FrancophonIA/ELRC3.0 huggingface dataset:
English: After an oral dose of metformin hydrochloride tablet, Cmax is reached in approximately 2.5 hours (Tmax).
Danish: Efter oral administration af en tablet med metforminhydrochlorid blev Cmax nået inden for ca. 2,5 time (Tmax).
English: These are two medicines that work together in different ways to lower blood glucose (sugar) levels in adults with type 2 diabetes.
Danish: Det er to lægemidler, der virker på hver sin måde med henblik på at sænke blodsukkeret (blodglucose) hos voksne med type 2-diabetes.
English: Plasma protein binding is negligible.
Danish: Bindingen til plasmaprotein er ubetydelig.
English: Metformin increases the transport capacity of the membrane glucose transporters GLUT-1 and GLUT-4.
Danish: Metformin øger transportkapaciteten af membranglucosetransportørerne GLUT-1 og GLUT-4.
English: • If your doctor has prescribed this medicine along with any medicine for lowering cholesterol such as cholestyramine you should take this medicine at least 1 hour before or 4 hours to
Danish: • Hvis din læge har foreskrevet dette lægemiddel sammen med et middel til sænkning af kolesteroltallet, såsom colestyramin, skal du tage Vokanamet mindst 1 time før eller 4-6 timer efter det kolesterolsænkende lægemiddel
English: Vokanamet contains two different active substances, canagliflozin and metformin.
Danish: Vokanamet indeholder to forskellige aktive stoffer, canagliflozin og metformin.
English: To assess risk factors for these adverse reactions, a larger pooled analysis (N = 9,439) of patients from eight controlled phase 3 studies including both doses of canagliflozin was conducted.
Danish: Til vurdering af risikofaktorerne for disse bivirkninger blev der gennemført en større poolet analyse (N = 9.439) af patienter fra otte kontrollerede fase 3-studier, der omfattede begge doser af canagliflozin.
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Danish: Det antages, at absorptionen af metformin er non-lineær.
English: More information is given below in "Other medicines and Vokanamet".
Danish: Du kan finde yderligere oplysninger nedenfor under "Brug af anden medicin sammen med Vokanamet"
English: Patients had an overall mean age of 59.6 years (range 21 years to 96 years), with 3,082 patients ≥ 65 years of age and 510 patients ≥ 75 years of age.
Danish: Patienternes samlede gennemsnitsalder var 59,6 år (interval 21-96 år), med 3.082 patienter ≥ 65 år og 510 patienter
English: The clinical relevance of these findings is unknown.
Danish: Den kliniske relevans af disse fund er ikke afklaret.
English: Patients with GFR 45 mL/min to < 60 mL/min
Danish: Patienter med GFR på 45 ml/min til < 60 ml/min
English: N/Ac a Intent-to-treat population using last observation in study.
Danish: Ikke relevantc a Intent-to-treat-population under anvendelse af den sidste observation i studiet.
English: There were no meaningful changes in bone density in trabecular and cortical regions.
Danish: Der sås ingen relevante ændringer i knogledensitet i trabekulære og kortikale områder.
English: b p < 0.001 compared to placebo.
Danish: b p < 0,001 sammenlignet med placebo.
English: There was no notable change in heart rate.
Danish: Der sås ingen ændring af betydning i hjertefrekvens.
English: • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis);
Danish: • Enhver type af akut metabolisk acidose (såsom laktatacidose, diabetisk ketoacidose)
English: Symptoms of lactic acidosis include:
Danish: Symptomerne på laktatacidose omfatter:
English: When starting or using such products in combination with Vokanamet, close monitoring of renal function is necessary.
Danish: Ved initiering eller brug af sådanne præparater i kombination med metformin skal nyrefunktionen monitoreres tæt.
English: This can lead to serious medical conditions such as heart disease, kidney disease, blindness, and amputation.
Danish: Det kan føre til en række alvorlige helbredsmæssige problemer såsom hjertesygdom, nyresygdom, blindhed og amputation.
English: • very rare: decreased vitamin B12 levels (may cause anaemia - low count of red blood cells),
Danish: • meget sjældne: nedsat indhold af B12-vitamin (kan give anæmi - lavt antal røde blodlegemer),
English: • corticosteroids (used to treat a variety of conditions, such as severe inﬂammation of the skin or in asthma) that are given by mouth, as an injection, or inhaled
Danish: • kortikosteroider (bruges ved en lang række tilstande som f.eks. svære betændelseslignende tilstande i huden eller astma), der indtages gennem munden, gives som injektion eller inhaleres
English: As metformin is recommended to be administered with a meal to reduce the incidence of gastrointestinal adverse reactions, it is recommended that Vokanamet be taken with a meal to reduce gastrointestinal intolerability associated with metformin.
Danish: Eftersom det anbefales, at metformin administreres i forbindelse med et måltid for at reducere incidensen af gastrointestinale bivirkninger, bør Vokanamet ligeledes indtages i forbindelse med et måltid for at reducere den gastrointestinale intolerans associeret med metformin.
English: Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g; although, lactic acidosis has occurred in such circumstances.
Danish: Metformin Hypoglykæmi er ikke set i forbindelse med doser af metforminhydrochlorid på op til 85 g, selv om der er forekommet laktatacidose under sådanne omstændigheder.
English: The majority of genital mycotic infections were treated with topical antifungal treatments, either prescribed by a healthcare professional or self-treated while continuing therapy with Vokanamet.
Danish: De fleste genitale svampeinfektioner blev behandlet med topikale antimykotika, enten efter lægeordination eller som egenbehandling under fortsat behandling med Vokanamet.
English: A pre-specified interim meta-analysis was conducted of adjudicated major cardiovascular events in the phase 2 and 3 clinical studies in 9,632 patients with type 2 diabetes, including 4,327 patients (44.9%) with cardiovascular disease or at high risk for cardiovascular disease who are participating in an ongoing cardiovascular study.
Danish: Der udførtes en præspecificeret interim metaanalyse af evaluerede større kardiovaskulære hændelser i kliniske fase 2- og 3-studier med 9.632 patienter med type 2-diabetes, herunder 4.327 patienter (44,9 %) med kardiovaskulær sygdom eller i højrisikogruppe for kardiovaskulær sygdom, som deltager i et igangværende kardiovaskulært studie.
English: The increases in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Danish: Den øgede eksponering for simvastatin og simvastatinsyre anses ikke for klinisk relevant.
English: • reduced body temperature and heartbeat
Danish: • nedsat kropstemperatur og langsommere puls
English: Patients with diabetes have been shown to have elevated renal glucose reabsorption which may contribute to persistent elevated blood glucose concentrations.
Danish: Det er påvist, at patienter med diabetes har forhøjet reabsorption af glucose i nyrerne, hvilket kan bidrage til vedvarende forhøjet blodglucose.
English: Some studies indicate that taking canagliflozin may have contributed to the risk of lower limb amputation (mainly toe amputations).
Danish: Visse studier peger på, at det at tage canagliflozin kan bidrage til risikoen for amputation af en underekstremitet (primært amputation af en tå).
English: Due to volume depletion, generally small mean decreases in GFR were seen within the first 6 weeks of treatment initiation with canagliflozin.
Danish: På grund af volumendepletering sås der generelt små gennemsnitlige fald i GFR i løbet af de første 6 behandlingsuger med canagliflozin.
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin hydrochloride is eliminated by glomerular filtration and tubular secretion.
Danish: Renal clearance af metformin er > 400 ml/min, hvilket tyder på, at metforminhydrochlorid elimineres ved glomerulær filtration og tubulær sekretion.
English: Cationic medicinal products 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 Kationiske lægemidler, der elimineres ved tubulær sekretion (f.eks. cimetidin), kan interagere med metformin ved at konkurrere om de fælles transportsystemer i nyretubuli.
English: In controlled clinical trials, Cmax did not exceed 5 μg/mL, even at maximum doses.
Danish: I kontrollerede kliniske studier oversteg Cmax ikke 5 mikrogram/ml selv ved de højeste doser.
English: Patients tolerating canagliflozin can continue use at a maximum total daily dose of 100 mg.
Danish: Patienter, der tolererer canagliflozin, kan fortsætte behandlingen ved en maksimal total daglig dosis på 100 mg.
English: Side effects when taking metformin alone that were not described for canagliflozin:
Danish: Bivirkninger, der er set ved behandling med metformin alene, og som ikke er beskrevet for canagliflozin:
English: Renal function GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Danish: Nyrefunktion GFR skal bestemmes inden behandlingsstart og regelmæssigt derefter, (se pkt.
English: Metformin is a biguanide with antihyperglycemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmiske virkninger, idet det både sænker basal og postprandial plasmaglucose.
English: • efavirenz or ritonavir (medicines used to treat HIV infection)
Danish: • efavirenz eller ritonavir (midler til at behandle hiv-infektion)
English: Liver function test abnormal, Hepatitis a 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 (e.g., megaloblastic anaemia).
Danish: Unormale leverfunktionsprøver, hepatitis a Langtidsbehandling med metformin er blevet associeret med nedsat absorption af vitamin B12, hvilket i meget sjældne tilfælde kan resultere i klinisk signifikant vitamin B12-mangel (f.eks. megaloblastisk anæmi).
English: • beta-2 agonists (such as salbutamol or terbutaline) used to treat asthma.
Danish: • beta-2-agonister (såsom salbutamol eller terbutalin) mod astma
English: Subjects responded to standard treatments while continuing canagliflozin treatment.
Danish: Personerne reagerede på standardbehandling under fortsat behandling med canagliflozin.
English: Lactic acidosis (very rare, may affect up to 1 in 10,000 people) Vokanamet may cause a very rare but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Danish: Laktatacidose (meget sjælden - kan berøre op til 1 ud af 10.000 personer) Vokanamet kan forårsage en meget sjælden, men meget alvorlig bivirkning, der kaldes laktatacidose (se afsnittet ”Advarsler og forsigtighedsregler”).
English: When pregnancy is detected, treatment with Vokanamet should be discontinued.
Danish: Hvis graviditet konstateres, bør Vokanamet seponeres.
English: The safety and efficacy of Vokanamet in children under 18 years of age have not been established.
Danish: Pædiatrisk population Vokanamets sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Frequency categories are based on information available from the metformin Summary of Product Characteristics.
Danish: Hyppigheder er baseret på oplysninger fra produktresuméet for metformin.
English: Lower limb amputations (mainly of the toe) especially in patients at high risk for heart disease
Danish: Amputation af underekstremitet (primært en tå) særligt hos patienter med høj risiko for hjertesygdom
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: Det er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langvarige kliniske studier, at metformin reducerer niveauet af totalkolesterol, LDL-kolesterol og triglycerid.
English: Do not take Vokanamet
Danish: Tag ikke Vokanamet
English: There was no change in metformin AUC; however, mean peak plasma concentration of metformin was decreased by 16% when administered with food.
Danish: Der sås ingen ændringer i metformins AUC, mens metformins maksimale plasmakoncentration faldt med 16 % ved samtidig fødeindtagelse.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på beholderen og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your health care professional.
Danish: • Det er vigtigt, at du regelmæssigt kontrollerer dine fødder og overholder de retningslinjer for fodpleje og passende væskeindtagelse, som du får af lægen eller sundhedspersonalet .
English: Frequency categories are defined according to the following convention: 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 (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighed defineres i henhold til følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden
English: A paediatric Phase 1 study examined the pharmacokinetics and pharmacodynamics of canagliflozin in children and adolescents ≥ 10 to < 18 years of age with type 2 diabetes mellitus.
Danish: Et pædiatrisk fase 1-studie undersøgte canagliflozins farmakokinetik og farmakodynamik hos børn og unge ≥ 10 til < 18 år med type 2 diabetes mellitus.
English: CYP3A4-mediated (oxidative) metabolism of canagliflozin is minimal (approximately 7%) in humans.
Danish: Hos mennesket er CYP3A4-medieret (oxidativ) metabolisme af canagliflozin minimal (ca. 7 %).
English: Among female patients taking canagliflozin, 2.3% experienced more than one infection.
Danish: Blandt de kvindelige patienter, der fik canagliflozin, oplevede 2,3 % mere end én infektion.
English: Environmental Risk Assessment: no environmental impact is anticipated from the clinical use of either of the active substances canagliflozin or metformin in Vokanamet.
Danish: Miljørisikovurdering: Der forventes ingen miljøpåvirkning fra klinisk anvendelse af de to aktive stoffer canagliflozin og metformin i Vokanamet.
English: In in vitro studies, canagliflozin neither inhibited cytochrome P450 CYP1A2, CYP2A6, CYP2C19, CYP2D6, or CYP2E1, CYP2B6, CYP2C8, CYP2C9, nor induced CYP1A2, CYP2C19, CYP2B6, CYP3A4 at higher than therapeutic concentrations.
Danish: I in vitro-studier udvirkede canagliflozin hverken hæmning af CYP1A2, CYP2A6, CYP2C19, CYP2D6, CYP2E1, CYP2B6, CYP2C8 eller CYP2C9 eller induktion af CYP1A2, CYP2C19, CYP2B6 eller CYP3A4 i koncentrationer over det terapeutiske niveau.
English: The bottles contain 20 or 60 film-coated tablets.
Danish: Beholderne indeholder 20 eller 60 filmovertrukne tabletter.
English: Stop taking Vokanamet 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 Vokanamet 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: The mean steady-state volume of distribution (Vd) of canagliflozin following a single intravenous infusion in healthy subjects was 83.5 litres, suggesting extensive tissue distribution.
Danish: Canagliflozins gennemsnitlige fordelingsvolumen (Vd) ved steady state efter en enkelt intravenøs infusion til raske forsøgspersoner var 83,5 liter, hvilket tyder på omfattende fordeling i væv.
English: • dabigatran (blood thinner medicine that lowers the risk of blood clot formation)
Danish: • dabigatran (blodfortyndende middel, der nedsætter risikoen for blodpropper)
English: Plasma Cmax and AUC of canagliflozin increased in a dose-proportional manner from 50 mg to 300 mg.
Danish: Plasma-Cmax og AUC for canagliflozin steg proportionalt med dosis i intervallet fra 50 mg til 300 mg.
English: Single dose study: After single doses of metformin hydrochloride 500 mg, paediatric patients have shown a similar pharmacokinetic profile to that observed in healthy adults.
Danish: Enkeltdosisstudie: Efter enkeltdoser på 500 mg metforminhydrochlorid udviste pædiatriske patienter en farmakokinetisk profil svarende til profilen hos raske voksne.
English: • carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
Danish: • carbamazepin, phenytoin eller phenobarbital (midler til kontrol af epilepsi)
English: Blood creatinine increased**, k, Blood urea increased**, l, Blood potassium increased**, m, Blood phosphate increasedn
Danish: Forhøjet kreatinin i blodet**, k, forhøjet urat i blodet**, l, forhøjet kalium i blodet**, m, forhøjet phosphat i blodetn
English: These symptoms could be a sign of “diabetic ketoacidosis” - a rare but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: Symptomerne kan være tegn på “diabetisk ketoacidose”, som er en sjælden men alvorlig og somme tider livstruende komplikation, du kan få ved sukkersyge på grund af forhøjet niveau af “ketonstoffer” i urinen eller blodet.
English: • blood tests may show increases in your blood phosphate level
Danish: • blodprøver kan vise forhøjet indhold af fosfat i blodet
English: Increases in urinary glucose excretion with canagliflozin can falsely lower 1,5-anhydroglucitol (1,5-AG) levels and make measurements of 1,5-AG unreliable in assessing glycemic control.
Danish: Øget udskillelse af glucose i urinen pga. canagliflozin kan give falsk lavere 1,5-anhydroglucitolværdier (1,5-AG-værdier) og gøre bestemmelser af 1,5-AG upålidelige til vurdering af glykæmisk kontrol.
English: Your doctor will decide whether you need any other treatment to control your blood sugar while you have stopped taking Vokanamet.
Danish: Din læge vil tage stilling til, om du har behov for anden behandling til at kontrollere blodsukkeret, mens du holder pause med Vokanamet.
English: • blood tests may show changes related to kidney function (increased creatinine or urea) or increased potassium
Danish: • blodprøver kan vise forandringer i nyrefunktionen (forhøjet kreatinin eller urinstof) eller forhøjet kalium
English: Consideration may also be given to stopping treatment with Vokanamet in patients that develop events preceding amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Danish: Det kan også overvejes at afbryde behandlingen med Vokanamet hos patienter, der udvikler lidelser, der kan være forløbere for amputation, som f.eks. sår på underekstremitet, infektion, osteomyelitis eller gangræn.
English: Vokanamet is available in HDPE bottles with child-resistant closure.
Danish: Vokanamet fås i HDPE-beholdere med børnesikret lukke.
English: Experience in New York Heart Association (NYHA) class III is limited, and there is no experience in clinical studies with canagliflozin in NYHA class IV.
Danish: Der er begrænsede erfaringer med patienter i NYHA-klasse III, og der er ingen erfaringer fra kliniske studier med canagliflozin hos patienter med NYHA-klasse IV.
English: h Balanitis or balanoposthitis includes the terms balanitis, balanoposthitis, balanitis candida, and genital infection fungal.
Danish: h Balanitis eller balanopostitis omfatter termerne balanitis, balanopostitis, balanitis candida og genital svampeinfektion.
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Danish: Plasmaproteinbindingen ændres ikke i væsentlig grad hos patienter med nedsat nyre- eller leverfunktion.
English: g Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis, vaginal infection, vulvitis, and genital infection fungal.
Danish: g Vulvovaginal candidiasis omfatter termerne vulvovaginal candidiasis, vulvovaginal svampeinfektion, vulvovaginitis, vaginal infektion, vulvitis og genital svampeinfektion.
English: No studies in lactating animals have been conducted with the combined active substances of Vokanamet.
Danish: Der er ikke udført studier med diegivende dyr, der fik en kombination af de aktive stoffer i Vokanamet.
English: Following oral administration of an 850 mg tablet, a 40% lower plasma peak concentration, a 25% decrease in AUC, and a 35-minute prolongation of time to peak plasma concentration were observed.
Danish: Efter oral administration af en 850 mg tablet observeres 40 % lavere maksimal plasmakoncentration, 25 % fald i AUC og 35-minutters forlængelse af tid til maksimal plasmakoncentration.
English: In the event of an overdose of Vokanamet, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute clinical measures as dictated by the patient's clinical status.
Danish: I tilfælde af overdosering med Vokanamet er det fornuftigt at anvende sædvanlig understøttende behandling og f.eks. fjerne ikke absorberet materiale fra mave-tarm-kanalen, anvende klinisk monitorering og iværksætte de foranstaltninger, som patientens kliniske status kræver.
English: • by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis
Danish: • ved reduktion af glucoseproduktion i leveren gennem hæmning af glukoneogenese og glykogenolyse
English: Among male patients taking canagliflozin, 0.9% had more than one infection.
Danish: Blandt de mandlige patienter, der fik canagliflozin, fik 0,9 % mere end én infektion.
English: Pharmacokinetic drug interaction studies with Vokanamet have not been performed; however, such studies have been conducted with the individual active substances (canagliflozin and metformin).
Danish: Der er ikke udført farmakokinetiske lægemiddelinteraktionsstudier med Vokanamet, men denne type studier er dog udført med de aktive stoffer (canagliflozin og metformin) enkeltvist.
English: A total of 714 patients ≥ 55 years of age to ≤ 80 years of age (227 patients 65 years of age to < 75 years of age and 46 patients 75 years of age to ≤ 80 years of age) with inadequate glycaemic control on current diabetes treatment (glucose-lowering medicinal products and/or diet and exercise) participated in a double-blind, placebo-controlled study over 26 weeks.
Danish: I alt 714 patienter i alderen ≥ 55 til ≤ 80 år (227 patienter i alderen 65 op til 75 år og 46 patienter i alderen 75 til ≤ 80 år) med utilstrækkelig glykæmisk kontrol med den igangværende diabetesbehandling (glucosesænkende lægemidler og/eller kost og motion) deltog i et dobbeltblindt, placebokontrolleret studie af 26 ugers varighed.
English: Your kidneys will be tested by a blood test before you start taking and during treatment with Vokanamet.
Danish: Du vil få undersøgt din nyrefunktion ved hjælp af en blodprøve, før du begynder at tage og under behandling med Vokanamet.
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition, or postnatal development (see section 5.3).
Danish: Dyrestudier med metformin indikerer ikke skadelige virkninger på drægtighed, embryonal/føtal udvikling, fødsel eller postnatal udvikling (se pkt.
English: The co-administration of canagliflozin and metformin has been studied in patients with type 2 diabetes inadequately controlled on metformin either alone or in combination with other glucose-lowering medicinal products.
Danish: Samtidig administration af canagliflozin og metformin blev undersøgt hos patienter med type 2diabetes, der opnåede utilstrækkelig kontrol med metformin enten alene eller i kombination med andre glucosesænkende lægemidler.