FrancophonIA/ELRC3.0 huggingface dataset:
English: Avoid excessive alcohol intake while taking Komboglyze since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
Danish: Du skal undgå at indtage store mængder alkohol, mens du er i behandling med Komboglyze, da det kan øge risikoen for laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: A lower proportion of patients in the saxagliptin group (1.1%) compared to the glimepiride group (15.3%), experienced a confirmed or severe hypoglycaemic event.
Danish: En lavere andel af patienter i saxagliptingruppen (1,1 %) sammenlignet med glimepiridgruppen (15,3 %) havde en bekræftet eller alvorlig hypoglykæmisk episode.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Komboglyze in all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Komboglyze i alle undergrupper af den pædiatriske population med type 2-diabetes mellitus (se pkt.
English: The active substances are saxagliptin and metformin hydrochloride.
Danish: Aktive stoffer: Saxagliptin og metforminhydrochlorid.
English: Saxagliptin also resulted in a significantly lower proportion of patients with hypoglycaemia, 3% (19 events in 13 subjects) vs. 36.3% (750 events in 156 patients) for glipizide.
Danish: Saxagliptin resulterede desuden i en signifikant lavere andel af patienter med hypoglykæmi, 3 % (19 hændelser hos 13 forsøgspersoner) vs. 36,3 % (750 hændelser hos 156 patienter) for glipizid.
English: CV deaths were balanced across the treatment groups.
Danish: Kardiovaskulær død var ligeligt fordelt i behandlingsgrupperne.
English: The percent of subjects with reported on-treatment events of major hypoglycaemia (defined as an event that required assistance of another person) was higher in the saxagliptin group than in the placebo group (2.1% and 1.6%, respectively).
Danish: Procentdelen af forsøgspersoner med rapporterede episoder med svær hypoglykæmi (defineret som en episode, der krævede assistance fra en anden person) var højere i saxagliptingruppen end i placebogruppen (henholdsvis 2,1 % og 1,6 %).
English: A lower proportion of patients in the saxagliptin group (44.7%) compared to the glimepiride group (54.7%) achieved an HbA1c target of 7.0%.
Danish: En lavere andel af patienter i saxagliptingruppen (44,7 %) sammenlignet med glimepiridgruppen (54,7 %) nåede et HbA1c-mål på 7,0 %.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Komboglyze.
Danish: Du skal eventuelt have kontrollere dit blodsukker eller din nyrefunktion hyppigere, eller lægen kan ændre din dosis af Komboglyze.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Komboglyze is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
Danish: Derudover skal patienterne advares om risikoen for hypoglykæmi, når Komboglyze anvendes i kombination med andre antidiabetika, der er kendt for at medføre hypoglykæmi (f.eks. insulin, sulfonylurinstoffer).
English: Studies in animals have shown excretion of both saxagliptin and/or metabolite and metformin in milk.
Danish: Dyreforsøg har påvist udskillelse af både saxagliptin og/eller dets metabolit og metformin i modermælk.
English: The SAVOR trial included 8240 patients treated with saxagliptin 5 mg or 2.5 mg once daily and 8173 patients on placebo.
Danish: SAVOR-studiet omfattede 8.240 patienter, som blev behandlet med saxagliptin 5 mg eller 2,5 mg én gang dagligt, og 8.173 patienter på placebo.
English: Stop taking Komboglyze for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Danish: Stop med at tage Komboglyze i en kort periode, hvis du har en tilstand, som kan være forbundet med dehydrering (betydeligt tab af kropsvæsker), såsom alvorlig opkastning, diarré, feber, udsættelse for varme eller indtagelse af mindre væske end normalt.
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Danish: Efter en oral dosis af metformin nås tmax på 2,5 t. Absolut biotilgængelighed af en 500 mg metformintablet er ca. 50-60 % hos raske forsøgspersoner.
English: Hazard ratio adjusted for baseline renal function category and baseline CVD risk category.
Danish: Hazard ratio justeret for baseline nyrefunktionskategori og baseline risikokategori for kardiovaskulær død.
English: Least squares mean adjusted for baseline value.
Danish: Mindste kvadraters metode justeret for baseline værdier.
English: The time for saxagliptin to reach Cmax (Tmax) was increased by approximately 0.5 hours with food compared with the fasted state.
Danish: Saxagliptins tid til at nå Cmax (Tmax) blev sammen med fødevarer forøget med ca. 0,5 time sammenlignet med fastende tilstand.
English: However, subjects on saxagliptin with a history of heart failure or impaired renal function at baseline were not at an increased risk relative to placebo for the primary or secondary composite endpoints or all-cause mortality.
Danish: Forsøgspersoner på saxagliptin, som havde hjertesvigt eller nedsat nyrefunktion i anamnesen ved baseline, havde imidlertid ikke en øget risiko i forhold til placebo for de primære eller sekundære sammensatte endepunkter eller total mortalitet.
English: Your doctor will decide when you must stop and when to restart your treatment with Komboglyze.
Danish: Lægen vil beslutte, hvornår du skal stoppe behandlingen med Komboglyze, og hvornår du kan genoptage den igen.
English: Caution is warranted if this medicinal product is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.
Danish: Forsigtighed tilrådes, hvis dette lægemiddel anvendes til patienter, som har kendte risikofaktorer for hospitalsindlæggelse for hjertesvigt, såsom hjertesvigt eller moderat til svært nedsat nyrefunktion, i anamnesen.
English: • being sick or indigestion (dyspepsia)
Danish: • være forkvalmet eller have fordøjelsesbesvær (dyspepsi)
English: Immunocompromised patients
Danish: Patienter med nedsat immunforsvar
English: • Komboglyze is available in aluminium foil blister.
Danish: • Komboglyze fås i blisterkort af aluminiumsfolie.
English: • Printing ink: shellac, indigo carmine aluminium lake (E132).
Danish: • Blæk: Shellac, indigotin (indigocarmin) aluminium lake (E132).
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Danish: Laktatacidose er en medicinsk nødsituation og skal behandles på hospitalet.
English: The study included patients with renal impairment classified on the basis of creatinine clearance as mild (approximately GFR ≥ 45 to < 90 mL/min), moderate (approximately GFR ≥ 30 to < 45 mL/min), or severe (approximately GFR < 30 mL/min) renal impairment.
Danish: Studiet omfattede patienter med nedsat nyreinsufficiens, der blev klassificeret på baggrund af kreatininclearance som mild (ca. GFR ≥ 45 til <90 ml/min), moderat (ca. GFR ≥ 30 til <45 ml/min ) eller svær (ca. GFR <30 ml/min ) nyreinsufficiens.
English: Reductions in HbA1c from baseline to Week 24 were observed in all evaluated subgroups defined by baseline HbA1c, with greater reductions observed in patients with a baseline HbA1c ≥ 10% (see Table 5).
Danish: Der blev set reduktioner i HbA1c fra baseline til uge 24 i alle vurderede undergrupper defineret ud fra baseline-HbA1c, og der sås størst reduktioner hos patienter med en baseline-HbA1c ≥ 10 % (se tabel 5).
English: In particular, if you are following a diabetic weight control diet, keep on with this while you are taking this medicine.
Danish: Hvis du følger en vægtkontroldiæt for diabetikere, er det særlig vigtigt, at du fortsætter med denne, mens du tager dette lægemiddel.
English: The results of bioequivalence studies in healthy subjects demonstrated that Komboglyze combination tablets are bioequivalent to co-administration of corresponding doses of saxagliptin and metformin hydrochloride as individual tablets.
Danish: Resultaterne af bioækvivalensstudier af raske forsøgspersoner viste, at Komboglyzekombinationstabletter er bioækvivalente med co-administration af tilsvarende doser af saxagliptin og metforminhydrochlorid som individuelle tabletter.
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1% in the saxagliptin group and 4.6% in the placebo group (see Table 7).
Danish: Et andet sekundært endepunkt, total mortalitet, forekom i en frekvens på 5,1 % i saxagliptingruppen og 4,6 % i placebogruppen (se tabel 7).
English: 60x1 film-coated tablets in perforated unit dose blisters.
Danish: 60x1 filmovertrukne tabletter i perforerede enkeltdosisblisterpakninger.
English: If you need to have an injection of contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Komboglyze before or at the time of the injection.
Danish: Brug af anden medicin sammen med Komboglyze Hvis du skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i dit blod, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal du stoppe med at tage Komboglyze forud for eller på tidspunktet for injektionen.
English: Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Danish: Saxagliptin blev hurtigt absorberet efter oral administration i fastende tilstand, og maksimale plasmakoncentrationer (Cmax) af saxagliptin og hovedmetabolitten blev nået inden for henholdsvis 2 og 4 timer (Tmax).
English: The increased risk of overall hypoglycaemia and major hypoglycaemia observed in the saxagliptin-treated group occurred primarily in subjects treated with SU at baseline and not in subjects on insulin or metformin monotherapy at baseline.
Danish: Den øgede risiko for total hypoglykæmi og svær hypoglykæmi observeret i saxagliptin-gruppen forekom primært hos forsøgspersoner, der blev behandlet med SU ved baseline og ikke hos forsøgspersoner på monoterapi med insulin eller metformin ved baseline.
English: Kidney tests or checks
Danish: Nyretest eller -kontrol
English: Table 4 presents adverse reactions by system organ class and by frequency category.
Danish: Tabel 4 præsenterer bivirkninger efter systemorganklasse og efter hyppighedskategori.
English: The reductions from baseline in HbA1c respectively for saxagliptin and sitagliptin in the primary per-protocol analysis were -0.5% (mean and median) and -0.6% (mean and median).
Danish: Reduktionerne i forhold til baseline i HbA1c for henholdsvis saxagliptin og sitagliptin i den primære pr. protokolanalyse var -0,5 % (middel og median) og -0,6 % (middel og median).
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 HbA1c <7 % ved baseline.
English: Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
English: Rash has been seen with saxagliptin and with certain anti-diabetic medicines in the same class as saxagliptin.
Danish: Der er set udslæt i forbindelse med saxagliptin og visse antidiabetiske lægemidler i samme gruppe som saxagliptin.
English: • The amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of saxagliptin and metformin.
Danish: • Den mængde af dette lægemiddel, som du skal tage, afhænger af din tilstand og af de doser metformin og/eller saxagliptin og metformin som separate tabletter, som du får aktuelt.
English: p-value = 0.99 for superiority (based on HR < 1.0) compared to placebo.
Danish: p-værdi = 0,99 for superioritet (baseret på HR < 1,0) sammenlignet med placebo.
English: The decreases in lymphocyte count were not associated with clinically relevant adverse reactions.
Danish: Faldet i lymfocyttal var ikke forbundet med klinisk relevante bivirkninger.
English: Therefore, a lower dose of insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia when used in combination with Komboglyze.
Danish: Derfor kan en lavere dosis insulin eller sulfonylurinstof være påkrævet for at nedsætte risikoen for hypoglykæmi, når insulin tages samtidig med Komboglyze.
English: Food had relatively modest effects on the pharmacokinetics of saxagliptin in healthy subjects.
Danish: Føde har relativt beskeden effekt på saxagliptins farmakokinetik hos raske forsøgspersoner.
English: In cynomolgus monkeys saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) at doses ≥ 3 mg/kg/day.
Danish: Hos cynomolgusaber gav saxagliptin reversible hudlæsioner (skorper, ulcerationer og nekrose) på yderpunkter (hale, fingre, scrotum og/eller næsen) på doser ≥ 3 mg/kg/dag.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om Komboglyze findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Patients treated with saxagliptin exhibited a significant decrease from baseline in body weight compared to a weight gain in patients administered glipizide (-1.1 vs. +1.1 kg).
Danish: Patienter behandlet med saxagliptin udviste en signifikant reduktion i legemsvægt i forhold til baseline sammenlignet med en vægtøgning hos patienter, der fik glipizid (-1,1 vs. +1,1 kg).
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: I forhold til baseline sås der et absolut middel-lymfocyttal på ca. 2.200 celler/μl og et gennemsnitligt fald på ca. 100 celler/μl i forhold til placebo i den placebokontrollerede fælles analyse.
English: p-value < 0.001 for noninferiority (based on HR < 1.3) compared to placebo.
Danish: p-værdi <0,001 for non-inferioritet (baseret på HR < 1,3) sammenlignet med placebo.
English: You should call your doctor, pharmacist or nurse immediately if you experience any of these symptoms.
Danish: Kontakt straks lægen, apotekspersonalet eller sundhedspersonalet, hvis du oplever nogen af disse symptomer.
English: In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite, were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine.
Danish: I studier udført på raske forsøgspersoner blev hverken saxagliptins eller dets hovedmetabolits farmakokinetik ændret væsentligt af metformin, glibenclamid, pioglitazon, digoxin, simvastatin, omeprazol, antacida eller famotidin.
English: No combination toxicity was observed at AUC exposures 68 and 1.5 times the RHDs for saxagliptin and metformin, respectively.
Danish: Der sås ingen kombinationstoksicitet ved AUC-eksponeringer på 68 og 1,5 gange RHD'er for henholdsvis saxagliptin og metformin.
English: However, among surviving mothers with evaluable litters, maternal toxicity was limited to marginal reductions in body weight over the course of gestation days 21 to 29; and associated developmental toxicity in these litters was limited to foetal body weight decrements of 7%, and a low incidence of delayed ossification of the foetal hyoid.
Danish: Blandt overlevende moderdyr med vurderbare kuld var maternel toksicitet dog begrænset til marginale reduktioner i kropsvægt i løbet af gestationsdagene 21 til 29, og associeret udviklingstoksicitet i disse kuld var begrænset til fald i føtal kropsvægt på 7 % g en lav incidens af forsinket ossifikation af det føtale tungeben.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Komboglyze på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: The study population included those ≥ 65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Danish: Studiepopulationen omfattede patienter ≥ 65 år (n=8.561) og ≥ 75 år (n=2.330) med normal eller let nedsat nyrefunktion (n=13.916), moderat (n=2.240) eller svært (n=336) nedsat nyrefunktion.
English: SAVOR trial results
Danish: Resultater af SAVOR-studiet
English: No dose adjustment is recommended for patients with mild renal impairment (GFR 60-89 mL/min).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let nedsat nyrefunktion (GFR 60-89 ml/min).
English: What Komboglyze contains
Danish: Komboglyze indeholder
English: Saxa 5 mg daily add-on to metformin plus sulphonylurea;
Danish: Saxa 5 mg dagligt som tillæg til metformin plus sulfonylurinstof;
English: Hepatobiliary disorders Liver function disorders, hepatitis
Danish: Lever og galdeveje Leverfunktionsforstyrrelser, hepatitis
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: Hvis du ikke er sikker, skal du tale med din læge eller apoteket, før du tager dette lægemiddel.
English: Following a single 50 mg dose of C-saxagliptin, 24%, 36%, and 75% of the dose was excreted in the urine as saxagliptin, its major metabolite, and total radioactivity respectively.
Danish: Efter en enkelt 50 mg dosis af C-saxagliptin, blev 24 %, 36 % og 75 % af dosen udskilt i urinen som henholdsvis saxagliptin, hovedmetabolitten og total radioaktivitet.
English: Stop taking Komboglyze and contact a doctor immediately if you notice any of the following serious side effects:
Danish: Stop med at tage dette lægemiddel og kontakt omgående din læge, hvis du bemærker en eller flere af følgende alvorlige bivirkninger:
English: In addition, saxagliptin did not meaningfully alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, the active components of a combined oral contraceptive (ethinyl estradiol and norgestimate), diltiazem or ketoconazole.
Danish: Desuden ændrede saxagliptin ikke farmakokinetikken for metformin, glibenclamid, pioglitazon, digoxin, simvastatin, de aktive bestanddele i et oralt antikonceptions kombinationspræparat (ethinylestradiol og norgestimat), diltiazem eller ketoconazol væsentligt.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • decreased vitamin B12 levels
Danish: • nedsat indhold af vitamin B12 i blodet
English: • Film-coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), iron oxide yellow (E172).
Danish: • Filmovertræk: Polyvinylalkohol, macrogol 3350, titandioxid (E171), talkum (E553b), jernoxid,
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Danish: Metformin stimulerer intracellulær glykogensyntese ved at indvirke på glycogensynthase.
English: Stop taking Komboglyze and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Danish: Stop med at tage Komboglyze og kontakt omgående læge eller nærmeste hospital, hvis du får et eller flere af nedenstående symptomer på laktatacidose, da denne tilstand kan føre til koma.
English: No carcinogenic potential was observed in two-year carcinogenicity assays with mice and rats.
Danish: Der sås intet karcinogent potentiale ved toårs-karcinogenicitetsassays med mus og rotter.
English: Co-administration of multiple doses of saxagliptin (2.5 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either saxagliptin or metformin in patients with type 2 diabetes.
Danish: Co-administration af flere doser af saxagliptin (2,5 mg to gange dagligt) og metformin (1000 mg to gange dagligt) ændrede ikke farmakokinetikken af hverken saxagliptin eller metformin væsentligt hos patienter med type 2-diabetes.
English: The mean plasma terminal half-life (t1/2) values for saxagliptin and its major metabolite are 2.5 hours and 3.1 hours respectively, and the mean t1/2 value for plasma DPP4 inhibition was 26.9 hours.
Danish: Middelværdierne for terminal plasma-halveringstid (t1/2) for saxagliptin og hovedmetabolitten er henholdsvis 2,5 timer og 3,1 time, og den gennemsnitlige t1/2-værdi for plasma-DPP-4-hæmning var 26,9 timer.
English: The no effect level (NOEL) for the lesions is 1 and 2 times the human exposure of saxagliptin and the major metabolite respectively, at the recommended human dose (RHD) of 5 mg/day.
Danish: Niveauet for ingen effekt (NOEL) er for læsionerne 1 og 2 gange den humane eksponering for henholdsvis saxagliptin og hovedmetabolitten på den anbefalede humane dosis (RHD) på 5 mg/dag.
English: Similar HbA1c reductions versus placebo were achieved for patients receiving saxagliptin 5 mg add-on to insulin regardless of metformin use (-0.4% for both subgroups).
Danish: Tilsvarende reduktion i HbA1c versus placebo blev opnået hos patienter, der fik saxagliptin 5 mg som tillæg til insulin uanset brug af metformin (-0,4 % for begge subgrupper).
English: It is especially important to mention the following: cimetidine, a medicine used to treat stomach problems ketoconazole which is used to treat fungal infections bronchodilators (beta-2 agonists) which are used to treat asthma diltiazem which is used for high blood pressure rifampicin, an antibiotic used to treat infections such as tuberculosis corticosteroids, which are used to treat inflammation in diseases like asthma and arthritis carbamazepine, phenobarbital or phenytoin, which are used to control fits (seizures) or long-term pain medicines which increase urine production (diuretics) medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Danish: Det er især vigtigt, at du nævner følgende: cimetidin, medicin til behandling af mavelidelser ketoconazol, der bruges til behandling af svampeinfektioner bronkodilatorer (beta-2-agonister), der bruges til behandling af astma diltiazem, der bruges mod forhøjet blodtryk rifampicin - et antibiotikum, der bruges til behandling af infektioner som tuberkulose binyrebarkhormoner (kortikosteroider), der bruges til behandling af inflammation ved sygdomme såsom astma og gigt (artritis) carbamazepin, phenobarbital eller phenytoin, der bruges til at kontrollere epilepsianfald (kramper) eller langvarige smerter vanddrivende lægemidler (diuretika) lægemidler mod smerter og betændelseslignende tilstande (NSAID'er og COX-2-hæmmere, såsom ibuprofen og celecoxib) visse lægemidler, der nedsætter blodtrykket (ACE-hæmmere og angiotensinII-receptorantagonister).