FrancophonIA/ELRC3.0 huggingface dataset:
English: The fracture incidence calculated was 1.9 fractures per 100 patient years in women treated with pioglitazone and 1.1 fractures per 100 patient years in women treated with a comparator.
Danish: Forekomsten af frakturer er beregnet til 1,9 frakturer pr. 100 patientår hos de kvinder, der blev behandlet med pioglitazon, og 1,1 frakturer pr. 100 patientår hos de kvinder, der blev behandlet med en komparator.
English: Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2).
Danish: Alogliptin udskilles primært uomdannet i urinen, og omsætning via cytokrom P450 (CYP)enzymsystemet er ubetydelig (se pkt.
English: - A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
Danish: - En alvorlig allergisk reaktion: hudlæsioner eller pletter på huden, der kan udvikle sig til et sår omgivet af blege eller røde ringe, blæredannelse og/eller afskalning af huden eventuelt med symptomer som kløe, feber, generel utilpashed, smertende led, synsforstyrrelser, brændende smertefuld eller kløende øjne og sår i munden (Steven-Johnson syndrome og erythema multiforme).
English: Table 3: Change in HbA1c (%) from baseline with alogliptin 25 mg by active-controlled study (PPS, LOCF)
Danish: Tabel 3: Ændring i HbA1c (%) fra baseline i aktivt kontrollerede studier af alogliptin 25 mg (PPS, LOCF)
English: Administration of 25 mg alogliptin to patients with type 2 diabetes mellitus produced peak inhibition of DPP-4 within 1 to 2 hours and exceeded 93% both after a single 25 mg dose and after 14 days of once-daily dosing.
Danish: Administration af 25 mg alogliptin til patienter med type 2-diabetes mellitus medførte maksimal hæmning af DPP-4 efter 1-2 timer, og hæmningsgraden var på mere end 93 % både efter administration af en enkeltdosis på 25 mg og efter administration af samme dosis én gang dagligt i 14 dage.
English: The pharmacokinetics of pioglitazone in children and adolescents < 18 years old has not been established.
Danish: Pioglitazons farmakokinetik hos børn og unge under 18 år er ikke klarlagt.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke Incresync efter den udløbsdato, der står på pakningen og blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: It is recommended, therefore, that patients treated with Incresync undergo periodic monitoring of liver enzymes.
Danish: Det anbefales derfor, at patienter behandlet med Incresync regelmæssigt får kontrolleret leverenzymer.
English: Nervous system disorders headache common common hypoaesthesia common insomnia uncommon
Danish: Nervesystemet hovedpine almindelig almindelig hypoæstesi almindelig søvnløshed ikke almindelig
English: Minimal quantities of alogliptin are removed by haemodialysis (approximately 7% of the substance was removed during a 3-hour haemodialysis session).
Danish: Kun meget små mængder alogliptin kan fjernes ved hæmodialyse (ca. 7 % af stoffet blev fjernet i løbet af en tretimers-dialysebehandling).
English: Similar changes were seen in metformin- (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea- and insulin- (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative-controlled studies with pioglitazone.
Danish: Lignende ændringer blev observeret hos patienter behandlet med metformin (hæmoglobin: 3-4 % relativ reduktion og hæmatokrit: 3,6-4,1 % relativ reduktion) og i mindre grad hos patienter behandlet med sulfonylurinstof og insulin (hæmoglobin: 1-2 % relativ reduktion og hæmatokrit: 1-3,2 % relativ reduktion) i kontrollerede sammenlignende studier af pioglitazon.
English: Common: - Symptoms of low blood sugar (hypoglycaemia) may occur when Incresync is taken in combination with insulin or sulphonylureas (e.g. glipizide, tolbutamide, glibenclamide).
Danish: Almindelige bivirkninger: - Tegn på lavt blodsukker (hypoglykæmi), som kan opstå, hvis Incresync tages i kombination med insulin eller sulfonylurinstof (f.eks. glipizid, tolbutamid eller glibenclamid).
English: Incresync should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Danish: Incresync bør bruges med forsigtighed ved samtidig administration af cytokrom P450 2C8-hæmmere (f.eks. gemfibrozil) eller -induktorer (f.eks. rifampicin).
English: In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively.
Danish: Hos patienter med moderat til svært nedsat nyrefunktion eller patienter med hæmodialysekrævende terminal nyresygdom sås en stigning i den systemiske eksponering for alogliptin på henholdsvis ca. 2 og 4 gange.
English: In active comparator-controlled studies, mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Danish: I aktivt kontrollerede komparator-studier af pioglitazon givet som enkeltstofbehandling var den gennemsnitlige vægtforøgelse 2-3 kg i løbet af et år.
English: Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Danish: Pioglitazon var uden genotoksisk potentiale i en omfattende række af genotoksicitetsundersøgelser foretaget in vivo og in vitro.
English: - Cold or flu-like symptoms such as sore throat, stuffy or blocked nose - Inflammation of the sinuses (sinusitis) - Itchy skin - Headache - Stomach ache - Diarrhoea - Indigestion, heartburn - Feeling sick - Muscle pain - Feeling numb in any part of your body - Blurred or distorted vision - Weight gain - Swollen or puffy hands or feet - Rash
Danish: - forkølelse eller influenzalignende symptomer som ondt i halsen og tilstoppet næse - bihulebetændelse (sinusitis) - hudkløe - hovedpine - mavesmerter - diarré - fordøjelsesbesvær, opstød - almen sygdomsfornemmelse - muskelsmerter - følelsesløshed i en del af kroppen - sløret eller forvrænget syn - vægtforøgelse - hævede hænder eller fødder - udslæt.
English: The recommended dose is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken.
Danish: Den anbefalede daglige dosis er én tablet a 25 mg/30 mg eller 25 mg/45 mg én gang dagligt, afhængigt af hvilken dosis pioglitazon, der allerede tages.
English: No clinically relevant accumulation after multiple dosing was observed in either healthy subjects or in patients with type 2 diabetes mellitus.
Danish: Der blev ikke observeret nogen klinisk relevant akkumulation efter gentagen administration hos hverken raske forsøgspersoner eller hos patienter med type 2-diabetes mellitus.
English: As there is a need for dose adjustment of alogliptin in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis, appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.2).
Danish: Da det er nødvendigt at justere dosis for alogliptin hos patienter med moderat eller svært nedsat nyrefunktion eller dialysekrævende terminal nyresygdom, anbefales det, at nyrefunktionen vurderes inden igangsættelsen af behandling med Incresync og regelmæssigt derefter (se pkt.
English: The incidence of hypoglycaemia was greater when alogliptin was used as triple therapy with pioglitazone and metformin (compared to active-control).
Danish: Forekomsten af hypoglykæmi var større, når alogliptin blev anvendt i kombination med både pioglitazon og metformin (sammenlignet med aktiv kontrol).
English: Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see above and section 4.2).
Danish: For at opretholde en systemisk eksponering for alogliptin svarende til den, der er observeret hos patienter med normal nyrefunktion, bør der derfor gives lavere doser alogliptin til patienter med moderat til svært nedsat nyrefunktion eller dialysekrævende terminal nyresygdom (se ovenfor og pkt.
English: Metabolism and nutrition disorders hypoglycaemia common common
Danish: Metabolisme og ernæring hypoglykæmi almindelig almindelig
English: No studies in lactating animals have been conducted with the combined active substances of Incresync.
Danish: Der er ikke foretaget studier af administration af kombinationen af de aktive stoffer i Incresync til diegivende dyr.
English: - if you are taking an anti-diabetic medicine known as sulphonylurea (e.g. glipizide, tolbutamide, glibenclamide) or insulin.
Danish: - hvis du tager diabetesmedicin af typen sulfonylurinstof (f.eks. glipizid, tolbutamid, glibenclamid) eller insulin.
English: No information is available on pioglitazone and alogliptin use in dialysed patients and, therefore, co-administered alogliptin plus pioglitazone should not be used in such patients (see sections 4.2 and 5.2).
Danish: Der foreligger ingen oplysninger om anvendelse af pioglitazon og alogliptin til dialysepatienter, og derfor bør alogliptin og pioglitazon ikke gives samtidigt til disse patienter (se pkt.
English: Hypersensitivity reactions, including Stevens-Johnson syndrome, anaphylactic reactions, and angioedema are serious and are attributed to the alogliptin component of Incresync (see section 4.4).
Danish: Overfølsomhedsreaktioner, herunder Stevens-Johnsons syndrom, anafylaktiske reaktioner og angioødem er alvorlige bivirkninger og tilskrives alogliptin-komponenten i Incresync (se pkt.
English: In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo when added to therapy that included insulin.
Danish: I et endepunktsstudie af patienter med betydende makrovaskulær sygdom var forekomsten af alvorlig hjerteinsufficiens ved kombinationsbehandling med insulin 1,6 % højere med pioglitazon end med placebo.
English: Gastrointestinal disorders abdominal pain common common gastroesophageal reflux disease common diarrhoea common dyspepsia common nausea common acute pancreatitis not known
Danish: Mave-tarm-kanalen mavesmerter almindelig almindelig gastroøsofageal reflukssygdom almindelig diarré almindelig dyspepsi almindelig kvalme almindelig akut pancreatitis ikke kendt
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens, eller apotekspersonalets anvisning.
English: Add-on combination therapy placebo-controlled studies Alogliptin 25 mg once daily with pioglitazone ± metformin or a sulphonylurea (n=195) FAS = full analysis set LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment
Danish: Placebokontrollerede studier med kombinationsbehandling som tillæg Alogliptin 25 mg én gang dagligt med pioglitazon ± metformin eller et sulfonylurinstof (n = 195) FAS = fuldt analysesæt LOCF (last observation carried forward) = sidste observation ekstrapoleret † Mindste kvadraters gennemsnit justeret mht. tidligere antihyperglykæmisk behandlingsstatus og baselineværdier * p < 0,001 sammenlignet med placebo eller placebo + kombinationsbehandling
English: Incresync tablets contain lactose.
Danish: Incresync-tabletter indeholder lactose.
English: In clinical studies of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels compared to placebo, metformin or gliclazide.
Danish: I kliniske studier af en varighed på op til to år reducerede pioglitazon totalplasmatriglycerider og frie fedtsyrer og forøgede HDL-kolesterolniveauet sammenlignet med placebo, metformin eller gliclazid.
English: A total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of co-administered alogliptin and pioglitazone on glycaemic control and their safety.
Danish: I alt 3.504 patienter med type 2-diabetes mellitus, herunder 1.908 patienter, som blev behandlet med alogliptin og pioglitazon, deltog i 4 dobbeltblindede, placebo- eller aktivt kontrollerede kliniske fase III-studier, som blev gennemført for at evaluere virkningen af samtidig administration af alogliptin og pioglitazon på den glykæmiske kontrol samt disse stoffers sikkerhed.
English: The information provided is based on a total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, who participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies.
Danish: De foreliggende data er baseret på i alt 3.504 patienter med type 2-diabetes mellitus, herunder 1.908 patienter, som blev behandlet med alogliptin og pioglitazon, og som deltog i 4 dobbeltblindede, placebo- eller aktivt kontrollerede kliniske fase III-studier.
English: Incresync may, therefore, be administered with or without food.
Danish: Incresync kan derfor tages med eller uden mad.
English: DPP-4 is the principal enzyme involved in the rapid degradation of the incretin hormones, glucagon-like peptide-1 (GLP-1) and GIP (glucosedependent insulinotropic polypeptide), which are released by the intestine and levels are increased in response to a meal.
Danish: DPP-4 er det primære enzym, der indgår i den hurtige nedbrydning af inkretinhormonerne GLP-1 (glukagonlignende peptid-1) og GIP (glucoseafhængigt insulinotropisk polypeptid).
English: Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Danish: Der blev observeret frakturer hos 2,6 % af de kvinder, der blev behandlet med pioglitazon, sammenlignet med 1,7 % af de kvinder, der blev behandlet med en komparator.
English: In clinical studies, alogliptin had no clinically relevant effect on the pharmacokinetics of caffeine, (R)-warfarin, pioglitazone, glyburide, tolbutamide, (S)-warfarin, dextromethorphan, atorvastatin, midazolam, an oral contraceptive (norethindrone and ethinyl oestradiol), digoxin, fexofenadine, metformin, or cimetidine, thus providing in vivo evidence of a low propensity to cause interaction with substrates of CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glycoprotein, and OCT2.
Danish: I kliniske studier havde alogliptin ingen klinisk relevant indvirkning på farmakokinetikken for koffein, (R)-warfarin, pioglitazon, glyburid, tolbutamid, (S)-warfarin, dextromethorphan, atorvastatin, midazolam (et oralt kontraceptivum indeholdende norethindron og ethinyløstradiol), digoxin, fexofenadin, metformin eller cimetidin, hvilket giver in vivo-evidens for stoffets lave tilbøjelighed til at forårsage interaktion med substrater af CYP1A2, CYP3A4, CYP2D6, CYP2C9, p-glykoprotein og OCT2.
English: An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Danish: Der sås øget forekomst af hyperplasi (hos hanner og hunner) og tumorer (hos hanner) i urinblærens epitel hos rotter behandlet med pioglitazon i op til 2 år.
English: Carnauba wax Glycerol mono-oleate Glycerol mono-oleate
Danish: Glycerol mono-oleat
English: For patients switching from separate tablets of alogliptin and pioglitazone, both alogliptin and pioglitazone should be dosed at the daily dose already being taken.
Danish: Patienter, som skifter fra separate tabletbehandlinger med henholdsvis alogliptin og pioglitazon til Incresync, skal fortsætte med den daglige dosis alogliptin og pioglitazon, der allerede indtages.
English: Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate Lactose monohydrate
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Croscarmellosenatrium Magnesiumstearat Lactosemonohydrat
English: Incresync should be taken once daily with or without food.
Danish: Incresync skal tages én gang dagligt alene eller i forbindelse med et måltid.
English: There was no tumourigenic response in mice of either sex. Hyperplasia of the urinary bladder was not seen in dogs or monkeys treated with pioglitazone for up to 12 months.
Danish: Hyperplasi af urinblæren sås ikke hos hunde eller aber behandlet med pioglitazon i op til 12 måneder.
English: Caution should be exercised when alogliptin is used in combination with metformin and a thiazolidinedione as an increased risk of hypoglycaemia has been observed with this triple therapy (see section 4.4).
Danish: Der skal udvises forsigtighed, når alogliptin bruges i kombination med metformin og et thiazolidindion, da der er observeret en øget risiko for hypoglykæmi ved denne kombinationsbehandling med 3 aktive substanser (se pkt.
English: Alogliptin was not teratogenic in rats or rabbits with a systemic exposure at the NOAELs far above the human exposure at the recommended dose.
Danish: Alogliptin var ikke teratogent hos rotter og kaniner, der blev udsat for systemisk eksponering med NOAEL, der var langt højere end den humane eksponering ved den anbefalede dosis.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Danish: Næsten alle patienterne (95 %) var i behandling med kardiovaskulære lægemidler (betablokkere, ACE-hæmmere, angiotensin II-antagonister, kalciumantagonister, nitrater, diuretika, acetylsalisylsyre, statiner og fibrater).
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical studies with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
Danish: En metaanalyse af kontrollerede kliniske studier af pioglitazon (19 tilfælde ud af 12.506 patienter, 0,15 %) viste en øget forekomst af blærecancer sammenlignet med kontrolgruppen (7 tilfælde ud af 10.212 patienter, 0,07 %) - HR = 2,64 (95 % konfidensinterval 1,11 - 6,31, p = 0,029).
English: In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was similar in patients ≥ 65 years old treated with 25 mg alogliptin (3.8%) to that in patients < 65 years old (3.6%).
Danish: En samlet analyse af data fra 12 studier viste, at den samlede forekomst af hypoglykæmi var den samme for patienter på 65 år og derover behandlet med 25 mg alogliptin (3,8 %) som for patienter under 65 år (3,6 %).
English: The following section outlines the pharmacokinetic properties of the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics.
Danish: I det følgende gennemgås de farmakokinetiske egenskaber ved de enkelte komponenter i Incresync (alogliptin og pioglitazon) som beskrevet i deres respektive produktresuméer.
English: The following section outlines the interactions observed with the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics.
Danish: I det følgende gennemgås de observerede interaktioner med de enkelte komponenter i Incresync (alogliptin og pioglitazon) som beskrevet i deres respektive produktresuméer.
English: Symptoms include excessive thirst, frequent urination, loss of appetite, nausea or vomiting and rapid weight loss.
Danish: De symptomer, du skal være opmærksom på, er udtalt tørst, hyppig vandladning, appetitløshed, kvalme eller opkastning og hurtigt vægttab.
English: No dose adjustment is necessary based on age (see section 4.4).
Danish: Dosistilpasning er ikke nødvendig på grund af alder (se pkt.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen, sundhedspersonalet eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: Add-on combination therapy studies Alogliptin 25 mg once daily with pioglitazone + metformin vs titrating pioglitazone + metformin
Danish: Studier med kombinationsbehandling som tillæg Alogliptin 25 mg én gang dagligt med pioglitazon + metformin versus titrering af pioglitazon + metformin
English: In combination studies, pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg and added to a sulphonylurea of 2.8 kg.
Danish: I studier af kombinationsbehandling medførte pioglitazon, givet som tillæg til metformin, en gennemsnitlig vægtforøgelse på 1,5 kg i løbet af et år og på 2,8 kg, hvis pioglitazon blev givet som tillæg til sulfonylurinstof.
English: Symptoms of a serious allergic reaction may include; rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Danish: Tegn på en alvorlig allergisk reaktion kan være udslæt, hævede røde områder på huden (nældefeber) og hævelse af ansigt, læber, tunge eller svælg, som kan gøre det svært for dig at trække vejret eller synke.
English: Patients should be advised to promptly seek the attention of their physician if macroscopic haematuria or other symptoms such as dysuria or urinary urgency develop during treatment.
Danish: Patienterne skal rådes til straks at kontakte egen læge, hvis de oplever symptomer på makroskopisk hæmaturi eller andre symptomer som dysuri eller imperiøs vandladning.
English: For patients with moderate renal impairment, Incresync 12.5 mg/30 mg or 12.5 mg/45 mg should be administered once daily.
Danish: Patienter med moderat nedsat nyrefunktion skal have Incresync 12,5 mg/30 mg eller 12,5 mg/45 mg én gang dagligt.
English: The maximum recommended daily dose is one 25 mg/45 mg tablet.
Danish: Den højeste anbefalede dosis er én 25 mg/45 mg-tablet dagligt.
English: Mean levels of liver enzymes decreased with treatment with pioglitazone.
Danish: De gennemsnitlige leverenzymniveauer faldt ved behandling med pioglitazon.
English: For patients inadequately controlled on dual therapy with pioglitazone and a maximally tolerated dose of metformin, the dose of metformin should be maintained, and Incresync administered concomitantly.
Danish: Patienter, som er utilstrækkeligt reguleret med en kombinationsbehandling bestående af pioglitazon og den højeste tolererede dosis metformin, skal fortsætte på samme dosis metformin og tage Incresync samtidigt.
English: Infections and infestations upper respiratory tract infections common common common nasopharyngitis common sinusitis uncommon common
Danish: Infektioner og parasitære sygdomme infektioner i de øvre luftveje almindelig almindelig almindelig nasofaryngitis almindelig sinusitis ikke almindelig almindelig
English: Due to its pioglitazone component, Incresync should not be used in patients with hepatic impairment (see section 4.2).
Danish: På grund af indholdet af pioglitazon må Incresync ikke anvendes til patienter med nedsat leverfunktion (se pkt.
English: No dose adjustment is necessary (see section 4.2).
Danish: Der er ikke behov for dosisjustering (se pkt.
English: In patients who fail to show an adequate response, Incresync should be discontinued.
Danish: Hvis patienten ikke opnår tilstrækkelig effekt af behandlingen, skal behandlingen med Incresync afbrydes.
English: Significantly more patients receiving 25 mg alogliptin (49.2%) achieved target HbA1c levels of ≤ 7.0% compared to those receiving placebo (34.0%) at Week 26 (p=0.004).
Danish: Signifikant flere patienter, der fik 25 mg alogliptin (49,2 %), nåede i uge 26 behandlingsmålet for HbA1c på ≤ 7,0 % sammenlignet med de placebobehandlede patienter (34,0 %) (p = 0,004).