FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies with pioglitazone, the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Danish: I kliniske studier af pioglitazon var forekomsten af forhøjede ALAT-tal tre gange den øvre normalgrænse identisk med placebo, men lavere end i komparatorgrupperne, der fik metformin eller sulfonylurinstof.
English: In comparator groups, addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
Danish: I komparatorgrupperne medførte sulfonylurinstof givet som tillæg til metformin en gennemsnitlig vægtforøgelse på 1,3 kg, og metformin givet som tillæg til sulfonylurinstof medførte et gennemsnitligt vægttab på 1,0 kg.
English: The co-administration of alogliptin and pioglitazone has been studied as dual therapy in patients initially treated with pioglitazone alone (with or without metformin or a sulphonylurea) and as add-on therapy to metformin.
Danish: Samtidig administration af alogliptin og pioglitazon er blevet undersøgt som kombinationsbehandling af patienter, der oprindelig er blevet behandlet med pioglitazon alene (med eller uden metformin eller et sulfonylurinstof), og som tillægsbehandling til metformin.
English: The pharmacokinetics of alogliptin in children and adolescents < 18 years old has not been established.
Danish: Alogliptins farmakokinetik hos børn og unge under 18 år er ikke klarlagt.
English: Effects of other medicinal products on alogliptin
Danish: Andre lægemidlers indvirkning på alogliptin
English: Both 25 mg alogliptin alone and in combination with 30 mg pioglitazone demonstrated significant decreases in postprandial glucose and postprandial glucagon whilst significantly increasing postprandial active GLP-1 levels at Week 16 compared to placebo (p<0.05).
Danish: Ved administration af 25 mg alogliptin både alene og sammen med 30 mg pioglitazon var der et betydeligt fald i postprandial glucose og postprandial glukagon, mens der var en betydelig stigning i de postprandiale aktive GLP-1-niveauer i uge 16 sammenlignet med placebo (p < 0,05).
English: Pioglitazone was associated with significant weight gain.
Danish: Pioglitazonbehandlingen var forbundet med en betydelig vægtforøgelse.
English: Studies in animals with alogliptin plus pioglitazone as combination treatment have shown reproductive toxicity (slight augmentation of pioglitazone-related foetal growth retardation and foetal visceral variations, see section 5.3).
Danish: Dyrestudie med kombinationsbehandling med alogliptin og pioglitazon har vist reproduktionstoksicitet (let forøgelse af føtal vækstretardering relateret til pioglitazon og føtale viscerale forandringer, se pkt.
English: The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p<0.001 at all time points).
Danish: De betydelige fald i HbA1c observeret med 25 mg alogliptin og 30 mg pioglitazon og metformin var konsistente i løbet af hele den 52 uger lange behandling sammenlignet med behandling med 45 mg pioglitazon og metformin (p < 0,001 på alle tidspunkter).
English: You may experience visual disturbances while taking this medicine.
Danish: Du kan opleve synsforstyrrelser, når du tager Incresync.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Lægemidlet bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: These studies evaluated the effects of co-administered alogliptin and pioglitazone on glycaemic control and their safety as initial combination therapy, as dual therapy in patients initially treated with pioglitazone alone (with or without metformin or a sulphonylurea), and as add-on therapy to metformin.
Danish: Formålet med disse studier var at evaluere virkningen af samtidig administration af alogliptin og pioglitazon på den glykæmiske kontrol samt disse stoffers sikkerhed, når de gives som initial kombination med de 2 aktive substanser ved behandling af patienter, der oprindelig er blevet behandlet med pioglitazon alene (med eller uden metformin eller et sulfonylurinstof), og som tillægsbehandling til metformin.
English: In addition, 25 mg alogliptin alone and in combination with 30 mg pioglitazone produced statistically significant (p<0.001) reductions in total triglycerides at Week 16 as measured by postprandial incremental AUC(0-8) change from baseline compared to placebo.
Danish: Desuden medførte 25 mg alogliptin administreret både alene og sammen med 30 mg pioglitazon statistisk signifikante (p < 0,001) fald i totaltriglycerider fra baseline til uge 16 målt som den postprandiale gradvise ændring i AUC(0-8) sammenlignet med placebo.
English: In one-year clinical studies, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
Danish: Pioglitazon gav konsekvent en statistisk signifikant reduktion i albumin/kreatinin-forholdet sammenlignet med baseline i kliniske studier af 1 års varighed.
English: The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Danish: Tillæg af 25 mg alogliptin én gang dagligt til pioglitazonbehandling (gennemsnitlig dosis = 35,0 mg, med eller uden metformin eller et sulfonylurinstof) resulterede i statistisk signifikante forbedringer af HbA1c og fasteplasmaglucose fra baseline til uge 26 sammenlignet med tillæg af placebo (tabel 2).
English: In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was lower in patients treated with 25 mg alogliptin than in patients treated with 12.5 mg alogliptin, active-control or placebo (3.6%, 4.6%, 12.9% and 6.2%, respectively).
Danish: En samlet analyse af data fra 12 studier viste, at den samlede forekomst af hypoglykæmi var lavere hos patienter behandlet med 25 mg alogliptin end hos patienter behandlet med enten 12,5 mg alogliptin, aktiv kontrol eller placebo (henholdsvis 3,6 %, 4,6 %, 12,9 % og 6,2 %).
English: Results from clinical interaction studies also demonstrate that there are no clinically relevant effects of gemfibrozil (a CYP2C8/9 inhibitor), fluconazole (a CYP2C9 inhibitor), ketoconazole (a CYP3A4 inhibitor), cyclosporine (a p-glycoprotein inhibitor), voglibose (an alpha-glucosidase inhibitor), digoxin, metformin, cimetidine, pioglitazone or atorvastatin on the pharmacokinetics of alogliptin.
Danish: Resultater fra kliniske interaktionsstudier viser også, at følgende lægemidler ikke har klinisk relevant virkning på alogliptins farmakokinetik: Det gælder gemfibrozil (en CYP2C8/9-hæmmer), fluconazol (en CYP2C9-hæmmer), ketoconazol (en CYP3A4-hæmmer), ciclosporin (en p-glykoproteinhæmmer), voglibose (en alfaglukosidasehæmmer), digoxin, metformin, cimetidin, pioglitazon og atorvastatin.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Danish: Efter markedsføring er der indberettet nye tilfælde eller forværring af diabetisk makulaødem med nedsat synsskarphed hos patienter, der blev behandlet med thiazolidindioner, herunder pioglitazon.
English: Alogliptin as add-on therapy to pioglitazone with metformin The addition of 25 mg alogliptin once daily to 30 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Danish: Alogliptin som tillæg til pioglitazon sammen med metformin 25 mg alogliptin én gang dagligt som tillægsbehandling til 30 mg pioglitazon i kombination med metforminhydrochloridbehandling (gennemsnitlig dosis = 1.867,9 mg) resulterede i forbedringer af HbA1c fra baseline til uge 52, som var både non-inferiøre og statistisk større end de forbedringer, som 45 mg pioglitazon i kombination med metforminhydrochloridbehandling gav (gennemsnitlig dosis = 1.847,6 mg, tabel 3).
English: Dietary acidification significantly decreased but did not abolish the incidence of tumours.
Danish: Tilsætning af syre til kosten reducerede tumorforekomster signifikant, men eliminerede ikke tumordannelse helt.
English: General disorders and administration site conditions oedema peripheral common weight increased common
Danish: Almene symptomer og reaktioner på administrationsstedet perifert ødem almindelig øget vægt almindelig
English: This is similar to that seen in a sulphonylurea active comparator group.
Danish: En lignende forøgelse forekom i komparatorgruppen, der fik sulfonylurinstof.
English: Incresync contains lactose
Danish: Incresync indeholder lactose
English: Incresync is not recommended for patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis.
Danish: Incresync frarådes til patienter med svært nedsat nyrefunktion (CrCl < 30 ml/min) eller med dialysekrævende terminal nyresygdom.
English: A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator-controlled, double-blind clinical studies in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Danish: Der blev udført en samlet analyse af bivirkninger i form af knoglefrakturer fra randomiserede, komparatorkontrollerede, dobbeltblindede kliniske studier (af en varighed på op til 3,5 år) af over 8.100 patienter i den pioglitazonbehandlede gruppe og 7.400 patienter i den komparatorbehandlede gruppe.
English: Fasting and postprandial glycaemic control is improved following treatment with pioglitazone in patients with type 2 diabetes mellitus.
Danish: Reguleringen af fastende og postprandialt blodsukker forbedres hos patienter med type 2-diabetes mellitus efter behandling med pioglitazon.
English: In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Danish: In vitro-undersøgelser har ikke vist hæmning af nogenle undertyper af cytokrom P450.
English: MACE Reported in cardiovascular outcomes study Number of Patients (%)
Danish: MACE indberettet i studiet med kardiovaskulære endepunkter
English: Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound).
Danish: N-demethyleret alogliptin, M-I (< 1 % af moderstoffet) og N-acetyleret alogliptin, M-II (< 6 % af moderstoffet).
English: In a pooled analysis of the data from 13 studies, the overall rates of pancreatitis reports in patients treated with 25 mg alogliptin, 12.5 mg alogliptin, active control or placebo were 2, 1, 1 or 0 events per 1,000 patient years, respectively.
Danish: I en samlet analyse af data fra 13 studier var den samlede forekomst af pancreatitis hos patienter behandlet med enten 25 mg alogliptin, 12,5 mg alogliptin, aktiv kontrol eller placebo henholdsvis 2, 1, 1 og 0 hændelser pr. 1.000 patientår.
English: Alogliptin was not genotoxic in a standard battery of in vitro and in vivo genotoxicity studies.
Danish: Alogliptin var ikke genotoksisk i en række standardgenotoksicitetsstudier udført in vitro og in vivo.
English: In addition, mean change from baseline in fasting plasma glucose at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
Danish: Endvidere var den gennemsnitlige ændring i fasteplasmaglucose fra baseline til uge 52 for 25 mg alogliptin plus 30 mg pioglitazon og metformin betydeligt større end for 45 mg pioglitazon og metformin (p < 0,001).
English: Clinical studies conducted to support the efficacy and safety of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
Danish: Kliniske studier, som blev udført for at understøtte virkningen af og sikkerheden ved Incresync, omfattede samtidig administration af alogliptin og pioglitazon som separate tabletter.
English: Eye disorders visual disturbance common macular oedema not known
Danish: Øjensygdomme synsforstyrrelser almindelig makulaødem ikke kendt
English: In light of potential risks with prolonged pioglitazone therapy, prescribers should confirm at subsequent routine reviews that the benefit of Incresync is maintained (see section 4.4).
Danish: De ordinerende læger skal ved længerevarende behandling med pioglitazon ved de efterfølgende rutinekontrolbesøg undersøge, om Incresync fortsat har den ønskede virkning (se pkt.
English: Symptoms may include: trembling, sweating, anxiety, blurred vision, tingling lips, paleness,
Danish: Tegnene kan være rysten, svedtendens, angst, sløret syn, prikkende fornemmelse i læber, bleghed,
English: Therefore, one tablet of 12.5 mg/30 mg or 12.5 mg/45 mg once daily, depending on the dose of pioglitazone already being taken, is recommended in patients with moderate renal impairment (see section 5.2).
Danish: Derfor anbefales én tablet på12,5 mg/30 mg eller 12,5 mg/45 mg 1 gang dagligt, afhængigt af, hvilken dosis pioglitazon de allerede får (se pkt.
English: Placebo-corrected change from baseline in HbA1c (%)†
Danish: Placebo-korrigeret ændring i HbA1c fra baseline (%)†
English: Clinical studies conducted to support the efficacy of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
Danish: Kliniske studier, som blev udført for at understøtte virkningen af Incresync, omfattede samtidig administration af alogliptin og pioglitazon som separate tabletter.
English: Heart failure has been reported rarely with marketing use of pioglitazone, but more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Danish: Hjerteinsufficiens er hyppigere indberettet ved brug af pioglitazon i kombination med insulin eller hos patienter med tidligere hjerteinsufficiens.
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC for pioglitazone.
Danish: Der er rapporter om, at samtidig administration af pioglitazon og rifampicin (en induktor af cytokrom P450 2C8) har resulteret i en 54 % nedsættelse af AUC for pioglitazon.
English: Significantly more patients receiving 25 mg alogliptin plus 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
Danish: Signifikant flere patienter, der fik 25 mg alogliptin plus 30 mg pioglitazon og metformin (33,2 %), nåede i uge 52 behandlingsmålet for HbA1c på ≤ 7,0 % sammenlignet med de patienter, der fik 45 mg pioglitazon og metformin (21,3 %) (p < 0,001).
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen, eller apotekspersonalet.
English: - if you are elderly and are taking insulin, because you may have an increased risk of heart problems.
Danish: Hvis du tager antiinflammatorisk medicin, som også kan forårsage væskeophobning og hævelse, skal du også fortælle din læge det. - hvis du er ældre og tager insulin, fordi du kan have en øget risiko for hjerteproblemer.
English: In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Danish: I PROactive-studiet (kardiovaskulær risikostudie), som forløb over 3,5 år, fik 44 ud af 870 (5,1 %; 1,0 frakturer pr. 100 patientår) pioglitazonbehandlede kvindelige patienter frakturer.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience with pioglitazone (see section 4.8).
Danish: Hepatocellulært funktionssvigt er i sjældne tilfælde indberettet efter markedsføring af pioglitazon (se pkt.
English: In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator.
Danish: I PROactive-studiet, som forløb over 3,5 år, fik 44/870 (5,1 %) af de pioglitazonbehandlede kvindelige patienter frakturer.
English: Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Danish: Indehaver af markedsføringstilladelsen Takeda Pharma A/S
English: Excipient(s) with known effect Each tablet contains 121 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder 121 mg lactose (som monohydrat).
English: You can take this medicine with or without food.
Danish: Du kan tage Incresync med eller uden et måltid.
English: There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Danish: Efter markedsføring har der været indberetninger af hjerteinsufficiens, hvor pioglitazon har været anvendt i kombination med insulin, eller hvor pioglitazon har været anvendt til patienter med tidligere hjerteinsufficiens.
English: Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis.
Danish: Incresync anbefales ikke til patienter med svært nedsat nyrefunktion eller med dialysekrævende terminal nyresygdom.
English: No adverse effects on fertility were observed in animal studies conducted with alogliptin (see section 5.3).
Danish: I dyrestudie med alogliptin er der ikke observeret bivirkninger relateret til fertilitet (se pkt.
English: Takeda Polska Sp. z o.o.
Danish: Takeda Italia S.p.A.
English: Excipient(s) with known effect Each tablet contains 105 mg of lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver tablet indeholder 105 mg lactose (som monohydrat).
English: Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.
Danish: Synsforstyrrelser er primært indberettet tidligt i et behandlingsforløb og er relateret til ændringer i blodglucoseværdier.
English: There is no experience of using Incresync in pregnant women or during breast-feeding.
Danish: Der er ingen erfaringer med brug af Incresync til gravide eller ammende kvinder.
English: A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Danish: Der er observeret en øget hyppighed af frakturer hos kvinder, der tog pioglitazon (2,6 %) sammenlignet med komparator (1,7 %).
English: Musculoskeletal and connective tissues disorders myalgia common fracture bone common
Danish: Knogler, led, muskler og bindevæv myalgi almindelig knoglefraktur almindelig
English: Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
Danish: Patienterne bør observeres for tegn og symptomer på hjerteinsufficiens, vægtøgning og ødem.
English: The symptoms may include: a rash, hives, swallowing or breathing problems, swelling of your lips, face, throat or tongue and feeling faint.
Danish: Tegnene kan være udslæt, nældefeber, synke- eller åndedrætsbesvær, opsvulmede læber, ansigt, svælg eller tunge og besvimelsesfornemmelse.
English: The pharmacokinetics of alogliptin has been shown to be similar in healthy subjects and in patients with type 2 diabetes mellitus.
Danish: Alogliptins farmakokinetik hos raske forsøgspersoner og patienter med type 2-diabetes mellitus er generelt ens.
English: How to take Incresync
Danish: Sådan skal du tage Incresync
English: For the different dose regimens Incresync is available in strengths of 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/30 mg and 12.5 mg/45 mg film-coated tablets.
Danish: Incresync fås som filmovertrukne tabletter i styrkerne 25 mg/30 mg, 25 mg/45 mg, 12,5 mg/30 mg og 12,5 mg/45 mg.
English: Mean baseline HbA1c (%) (SD)
Danish: Gennemsnitlig HbA1c ved baseline (%) (SD)
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC for pioglitazone.
Danish: Der er rapporter om, at samtidig administration af pioglitazon og gemfibrozil (en hæmmer af cytokrom P450 2C8) har resulteret i en tredobling af AUC for pioglitazon.
English: - Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Danish: - Stærke og vedvarende smerter i maven, som kan stråle ud i ryggen, samt kvalme og opkastning.
English: In most clinical studies, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo with small, but not clinically significant, increases in LDL-cholesterol levels.
Danish: I de fleste kliniske studier blev der observeret en reduktion af niveauerne af totalplasmatriglycerider, frie fedtsyrer og en øgning i HDL-kolesterolniveauer sammenlignet med placebo.
English: Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets
Danish: Incresync 12,5 mg/30 mg filmovertrukne tabletter Incresync 12,5 mg/45 mg filmovertrukne tabletter Incresync 25 mg/30 mg filmovertrukne tabletter Incresync 25 mg/45 mg filmovertrukne tabletter
English: Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
Danish: Incresync 12,5 mg/30 mg filmovertrukne tabletter Incresync 12,5 mg/45 mg filmovertrukne tabletter Incresync 25 mg/30 mg filmovertrukne tabletter Incresync 25 mg/45 mg filmovertrukne tabletter alogliptin/pioglitazon
English: Postmarketing reports of hepatic dysfunction including hepatic failure have been received for alogliptin.
Danish: Der er desuden indberettet tilfælde af leverfunktionssvigt, herunder leversvigt, efter markedsføring af alogliptin.
English: However, the results of bioequivalence studies have demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Danish: Bioækvivalensstudier viser imidlertid, at Incresync, filmovertrukne tabletter er bioækvivalente med tilsvarende doser af alogliptin og pioglitazon givet samtidigt som separate tabletter.
English: For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of Incresync is necessary (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis for Incresync hos patienter med let nedsat nyrefunktion (kreatininclearance (CrCl) > 50 til ≤ 80 ml/min) (se pkt.
English: INFORMATION IN BRAILLE Incresync 25 mg/45 mg
Danish: INFORMATION I BRAILLE-SKRIFT Incresync 25 mg/45 mg
English: Cardiac failure or history of cardiac failure (NYHA stages I to IV; see section 4.4) Hepatic impairment (see section 4.4)
Danish: 4.4 og 4.8) - Hjerteinsufficiens eller tidligere hjerteinsufficiens (NYHA-klasse I til IV, se pkt.
English: Alogliptin as add-on therapy to pioglitazone
Danish: Alogliptin som tillæg til pioglitazon