FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
Danish: • hvis du har haft en alvorlig allergisk reaktion over for lignende medicin, som du tager for at kontrollere blodsukkeret.
English: • if you have or have had a disease of the pancreas;
Danish: • hvis du har eller har haft en sygdom i bugspytkirtlen.
English: • Ketoconazole.
Danish: • Ketoconazol.
English: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years).
Danish: Ældre patienter (65-80 år) har omkring 60 % højere saxagliptin AUC end yngre patienter (18-40 år).
English: • If you forget to take a dose of Onglyza, take it as soon as you remember it.
Danish: • Hvis du glemmer at tage en dosis af Onglyza, skal du tage den, så snart du husker det.
English: Talk to your doctor if you want to breast-feed while taking this medicine.
Danish: Tal med din læge, hvis du vil amme, mens du tager denne medicin.
English: Onset of symptoms following initiation of drug therapy may be rapid or may occur after longer periods of treatment.
Danish: Symptomdebut efter start af behandling med lægemidlet kan opstå hurtigt eller efter længere behandlingsperioder.
English: • Carbamazepine, phenobarbital or phenytoin.
Danish: • Carbamazepin, phenobarbital eller phenytoin.
English: However, if it is nearly time for the next dose, skip the missed dose.
Danish: Hvis det næsten er tid til næste dosis, springer du den glemte dosis over.
English: Table 4 Primary and Secondary Clinical Endpoints by Treatment Group in the SAVOR Study*
Danish: Tabel 4Primære og sekundære endepunkter og sekundære kliniske endepunkter efter behandlingsgruppe i SAVOR-studiet*
English: No carcinogenic potential was observed in two-year carcinogenicity assays with mice and rats.
Danish: Der blev ikke observeret karcinogent potentiale i to-års karcinogenicitets assays i mus og rotter.
English: In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Danish: Ved overdosering skal passende understøttende behandling initieres ud fra patientens kliniske status.
English: Experience in NYHA class III-IV is still limited.
Danish: Erfaring med patienter i NYHA (New York Heart Association) klasse III-IV er endnu begrænset.
English: Onglyza is not recommended for children and adolescents under 18 years.
Danish: Onglyza frarådes til børn og teenagere under 18 år.
English: Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low.
Danish: De kliniske data beskrevet nedenfor antyder, at risikoen for klinisk betydningsfulde interaktioner med samtidigt administrerede lægemidler er lav.
English: • Very common: low blood sugar (hypoglycaemia)
Danish: • Meget almindelig: Lavt blodsukker (hypoglykæmi).
English: Talk to your doctor before you take Onglyza if you are pregnant or plan to become pregnant.
Danish: Tal med din læge, før du tager Onglyza, hvis du er gravid eller planlægger at blive gravid.
English: Interaction with food
Danish: Interaktion med føde
English: The mean metformin dose was approximately 1900 mg in each treatment group.
Danish: Den gennemsnitlige metformindosis var ca. 1900 mg for hver behandlingsgruppe.
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Danish: Din læge kan ordinere medicin til behandling af din allergiske reaktion og et andet lægemiddel til behandling af din sukkersyge.
English: For this dose, a different tablet strength is available.
Danish: Der findes tabletter med en anden styrke til denne dosis.
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome, have not been studied in the Onglyza clinical program.
Danish: Immunkompromitterede patienter, såsom patienter der har fået foretaget en organtransplantation eller patienter diagnosticerede med human immundefektsyndrom, er ikke blevet undersøgt i det kliniske program for Onglyza.
English: Metformin was uptitrated from 500 to 2000 mg per day as tolerated.
Danish: Metformin blev optitreret fra 500 til 2000 mg pr. dag som tolereret.
English: • Dexamethasone - a steroid medicine.
Danish: • Dexamethason - et steroid.
English: Do not use this medicine if the package is damaged or shows signs of tampering.
Danish: Brug ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på at være forsøgt åbnet.
English: If applicable, remember to take these other medicines as directed by your doctor to achieve the best results for your health.
Danish: Hvis du får anden medicin, skal du huske at tage den anden medicin på den måde, din læge har instrueret dig i, for at opnå det bedste resultat for dit helbred.
English: When driving or using machines, it should be taken into account that dizziness has been reported in studies with saxagliptin.
Danish: Ved bilkørsel og betjening af maskiner bør der tages hensyn til, at svimmelhed er blevet rapporteret ved studier med saxagliptin.
English: Therefore, the efficacy and safety profile of saxagliptin in these patients has not been established.
Danish: Derfor er saxagliptins effekt- og sikkerhedsprofil hos disse patienter ikke fastslået.
English: You should stop taking Onglyza and contact a doctor immediately if you notice any of the following serious side effects:
Danish: Du skal stoppe med at tage Onglyza og omgående kontakte din læge, hvis du oplever nogle af de følgende alvorlige bivirkninger:
English: Onglyza should not be used to treat these conditions;
Danish: Onglyza må ikke bruges til behandling af disse tilstande.
English: This is not considered clinically meaningful, therefore, no dose adjustment for Onglyza is recommended on the basis of age alone.
Danish: Dette anses ikke som klinisk relevant, og derfor rekommanderes ingen dosisjustering af Onglyza alene på baggrund af alderen.
English: Clinically relevant factors predictive of increased relative risk with saxagliptin treatment could not be definitively identified.
Danish: Klinisk relevante faktorer, der er prædiktive for øget relativ risiko med saxagliptinbehandling kunne ikke med sikkerhed identificeres.
English: It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Danish: Det er vigtigt, at du fortsætter med at følge de råd om diæt og motion, som din læge eller sygeplejerske har givet dig.
English: There was no adverse effect on renal function as determined by estimated glomerular filtration rate or CrCL at Week 12 and Week 52.
Danish: Der var ingen skadelig virkning på nyrefunktionen, som blev fastlagt ved en estimeret glomerulær filtrationshastighed eller CrCL i uge 12 og uge 52.
English: Primary endpoint was the proportion of patients reaching HbA1c < 7% without confirmed or severe hypoglycaemia.
Danish: Det primære endepunkt var andelen af patienter, der opnåede HbA1c < 7 % uden bekræftet eller alvorlig hypoglykæmi.
English: Also reported during postmarketing surveillance (see section 4.4).
Danish: Også rapporteret under postmarketing-overvågning (se pkt.
English: Randomised and treated patients with baseline and at least 1 post baseline efficacy measurement.
Danish: Randomiserede og behandlede patienter med baseline efficacy måling og mindst én efficacy måling efter baseline.
English: • if you are allergic to saxagliptin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for saxagliptin eller et af de øvrige indholdsstoffer i Onglyza (angivet i punkt 6).
English: There appeared to be no difference in percentage responders: 37.9% (saxagliptin) and 38.2% (glimepiride) achieved the primary endpoint.
Danish: Der forekom ikke at være nogen forskel i procentdelen af respondenter: 37,9 % (saxagliptin) og 38,2 % (glimepirid) nåede det primære endepunkt.
English: You should not use Onglyza if you are pregnant.
Danish: Du må ikke bruge Onglyza, hvis du er gravid.
English: You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Danish: Du rådes til at følge de anbefalinger for hud- og fodpleje, som din læge eller sygeplejerske har givet dig.
English: For the major metabolite, renal clearance values were comparable to estimated glomerular filtration rate.
Danish: For hovedmetabolitten var værdierne for den renale clearance sammenlignelige med den estimerede glomerulære filtrationshastighed.
English: Use with potent CYP3A4 inducers
Danish: Brug sammen med potente CYP3A4-inducere
English: Onglyza contains the active substance saxagliptin, which belongs to a group of medicines called ‘oral anti-diabetics'.
Danish: Onglyza indeholder det aktive stof saxagliptin, som tilhører en gruppe medicin kaldet 'orale antidiabetika'.
English: The corresponding plasma Cmax values were 24 ng/ml and 47 ng/ml, respectively.
Danish: De tilsvarende plasma-Cmax-værdier var henholdsvis 24 ng/ml og 47 ng/ml.
English: Onglyza had no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose).
Danish: Onglyza havde ingen klinisk betydende effekt på QTc interval eller hjertefrekvens ved orale doser på op til 400 mg dagligt i 2 uger (80 gange den anbefalede dosis).
English: Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Danish: Det gennemsnitlige absolutte lymfocyttal forblev stabilt ved en daglig dosis i op til 102 ugers varighed.
English: • if you suffer from heart failure or you have other risk factors for developing heart failure such as problems with your kidneys.
Danish: • hvis du har hjertesvigt, eller hvis du har risikofaktorer for at udvikle hjertesvigt, såsom problemer med nyrerne.
English: A small decrease in absolute lymphocyte count was observed.
Danish: Et lille fald i det absolutte lymfocyttal blev observeret.
English: There was also no apparent change in body weight associated with saxagliptin.
Danish: Der var heller ikke nogen tydelige vægtændringer associeret med saxagliptin.
English: Onglyza may have a negligible influence on the ability to drive and use machines.
Danish: Onglyza påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The effects of smoking, diet, herbal products, and alcohol use on the pharmacokinetics of saxagliptin have not been specifically studied.
Danish: Effekten af rygning, diæt, naturlægemidler og alkohol på saxagliptins farmakokinetik er ikke undersøgt specifikt.
English: The reduction in FPG was slightly less in the saxagliptin-group and there were more discontinuations (3.5% vs. 1.2%) due to lack of efficacy based on FPG criteria during the first 24 weeks of the study.
Danish: Reduktionen i FPG var en smule mindre i saxagliptin-gruppen, og der var flere afbrydelser (3,5 % vs. 1,2 %) som følge den manglende virkning baseret på FPG-kriterierne i løbet af de første 24 uger af forsøget.
English: In patients with type 2 diabetes, administration of saxagliptin led to inhibition of DPP4 enzyme activity for a 24-hour period.
Danish: Hos patienter med type 2-diabetes medførte administration af saxagliptin hæmning af DPP4 enzymaktiviteten i en 24-timers periode.
English: The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than 12%.
Danish: Den intraindividuelle variationskoefficient på saxagliptin Cmax og AUC var mindre end 12 %.
English: These may be used to control fits (seizures) or chronic pain.
Danish: Disse kan anvendes til at kontrollere krampeanfald eller kroniske smerter.
English: Saxagliptin was not teratogenic at any doses evaluated in rats or rabbits.
Danish: Saxagliptin var ikke teratogent i nogen af de doser, som blev undersøgt hos rotter eller kaniner.
English: Rash has been seen with Onglyza (see section 4) and with certain anti-diabetic medicines in the same class as Onglyza.
Danish: Udslæt er set ved brug af Onglyza (se punkt 4) og visse anti-diabetiske lægemidler i samme klasse som Onglyza.
English: They work by helping to control the level of sugar in your blood.
Danish: De hjælper med at kontrollere sukkerindholdet i blodet.
English: • Uncommon (may affect 1 to 10 users in 1,000): joint pain (arthralgia) and difficulties in getting or maintaining an erection (erectile dysfunction).
Danish: • Ikke almindelig (kan forekomme hos 1 til 10 ud af 1.000 behandlede): Ledsmerter (artralgi) og problemer med at opnå og fastholde en erektion (erektil dysfunktion).
English: Onglyza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Danish: Onglyza må ikke anvendes til patienter med type 1-diabetes mellitus eller til behandling af diabetisk ketoacidose.
English: Animal studies have shown excretion of saxagliptin and/or metabolite in milk.
Danish: Dyrestudier har vist at saxagliptin og/eller metabolitten udskilles i mælk.
English: Saxagliptin and its major metabolite can be removed by haemodialysis (23% of dose over 4 hours).
Danish: Saxagliptin og dets hovedmetabolit kan fjernes ved hæmodialyse (23 % af dosis over 4 timer).
English: Because increases of this magnitude are not clinically relevant, dose adjustment in patients with mild renal impairment is not recommended.
Danish: Da stigninger af denne størrelse ikke er klinisk relevante, anbefales dosisjustering ikke til patienter med let nedsat nyrefunktion.
English: The clinical significance of this decrease in lymphocyte count relative to placebo is not known.
Danish: Den kliniske signifikans af dette fald i lymfocyttal relativt til placebo er ikke kendt.
English: Administration with food (a high-fat meal) resulted in no change in saxagliptin Cmax and a 27% increase in AUC compared with the fasted state.
Danish: Administration sammen med føde (et fedtrigt måltid) resulterede ikke i nogen ændring af Cmax og en 27 % stigning i AUC for saxagliptin sammenlignet med fastende tilstand.
English: Onglyza contains lactose
Danish: Onglyza indeholder lactose
English: The findings of these studies were confirmed with two subsequent 24-week regional (Asian) monotherapy studies comparing saxagliptin 5 mg with placebo.
Danish: Resultaterne af disse studier blev bekræftet af to efterfølgende 24-ugers regionale (asiatiske) monoterapistudier, der sammenlignede saxagliptin 5 mg med placebo.
English: • if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting).
Danish: • hvis du har type 1-diabetes (din krop producerer ikke noget insulin) eller diabetisk ketoacidose (en følgesygdom til diabetes som medfører højt blodsukker, hurtigt vægttab, kvalme eller opkastning).
English: The in vitro protein binding of saxagliptin and its major metabolite in human serum is negligible.
Danish: In vitro proteinbinding af saxagliptin og hovedmetabolitten i humant serum er negligerbar.
English: The degree of renal impairment did not affect the Cmax of saxagliptin or its major metabolite.
Danish: Graden af nedsat nyrefunktion havde ingen indvirkning på Cmax for saxagliptin eller dets hovedmetabolit.
English: Patients experienced relief of symptoms after discontinuation of the medication and some experienced recurrence of symptoms with reintroduction of the same or another DPP4 inhibitor.
Danish: Patienterne oplevede lindring af symptomerne efter seponering af lægemidlet, og nogle oplevede, at symptomerne vendte tilbage, når behandling med den samme eller en anden DPP4-hæmmer blev genoptaget.
English: Saxagliptin was not genotoxic in a conventional battery of genotoxicity studies in vitro and in vivo.
Danish: Saxagliptin var ikke genotoksisk i en konventionel række af in vitro og in vivo genotoksiske studier.
English: The clinical relevance of the skin lesions is not known, however, clinical correlates to skin lesions in monkeys have not been observed in human clinical trials of saxagliptin.
Danish: Den kliniske relevans af hudlæsionerne kendes ikke, men kliniske korrelationer til hudlæsioner hos aber er ikke observeret hos mennesker i kliniske undersøgelser af saxagliptin.
English: Adjusted mean change from baseline adjusted for baseline value (ANCOVA).
Danish: Justeret genn,emsnitlig ændring fra baseline justeret for baseline værdier (ANCOVA).
English: • if you have moderate or severe liver problems.
Danish: • hvis du har moderate til svære leverproblemer.
English: • Tablets available in aluminium foil blisters.
Danish: • Tabletterne fås i aluminium-folie-blister.
English: If you have reduced kidney function, your doctor may prescribe a lower dose.
Danish: Hvis du har nedsat nyrefunktion, kan din læge ordinere en lavere dosis.
English: Placebo group had uptitration of glibenclamide from 7.5 to 15 mg total daily dose.
Danish: Placebogruppe fik optitreret glibenclamid fra 7,5 til 15 mg total daglig dosis.
English: The use of saxagliptin has not been studied in pregnant women.
Danish: Anvendelse af saxagliptin hos gravide kvinder er ikke blevet undersøgt.
English: The effect of saxagliptin on fertility in humans has not been studied.
Danish: Saxagliptins påvirkning af fertiliteten hos mennesker er ikke blevet undersøgt.
English: During postmarketing experience, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema.
Danish: Efter markedsføring, inklusive i spontane rapporter og kliniske forsøg, er der indberettet følgende bivirkninger efter anvendelse af saxagliptin: alvorlige overfølsomhedsreaktioner, herunder anafylaktisk reaktion, anafylaktisk shock og angioødem.
English: The adverse reactions are listed by system organ class and absolute frequency.
Danish: Bivirkningerne er opstillet efter organklassificering og frekvens.
English: The effect on offspring body weights were noted until postnatal day 92 and 120 in females and males, respectively.
Danish: Effekten på afkommets kropsvægt blev observeret indtil dag 92 og dag 120 hos henholdsvis hun- og hanrotter.
English: Glycaemic control should be carefully assessed when saxagliptin is used concomitantly with a potent CYP3A4/5 inducer.
Danish: Glykæmisk kontrol skal nøje vurderes, når saxagliptin anvendes samtidig med en potent CYP3A4inducer.
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Danish: Immunrelaterede fund af minimal, ikke-progressiv, lymfoid hyperplasi i milt, lymfeknuder og knoglemarv uden følgetilstande er rapporteret hos alle arter testet ved eksponeringer begyndende ved 7 gange RHD.
English: You should not take this medicine if you are breast-feeding or plan to breast-feed.
Danish: Du bør ikke tage dette lægemiddel, hvis du ammer eller planlægger at amme.
English: The increased risk of overall and major hypoglycaemia was primarily observed in subjects with A1C <7% at baseline.
Danish: Den øgede risiko for total og svær hypoglykæmi blev primært observeret hos forsøgspersoner med A1C <7 % ved baseline.
English: If you have these symptoms, stop taking Onglyza and call your doctor or nurse right away.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Onglyza og omgående kontakte lægen eller sundhedspersonalet.
English: The major metabolite of saxagliptin is also a selective, reversible, competitive DPP4 inhibitor, half as potent as saxagliptin.
Danish: Hovedmetabolitten af saxagliptin er også en selektiv, reversibel, kompetitiv DPP4-hæmmer, halvt så potent som saxagliptin.
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), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Danish: Frekvenser defineres som meget almindelig (≥1/10), almindelig (≥1/100, <1/10, ikke almindelig (≥1/1.000, <1/100), sjælden
English: This is one 2.5 mg tablet once a day.
Danish: Det er en 2,5 mg tablet én gang om dagen.
English: Reductions in HbA1c were seen across subgroups including gender, age, race, and baseline body mass index (BMI) and higher baseline HbA1c was associated with a greater adjusted mean change from baseline with saxagliptin.
Danish: Reduktioner i HbA1c blev set på tværs af undergrupper inklusiv køn, alder, race og baseline body mass index (BMI) og højere baseline HbA1c var associeret med en større justeret gennemsnitsændring fra baseline med saxagliptin.
English: A1C was lower with saxagliptin compared to placebo in an exploratory analysis.
Danish: A1C var lavere for saxagliptin sammenlignet med placebo i en eksplorativ analyse.
English: Subjects at higher risk for hospitalisation for heart failure, irrespective of treatment assignment, could be identified by known risk factors for heart failure such as baseline history of heart failure or impaired renal function.
Danish: Forsøgspersoner med højere risiko for hospitalsindlæggelse pga. hjertesvigt, uanset tildeling af behandling, kunne identificeres ved kendte risikofaktorer for hjertesvigt såsom baseline anamnese med hjertesvigt eller nedsat nyrefunktion.
English: The exposure of the active metabolite and the plasma DPP4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Danish: Eksponeringen af den aktive metabolit og inhiberingen af plasma DPP4 aktiviteten over et dosisinterval blev ikke influeret af rifampicin (se pkt.
English: Infections and infestations Upper respiratory infection
Danish: Infektioner og parasitære sygdomme Øvre luftvejsinfektion
English: This may be used to treat fungal infections.
Danish: Dette kan bruges til at behandle svampeinfektioner.
English: It is not known if Onglyza passes into human breast milk.
Danish: Det vides ikke, om Onglyza går over i modermælken.
English: From a baseline mean absolute lymphocyte count of approximately 2,200 cells/μl, a mean decrease of approximately 100 cells/μl relative to placebo was observed in the placebo-controlled-pooled analysis.
Danish: Fra baseline-gennemsnittet af et absolut lymfocyttal på omkring 2.200 celler/μl, blev et gennemsnitligt fald på omkring 100 celler/μl i forhold til placebo observeret i den placebokontrollerede poolede analyse.
English: Events accumulated consistently over time, and the event rates for Onglyza and placebo did not diverge notably over time.
Danish: # Episoder akkumuleret konsekvent over tid og hyppigheden af episoder for saxagliptin og placebo adskilte sig ikke bemærkelsesværdigt over tid.
English: Onglyza is not a substitute for insulin in insulin-requiring patients.
Danish: Onglyza kan ikke erstatte insulin hos insulinkrævende patienter.
English: Your doctor may prescribe Onglyza alone or together with insulin or other anti-diabetic medicines.
Danish: Din læge kan ordinere Onglyza alene eller sammen med insulin eller anden anti-diabetisk medicin.
English: 7.9 -0.7 (morning)
Danish: -0,7 (morgen)
English: You should call your doctor if you experience the following side effect: • Severe joint pain.
Danish: Kontakt lægen, hvis du får følgende bivirkning: • Svære ledsmerter.
English: Onglyza is used for adult patients aged 18 years and older with ‘type 2 diabetes', if the disease cannot be adequately controlled with one oral anti-diabetic medicine, diet and exercise.
Danish: Onglyza anvendes til voksne patienter på 18 år eller derover med type 2-diabetes, når sygdommen ikke kan kontrolleres tilstrækkeligt med et oralt antidiabetisk lægemiddel, diæt og motion.
English: Some patients have experienced constipation at an unknown frequency (cannot be determined from the available data) when Onglyza was used alone or in combination.
Danish: Nogle patienter har haft forstoppelse i ukendt hyppighed (kan ikke vurderes ud fra forhåndenværende data) ved anvendelse af Onglyza alene eller sammen med andre lægemidler.