FrancophonIA/ELRC3.0 huggingface dataset:
English: In an in vitro mammalian cytogenetic test with metabolic activation, sevelamer hydrochloride caused a statistically significant increase in the number of structural chromosome aberrations.
Danish: I en mammal in vitro-cytogenetisk test med metabolisk aktivering forårsagede sevelamerhydrochlorid en statistisk signifikant øgning i antallet af strukturelle kromosomafvigelser.
English: Sevelamer does not contain calcium and decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone.
Danish: Sevelamer indeholder ikke kalcium og reducerer incidensen af episoder med hyperkalcæmi sammenlignet med patienter, der kun tager kalciumbaserede fosfatbindere.
English: This medicine should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Danish: Dette lægemiddel bør anvendes med andre behandlinger såsom calciumtilskud og D-vitamin for at forhindre udviklingen af knoglesygdom.
English: It is unknown whether sevelamer/metabolites are excreted in human milk.
Danish: Det vides ikke, om sevelamer/metabolitter udskilles i brystmælk hos mennesker.
English: • major gastrointestinal tract surgery Treatment of these patients with Renvela should only be initiated after careful benefit/risk assessment.
Danish: Behandling af disse patienter med Renvela bør først påbegyndes efter en omhyggelig benefit/risk assessment.
English: • have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body tissue.
Danish: • har forstyrret indhold af bikarbonat i blodet, og øget surhedsgrad i blodet og andre kropsvæv.
English: Patients taking anti-arrhythmic medicinal products for the control of arrhythmias and anti-seizure medicinal products for the control of seizure disorders were excluded from clinical trials.
Danish: Patienter, der får antiarytmika til kontrol af arytmi og lægemidler mod krampeanfald til kontrol af krampelidelser, blev udelukket fra de kliniske studier.
English: Renvela contains sevelamer, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium.
Danish: Renvela indeholder sevelamer, en ikke-absorberbar fosfatbindende krydsbunden polymer fri for metal og kalcium.
English: The treatment response was maintained in the paediatric patients who received sevelamer carbonate during the 6month open-label DTP.
Danish: Behandlingsresponset blev opretholdt hos de pædiatriske patienter, der fik sevelamercarbonat i løbet af den 6-måneder åbne DTP.
English: This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:
Danish: Dette lægemiddel anvendes til kontrol af hyperfosfatæmi (forhøjet fosfat niveauer) hos:
English: Sevelamer contains multiple amines separated by one carbon from the polymer backbone which become protonated in the stomach.
Danish: Sevelamer indeholder adskillige aminer adskilt af et karbon fra polymerens hovedkæde, som protoneres i maven.
English: • have a low amount of vitamin D in your blood.
Danish: • Du kan have for lidt D-vitamin i blodet.
English: Talk to your doctor while taking Renvela:
Danish: Tal med din læge, mens du tager Renvela:
English: Peritonitis is a known complication in patients receiving peritoneal dialysis and in a clinical trial with sevelamer hydrochloride, a greater number of peritonitis cases were reported in the sevelamer group than in the control group.
Danish: Peritonitis er en kendt komplikation hos patienter i peritonealdialyse, og i et klinisk studie med sevelamerhydrochlorid blev der rapporteret flere tilfælde af peritonitis i sevelamergruppen end i kontrolgruppen.
English: For paediatric patients with a <1.2 BSA (m2), the oral suspension should be administered, as tablet formulations were not tested in this population and therefore are not appropriate for this population.
Danish: For pædiatriske patienter med et legemsoverfladeareal < 1,2 m bør den orale suspension administreres, da tabletformuleringer ikke er testet i denne population og derfor ikke er hensigtsmæssige til denne population.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Danish: Rapporteringsfrekvensen klassificeres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The non-absorbed nature of sevelamer indicates that excretion of sevelamer in breast milk is unlikely.
Danish: Sevelamers ikkeabsorberende egenskaber indikerer, at sevelamer sandsynligvis ikke udskilles i brystmælk.
English: It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood);
Danish: Det kan anvendes til patienter i hæmodialyse (ved hjælp af en blodfiltreringsmaskine) eller peritonealdialyse (hvor væske pumpes ind i bughulen og en indre membran i kroppen filtrerer blodet);
English: Fat-soluble vitamins and folate deficiency
Danish: Fedtopløselige vitaminer og folatmangel
English: This risk can be reduced by careful adherence to sterile techniques during bag changes.
Danish: Risikoen herfor kan reduceres ved nøje at følge anvisningerne, når poserne udskiftes.
English: The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of ciclosporin, mycophenolate mofetil and tacrolimus should be considered during the use of combination and after its withdrawal.
Danish: Muligheden for en interaktion kan ikke udelukkes, og koncentrationerne af ciclosporin, mycophenolatmofetil og tacrolimus i blodet skal overvåges nøje under anvendelse af disse kombinationer og efter ophør.
English: • severe gastrointestinal motility disorders including untreated or severe gastroparesis, retention of gastric contents and abnormal or irregular bowel motion
Danish: • svær gastrointestinal motilitetslidelse inklusive ubehandlet eller alvorlig gastroparese, retention af gastrisk indhold og abnorm eller uregelmæssig tarmbevægelse
English: The recommended starting dose of Renvela tablets for adults and elderly is one to two tablets of 800 mg with each meal, 3 times a day.
Danish: Den anbefalede startdosis af Renvela-tabletter for voksne og ældre er en til to tabletter af 800 mg sammen med hvert hovedmåltid 3 gange dagligt.
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Renvela.
Danish: • Virkningen af medicin såsom ciclosporin, mycophenolatmofetil og tacrolimus (medicin der anvendes til at hæmme immunsystemet) kan blive reduceret af Renvela.
English: Patients receiving dialysis are subject to certain risks for infection specific to dialysis modality.
Danish: Patienter i dialyse har en vis risiko for infektion, der er specifik for dialysemodalitet.
English: Increased levels of serum phosphorus can lead to hard deposits in your body called calcification.
Danish: Et øget indhold af serumfosfat kan føre til hårde aflejringer i din krop, kaldet forkalkning.
English: • Medicines treating heartburn and reflux from your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may reduce the efficacy of Renvela.
Danish: • Medicin til behandling af halsbrand og reflux fra din mave eller spiserør, såsom omeprazol, pantoprazol eller lansoprazol, kendt som "protonpumpehæmmere", kan nedsætte Renvelas virkning.
English: If you get any of the following side effects, seek immediate medical attention: - Allergic reaction (signs including rash, hives, swelling, trouble breathing).
Danish: Hvis du får nogen af de følgende bivirkninger, skal du omgående søge lægehjælp: - Allergisk reaktion (symptomer omfatter udslæt, nældefeber, hævelse, vejrtrækningsproblemer).
English: Increased serum phosphorus can also lead to itchy skin, red eyes, bone pain and fractures.
Danish: Et øget niveau af fosfat i blodet kan også medføre hudkløe, røde øjne og smerter i knogler eller knoglebrud.
English: Renvela film-coated tablets are white tablets with Renvela 800 imprinted on one side.
Danish: Renvela filmovertrukne tabletter er hvide og har Renvela 800 trykt på den ene side.
English: In patients not taking supplemental folic acid but on sevelamer, folate level should be assessed regularly.
Danish: Hos patienter, der behandles med sevelamer, men som ikke tager supplerende folinsyre, skal folatniveauet vurderes regelmæssigt.
English: Serum phosphorus level in patients
Danish: Patientens serumfosfatniveau
English: Only for bottle label of 180 tablets: 2D barcode carrying the unique identifier included.
Danish: Kun til tabletbeholder etiket for 180 tabletter: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Each bottle contains 30 tablets or 180 tablets.
Danish: Hver tabletbeholder indeholder 30 eller 180 tabletter.
English: Further instructions are detailed in the patient leaflet.
Danish: Yderligere vejledning er beskrevet i indlægssedlen.
English: Sevelamer carbonate does not contain any calcium.
Danish: Sevelamercarbonat indeholder ikke kalcium.
English: • have undergone major surgery on your stomach or bowel
Danish: • hvis du har fået en større operation i maven eller tarmene
English: Titration and maintenance
Danish: Titrering og vedligeholdelse
English: For paediatric patients the oral suspension should be administered, as tablet formulations are not appropriate for this population.
Danish: Den orale suspension bør administreres til pædiatriske patienter, da tabletformuleringer ikke er hensigtsmæssige til denne population.
English: Animal studies have shown some reproductive toxicity when sevelamer was administered to rats at high doses (see section 5.3).
Danish: Dyrestudier har påvist nogen reproduktionstokcisitet, når sevelamer administreres til rotter i høje doser (se pkt.
English: Patients taking sevelamer carbonate should adhere to their prescribed diets.
Danish: Patienter, der tager sevelamercarbonat, skal overholde den ordinerede diæt.
English: Talk to your doctor who will decide if you can continue the treatment with Renvela.
Danish: Tal med din læge, som vil afgøre, om du kan fortsætte behandlingen med Renvela.
English: For children, the powder is preferred, as tablets are not appropriate in this population.
Danish: Pulveret anbefales til børn, da tabletter ikke er hensigtsmæssige til denne population.
English: Sevelamer carbonate should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus.
Danish: Sevelamercarbonat bør kun anvendes på tvingende indikation til gravide og kun efter udførelse af en omhyggelig risk-benefit-analyse for både mor og foster.
English: Proper swallowing ability should be carefully monitored in patients with co-morbid conditions.
Danish: Korrekt synkeevne bør kontrolleres omhyggeligt hos patienter med følgesygdomme.
English: Sevelamer hydrochloride was not mutagenic in the Ames bacterial mutation assay.
Danish: Sevelamerhydrochlorid var ikke mutagen i Ames bakterielle mutationsanalyse.
English: Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when co-administered with sevelamer hydrochloride without any clinical consequences (e.g., graft rejection).
Danish: Ciclosporin, mycophenolatmofetil og tacrolimus hos transplantationspatienter Reducerede niveauer af ciclosporin, mycophenolatmofetil og tacrolimus er rapporteret hos transplantationspatienter ved samtidig administration af sevelamerhydrochlorid, uden kliniske konsekvenser (fx afstødelse af transplanteret organ).
English: Hypromellose (E464) Diacetylated monoglycerides
Danish: Hypromellose (E464) Diacetyleret monoglycerid
English: 180 (6 bottles of 30) film-coated tablets
Danish: 180 (6 glas med 30) filmovertrukne tabletter
English: Renvela powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal.
Danish: Renvela pulver til oral suspension er et lysegult pulver, der leveres i et varmeforseglet foliebrev.
English: Renvela is indicated for the control of hyperphosphataemia in paediatric patients (>6 years of age and a body surface area (BSA) of >0.75 m2) with chronic kidney disease.
Danish: Renvela er indiceret til kontrol af hyperfosfatæmi hos pædiatriske patienter (> 6 år og et legemsoverfladeareal > 0,75 m2) med kronisk nyresygdom.
English: Do not crush, chew or break into pieces.
Danish: De må ikke knuses, tygges eller brækkes i stykker.
English: Taking your Renvela treatment is important to maintain an appropriate phosphate level in your blood.
Danish: Det er vigtigt, at du tager Renvela, for at opretholde et passende fosfatindhold i dit blod.
English: It can be an early symptom of a blockage in your intestine.
Danish: Det kan være et tidligt symptom på tilstopning af tarmene.
English: The highest dose in this study was 4.5 g/kg/day (human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative BSA).
Danish: Den højeste dosis i dette studie var 4,5 g/kg/dag (tilsvarende dosis for mennesker var 2 gange den maksimale dosis på 13 g/dag baseret på en sammenligning af relativ legemsoverfladeareal).
English: Microcrystalline cellulose Sodium chloride Zinc stearate
Danish: Mikrokrystallinsk cellulose Natriumchlorid Zinkstearat
English: Patients with CKD may develop hypocalcaemia or hypercalcaemia.
Danish: Patienter med kronisk nyresygdom kan udvikle hypokalcæmi eller hypercalcæmi.
English: The powder should not be heated (e.g. microwave).
Danish: Pulveret bør ikke varmes op (fx i mikrobølgeovn).
English: These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystals deposit in your bowel.
Danish: Disse symptomer kan skyldes alvorlig inflammatorisk tarmsygdom forårsaget af sevelamerkrystaller aflejret i tarmen.
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride (capsules/tablets), which contains the same active moiety as sevelamer carbonate.
Danish: I meget sjældne tilfælde er intestinal obstruktion og ileus/subileus observeret hos patienter i behandling med sevelamerhydrochlorid (kapsler/tabletter), der indeholder samme aktive fragment som sevelamercarbonat.
English: It is recommended that CKD patients not on dialysis are given vitamin D supplements (approximately 400 IU of native vitamin D daily) which can be part of a multivitamin preparation to be taken apart from their dose of sevelamer carbonate.
Danish: Det anbefales, at patienter med kronisk nyresygdom, der ikke er i dialyse, får D-vitamintilskud (ca. 400 IU naturligt D-vitamin dagligt), hvilket kan være del af et multivitaminpræparat, der tages udover dosen af sevelamercarbonat.
English: Sachet of ethylene methacrylic acid copolymer, polyester, LDPE and aluminium foil laminate, with a heat seal.
Danish: Breve af ethylenmethacrylsyre copolymer, polyester, LDPE og aluminium folielaminat, med varmeforsegling.
English: Current available data are described in section 5.1.
Danish: Tilgængelige data er beskrevet i pkt.
English: Sanofi A/S Tlf: +45 45 16 70 00
Danish: Danmark Sanofi A/S Tlf: +45 45 16 70 00
English: Common (may affect up to 1 in 10 people): diarrhoea, stomach ache, indigestion, flatulence
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer): Diarré, mavesmerter, fordøjelsesbesvær, luft i maven
English: The study met its primary endpoint, meaning Sevelamer carbonate reduced serum phosphorus by an LS mean difference of 0.90 mg/dL compared to placebo, and secondary efficacy endpoints.
Danish: Studiet nåede sit primære endepunkt, da sevelamercarbonat reducerede serumfosfat med en mindste kvadrater gennemsnitlig forskel på -0,90 mg/dL sammenlignet med placebo og sekundære effektmål.
English: Renvela is unlikely to affect your ability to drive or to use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Renvela påvirker din evne til at køre eller betjene maskiner.
English: Serum calcium levels should therefore be monitored at regular intervals and elemental calcium should be given as a supplement if required.
Danish: Serumkalcium koncentrationen skal derfor måles jævnligt, og elementært kalcium bør gives som tilskud efter behov.
English: **Plus subsequent titrating, see section “Titration and maintenance”
Danish: *Plus efterfølgende titrering, se pkt.
English: Stopping Renvela would lead to important consequences such as calcification in the blood vessels.
Danish: Hvis du holder op med at tage Renvela kan det medføre alvorlige konsekvenser som forkalkning i blodkarrene.
English: These protonated amines bind negatively charged ions such as dietary phosphate in the intestine.
Danish: Disse protonerede aminer binder negativt ladede ioner, som fx fosfat fra maden, i tarmen.
English: The safety of sevelamer (as either carbonate and hydrochloride salts) has been investigated in numerous clinical trials involving a total of 969 haemodialysis patients with treatment duration of 4 to 50 weeks (724 patients treated with sevelamer hydrochloride and 245 with sevelamer carbonate), 97 peritoneal dialysis patients with treatment duration of 12 weeks (all treated with sevelamer hydrochloride) and 128 patients with CKD not on dialysis with treatment duration of 8 to 12 weeks (79 patients treatment with sevelamer hydrochloride and 49 with sevelamer carbonate).
Danish: Sikkerheden af sevelamer (som enten carbonat- eller hydrochloridsalte) er blevet undersøgt i adskillige kliniske studier, der har involveret i alt 969 hæmodialysepatienter med behandlingsvarigheder på 4 til 50 uger (724 patienter behandlet med sevelamerhydrochlorid og 245 med sevelamercarbonat), 97 patienter i peritonealdialyse med behandlingsvarighed på 12 uger (alle behandlet med sevelamerhydrochlorid) og 128 patienter med kronisk nyresygdom, der ikke var i dialyse, med behandlingsvarigheder på 8 til 12 uger (79 patienter behandlet med sevelamerhydrochlorid og 49 med sevelamercarbonat).
English: Regular monitoring of serum phosphorus levels is always necessary during phosphate binder administration.
Danish: Jævnlig måling af serumfosfat koncentrationen er altid nødvendig ved administration af fosfatbindere.
English: If you forget to take Renvela
Danish: Hvis du har glemt at tage Renvela
English: Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, is not absorbed from the gastrointestinal tract, as confirmed by an absorption study in healthy volunteers.
Danish: Sevelamerhydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, absorberes ikke fra mave-tarm-kanalen, hvilket er bekræftet i et absorptionsstudie med raske frivillige.
English: Anti-arrhythmics and anti-seizure medicinal products
Danish: Antiarytmika og lægemidler mod krampeanfald
English: • paediatric patients with chronic (long-term) kidney disease above the age of 6 and above a certain height and weight (used to calculate body surface area by your physician).
Danish: • børn med kronisk (langvarig) nyresygdom over 6 år og med en vis højde og vægt (bruges til at beregne legemsoverfladeareal af lægen).
English: In paediatric patients with hyperphosphatemia secondary to CKD, sevelamer carbonate significantly reduced serum phosphorus levels compared to placebo during a 2-week FDP.
Danish: Hos pædiatriske patienter med hyperfosfatæmi sekundært til kronisk nyresygdom reducerede sevelamercarbonat signifikant serumfosfatniveauet sammenlignet med placebo i løbet af en 2ugers FDP.
English: Renvela must be taken three times per day with meals or snacks.
Danish: Renvela skal tages tre gange dagligt sammen med måltider eller mellemmåltider.
English: Always use the dosing spoon provided in the carton.
Danish: Brug altid måleskeen i æsken
English: Studies in animals have shown that sevelamer did not impair fertility in male or female rats at exposures at a human equivalent dose 2 times the maximum clinical trial dose of 13 g/day, based on a comparison of relative BSA.
Danish: Dyrestudier har vist, at sevelamer ikke nedsætter fertiliteten hos hun- eller hanrotter ved udsættelse for en human dosis svarende til 2 gange den maksimale dosis i kliniske studier på 13 g/dag, baseret på en sammenligning af relativ legemsoverfladeareal.
English: Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary.
Danish: Lægen vil derfor måle indholdet af D-vitamin i dit blod og udskrive et D-vitamintilskud, hvis det er nødvendigt.
English: Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Renvela treatment.
Danish: Tal med din læge, som vil beslutte, om du kan amme din baby eller ej, og om det er nødvendigt at stoppe behandling med Renvela.
English: Patients who are constipated should be monitored carefully while being treated with Renvela.
Danish: Obstiperede patienter skal overvåges nøje under behandling med Renvela.
English: In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Danish: I interaktionsstudier med raske forsøgspersoner havde sevelamerhydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, ingen virkning på biotilgængeligheden af digoxin, warfarin, enalapril eller metoprolol.
English: It binds phosphate from food in the digestive tract and so reduces serum phosphorus levels in the blood.
Danish: Det binder fosfat fra maden i fordøjelseskanalen og nedsætter på denne måde fosfat niveauet i blodet.
English: Iron oxide black (E172) Propylene glycol Isopropyl alcohol Hypromellose (E464)
Danish: Jernoxid sort (E172) Propylenglycol Isopropylalkohol Hypromellose (E464)
English: Pack size: 90 sachets per carton
Danish: Pakningsstørrelser: 90 breve pr. karton
English: Not known: cases of itching, rash, slow intestine motility (movement)
Danish: Ikke kendt: Tilfælde af kløe, hududslæt, nedsat tarmbevægelse (motilitet).
English: In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily dose is expected to be an average of approximately 6 g per day.
Danish: I klinisk praksis vil behandling kontinuerligt blive baseret på behovet for at kontrollere serumfosfatniveauet, og den daglige dosis forventes gennemsnitligt at ligge på ca. 6 g.
English: The safety and effectiveness of sevelamer carbonate in hyperphosphatemic paediatric patients with CKD was evaluated in a multicenter study with a 2-week, randomised, placebo-controlled, fixed dose period (FDP) followed by a 6-month, single-arm, open-label, dose titration period (DTP).
Danish: Sikkerheden og effekten af sevelamercarbonat hos hyperfosfatemiske pædiatriske patienter med kronisk nyresygdom blev evalueret i et multicenterstudie med en 2-ugers randomiseret, placebo-kontrolleret, fast dosisperiode (FDP) efterfulgt af en 6 måneders enkelt-arm, åben, dosistitreringsperiode (DTP).
English: • develop low or high levels of calcium in your blood.
Danish: • Du kan få enten et højt eller lavt indhold af kalk i blodet.
English: Patients with CKD may develop low levels of fat-soluble vitamins A, D, E and K, depending on dietary intake and the severity of their disease.
Danish: Patienter med kronisk nyresygdom kan udvikle lavt indhold af de fedtopløselige A-, D-, E- og K-vitaminer afhængigt af diæt og sygdommens sværhedsgrad.
English: • Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Renvela.
Danish: • Underskud af stofskiftehormoner ses i sjældne tilfælde hos visse personer, der tager levothyroxin (bruges til at behandle lavt indhold af tyreoideahormon) og Renvela.
English: If you stop taking Renvela
Danish: Hvis du holder op med at tage Renvela