FrancophonIA/ELRC3.0 huggingface dataset:
English: The anti-arrhythmic medical product should be taken at least one hour before or three hours after Renvela, and blood monitoring can be considered.
Danish: Antiarytmika bør tages mindst én time før eller tre timer efter Renvela, og blodovervågning kan overvejes.
English: Closer monitoring of thyroid stimulating hormone (TSH) levels is therefore recommended in patients receiving sevelamer carbonate and levothyroxine.
Danish: Øget overvågning af thyreoideastimulerende hormon (TSH) koncentrationen anbefales derfor hos patienter, der får sevelamercarbonat og levothyroxin.
English: Other side effects have been reported in patients taking Renvela:
Danish: Andre bivirkninger er rapporteret hos patienter, der tager Renvela:
English: Keep the bottle container tightly closed in order to protect from moisture.
Danish: Hold tabletbeholderen tæt tillukket for at beskytte mod fugt.
English: In clinical practice, treatment will be continuous based on the need to control serum phosphorus levels and the daily adult 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 for voksne forventes gennemsnitligt at ligge på ca. 6 g.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with sevelamer carbonate should be made taking into account the benefit of breast-feeding to the child and the benefit of sevelamer carbonatetherapy to the woman.
Danish: Det bør overvejes, om amning skal fortsætte/stoppes, eller om behandling med sevelamercarbonat skal fortsætte/seponeres, hvor overvejelserne skal omfatte fordelene for barnet ved amning og fordelene for kvinden ved behandling med sevelamercarbonat.
English: In a 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
Danish: I et 12 ugers studie med peritonealdialysepatienter sås dog lignende reduktioner af iPTH sammenlignet med patienter, der fik kalciumacetat.
English: The safety and efficacy of Renvela in children below the age of 6 years or in children with a BSA below 0.75 m2 have not been established.
Danish: Virkningen og sikkerheden af Renvela for børn under 6 år eller hos børn med en legemsoverfladeareal under 0,75 m er ikke klarlagt.
English: Pale yellow powder.
Danish: Lysegult pulver.
English: In pregnant rabbits given oral doses of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose).
Danish: Hos drægtige kaniner, der fik orale doser af sevelamerhydrochlorid via sondeernæring under organogenese, forekom en øgning af tidlig resorption i højdosisgruppen (tilsvarende dosis for mennesker var dobbelt den maksimale dosis i det kliniske studie).
English: Patients with CKD are predisposed to developing metabolic acidosis.
Danish: Patienter med kronisk nyresygdom kan udvikle metabolisk acidose.
English: - The active substance is sevelamer carbonate.
Danish: - Aktivt stof: sevelamercarbonat.
English: The recommended starting dose of this medicine for adults and elderly is 2.4-4.8 g per day equally divided over three meals.
Danish: Den anbefalede startdosis af dette lægemiddel for voksne og ældre er 2,4-4,8 g/dag ligeligt fordelt over tre måltider.
English: In patients not taking supplemental vitamins but on sevelamer, serum vitamin A, D, E and K status should be assessed regularly.
Danish: For patienter, der ikke tager vitamintilskud, men får sevelamer, bør A-, D-, E- og K-vitaminindholdet vurderes jævnligt.
English: Cases of serious inflammatory disorders of different parts of the gastrointestinal tract (including serious complications such as haemorrhage, perforation, ulceration, necrosis, colitis and colonic/caecal mass) associated with the presence of sevelamer crystals have been reported (see section 4.8).
Danish: Tilfælde af alvorlige inflammatoriske sygdomme i forskellige dele af mave-tarmkanalen (herunder alvorlige komplikationer såsom hæmoragi, perforation, ulceration, nekrose, colitis og svulst i colon/ coecum) forbundet med tilstedeværelsen af sevelamer krystaller er blevet rapporteret (se pkt.
English: Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Danish: Renvela er indiceret til kontrol af hyperfosfatæmi hos voksne patienter, der er i hæmodialyse eller peritonealdialyse.
English: The safety and efficacy in children (below the age of 6 years) have not been studied.
Danish: Sikkerheden og virkningen af Renvela er ikke undersøgt for børn (under 6 år).
English: • active inflammatory bowel disease
Danish: • aktiv inflammatorisk tarmsygdom
English: To achieve the correct dose, the dosing spoon provided in the carton must be used to measure 0.4 g of Renvela Powder.
Danish: For at opnå den korrekte dosis skal måleskeen i pakningen anvendes til at afmåle 0,4 g Renvela pulver.
English: Sevelamer hydrochloride did not impair the fertility of male or female rats in a dietary administration study in which the females were treated from 14 days prior to mating through gestation and the males were treated for 28 days prior to mating.
Danish: Sevelamerhydrochlorid hæmmede ikke fertiliteten hos han- eller hunrotter i et diætadministrationsstudie, hvor behandling af hunrotterne varede fra 14 dage inden parring og gennem hele gestationen, og hanrotterne blev behandlet i 28 dage inden parring.
English: Deficits in skeletal ossification were observed in several locations in foetuses of female rats dosed with sevelamer at intermediate and high doses (human equivalent dose less than the maximum clinical trial dose of 14.4 g).
Danish: Mangler i skeletal ossifikation blev observeret adskillige steder i hunrottefostre, som fik sevelamer i middelstore og høje doser (tilsvarende dosis for mennesker var mindre end den maksimale dosis på 14,4 g i det kliniske studie).
English: Very rare cases of hypothyroidism have been reported in patients co-administered with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, and levothyroxine.
Danish: Meget sjældne tilfælde af hypotyreose er rapporteret hos patienter ved samtidig indgivelse af sevelamerhydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, og levothyroxin.
English: The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.
Danish: Filmovertrækket indeholder hypromellose (E464) og diacetyleret monoglycerid.
English: You may develop peritonitis (infection of your abdominal fluid) associated with your peritoneal dialysis.
Danish: Du kan udvikle bughindebetændelse (peritonitis) i forbindelse med peritonealdialysen.
English: EU/1/09/521/002 180 (6 bottles of 30) film-coated tablets
Danish: EU/1/09/521/002 180 (6 glas med 30) filmovertrukne tabletter
English: For a 0.4 g dose: o Shake the sachet holding the top corner before opening, to move the powder to the bottom of the sachet o Open the sachet by tearing along the marked line.
Danish: Til en 0,4 g dosis: o Hold i det øverste hjørne af brevet, og ryst for at flytte pulveret til bunden af brevet, før åbning.
English: *post-marketing experience
Danish: *post-marketing erfaring Se advarsel vedr.
English: The suspension powder is pale yellow and has a citrus flavour.
Danish: Pulveret er lysegult og har citrussmag.
English: Caution should be exercised when prescribing PPI to patients concomitantly treated with Renvela.
Danish: Forsigtighed bør udvises ved ordinering af protonpumpehæmmere til patienter, der samtidig behandles med Renvela.
English: The powder may also be pre-mixed with cold beverage or unheated food (see 4.2).
Danish: Pulveret kan også opblandes i kold væske eller uopvarmet mad (se pkt.
English: For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Renvela should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Danish: Patienter, der tidligere har taget fosfatbindere (baseret på sevelamerhydrochlorid eller kalcium), bør indgives Renvela på gram til gram basis under overvågning af serumfosfatniveauet for at sikre en optimal daglig dosis.
English: The printing ink contains iron oxide black (E172), isopropyl alcohol and propylene glycol.
Danish: Trykfarven indeholder jernoxid sort (E172), isopropylalkohol og propylenglycol.
English: (Instructions for presentation with dosing spoon) The sachet has to be discarded after 24 hours of opening.
Danish: (Instruktioner til pakning med måleske) Brevet skal bortskaffes 24 timer efter anbrud.
English: Instead of water, the powder may be pre-mixed with a small amount of cold beverage (about 120 ml or half a glass) or food (about 100 grams) and consumed within 30 minutes.
Danish: Pulveret kan opblandes i lidt kold væske (omkring 120 ml eller et halvt glas) eller mad (omkring 100 gram) i stedet for vand og indtages indenfor 30 minutter.
English: Inflammatory disorders may resolve upon sevelamer discontinuation.
Danish: Inflammatoriske sygdomme kan forsvinde efter seponering af sevelamer.
English: The use of sevelamer carbonate powder in patients with a history of difficulty swallowing should be considered.
Danish: Brugen af sevelamercarbonat pulver til patienter, som tidligere har haft problemer med at sluge tabletter bør overvejes.
English: Total daily dose of sevelamer carbonate to be taken over 3 meals/snacks per day
Danish: Samlet daglig dosis sevelamercarbonat fordelt på 3 måltider/mellemmåltider per dag
English: (Instructions for presentation WITHOUT dosing spoon)
Danish: (Instruktioner til pakning UDEN måleske)
English: Your doctor may monitor the phosphate level in your blood.
Danish: Din læge kan måle fosfatniveauet i dit blod.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt
English: During post-marketing experience, very rare cases of increased phosphate levels have been reported in patients taking proton pump inhibitors co-administered with sevelamer carbonate.
Danish: Efter markedsføring er der rapporteret om meget sjældne tilfælde af forhøjede fosfatniveauer hos patienter hvor protonpumpehæmmere og sevelamercarbonat er administreret samtidig.
English: SANOFI-AVENTIS Zrt Tel: +36 1 505 0050
Danish: Magyarország SANOFI-AVENTIS Zrt Tel: +36 1 505 0050
English: 30 film-coated tablets 180 film-coated tablets
Danish: 30 filmovertrukne tabletter 180 filmovertrukne tabletter
English: For doses of less than 0.8 g, the powder in the sachet may be divided.
Danish: For doser mindre end 0,8 g kan pulveret i brevet opdeles.
English: As part of good clinical practice, monitoring of serum bicarbonate levels is therefore recommended.
Danish: Det anbefales derfor, at man som led i god klinisk praksis overvåger serumbikarbonat koncentrationen.
English: There was no increased incidence of tumours observed in mice (human equivalent dose 3 times the maximum clinical trial dose).
Danish: Der blev ikke observeret øget incidens af tumorer hos mus (tilsvarende dosis for mennesker er 3 gange den maksimale dosis i det kliniske studie).
English: You should tell your doctor immediately if you experience any new signs or symptoms of abdominal distress, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal rigidity, constipation, fever, chills, nausea or vomiting.
Danish: Tal straks med lægen, hvis du oplever nye tegn eller symptomer på mavebesvær, oppustet mave, mavesmerter, ømhed i maven, stivhed i maven, forstoppelse, feber, kulderystninger, kvalme eller opkastning.
English: Total daily dose of sevelamer carbonate to be taken over 3 meals per day
Danish: Samlet daglig dosis sevelamercarbonat fordelt på 3 måltider per dag
English: In CKD patients, the maximum average daily dose studied was 14.4 grams of sevelamer carbonate in a single daily dose.
Danish: Hos patienter med kronisk nyresygdom er den maksimale, gennemsnitlige, daglige dosis, der er undersøgt, 14,4 gram sevelamercarbonat som enkeltdosis.
English: In interaction studies in healthy volunteers, sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, decreased the bioavailability of ciprofloxacin by approximately 50% when coadministered with sevelamer hydrochloride in a single dose study.
Danish: I interaktionsstudier med raske forsøgspersoner reducerede sevelamerhydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, biotilgængeligeheden af ciprofloxacin med ca. 50 %, når dette blev administreret sammen med sevelamerhydrochlorid i et enkeltdosisstudie.
English: In some cases where Renvela should be taken at the same time as another medicine, your doctor may advise you to take this medicine 1 hour before or 3 hours after Renvela intake.
Danish: I nogle tilfælde, hvor Renvela skal tages sammen med anden medicin, vil lægen rådgive dig, hvis du skal tage den anden medicin 1 time før eller 3 timer efter, at du har taget Renvela.
English: The sachet has to be discarded after 24 hours of opening.
Danish: Brevet skal kasseres efter 24 timers åbning.
English: The recommended starting dose of sevelamer carbonate is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Danish: Den anbefalede startdosis af sevelamercarbonat er 2,4 g eller 4,8 g dagligt baseret på kliniske behov og serumfosfatniveau.
English: Renvela 800 mg film-coated tablets
Danish: Renvela 800 mg filmovertrukne tabletter
English: Paediatric dose based on BSA (m2)
Danish: Pædiatrisk dosis baseret på legemsoverfladeareal (m
English: Uncommon reports of difficulty swallowing the Renvela tablet have been reported.
Danish: Der er i ikke almindelige tilfælde rapporteret, at patienter har haft svært ved at sluge Renvela-tabletten.
English: Do not use this medicine after the expiry date stated on the bottle and carton after the letters “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på brevet og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In patients undergoing peritoneal dialysis additional monitoring of fat-soluble vitamins and folic acid is recommended, since vitamin A, D, E and K levels were not measured in a clinical study in these patients.
Danish: Det anbefales yderligere at overvåge niveauet af fedtopløselige vitaminer og folinsyre anbefales hos patienter i peritonealdialyse, da indholdet af A-, D-, E- og K-vitamin ikke blev målt i et klinisk studie med sådanne patienter.
English: In two randomised, cross over clinical trials, sevelamer carbonate has been shown to be therapeutically equivalent to sevelamer hydrochloride and therefore effective in controlling serum phosphorus in CKD patients on haemodialysis.
Danish: I to randomiserede, cross-over kliniske studier har sevelamercarbonat vist sig at være terapeutisk ækvivalent med sevelamerhydrochlorid og er derfor effektivt til kontrol af serumfosfat koncentrationen hos patieter med kronisk nyresygdom i hæmodialyse.
English: 60 sachets per carton 90 sachets per carton
Danish: Pakningsstørrelser: 60 breve pr. karton 90 breve pr. karton
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om Renvela findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: As an alternative to water, the powder may be pre-mixed with a small amount of beverage or food (e.g. 100grams/120 ml) and consumed within 30 minutes.
Danish: Alternativt til vand kan pulveret opblandes i lidt væske eller mad (fx 120 ml/100 gram) og indtages indenfor 30 minutter.
English: o Mix the powder from the dosing spoon in 30 mL of water.
Danish: o Opløs pulveret fra måleskeen i 30 ml vand.
English: Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the dose of Renvela when necessary to reach an adequate phosphate level.
Danish: I starten vil lægen måle indholdet af fosfat i dit blod hver 2.-4. uge og ændrer om nødvendigt doseringen af Renvela, så indholdet af fosfat kommer til at ligge på et passende niveau.
English: The recommended starting dose of sevelamer carbonate for adults is 2.4 g or 4.8 g per day based on clinical needs and serum phosphorus level.
Danish: Den anbefalede startdosis af sevelamercarbonat for voksne er 2,4 g eller 4,8 g dagligt baseret på kliniske behov og serumfosfatniveau.
English: EU/1/09/521/001 30 film-coated tablets EU/1/09/521/003 180 film-coated tablets
Danish: EU/1/09/521/001 30 filmovertrukne tabletter EU/1/09/521/003 180 filmovertrukne tabletter
English: Stir the suspension and drink it within 30 minutes of being prepared.
Danish: Rør rundt i suspensionen og drik den inden for 30 minuter.
English: By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer lowers the phosphorus concentration in the serum.
Danish: Ved at binde fosfat i mave-tarm-kanalen og reducere absorption, nedsætter sevelamer serumfosfat koncentrationen.
English: Your doctor should monitor the level of bicarbonate in your blood.
Danish: Din læge bør overvåge indholdet af bikarbonat i dit blod.
English: Do not heat Renvela powder (e.g. microwave) or add to hot foods or liquids.
Danish: Opvarm ikke Renvela pulver (fx i mikrobølgeovn) og tilsæt det ikke til varme madvarer eller væsker.
English: **Children and adolescents (>6 years of age and a BSA of >0.75m2) For paediatric patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated in increments based on patient's BSA, three times per day every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Danish: **Børn og unge (> 6 år og et legemsoverfladeareal > 0,75 m For pædiatriske patienter skal serumfosfatniveauet overvåges, og dosen af sevelamercarbonat titreres med forøgelser baseret på patients legemsoverfladeareal tre gange daglig hver 2.-4. uge, indtil et acceptabelt serumfosfatniveau er nået.
English: The suspension should be ingested within 30 minutes after being prepared.
Danish: Opløsningen skal indtages inden for 30 minutter efter forberedelse.
English: Renvela 800 mg film-coated tablets sevelamer carbonate
Danish: Renvela 800 mg filmovertrukne tabletter sevelamercarbonat
English: The safety and efficacy of sevelamer carbonate have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l.
Danish: Sikkerheden og virkningen af sevelamercarbonat er ikke klarlagt hos voksne patienter med kronisk nyresygdom, som ikke er i dialyse og med serumfosfat < 1,78 mmol/l.
English: • swallowing problems.
Danish: • synkevanskeligheder
English: Powder for oral suspension 90 sachets
Danish: Pulver til oral suspension 90 breve
English: In rats and dogs, sevelamer reduced absorption of fat soluble vitamins D, E and K (coagulation factors), and folic acid.
Danish: Sevelamer reducerede absorption af de fedtopløselige D-, E- og K-vitaminer (koagulationsfaktorer) og folinsyre hos rotter og hunde.
English: Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse reactions.
Danish: Sevelamerhydrochlorid, der indeholder samme aktive fragment som sevelamercarbonat, er blevet administreret til raske forsøgspersoner i doser på op til 14 gram dagligt i otte dage uden bivirkninger.
English: Proton pump inhibitors
Danish: Protonpumpehæmmere
English: The oral suspension must be administered within 30 minutes.
Danish: Efter rekonstituering Den orale suspension skal indtages inden for 30 minutter.
English: • if you experience severe abdominal pain, stomach or intestine disorders, or blood in the stool (gastrointestinal bleeding).
Danish: • hvis du oplever svære mavesmerter, mave eller tarmsygdomme, eller blod i afføringen (gastrointestinal blødning).
English: Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Danish: Renvela er også indiceret til kontrol af hyperfosfatæmi hos voksne patienter med kronisk nyresygdom, som ikke er i dialyse, men har et indhold af serumfosfat ≥ 1,78 mmol/l.
English: Bile acid binding by ion exchange resins is a well-established method of lowering blood cholesterol.
Danish: Galdesyrebinding vha. ionbytterresiner er en dokumenteret metode til reduktion af kolesterol i blodet.
English: Inflammatory gastrointestinal disorders
Danish: Inflammatoriske gastrointestinale sygdomme
English: Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
Danish: Derfor vil lægen nøje måle indholdet af tyreoidea-stimulerende hormon i dit blod.
English: Very common Common
Danish: Meget almindelig Almindelig Meget sjælden Ikke kendt
English: gastrointestinal necrosis*1, colitis*1,
Danish: gastrointestinal nekrose* colitis* intestinal svulst*
English: The second study demonstrated that sevelamer carbonate powder dosed three times per day was equivalent to sevelamer hydrochloride tablets dosed three times per day in 31 hyperphosphataemic (defined as serum phosphorus levels ≥ 1.78 mmol/l) haemodialysis patients over two randomised 4 week treatment periods (mean serum phosphorus time-weighted averages were 1.6 ± 0.5 mmol/l for sevelamer carbonate powder and 1.7 ± 0.4 mmol/l for sevelamer hydrochloride tablets).
Danish: Det andet studie påviste, at sevelamercarbonatpulver doseret tre gange dagligt var ækvivalent med sevelamerhydrochloridtabletter doseret tre gange dagligt hos 31 hyperfosfatæmiske (defineret som serum-fosfat-niveauer ≥ 1,78 mmol/l) hæmodialyse-patienter over to randomiserede 4-ugers behandlingsperioder (gennemsnitlig serumfosfat koncentration var 1,6 ± 0,5 mmol/l for sevelamercarbonatpulver og 1,7 ± 0,4 mmol/l for sevelamerhydrochloridtabletter).
English: o Do not tap the dosing spoon to compact the powder.
Danish: o Bank ikke på måleskeen for at få pulveret til at falde sammen.
English: Powder for oral suspension 60 sachets
Danish: Pulver til oral suspension 60 breve
English: Do not heat Renvela powder (e.g. microwave) or add to heated foods or liquids.
Danish: Opvarm ikke Renvela pulver (fx i mikrobølgeovn) og tilsæt ikke pulveret til opvarmede madvarer eller væsker.
English: (Instructions for presentation with dosing spoon) A 0.4 g dosing spoon is provided in the carton.
Danish: (Instruktioner til pakning med måleske) Der er en 0,4 g måleske i æsken.
English: What you need to know before you take Renvela 3.
Danish: Det skal du vide, før du begynder at tage Renvela
English: There was an increased incidence of urinary bladder transitional cell papilloma in male rats of the high dose group (human equivalent dose twice the maximum clinical trial dose of 14.4 g).
Danish: Der var en øget incidens af transitionalcellepapillom i urinblæren hos hanrotter i den gruppe, der fik den høje dosis (tilsvarende dosis for mennesker er dobbelt den maksimale dosis på 14,4 g administreret i det kliniske studie).
English: Sevelamer has also been shown to reduce the absorption of several vitamins including folic acid (see sections 4.4 and 5.3).
Danish: Det er også blevet påvist, at sevelamer reducerer absorption af flere vitaminer, inklusive folinsyre (se pkt.
English: *Plus subsequent titrating, see section “Titration and maintenance” Children/adolescents (>6 years of age and a BSA of >0.75m2) The recommended starting dose of sevelamer carbonate for children is between 2.4 g and 4.8 g per day based on the patient's BSA category.
Danish: Børn/unge (> 6 år og et legemsoverfladeareal > 0,75 m Den anbefalede startdosis af sevelamercarbonat for børn er mellem 2,4 g eller 4,8 g dagligt baseret på patientens legemsoverfladearealkategori.
English: o Fill the powder to the spoon level.
Danish: o Fyld måleskeen med pulver til kanten.
English: Each tablet contains 800 mg sevelamer carbonate.
Danish: Hver tablet indeholder 800 mg sevelamercarbonat.