FrancophonIA/ELRC3.0 huggingface dataset:
English: It is assumed that the pharmacokinetics of metformin hydrochloride absorption are non-linear.
Danish: Det antages, at farmakokinetikken for absorption af metformin er non-lineær.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTRE
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: Immune system disorders Hypersensitivity (e.g. bronchial hyperreactivity)
Danish: Immunsystemet Overfølsomhed (f.eks. bronkial hyperreaktivitet)
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: General Jentadueto should not be used in patients with type 1 diabetes.
Danish: Generelt Jentadueto bør ikke anvendes til patienter med type 1-diabetes.
English: Patients received metformin and/or sulphonylurea and/or insulin as background therapy.
Danish: Patienterne fik metformin og/eller sulfonylurinstof og/eller insulin som baggrundsbehandling.
English: Other side effects of Jentadueto include:
Danish: Symptomerne på laktatacidose omfatter:
English: However, patients should be alerted to the risk of hypoglycaemia when Jentadueto is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. sulphonylureas).
Danish: Patienterne bør advares om risikoen for hypoglykæmi, når Jentadueto anvendes i kombination med andre antidiabetiske lægemidler, der er kendt for at forårsage hypoglykæmi (f.eks. sulfonylurinstoffer).
English: Studies in animals have shown excretion of both metformin and linagliptin into milk in lactating rats.
Danish: Dyrestudier har vist udskillelse af både metformin og linagliptin i mælk hos diegivende rotter.
English: Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
Danish: Vurderingen skal inkludere bestemmelse af serumelektrolytter og ketoner, blodglucose og, hvis indiceret, blod-pH, laktat, pyruvat og metformin.
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: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: Single dose study: after single doses of metformin hydrochloride 500 mg, paediatric patients have shown a similar pharmacokinetic profile to that observed in healthy adults.
Danish: Studie af enkeltdosis: Efter administration af enkeltdoser på 500 mg metformin har pædiatriske patienter fremvist den samme farmakokinetiske profil som den, der er observeret hos raske voksne.
English: Metformin hydrochloride is excreted unchanged in the urine.
Danish: Biotransformation Metformin udskilles uændret i urinen.
English: Food decreases the extent and slightly delays the absorption of metformin hydrochloride.
Danish: Mad mindsker graden af og forsinker i mindre omfang absorptionen af metformin.
English: - Film coating: hypromellose, titanium dioxide (E171), talc, propylene glycol.
Danish: Filmovertræk: Hypromellose, titaniumdioxid (E171), talcum, propylenglycol.
English: Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances.
Danish: Der er ikke set hypoglykæmi ved metformindoser på op til 85 g, selvom der er forekommet laktatacidose i sådanne tilfælde.
English: Caution is therefore advised, especially in patients with renal impairment, when these drugs are coadministered with metformin, as metformin plasma concentration may increase.
Danish: Der bør derfor udvises forsigtighed, især hos patienter med nedsat nyrefunktion, når disse lægemidler administreres samtidigt med metformin, da plasmakoncentrationen af metformin kan stige.
English: The amount of Jentadueto that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of linagliptin and metformin.
Danish: Din dosis af Jentadueto afhænger af din helbredstilstand og af den dosis, du i øjeblikket tager af metformin og/eller af linagliptin- og metformin-tabletter.
English: Jentadueto may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section ‘Warnings and precautions').
Danish: Jentadueto kan forårsage en meget sjælden (kan forekomme hos op til 1 ud af 10.000 brugere), men meget alvorlig bivirkning, der kaldes laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: Oral 2 year carcinogenicity studies in rats and mice revealed no evidence of carcinogenicity in rats or male mice.
Danish: 2-årige, orale karcinogenicitetsstudier i rotter og mus viste ikke evidens for karcinogenicitet hos rotter eller hanmus.
English: Clinically meaningful interactions would not be expected with other sulphonylureas (e.g., glipizide, tolbutamide, and glimepiride) which, like glibenclamide, are primarily eliminated by CYP2C9.
Danish: Der forventes ikke klinisk relevante interaktioner med andre sulfonylurinstoffer (f.eks. glipizid, tolbutamid og glimepirid), der som glibenclamid primært elimineres af CYP2C9.
English: Diarrhoea common
Danish: Diarré almindelig
English: Metabolism and nutrition disorders Hypoglycaemia very common
Danish: Metabolisme og ernæring Hypoglykæmi meget almindelig
English: Your doctor will decide when you must stop and when to restart your treatment with Jentadueto.
Danish: Lægen vil beslutte, hvornår du skal stoppe behandlingen med Jentadueto, og hvornår du kan genoptage den igen.
English: Patients with heart failure are more at risk of hypoxia and renal impairment.
Danish: Patienter med hjerteinsufficiens har større risiko for hypoxi og nedsat nyrefunktion.
English: Simulations of steady-state plasma concentrations of linagliptin with and without ritonavir indicated that the increase in exposure will not be associated with an increased accumulation.
Danish: Simulationer af steady state-plasmakoncentrationer for linagliptin - med og uden samtidig administration af ritonavir - tydede på, at øget eksponering ikke er forbundet med øget akkumulering.
English: A paediatric Phase 2 study examined the pharmacokinetics and pharmacodynamics of 1 mg and 5 mg linagliptin in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus.
Danish: Et pædiatrisk fase 2-studie undersøgte farmakokinetikken og farmakodynamikken af 1 mg og 5 mg linagliptin hos børn og unge i alderen ≥ 10 til < 18 år med type 2 diabetes mellitus.
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Danish: Du skal omgående stoppe med at tage Jentadueto og straks kontakte en læge eller tage til det nærmeste hospital (se afsnit 2).
English: Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis.
Danish: Laktatacidose er en meget sjælden, men alvorlig metabolisk komplikation, som oftest indtræder ved akut forværring af nyrefunktionen eller ved kardiopulmonal sygdom eller sepsis.
English: Patients switching from co-administration of linagliptin and metformin For patients switching from co-administration of linagliptin and metformin, Jentadueto should be initiated at the dose of linagliptin and metformin already being taken.
Danish: Patienter, der skifter fra samtidig administration af linagliptin og metformin Til patienter, der skifter fra samtidig administration af linagliptin og metformin, bør Jentadueto initieres med den dosis af linagliptin og metformin, der allerede tages.
English: • Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib,
Danish: • hæmmere af OCT2 (f.eks. cimetidin, dolutegravir, ranolazin, trimethoprim, vandetanib,
English: C] linagliptin oral 10 mg dose, approximately 5% of the radioactivity was excreted in urine.
Danish: C] -linagliptin 10 mg dosis blev ca. 5 % af radioaktiviteten udskilt med urinen.
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in metformin-treated patients.
Danish: Lægemidler, som kan medføre akut nedsættelse af nyrefunktionen (såsom antihypertensiva, diuretika og NSAID'er), bør opstartes med forsigtighed hos patienter i behandling med metformin.
English: Multiple daily doses of 5 mg linagliptin did not alter the pharmacokinetics of S(-) or R(+) warfarin, a CYP2C9 substrate, administered in a single dose.
Danish: Daglige doser på 5 mg linagliptin ændrede ikke farmakokinetikken for S(-)- eller R(+)-warfarin, et CYP2C9-substrat, administreret som en enkelt dosis.
English: Plasma concentrations of linagliptin decline in a triphasic manner with a long terminal half-life (terminal half-life for linagliptin more than 100 hours), that is mostly related to the saturable, tight binding of linagliptin to DPP-4 and does not contribute to the accumulation of the active substance.
Danish: Plasmakoncentrationen af linagliptin aftager tre-fasisk med en lang, terminal halveringstid (terminal halveringstid for linagliptin på mere end 100 timer), som overvejende er relateret til linagliptins mætbare, tætte binding til DPP-4, uden at bidrage til akkumulationen af det aktive stof.
English: Approximately 19% of the population had eGFR ≥45 to <60 mL/min/1.73 m2, 28% of the population had eGFR ≥30 to <45 mL/min/1.73 m2) and 15%
Danish: Ca. 19 % af populationen havde eGFR ≥ 45 til < 60 ml/min/1,73 m2, 28 % af populationen havde eGFR ≥ 30 til < 45 ml/min/1,73 m 2, og 15 % havde eGFR < 30 ml/min/1,73 m
English: Nervous system disorders Taste disturbance common
Danish: Nervesystemet Smagsforstyrrelser almindelig
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD11
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationer af orale blodglucosesænkende midler, ATC-kode: A10BD11.
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: Metformin is contraindicated
Danish: Metformin er kontraindiceret.
English: Administration of Jentadueto 2.5/1,000 mg with food resulted in no change in overall exposure of linagliptin.
Danish: Indtagelse af Jentadueto 2,5/1.000 mg ved måltider medførte ingen ændring i den samlede eksponering for linagliptin.
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see section 4.5).
Danish: • Nedsat leverfunktion, akut alkoholforgiftning, alkoholisme (se pkt.
English: receptor antagonists) - medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine,
Danish: II-receptorantagonister) - Lægemidler, der kan ændre mængden af metformin i dit blod, især hvis du har nedsat nyrefunktion (f.eks. verapamil, rifampicin, cimetidin, dolutegravir, ranolazin, trimethoprim,
English: Some patients have experienced the following side effects while taking Jentadueto with insulin - Uncommon: liver function disorders, constipation
Danish: Nogle patienter har oplevet følgende bivirkninger, mens de tager Jentadueto sammen med insulin - Ikke almindelig: nedsat leverfunktion, forstoppelse
English: This medicine does not require any special temperature storage conditions.
Danish: Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
English: The study population included 2089 (35%) patients with cardiovascular disease and 1130 (19%) patients with renal impairment with an eGFR < 60ml/min/1.73m2 at baseline.
Danish: Studiepopulationen omfattede 2089 (35 %) patienter med kardiovaskulær sygdom og 1130 (19 %) patienter med nedsat nyrefunktion med en eGFR < 60 ml/min/1,73 m2 ved baseline.
English: There was no meaningful change from baseline in body weight in either group.
Danish: Med hensyn til kropsvægt var der ingen betydningsfuld ændring fra baseline i nogen af grupperne.
English: For prevention, it is recommended that Jentadueto be taken during or after meals.
Danish: For at undgå gastrointestinale gener anbefales det, at Jentadueto tages under eller efter måltider.
English: A NOAEL of 78 times human exposure was derived for embryo-fetal toxicity in rabbits, and for maternal toxicity the NOAEL was 2.1 times human exposure.
Danish: Et NOAEL på 78 gange den humane eksponering blev udledt for embryo-føtal toksicitet i kaniner, og NOAEL for toksicitet i moderdyret var 2,1 gange den humane eksponering.
English: Metformin hydrochloride is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmisk virkning, som sænker både basal og postprandial plasmaglucose.
English: Stop taking Jentadueto 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 Jentadueto 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: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: Gastrointestinal disorders such as, nausea, vomiting, diarrhoea and decreased appetite and abdominal pain occur most frequently during initiation of therapy with Jentadueto or metformin hydrochloride and resolve spontaneously in most cases.
Danish: Gastrointestinale gener såsom kvalme, opkastning, diarré og nedsat appetit og abdominalsmerter forekommer hyppigst i begyndelsen af behandling med Jentadueto eller metformin og er i de fleste tilfælde forbigående.
English: You should continue your diet during treatment with Jentadueto and take care that your carbohydrate intake is equally distributed over the day.
Danish: Du skal fortsætte med diæt, mens du får Jentadueto, og sørge for, at din indtagelse af kulhydrater fordeles jævnt over dagen.
English: Hypoglycaemia may occur when Jentadueto is administered together with sulphonylurea (≥ 1 case per 10 patients).
Danish: Hypoglykæmi kan forekomme, når Jentadueto administreres sammen med sulfonylurinstof (≥ 1 tilfælde ud af 10 patienter).
English: Adults with normal renal function (GFR ≥90 ml/min) The dose of antihyperglycaemic therapy with Jentadueto should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability, while not exceeding the maximum recommended daily dose of 5 mg linagliptin plus 2,000 mg of metformin hydrochloride.
Danish: Voksne med normal nyrefunktion (GFR ≥ 90 ml/min) Doseringen af antihyperglykæmisk behandling med Jentadueto bør tilpasses individuelt på basis af patientens aktuelle regime, virkning og tolerabilitet, uden at overskride den maksimale anbefalede daglige dosis på 5 mg linagliptin plus 2.000 mg metformin.
English: Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.
Danish: Symptomerne omfatter mavesmerter, hurtig og dyb vejrtrækning og søvnighed, og din ånde kan få en udsædvanlig frugtagtig lugt.
English: Jentadueto is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Danish: Jentadueto er indiceret til behandling af voksne med type 2-diabetes mellitus som supplement til diæt og motion for at forbedre den glykæmiske kontrol:
English: Therefore, clinically relevant interactions would not be expected with other P-glycoprotein/CYP3A4 inhibitors.
Danish: Der forventes derfor ikke klinisk relevante interaktioner med andre P-glykoprotein/CYP3A4-hæmmere.
English: C] linagliptin dose to healthy subjects, approximately 85% of the administered radioactivity was eliminated in faeces (80%) or urine (5%) within 4 days of dosing.
Danish: C]-linagliptin til raske frivillige blev ca. 85 % af den indgivne radioaktivitet udskilt gennem fæces (80 %) eller urin (5 %) inden for 4 dage efter doseringen.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Jentadueto before or at the time of the injection.
Danish: Brug af anden medicin sammen med Jentadueto Hvis du skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i dit blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal du stoppe med at tage Jentadueto forud for eller på tidspunktet for injektionen.
English: Co-administration with other potent inducers of P-glycoprotein and CYP3A4, such as carbamazepine, phenobarbital and phenytoin has not been studied.
Danish: Samtidig administration af andre potente P-glykoprotein- og CYP3A4-induktorer, såsom carbamazepin, phenobarbital og phenytoin, er ikke undersøgt.
English: In clinical trials, the incidence rates of hypoglycemia were comparably low in patients taking linagliptin in combination with metformin or metformin alone.
Danish: I kliniske studier var forekomsten for hypoglykæmi sammenlignelig lav hos patienter, der tog linagliptin i kombination med metformin eller metformin alene.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: A delayed time to peak serum concentrations by 2 hours was observed for metformin under fed conditions.
Danish: En forsinkelse på 2 timer til den maksimale serumkoncentration blev observeret for metformin efter indtagelse i forbindelse med føde.
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Danish: Den absolutte biotilgængelighed for en 500 mg eller 850 mg metformintablet er ca. 50-60 % hos raske frivillige.
English: The mean HbA1c at baseline was 7.15%.
Danish: Den gennemsnitlige HbA1c ved baseline var 7,15 %.
English: Linagliptin is an inhibitor of the enzyme DPP-4 (Dipeptidyl peptidase 4) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucosedependent insulinotropic polypeptide).
Danish: Linagliptin hæmmer enzymet DPP-4 (dipeptidylpeptidase 4), et enzym, der er involveret i inaktiveringen af inkretinhormonerne GLP-1 og GIP (glucagonlignende peptid 1, glucoseafhængigt insulinotropt polypeptid).
English: In analyses for albuminuria progression (change from normoalbuminuria to micro- or macroalbuminuria, or from microalbuminuria to macroalbuminuria) the estimated hazard ratio was 0.86 (95% CI 0.78, 0.95) for linagliptin versus placebo.
Danish: I analyser for progression af albuminuri (ændring fra normoalbuminuri til mikro- eller makroalbuminuri eller fra mikroalbuminuri til makroalbuminuri) var den estimerede hazard ratio 0,86 (95 % CI 0,78; 0,95) for linagliptin vs placebo.
English: Skin and subcutaneous tissue disorders Angioedema rare
Danish: Hud og subkutane væv Angioødem sjælden
English: If you stop taking Jentadueto
Danish: Hvis du holder op med at tage Jentadueto
English: Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC (area under the curve) and a 35 minute prolongation of the time to peak plasma concentration were observed.
Danish: Efter indtagelse af en dosis på 850 mg blev der observeret en 40 % lavere maksimal plasmakoncentration, 25 % fald i AUC (areal under kurven) og en forlængelse af tiden til maksimal plasmakoncentration på 35 minutter.
English: When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin hydrochloride in plasma.
Danish: Når nyrefunktionen er nedsat, er den renale clearance nedsat i forhold til kreatinins, og derfor er halveringstiden for elimination forlænget, hvilket fører til øgede niveauer af metformin i plasma.
English: In addition, linagliptin is not expected to be eliminated to a therapeutically significant degree by hemodialysis or peritoneal dialysis.
Danish: Linagliptin forventes ikke at blive udskilt i en terapeutisk signifikant grad ved hæmodialyse eller peritonealdialyse.
English: Co-administration of a high-fat meal with linagliptin prolonged the time to reach Cmax by 2 hours and lowered Cmax by 15%, but no influence on AUC 0-72h was observed.
Danish: Samtidig indtagelse af et måltid med højt fedtindhold og linagliptin, forlængede tiden til at opnå Cmax med 2 timer og sænkede Cmax med 15 %, men der blev ikke observeret nogen påvirkning af AUC 0-72t.
English: After oral administration of a 5 mg dose to healthy volunteers or patients, linagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1.5 hours post-dose.
Danish: Efter oral administration af en 5 mg dosis til enten raske frivillige eller patienter absorberes linagliptin hurtigt, og maksimal plasmakoncentration (median Tmax) blev opnået 1,5 time efter indtagelsen.
English: During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were not associated with a dose dependent increase in adverse events.
Danish: I kontrollerede kliniske studier hos raske frivillige var enkeltdoser på op til 600 mg linagliptin (svarende til 120 gange den anbefalede dosis) ikke forbundet med en dosisafhængig øgning af bivirkninger.
English: After repeated doses of 500 mg twice daily for 7 days in paediatric patients the peak plasma concentration (Cmax) and systemic exposure (AUC0-t) were reduced by approximately 33% and 40%, respectively compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days.
Danish: Efter gentagen administration af doser på 500 mg 2 gange dagligt i 7 dage hos pædiatriske patienter var den maksimale plasmakoncentration (Cmax), og systemisk eksponering (AUC0-t) reduceret med henholdsvis ca. 33 % og 40 % sammenlignet med voksne diabetikere, der modtog gentagne doser på 500 mg 2 gange dagligt i 14 dage.
English: Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and an 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: Linagliptin also showed significant improvements in fasting plasma glucose (FPG) compared to placebo.
Danish: Linagliptin medførte desuden signifikante forbedringer i faste-plasma-glucose (FPG) sammenlignet med placebo.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Jentadueto therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Jentadueto skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.