FrancophonIA/ELRC3.0 huggingface dataset:
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Tasermity.
Danish: • Effekten af medicin såsom ciclosporin, mycophenolatmofetil og tacrolimus (medicin, som anvendes til transplantationspatienter) kan reduceres af Tasermity.
English: Long term chronic treatment
Danish: Langtidsbehandling
English: In animal studies there was no evidence that sevelamer induced embryo-foetal toxicity.
Danish: Ved dyrestudier var der ingen tegn på, at sevelamer medførte embryoføtal toksicitet.
English: Serum calcium levels should be monitored as is done in normal follow-up of a dialysis patient.
Danish: Serumcalciumniveauerne bør monitoreres, som det sker ved normal opfølgning af dialysepatienter.
English: One gram of sevelamer hydrochloride contains approximately 180 mg (5.1 mEq) chloride.
Danish: Et gram sevelamerhydrochlorid indeholder cirka 180 mg (5,1 mEq) chlorid.
English: The possibility of an interaction cannot be excluded and a close monitoring of blood concentrations of mycophenolate mofetil, ciclosporin and tacrolimus should be considered during the use of combination and after its withdrawal.
Danish: Muligheden for en interaktion kan ikke udelukkes og nøje monitorering af blodkoncentrationerne af mycophenolatmofetil, ciclosporin og tacrolimus bør overvejes ved kombinationsbehandling, og efter behandlingen er afsluttet.
English: • patients with a history of major gastrointestinal surgery
Danish: • patienter med større gastrointestinale kirurgiske indgreb i anamnesen.
English: The amount of phosphate then rises (your doctor will call this hyperphosphataemia).
Danish: Mængden af fosfat stiger således (dette kaldes hyperfosfatæmi).
English: In some cases where Tasermity 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 Tasermity intake, or he/she may consider monitoring the blood levels of that medicine.
Danish: I visse tilfælde, hvor Tasermity skal tages samtidigt med anden medicin, kan din læge råde dig til at tage medicinen 1 time før eller 3 timer efter du har taget Tasermity, eller han/hun kan overveje at kontrollere blodets indhold af medicinen.
English: Very rare (may affect up to 1 in 10000 people): hypersensitivity.
Danish: Meget sjælden (kan påvirke op til 1 ud af 10.000 personer): overfølsomhed.
English: Sevelamer decreases the incidence of hypercalcaemic episodes as compared to patients using calcium based phosphate binders alone, probably because the product itself does not contain calcium.
Danish: Sevelamer nedsætter forekomsten af hypercalcæmi-tilfælde sammenlignet med patienter, der alene indtager calcium-baserede phosphatbindemidler, formentlig fordi selve præparatet ikke indeholder calcium.
English: Therefore, patients on PD should be closely monitored to ensure the reliable use of appropriate aseptic technique with the prompt recognition and management of any signs and symptoms associated with peritonitis.
Danish: Patienter i peritonealdialyse skal derfor overvåges nøje for at sikre pålidelig brug af aseptisk teknik samt øjeblikkelig erkendelse og behandling af tegn og symptomer på peritonitis.
English: Serum phosphate levels should be closely monitored and the dose of sevelamer hydrochloride titrated by 0.8 g three times per day (2.4 g/day) increments with the goal of lowering serum phosphate to 1.76 mmol/L (5.5 mg/dl) or less.
Danish: Serumphosphatniveauerne bør nøje monitoreres, og dosen af sevelamerhydrochlorid titreres med 0,8 g forøgelse tre gange dagligt (2,4 g/dag) med det formål at sænke serumphosphatet til 1,76 mmol/l (5,5 mg/dl) eller derunder.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL with Blue Box - 1 BOTTLE OF 180 TABLETS 800 mg WITHOUT OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKET med blå boks- 1 FLASKE MED 180 TABLETTER 800 mg UDEN YDRE PAKNING
English: Patients receiving dialysis are subject to certain risks for infection specific to the dialysis modality.
Danish: Patienter i dialyse er i en vis risiko for infektion, der er specifik for dialysemetoden.
English: Patients should take sevelamer hydrochloride with meals and adhere to their prescribed diets.
Danish: Patienterne bør indtage sevelamerhydrochlorid sammen med måltider og holde sig til deres foreskrevne diæter.
English: These amines become partially protonated in the intestine and interact with phosphate molecules through ionic and hydrogen bonding.
Danish: Disse aminer bliver delvist protoneret i tarmen og reagerer med phosphatmolekyler gennem ion- og hydrogenbinding.
English: Although no clinically significant serum chloride increase has been observed in the clinical studies, serum chloride should be monitored as is done in the routine follow-up of a dialysis patient.
Danish: Selv om der ikke er observeret nogen klinisk signifikant forøgelse af serumchlorid i de kliniske studier bør serumchlorid monitoreres, som det sker ved rutinemæssig opfølgning hos en dialysepatient.
English: Sevelamer hydrochloride has been given to normal healthy volunteers in doses up to 14 grams, the equivalent of seventeen 800 mg tablets, per day for eight days with no undesirable effects.
Danish: Sevelamerhydrochlorid er blevet givet til almindelige, raske frivillige i doser på op til 14 gram, hvilket svarer til 17 tabletter af 800 mg pr. dag i otte dage uden bivirkninger.
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: Du skal omgående fortælle lægen det, hvis du oplever nye tegn eller symptomer på fordøjelsesproblemer, opsvulmet mave, mavesmerter, maveømhed eller stivhed i maven, forstoppelse, feber, kuldegysninger, kvalme og opkastning.
English: You should expect to be monitored more carefully for problems with low levels of vitamins A, D, E, K and folic acid.
Danish: Desuden skal du forvente at blive overvåget nøjere for problemer med lave niveauer af vitamin A, D, E, K og folat.
English: Peritonitis is a known complication in patients receiving peritoneal dialysis (PD) and in a clinical study with sevelamer hydrochloride, a number of peritonitis cases were reported.
Danish: Peritonitis er en kendt komplikation hos patienter i peritonealdialyse (PD), og i et klinisk studie med sevelamerhydrochlorid blev et antal peritonitistilfælde rapporteret.
English: Therefore, in patients not taking these vitamins, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of thromboplastin time should be considered and the vitamins should be supplemented if necessary.
Danish: Hos patienter, der ikke tager disse vitaminer, bør det derfor overvejes nøje at monitorere niveauerne af A-, D- og E-vitamin og vurdere status af vitamin-K gennem måling af tromboplastintid og om nødvendigt give vitamintilskud.
English: Deficits in skeletal ossification were observed in several locations in fetuses of female rats dosed with sevelamer at 8-20 times the maximum human dose of 200 mg/kg.
Danish: Manglende skeletal ossifikation blev observeret flere steder på fostre hos hunrotter, der havde modtaget doser af sevelamer på 8-20 gange den maksimale humane dosis på 200 mg/kg.
English: Elemental calcium should be given as a supplement in case of hypocalcaemia.
Danish: Der bør gives usammensat calcium som tilskud i tilfælde af hypokalcæmi.
English: When administering any medicinal product where a reduction in the bioavailability could have a clinically significant effect on safety or efficacy, the medicinal product should be administered at least one hour before or three hours after sevelamer hydrochloride, or the physician should consider monitoring blood levels.
Danish: Ved indgivelse af et lægemiddel, hvor en reduktion af biotilgængeligheden kan have en klinisk signifikant effekt på sikkerheden og virkningen, skal det pågældende lægemiddel indgives mindst en time inden eller tre timer efter sevelamerhydrochlorid, eller lægen bør overveje at måle blodkoncentrationerne.
English: • if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory bowel disease)
Danish: • Hvis du har længerevarende diarré eller smerter i maven (symptomer på inflammatorisk tarmsygdom)
English: Patients with chronic renal failure are predisposed to developing metabolic acidosis.
Danish: Patienter med kronisk nyreinsufficiens er disponeret for at udvikle metabolisk acidose.
English: In a study in rats, administering sevelamer in 15-30 x the human dose, an increase in serum copper was detected.
Danish: Ved et studie på rotter, hvor sevelamer blev indgivet i 15-30 gange den humane dosis, blev der fundet en forøgelse af serumkobber.
English: If you do not take multivitamin supplements you may also develop low levels of vitamins A, E, K and folic acid in your blood and therefore your doctor may monitor these levels and prescribe supplemental
Danish: Hvis du ikke tager multivitamintilskud, kan du også udvikle lave niveauer af vitamin A, E, K og folat i blodet, og lægen kan derfor holde øje med disse niveauer og ordinere vitamintilskud
English: Worsening of acidosis has been reported upon switching from other phosphate binders to sevelamer in a number of studies where lower bicarbonate levels in the sevelamer-treated patients compared to patients treated with calcium-based binders were observed.
Danish: Forværring af acidose er rapporteret efter skift fra andre phosphatbindere til sevelamer i en række studier, hvor der blev observeret lavere bicarbonatniveauer hos patienter, der blev behandlet med sevelamer, sammenlignet med patienter, der blev behandlet med calciumbaserede bindere.
English: Your doctor will advise you if you are taking these medicines.
Danish: Lægen vil rådgive dig, hvis
English: Sevelamer hydrochloride alone is not indicated for the control of hyperparathyroidism.
Danish: Sevelamerhydrochlorid alene er ikke indiceret til kontrol af hyperparathyreose.
English: For patients previously on phosphate binders, Sevelamer hydrochloride 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 phosphatbindere, bør have sevelamerhydrochlorid på gram til gram basis under monitorering af serumphosphatniveauet for at sikre en optimal daglig dosis.
English: Depending on diet intake and the nature of end stage renal failure, dialysis patients may develop low vitamin A, D, E and K levels.
Danish: Afhængigt af fødeindtagelse og graden af terminal nyresvigt kan dialysepatienter udvikle lave niveauer af A-, D-, E- og K-vitamin.
English: Serum chloride may increase during sevelamer hydrochloride treatment as chloride may be exchanged for phosphorus in the intestinal lumen.
Danish: Serumchlorid kan blive forøget under behandling med sevelamerhydrochlorid, idet chlorid kan udveksles med phosphor i det intestinale lumen.
English: Do not use this medicine after the expiry date stated on the bottle after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Sevelamer has been shown to bind bile acids in vitro and in vivo in experimental animal models.
Danish: Sevelamer har vist sig at binde galdesyrer in vitro og in vivo ved dyreforsøgsmodeller.
English: Pharmacokinetic studies have not been carried out in renal failure patients (see section 4.4).
Danish: Der er ikke gennemført farmakokinetiske studier hos patienter med nyresvigt (se pkt.
English: Ciclosporin, mycophenolate mofetil and tacrolimus in transplant patients Reduced levels of ciclosporin, mycophenolate mofetil and tacrolimus have been reported in transplant patients when coadministered with sevelamer hydrochloride without any clinical consequences (i.e graft rejection).
Danish: Ciclosporin, mycophenolatmofetil og tacrolimus hos transplantationspatienter Reducerede ciclosporin-, mycophenolatmofetil- og tacrolimus-niveauer er blevet rapporteret hos transplantationspatienter co-administreret sevelamerhydrochlorid uden kliniske konsekvenser (dvs. organafstødning).
English: Iron oxide black (E172) Propylene glycol Hypromellose (E464)
Danish: Sort jernoxid (E172) Propylenglycol Hypromellose (E464)
English: In interaction studies in healthy volunteers, sevelamer hydrochloride had no effect on the bioavailability of digoxin, warfarin, enalapril or metoprolol.
Danish: Ved interaktionsstudier med raske frivillige havde sevelamerhydrochlorid ingen virkning på biotilgængeligheden af digoxin, warfarin, enalapril eller metoprolol.
English: - The other ingredients are silica colloidal anhydrous and stearic acid, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172) and propylene glycol.
Danish: - Øvrige indholdsstoffer: kolloid vandfri silica og stearinsyre, hypromellose (E464), diacetylerede monoglycerider, sort jernoxid (E172) og propylenglycol.
English: Renal impairment The safety and efficacy of this product have not been established in predialysis patients.
Danish: Nedsat nyrefunktion Sikkerheden og virkningen af dette lægemiddel er ikke dokumenteret hos prædialysepatienter.
English: Common (may affect up to 1 in 10 people): diarrhoea, indigestion, abdominal pain, constipation, flatulence.
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer): diaré, fordøjelsesproblemer, mavesmerter, forstoppelse, luftafgang fra tarmen.
English: Sevelamer hydrochloride does not contain calcium.
Danish: Sevelamerhydrochlorid indeholder ikke calcium.
English: In the 12 week study involving peritoneal dialysis patients however, similar iPTH reductions were seen compared with patients receiving calcium acetate.
Danish: I det 12 ugers lange studie, som omfatter patienter i peritonealdialyse, blev der dog set lignende iPTH-reduktioner sammenlignet med patienter, som modtog calciumacetat.
English: - If you get any side effects talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Patients who are constipated should be monitored carefully while being treated with sevelamer hydrochloride.
Danish: Patienter med obstipation skal overvåges omhyggeligt, medens de behandles med sevelamerhydrochlorid.
English: Additional monitoring of vitamins and folic acid is recommended in patients receiving peritoneal dialysis, since in the clinical study, vitamin A, D, E and K levels were not measured in these patients.
Danish: Ekstra monitorering af vitaminer og folat anbefales hos patienter i peritonealdialyse, eftersom niveauet af A-, D-, E- og Kvitamin ikke blev målt i kliniske studier hos sådanne patienter.
English: Not known (frequency cannot be estimated from the available data): cases of itching, rash, abdominal pain, slow intestine motility (movement), blockages in the intestine, inflammation of abnormal small pouches (called diverticula) in the large intestine and perforation in the intestine wall have been reported.
Danish: Ikke kendt (kan ikke vurderes ud fra tilgængelige data): kløe, udslæt, mavesmerter, nedsat bevægelse i tarmene (tarmmotilitet), forstoppelse, betændelse i udposninger (kaldet divertikler) af tyktarmen og perforering af tarmvæggen er blevet rapporteret.
English: Patients taking Tasermity should adhere to their prescribed diet and liquid intake.
Danish: Patienter, der tager Tasermity, skal holde sig til deres foreskrevne diæt og væskeindtagelse.
English: Uncommon (may affect up to 1 in 100 people): increased acidity of the blood.
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 personer): For meget syre i blodet.
English: Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary.
Danish: Din læge kan derfor finde det hensigtsmæssigt at følge D-vitaminkoncentrationen i blodet og om nødvendigt give ekstra D-vitamintilskud.
English: In a clinical trial of one-year duration, sevelamer hydrochloride had no adverse effect on bone turnover or mineralisation compared to calcium carbonate.
Danish: I et klinisk studie af et års varighed viste sevelamerhydrochlorid ingen negativ påvirkning af knogleomsætning eller mineralisering sammenlignet med calciumcarbonat.
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with sevelamer hydrochloride.
Danish: I meget sjældne tilfælde er der observeret tarmobstruktion og ileus/subileus hos patienter under behandling med sevelamerhydrochlorid.
English: Inflammatory Gastrointestinal Disorders
Danish: Inflammatoriske gastrointestinale sygdomme
English: In the clinical studies in haemodialysis patients, sevelamer hydrochloride alone did not have a consistent and clinically significant effect on serum intact parathyroid hormone (iPTH).
Danish: I kliniske studier med hæmodialysepatienter havde sevelamerhydrochlorid givet alene ikke nogen vedvarende og klinisk signifikant virkning på serumintakt parathyroideahormon (iPTH).
English: In interaction studies in healthy volunteers, sevelamer hydrochloride decreased the bioavailability of ciprofloxacin by approximately 50% when co-administered with sevelamer hydrochloride in a single dose study.
Danish: Ved interaktionsstudier på raske frivillige reducerede sevelamerhydrochlorid ciprofloxacins biotilgængelighed med cirka 50 % ved samtidig indgivelse af sevelamerhydrochlorid i et enkeltdosisstudie.
English: nausea and/or vomiting
Danish: kvalme og/eller opkastning
English: • if you have problems with motility (movement) in your stomach and bowel
Danish: • Hvis du har problemer med bevægelserne (motiliteten) i mave-tarm-kanalen
English: • if you have swallowing problems
Danish: • Hvis du har synkebesvær
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: Tasermity is unlikely to affect your ability to drive or to use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Tasermity påvirker din evne til at køre bil eller betjene maskiner.
English: Each tablet contains 800 mg sevelamer hydrochloride.
Danish: Hver tablet indeholder 800 mg sevelamerhydrochlorid.
English: Do not crush, chew or break into pieces prior to swallowing.
Danish: De må ikke knuses, tygges eller brækkes i stykker inden indtagelse.
English: - The active substance is sevelamer hydrochloride.
Danish: - Aktivt stof: sevelamerhydrochlorid.
English: Anti-arrhythmics and anti-seizure medicinal products 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 i behandling med antiarytmika til kontrol af arytmier og antiepileptika mod krampeanfald blev ekskluderet fra de kliniske studier.
English: • If you are taking medicine such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor when taking Tasermity.
Danish: • Hvis du tager medicin til behandling af halsbrand, gastroøsofageal reflukssygdom (GØRS) eller mavesår, såsom omeprazol, pantoprazol, eller lansoprazol, skal du konsultere din læge, når du tager Tasermity.
English: Serum phosphate level in patients not on
Danish: Serumphosphatniveauer hos patienter,
English: Abdominal pain, intestinal obstruction, ileus/subileus, diverticulitis, intestinal perforation
Danish: Mavesmerter, tarmobstruktion, ileus/subileus, divertikulitis og tarmperforation.
English: Film-coated tablet (tablet) The off-white, oval tablets are imprinted with “SH800” on one side.
Danish: Tabletter, filmovertrukne De off-white, ovale tabletter har påtrykt ”SH800” på den ene side.
English: • gastrointestinal motility disorders including untreated or severe gastroparesis, diverticulosis,
Danish: • gastrointestinale motilitetsproblemer, inklusive ubehandlet eller svær gastroparese, retention af ventrikelindhold pga. divertikulose, unormal eller uregelmæssig tarmbevægelse
English: It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood.
Danish: Det binder fosfat fra levnedsmidler i fordøjelseskanalen og reducerer derved fosfatkoncentrationen i blodet.
English: Tasermity 800 mg
Danish: 800 mg
English: Serum chloride
Danish: Serumchlorid
English: Bile acid binding by ion exchange resins is a well-established method of lowering blood cholesterol.
Danish: Galdesyrebinding ved ionbytter-resiner er en anerkendt måde at sænke blodets kolesteroltal på.
English: Tasermity tablets are film-coated, off-white, oval tablets with “SH800” imprinted on one side.
Danish: Tasermity er filmovertrukne, offwhite, ovale tabletter, som har påtrykt ”SH800” på én side.
English: The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and an induction seal.
Danish: Tabletterne er pakket i meget tætte polythylenflasker med børnesikret polypropylenhætte samt et induktionssegl.
English: 1 tablet, 3 times per day 2 tablets, 3 times per day
Danish: Startdosis Sevelamerhydrochlorid 800 mg tabletter 1 tablet 3 gange dagligt 2 tabletter 3 gange dagligt
English: EU/1/14/953/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/953/001
English: Acidosis, increased chloride
Danish: Acidose, forhøjede chloridniveauer i serum
English: Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate in their blood.
Danish: Voksne patienter med nyresvigt, og som er i hæmodialyse eller peritonealdialyse, kan ikke opretholde normalt serumfosfatniveau i blodet.
English: Sevelamer hydrochloride treatment should be re-evaluated in patients who develop severe gastrointestinal symptoms.
Danish: Sevelamerhydrochlorid behandling skal reevalueres hos patienter, som udvikler svære gastrointestinale symptomer.
English: Sevelamer hydrochloride should only be given to breast-feeding women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the infant (see section 5.3).
Danish: Sevelamerhydrochlorid bør kun gives til ammende kvinder, hvis det er strengt nødvendigt, og først efter at der er blevet gennemført en omhyggelig afvejning af risici og fordele for såvel mor som barn (se pkt.
English: Caution should be exercised when prescribing sevelamer hydrochloride to patients also taking these medicinal products.
Danish: Der skal udvises forsigtighed ved ordination af sevelamerhydrochlorid til patienter, der også tager sådanne lægemidler.
English: HDPE bottles, with a child resistant polypropylene closure and a foil induction seal.
Danish: HPDE-flasker med et børnesikret polypropylenhætte og en induktionsforsegling af folie.
English: Sevelamer hydrochloride has no or negligible influence on the ability to drive and use machines.
Danish: Sevelamerhydrochlorid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Sevelamer hydrochloride 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 (see section 5.3).
Danish: Sevelamerhydrochlorid bør kun gives til gravide kvinder, hvis det er strengt nødvendigt, og først efter at der er blevet gennemført en omhyggelig afvejning af risici og fordele for såvel mor som foster (se pkt.