FrancophonIA/ELRC3.0 huggingface dataset:
English: In these studies, more patients taking Remicade in combination with methotrexate showed a reduction in symptoms than those taking methotrexate alone, as well as less damage to the joints and greater improvements in physical function.
Danish: I disse studier var der flere af de patienter, som fik Remicade i kombination med methotrexat, der oplevede en reduktion i symptomerne, end dem, der fik methotrexat alene, og de havde desuden færre ledskader og opnåede en større forbedring af deres fysiske funktion.
English: Remicade must not be used in patients who have experienced hypersensitivity (allergy) to infliximab in the past, or who are hypersensitive (allergic) to mouse proteins or any of the other ingredients of Remicade.
Danish: Remicade må ikke anvendes til patienter, der tidligere har haft overfølsomhedsreaktioner (allergiske reaktioner) på infliximab, eller som er hypersensitive (allergiske) over for museproteiner eller andre af indholdsstofferne i Remicade.
English: In these studies Remicade produced a greater improvement in symptoms, led to fistulae healing in more patients and increased the time that patients continued to respond to treatment.
Danish: I disse studier bevirkede Remicade en større bedring i symptomerne, førte til heling af fistler hos flere patienter og forlængede den tid, som patienterne responderede på behandlingen i.
English: More adult patients receiving Remicade had a reduction in symptoms than those receiving placebo.
Danish: Flere voksne patienter, der fik Remicade, oplevede en reduktion i symptomer en dem, der fik placebo.
English: Remicade is used with methotrexate (a medicine that acts on the immune system);
Danish: Remicade anvendes sammen med methotrexat (et lægemiddel, der virker på immunsystemet)
English: • Crohn's disease (a disease causing inflammation of the digestive tract), when the disease is moderate to severe or fistulising (with the formation of fistulae, abnormal passageways between the gut and other organs);
Danish: • Crohns sygdom (en sygdom, der medfører inflammation i fordøjelseskanalen), når sygdommen er moderat til svær eller har medført dannelse af fistler (abnorme passager mellem tarmen og andre organer)
English: For the full list of side effects of Remicade, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Remicade fremgår af indlægssedlen.
English: How is Remicade used?
Danish: Hvordan anvendes Remicade?
English: This messenger is involved in causing inflammation and is found at high levels in patients with the diseases that Remicade is used to treat.
Danish: Dette signalstof er en medvirkende årsag til betændelsestilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Remicade.
English: What benefits of Remicade have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Remicade?
English: Remicade is available as a powder that is made up into a solution for infusion (drip into a vein).
Danish: Remicade leveres som et pulver, der opblandes til en opløsning og indgives ved infusion (drop i en vene).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Remicade have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Remicade.
English: • rheumatoid arthritis (an immune system disease causing inflammation of the joints).
Danish: • leddegigt (reumatoid artritis, en sygdom i immunsystemet, der medfører inflammation
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Danish: • colitis ulcerosa (blødende tyktarmsbetændelse, en sygdom, som giver betændelse og sår i tarmvæggen)
English: How does Remicade work?
Danish: Hvordan virker Remicade?
English: Vital status was obtained for 99.6% of subjects across the studies.
Danish: Vital status blev opnået for 99,6 % af forsøgspersonerne på tværs af studierne.
English: Date of first authorisation: 23 April 2014 Date of latest renewal: 18 December 2018
Danish: Dato for første markedsføringstilladelse: 23. april 2014 Dato for seneste fornyelse: 18. december 2018
English: The mean age was 63 years and 64% were male.
Danish: Gennemsnitsalderen var 63 år, og 64 % var mænd.
English: Following administration of a single oral [
Danish: Efter administration af en enkelt oral dosis [
English: Fournier's gangrene has to be treated immediately.
Danish: Fourniers gangræn skal behandles øjeblikkeligt
English: Some patients had more than one amputation.
Danish: Nogle patienter fik foretaget mere end én amputation.
English: Thereafter, eGFR was maintained or gradually increased during continued treatment.
Danish: Herefter blev eGFR opretholdt eller gradvist forøget under den fortsatte behandling.
English: Not known (freqency cannot be estimated from the available data)
Danish: Ikke kendt (hyppigheden kan ikke fastslås ud fra forhåndenværende data)
English: A patient's follow-up is calculated from Day 1 to the first amputation event date.
Danish: Opfølgningen af en patient regnes fra dag 1 til datoen for første amputation.
English: Each MACE component positively contributed to the overall composite, as shown in Figure 2.
Danish: Hver enkelt MACE-komponent bidrog positivt til den samlede sammensætning som vist i figur 2.
English: receptor antagonists)
Danish: receptorantagonister)
English: Component of a 3 bottle multipack, can not be sold separately.
Danish: Del af multipakning med 3 beholdere, kan ikke sælges separat.
English: Figure 2: Treatment effect for the primary composite endpoint and its components
Danish: Figur 2: Behandlingseffekt for det primære komposit endepunkt og dets komponenter
English: Note: Incidence is based on the number of patients with at least one amputation, and not the total number of amputation events.
Danish: Bemærk: Incidens er baseret på antal patienter med mindst én amputation og ikke det samlede antal amputationer.
English: Ankle, below knee and above knee
Danish: * Tå og mellemfod † Ankel, under knæ og over knæ
English: ATC code: A10BD16.
Danish: ATCkode: A10BD16.
English: Hypotension a, Orthostatic hypotension
Danish: Hypotension a, ortostatisk hypotension
English: The percentage of minor and major amputations is based on the highest level amputation for each patient.
Danish: Procenten for mindre og større amputationer er baseret på det højeste amputationsniveau for den enkelte patient.
English: Figure 1: Time to first occurrence of MACE
Danish: Tid til første forekomst af MACE
English: The primary endpoint in the CANVAS Program was the time to first occurrence of a MACE.
Danish: Det primære endepunkt i CANVAS-programmet var tiden frem til første forekomst af en MACE.
English: • if you have type 1 diabetes because Vokanamet should not be used to treat this condition.
Danish: • hvis du har type 1-diabetes, da Vokanamet ikke må anvendes til at behandle denne sygdom
English: P value for superiority (2-sided) = 0.0158.
Danish: P-værdi for overlegenhed (2-sidet) = 0,0158.
English: These studies were multicenter, multi-national, randomised, double-blind, parallel group, with similar inclusion and exclusion criteria and patient populations.
Danish: Disse studier var multicenter, multinationale, randomiserede, dobbeltblinde, med parallelle grupper med sammenlignelige kriterier for inklusion og eksklusion og patientpopulationer.
English: Constipation, Thirst f, Nausea
Danish: Obstipation, tørst f, kvalme
English: • about what you can do to prevent dehydration (see section 4 for signs of dehydration).
Danish: • for at få at vide, hvad du kan gøre for at forebygge dehydrering (se punkt 4 angående tegn på dehydrering)
English: 58% of patients were male.
Danish: 58 % af patienterne var af hankøn.
English: The amputation results for the Integrated CANVAS Program are shown in table 2.
Danish: Amputationsresultaterne for det integrerede CANVAS-program fremgår af tabel 2.
English: Intent-to-treat population using last observation in study.
Danish: Intent-to-treat-population under anvendelse af den sidste observation i studiet.
English: Concomitant antidiabetic and atherosclerotic therapies could be adjusted, according to the standard care for these diseases.
Danish: Samtidige antidiabetiske og aterosklerotiske behandlinger kunne justeres i henhold til standardbehandlingen af disse sygdomme.
English: The MACE findings in this subgroup were consistent with the overall findings.
Danish: MACE-fundene i denne undergruppe var forenelige med de samlede fund.
English: The imbalance occurred as early as the first 26 weeks of therapy.
Danish: Ubalancen opstod allerede inden for de første 26 ugers behandling.
English: Treatment with Vokanamet may be restarted when the ketone values are normal and the patient's condition has stabilised.
Danish: Behandlingen med Vokanamet kan genoptages, når ketonstofværdierne er normale, og patientens tilstand er stabiliseret.
English: 17% of patients were Hispanic.
Danish: 17 % af patienterne var af latinamerikansk afstamning.
English: The safety and efficacy of Vokanamet in children under 18 years of age have not been established.
Danish: Vokanamets sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Renal failure h (mainly in the context of volume depletion)
Danish: Nyresvigt h (hovedsageligt i forbindelse med volumendepletering)
English: Infections and infestations not known
Danish: Infektioner og parasitære sygdomme Ikke kendt
English: • in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
Danish: • i kombination med andre lægemidler til behandling af diabetes hos patienter, der er utilstrækkeligt kontrollerede med metformin og disse lægemidler
English: Severe allergic reaction (rare, may affect up to 1 in 1,000 people) Possible signs of severe allergic reaction may include:
Danish: Alvorlig allergisk reaktion (sjælden - kan berøre op til 1 ud af 1.000 personer) Mulige tegn på en alvorlig allergisk reaktion kan omfatte:
English: OUTER CARTON FOR 1 COMPONENT OF MULTIPACK (WITHOUT BLUE BOX)
Danish: YDERKARTON TIL 1 MULTIPAKNING (UDEN BLÅ BOKS)
English: Vokanamet is not recommended for children and adolescents under 18 years, because data are not available in these patients.
Danish: Børn og unge under 18 år må normalt ikke få Vokanamet, da der ikke foreligger data fra sådanne patienter.
English: Talk to your doctor, pharmacist or nurse before taking Vokanamet, and during treatment:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Vokanamet og under behandlingen:
English: Patients in CANVAS and CANVAS-R were followed for an average of 5.7 and 2.1 years, respectively.
Danish: Patienter i CANVAS og CANVAS-R blev fulgt i henholdsvis 5,7 og 2,1 år i gennemsnit.
English: Least squares mean adjusted for covariates including baseline value and stratification factor Adjusted p = 0.001
Danish: Least squares mean justeret for kovarianter, inklusive værdi ved baseline og stratifikationsfaktor Justeret p = 0,001
English: The mean HbA1c at baseline was 8.2% and mean duration of diabetes was 13.5 years.
Danish: Gennemsnitlig HbA1c ved baseline var 8,2 %, og den gennemsnitlige varighed af diabetes var 13,5 år.
English: • if you are allergic to canagliflozin, metformin or any of the other ingredients of this medicine
Danish: • hvis du er allergisk over for canagliflozin, metformin eller et af de øvrige indholdsstoffer i
English: If Fournier's gangrene is suspected, Vokanamet should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Invokana seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: As precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Danish: Som en forebyggende foranstaltning bør der træffes foranstaltninger med henblik på en tæt overvågning af patienter med øget risiko for amputation og at rådgive patienterne om vigtigheden af rutinemæssig forebyggende fodpleje og opretholdelse af passende hydrering.
English: Of the subjects who had an amputation, the toe and midfoot were the most frequent sites (71%) in both treatment groups (see table 2).
Danish: For de forsøgspersoner, der fik foretaget en amputation, var tå og mellemfod de hyppigste steder (71 %) for begge behandlingsgrupper (se tabel 2).
English: Patients had an overall mean age of 59.5 years (range 21 years to 96 years), with 3,135 patients ≥ 65 years of age and 513 patients ≥ 75 years of age.
Danish: Patienternes samlede gennemsnitsalder var 59,5 år (interval 21-96 år), med 3.135 patienter ≥ 65 år og 513 patienter ≥ 75 år.
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 2).
Danish: Stop omgående med at tage dette lægemiddel, og kontakt straks lægen eller nærmeste hospital (se punkt 2).
English: Diabetic ketoacidosis b, h
Danish: Diabetisk ketoacidose b, h
English: At baseline, patients were treated with one or more antidiabetic medications including metformin (77%), insulin (50%), and sulfonylurea (43%).
Danish: Ved baseline blev patienterne behandlet med et eller flere antidiabetiske lægemidler, herunder metformin (77 %), insulin (50 %) og sulfonylurinstof (43 %).
English: The mean Vd ranged between 63-276 litres.
Danish: Det gennemsnitlige Vd lå mellem 63 og 276 l.
English: The risk of lower limb amputation was not dose-dependent.
Danish: Risikoen for amputation af underekstremitet var ikke dosisafhængig.
English: Sixty-six percent of subjects had a history of established cardiovascular disease, with 56% having a history of coronary disease, 19% with cerebrovascular disease, and 21% with peripheral vascular disease; 14% had a history of heart failure.
Danish: Seksogtreds procent af forsøgspersonerne havde en anamnese med etableret kardiovaskulær sygdom, med 56 % med en anamnese med koronar hjertesygdom, 19 % med cerebrovaskulær sygdom og 21 % med perifer vaskulær sygdom; 14 % havde en anamnese med hjertesvigt.
English: Based on the Kaplan-Meier plot for the first occurrence of MACE, shown below, the reduction in MACE in the canagliflozin group was observed as early as Week 26 and was maintained throughout the remainder of the study (see Figure 1).
Danish: Baseret på Kaplan-Meier-kurven over første forekomst af MACE, vist herunder, blev reduktionen i MACE i canagliflozin-gruppen observeret allerede i uge 26 og blev opretholdt i hele den resterende periode af studiet (se figur 1).
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Danish: I en række af disse tilfælde fremstod tilstanden atypisk med kun moderat forhøjet blodglucose, under 14 mmol/l (250 mg/dl).
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, dvs. det er i det væsentlige ”natriumfrit”.
English: CARTON FOR MULTIPACK COMPRISING 3 PACKS (INCLUDING BLUE BOX)
Danish: KARTON TIL MULTIPAKNING BESTÅENDE AF 3 PAKKER (INKLUSIVE BLÅ BOKS)
English: Secondary endpoints within a sequential conditional hypothesis testing were all-cause mortality and cardiovascular mortality.
Danish: Sekundære endepunkter inden for en sekventiel, betinget hypoteseprøvning var død af en hvilken som helst årsag og kardiovaskulær død.
English: Both improvement in glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Danish: Såvel forbedring af glykæmisk kontrol som reduktion af kardiovaskulær morbiditet og mortalitet er integrerede dele i behandlingen af type 2-diabetes.
English: (listed in section 6)
Danish: Vokanamet (angivet i punkt 6)
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 (e.g., megaloblastic anaemia).
Danish: 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: • Swallow the tablet whole with water.
Danish: • Synk tabletten hel med vand
English: Renal endpoints
Danish: Renale endepunkter
English: Intent-to-treat population using last observation in study prior to glycaemic rescue therapy.
Danish: Intent-to-treat-population under anvendelse af den sidste observation i studiet før glykæmisk nødmedicin.
English: Multiple amputations (some involving both lower limbs) were observed infrequently and in similar proportions in both treatment groups.
Danish: Multiple amputationer (hvoraf nogle involverede begge underekstremiteter) sås sjældent og i lige stort omfang hos begge behandlingsgrupper.
English: p = 0.013 compared to placebo.
Danish: p = 0,013 sammenlignet med placebo.
English: Polyuria or Pollakiuria j, Urinary tract infection (pyelonephritis and urosepsis have been reported postmarketing)
Danish: Polyuri eller pollakisuri j, urinvejsinfektion (pyelonephritis og urosepsis er blevet indberettet efter markedsføringen)
English: Balanitis or balanoposthitis occurred primarily in uncircumcised male patients which in some instances resulted in phimosis and/or circumcision.
Danish: Balanitis og balanopostitis optrådte primært hos mandlige patienter, der ikke var omskåret, hvilket i nogle tilfælde resulterede i phimosis og/eller omskæring.
English: Mean eGFR returned to baseline after treatment discontinuation suggesting that haemodynamic changes may play a role in these renal function changes.
Danish: Den gennemsnitlige eGFR returnerede til baseline efter seponering af behandlingen, hvilket antyder, at hæmodynamiske ændringer kan spille en rolle i disse ændringer i nyrefunktionen.
English: Total number of subjects with events, n
Danish: Samlet antal forsøgspersoner med hændelser, n (%)
English: To assess risk factors for these adverse reactions, a larger pooled analysis (N = 12,441) of patients from 13 controlled phase 3 and phase 4 studies including both doses of canagliflozin was conducted.
Danish: Til vurdering af risikofaktorerne for disse bivirkninger blev der gennemført en større puljet analyse (N = 12.441) af patienter fra 13 kontrollerede fase 3- og fase 4-studier, der omfattede begge doser af canagliflozin.
English: Related to bone fracture; see description of AR below.
Danish: Relateret til knoglebrud; se beskrivelse af bivirkninger nedenfor.
English: Canagliflozin as add-on therapy to insulin (with or without other glucose-lowering medicinal products).
Danish: Canagliflozin som tillægsbehandling til insulin (med eller uden andre glucosesænkende lægemidler).
English: Patients treated with canagliflozin regardless of baseline eGFR experienced an initial fall in mean eGFR.
Danish: Patienter, der blev behandlet med canagliflozin uanset baseline-eGFR, oplevede indledningsvist et fald i gennemsnitlig eGFR.
English: Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g; although, lactic acidosis has occurred in such circumstances.
Danish: 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: Thirst includes the terms thirst, dry mouth, and polydipsia.
Danish: Tørst omfatter termerne tørst, mundtørhed og polydipsi.
English: An eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter.
Danish: eGFR skal bestemmes, inden behandling med metforminholdige præparater iværksættes og derefter mindst én gang om året.
English: Regardless of treatment with canagliflozin or placebo, the risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.
Danish: Uanset om behandlingen skete med canagliflozin eller placebo, var risikoen for amputation størst hos patienter med en baseline-anamnese med tidligere amputation, perifer vaskulær sygdom og neuropati.
English: Balanitis or balanoposthitis b, l
Danish: Balanitis eller balanopostitis b, l
English: In the CANVAS Program, median duration of the infection was longer in the canagliflozin group compared to the placebo group.
Danish: I CANVAS-programmet var den mediane varighed af infektionen længere i canagliflozingruppen end i placebogruppen.
English: • phimosis - difficulty pulling back the foreskin around the tip of the penis.
Danish: • forhudsforsnævring - problemer med at trække forhuden omkring penishovedet tilbage.
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, der elimineres ved tubulær sekretion (f.eks. cimetidin), kan interagere med metformin ved at konkurrere om de fælles transportsystemer i nyretubuli.
English: • swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing.
Danish: • hævelser af ansigt, læber, mund, tunge eller svælg, som kan gøre det vanskeligt at trække vejret eller synke.
English: Further symptoms are reduced body temperature and heartbeat.
Danish: Yderligere symptomer omfatter nedsat kropstemparatur og hjerteslag.
English: In a pooled analysis of 13 placebo-controlled and active-controlled studies, the safety profile of canagliflozin in elderly patients was generally consistent with younger patients.
Danish: I en puljet analyse af 13 placebokontrollerede og aktivt kontrollerede studier svarede sikkerhedsprofilen for canagliflozin hos ældre patienter generelt til profilen hos yngre patienter.
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2):
Danish: Diabetisk ketoacidose (sjælden - kan berøre op til 1 ud af 1.000 personer) Symptomerne på diabetisk ketoacidose (se også punkt 2) er:
English: In controlled clinical studies, 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: However, if it is time for the next dose, skip the missed dose.
Danish: Hvis det er tid til næste dosis, skal du springe den glemte dosis over
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference 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 Lgæemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Dizziness postural a, Syncope
Danish: Postural svimmelhed a, synkope
English: Adverse reactions in table 1 are based on the pooled analysis of the placebo- and active-controlled studies described above.
Danish: Bivirkningerne i tabel 1 er baseret på den puljede analyse af de placebokontrollerede og aktivt kontrollerede studier beskrevet ovenfor.
English: These are two medicines that work together in different ways to lower blood glucose (sugar) levels and can help prevent heart disease in adults with type 2 diabetes.
Danish: Det er to lægemidler, der virker på hver sin måde med henblik på at sænke blodsukkeret (blodglucose), og som kan medvirke til at forebygge hjertesygdom hos voksne med type 2-diabetes.
English: Vulvovaginal candidiasis b, k common
Danish: Vulvovaginal candidiasis b, k