FrancophonIA/ELRC3.0 huggingface dataset:
English: Significantly elevated ferritin levels were observed particularly when concomitant intravenous iron was used.
Danish: Signifikant forhøjede koncentrationer af ferritin i serum blev især observeret, når der blev givet samtidig behandling med intravenøst jern.
English: The dose of phosphate binder was titrated as needed to maintain serum phosphorus levels between 3.5 and 5.5 mg/dl, to a maximum of 12 g/day.
Danish: Dosis af fosfatbinder blev titreret efter behov for at fastholde en koncentration af fosfor i serum mellem 3,5 og 5,5 mg/dl, op til et maksimum på 12 g/dag.
English: Contents of the pack and other information What Fexeric contains
Danish: Pakningsstørrelser og yderligere oplysninger Fexeric indeholder:
English: The starting dose of Fexeric was 6 tablets/day (6 g/day), in divided doses with meals.
Danish: Startdosis for Fexeric var 6 tabletter/dag (6 g/dag) i opdelte doser med måltider.
English: Treatment of high blood phosphorus levels is usually required for a long period of time.
Danish: Behandlingen for forhøjet koncentration af fosfor i blodet er normalt langvarig.
English: Uncommon side effects (may affect up to 1 in 100 people): changes in iron blood test results decreased or increased appetite indigestion, flatulence inflammation of stomach lining, ulcer of mucosal lining of the stomach or the first part of the bowel reflux of stomach juices in the oesophagus abnormal stools, irregularity in bowel movement shortness of breath, wheezing, abnormal breath sounds
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer): ændringer i blodprøveresultater for jern nedsat eller øget appetit fordøjelsesbesvær, afgang af tarmluft betændelse i mavehinden, sår i maveslimhinden eller den første del af tarmen unormal afføring, uregelmæssig afføring åndenød, hvæsende åndedræt, unormale vejtrækningslyde
English: The most commonly reported adverse reactions in non-dialysis dependent CKD (CKD ND) patients during treatment were discoloured faeces, constipation and diarrhoea occurring in 27%, 13% and 11% of patients, respectively.
Danish: De hyppigst indberettede bivirkninger under behandlingen af ikke-dialyseafhængige CKD-patienter (CKD ND) var misfarvning af fæces, konstipation og diarré, som forekom hos henholdsvis 27 %, 13 % og 11 % af patienterne.
English: This compound is insoluble and is excreted in the stool, reducing the amount of phosphate that is absorbed from the GI tract.
Danish: Dette stof er uopløseligt og udskilles i afføringen, hvorved mængden af fosfat, der absorberes fra mave-tarm-kanalen, reduceres.
English: In patients with CKD, the maximum dose studied was 12 g (12 tablets) of Fexeric per day.
Danish: Hos CKD-patienter i dialyse var den maksimale undersøgte dosis 12 g (12 tabletter) Fexeric om dagen.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fexeric 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 eller behandling med Fexeric skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske
English: Long term safety data are limited in non-dialysis and peritoneal dialysis (PD) patients (see section
Danish: Der foreligger begrænsede data om langtidssikkerheden hos patienter, der ikke er i dialyse, og patienter i peritonealdialyse (se pkt.
English: Serum ferritin and TSAT levels increase after intravenous iron administration; hence, blood samples for measurement of iron storage parameters should be obtained at a time appropriate to reflect the patient's iron status after intravenous iron dosing taking into account the product used, the amount of iron given and the frequency of dosing, but a minimum of 7 days after intravenous iron dosing.
Danish: Derfor skal der tages blodprøver med henblik på måling af serumjerndepotparametre på et tidspunkt, der er passende til at afspejle patientens jernstatus efter intravenøs administration af jern under hensyntagen til det anvendte produkt, den administrerede mængde jern og doseringshyppigheden, men mindst 7 dage efter intravenøs administration af jern.
English: The recommended starting dose of Fexeric is 3 to 6 g (3 to 6 tablets) per day based on serum
Danish: Den anbefalede startdosis for Fexeric er 3 til 6 g (3 til 6 tabletter) om dagen baseret på koncentrationen
English: If you take too much Fexeric, tell your doctor of pharmacist.
Danish: Hvis du har taget for meget Fexeric, skal du sige det til din læge eller apotekspersonalet.
English: No dosage reduction is considered necessary but patients with hepatic impairment should initiate treatment with the lower starting dose, 3 g (3 tablets) per day (see section 5.1).
Danish: Det betragtes ikke som nødvendigt at reducere dosis, men patienter med leverinsufficiens skal påbegynde behandlingen med den lave startdosis på 3 g (3 tabletter) om dagen (se pkt.
English: Fexeric has no influence on the ability to drive and use machines.
Danish: Fexeric påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: In the remaining non-dialysis studies, a total of 3 serious adverse reactions reported in 2 patients were gastrointestinal in nature (gastrointestinal ulcer, gastric polyps and colonic polyps).
Danish: I de resterende studier med ikke-dialysekrævende patienter var i alt 3 af de alvorlige bivirkninger, der indberettedes for 2 patienter, af gastrointestinal art (sår i mave-tarm-kanalen, gastriske polypper og colonpolypper).
English: All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhoea, gastritis, gastritis erosive, and haematemesis).
Danish: Alle alvorlige bivirkninger var af gastrointestinal art (abdominalsmerter, konstipation, diarré, gastritis, erosiv gastritis og hæmatemese).
English: Increases in ferritin and TSAT above safety thresholds are observed with Fexeric use.
Danish: Der er set stigninger i ferritin og TSAT over sikkerhedstærsklerne i forbindelse med anvendelse af
English: Experience from clinical studies in patients with hepatic impairment is limited.
Danish: Erfaringen fra kliniske studier med patienter med leverinsufficiens er begrænset.
English: These adverse reactions are characteristic of iron-containing medicinal products and abated with time with continued dosing.
Danish: Disse bivirkninger er karakteristiske for jernholdige lægemidler og går over med tiden også ved fortsat dosering.
English: Patients previously on other phosphate binders who are switched to Fexeric should start taking 3 to 6 g
Danish: Patienter, der tidligere har været i behandling med andre fosfatbindere, og som skifter til Fexeric, skal starte med at tage 3 til 6 g (3 til 6 tabletter) om dagen.
English: In iron replete dogs, microscopic and macroscopic findings in the liver were consistent with signs of iron accumulation.
Danish: Hos hunde uden jernmangel var de mikroskopiske og makroskopiske fund i overensstemmelse med tegn på ophobning
English: The starting dose of Fexeric was 3 tablets a day (3 g/day) in divided doses with meals and was adjusted as needed to a maximum of 12 g/day in order to maintain serum phosphorus levels between 3.0 and 3.5 mg/dl.
Danish: Startdosis for Fexeric var 3 tabletter om dagen (3 g/dag) i opdelte doser med måltider og blev justeret efter behov til et maksimum på 12 g/dag med henblik på at opretholde en koncentration af fosfor i serum mellem 3,0 og 3,5 mg/dl.
English: The ability of Fexeric to control serum phosphorus in CKD patients was principally evaluated in one long-term, pivotal Phase III trial (Study 304) in CKD 5D patients, and in one pivotal Phase II, 12 week, placebo-controlled trial (Study 204) in CKD ND patients with anaemia.
Danish: Fexerics evne til at kontrollere koncentrationen af fosfor i serum hos CKD-patienter blev fortrinsvis evalueret i et pivotalt, fase III-langtidsstudie (Studie 304) med CKD 5D-patienter og i et pivotalt 12ugers, placebokontrolleret fase II-studie (Studie 204) med CKD ND-patienter med anæmi.
English: Fexeric should be temporarily discontinued if serum ferritin exceeds 800 ng/ml.
Danish: Fexeric skal seponeres midlertidigt, hvis serumferritin overstiger 800 ng/ml.
English: The other ingredients are pregelatinised starch, calcium stearate, hypromellose, titanium dioxide, triacetin, sunset yellow FCF (E110), allura red AC (E129), indigo carmine.
Danish: Øvrige indholdsstoffer: prægelatiniseret stivelse, calciumstearat, hypromellose, titandioxid, triacetin, sunset yellow FCF (E110), allura red AC (E129), indigokarmin.
English: Increases in ferritin and transferrin saturation (TSAT) are observed with Fexeric use.
Danish: Der ses en stigning i ferritin- og transferrinmætningen (TSAT) under anvendelse af Fexeric.
English: Peach-coloured, oval shaped, film-coated tablet, embossed with “KX52”.
Danish: Ferskenfarvet, oval filmovertrukket tablet præget med "KX52".
English: Abnormal breath sounds, increased serum ferritin, increased transferrin saturation, increased weight
Danish: Unormale vejtrækningslyde, forhøjet serumferritin, forhøjet transferrinmætning, vægtøgning
English: Fexeric binds to the phosphorus from food in your digestive tract to prevent it from being absorbed into your blood.
Danish: I mave-tarm-kanalen binder Fexeric sig til fosfor, i det du spiser, og forhindrer dermed, at det bliver optaget i blodet.
English: CKD patients who are not on dialysis require the lower starting dose, 3 g (3 tablets) per day.
Danish: CKD-patienter, som ikke er i dialyse, kræver den laveste startdosis på 3 g (3 tabletter) om dagen.
English: By binding phosphate in the GI tract and decreasing absorption, Fexeric lowers the levels of serum phosphorus.
Danish: Ved at binde fosfat i mave-tarm-kanalen og nedsætte absorptionen sænker Fexeric koncentrationen af fosfor i serum.
English: The target organ for primary toxicity of ferric citrate is the GI tract, with evidence of mucosal erosion and acute to sub-acute inflammation of the GI tract in dogs at elevated doses.
Danish: Målorganet for jerncitrats primære toksicitet er mave-tarm-kanalen med tegn på slimhindeerosion og akut til subakut inflammation af mave-tarm-kanalen ved høje doser hos hunde.
English: This medicine contains ferric citrate coordination complex as the active substance.
Danish: Dette lægemiddel indeholder koordinationskompleks af jerncitrat som det aktive stof.
English: Each 1 g film-coated tablet contains sunset yellow FCF (E110) (0.99 mg) and Allura Red AC (E129) (0.70 mg) which may cause allergic reaction.
Danish: Hver 1 g filmovertrukket tablet indeholder sunset yellow FCF (E110) (0,99 mg) og Allura Red AC (E129) (0,70 mg), som kan give anledning til en allergisk reaktion.
English: The most common side effects (affecting more than 1 in 10 people) in patients not on dialysis also
Danish: De mest almindelige bivirkninger (påvirker mere end 1 ud af 10 personer) hos patienter, der ikke er i dialyse, har også at gøre med maven eller tarmen:
English: During the subsequent 4-week placebo-controlled period, the serum phosphorus levels remained stable in patients receiving Fexeric (mean decrease of 0.24 mg/dl), whereas patients receiving placebo had a mean increase of 1.79 mg/dl (p < 0.0001 for treatment difference).
Danish: I løbet af den efterfølgende 4-ugers placebokontrollerede periode forblev koncentrationen af fosfor i serum stabil hos patienter, der fik Fexeric (middelfald på 0,24 mg/dl), hvorimod patienter, der fik placebo, havde en middelstigning på 1,79 mg/dl (p<0,0001 for behandlingsforskel).
English: The most commonly reported adverse reactions in dialysis-dependent chronic kidney disease (CKD 5D) patients during treatment were discoloured faeces and diarrhoea occurring in 18% and 13% of patients, respectively.
Danish: De hyppigst indberettede bivirkninger under behandling af dialyseafhængige patienter med kronisk nyresygdom (CKD 5D) var misfarvning af fæces og diarré, som forekom hos henholdsvis 18 % og 13 % af patienterne.
English: During the 12-week treatment period, patients treated with Fexeric had a significant decrease in serum phosphorus, compared to the placebo group (p < 0.001 for treatment difference) (Table 3).
Danish: I løbet at den 12 uger lange behandlingsperiode havde de patienter, der blev behandlet med Fexeric, et signifikant fald i koncentrationen af fosfor i serum sammenlignet med placebogruppen (p<0,001 for behandlingsforskel) (tabel 3).
English: There are limited data available for doses higher than 9 g (9 tablets) per day in CKD patients not on dialysis; therefore in this population doses higher than 9 g/day should be used with caution.
Danish: Der foreligger begrænsede data for doser på over 9 g (9 tabletter) om dagen hos CKD-patienter, der ikke er i dialyse.
English: Monitoring blood levels of these medicines may also be considered: - ciprofloxacin, doxycycline, cefdinir: medicines to treat bacterial infections - valproic acid: a medicine to treat epilepsy and mental disorders - sertraline: a medicine to treat depression - methotrexate: a medicine to treat rheumatoid arthritis, cancer and the skin disease, psoriasis - alendronate: a medicine to treat decreased bone mass and density - levodopa: a medicine to treat Parkinson's disease - levothyroxine: a medicine to treat thyroid hormone deficiency
Danish: Det kan også blive aktuelt at tage blodprøver for at følge indholdet i blodet af disse lægemidler: - ciprofloxacin, doxycyclin, cefdinir: lægemidler til behandling af infektioner med bakterier - valproinsyre: et lægemiddel til behandling af epilepsi og sindslidelser - sertralin: et lægemiddel til behandling af depression - methotrexat: et lægemiddel til behandling af rheumatoid arthritis, cancer og hudsygdommen
English: Table 4: Summary of results on iron homeostasis at Week 12 and Week 52 in Study 304 (CKD 5D) and at Week 12 in Study 204 (CKD ND)
Danish: Tabel 4 Oversigt over resultater for jernhomeostase ved uge 12 og uge 52 i Studie 304 (CKD 5D) og ved uge 12 i Studie 204 (CKD ND)
English: - maximum dose: 12 tablets daily, in separated doses, with or immediately after meals of the
Danish: - maksimal dosis: 12 tabletter dagligt i opdelte doser sammen med eller umiddelbart efter
English: Although the potential for interactions with medicinal products seems low, for concomitant treatment with products with a narrow therapeutic window, the clinical effect/adverse events should be monitored on initiation or dose adjustment of Fexeric or the concomitant product.
Danish: I forbindelse med samtidig behandling med produkter med et snævert terapeutisk vindue skal den kliniske effekt/bivirkninger overvåges ved igangsættelse af behandling med eller dosisjustering af Fexeric eller det samtidige produkt, selv om potentialet for lægemiddelinteraktion synes at være lavt.
English: In the pivotal dialysis study 304, CKD 5D patients treated with Fexeric, compared with patients treated with active control, had significantly higher increases in ferritin and TSAT levels after 52 weeks of treatment (Table 4), and significantly lower cumulative intravenous iron (96 versus 149 mg/month) and ESA use (7,713 versus 9,183 IU/week) during the same period.
Danish: I det pivotale dialysestudie 304 havde CKD 5D-patienter, der blev behandlet med Fexeric, signifikant højere stigninger i ferritin- og TSAT-koncentration efter 52 ugers behandling (tabel 4) sammenlignet med patienter behandlet med aktiv kontrol, og signifikant lavere akkumuleret intravenøst jern (96 mod 149 mg/måned) og ESA-brug (7 713 mod 9.183 IE/uge) i løbet af den samme periode.
English: In the pivotal dialysis study 304, following a 2-week washout period, 441 CKD 5D patients with hyperphosphatemia were randomised to receive Fexeric (n=292) or active control (sevelamer carbonate and/or calcium acetate; n=149) open-label for 52 weeks.
Danish: I det pivotale dialysestudie 304 blev 441 CKD 5D-patienter randomiseret til at få Fexeric (n=292) eller aktiv kontrol (sevelamercarbonat og/eller calciumacetat; n=149) ublindet i 52 uger efter en 2-ugers udvaskningsperiode.
English: Table 3: Summary of efficacy parameters on phosphorus homeostasis at Week 12 and Week 52 in Study 304 (CKD 5D) and at Week 12 in Study 204 (CKD ND)
Danish: Tabel 3 Oversigt over effektparametre for fosforhomeostase ved uge 12 og uge 52 i Studie 304 (CKD 5D) og ved uge 12 i Studie 204 (CKD ND)
English: The iron component reacts with dietary phosphate in the gastrointestinal (GI) tract and precipitates phosphate as ferric phosphate.
Danish: Jernkomponenten reagerer med fosfat i kosten i mave-tarm-kanalen og udfælder fosfat som jernfosfat.
English: Reductions in ESA use with Fexeric have been observed.
Danish: Der er observeret et fald i behovet for ESA under anvendelse af Fexeric.
English: In the pivotal non-dialysis study 204 CKD ND patients treated with Fexeric had a significant increase in serum TSAT, ferritin and haemoglobin levels compared to the placebo group after 12 weeks of treatment (p< 0.001 for treatment difference for each parameter) (Table 4).
Danish: I det pivotale ikke-dialysestudie 204 havde CKD ND-patienter, der blev behandlet med Fexeric, en signifikant forhøjelse af koncentrationen af TSAT, ferritin og hæmoglobin sammenlignet med placebogruppen efter 12 ugers behandling (p<0,001 for behandlingsforskel for hvert parameter) (tabel
English: Fexeric contains sunset yellow FCF (E110) and Allura Red AC (E129)
Danish: Fexeric indeholder sunset yellow FCF (E110) og Allura Red AC (E129)
English: During the overall 52-week active-controlled period, the decrease in serum phosphorus (approximately 2.0 mg/dl following up to a 2 week washout period) and the percentage of patients who achieved and maintained serum phosphorus ≤ 5.5 mg/dl (approximately 62%) were comparable in both the Fexeric and the active control groups (Table 3).
Danish: I løbet af den generelle 52-ugers aktiv-kontrollerede periode var faldet i fosfor i serum (cirka 2,0 mg/dl efter en op til 2 uger lang udvaskningsperiode) og procentdelen af patienter, som opnåede og fastholdt en koncentration af fosfor i serum ≤ 5,5 mg/dl
English: Following absorption, citrate is converted
Danish: Efter absorptionen omdannes citrat til bikarbonat i vævene.
English: Your doctor will monitor the phosphorus levels regularly.
Danish: Lægen tager blodprøver med regelmæssige mellemrum for at holde øje med fosforkoncentrationen.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for
English: If you are able to become pregnant, you must use birth control during treatment.
Danish: Hvis du er i den fødedygtige alder, skal du bruge prævention, så længe behandlingen varer ved.
English: Common side effects (may affect up to 1 in 10 people): abdominal distension or bloating nausea, vomiting
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): forstoppelse mavesmerter/ubehag udspilet eller oppustet mave kvalme, opkastning
English: The total daily dose should be divided
Danish: Den samlede daglige dosis skal deles op og tages sammen med dagens måltider.
English: Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of
Danish: Hver filmovertrukket tablet indeholder 1g koordinationskompleks af jerncitrat (svarende til 210 mg
English: Therefore, patients may need reduction in, or discontinuation of, intravenous iron
Danish: Der kan derfor være behov for at nedsætte patientens dosis af eller seponere intravenøst jern og/eller ESA'er.
English: NAP
Danish: Der
English: Table 2: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD ND patients.
Danish: Tabel 1 Bivirkninger observeret under kliniske studier, hvor Fexeric blev administreret til
English: During the 52-week treatment period, haemoglobin remained relatively stable in the Fexeric group compared to
Danish: I løbet af den 52 uger lange behandlingsperiode forblev hæmoglobin relativt stabilt i Fexeric-gruppen sammenlignet med den aktive kontrolgruppe (tabel 4).
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
English: Also contains sunset yellow FCF (E110), Allura Red AC (E129), see the package leaflet for futher
Danish: Indeholder også sunset yellow FCF (E110), Allura Red AC (E129), se indlægssedlen for yderligere
English: Your doctor may want to change the dose of these medicines or advise you to take these medicines 2 hours before or after Fexeric.
Danish: • Du skal også fortælle det til lægen eller apotekspersonalet, hvis du tager eller måske får brug for at tage nedenstående lægemidler: Lægen vil muligvis ændre dosis af disse lægemidler eller bede dig om at tage dem 2 timer før eller efter, du tager Fexeric.
English: Diarrhoea, discoloured faeces Abdominal pain/discomfort/distension, constipation, nausea, vomiting Abnormal faeces, bowel movement irregularity, dry mouth, dysgeusia, dyspepsia, flatulence, frequent bowel movements, gastritis, gastritis erosive, gastrooesophageal reflux disease, haematemesis, peptic ulcer
Danish: Unormal fæces, uregelmæssig afføring, tør mund, dysgeusi, dyspepsi, flatulens, hyppig afføring, gastritis,erosiv gastritis, gastroøsofageal reflukssygdom, hæmatemese, peptisk ulcus Pruritus, udslæt
English: Fexeric contains ferric citrate coordination complex as the active ingredient.
Danish: Fexeric indeholder et koordinationskompleks af jerncitrat som det aktive stof.
English: Due date
Danish: 2 år.
English: After 12 weeks of treatment, the mean (± SD) change in serum phosphorus from baseline was −2.02 ± 2.0 mg/dl for Fexeric and −2.21 ± 2.18 mg/dl for sevelamer carbonate, demonstrating non-inferiority of Fexeric to sevelamer.
Danish: −2,02 ± 2,0 mg/dl for Fexeric og −2,21 ± 2,18 mg/dl for sevelamercarbonat, hvilket påviser noninferioritet for Fexeric i forhold til sevelamer.
English: Decreased appetite, hyperkalaemia, hypophosphataemia, increased appetite Dizziness, headache Palpitations, dyspnoea Malignant hypertension
Danish: Nedsat appetit, hyperkaliæmi, hypofosfatæmi, øget appetit
English: The recommended dose is: - starting dose for adults: 3 to 6 tablets daily, in separated doses, with or immediately after main meals of the day.
Danish: - startdosis for voksne: 3 til 6 tabletter i opdelte doser sammen med eller umiddelbart efter dagens hovedmåltider.
English: Patients not on dialysis require the lower starting dose: 3 tablets daily, in separated doses, with or
Danish: Patienter, der ikke er i dialyse, skal begynde med den laveste startdosis: 3 tabletter i opdelte doser sammen med eller umiddelbart efter dagens måltider.
English: Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron).
Danish: Hver filmovertrukket tablet indeholder 1 g koordinationskompleks af jerncitrat (svarende til 210 mg jern).
English: The symptoms of acute iron overdose include vomiting, diarrhoea, abdominal pain, irritability, and drowsiness.
Danish: Overdosering af jern er farlig især hos børn og kræver øjeblikkelig indgriben, Symptomerne på akut overdosering af jern omfatter opkastning, diarré, abdominalsmerter, irritabilitet og sløvhed.
English: for sevelamer only)
Danish: Serumfosfor ved baseline for sevelamer alene)
English: After first opening of the bottle, use within 60 days.
Danish: Skal anvendes inden 60 dage efter første åbning af glasset.
English: The active substance is ferric citrate coordination complex.
Danish: Aktivt stof: jerncitrat koordinationskompleks.
English: HDPE bottles with child-resistant closure with desiccant.
Danish: HDPE-glas med børnesikret låg med tørremiddel.
English: Muscle injury
Danish: Muskelskade
English: *Proportion of patients achieving serum phosphorus ≤ 5.5 mg/dl in CKD 5D patients; **Proportion of patients achieving serum phosphorus ≤ 4.0 mg/dl in CKD ND patients NAP: not applicable; SD: standard deviation
Danish: * Andel af patienter der opnåede serumfosfor ≤ 5,5 mg/dl hos CKD 5D-patienter.