FrancophonIA/ELRC3.0 huggingface dataset:
English: • carbamazepine (used to treat seizures [fits]);
Danish: • carbamazepin (anvendes til behandling af krampeanfald)
English: How does Vfend work?
Danish: Hvordan virker Vfend?
English: Current available data are described in section 5.1.
Danish: Det tilgængelige data er beskrevet i punkt 5.1.
English: Date of first authorisation: 15 January 2015 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 15. januar 2015 Dato for seneste fornyelse:
English: Additional treatments: Due to either your kidney condition or your dialysis treatment you may:
Danish: Øvrige behandlinger: På grund af enten din nyresygdom eller din dialysebehandling kan følgende gælde for dig:
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data):
English: Do not give this medicine to children below the age of 6 years because the safety and efficacy in children (below the age of 6 years) have not been studied.
Danish: Giv ikke dette lægemiddel til børn under 6 år, da sikkerheden og virkningen hos børn (under 6 år) ikke er undersøgt.
English: Frequency is not known.
Danish: Frekvens er ikke kendt.
English: o Discard sachets of powder that have been opened for more than 24 hours.
Danish: o Bortskaf breve med pulver, der har været åbne i mere end 24 timer.
English: The sachets are packaged in an outer carton.
Danish: Brevet er pakket i en ydre karton.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Danish: Non-kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet.
English: Constipation is a very common side effect.
Danish: Forstoppelse er en meget almindelig bivirkning.
English: Treatment of these patients with Sevelamer carbonate Winthrop should only be initiated after careful benefit/risk assessment.
Danish: Behandling af disse patienter med Sevelamer carbonate Winthrop bør først påbegyndes efter en omhyggelig benefit/risk assessment.
English: • if you have problems with motility (movement) in your stomach and bowel
Danish: • hvis du har problemer med motiliteten (bevægeligheden) i maven og tarmene
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: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR 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 den europæiske webportal for lægemidler.
English: • slow intestine motility (movement).
Danish: • nedsat tarmbevægelse (motilitet).
English: Most of adverse reactions reported were gastrointestinal in nature.
Danish: De fleste bivirkninger rapporteret var af gastrointestinal karakter.
English: Sevelamer carbonate Winthrop should be taken with food and not on an empty stomach.
Danish: Sevelamer carbonate Winthrop skal tages sammen med mad og ikke på tom mave.
English: Many of these cases involved patients with co-morbid conditions including swallowing disorders or oesophageal abnormalities.
Danish: Mange af disse tilfælde har involveret patienter med følgesygdomme, bl.a. synkeforstyrrelser eller esophagusabnormaliteter.
English: • Sevelamer carbonate Winthrop should not be taken at the same time as ciprofloxacin (an antibiotic).
Danish: • Sevelamer carbonate Winthrop må ikke tages på samme tid som ciprofloxacin (antibiotikum).
English: If you consider stopping your Sevelamer carbonate Winthrop treatment, contact your doctor or pharmacist first.
Danish: Hvis du overvejer at stoppe din Sevelamer carbonate Winthrop-behandling, skal du først kontakte din læge eller apotekspersonalet.
English: • diarrhoea,
Danish: • Diarré,
English: • have disturbed level of bicarbonate in your blood and increased acidity in the blood and other body tissue.
Danish: • Der har forstyrret indhold af bikarbonat i blodet, og øget surhedsgrad i blodet og andre kropsvæv.
English: The recommended starting dose of this medicine for adults and elderly is one to two tablets of 800 mg with each meal, 3 times a day.
Danish: Den anbefalede startdosis af dette lægemiddel for voksne ældre er en til to tabletter af 800 mg sammen med hvert hovedmåltid 3 gange dagligt.
English: It is unknown whether Sevelamer carbonate Winthrop is excreted in breast milk and may affect your baby.
Danish: Det vides ikke om Sevelamer carbonate Winthrop udskilles i modermælken, og kan påvirke din baby.
English: Each bottle contains 30 tablets or 180 tablets.
Danish: Hver tabletbeholder indeholder 30 tabletter eller 180 tabletter.
English: The recommended starting dose of Sevelamer carbonate Winthrop for children is based on their height and weight (used to calculate body surface area by your physician).
Danish: Den anbefalede startdosis af Sevelamer carbonate Winthrop til børn er baseret på deres højde og vægt (bruges til at beregne legemsoverfladeareal af lægen).
English: Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients
Danish: Ciclosporin, mycophenolatmofetil og tacrolimus hos transplantationspatienter
English: Interaction studies have not been conducted in patients on dialysis.
Danish: Der er ikke gennemført interaktionsstudier på patienter i dialyse.
English: Take Sevelamer carbonate Winthrop after your meal or with food.
Danish: Tag Sevelamer carbonate Winthrop efter eller sammen med din mad.
English: The most serious adverse reactions are hypersensitivity (very rare frequency), intestinal obstruction (not known frequency), ileus/subileus (not known frequency), intestinal perforation (not known frequency), serious inflammatory gastrointestinal disorders associated with the presence of sevelamer crystals (not known frequency).
Danish: De mest alvorlige bivirkninger er overfølsomhed (meget sjælden hyppighed), intestinal obstruktion (ikke kendt hyppighed), ileus/subileus (ikke kendt hyppighed), tarmperforation (ikke kendt hyppighed), alvorlige inflammatoriske gastrointestinale sygdomme forbundet med tilstedeværelsen af sevelamer krystaller (ikke kendt hyppighed).
English: Talk to your doctor who will decide if you can breastfeed your baby or not, and if it is necessary to stop Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop.
English: A total of 101 patients (6 to 18 years old with a BSA range of 0.8 m2 to 2.4 m2) were randomised in the study.
Danish: I alt blev 101 patienter (6 til 18 år med et legemsoverfladearealinterval på 0,8 m2 til 2,4 m2) randomiseret i studiet.
English: The potential risk of Sevelamer carbonate Winthrop during human pregnancy is unknown.
Danish: Den mulige risiko ved at tage Sevelamer carbonate Winthrop under graviditet er ukendt.
English: Constipation can be an early symptom of serious gastrointestinal adverse reactions.
Danish: Obstipation kan være et tidligt symptom på alvorlige gastrointestinale bivirkninger.
English: Your doctor will check for interactions between Sevelamer carbonate Winthrop and other medicines on a regular basis.
Danish: Lægen vil jævnligt kontrollere vekselvirkningen mellem Sevelamer carbonate Winthrop og eventuel anden medicin.
English: • if you have low levels of phosphate in your blood (your doctor will check this for you)
Danish: • hvis du har et lavt indhold af fosfat i blodet (lægen måler dette)
English: o Ensure the dosing spoon is dry.
Danish: o Sørg for at måleskeen er tør.
English: • if you have undergone major surgery on your stomach or bowel.
Danish: • hvis du har fået en større operation i maven eller tarmene
English: The recommended starting dose of this medicine for adults and elderly is 2.4-4.8g 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: Pharmacotherapeutic group: All other therapeutic products, drugs for treatment of hyperkalemia and hyperphosphataemia.
Danish: Farmakoterapeutisk klassifikation: Alle andre therapeutiske produkter, lægemidler til behandling af hyperkaliæmi og hyperfosfatæmi.
English: • if you are allergic to sevelamer carbonate or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer carbonate Winthrop.
Danish: • Virkningen af medicin såsom ciclosporin, mycophenolatmofetil og tacrolimus (medicin der anvendes til at hæmme immunsystemet) kan blive reduceret af Sevelamer carbonate Winthrop.
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 Sevelamer carbonate Winthrop.
Danish: • Medicin til behandling af halsbrand og reflux fra din mave eller spiserør, såsom omeprazol, pantoprazol eller lansoprazol, kendt som "protonpumpehæmmere", kan nedsætte Sevelamer carbonate Winthrops virkning.
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 carbonate therapy 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: Sevelamer carbonate Winthrop film-coated tablets are white to off-white tablets with SC800 imprinted on one side.
Danish: Sevelamer carbonate Winthrop filmovertrukne tabletter er hvide til offwhite og har SC800 trykt på den ene side.
English: Patients with CKD are predisposed to developing metabolic acidosis.
Danish: Patienter med CKD kan udvikle metabolisk acidose.
English: Each carton contains 90 sachets and a dosing spoon to measure the 0.4 g dose of powder.
Danish: Hver karton indeholder 90 breve samt en måleske til afmåling af 0,4 g dosis af pulveret.
English: • If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Sevelamer carbonate Winthrop.
Danish: • Hvis du tager medicin for problemer med hjerterytmen eller for epilepsi, skal du fortælle det til lægen, inden du tager Sevelamer carbonate Winthrop.
English: Your doctor can rather prescribe sevelamer carbonate powder for oral suspension.
Danish: Din læge kan ordinere sevelamarcarbonate pulver til oral suspension
English: Sevelamer carbonate Winthrop must be taken three times per day with meals.
Danish: Sevelamer carbonate Winthrop skal tages tre gange dagligt sammen med måltider.
English: Always use the dosing spoon provided in the carton.
Danish: Brug altid måleskeen i æsken.
English: - The other ingredients are microcrystalline cellulose, sodium chloride, zinc stearate, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172), isopropyl alcohol, propylene glycol and hypromellose (E464).
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, natriumchlorid og zinkstearat, hypromellose (E464), diacetyleret monoglycerid, jernoxid sort (E172), isopropylalkohol, propylenglycol og hypromellose (E464).
English: 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: 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: Sevelamer carbonate Winthrop contains sevelamer, a non-absorbed phosphate binding crosslinked polymer.
Danish: Sevelamer carbonate Winthrop indeholder sevelamer, en ikke-absorberbar fosfatbindende krydsbunden polymer.
English: The most frequently occurring (≥5% of patients) adverse reactions were all in the gastrointestinal disorders system organ class: nausea (very common), vomiting (very common), upper abdominal pain (very common), constipation (very common), diarrhea (common), dyspepsia (common) and flatulence (common).
Danish: De hyppigst forekommende (≥ 5 % af patienterne) bivirkninger var alle i systemorganklassen mave-tarmkanalen: kvalme (meget almindelig), opkastning (meget almindelig) abdominalsmerter (meget almindelig) obstipation (meget almindelig), diaré (almindelig), dyspepsi (almindelig) og flatulens (almindelig).
English: Special note for patients on peritoneal dialysis:
Danish: Patienter i peritonealdialyse:
English: In some cases where Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop intake.
Danish: I nogle tilfælde, hvor Sevelamer carbonate Winthrop tages sammen med anden medicin, vil lægen rådgiver dig, hvis du skal tage den anden medicin 1 time før eller 3 timer efter, at du har taget Sevelamer carbonate Winthrop.
English: 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: Diarrhoea, Dyspepsia, Flatulence, Abdominal pain
Danish: Diaré, dyspepsi, flatulens, abdominalsmerter
English: For children, the powder is preferred, as tablets are not appropriate for this population.
Danish: Pulveret anbefales til børn, da tabletter ikke er hensigtsmæssige til denne population.
English: Sevelamer carbonate Winthrop is unlikely to affect your ability to drive or to use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Sevelamer carbonate Winthrop påvirker din evne til at køre eller betjene maskiner.
English: Talk to your doctor who will decide if you can continue the treatment with Sevelamer carbonate Winthrop.
Danish: Tal med din læge, som vil afgøre, om du kan fortsætte behandlingen med Sevelamer carbonate Winthrop.
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: The phosphate serum level should be monitored and the Sevelamer carbonate dosage adjusted consequently.
Danish: Fosfat-serum niveauet bør overvåges, og sevelamercarbonate dosis justeret i overensstemmelse hermed.
English: The oral suspension must be administered within 30 minutes.
Danish: Den orale suspension skal indtages inden for 30 minutter.
English: Stopping Sevelamer carbonate Winthrop would lead to important consequences such as calcification in the blood vessels.
Danish: Hvis du holder op med at tage Sevelamer carbonate Winthrop kan det medføre alvorlige konsekvenser som forkalkning i blodkarrene.
English: For patients previously on phosphate binders (sevelamer hydrochloride or calcium based), Sevelamer carbonate Winthrop should be given on a gram for gram basis with monitoring of serum phosphorus levels to ensure optimal daily doses.
Danish: ”Titrering og vedligeholdelse” Patienter, der tidligere har taget fosfatbindere (baseret på sevelamerhydrochlorid eller kalcium), bør indgives Sevelamer carbonate Winthrop på gram til gram basis under overvågning af serumfosfatniveauet for at sikre en optimal daglig dosis.
English: These symptoms can be due to serious inflammatory bowel disease caused by sevelamer crystal deposit in your bowel.
Danish: Disse symptomer kan skyldes alvorlig inflammatorisk tarmsygdom grundet opbygning af sevelamerkrystaller i tarmen.
English: 90 sachets per carton
Danish: Pakningsstørrelse: 90 breve pr. karton
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 fosfatniveauet i blodet.
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: Sevelamer carbonate Winthrop powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal.
Danish: Sevelamer carbonate Winthrop pulver til oral suspension er et lysegult pulver, der leveres i et varmeforseglet foliebrev.
English: Sevelamer carbonate Winthrop must be taken three times per day with meals or snacks.
Danish: Sevelamer carbonate Winthrop skal tages tre gange dagligt sammen med måltider eller mellemmåltider.
English: If you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal.
Danish: Hvis du har glemt at tage Sevelamer carbonate Winthrop Hvis du har glemt en dosis, skal du springe den over og tage næste dosis til sædvanlig tid sammen med et måltid.
English: Do not heat Sevelamer carbonate Winthrop powder (e.g. microwave) or add to hot foods or liquids.
Danish: Opvarm ikke Sevelamer carbonate Winthrop pulver (fx i mikrobølgeovn) og tilsæt det ikke til varme madvarer eller væsker.
English: For a 2.4 g dose, the powder for oral suspension should be dispersed in 60 ml of water per sachet.
Danish: Til en 2,4 g dosis, skal pulveret til oral suspension opløses i 60 ml vand.
English: There was no increased incidence of tumors 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: Packs of 1 bottle of 30 tablets or bottles of 180 tablets without outer carton.
Danish: Pakninger af 1 tabletbeholder med 30 tabletter eller 180 tabletter uden yderkarton.
English: Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the dose of Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop, så indholdet af fosfat kommer til at ligge på et passende niveau.
English: Patients who are constipated should be monitored carefully while being treated with sevelamer carbonate.
Danish: Obstiperede patienter skal overvåges nøje under behandling med sevelamer carbonate.
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: Caution should be exercised when prescribing PPI to patients concomitantly treated with Sevelamer carbonate Winthrop.
Danish: Forsigtighed bør udvises ved ordinering af protonpumpehæmmere til patienter, der samtidig behandles med Sevelamer carbonate Winthrop.
English: Taking your Sevelamer carbonate Winthrop treatment is important to maintain an appropriate phosphate level in your blood.
Danish: Hvis du holder op med at tage Sevelamer carbonate Winthrop Det er vigtigt, at du tager Sevelamer carbonate Winthrop, for at opretholde et passende fosfatindhold i dit blod.
English: • if you have swallowing problems.
Danish: • hvis du har problemer med at synke.
English: Sevelamer carbonate Winthrop 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: Sevelamer carbonate Winthrop er indiceret til kontrol af hyperfosfatæmi hos pædiatriske patienter (> 6 år og et legemsoverfladeareal > 0,75 m2) med kronisk nyresygdom.
English: In case of constipation, please inform your doctor or pharmacist if you experience it.
Danish: I tilfælde af forstoppelse, skal du fortælle det til lægen eller apotekspersonalet.
English: • if you have active inflammation of the bowel
Danish: • hvis du har aktiv betændelse i tarmen
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 blevadministreret sammen med sevelamerhydrochlorid i et enkeltdosisstudie.
English: Each film-coated tablet contains 800 mg of sevelamer carbonate.
Danish: Hver filmovertrukket tablet indeholder 800 mg sevelamercarbonat.
English: EU/1/14/952/001 180 film-coated tablets
Danish: EU/1/14/952/001 180 filmovertrukne tabletter
English: The anti-arrhythmic medical product should be taken at least one hour before or three hours after Sevelamer carbonate Winthrop, and blood monitoring can be considered.
Danish: Antiarytmika bør tages mindst én time før eller tre timer efter Sevelamer carbonate Winthrop, og blodovervågning kan overvejes.
English: Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Danish: Sevelamer carbonate Winthrop er indiceret til kontrol af hyperfosfatæmi hos voksne patienter, der er i hæmodialyse eller peritonealdialyse.
English: EU/1/14/952/004 30 film-coated tablets
Danish: EU/1/14/952/004 30 filmovertrukne tabletter
English: • Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treat low thyroid hormone levels) and Sevelamer carbonate Winthrop.
Danish: • Underskud af stofskiftehormoner ses i sjældne tilfælde hos visse personer, der tager levothyroxin (bruges til at behandle lavt indhold af tyreoideahormon) og Sevelamer carbonate Winthrop.
English: • if you have bowel obstruction
Danish: • hvis du har tilstoppede tarme
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: You must take Sevelamer carbonate Winthrop as prescribed by your doctor.
Danish: Tag altid Sevelamer carbonate Winthrop nøjagtigt efter lægens anvisning.