FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains two different substances called:
Danish: Dette lægemiddel indeholder to forskellige stoffer, der hedder:
English: Date of first authorisation: 24 November 2011 Date of latest renewal: 15 July 2016
Danish: Dato for første markedsføringstilladelse: 24. november 2011 Dato for seneste fornyelse: 15. juli 2016
English: Treatment may be continued in the well-informed patients with close monitoring.
Danish: Behandling kan fortsættes hos velinformerede patienter under tæt monitorering.
English: • The recommended dosing is one tablet twice a day.
Danish: • Den anbefalede dosis er én tablet to gange dagligt.
English: n=Randomised patients
Danish: n=Randomiserede patienter
English: Significance not tested.
Danish: Signifikans ikke undersøgt.
English: It is not recommended to initiate treatment in these patients.
Danish: Det frarådes at indlede behandling hos disse patienter.
English: These changes were not considered to be clinically meaningful.
Danish: Disse ændringer blev ikke anset for at være af klinisk betydning.
English: They increase the levels of insulin after a meal.
Danish: De forhøjer insulinniveauet efter et måltid.
English: Component of a multipack, can't be sold separately.
Danish: Del af flerstykspakning, kan ikke sælges separat.
English: This medicinal product should not be used during pregnancy.
Danish: Dette lægemiddel bør ikke anvendes under graviditeten.
English: No benefit was observed for MACE or all-cause mortality.
Danish: Der blev ikke observeret nogen fordel for MACE eller total mortalitet.
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Danish: LRM = Longitudinal repeated measures (ved hjælp af værdier før behandling).
English: If you have ever had a diabetic coma;
Danish: - Hvis du nogensinde har haft diabetisk koma.
English: Only in the initial combination therapy.
Danish: Kun ved den initiale kombinationsbehandling.
English: Diabetic skin lesions are a common complication of diabetes.
Danish: Diabetiske hudlæsioner er en almindelig komplikation til diabetes.
English: Do not take this medicine if any of the above apply to you.
Danish: Tag ikke dette lægemiddel, hvis noget af det ovenstående gælder for dig.
English: Patients who completed the initial 24-week study period were eligible to enter a controlled 28-week long-term study extension (52 weeks).
Danish: Patienter, der gennemførte den indledende 24-ugers undersøgelsesperiode, var kvalificerede til at komme ind i et kontrolleret 28 ugers langtids-forlængelses-studie (52 uger).
English: The intent-to-treat analysis showed consistent results.
Danish: Intent to treat-analysen viste overensstemmende resultater.
English: This is not considered clinically meaningful, therefore, no dose adjustment for this medicinal product is recommended on the basis of age alone.
Danish: Dette anses ikke for klinisk betydende, hvorfor der ikke anbefales dosisjustering for dette lægemiddel udelukkende på baggrund af alder.
English: Common • a metallic taste in your mouth.
Danish: Almindelige • en metallisk smag i munden.
English: Reductions in A1c were seen across subgroups including gender, age, race, and baseline BMI.
Danish: Der blev set reduktioner i A1c på tværs af undergrupper, herunder køn, alder, race og baseline-BMI.
English: Keep taking this medicine until your doctor tells you to stop.
Danish: Fortsæt med at tage dette lægemiddel, indtil lægen siger, at du skal stoppe.
English: The clinical relevance of this decrease is unknown.
Danish: Den kliniske relevans af denne reduktion er ikke kendt.
English: Along with diet and exercise, this helps lower your blood sugar.
Danish: Sammen med diæt og motion hjælper det med at sænke dit blodsukker.
English: These reactions were also identified in the pre-approval clinical trials, but do not meet the criteria for Table 2.
Danish: Disse reaktioner blev også påvist i kliniske forsøg før godkendelse af lægemidlet, men opfylder ikke kriterierne i tabel 2.
English: The mean Vd ranged between 63-276 L.
Danish: Middel-Vd lå mellem 63-276 l.
English: HbA1c (%) at week 24
Danish: HbA1c (%) i uge 24
English: Overall population (n=300)
Danish: Samlet population (n=300)
English: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years).
Danish: Ældre patienter (65-80 år) havde omkring 60 % højere saxagliptin-AUC end unge patienter (18-40 år).
English: • difficulties in getting or maintaining an erection (erectile dysfunction).
Danish: • besvær med at få eller at opretholde erektion (erektil dysfunktion).
English: Both belong to a group of medicines called oral anti-diabetics.
Danish: Begge tilhører en gruppe medicin kaldet orale antidiabetika.
English: No data are available with regard to overdose of Komboglyze.
Danish: Der er ingen data til rådighed med hensyn til overdosering af Komboglyze.
English: • Take with a meal to lower your chance of getting an upset stomach.
Danish: • Tag den sammen med et måltid for at sænke risikoen for at få mavebesvær.
English: If acidosis of either form occurs, this medicinal product must be stopped immediately and other appropriate corrective measures initiated.
Danish: Hvis der opstår acidose af den ene eller anden form skal dette lægemiddel standses omgående, og der skal påbegyndes andre relevante, korrigerende forholdsregler.
English: 12-weeks
Danish: 12 uger
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), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheder defineres 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) eller meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Danish: I tilfælde af en overdosis skal der indledes relevant støttebehandling svarende til patientens kliniske status.
English: Subjects with events n (%)
Danish: Forsøgspersoner med episoder n (%)
English: p-value < 0.0001. p-value=0.0166.
Danish: p-værdi < 0,0001. p-værdi=0,0166.
English: This is to help keep your blood sugar under control.
Danish: Medicinen er med til at holde dit blodsukker under kontrol.
English: Side effects seen when taking metformin alone: Very common (may affect more than 1 in 10 people)
Danish: Bivirkninger, der er set ved indtagelse af metformin alene: Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer)
English: The patient should be informed and more frequent blood glucose monitoring perfomed, especially at the beginning of treatment with such medicinal products.
Danish: Patienten skal informeres, og der skal foretages hyppigere blodglucosemonitorering, især i begyndelses af behandling med den slags lægemidler.
English: Event rate per 100 patient-years
Danish: Hyppigheden af episoder pr. 100 patientår
English: Clinical trial data and postmarketing data
Danish: Kliniske forsøgsdata og postmarketing-data
English: • If you forget to take a dose of this medicine, take it as soon as you remember.
Danish: • Hvis du glemmer at tage en dosis af dette lægemiddel, skal du tage den så snart, du kommer i tanker om det.
English: • Do not take a double dose of this medicine to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The mean metformin dose was approximately 1900 mg in each treatment group.
Danish: Den gennemsnitlige metformindosis var ca. 1900 mg i hver behandlingsgruppe.
English: If no adequate strength of Komboglyze is available, individual monocomponents should be used instead of the fixed dose combination.
Danish: Hvis der ikke findes en passende styrke af Komboglyze, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosis-kombinationen.
English: However, if it is time for your next dose, skip the missed dose and take your next dose at the usual time.
Danish: Hvis det er tid til næste dosis, skal du springe den glemte dosis over og tage den næste dosis til sædvanlig tid.
English: In the SAVOR study subgroups over 65 and over 75 years of age, efficacy and safety were consistent with the overall study population.
Danish: I SAVOR-studiets undergrupper af patienter over 65 og over 75 år var virkning og sikkerhed i overensstemmelse med den samlede studiepopulation.
English: Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low.
Danish: De kliniske data, der er beskrevet herunder, tyder på, at risikoen for klinisk betydende interaktioner med co-administrerede lægemidler er lav.
English: In rabbits, co-administration was poorly tolerated in many mothers, resulting in death, moribundity or abortion.
Danish: Hos kaniner blev co-administration tålt dårligt af mange moderdyr, hvilket resulterede i død, moribund tilstand eller abort.
English: Other side effects of Komboglyze include:
Danish: Andre bivirkninger til Komboglyze omfatter:
English: The starting dose is at most half of the maximum dose.
Danish: Startdosen er højst halvdelen af den maksimale dosis.
English: The frequencies are based on the experience from clinical trials.
Danish: Hyppigheden er baseret på erfaringer fra kliniske forsøg.
English: The use of Komboglyze or saxagliptin has not been studied in pregnant women.
Danish: Brug af Komboglyze eller saxagliptin er ikke blevet undersøgt hos gravide kvinder.
English: This medicine can be used alone or together with other antidiabetic medicines, including insulin.
Danish: Dette lægemiddel kan anvendes alene eller sammen med anden medicin mod diabetes, herunder insulin.
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: • liver problems (hepatitis)
Danish: • leverproblemer (hepatitis)
English: Your doctor will tell you exactly the dose of this medicine to take.
Danish: Din læge vil give dig klar besked om den rette dosis af dette lægemiddel.
English: Saxagliptin and metformin work together to control your blood sugar.
Danish: Saxagliptin og metformin arbejder sammen for at kontrollere dit blodsukker.
English: What Komboglyze is used for This medicine is used to treat a type of diabetes called ‘type 2 diabetes'.
Danish: Hvad Komboglyze bruges til Dette lægemiddel bruges til behandling af en type diabetes kaldet "type 2-diabetes".
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Danish: Det antages, at farmakokinetikken for metforminabsorption er ikke lineær.
English: 24-weeks
Danish: 24 uger
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • Når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: If the patient wishes to become pregnant, or if a pregnancy occurs, treatment with this medicinal product should be discontinued and switched to insulin treatment as soon as possible.
Danish: Hvis patienten er gravid eller ønsker at blive gravid, skal behandling med dette lægemiddel seponeres og ændres til insulinbehandling så hurtigt som muligt.
English: The safety and efficacy of this medicinal product in children and adolescents from birth to < 18 years of age have not been established.
Danish: Sikkerhed og effekt af dette lægemiddel hos børn og unge fra fødsel til < 18 år er ikke klarlagt.
English: Skin and subcutaneous tissue disorders Urticaria, erythema, pruritus
Danish: Hud og subkutane væv Urticaria, erytem, pruritus
English: Table 7 Primary and secondary clinical endpoints by treatment group in the SAVOR study*
Danish: Tabel 7: Primære og sekundære kliniske endepunkter efter behandlingsgruppe i SAVORstudiet*
English: During treatment with this medicine, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med dette lægemiddel vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, og/eller hvis din nyrefunktion bliver dårligere.
English: A limited amount of data suggest the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Danish: En begrænset datamængde tyder på, at brugen af metformin til gravide kvinder ikke er forbundet med en øget risiko for medfødte misdannelser.
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 ske hurtigt eller efter længere behandlingsperioder.
English: Talk to your doctor or pharmacist before taking Komboglyze If you have type1diabetes (your body does not produce any insulin).
Danish: Kontakt lægen eller apoteket, før du tager Komboglyze - hvis du har type 1-diabetes (din krop producerer ikke insulin).
English: The effect of saxagliptin on fertility in humans has not been studied.
Danish: Virkningen af saxagliptin på fertilitet hos mennesker er ikke blevet undersøgt.
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Danish: Lægen kan give dig medicin for den allergiske reaktion og en anden medicin til behandling af diabetes.
English: Patients should be advised of the characteristic symptoms of heart failure, and to immediately report such symptoms.
Danish: Patienterne skal informeres om de karakteristiske symptomer på hjertesvigt og om straks at rapportere sådanne symptomer.
English: • in patients inadequately controlled on their maximally tolerated dose of metformin alone
Danish: • hos patienter med utilstrækkelig kontrol på deres maksimalt tålte dosis af metformin alene
English: Therefore, the efficacy and safety profile of saxagliptin in these patients has not been established.
Danish: Effekt- og sikkerhedsprofilen for saxagliptin er derfor ikke fastslået hos disse patienter.
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 en øget relativ risiko ved saxagliptinbehandling, kunne ikke med sikkerhed identificeres.
English: Komboglyze should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Komboglyze skal gives to gange dagligt sammen med måltider for at reducere de gastrointestinale bivirkninger, der er forbundet med metformin.
English: Komboglyze is not recommended for use in children and adolescents under 18 years.
Danish: Komboglyze anbefales ikke til børn og unge under 18 år.
English: As metformin and saxagliptin are excreted by the kidney, this medicinal product should be used with caution in the elderly.
Danish: Da metformin og saxagliptin udskilles af nyrerne, skal dette lægemiddel anvendes med forsigtighed til ældre.
English: Follow the recommendations for skin and foot care that your doctor or nurse gave you.
Danish: Følg de anbefalinger for hud- og fodpleje, som du har fået af din læge eller sygeplejerske.
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Danish: Det vides ikke, om denne medicin er sikker og effektiv hos børn og unge under 18 år.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL-C and triglyceride levels.
Danish: Dette er påvist på terapeutiske doser i kontrollerede mellemlange og lange kliniske studier: Metformin reducerer niveauerne af totalt kolesterol, LDL-C og triglycerider.
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: Glycaemic control should be carefully assessed when saxagliptin is used concomitantly with a potent CYP3A4 inducer.
Danish: Glykæmisk kontrol skal vurderes omhyggeligt, når saxagliptin anvendes samtidig med en potent CYP3A4-inducer.
English: • Tablet core: povidone K30, magnesium stearate.
Danish: • Tabletkerne: Povidon K30, magnesiumstearat.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 μg/mL, even at maximum doses.
Danish: I kontrollerede kliniske forsøg oversteg de maksimale metformin-plasmaniveauer (Cmax) ikke 4 μg/ml, selv ved maksimumdoser.
English: < 30 Metformin is contraindicated.
Danish: Metformin er kontraindiceret.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Det prospektive randomiserede studie (UKPDS) har fastslået fordelen ved intensiv blodglucosekontrol ved type 2-diabetes på langt sigt.
English: So it is important to keep following the advice about diet and exercise from your doctor or nurse.
Danish: Det er derfor vigtigt at blive ved med at følge din læges eller sygeplejerskes råd om diæt og motion.
English: The effects of smoking, diet, herbal products, and alcohol use on the pharmacokinetics of saxagliptin have not been specifically studied.
Danish: Virkningerne af rygning, diæt, urtemedicin og brug af alkohol på saxagliptins farmakokinetik er ikke blevet undersøgt specifikt.
English: If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt skal dosen af det antihyperglykæmiske lægemiddel justeres under behandling med det andet lægemiddel og ved seponering af det.
English: Vitamin B12 deficiency
Danish: Vitamin B12-mangel
English: Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Danish: Det gennemsnitlige absolutte lymfocyttal forblev stabilt ved daglig dosering op til 102 ugers varighed.
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 fødevarer (et fedtholdigt måltid) medførte ikke nogen ændring i saxagliptins Cmax og en 27 % forøgelse af AUC sammenlignet med fastende tilstand.
English: Komboglyze should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Danish: Komboglyze må ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Komboglyze.
Danish: De følgende redegørelser afspejler de farmakokinetiske egenskaber hos de individuelle aktive indholdsstoffer i Komboglyze.
English: Side effects seen when taking saxagliptin alone: Common
Danish: Bivirkninger, der er set ved indtagelse af saxagliptin alene: Almindelige
English: Saxagliptin was not genotoxic in a conventional battery of genotoxicity studies in vitro and in vivo.
Danish: Saxagliptin var ikke genotoksisk ved et konventionelt batteri af genotoksicitetsstudier in vitro og in vivo.
English: It is unknown whether saxagliptin is excreted in human milk, but metformin is excreted in human milk in small amounts.
Danish: Det er ukendt, om saxagliptin udskilles i human mælk, men metformin udskilles i human mælk i små mængder.
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Danish: Nedsat nyrefunktion er asymptomatisk og hyppig hos ældre patienter.
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Renal clearance af metformin ligger > 400 ml/min, hvilket viser, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: Saxagliptin was not teratogenic at any doses evaluated in rats or rabbits.
Danish: Saxagliptin var ikke teratogent på nogen doser, der blev vurderet på rotter eller kaniner.
English: Frequency categories are based on information available from metformin Summary of Product Characteristics available in the European Union.
Danish: Hyppighedskategorierne er baseret på information fra det produktresume for metformin, der er tilgængeligt i Den Europæiske Union.
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 lidt mindre i saxagliptingruppen, og der var flere ophør (3,5 % vs. 1,2 %) forårsaget af manglende effekt på basis af FPG-kriterier i løbet af studiets første 24 uger.
English: Komboglyze may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Komboglyze kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktatacidose, især hvis dine nyrer ikke fungerer korrekt.
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 det dog tages i betragtning, at der er blevet rapporteret svimmelhed i studier med saxagliptin.
English: Saxagliptin is eliminated by both renal and hepatic pathways.
Danish: Saxagliptin elimineres både ad renal og hepatisk vej.
English: Table 1 Dosage in patients with renal impairment
Danish: Tabel 1 Dosering til patienter med nedsat nyrefunktion
English: If you need to have major surgery, you must stop taking Komboglyze during and for some time after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Komboglyze under indgrebet og i nogen tid herefter.
English: This is because metformin passes into human milk in small amounts.
Danish: Det skyldes, at metformin går over i modermælken i små mængder.
English: Events accumulated consistently over time, and the event rates for saxagliptin 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: 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: For the major metabolite, renal clearance values were comparable to estimated glomerular filtration rate.
Danish: For hovedmetabolitten var de renale clearance-værdier sammenlignelige med beregnet glomerulær filtrationsrate.
English: Thus, changes in blood protein levels in various disease states (e.g. renal or hepatic impairment) are not expected to alter the disposition of saxagliptin.
Danish: Ændringer i proteinniveauer i blodet ved forskellige sygdomstilstande (f.eks. nedsat leverfunktion) forventes derfor ikke at ændre det saxagliptin, der er til rådighed.
English: (uncommon), and erectile dysfunction (uncommon).
Danish: (ikke almindelig) og erektil dysfunktion (ikke almindelig).
English: Use of DPP4 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 clinical significance of this decrease in lymphocyte count relative to placebo is not known.
Danish: Den kliniske betydning af dette fald i lymfocyttal i forhold til placebo kendes ikke.