FrancophonIA/ELRC3.0 huggingface dataset:
English: It should not be heated (e.g. microwaved) or added to heated foods or liquids.
Danish: Det må ikke opvarmes (f.eks. i mikrobølgeovn) eller tilsættes opvarmede madvarer eller væsker.
English: Animal studies showed no effects on reproductive function or fertility (see section 5.3).
Danish: Dyrestudier viste ingen virkninger på forplantningsfunktion eller fertilitet (se pkt.
English: Low Magnesium
Danish: Lavt niveau af magnesium
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 July 2017
Danish: Dato for første markedsføringstilladelse: 19 juli 2017
English: When discontinuing patiromer, serum potassium levels may rise, especially if RAAS inhibitor treatment is continued.
Danish: Ved ophør af behandling med patiromer kan serumkaliumniveauerne stige, især hvis behandling med RAAS-inhibitor fortsættes.
English: Your doctor will check the magnesium level during treatment with Veltassa for at least 1 month and may prescribe a magnesium supplement if required.
Danish: Din læge vil kontrollere dit magnesiumniveau under behandlingen med Veltassa i mindst 1 måned og om nødvendigt ordinere magnesiumtilskud.
English: If a dose is missed, the missed dose should be taken as soon as possible on the same day.
Danish: Hvis en dosis glemmes, skal den glemte dosis tages så hurtigt som muligt samme dag.
English: If powder remains in the glass after drinking, more water should be added and the suspension stirred and taken immediately.
Danish: Hvis der stadig er pulver tilbage i glasset, når indholdet er drukket, skal der tilsættes mere vand, og suspensionen skal omrøres og indtages med det samme.
English: In radiolabeled studies in rats and dogs, patiromer was not systemically absorbed and was excreted in the faeces.
Danish: I radiomærkede forsøg med rotter og hunde blev patiromerne ikke systemisk absorberet og blev udskilt i fæces.
English: In an open label study to assess the time to onset of action, a statistically significant reduction in serum potassium in hyperkalaemic patients was observed at 7 hours after the first dose.
Danish: I et ikke-blindet forsøg til vurdering af tiden til indsættelse af virkning blev der observeret en statistisk signifikant reduktion i serumkalium hos hyperkaliæmiske patienter 7 timer efter den første dosis.
English: Veltassa has no or negligible influence on your ability to drive and use machines.
Danish: Veltassa påvirker ikke eller kun i ubetydelig grad din evne til at føre motorkøretøj og betjene maskiner.
English: Veltassa is used to treat adults with high levels of potassium in their blood.
Danish: Veltassa anvendes til at behandle voksne, der har høje niveauer af kalium i blodet.
English: 92042 Paris La Défense Cedex France
Danish: 92042 Paris La Défense Cedex Frankrig
English: Can be stored below 25°C for up to 6 months.
Danish: Kan opbevares under 25°C i op til 6 måneder.
English: The recommended starting dose is 8.4 g patiromer once daily.
Danish: Den anbefalede startdosis er 8,4 g patiromer én gang dagligt.
English: There are no data on the effect of patiromer on fertility in humans.
Danish: Der er ingen data om virkningen af patiromer på fertiliteten hos mennesker.
English: Another approximately 40 mL of water should be added, and the suspension stirred again thoroughly.
Danish: Yderligere ca. 40 ml vand tilføjes, og herefter skal suspensionen omrøres grundigt igen.
English: Veltassa contains sorbitol.
Danish: Veltassa indeholder sorbitol.
English: Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. RAAS inhibitors or diuretics) and after the patiromer dose is titrated.
Danish: Serumkalium bør overvåges ved klinisk indikation, også efter der foretages medicinændringer, der påvirker serumkaliumkoncentrationen (f.eks. RAAS-inhibitorer eller diuretika), og efter patiromerdosis er titreret.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til indehaveren af markedsføringstilladelsen
English: Never heat Veltassa or add it to heated foods or liquids.
Danish: Veltassa må aldrig opvarmes eller tilføjes til opvarmede madvarer eller væsker.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: I hver hyppighedsgruppe er bivirkningerne anført efter faldende alvorlighedsgrad.
English: Hypomagnesaemia was mild to moderate, with no patient developing a serum magnesium level <1 mg/dL (0.4 mmol/L).
Danish: Hypomagnesæmi var mild til moderat, og ingen patient udviklede et niveau af serummagnesium < 1 mg/dl (0,4 mmol/l).
English: Veltassa is indicated for the treatment of hyperkalaemia in adults.
Danish: Veltassa er indiceret til behandling af hyperkaliæmi hos voksne.
English: In vitro studies have shown no potential interaction of patiromer with the following active substances: allopurinol, amoxicillin, apixaban, acetylsalicylic acid, atorvastatin, cephalexin, digoxin, glipizide, lisinopril, phenytoin, riboflavin, rivaroxaban, spironolactone and valsartan.
Danish: In vitro-studier viste ingen potentiel interaktion mellem patiromer og følgende aktive stoffer: allopurinol, amoxicillin, apixaban, acetylsalicylsyre, atorvastatin, cephalexin, digoxin, glipizid, lisinopril, phenytoin, riboflavin, rivaroxaban, spironolacton og valsartan.
English: Quantitative whole-body autoradiography analysis in rats demonstrated that radioactivity was limited to the gastrointestinal tract, with no detectable level of radioactivity in any other tissues or organs.
Danish: Kvantitativ helkrops-autoradiografianalyse hos rotter demonstrerede, at radioaktiviteten var begrænset til mave-tarm-kanalen, uden påviselige radioaktive niveauer i andre væv eller organer.
English: powder for oral suspension 30 sachets
Danish: pulver til oral suspension 30 breve
English: The European Medicines Agency has deferred the obligation to submit the results of studies with patiromer in one or more subsets of the paediatric population in the treatment of hyperkalaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med patiromer i én eller flere undergrupper af den pædiatriske population ved behandling af hyperkaliæmi (se pkt.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen.
English: 8.4 g, 16.8 g or 25.2 g of patiromer, as powder in sachets made of five layers: polyethylene, aluminium, polyethylene, polyester and paper.
Danish: 8,4 g, 16,8 g eller 25,2 g patiromerpulver i breve bestående af fem lag: polyethylen, aluminium, polyethylen, polyester og papir.
English: Take all medicines taken by mouth at least 3 hours before or after you take Veltassa, unless your doctor or pharmacist gives you different advice.
Danish: Tag alle lægemidler, der indtages gennem munden, mindst 3 timer før eller efter at du har taget Veltassa, medmindre din læge eller apotekspersonalet har anvist andet.
English: Patiromer has been studied only in a limited number of patients with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m² and patients receiving dialysis treatment.
Danish: Patiromer er kun blevet undersøgt hos et begrænset antal patienter med anslået glomerulær filtrationshastighed (eGFR) <15 ml/min/1,73 m² samt patienter, der får dialysebehandling.
English: In Part B, serum potassium in patients on placebo increased significantly relative to patients who remained on patiromer (p<0.001).
Danish: I Del B steg serumkaliumniveauet hos patienter, der fik placebo, betydeligt i forhold til patienter, der stadig fik patiromer (p < 0,001).
English: Take Veltassa at least 3 hours before or after other medicines taken by mouth unless your doctor or pharmacist gives you different advice.
Danish: Tag Veltassa mindst 3 timer før eller 3 timer efter andre lægemidler, der indtages gennem munden, medmindre din læge eller apotekspersonalet har anvist andet.
English: The sorbitol content is approximately 4 g (10.4 kcal) per 8.4 g of patiromer.
Danish: Sorbitol-indholdet er ca. 4 g (10,4 kcal) pr. 8,4 g patiromer.
English: If serum potassium falls below the desired range, the dose should be reduced or discontinued.
Danish: Hvis serumkaliumniveauet falder under det ønskede målinterval, bør dosen reduceres, eller behandlingen ophøre.
English: If you stop taking Veltassa
Danish: Hvis du holder op med at tage Veltassa
English: Patiromer is excreted after approximately 24 to 48 hours, based on average gastrointestinal transit time.
Danish: Patiromer udskilles efter ca. 24 til 48 timer, baseret på den gennemsnitlige gastrointestinale transittid.
English: Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in the clinical studies.
Danish: Patienter med en anamnese med tarmobstruktion eller større mave-tarmkirurgi, svære mavetarmforstyrrelser eller synkebesvær blev ikke inkluderet i de kliniske studier.
English: • Add about 40 mL (3 tablespoons) of additional water and stir thoroughly.
Danish: • Tilføj yderligere ca. 40 ml (3 spiseskefulde) vand, og omrør grundigt.
English: Mean serum potassium levels and change in serum potassium from Part A Baseline to Part A Week 4 is shown in Table 1.
Danish: Gennemsnitlige niveauer af serumkalium og ændring i serumkalium fra baseline til uge 4 i Del A er vist i Tabel 1.
English: Other liquids should be avoided as they may contain high amounts of potassium.
Danish: Andre væsker bør undgås, da de kan indeholde store mængder kalium.
English: Mean decreases in serum magnesium were 0.17 mg/dL (0.070 mmol/L) or less.
Danish: Den gennemsnitlige reduktion i serummagnesium var 0,17 mg/dl (0,070 mmol/l) eller derunder.
English: 21 [0.07] mEq/L) as compared to the placebo group (LS mean [SEM]: +0.23 [0.07] mEq/L).
Danish: mEq/l) sammenlignet med placebogruppen (LS middelværdi [SEM]: +0,23 [0,07] mEq/l).
English: 5.1 to <5.5 mEq/L (n=90)
Danish: 5,1 til < 5,5 meq/l (n=90)
English: Low blood magnesium can occur when taking Veltassa.
Danish: Du kan få et lavt niveau af magnesium i blodet, når du tager Veltassa.
English: The other ingredient is xanthan gum.
Danish: Øvrige indholdsstoffer: xanthangummi.
English: A decision must be made whether to discontinue breast feeding or to discontinue/abstain from patiromer therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med patiromer seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Mean baseline serum potassium values were 4.71 mEq/L for patiromer and 4.68 mEq/L for placebo.
Danish: Gennemsnitlige serumkaliumværdier ved baseline var 4,71 mEq/l for patiromer og 4,68 mEq/l for placebo.
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalaemia and hyperphosphataemia.
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af hyperkaliæmi og hyperfosfatæmi.
English: • severe stomach or bowel problems
Danish: • alvorlige problemer med maven eller tarmene
English: Decreases in serum potassium with patiromer treatment were maintained over 1 year of chronic treatment as shown in Figure 1, with a low incidence of hypokalaemia (2.3%) and the majority of subjects reaching (97.7%) and maintaining target serum potassium levels (overall during maintenance period, serum potassium was within the target range for approximately 80% of the time).
Danish: Reduktioner i serumkalium ved behandling med patiromer blev opretholdt over 1 år med kronisk behandling som vist i Figur 1, med en lav forekomst af hypokaliæmi (2,3 %), og størstedelen af forsøgspersonerne nåede (97,7 %) og opretholdt målniveauerne for serumkalium (samlet gennem perioden for opretholdelse var serumkalium inden for målintervallet i ca. 80 % af tiden).
English: Patiromer is excreted approximately 24 to 48 hours after intake, based on average gastrointestinal transit time.
Danish: Patiromer udskilles ca. 24 til 48 timer efter indtagelse, baseret på den gennemsnitlige gastrointestinale transittid.
English: Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, levothyroxine and metformin.
Danish: Ved samtidig administration af patiromer blev der set reduceret biotilgængelighed af ciprofloxacin, levothyroxin og metformin.
English: Use Veltassa during pregnancy and breast feeding only if your doctor considers it necessary.
Danish: Tag kun Veltassa under graviditeten, og når du ammer, hvis din læge har sagt, at det er nødvendigt.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris La Défense Cedex France
Danish: 100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris La Défense Cedex Frankrig
English: In clinical studies, serum magnesium values <1.4 mg/dL (0.58 mmol/L) occurred in 9% of patients treated with patiromer.
Danish: I kliniske studier opstod der lave serummagnesiumniveauer < 1,4 mg/dl (0,58 mmol/l) hos 9 % af de patienter, der blev behandlet med patiromer.
English: The majority of the adverse reactions (ARs) reported from trials were gastrointestinal disorders, with the most frequently reported ARs being constipation (6.2%), diarrhoea (3%), abdominal pain (2.9%), flatulence (1.8%) and hypomagnesaemia (5.3%).
Danish: Størstedelen af de rapporterede bivirkninger fra forsøg var gastrointestinale lidelser, hvor de hyppigst rapporterede bivirkninger var forstoppelse (6,2 %), diarré (3 %), mavesmerter (2,9 %), luft i maven (1,8 %) og hypomagnesæmi (5,3 %).
English: The benefits and risks of administering patiromer should be carefully evaluated in patients with current or history of severe gastrointestinal disorders, before and during treatment.
Danish: Fordele og risici ved at administrere patiromer bør evalueres omhyggeligt før og under behandling af patienter, som har eller tidligere har haft alvorlige gastrointestinale lidelser.
English: Overall, in the phase 2 and 3 clinical studies, 99.4% of patients were receiving RAAS inhibitor therapy at baseline, 81.2% had CKD with eGFR <60 mL/min/1.73 m2, 72.8% had diabetes mellitus and 48.7% had heart failure.
Danish: I fase 2 og 3 af de kliniske studier fik samlet set 99,4 % af patienterne RAAS-inhibitorbehandling ved baseline, 81,2 % havde CKD med eGFR <60 ml/min/1,73 m², 72,8 % havde diabetes mellitus og 48,7 % havde hjertesvigt.
English: Take within 1 hour after preparation of suspension.
Danish: Skal tages inden for 1 time efter klargøring af suspensionen.
English: Baseline Serum K+ > 5.5 to < 6.0 mEq/L
Danish: Baseline-serum K+ > 5,5 til < 6,0 meq/l
English: This prevents potassium from entering your bloodstream and lowers potassium levels in your blood back to normal.
Danish: Dette forhindrer kalium i at komme ind i din blodbane, så niveauet af kalium i dit blod falder til det normale niveau.
English: Patiromer works by binding potassium in the gastrointestinal tract and thus the serum concentration is not relevant for its efficacy.
Danish: Patiromer fungerer ved binding af kalium i mave-tarm-kanalen, og serumkoncentrationen er derfor ikke relevant for dets virkning.
English: Serum potassium at the end of treatment, the change from baseline in serum potassium, and the mean dose of patiromer were similar between groups.
Danish: Serum-kalium i slutningen af behandlingen, ændringen i serumkalium i forhold til baseline og den gennemsnitlige dosis patiromer var ens mellem grupperne.
English: More water may be added to the mixture as needed for desired consistency.
Danish: For at opnå den ønskede konsistens kan der efter behov tilsættes mere vand til blandingen.
English: Concomitant administration of patiromer did however not affect the bioavailability as measured by the area under the curve (AUC) of amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil and warfarin.
Danish: Samtidig administration af patiromer påvirkede imidlertid ikke biotilgængeligheden i henhold til målingen af arealet under kurven (AUC) for amlodipin, cinacalcet, clopidogrel, furosemid, lithium, metoprolol, trimethoprim, verapamil og warfarin.
English: The effect of treatment with patiromer for up to 52 weeks was evaluated in an open label study of 304 hyperkalaemic patients with CKD and type 2 diabetes mellitus on stable doses of a RAAS inhibitor.
Danish: Virkningen af behandling med patiromer i op til 52 uger blev vurderet i et ikke-blindet studie med 304 patienter med hyperkaliæmi med CKD og type 2-diabetes mellitus, der modtog stabile doser af en RAAS-inhibitor.
English: Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels.
Danish: Binding af kalium reducerer koncentrationen af frit kalium i det gastrointestinale lumen, hvilket resulterer i en reduktion i niveauerne af serumkalium.
English: Patiromer is a non-absorbed, cation exchange polymer that contains a calcium-sorbitol complex as a counterion.
Danish: Patiromer er en ikke-absorberet kationbytterpolymer, der indeholder et calcium-sorbitol-kompleks som modion.
English: If you forget to take Veltassa
Danish: Hvis du har glemt at tage Veltassa
English: The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily.
Danish: For at opnå det ønskede målinterval kan den daglige dosis efter behov øges eller reduceres med 8,4 g, dog højst til en maksimumdosis på 25,2 g dagligt.
English: Patiromer has the potential to bind some oral co administered medicinal products, which could decrease their gastrointestinal absorption.
Danish: Patiromer har potentialet til at binde visse co-administrerede lægemidler, hvilket kan reducere deres absorption i mave-tarm-kanalen.
English: The potential of patiromer to enable concomitant RAAS inhibitor treatment was also assessed in part B. Fifty two percent (52%) of subjects receiving placebo discontinued RAAS inhibitor treatment because of recurrent hyperkalaemia compared with 5% of subjects treated with patiromer.
Danish: Potentialet for patiromer til at muliggøre samtidig behandling med RAAS-inhibitorer blev også vurderet i del B: Tooghalvtreds procent (52 %) af de forsøgspersoner, der modtog placebo, ophørte med behandling med RAAS-inhibitorer på grund af tilbagevendende hyperkaliæmi sammenlignet med 5 % af de forsøgspersoner, der blev behandlet med patiromer.
English: Patients may store Veltassa below 25°C for up to 6 months.
Danish: Patienter kan opbevare Veltassa under 25 °C i op til 6 måneder.
English: What you need to know before you take Veltassa Do not take Veltassa
Danish: Det skal du vide, før du begynder at tage Veltassa Tag ikke Veltassa
English: Severe hyperkalaemia
Danish: Svær hyperkaliæmi
English: Mix Veltassa with water and stir until it is thoroughly mixed, as follows:
Danish: Bland Veltassa med vand, og omrør, til det er grundigt blandet.
English: Other medicines and Veltassa
Danish: Brug af anden medicin sammen med Veltassa
English: The powder for oral suspension is off white to light brown, with occasional white particles.
Danish: Pulveret til oral suspension er offwhite til lysebrunt med sporadiske hvide partikler.
English: Hypomagnesaemia
Danish: Hypomagnesæmi
English: Your doctor may adjust the dose depending on the potassium level in your blood.
Danish: Din læge kan justere dosis i forhold til mængden af kalium i blodet.
English: The ability of patiromer to enable concomitant spironolactone treatment was investigated in a randomised, double-blind, placebo-controlled study in heart failure patients who were clinically indicated to receive AA.
Danish: Patiromers evne til at muliggøre samtidig spironolacton-behandling blev undersøgt i et randomiseret, dobbeltblindt, placebokontrolleret studie af hjertesvigtpatienter, der var klinisk indiceret til at modtage AA.
English: Off white to light brown powder, with occasional white particles.
Danish: Offwhite til lysebrunt pulver med sporadiske hvide partikler.
English: 25.2 g of patiromer, administered once daily for 6 days, resulted in a mean increase in faecal potassium excretion of 1283 mg/day, and a mean decrease in urinary potassium excretion of 1438 mg/day.
Danish: 25,2 g patiromer administreret én gang dagligt i 6 dage medførte en gennemsnitlig stigning i den fækale udskillelse af kalium på 1283 mg/dag og en gennemsnitlig reduktion i udskillelsen af kalium i urinen på 1438 mg/dag.
English: The mean age of patients was 64 years (54% aged 65 and over, 17% aged 75 and over), 58% of patients were men, and 98% were Caucasian.
Danish: Patienternes gennemsnitsalder var 64 år (54 % i alderen 65 og derover, 17 % i alderen 75 og derover), 58 % af patienterne var mænd, og 98 % var kaukasere.
English: Of the 105 patients who were randomised and received study treatment (patiromer 56; placebo 49), mean age was 68.3 years, 60.6% were men, 97.1% were Caucasian, and mean eGFR was 81.3 mL/min.
Danish: Af de 105 patienter, som var randomiseret og modtog forsøgsbehandling (patiromer 56; placebo; 49) og havde en gennemsnitsalder på 68,3 år, var 60,6 % mænd, 97,1 % var af kaukasisk afstamning og den gennemsnitlige eGFR lå på 81,3 ml/min.
English: There were also fewer patients in the patiromer group with serum potassium values >5.5 mEq/L (7.3% vs. 24.5%; p=0.027) and more patients on spironolactone 50 mg/day (90.9% versus 73.5%, p=0.022).
Danish: Der var også færre patienter i patiromer-gruppen med serumkaliumværdier >5,5 mEq/l (7,3 % vs. 24,5 %, p = 0,027) og flere patienter, der fik spironolacton 50 mg/dag (90,9 % vs 73,5 %, p = 0,022).
English: PHARMACEUTICAL FORM AND CONTENTS powder for oral suspension
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) pulver til oral suspension
English: The dose was titrated, as needed, based on the serum potassium level, assessed starting on Day 3 and then at weekly visits to the end of the 4 week treatment period, with the aim of maintaining serum potassium in the target range (3.8 mEq/L to <5.1 mEq/L).
Danish: Dosis blev, om nødvendigt, titreret på baggrund af niveauet af serumkalium, som blev vurderet første gang på dag 3 og derefter ved ugentlige besøg indtil slutningen af behandlingsperioden på 4 uger med det formål at opretholde serumkalium i målintervallet (3,8 meq/l til < 5,1 meq/l).
English: Once you have received Veltassa, it can be stored below 25°C for up to 6 months.
Danish: Når du har modtaget Veltassa, kan du opbevare det under 25 °C i op til 6 måneder.
English: Patiromer was not genotoxic in the reverse mutation test (Ames assay), chromosome aberration or rat micronucleus assays.
Danish: Patiromer var ikke gentoksisk i tilbagemutationstest (Ames' test), kromosomafvigelsestest eller rottemikronukleus-test.
English: The primary efficacy endpoint, change from baseline in serum potassium to the end of the 28-day treatment period, was significantly lower (p<0.001) in the patiromer group (LS mean [SEM]: −0.
Danish: Det primære effektmål, ændringen i serumkalium fra baseline til udgangen af behandlingsperioden på 28 dage, var signifikant lavere (p < 0,001) i patiromer-gruppen (LS middelværdi [SEM]: −0,21 [0,07]