FrancophonIA/ELRC3.0 huggingface dataset:
English: Both treatments were added to standard of care targeting regional standards for HbA1c and CV risk factors.
Danish: Begge behandlinger blev tilføjet til standardbehandling rettet mod regionale standarder for HbA1c og kardiovaskulære risikofaktorer.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: If no adequate strength of Jentadueto is available, individual monocomponents should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af Jentadueto, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Jentadueto.
Danish: De efterfølgende oplysninger afspejler de farmakokinetiske egenskaber for de enkelte aktive stoffer i Jentadueto.
English: - Metformin belongs to a class of medicines called biguanides.
Danish: - Metformin tilhører en klasse af lægemidler, der kaldes biguanider.
English: In vitro assessment of interactions
Danish: In vitro-vurdering af interaktioner
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), or very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: After an oral dose of metformin, Tmax is reached in 2.5 hours.
Danish: Efter en oral dosis metformin, nås Tmax efter 2,5 timer.
English: The mean age for study population was 64 years and included 2030 (34%) patients ≥ 70 years of age.
Danish: Gennemsnitsalderen for studiepopulationen var 64 år og omfattede 2030 (34 %) patienter ≥ 70 år.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Danish: Efter en oral dosis var den ikke-absorberede fraktion i fæces 20-30 %.
English: You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Danish: Det er vigtigt at følge anbefalingerne for hud- og fodpleje, som er givet af lægen eller sygeplejersken.
English: No teratogenic effects were observed in rabbits at > 1,000 times human exposure.
Danish: Der blev ikke observeret teratogene virkninger i kaniner ved > 1.000 gange den humane eksponering.
English: HbA1c (%) Number of patients n = 65 n = 135
Danish: HbA1c (%) Antal patienter n = 65 n = 135
English: Patients should be informed of the characteristic symptoms of acute pancreatitis.
Danish: Patienter bør informeres om de karakteristiske symptomer på akut pankreatitis.
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Danish: Din læge kan ordinere et lægemiddel til behandling af din overfølsomhedsreaktion og en anden type medicin til din diabetes.
English: OUTER CARTON AND LABEL - HDPE BOTTLE (17 AND 18 APPLICABLE ONLY FOR CARTON)
Danish: YDRE PAKNING OG LABEL - HDPE BEHOLDER (PUNKT 17 OG 18 GÆLDER KUN FOR PAKNINGEN)
English: Adverse reactions previously reported with one of the individual active substances may be potential adverse reactions with Jentadueto, even if not observed in clinical trials with this medicinal product.
Danish: Bivirkninger tidligere rapporteret med et af de individuelle aktive stoffer kan være mulige bivirkninger ved Jentadueto, selvom de ikke blev observeret i kliniske studier med dette lægemiddel.
English: Component of a multipack, cannot be sold separately.
Danish: Delpakning - kan ikke sælges separat.
English: The adverse reactions are listed by system organ class and absolute frequency.
Danish: Bivirkningerne er inddelt i systemorganklasse og hyppighed.
English: Both incretin hormones are involved in the physiological regulation of glucose homeostasis.
Danish: Begge inkretinhormoner er involveret i den fysiologiske regulering af glucosehomøostasen.
English: In that case, the missed dose should be skipped.
Danish: I sådanne tilfælde skal den glemte dosis springes over.
English: A limited amount of data suggests that the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Danish: Begrænsede data antyder, at anvendelse af metformin til gravide kvinder ikke er forbundet med en øget risiko for medfødte misdannelser.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 July 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 20. juli 2012 Dato for seneste fornyelse: 22. marts 2017
English: After oral administration, metformin hydrochloride absorption is saturable and incomplete.
Danish: Efter oral administration er absorptionen af metformin mætbar og ufuldstændig.
English: INFORMATION IN BRAILLE Jentadueto
Danish: INFORMATION I BRAILLESKRIFT Jentadueto
English: Talk to your doctor, pharmacist or nurse before taking Jentadueto - if you have type 1 diabetes (your body does not produce any insulin).
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Jentadueto - hvis du har type 1-diabetes (dvs. at din krop ikke danner insulin).
English: Effects of linagliptin on other medicinal products
Danish: Linagliptins indvirkning på andre lægemidler
English: • in combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products
Danish: • i kombination med andre antidiabetika, herunder insulin, hos patienter, der ikke er tilstrækkeligt kontrolleret på metformin og disse lægemidler
English: - if you have or have had a disease of the pancreas.
Danish: - hvis du har eller tidligere har haft sygdom i bugspytkirtlen.
English: If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt bør dosis af det antihyperglykæmiske lægemiddel justeres under behandling med det andet lægemiddel og ved seponering af dette.
English: Metabolism plays a subordinate role in the elimination of linagliptin.
Danish: Metabolisering spiller en underordnet rolle i eliminationen af linagliptin.
English: Metformin hydrochloride may act via 3 mechanisms:
Danish: Metformin kan virke via 3 mekanismer:
English: Metformin hydrochloride increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.
Danish: Metformin øger transportkapaciteten for alle typer af membranglucosetransportører (GLUT'er), der kendes til dato.
English: If acidosis of either form occurs, Jentadueto must be stopped immediately and other appropriate corrective measures initiated.
Danish: Hvis acidose i en af formerne forekommer, skal Jentaduetobehandlingen stoppes omgående og andre hensigtsmæssige og korrigerende tiltag påbegyndes.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Danish: Maksimum for blod er lavere end maksimum for plasma og fremkommer på ca. samme tidspunkt.
English: This has been shown at therapeutic doses in controlled, medium-term or longterm clinical studies: metformin hydrochloride reduces total cholesterol, LDL cholesterol and triglyceride levels.
Danish: Dette er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langvarige kliniske studier: Metformin reducerer totalkolesterol, LDL-kolesterol og triglyceridniveauerne.
English: Glimepiride (1-4mg)
Danish: Glimepirid (1-4 mg)
English: Do not use this medicine if the package is damaged or shows signs of tampering.
Danish: Brug ikke Jentadueto, hvis pakningen er beskadiget eller viser tegn på at være forsøgt åbnet.
English: Therefore, it is considered unlikely that linagliptin affects reproduction at therapeutic exposures in humans.
Danish: Det anses derfor for usandsynligt, at linagliptin påvirker reproduktionen ved terapeutiske doser hos mennesker.
English: When starting or using such products in combination with metformin, close monitoring of renal function is necessary.
Danish: Ved initiering eller brug af sådanne præparater sammen med metformin skal nyrefunktionen monitoreres tæt.
English: Patients and/or care-givers should be informed of the risk of lactic acidosis.
Danish: Patienter og/eller omsorgspersoner skal informeres om risikoen for laktatacidose.
English: Jentadueto should be taken twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Jentadueto bør tages 2 gange dagligt i forbindelse med et måltid for at reducere de gastrointestinale bivirkninger, som metformin er forbundet med.
English: • in patients already being treated with the combination of linagliptin and metformin as separate tablets.
Danish: • hos patienter, der allerede er i behandling med en kombination af linagliptin og metformin som separate tabletter.
English: The study was designed to demonstrate non-inferiority for the primary cardiovascular endpoint which was a composite of the first occurrence of cardiovascular death or a non-fatal myocardial infarction (MI) or a non-fatal stroke (3P-MACE).
Danish: Studiet blev designet til at vise non-inferioritet for det primære kardiovaskulære endepunkt, som var en sammensætning af den første forekomst af kardiovaskulær mortalitet eller ikke-dødeligt myokardieinfarkt (MI) eller ikke-dødelig apopleksi (3P-MACE).
English: Do not take Jentadueto if any of the above applies to you.
Danish: Tag ikke Jentadueto, hvis du mener, at noget af ovenstående passer på dig.
English: If you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Danish: Hvis der dannes blistre på din hud, kan det være et tegn på en tilstand, der kaldes bulløs pemfigoid.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Det prospektive, randomiserede studie (UKPDS) har fastslået en langvarig gavnlig virkning af intensiv blodglucosekontrol ved type 2-diabetes.
English: If you experience any of the signs of illness mentioned above, stop taking Jentadueto and call your doctor right away.
Danish: Hvis du oplever nogen af ovenstående tegn på sygdom, skal du holde op med at tage Jentadueto og straks kontakte din læge.
English: Along with diet and exercise, this medicine helps to improve the levels and effects of insulin after a meal and lowers the amount of sugar made by your body.
Danish: Sammen med diæt og motion hjælper Jentadueto med at forbedre insulinniveauet og -virkningen efter et måltid og nedsætter mængden af sukker, der dannes af kroppen.
English: • Acute conditions with the potential to alter renal function such as: dehydration, severe infection,
Danish: • Akutte tilstande med risiko for ændring i nyrefunktionen såsom dehydrering, svær infektion,
English: • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
Danish: • Enhver type af akut metabolisk acidose (såsom laktatacidose, diabetisk ketoacidose)
English: The intra-subject and inter-subject coefficients of variation for linagliptin AUC were small (12.6% and 28.5%, respectively).
Danish: Intra- og intervariationskoefficienter for linagliptins AUC var lave (henholdsvis 12,6 % og 28,5 %).
English: At the recommended metformin hydrochloride doses and dosing schedules, steady-state plasma concentrations are reached within 24 to 48 hours and are generally less than 1 microgram/ml.
Danish: Ved de anbefalede metformindoser og doseringsregimer nås steady state plasmakoncentrationer inden for 24-48 timer og er generelt under 1 mikrogram/ml.
English: Investigations Amylase increased uncommon
Danish: Undersøgelser Forhøjet amylase ikke almindelig
English: At more than 100 times human exposure, irritation of the stomach was the major finding in these monkeys.
Danish: Ved en eksponering på mere end 100 gange den humane eksponering var irritation af mavesækken det primære fund i disse aber.
English: This medicine can be used alone or with certain other medicines for diabetes like sulphonylureas, empagliflozin, or insulin.
Danish: Dette lægemiddel kan bruges alene eller sammen med andre typer lægemidler til behandling af diabetes, f.eks. sulfonylurinstof, empagliflozin eller insulin.
English: A slow increase in dose of metformin hydrochloride may also improve gastrointestinal tolerability.
Danish: Langsom dosisøgning af metforminhydrochlorid kan også forbedre den gastrointestinale tolerabilitet.
English: Jentadueto should not be used during pregnancy.
Danish: Jentadueto bør ikke anvendes under graviditet.
English: Talk to your doctor for further instruction.
Danish: Kontakt lægen for at få yderligere rådgivning.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:
Danish: En analyse af resultaterne for overvægtige metforminbehandlede patienter, efter at diæt alene havde svigtet, viste:
English: Based on these results and in vivo drug interaction studies, linagliptin is considered unlikely to cause interactions with other P-gp substrates.
Danish: På baggrund af disse resultater og in vivo-studier af lægemiddelinteraktioner anses det for usandsynligt, at linagliptin interagerer med andre P-gp-substrater.
English: The renal composite endpoint was defined as renal death or sustained end stage renal disease or sustained decrease of 40% or more in eGFR.
Danish: Det renale sammensatte endepunkt blev defineret som nyredød eller vedvarende nyresygdom i slutstadiet eller en vedvarende reduktion på 40 % eller mere i eGFR.
English: A significantly higher incidence of malignant lymphomas only in female mice at the highest dose (> 200 times human exposure) is not considered relevant for humans (explanation: nontreatment related but due to highly variable background incidence).
Danish: En signifikant højere forekomst af maligne lymfomer set i hunmus ved den højeste dosis (> 200 gange human eksponering), betragtes ikke som relevant for mennesker (forklaring: ikke-behandlingsrelateret, men skyldes baggrundsincidens med stor variabilitet).
English: If pancreatitis is suspected, Jentadueto should be discontinued; if acute pancreatitis is confirmed, Jentadueto should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, skal Jentadueto seponeres; hvis akut pankreatitis bekræftes, må behandling med Jentadueto ikke påbegyndes igen.
English: Your doctor may ask you to stop Jentadueto.
Danish: Din læge kan beslutte, at du skal stoppe med at tage Jentadueto.
English: Number of patients n = 61 n = 134
Danish: Antal patienter n = 61 n = 134
English: Body weight did not differ significantly between the groups.
Danish: Kropsvægten varierede ikke signifikant grupperne imellem.
English: These changes in linagliptin pharmacokinetics were not considered to be clinically relevant.
Danish: Ændringerne i linagliptins farmakokinetik blev ikke betragtet som klinisk relevante.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim (Logo)
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim (Logo)
English: Jentadueto with alcohol
Danish: Brug af Jentadueto sammen med alkohol
English: Oral use
Danish: Oral anvendelse.
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Danish: Brug af DPP-4-hæmmere er forbundet med risiko for udvikling af akut pankreatitis.
English: • Severe renal failure (GFR <30 ml/min).
Danish: • Svær nyreinsufficiens (GFR < 30 ml/min)
English: Elderly Caution should be exercised when treating patients 80 years and older (see section 4.2).
Danish: Ældre Forsigtighed bør udvises ved behandling af patienter på 80 år og derover (se pkt.
English: The study included 3494 patients treated with linagliptin (5 mg) and 3485 patients treated with placebo.
Danish: Studiet omfattede 3494 patienter, der blev behandlet med linagliptin (5 mg), og 3485 patienter, der fik placebo.
English: The incidence of hypoglycaemia in the linagliptin group (7.5%) was significantly lower than that in the glimepiride group (36.1%).
Danish: Incidensen af hypoglykæmi i linagliptingruppen (7,5 %) var signifikant lavere end i glimepiridgruppen (36,1 %).
English: All patients should continue their diet with an adequate distribution of carbohydrate intake during the day.
Danish: Alle patienter bør fortsætte på diæt med en jævn fordeling af kulhydrater hen over dagen.
English: The absolute bioavailability of linagliptin is approximately 30%.
Danish: Linagliptins absolutte biotilgængelighed var ca. 30 %.
English: If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efficacy of metformin.
Danish: Hvis det er nødvendigt, kan en dosisjustering af metformin overvejes, da hæmmere/induktorer af OCT kan ændre virkningen af metformin.
English: Jentadueto has no or negligible influence on the ability to drive and use machines.
Danish: Jentadueto påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: Cardiac function
Danish: Hjertefunktion
English: In controlled clinical trials, maximum metformin hydrochloride plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.
Danish: I kontrollerede kliniske studier oversteg metformins maksimale plasmakoncentrationer (Cmax) ikke 5 mikrogram/ml, selv ved maksimale doser.
English: There was no increased risk in hospitalization for heart failure which was an additional adjudicated endpoint observed compared to standard of care without linagliptin in patients with type 2 diabetes (table 4).
Danish: Der var ingen øget risiko for indlæggelse for hjertesvigt, hvilket var et ekstra adjudikeret endepunkt, som blev observeret, sammenlignet med standardbehandling uden linagliptin hos patienter med type 2-diabetes (tabel 4).
English: The observed pharmacokinetic and pharmacodynamic responses were consistent with those found in adult subjects.
Danish: Det observerede farmakokinetiske og farmakodynamiske respons var i overensstemmelse med responset hos voksne personer.
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, and institute clinical measures if required.
Danish: I tilfælde af en overdosis er det hensigtsmæssigt at benytte de sædvanlige understøttende foranstaltninger såsom at fjerne ikke-absorberet lægemiddel fra mave-tarm-kanalen, sikre klinisk monitorering og om nødvendigt igangsætte kliniske foranstaltninger.
English: Total daily dose of linagliptin is equal to 5 mg
Danish: Total daglig dosis af linagliptin er lig med 5 mg
English: Mean reductions from baseline in HbA1c were generally greater for patients with higher baseline HbA1c values.
Danish: De gennemsnitlige reduktioner i HbA1c i forhold til baseline var generelt større for patienter med højere baseline-HbA1c -værdier.
English: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes.
Danish: Linagliptin er en svag kompetitiv hæmmer og en svag til moderat mekanisme-baseret hæmmer af CYP-isozymet CYP3A4, men hæmmer ikke andre CYP-isozymer.
English: Thus full efficacy of linagliptin in combination with strong P-gp inducers might not be achieved, particularly if these are administered long-term.
Danish: Derfor opnås muligvis ikke en fuld virkning af linagliptin, når det kombineres med stærke P-gp-induktorer, især ikke ved langvarig behandling.
English: If you need to have major surgery you must stop taking Jentadueto during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Jentadueto under indgrebet og i nogen tid herefter.
English: Because glibenclamide is primarily metabolised by CYP2C9, these data also support the conclusion that linagliptin is not a CYP2C9 inhibitor.
Danish: Da glibenclamid primært metaboliseres af CYP2C9, understøtter data, at linagliptin ikke er en CYP2C9-hæmmer.
English: You should not use Jentadueto if you are pregnant.
Danish: Brug ikke Jentadueto, hvis du er gravid.
English: Abdominal pain very common
Danish: Abdominalsmerter meget almindelig
English: Older subjects (65 to 80 years, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Danish: Ældre (65 til 80 år, den ældste patient var 78 år) og yngre havde sammenlignelige plasmakoncentrationer af linagliptin.
English: General toxicity studies in rats for up to 13 weeks were performed with the co-administration of linagliptin and metformin.
Danish: Generelle toksikologiske studier i rotter, der varede op til 13 uger, blev udført med samtidig administration af linagliptin og metformin.
English: If the patient plans to become pregnant, or if pregnancy occurs, treatment with Jentadueto should be discontinued and switched to insulin treatment as soon as possible in order to lower the risk of foetal malformations associated with abnormal blood glucose levels.
Danish: Hvis patienten planlægger graviditet, eller hvis graviditet opstår, bør Jentadueto seponeres og hurtigst muligt erstattes af insulin for at reducere risikoen for føtale misdannelser, der er forbundet med abnorme blodglucoseniveauer.
English: The unbound concentrations, which are usually less than 1% at the therapeutic dose of linagliptin, were increased 4-5-fold after co-administration with ritonavir.
Danish: De ubundne koncentrationer, der normalt er mindre end 1 % ved den terapeutiske dosis for linagliptin, blev forøget 4-5 gange efter samtidig administration med ritonavir.
English: Renal clearance of metformin hydrochloride is > 400 ml/min, indicating that metformin hydrochloride is eliminated by glomerular filtration and tubular secretion.
Danish: Metformins renale clearance er > 400 ml/min, hvilket tyder på, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: The study population included 1211 (17.4%) patients ≥ 75 years of age and 4348 (62.3%) patients with renal impairment.
Danish: Studiepopulationen omfattede 1211 (17,4 %) patienter ≥ 75 år, og 4348 (62,3 %) patienter med nedsat nyrefunktion.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager Jentadueto.
English: No clinically relevant effect of Cmax and Tmax changes is expected; therefore linagliptin may be administered with or without food.
Danish: Der forventes ingen klinisk relevante virkninger af ændringer i Cmax og Tmax, og linagliptin kan indtages med eller uden mad.
English: Further symptoms are reduced body temperature and heartbeat.
Danish: Andre symptomer er nedsat kropstemperatur og langsommere puls.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
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 medføre diabetisk koma.