FrancophonIA/ELRC3.0 huggingface dataset:
English: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Danish: - En signifikant reduktion af den absolutte risiko for enhver diabetesrelateret komplikation i metformingruppen (29,8 hændelser/1.000 patientår) versus diæt alene (43,3 hændelser/1.000 patientår), p=0,0023, og versus den kombinerede gruppe af sulfonylurinstoffer og insulin-monoterapigruppen (40,1 hændelser/1.000 patientår), p=0,0034 - En signifikant reduktion af den absolutte risiko for en diabetesrelateret mortalitet: metformin 7,5 hændelser/1.000 patientår, diæt alene 12,7 hændelser/1.000 patientår, p=0,017 - En signifikant reduktion af den absolutte risiko for samlet mortalitet: metformin 13,5 hændelser/1.000 patientår versus diæt alene 20,6 hændelser/1.000 patientår, (p=0,011), og versus den kombinerede gruppe af sulfonylurinstoffer og insulin-monoterapigruppen 18,9 hændelser/1.000 patientår (p=0,021) - En signifikant reduktion af den absolutte risiko for myokardieinfarkt: metformin 11 hændelser/1.000 patientår, diæt alene 18 hændelser/1.000 patientår, (p=0,01).
English: • inflamed stomach (gastritis) or gut, sometimes caused by an infection (gastro-enteritis)
Danish: • betændelsestilstand i mavesæk (gastritis) eller tarm, undertiden forårsaget af en infektion
English: Immune system disorders Hypersensitivity reactions
Danish: Immunsystemet Overfølsomhedsreaktioner
English: A 3-month dog study and embryo-foetal development studies in rats and rabbits have been conducted with the combination of saxagliptin and metformin.
Danish: Der er blevet udført et 3-måneders studie på hunde og embryo-føtale udviklingsstudier på rotter og kaniner med kombinationen af saxagliptin og metformin.
English: For patients inadequately controlled on maximal tolerated dose of metformin monotherapy Patients not adequately controlled on metformin alone should receive a dose of this medicinal product equivalent to the total daily dose of saxagliptin 5 mg, dosed as 2.5 mg twice daily, plus the dose of metformin already being taken.
Danish: Til patienter, der er utilstrækkeligt kontrolleret på maksimal tålt dosis af metformin-monoterapi Patienter, der ikke er tilstrækkeligt kontrolleret på metformin alene, skal have en dosis af dette lægemiddel svarende til den totale daglige dosis af saxagliptin 5 mg doseret som 2,5 mg to gange dagligt plus den dosis metformin, der tages allerede.
English: After 18 weeks, saxagliptin was non-inferior to sitagliptin in mean reduction from baseline in HbA1c in both the per-protocol and the full analysis sets.
Danish: Efter 18 uger var saxagliptin ikke væsentligt ringere (non-inferior) end sitagliptin mht. middelreduktion i HbA1c i forhold til baseline i såvel pr. protokol-analysen som det fulde analysesæt.
English: The overall incidence of AEs in patients treated with saxagliptin in this trial was similar to placebo (72.5% versus 72.2%, respectively).
Danish: Den samlede bivirkningsfrekvens hos patienter, der blev behandlet med saxagliptin i dette studie, var sammenlignelig med den for placebo (henholdsvis 72,5 % versus 72,2 %).
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: Fra perioden efter markedsføringen, inklusive i spontane rapporter og kliniske forsøg, er der indberettet følgende bivirkninger efter anvendelse af saxagliptin: alvorlige overfølsomhedsreaktioner, der omfattede anafylaktisk reaktion, anafylaktisk shock og/eller angioødem.
English: saxagliptin, part of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin, part of a class of medicines called biguanides.
Danish: saxagliptin, som tilhører en gruppe lægemidler, der hedder DPP-4-hæmmere (dipeptidyl-peptidase-4-hæmmere) og metformin, som tilhører en gruppe lægemidler, der hedder biguanider.
English: This medicinal product must therefore not be used in women who are breast-feeding (see section 4.3).
Danish: Dette lægemiddel må derfor ikke anvendes af kvinder, der ammer (se pkt.
English: After 52 weeks, the saxagliptin and glipizide groups had similar mean reductions from baseline in HbA1c in the per-protocol analysis (-0.7% vs. -0.8%, respectively, mean baseline HbA1c of 7.5% for both groups).
Danish: Efter 52 uger havde saxagliptin- og glipizidgrupperne ens middelreduktioner i HbA1c i forhold til baseline i pr. protokolanalysen (henholdsvis -0,7 % vs. -0,8 %, middel-baseline-HbA1c på 7,5 % for begge grupper).
English: The co-administration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) have not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite.
Danish: Den samtidige administration af saxagliptin og CYP3A4/5-inducere, bortset fra rifampicin (såsom carbamazepin, dexamethason, phenobarbital og phenytoin) er ikke blevet undersøgt og kan muligvis resultere i nedsat plasmakoncentration af saxagliptin og øget koncentration af dets hovedmetabolit.
English: The effect on HbA1c observed at Week 24 was sustained at Week 52.
Danish: Virkningen på HbA1c observeret i uge 24 blev opretholdt i uge 52.
English: If this happens you must stop taking Komboglyze and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Danish: Hvis dette sker for dig, skal du omgående stoppe med at tage Komboglyze og kontakte læge eller nærmeste hospital, da laktatacidose kan føre til koma.
English: When used as add-on to insulin (with or without metformin), the overall incidence of reported hypoglycaemia was 18.4% for saxagliptin 5 mg and 19.9% for placebo.
Danish: Når det blev givet som tillægsbehandling til insulin (med eller uden metformin), var den samlede forekomst af rapporteret hypoglykæmi 18,4 % for saxagliptin 5 mg og 19,9 % for placebo.
English: A 3-month dog study was conducted with the combination of saxagliptin and metformin.
Danish: Der blev udført et 3-måneders studie af hunde med kombinationen af saxagliptin og metformin.
English: Co-administration of saxagliptin and metformin, to pregnant rats and rabbits during the period of organogenesis, was neither embryolethal nor teratogenic in either species when tested at doses yielding systemic exposures (AUC) up to 100 and 10 times the maximum recommended human doses (RHD; 5 mg saxagliptin and 2000 mg metformin), respectively, in rats; and 249 and 1.1 times the RHDs in rabbits.
Danish: Co-administration af saxagliptin og metformin til drægtige rotter og kaniner i organdannelsesperioden var hverken embryoletal eller teratogen hos nogen af arterne, når de blev testet med doser, der giver systemiske eksponeringer (AUC) på op til henholdsvis 100 og 10 gange de maksimalt anbefalede humane doser (RHD: 5 mg saxagliptin og 2000 mg metformin) til rotter, og 249 og 1,1 gange RHD'erne til kaniner.
English: During post-approval use of saxagliptin, additional side effects have been reported that include serious allergic reactions (anaphylaxis), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Danish: Efter brug af godkendte præparater med saxagliptin er der indberettet flere bivirkninger, som omfatter alvorlige allergiske reaktioner (anafylaksi), og hævelser i ansigt, læber, tunge og hals, som kan give besvær med at trække vejret eller synke.
English: Adverse reactions reported in ≥ 5% of patients treated with saxagliptin 5 mg and more commonly than in patients treated with placebo or that were reported in ≥ 2% of patients treated with saxagliptin 5 mg and ≥ 1% more frequently compared to placebo are shown in Table 2.
Danish: Bivirkninger, der er blevet rapporteret hos ≥ 5 % af patienterne, der blev behandlet med saxagliptin 5 mg, og hyppigere end hos patienter behandlet med placebo, eller som blev rapporteret hos ≥ 2 % af patienterne, der blev behandlet med saxagliptin 5 mg og ≥ 1 % hyppigere sammenlignet med placebo, er vist i tabel 2.
English: The effect in HbA1c observed at Week 24 was sustained at Week 52.
Danish: Effekten i HbA1c observeret i uge 24 blev opretholdt i uge 52.
English: Table 5 Key efficacy results in placebo-controlled, combination therapy studies of saxagliptin and metformin
Danish: Tabel 5 Vigtigste effektresultater i placebokontrollerede studier med kombinationsbehandling med saxagliptin og metformin
English: A total of 22% of the administered radioactivity was recovered in faeces representing the fraction of the saxagliptin dose excreted in bile and/or unabsorbed medicinal product from the gastrointestinal tract.
Danish: I alt 22 % af den administrerede radioaktivitet blev genfundet i fæces, hvilket repræsenterer den fraktion af saxagliptindosen, der er blevet udskilt med galde og/eller uabsorberet lægemiddel fra mave-tarm-kanalen.
English: Nervous system disorders Headache
Danish: Nervesystemet Hovedpine
English: No appreciable accumulation of either saxagliptin or its major metabolite was observed with repeated once-daily dosing at any dose level.
Danish: Der blev ikke set væsentlig ophobning af hverken saxagliptin eller hovedmetabolitten på noget dosisniveau ved gentagen dosering en gang dagligt.
English: For patients switching from separate tablets of saxagliptin and metformin Patients switching from separate tablets of saxagliptin and metformin should receive the doses of saxagliptin and metformin already being taken.
Danish: Til patienter, der skifter fra separate saxagliptin- og metformintabletter Patienter, der skifter fra separate saxagliptin- og metformintabletter, skal have de doser af saxagliptin og metformin, der tages allerede.
English: The exposures to saxagliptin were 1.2-, 1.4- and 2.1-fold higher, respectively, and the exposures to BMS-510849 were 1.7-, 2.9- and 4.5-fold higher, respectively, than those observed in subjects with normal renal function.
Danish: Eksponeringerne for saxagliptin var henholdsvis 1,2, 1,4 og 2,1 gange højere, og eksponeringerne for BMS-510849 var henholdsvis 1,7, 2,9 og 4,5 gange højere end de eksponeringer, der sås hos forsøgspersoner med normal nyrefunktion.
English: Pack sizes of 14, 28, 56 and 60 film-coated tablets in non-perforated blisters.
Danish: Pakningsstørrelser på 14, 28, 56 og 60 filmovertrukne tabletter i uperforerede blisterpakninger.
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a 10 mg oral dose of saxagliptin in subjects with varying degrees of chronic renal impairment compared to subjects with normal renal function.
Danish: Der blev udført et åbent, enkeltdosis-studie for at vurdere farmakokinetik af en oral dosis på 10 mg af saxagliptin til forsøgspersoner med varierende grader af kronisk nyreinsufficiens sammenlignet med forsøgspersoner med normal nyrefunktion.
English: Patients were randomised to one of three double-blind treatment groups to receive saxagliptin 5 mg and dapagliflozin 10 mg added to metformin, saxagliptin 5 mg and placebo added to metformin, or dapagliflozin 10 mg and placebo added to metformin.
Danish: Patienterne blev randomiseret til en af tre dobbeltblindede behandlingsgrupper til at modtage saxagliptin 5 mg og dapagliflozin 10 mg i tillæg til metformin, saxagliptin 5 mg og placebo i tillæg til metformin eller dapagliflozin 10 mg og placebo i tillæg til metformin.
English: Across clinical studies, the incidence of laboratory AEs was similar in patients treated with saxagliptin 5 mg compared to patients treated with placebo.
Danish: På tværs af kliniske studier var incidensen af bivirkninger målt på laboratorieværdier ens hos patienter behandlet med saxagliptin 5 mg sammenlignet med patienter behandlet med placebo.
English: Gastrointestinal disorders Gastrointestinal symptoms
Danish: Mave-tarm-systemet Gastrointestinale symptomer
English: The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Danish: Saxagliptins og hovedmetabolittens Cmax og AUC blev forøget proportionalt med saxagliptin-dosen.
English: Ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies for saxagliptin (see section 5.3).
Danish: Ulcererende og nekrotiske hudlæsioner er blevet rapporteret på ekstremiteter på aber i ikke-kliniske toksikologistudier af saxagliptin (se pkt.
English: If a serious hypersensitivity reaction to saxagliptin is suspected, discontinue this medicinal product, assess for other potential causes for the event, and institute alternative treatment for diabetes (see sections 4.3 and 4.8).
Danish: Ved mistanke om en alvorlig overfølsomhedsreaktion over for saxagliptin skal patienten stoppe med dette lægemiddel og evalueres for andre mulige årsager til hændelsen, og der skal skiftes til anden antidiabetisk behandling (se pkt.
English: The safety profile of saxagliptin added to dapagliflozin plus metformin in the long-term treatment period was consistent with that observed in the 24-week treatment period in this study and in the trial in which saxagliptin and dapagliflozin were given concomitantly as add-on therapy to patients treated with metformin (described below).
Danish: Sikkerhedsprofilen af saxagliptin i tillæg til dapagliflozin og metformin i den langsigtede behandlingsperiode var i overensstemmelse med det, der blev observeret i 24 ugers behandlingsperioden i dette studie og i studiet, hvor saxagliptin og dapagliflozin blev givet til patienterne samtidig i tillæg til behandling med metformin (beskrevet nedenfor).
English: Saxagliptin in combination with metformin for glycaemic control The co-administration of saxagliptin and metformin has been studied in patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naive patients inadequately controlled on diet and exercise alone.
Danish: Saxagliptin kombineret med metformin til glykæmisk kontrol Co-administration af saxagliptin og metformin er blevet undersøgt hos patienter med type 2-diabetes, som var utilstrækkeligt kontrolleret på metformin alene, og hos behandlingsnaive patienter, der var utilstrækkeligt kontrolleret på diæt og motion alene.
English: Table 4 The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Danish: Tabel 4 Bivirkningshyppigheden for metformin bestemt ud fra kliniske forsøgsdata og postmarketing-data
English: Joint pain, which may be severe, has been reported in postmarketing reports for DPP4 inhibitors (see section 4.8).
Danish: Der er rapporteret om ledsmerter, som kan være svære, i postmarketingsrapporter for DPP4-hæmmere (se pkt.
English: Mean change from baseline HbA1c (%)
Danish: Middelændring fra baselineHbA1c (%)
English: - For renal function with GFR levels approaching moderate renal impairment and in elderly patients, at least 2 to 4 times per year.
Danish: - Mindst 2 til 4 gange årligt ved nyrefunktion med GFR-niveau, der nærmer sig moderat nedsat nyrefunktion, og hos ældre patienter.
English: The overall incidence of reported hypoglycaemia (recorded in daily patient diaries) was 17.1% in subjects treated with saxagliptin and 14.8% among patients treated with placebo.
Danish: Den samlede forekomst af rapporteret hypoglykæmi (registreret i daglige patientdagbøger) var 17,1 % hos forsøgspersoner, der blev behandlet med saxagliptin, og 14,8 % hos patienter, der fik placebo.
English: Decrease in body weight in the treatment groups given saxagliptin in combination with metformin was similar to that in the groups given metformin alone.
Danish: Reduktionen i legemsvægt i behandlingsgrupperne, der fik saxagliptin kombineret med metformin, var lig reduktionen i grupperne, der kun fik metformin.
English: There have been no therapeutic clinical trials conducted with Komboglyze tablets, however, bioequivalence of Komboglyze with co-administered saxagliptin and metformin has been demonstrated (see section 5.2).
Danish: Der er ikke blevet udført terapeutiske kliniske forsøg med Komboglyze-tabletter, men der er blevet påvist bioækvivalens for Komboglyze sammen med co-administreret saxagliptin og metformin (se pkt.
English: As add-on to metformin: dyspepsia (common) and myalgia (common).
Danish: Som tillæg til metformin: Dyspepsi (almindelig) og myalgi (almindelig).
English: The saxagliptin and dapagliflozin group achieved significantly greater reductions in HbA1c versus either the saxagliptin group or dapagliflozin group at 24 weeks (see Table 6).
Danish: Saxagliptin- og dapagliflozin-gruppen opnåede signifikant større reduktion i HbA1c versus både saxagliptin-gruppen og dapagliflozin-gruppen efter 24 uger (se tabel 6).
English: AEs, considered by the investigator to be at least possibly drug-related and reported in at least two more patients treated with saxagliptin 5 mg compared to control, are described below by treatment regimen.
Danish: Bivirkninger, som af forsøgsansvarlig er blevet vurderet til at være muligt relateret til lægemidlet, og som er rapporteret i mindst 2 patienter yderligere behandlet med saxagliptin 5 mg sammenlignet med kontrolgruppen, er beskrevet nedenfor opdelt efter behandlingsregime.
English: Tell your doctor or pharmacist 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: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Danish: Visse lægemidler kan påvirke nyrefunktionen negativt, hvilket kan øge risikoen for laktatacidose, f.eks. NSAID'er, herunder selektive cyklooxygenase (COX) II-hæmmere, ACE-hæmmere, angiotensin IIreceptorantagonister og diuretika, især loop-diuretika.
English: The Cmax and AUC values of saxagliptin and its major metabolite increased proportionally with the increment in the saxagliptin dose, and this dose-proportionality was observed in doses up to 400 mg.
Danish: Cmax- og AUC-værdierne for saxagliptin og hovedmetabolitten steg proportionalt med forøgelsen af saxagliptin-dosen, og denne dosis-proportionalitet blev set ved doser op til 400 mg.
English: Frequency estimates are based on the pooled analysis of the saxagliptin monotherapy, add-on to metformin and initial combination with metformin, add-on to sulphonylurea and add-on to thiazolidinedione clinical trials.
Danish: Hyppighedsestimater er baseret på den poolede analyse af saxagliptin som monoterapi, tillæg til metformin og initial kombination med metformin, tillæg til sulfonylurinstoffer og som tillæg til thiazolidinedion i kliniske forsøg.
English: There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Danish: Der blev randomiseret 4.148 patienter med type 2-diabetes, heraf blev 3.021 patienter behandlet med saxagliptin, til seks dobbeltblindede, kontrollerede kliniske sikkerheds- og effektstudier udført med henblik på at vurdere saxagliptins effekt på glykæmisk kontrol.
English: The biotransformation of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Danish: Saxagliptins biotransformation medieres primært af cytokrom P450 3A4/5 (CYP3A4/5).
English: Saxagliptin (n=127) provided significant improvements in HbA1c and PPG compared with the placebo (n=128).
Danish: Saxagliptin (n=127) medførte signifikante forbedringer i HbA1c og PPG sammenlignet med placebo (n=128).
English: The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Danish: Saxagliptins metabolisering medieres primært af cytokrom P450 3A4/5 (CYP3A4/5).
English: Initial therapy with the combination of saxagliptin 5 mg plus metformin (n=306) provided significant improvements in HbA1c, FPG, and PPG compared to with either saxagliptin (n=317) or metformin (n=313) alone as initial therapy.
Danish: Initialbehandling med kombinationen af saxagliptin 5 mg plus metformin (n=306) gav signifikante forbedringer i HbA1c, FPG og PPG sammenlignet med enten saxagliptin (n=317) eller metformin (n=313) alene som initialbehandling.
English: No dose- and time-dependence was observed in the clearance of saxagliptin and its major metabolite over 14 days of once-daily dosing with saxagliptin at doses ranging from 2.5 mg to 400 mg.
Danish: Der sås ingen dosis- og tidsafhængighed ved clearance af saxagliptin og hovedmetabolitten i løbet af en 14 dages dosering en gang dagligt med saxagliptin i doser fra 2,5 mg til 400 mg.
English: The incidence of reported hypoglycaemia was 3.4% in treatment-naive patients given saxagliptin 5 mg plus metformin and 4.0% in patients given metformin alone.
Danish: Incidensen af rapporteret hypoglykæmi var 3,4 % hos behandlingsnaive patienter, der fik saxagliptin 5 mg plus metformin, og 4,0 % hos patienter der kun fik metformin.
English: In subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment the exposures to saxagliptin were 1.1-, 1.4- and 1.8-fold higher, respectively, and the exposures to BMS-510849 were 22%, 7%, and 33% lower, respectively, than those observed in healthy subjects.
Danish: Hos forsøgspersoner med mild (Child-Pugh klasse A), moderat (Child-Pugh klasse B) eller svær (Child-Pugh klasse C) nedsat leverfunktion var eksponeringerne for saxagliptin henholdsvis 1,1, 1,4 og 1,8 gange højere, og eksponeringerne for BMS-510849 var henholdsvis 22 %, 7 % og 33 % lavere end de eksponeringer, der sås hos raske forsøgspersoner.
English: The pharmacokinetics of saxagliptin and its major metabolite were similar in healthy subjects and in patients with type 2 diabetes.
Danish: Saxagliptins og hovedmetabolittens farmakokinetik var ens hos raske forsøgspersoner og patienter med type 2-diabetes.
English: If you stop taking Komboglyze
Danish: Hvis du holder op med at tage Komboglyze
English: Mechanism of action and pharmacodynamic effects Komboglyze combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: saxagliptin, a dipeptidyl peptidase 4 (DPP4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Danish: Virkningsmekanisme og farmakodynamisk virkning Komboglyze kombinerer to antihyperglykæmiske lægemidler med komplementære virkningsmekanismer for at forbedre glykæmisk kontrol hos patienter med type 2-diabetes: Saxagliptin, en dipeptidylpeptidase-4-hæmmer (DPP-4-hæmmer) og metforminhydrochlorid, et medlem af biguanid-gruppen.
English: Frequency of adverse reactions by treatment regimen
Danish: Bivirkningshyppighed efter behandlingsregime
English: If pancreatitis is suspected, this medicinal product should be discontinued; if acute pancreatitis is confirmed, this medicinal product should not be restarted.
Danish: Hvis akut pancreatitis bliver bekræftet, må behandlingen med dette lægemiddel ikke genoptages.