FrancophonIA/ELRC3.0 huggingface dataset:
English: The three medicines in Qtrilmet lower the amount of sugar in the blood by causing it to be taken up into cells or passed out of the body in the urine.
Danish: De tre lægemidler i Qtrilmet nedsætter mængden af blodsukker ved at få det til at blive optaget i cellerne eller ført ud af kroppen med urinen.
English: Saxagliptin: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years).
Danish: Saxagliptin: Ældre patienter (65-80 år) har omkring 60 % højere saxagliptin-AUC end yngre patienter (18-40 år).
English: To control your diabetes, you need to follow your doctor's advice on diet and exercise, even when you are taking this medicine.
Danish: For at kontrollere din diabetes skal du følge lægens råd om kost og motion, også selvom du tager denne medicin.
English: Occasionally, the inactive ingredients of this medicine will be eliminated in the faeces as a soft, hydrated mass that may resemble the original tablet.
Danish: Lejlighedsvis elimineres de inaktive ingredienser i dette lægemiddel i fæces som en blød, hydreret masse, der kan ligne den oprindelige tablet.
English: Do not take a double dose of Qtrilmet to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis af Qtrilmet som erstatning for den glemte dosis.
English: The safety and efficacy in patients with type 1 diabetes have not been established and Qtrilmet should not be used in patients with type 1 diabetes.
Danish: Sikkerhed og virkning hos patienter med type 1-diabetes er ikke klarlagt, og Qtrilmet bør ikke anvendes til patienter med type 1-diabetes.
English: These pharmacokinetic effects are not clinically meaningful and do not require dose adjustment.
Danish: Disse farmakokinetiske virkninger er ikke klinisk betydningsfulde og kræver ikke dosisjustering.
English: N is the number of randomised and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Danish: † N er antallet af randomiserede og behandlede patienter med baseline og mindst 1 post-baseline effektmåling.
English: Therefore, renal function and risk of volume depletion should be taken into account prior to starting treatment with Qtrilmet.
Danish: Derfor bør nyrefunktionen og risikoen for volumendepletering tages i betragtning inden start af behandling med Qtrilmet.
English: Additional safety data include clinical trials, post-authorisation safety studies and post-marketing experience with the mono-components.
Danish: Yderligere sikkerhedsdata omfatter kliniske studier, sikkerhedsstudier efter godkendelse og post-marketing erfaring med monokomponenterne.
English: Therefore, dapagliflozin is not expected to alter the metabolic clearance of co-administered medicinal products that are metabolised by these enzymes.
Danish: Derfor forventes dapagliflozin ikke at ændre den metaboliske clearance af co-administrerede lægemidler, der metaboliseres af disse enzymer.
English: The volume of distribution of saxagliptin was 205 L.
Danish: Fordelingsvolumen af saxagliptin var 205 l.
English: Due to the limited therapeutic experience with this medicinal product in patients 75 years and older, initiation of therapy is not recommended in this population.
Danish: På grund af den begrænsede terapeutiske erfaring med dette lægemiddel til patienter på 75 år og derover, anbefales det ikke at initiere behandling i denne population.
English: Each belongs to a group of medicines called “oral anti-diabetics”.
Danish: De tilhører alle en gruppe lægemidler, der kaldes "orale antidiabetika".
English: Gastrointestinal symptoms
Danish: Gastrointestin ale symptomer
English: Interference with 1,5-anhydroglucitol (1,5-AG) assay
Danish: Interferens med 1,5-anhydroglucitol (1,5-AG) assay
English: If no adequate strength of Qtrilmet is available, individual mono-components should be used instead of the modified-release combination.
Danish: Hvis en passende styrke af Qtrilmet ikke er tilgængelig, skal de enkelte monokomponenter anvendes i stedet for depottabletkombinationen.
English: Your doctor will prescribe an appropriate dose of Qtrilmet depending on your blood sugar level and the diabetes medicines you were taking before.
Danish: Lægen vil udskrive en passende dosis Qtrilmet, der afhænger af dit blodsukkerniveau og den diabetesmedicin, du tog tidligere.
English: Patients with signs and symptoms of urinary tract infections should be evaluated and promptly treated, if indicated.
Danish: Patienter med tegn og symptomer på urinvejsinfektioner bør vurderes og straks behandles, hvis det er indiceret.
English: This medicine is taken by mouth to treat diabetes and each of the active substances works in a different way to treat the condition.
Danish: Dette lægemiddel tages gennem munden til behandling af diabetes (sukkersyge), og alle de aktive stoffer virker på hver sin måde i behandlingen af sygdommen.
English: No metabolites have been identified in humans.
Danish: Ingen metabolitter er blevet identificeret hos mennesker.
English: Because elderly patients (≥ 65 years) are more likely to have decreased renal function, this medicinal product should be used with caution as age increases.
Danish: Da ældre patienter (≥ 65 år) har større sandsynlighed for at få nedsat nyrefunktion, bør dette lægemiddel anvendes med forsigtighed efterhånden som alderen stiger.
English: If pregnancy is detected, treatment with this medicinal product should be discontinued.
Danish: Hvis graviditet opdages, skal behandlingen med dette lægemiddel seponeres.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/litres.
Danish: I et antal tilfælde fremstod tilstanden atypisk, idet der kun var moderat forhøjet blodglucose, under 14 mmol/liter.
English: There was no effect of food on Cmax and Tmax of metformin.
Danish: Der var ingen effekt af mad på Cmax og Tmax af metformin.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency.
Danish: Langsigtet behandling med metformin har været forbundet med et fald i absorption af vitamin B12, hvilket meget sjældent kan resultere i klinisk signifikant vitamin B12-mangel.
English: You may see some remains of the tablet shell in your stools.
Danish: Du kan måske se rester af tablettens skal i din afføring.
English: You should have a blood test to check how well your kidneys are working before you start taking and while you are on this medicine.
Danish: Du skal have taget en blodprøve for at undersøge, hvor godt dine nyrer fungerer, før du starter med at tage denne medicin, og mens du er i behandling.
English: It is taken on its own, or it can be combined with a different type of diabetes medicine called a sulphonylurea.
Danish: Det tages alene, eller det kan kombineres med en anden type lægemiddel mod diabetes, som kaldes sulfonylurinstof.
English: The remaining 219 patients started to take 5 mg saxagliptin 16 weeks ahead of the study start.
Danish: De resterende 219 patienter begyndte at tage 5 mg saxagliptin 16 uger før studiestart.
English: However, if you feel dizzy while taking Qtrilmet, do not drive or use tools or machines.
Danish: Men hvis du føler dig svimmel, mens du tager Qtrilmet, må du ikke køre eller bruge værktøj eller maskiner.
English: Swallow the tablets whole with half a glass of water.
Danish: Sådan tager du medicinen - Synk tabletten hel med et halvt glas vand.
English: In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking Qtrilmet.
Danish: Især hvis du følger en diabetesdiæt med vægtkontrol, skal du fortsat følge denne, mens du tager Qtrilmet.
English: Organic cation transporters (OCT) Metformin is a substrate of both transporters OCT1 and OCT2.
Danish: Organiske kationtransportører (OCT) Metformin er et substrat af både transportøren OCT1 og OCT2.
English: Qtrilmet is not recommended for children and adolescents under 18 years of age because it has not been studied in these patients.
Danish: Børn og unge Qtrilmet frarådes til børn og unge under 18 år, da det ikke er undersøgt hos disse patienter.
English: It does not stimulate insulin secretion and therefore, does not produce hypoglycaemia.
Danish: Det stimulerer ikke insulinsekretionen og fremmer derfor ikke hypoglykæmi.
English: The numerical imbalance of breast, bladder, and prostate tumours must be considered with caution; it will be further investigated in post-authorisation studies.
Danish: Den numeriske ubalance for bryst-, blære- og prostatatumorer skal tolkes med varsomhed; den vil blive undersøgt nærmere i postmarketingstudier.
English: Proportion of patients achieving HbA1c < 7%
Danish: Andel af patienter, der opnåede HbA1c < 7 %
English: When starting or using such products in combination with metformin, close monitoring of renal function is necessary.
Danish: Når behandlingen initieres eller ved fortsat brug af disse lægemidler i kombination med metformin, er nøje overvågning af nyrefunktionen nødvendig.
English: Frequency categories were defined according to 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 ( 1/100,000 to < 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighedskategorierne er defineret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til ˂ 1/10), ikke almindelig (≥ 1/1.000 til ˂ 1/100), sjælden ( 1/10.000 til < 1/1.000), meget sjælden (≥ 1/100.000 til ˂ 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Use with potent CYP3A4 inducers
Danish: Anvendelse sammen med potente CYP3A4-induktorer
English: The treatment groups were proportionally well balanced with regard to demographics, subject characteristics, disease characteristics, and medical history.
Danish: Behandlingsgrupperne var forholdsmæssigt velafbalancerede med hensyn til demografi, patientkarakteristika, sygdomsbeskrivelse og anamnese.
English: If necessary, the dose of the glucose-lowering medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt skal dosis af glucosesænkende lægemiddel justeres under behandling med det andet lægemiddel og ved seponering.
English: Qtrilmet dose is taken orally once daily at the same time of the day with food to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Qtrilmet dosis tages oralt én gang dagligt på samme tidspunkt af dagen sammen med måltider for at reducere de gastrointestinale bivirkninger, der er forbundet med metformin.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Danish: Metformin øger transportkapaciteten af specifikke typer af membranglucosetransportører (GLUT-1 og GLUT-4).
English: Remember to take other medicines as your doctor has told you.
Danish: Husk at tage din anden medicin, som lægen har anvist.
English: Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Danish: Behandlingen bør afbrydes hos patienter, som hospitalsindlægges på grund af større operationer eller alvorlige akutte sygdomme.
English: To avoid overdose, do not continue taking the separate tablets of these medicines as well as Qtrilmet.
Danish: For at undgå en overdosis, må du ikke fortsætte med at tage disse lægemidler som særskilte tabletter samtidig med, at du tager Qtrilmet.
English: Use in patients at risk for volume depletion, hypotension, and/or electrolyte imbalances
Danish: Anvendelse til patienter med risiko for volumendepletering, hypotension og/eller forstyrrelser i elektrolytbalancen
English: Each tablet is to be swallowed whole.
Danish: Tabletten skal sluges hel.
English: n = number of subjects with non-missing baseline and a week 24 value.
Danish: n = antal forsøgspersoner med alle baseline-værdier og en uge 24-værdi.
English: The adjusted percent difference at week 52 between the treatment groups was
Danish: Den justerede procentvise forskel i uge 52 mellem behandlingsgrupperne var
English: Thereafter, glimepiride/placebo dose were kept constant, except for down-titration to prevent hypoglycaemia.
Danish: Derefter blev glimepirid/placebo-dosis holdt konstant, bortset fra nedtitrering for at forhindre hypoglykæmi.
English: Metformin No clinically relevant interaction has been identified.
Danish: Metformin Ingen klinisk relevant interaktion er identificeret.
English: When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product, but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus associated with abnormal blood glucose levels.
Danish: Når patienten planlægger at blive gravid og under graviditet anbefales det, at diabetes ikke behandles med dette lægemiddel, men at insulin anvendes til at opretholde blodglucoseniveauer så tæt på det normale som muligt for at reducere faren for misdannelser hos fosteret forbundet med unormale blodglucoseniveauer.
English: Experience in NYHA class III-IV is limited with saxagliptin.
Danish: Erfaring med NYHA-klasse III-IV er begrænset for saxagliptin.
English: The clinical relevance of the skin lesions is not known, and skin lesions have not been observed in humans.
Danish: Den kliniske relevans af hudlæsionerne kendes ikke, og der er ikke observeret hudlæsioner hos mennesker.
English: Before initiating Qtrilmet, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Inden behandlingen med Qtrilmet påbegyndes, skal faktorer i patientens anamnese, der kan prædisponere for ketoacidose, vurderes.
English: If Fournier's gangrene is suspected, Qtrilmet should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Qtrilmet seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: In the clinical program, 34.4% of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9% had hypertension.
Danish: I det kliniske program havde 34,4 % af patienterne en hjerte-kar-sygdom i anamnesen (foruden hypertension) ved baseline og 67,9 % havde hypertension.
English: If you need major surgery, you must stop taking Qtrilmet during and for some time after the operation.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Qtrilmet under indgrebet og i nogen tid efter operationen.
English: The extent of metformin absorption (as measured by AUC) from the metformin extended-release tablet increased by approximately 50% when given with food.
Danish: Omfanget af absorption (målt ved AUC) af metformin tabletter med forlænget frigivelse steg med ca. 50 %, når det blev givet sammen med mad.
English: A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter.
Danish: GFR skal bestemmes inden behandling med metforminholdige lægemidler iværksættes og derefter mindst én gang om året.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: p-value < 0.0001. p-value = 0.0166.
Danish: p-værdi = 0,0166.
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Danish: Brug af DPP-4-hæmmere er blevet forbundet med en risiko for udvikling af akut pankreatitis.
English: The dose should be taken as two tablets orally, once daily at the same time of the day, with food.
Danish: Dosis bør tages som to tabletter oralt, en gang dagligt på samme tidspunkt af dagen, med mad.
English: Metformin: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Metformin: Renal clearance af metformin er > 400 ml/min, hvilket indikerer at metformin elimineres ved glomerulær filtrering og tubulær sekretion.
English: If renal function falls below GFR < 60 mL/min, treatment should be discontinued.
Danish: Hvis nyrefunktion falder til GFR < 60 ml/min, bør behandlingen seponeres.
English: Saxagliptin: Females had approximately 25% higher systemic exposure values for saxagliptin.
Danish: Saxagliptin: Kvinder havde ca. 25 % højere systemisk eksponering for saxagliptin.
English: A clinically relevant effect with other inducers (e.g. carbamazepine, phenytoin and phenobarbital) is not expected.
Danish: En klinisk relevant effekt med andre induktorer (f.eks. carbamazepin, phenytoin og phenobarbital) forventes ikke.
English: Metformin: Plasma protein binding is negligible.
Danish: Metformin: Plasmaproteinbindingen er ubetydelig.
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Danish: Øgningen af simvastatin- og simvastatinsyreeksponeringer anses ikke for klinisk relevant.
English: Generally, the most common adverse events reported in ≥ 65 years old were similar to < 65 years old.
Danish: Generelt var de hyppigst rapporterede bivirkninger hos forsøgspersoner ≥ 65 år de samme som hos forsøgspersoner < 65 år.
English: Due to its mechanism of action, patients taking dapagliflozin will test positive for glucose in their urine.
Danish: På grund af dets virkningsmekanisme vil patienter, der tager dapagliflozin, få et positivt analyseresultat for glucose i urinen.
English: Onset of symptoms following initiation of therapy may be rapid or may occur after longer periods of treatment.
Danish: Symptomdebut kan opstå hurtigt efter behandlingsstart eller efter længerebehandlingsperioder.
English: Stop taking Qtrilmet for a short time if you have a condition that leads to dehydration and talk to your doctor about what to do and when to start taking Qtrilmet again;
Danish: Stop med at tage Qtrilmet i en kort periode, hvis du har en tilstand, som fører til væskemangel (dehydrering), og tal med lægen om, hvad du skal gøre, og hvornår du kan begynde at tage Qtrilmet igen.
English: The adverse reactions associated with Qtrilmet are presented in Table 1.
Danish: De bivirkninger, der er forbundet med Qtrilmet er angivet i tabel 1.
English: Each tablet contains 48 mg of lactose (as anhydrous).
Danish: Hver tablet indeholder 48 mg lactose (som vandfri lactose).
English: Metformin: The available data in subjects with moderate renal insufficiency are scarce and no reliable estimation of the systemic exposure to metformin in this subgroup as compared to subjects with normal renal function could be made.
Danish: Metformin: De tilgængelige data hos personer med moderat nedsat nyrefunktion er begrænsede, og der kan ikke laves nogen pålidelig estimering af den systemiske eksponering for metformin i denne undergruppe sammenlignet med personer med normal nyrefunktion.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Qtrilmet before or at the time of the injection.
Danish: 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 Qtrilmet forud for eller på tidspunktet for injektionen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Qtrilmet in all subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Qtrilmet i alle undergrupper af den pædiatriske population ved behandling af type 2-diabetes (se pkt.
English: Skin damage, such as sores or ulcers is a common complication of diabetes.
Danish: Hudlæsioner såsom sår er en almindelig komplikation ved diabetes.
English: If you take more Qtrilmet tablets than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget flere Qtrilmet-tabletter, end du skulle, skal du straks tale med lægen eller tage på skadestuen.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjælden, arvelig galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption bør ikke anvende dette lægemiddel.
English: for renal function with GFR levels approaching moderate renal impairment and in elderly patients, at least 2 to 4 times per year.
Danish: 4.5) - for nyrefunktion med GFR-niveauer, som nærmer sig moderat nyreinsufficiens, og for ældre patienter, mindst 2 til 4 gange om året.
English: Diabetic skin and foot problems
Danish: Diabetiske hud- og fodproblemer
English: Saxagliptin: Across clinical studies in the saxagliptin programme a small decrease in absolute lymphocyte count was observed, approximately 100 cells/microL relative to placebo.
Danish: Saxagliptin: På tværs af kliniske studier i saxagliptinprogrammet blev der observeret et lille fald i absolut lymfocyttal, ca. 100 celler/mikroliter i forhold til placebo.
English: With this condition, the levels of substances called “ketone bodies” increase in your urine or blood and this can be picked up in tests.
Danish: Ved denne tilstand stiger niveauet af nogle stoffer, som kaldes "ketonstoffer" i urinen eller blodet, og dette kan ses i laboratorieanalyser.
English: In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), Qtrilmet should be temporarily discontinued and contact with a health care professional is recommended.
Danish: I tilfælde af dehydrering (alvorlig diarré eller opkastning, feber eller nedsat væskeindtagelse) skal Qtrilmet-behandlingen afbrydes midlertidigt, og det anbefales at kontakte en læge.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products, and observed for loss of blood glucose control or hypoglycaemia.
Danish: Patienten skal informeres, og der skal udføres hyppigere blodglucosemonitorering, især ved behandlingens initiering med sådanne lægemidler, og observeres for manglende blodglucosekontrol eller hypoglykæmi.
English: Of the 1,169 subjects treated in the pooled safety data from the 3 clinical trials, 1,007 subjects (86.1%) were aged < 65 years, 162 subjects (13.9%) were aged ≥ 65 years and 9 subjects (0.8%) were aged ≥ 75 years.
Danish: Af de 1.169 forsøgspersoner, som indgik i de samlede sikkerhedsdata fra de 3 kliniske studier, var 1.007 forsøgspersoner (86,1 %) < 65 år, 162 forsøgspersoner (13,9 %) var ≥ 65 år, og 9 forsøgspersoner (0,8 %) var ≥ 75 år.
English: Considering the lack of tumour findings in non-clinical studies as well as the short latency between first drug exposure and tumour diagnosis, a causal relationship is considered unlikely.
Danish: Under hensyntagen til de manglende tumorfund i non-kliniske studier samt den korte latensperiode mellem første eksponering for lægemidlet og tumordiagnose, anses en kausal sammenhæng for værende usandsynlig.
English: Urine test Because of how Qtrilmet works, your urine will test positive for sugar while you are on this medicine.
Danish: På grund af den måde, hvorpå Qtrilmet virker, vil en urinprøve være positiv for sukker, mens du får denne medicin.
English: Temporary interruption of treatment should be considered when treating pyelonephritis or urosepsis.
Danish: Det bør overvejes midlertidigt at afbryde behandlingen under behandling af pyelonefritis eller urosepsis.