FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal symptoms occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Danish: Gastrointestinale symptomer opstår oftest i begyndelsen af behandlingsforløbet og går i de fleste tilfælde over af sig selv.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Danish: Efter en oral dosis er den ikke-absorberede fraktion i fæces 20-30 %.
English: Vipdomet should be taken twice daily because of the pharmacokinetics of its metformin component.
Danish: Vipdomet skal tages to gange dagligt som følge af metformins farmakokinetik.
English: Vipdomet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Danish: Vipdomet kan forårsage en meget sjælden, men meget alvorlig bivirkning, som kaldes laktatacidose, især hvis dine nyrer ikke fungerer korrekt.
English: Renal clearance of metformin is >400 mL/min indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Den renale clearance for metformin er > 400 ml/min, hvilket indikerer, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Danish: Efter en oral dosis er den konstaterede terminale eliminationshalveringstid ca. 6,5 timer.
English: However, patients should be alerted to the risk of hypoglycaemia especially when used in combination with insulin or pioglitazone.
Danish: Patienter bør dog advares om risikoen for hypoglykæmi, især hvis Vipdomet bruges i kombination med insulin eller pioglitazon.
English: These may be prevented by taking metformin in 2 daily doses during or after meals.
Danish: Sådanne symptomer kan forebygges ved, at patienten tager metformin i 2 daglige doser sammen med eller efter måltider.
English: Administration of Vipdomet with food resulted in no change in total exposure (AUC) to alogliptin or metformin.
Danish: Administration af Vipdomet sammen med mad resulterede ikke i ændringer i den samlede eksponering (AUC) for alogliptin eller metformin.
English: In studies performed with the individual active substances, both alogliptin and metformin were excreted in the milk of lactating rats.
Danish: I studier udført med de enkelte aktive stoffer blev både alogliptin og metformin udskilt i mælken hos mælkeproducerende rotter.
English: If you have reduced kidney function, your doctor may prescribe a lower dose, which may need to be given as separate tablets of alogliptin and metformin.
Danish: Hvis du har nedsat nyrefunktion, vil lægen eventuelt ordinere en lavere dosis, som eventuelt skal gives som separate tabletter med alogliptin og metformin.
English: The following data are findings from studies performed with alogliptin or metformin individually.
Danish: Følgende data er resultater af studier udført af alogliptin og metformin hver for sig.
English: However, mean peak plasma concentrations of alogliptin and metformin were decreased by 13% and 28% when Vipdomet was administered with food, respectively.
Danish: Den gennemsnitlige højeste plasmakoncentration af alogliptin og metformin faldt dog med henholdsvis 13 % og 28 %, når Vipdomet blev indtaget sammen med mad.
English: If you are already taking both alogliptin and metformin as single tablets, Vipdomet can replace them in one tablet.
Danish: Hvis du allerede tager både alogliptin og metformin som separate tabletter, kan Vipdomet erstatte dem begge.
English: STOP taking Vipdomet and contact a doctor or the nearest hospital immediately if you notice any of the symptoms of the following serious side effects:
Danish: STOP med at tage Vipdomet, og kontakt lægen eller det nærmeste hospital med det samme, hvis du får nogen af symptomerne på de følgende alvorlige bivirkninger:
English: Your doctor will decide when you must stop and when to restart your treatment with Vipdomet.
Danish: Lægen vil beslutte, hvornår du skal stoppe behandlingen med Vipdomet, og hvornår du kan genoptage den igen.
English: Specific pharmacokinetic drug interaction studies have not been performed with Vipdomet.
Danish: Der er ikke udført farmakokinetiske lægemiddelinteraktionsstudier med Vipdomet.
English: At the recommended metformin doses and dosing schedules, steady-state plasma concentrations of metformin are reached within 24 to 48 hours and are generally less than 1 microgram/mL.
Danish: Ved de anbefalede metformin-doser og doseringsplaner nås steady state-plasmakoncentrationer af metformin inden for 24 til 48 timer efter administrationen og er generelt på mindre end 1 mikrogram/ml.
English: In that case, the missed dose should be skipped.
Danish: Den glemte dosis skal i givet fald springes over.
English: In these studies, 696 alogliptin/metformin-treated patients were ≥ 65 years old.
Danish: I disse studier var 696 af de patienter, der blev behandlet med alogliptin/metformin, 65 år gamle eller derover.
English: ATC code: A10BD13.
Danish: af orale blodglucosesænkende midler, ATC-kode: A10BD13.
English: Patients (≥65 years old) with type 2 diabetes mellitus are considered more susceptible to episodes of hypoglycaemia than patients <65 years old.
Danish: Patienter (≥ 65 år) med type 2-diabetes mellitus vurderes at have større risiko for hypoglykæmi end patienter under 65 år.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID).
Danish: Der skal udvises særlig forsigtighed i situationer, hvor nyrefunktionen risikerer at blive nedsat, f.eks. ved påbegyndelse af antihypertensiv eller diuretisk behandling eller ved påbegyndelse af behandling med et non-steroid antiinflammatorisk lægemiddel (NSAID).
English: Alogliptin exists predominantly as the (R)-enantiomer (>99%) and undergoes little or no chiral conversion in vivo to the (S)-enantiomer.
Danish: Alogliptin findes primært som (R)-enantiomeren (> 99 %) og gennemgår ingen eller kun meget begrænset kiral konvertering til (S)-enantiomeren in vivo.
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Danish: Derfor skal nøje overvågning af den glykæmiske regulering, dosisjustering inden for det anbefalede dosisområde og ændring af diabetesbehandlingen overvejes, hvis kationiske lægemidler, som elimineres ved tubulær sekretion, administreres samtidigt.
English: Vipdomet should not be used in patients with type 1 diabetes mellitus.
Danish: Vipdomet må ikke gives til patienter med type 1-diabetes mellitus.
English: A lower dose of insulin may be considered to reduce the risk of hypoglycaemia.
Danish: En lavere dosis insulin kan overvejes for at mindske risikoen for hypoglykæmi.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Danish: Patienter, der behandles med sådanne lægemidler, skal informeres om dette og have hyppigere blodglucoseovervågning, især ved begyndelsen af behandlingen.
English: Elimination Alogliptin was eliminated with a mean terminal half-life (T1/2) of approximately 21 hours.
Danish: Elimination Alogliptin blev elimineret med en gennemsnitlig terminalhalveringstid (T1/2) på ca. 21 timer.
English: Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 8% lower in patients with moderate hepatic impairment compared to control subjects.
Danish: Den samlede eksponering for alogliptin var ca. 10 % lavere, og den højeste eksponering var ca. 8 % lavere hos patienter med moderat nedsat leverfunktion sammenlignet med raske forsøgspersoner.
English: Maximum daily dose The maximum recommended daily dose of 25 mg alogliptin should not be exceeded.
Danish: Højeste anbefalede daglige dosis Den højeste anbefalede daglige dosis på 25 mg alogliptin bør ikke overskrides.
English: Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger.
English: It does not stimulate insulin secretion and, therefore, does not produce hypoglycaemia.
Danish: Stoffet stimulerer ikke udskillelsen af insulin og medfører derfor ikke hypoglykæmi.
English: Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
Danish: Formålet med alogliptin er at øge insulinniveauet i kroppen efter et måltid og sænke mængden af sukker i kroppen.
English: No data are available with regard to overdose of Vipdomet.
Danish: Der findes ingen data om overdosis af Vipdomet.
English: However, it may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Danish: En sådan behandling kan dog i meget sjældne tilfælde medføre klinisk signifikant B12-vitaminmangel (f.eks. megaloblastisk anæmi).
English: Maximum daily dose is 3,000 mg Dose reduction may be considered in relation to declining renal function.
Danish: Den maksimale daglige dosis er 3.000 mg Dosisreduktion kan overvejes i forbindelse med tiltagende nedsættelse af nyrefunktionen.
English: Change in clinical status of patients with previously controlled type 2 diabetes mellitus
Danish: Ændring af klinisk status for patienter med tidligere reguleret type 2-diabetes mellitus
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Danish: Kationiske lægemidler, som elimineres renalt ved tubulær sekretion (f.eks. cimetidin), kan interagere med metformin ved at konkurrere om fælles tubulære transportsystemer.
English: Vipdomet is not a substitute for insulin in insulin-requiring patients.
Danish: Vipdomet kan ikke erstatte insulin hos patienter med insulinkrævende diabetes.
English: Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate and metformin levels.
Danish: Undersøgelsen skal omfatte test af serumelektrolytter og ketoner, blodglucose og - hvis det er indiceret - blodets pH-værdi samt laktat-, pyruvat- og metforminværdier.
English: ACE inhibitors may decrease blood glucose levels.
Danish: ACE-hæmmere kan sænke blodglucoseniveauet.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmisk virkning, som sænker både de basale og de postprandiale plasmaglucoseværdier.
English: The most effective method of removing lactate and metformin is haemodialysis.
Danish: Den mest effektive metode til fjernelse af laktat og metformin er hæmodialyse.
English: Maximum daily dose is 12.5 mg
Danish: Maksimal daglig dosis er 12,5 mg
English: Stop taking Vipdomet 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 Vipdomet 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: Higher doses of alogliptin decreased offspring body weight and exerted some developmental effects considered secondary to the low body weight.
Danish: Højere doser alogliptin medførte en lavere kropsvægt hos afkommet og havde en vis indvirkning på afkommets udvikling, som blev betragtet som en konsekvens af den lave kropsvægt.
English: Vipdomet is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Danish: Vipdomet anbefales ikke til børn og unge under 18 år, da der ikke foreligger tilstrækkelige data for denne aldersgruppe.
English: Metformin is contraindicated in patients with GFR<30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Danish: Metformin er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: Taking Vipdomet in combination with medicines called pioglitazone or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
Danish: Hvis du tager Vipdomet samtidig med lægemidlerne pioglitazon eller insulin, kan du få for lavt blodsukker (hypoglykæmi), hvilket kan påvirke din evne til at køre bil og betjene maskiner.
English: A large overdose of metformin or concomitant risks may lead to lactic acidosis.
Danish: En stor overdosis metformin eller samtidige risikofaktorer kan medføre laktatacidose.
English: Alogliptin therefore improves glycaemic control via a glucose-dependent mechanism, whereby insulin release is enhanced and glucagon levels are suppressed when glucose levels are high.
Danish: Alogliptin forbedrer således den glykæmiske kontrol via en glucoseafhængig mekanisme, hvorved insulinfrigivelsen øges og glukagonmængden sænkes, når glucosekoncentrationen er høj.
English: Nonfatal Stroke *Overall there were 153 subjects (5.7%) in the alogliptin group and 173 subjects (6.5%) in the placebo group who died (all-cause mortality)
Danish: *Samlet var der 153 forsøgspersoner (5,7 %) i alogliptin-gruppen og 173 forsøgspersoner (6,5 %) i placebogruppen, som døde (mortalitet af enhver årsag).
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktionstoksicitet.
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 Vipdomet before or at the time of the injection.
Danish: Brug af anden medicin sammen med Vipdomet 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 Vipdomet forud for eller på tidspunktet for injektionen.
English: Interactions with metformin
Danish: Interaktioner med metformin
English: Adults (≥18 years old) with normal renal function (glomerular filtration rate (GFR)≥90 mL/min) The dose should be individualised on the basis of the patient's current treatment regimen.
Danish: Voksne (≥ 18 år) med normal nyrefunktion (glomerulær filtrationshastighed (GFR) ≥ 90 ml/min) Dosis skal tilpasses den enkelte patient ud fra dennes aktuelle behandling.
English: If you need to have major surgery you must stop taking Vipdomet during and for some time before and after the procedure.
Danish: Hvis du skal have en større operation, skal du stoppe med at tage Vipdomet under indgrebet og i nogen tid herefter.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Danish: Hos mennesker har metformin, uafhængigt af stoffets virkning på glykæmi, en gunstig virkning på lipidomsætningen.
English: Concomitant treatment with alogliptin and metformin did not produce new toxicities and no effects on the toxicokinetics of either compound were observed.
Danish: Samtidig behandling med alogliptin og metformin viste ingen ny toksicitet, og der blev ikke observeret effekt på stoffernes toksikokinetik.
English: Gastrointestinal disorders gastroenteritis common abdominal pain common very common common diarrhoea common very common common vomiting very common common gastritis common gastroesophageal reflux disease common common loss of appetite very common nausea very common acute pancreatitis not known
Danish: Mave-tarm-kanalen gastroenteritis almindelig mavesmerter almindelig meget almindelig almindelig diarré almindelig meget almindelig almindelig opkastning meget almindelig almindelig gastritis almindelig gastroøsofageal reflukssygdom almindelig almindelig appetitløshed meget almindelig kvalme meget almindelig akut pancreatitis ikke kendt
English: As Vipdomet contains metformin it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Danish: Da Vipdomet indeholder metformin skal det seponeres på operationstidspunktet i forbindelse med generel, rygmarvs- eller epiduralbedøvelse.
English: Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus:
Danish: Vipdomet er indiceret til behandling af voksne patienter i alderen 18 år og opefter med type 2-diabetes mellitus:
English: Following oral administration of an 850 mg metformin hydrochloride tablet, the peak plasma concentration was 40% lower, AUC was decreased by 25% and the time to peak plasma concentration (Tmax) was prolonged by 35 minutes.
Danish: Efter oral administration af en 850 mg metforminhydrochloridtablet var den højeste plasmakoncentration 40 % lavere, AUC faldt med 25 % og tiden indtil maksimal plasmakoncentration (Tmaks) var forlænget med 35 minutter.
English: When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and, thus, the elimination half-life is prolonged leading to increased levels of metformin in the plasma.
Danish: Hvis nyrefunktionen er nedsat, er den renale clearance nedsat i forhold til kreatinins, og derfor er eliminationshalveringstiden forlænget, hvilket fører til øget plasmakoncentration af metformin.
English: Skin and subcutaneous tissue disorders pruritus common very rare common rash common common erythema very rare exfoliative skin conditions including StevensJohnson syndrome not known erythema multiforme not known angioedema not known urticaria not known very rare
Danish: Hud og subkutane væv pruritus almindelig meget sjælden almindelig udslæt almindelig almindelig erytem meget sjælden eksfoliative hudsygdomme, herunder Stevens-Johnsons syndrom ikke kendt erythema multiforme ikke kendt angioødem ikke kendt urticaria ikke kendt meget sjælden
English: The European Medicines Agency has waived the obligation to submit the results of studies with Vipdomet in all subsets of the paediatric population in the treatment of 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 Vipdomet i alle undergrupper af den pædiatriske population med type 2-diabetes mellitus (se pkt.
English: Vipdomet is taken when your blood sugar cannot be adequately controlled by diet, exercise and other anti-diabetic medicines such as metformin alone; insulin alone; or metformin and pioglitazone taken together.
Danish: Du kan tage Vipdomet, hvis dit blodsukker ikke kan styres godt nok gennem kost, motion og andre antidiabetika såsom metformin taget alene, insulin taget alene eller metformin og pioglitazon taget samtidigt.
English: Infections and infestations upper respiratory tract infections common common nasopharyngitis common common
Danish: Infektioner og parasitære sygdomme infektioner i de øvre luftveje almindelig almindelig nasofaryngitis almindelig almindelig
English: Intravascular administration of iodinated contrast media may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Danish: Intravaskulær administration af iodholdige kontrastmidler kan medføre kontrastinduceret nefropati, resulterende i akkumulation af metformin og en øget risiko for laktatacidose.
English: Stop taking Vipdomet 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 Vipdomet 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: Combination requiring precautions for use
Danish: Kombinationer, der kræver særlige forholdsregler
English: LOCF = last observation carried forward *Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
Danish: LOCF = sidste observation fremført * Non-inferioritet og superioritet statistisk bevist † Mindste kvadraters gennemsnit justeret mht. tidligere antihyperglykæmisk behandlingsstatus og baselineværdier
English: Results from studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Danish: Data fra studier med metformin, pioglitazon (thiazolidindion), voglibose (alfaglukosidase-hæmmer) og glyburid (sulfonylurinstof) har ikke vist klinisk relevante farmakokinetiske interaktioner.
English: Your doctor may want to reduce your dose of insulin or a thiazolidinedione when you take it together with Vipdomet in order to avoid too low blood sugar (hypoglycaemia).
Danish: Din læge vil muligvis nedsætte din insulin- eller thiazolidindion-dosis, hvis du også tager Vipdomet, så du undgår at få for lavt blodsukker (hypoglykæmi).
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Vipdomet.
Danish: Du skal eventuelt have kontrolleret dit blodsukker eller din nyrefunktion hyppigere, eller lægen kan ændre din dosis af Vipdomet.
English: Patients should be observed closely for possible liver abnormalities.
Danish: Patienterne skal observeres nøje, så mulige leverfunktionssvigt opdages.
English: The efficacy and safety of the recommended doses of alogliptin and metformin in a subgroup of patients with type 2 diabetes mellitus and ≥65 years old were reviewed and found to be consistent with the profile obtained in patients <65 years old.
Danish: Virkningen af og sikkerheden ved de anbefalede doser alogliptin og metformin hos en undergruppe af patienter på 65 år og derover med type 2-diabetes mellitus er blevet undersøgt, og data stemte overens med profilen for patienter under 65 år.
English: Overall, treatment with the recommended total daily dose of 25 mg alogliptin in combination with metformin improved glycaemic control.
Danish: Generelt forbedrede behandlingen med den anbefalede daglige dosis på 25 mg alogliptin i kombination med metformin den glykæmiske kontrol.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Vipdomet therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Vipdomet seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: If pancreatitis is suspected, Vipdomet should be discontinued; if acute pancreatitis is confirmed, Vipdomet should not be restarted.
Danish: Hvis der er mistanke om akut pancreatitis, skal behandlingen med Vipdomet afbrydes, og hvis mistanken bekræftes, må behandlingen med Vipdomet ikke genoptages.
English: As Vipdomet contains metformin, any patient with type 2 diabetes mellitus previously well controlled on Vipdomet who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Danish: Da Vipdomet indeholder metformin, skal alle patienter med type 2-diabetes mellitus, som tidligere har været velregulerede på Vipdomet, og som har uregelmæssige værdier set i laboratorietest eller klinisk sygdom (især uvisse og svagt definerede sygdomme), straks undersøges for tegn på ketoacidose eller laktatacidose.