin B12-absorption med reduktion af serumniveauer er observeret meget sjældent hos patienter, der blev behandlet i længere tid med metformin.
English: In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
Danish: I et 13-ugers toksikologistudie på cynomolgusaber er der registreret hudlæsioner ved doser ≥ 5 mg/kg daglig.
English: The incidence of hypoglycaemia in the overall population was 8.4% and 7.2% in the vildagliptin and placebo groups, respectively.
Danish: Hyppigheden af hypoglykæmi i den samlede population var 8,4 % og 7,2 % i henholdsvis vildagliptin- og placebo-gruppen.
English: Two patients reported severe hypoglycaemic events in the vildagliptin group, and 6 patients in the placebo group.
Danish: To patienter i vildagliptin-gruppen rapporterede om alvorlige hypoglykæmiske tilfælde og 6 patienter i placebo-gruppen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with vildagliptin in combination with metformin in all subsets of the paediatric population with type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med vildagliptin i kombination med metformin i alle undergrupper af den pædiatriske population med type 2-diabetes mellitus (se pkt.
English: Continue to follow any advice about diet that your doctor has given you.
Danish: Fortsæt med at følge eventuelle kostråd, som din læge har givet dig.
English: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter.
Danish: GFR skal bestemmes, inden behandling med metforminholdige præparater iværksættes og derefter mindst én gang om året.
English: Necrotic lesions of the tail were observed at ≥ 80 mg/kg/day.
Danish: Der blev observeret nekrotiske læsioner på halen ved ≥ 80 mg/kg daglig.
English: Liver function should be monitored during treatment with Zomarist at three-month intervals during the first year and periodically thereafter.
Danish: Leverfunktionen skal monitoreres under behandling med Zomarist med 3 måneders interval i det første år og derefter regelmæssigt.
English: At 400 mg, there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels.
Danish: Ved 400 mg var der tre tilfælde af muskelsmerter, et enkelt tilfælde af mild og forbigående paræstesi, feber, ødem og en forbigående stigning i lipaseniveauerne.
English: Following oral administration in the fasting state, vildagliptin is rapidly absorbed with peak plasma concentrations observed at 1.7 hours.
Danish: Efter oral administration hos fastende absorberes vildagliptin hurtigt med maksimale plasmakoncentrationer ved 1,7 timer.
English: Studies in animals have shown excretion of both metformin and vildagliptin in milk.
Danish: Dyreforsøg har påvist udskillelse i mælk af både metformin og vildagliptin.
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX)
Danish: YDERKARTON FOR MULTIPAKNINGER (MED BLUE BOX)
English: A large overdose of metformin (or co-existing risk of lactic acidosis) may lead to lactic acidosis, which is a medical emergency and must be treated in hospital.
Danish: En stor overdosis metformin (eller samtidig eksisterende risiko for laktatacidose) kan medføre laktatacidose, der er et akut medicinsk tilfælde og skal behandles på hospitalet.
English: Metformin partitions into erythrocytes.
Danish: Metformin opdeles i erytrocytter.
English: Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin.
Danish: Der er udført lægemiddel-lægemiddel-interaktionsstudier på raske forsøgspersoner med amlodipin, ramipril, valsartan og simvastatin.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase and increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Danish: Metformin stimulerer den intracellulære glykogensyntese ved at virke på glykogensyntase og øger transportkapaciteten for specifikke typer membran-glucosetransportører (GLUT-1 og GLUT-4).
English: Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Zomarist should not be used during breast-feeding (see section 4.3).
Danish: På grund af både den potentielle risiko for neonatal hypoglykæmi relateret til metformin og manglen på humane data for vildagliptin, må Zomarist ikke anvendes under amning (se pkt.
English: A greater proportion of cases were reported when vildagliptin was administered in combination with an ACE inhibitor.
Danish: En større andel af tilfælde blev rapporteret, når vildagliptin blev administreret i kombination med en ACE-hæmmer.
English: Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Zomarist therapy is recommended.
Danish: Hvis en øgning i ASAT eller ALAT på 3x ULN eller derover varer ved, anbefales seponering af Zomarist.
English: In vitro studies demonstrated that vildagliptin does not inhibit/induce CYP 450 enzymes.
Danish: In vitro-studier har vist, at vildagliptin ikke hæmmer/inducerer CYP 450-enzymer.
English: What Zomarist contains - The active substances are vildagliptin and metformin hydrochloride.
Danish: Zomarist indeholder: - Aktive stoffer: vildagliptin og metforminhydrochlorid.
English: If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt skal doseringen af det antihyperglykæmiske lægemiddel justeres under behandling med de andre lægemidler og ved seponering.
English: 60 film-coated tablets.
Danish: 60 filmovertrukne tabletter.
English: **Isolated cases of liver function test abnormalities or hepatitis resolving upon metformin discontinuation have been reported.
Danish: **Isolerede tilfælde af unormale værdier ved leverfunktionstests eller hepatitis, der afhjælpes ved seponering af metformin, er rapporteret.
English: At 5 mg/kg/day (approximately equivalent to human AUC exposure at the 100 mg dose), only blisters were observed.
Danish: Ved 5 mg/kg daglig (omtrent svarende til human AUC-eksponering ved en dosis på 100 mg), blev der kun observeret vabler.
English: Hypromellose Titanium dioxide (E 171) Iron oxide, yellow (E 172) Macrogol 4000
Danish: Filmovertræk Hypromellose Titandioxid (E 171) Jernoxid, gul (E 172) Macrogol 4000
English: - Do not store above 30C.
Danish: - Må ikke opbevares ved temperaturer over 30 °C.
English: Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Danish: Glukokortikoider, beta-2-agonister og diuretika har indbygget hyperglykæmisk aktivitet.
English: Stop taking Zomarist for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Danish: Stop med at tage Zomarist i en kort periode, hvis du har en tilstand, som kan være forbundet med dehydrering (betydeligt tab af kropsvæsker), såsom alvorlig opkastning, diarré, feber, udsættelse for varme eller indtagelse af mindre væske end normalt.
English: A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose).
Danish: Der blev udført et to-årigt karcinogenicitetsstudie med rotter ved orale doser på op til 900 mg/kg (ca. 200 gange human eksponering ved den maksimale anbefalede dosis).
English: Hepatic impairment: In subjects with mild, moderate or severe hepatic impairment (Child-Pugh A-C) there were no clinically significant changes (maximum ~30%) in exposure to vildagliptin.
Danish: Leverinsufficiens: Hos forsøgspersoner med let, moderat eller stærkt nedsat leverfunktion (ChildPugh-A-C) var der ingen klinisk signifikante forandringer (maksimalt ~30%) i eksponeringen af vildagliptin.
English: Sulphonylureas are known to cause hypoglycaemia.
Danish: Det er velkendt, at sulfonylurinstoffer forårsager hypoglykæmi.
English: There have been no therapeutic clinical trials conducted with Zomarist.
Danish: Der er ikke foretaget nogen terapeutiske kliniske forsøg med Zomarist.
English: Adverse reactions reported in patients who received vildagliptin in double-blind studies as monotherapy and add-on therapies are listed below by system organ class and absolute frequency.
Danish: De bivirkninger, der blev rapporteret hos patienter, der fik vildagliptin som monoterapi og tillægsbehandling i dobbeltblindede studier, er opført nedenfor efter organsystemklasse og absolut hyppighed.
English: For vildagliptin studies in animals have shown reproductive toxicity at high doses.
Danish: For vildagliptin har dyreforsøg påvist reproduktionstoksicitet ved høje doser.
English: Other medicines and Zomarist
Danish: Brug af anden medicin sammen med Zomarist
English: The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Danish: Den større øgning af insulin/glucagon-ratioen under hyperglykæmi på grund af forhøjede inkretinhormonniveauer bevirker, at der sker et fald i fastende og postprandial glucoseproduktion i leveren, hvilket fører til nedsat glykæmi.
English: The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP.
Danish: Administration af vildagliptin medfører en hurtig og fuldstændig hæmning af DPP-4-aktiviteten, hvilket medfører øget fastende og postprandiale endogene værdier for inkretinhormonerne GLP-1 og GIP.
English: The rate and extent of absorption of metformin from Zomarist 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Danish: Absorptionshastighed og -omfang for metformin fra Zomarist 50 mg/1000 mg blev reduceret ved indgivelse med mad, som er afspejlet af en reduktion i Cmax på 26 %, AUC på 7 % og forsinket Tmax (2,0 til 4,0 t).
English: Metformin is contraindicated in patients with GFR <30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Danish: Metformin er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: No data are available with regard to overdose of Zomarist.
Danish: Der findes ingen data vedrørende overdosering af Zomarist.