FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Fexeric in children and adolescents aged 0 to 18 years have not yet been
Danish: Fexerics sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er endnu ikke klarlagt.
English: Tell your doctor if you wish to breast-feed your baby.
Danish: Sig det til lægen, hvis du gerne vil amme dit barn.
English: Consequently, ciprofloxacin should not be taken at the same time, but at least 2 hours before or after Fexeric.
Danish: Derfor bør ciprofloxacin ikke tages på samme tid som Fexeric men mindst 2 timer før eller efter.
English: Examination of serum iron storage parameters has shown that there is low systemic absorption of iron
Danish: Undersøgelser af serumjerndepotparametre har vist, at der er en lav systemisk absorption af jern på
English: Experience from clinical studies in patients above the age of 75 years is limited.
Danish: Erfaringen fra kliniske studier med patienter over 75 år er begrænset.
English: This blood test may be part of your routine tests for your
Danish: Disse blodprøver kan udgøre en del af de rutinemæssige prøver, du får
English: Study 204 (CKD ND)
Danish: Studie 204 (CKD ND)
English: Tablets are 19 mm long, 7.2 mm thick and 10 mm wide.
Danish: Tabletterne er 19 mm lange, 7,2 mm tykke og 10 mm brede.
English: As a secondary endpoint in dialysis patients, and a co-primary endpoint in non-dialysis patients, the ability of Fexeric to increase iron stores was also evaluated.
Danish: Som et sekundært endepunkt hos dialysepatienter og et co-primært endepunkt hos ikkedialysepatienter blev Fexerics evne til at øge jerndepoterne også evalueret.
English: If someone is known or suspected to have accidentally or intentionally ingested an overdose of Fexeric, immediate medical attention should be sought.
Danish: Hvis det vides, eller der er mistanke om, at en person utilsigtet eller ved et uheld har indtaget en overdosis af Fexeric, skal der øjeblikkeligt søges lægehjælp.
English: Fexeric should not be taken at the same time as aluminium containing medicines.
Danish: Fexeric må ikke tages samtidig med lægemidler, der indeholder aluminium.
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold glasset tæt tillukket for at beskytte mod fugt.
English: Contact a doctor or poison control centre immediately if a child accidentally takes Fexeric.
Danish: Kontakt straks en læge eller en forgiftningscentral, hvis et barn ved et uheld kommer til at tage
English: Study 304 (CKD 5D)
Danish: Studie 304 (CKD 5D)
English: You may have been advised to follow a special diet to prevent the phosphorus in your blood rising to high levels.
Danish: Du er muligvis blevet bedt om at følge en særlig diæt med henblik på at forhindre, at koncentrationen af fosfor i blodet stiger til meget høje niveauer.
English: This can lead to high phosphorus levels in the blood.
Danish: Dette kan føre til forhøjede niveauer af fosfor i blodet.
English: - if you are allergic to ferric citrate coordination complex or any of the other ingredients of this medicine (listed in section 6) - if you have low levels of phosphorus in your blood - if you have a severe stomach or bowel disease such as stomach or bowel bleeding
Danish: - hvis du er allergisk over for koordinationskomplekset af jerncitrat eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) - hvis du har et lavt indhold af fosfor i blodet - hvis du lider af en alvorlig mave- eller tarmsygdom som f.eks. mave- eller tarmblødning
English: These serious adverse reactions were uncommon (less than 1 case of each per 100 patients) and were each reported in 0.2% (1/557) of CKD 5D patients who received Fexeric.
Danish: Disse alvorlige bivirkninger var ikke almindelige (færre end 1 tilfælde pr. 100 patienter) og blev hver især indberettet for 0,2 % (1/577) af de CKD 5D-patienter, som fik Fexeric.
English: No data are available regarding overdose of Fexeric in humans.
Danish: Der findes ingen data vedrørende overdosering af Fexeric hos mennesker.
English: Data from carcinogenicity studies have shown that ferric citrate is not carcinogenic in mice and rats when administered intramuscularly or subcutaneously.
Danish: Data fra studier af carcinogeniticitet har vist, at jerncitrat ikke er carcinogent hos mus og rotter, når det administreres intramuskulært eller subkutant.
English: Your doctor may decrease or increase the starting dose depending on the level of phosphorus in your blood.
Danish: Lægen kan beslutte at hæve eller sænke startdosen, afhængig af hvor meget fosfor, der er i dit blod.
English: Of the 557 patients receiving Fexeric in the pooled safety population, there were 67 (12%) patients with evidence of liver dysfunction at baseline.
Danish: Af de 557 patienter, som fik Fexeric i den poolede sikkerhedspopulation, var der 67 (12 %) patienter med tegn på leverdysfunktion ved baseline.
English: Active Control N=146
Danish: Aktiv kontrol (n=146)
English: These patients were treated according to the recommended dosing regimen without any safety concerns.
Danish: Disse patienter blev behandlet i henhold til det anbefalede dosisregime uden nogen sikkerhedsproblemer.
English: Fexeric has been administered to over 400 patients ≥ 65 years of age in studies where the dose was titrated to achieve target serum phosphorus levels.
Danish: Fexeric har været administreret til mere end 400 patienter ≥ 65 år i studier, hvor dosis blev titreret med henblik på at opnå tilsigtede koncentrationer af fosfor i serum.
English: Because too much iron is unsafe, your blood will be tested at regular intervals to check iron levels.
Danish: Da for meget jern kan være skadeligt, vil du få taget blodprøver med regelmæssige mellemrum for at kontrollere jernindholdet.
English: Hgb: haemoglobin; NAP: not applicable; SD: standard deviation; TSAT: transferrin saturation
Danish: Hgb: hæmoglobin; I/R: ikke relevant; SD: standardafvigelse; TSAT: transferrinmætning
English: Frequencies of adverse reactions are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Danish: Hyppigheden af bivirkninger defineres i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1 000 til <1/100), sjælden (≥1/10
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den
English: The elderly patients were treated according to the recommended dosing regimen without any safety concerns.
Danish: De ældre patienter blev behandlet i henhold til det anbefalede dosisregime uden nogen sikkerhedsproblemer.
English: Pregnancy and women of childbearing potential
Danish: Graviditet og kvinder i den fertile alder
English: System Organ Class by MedDRA
Danish: Systemorganklasse i henhold til MedDRA Bivirkning
English: The tablets are packed in plastic bottles with child-resistant caps.
Danish: Tabletterne er pakket i plastflasker med børnesikret låg.
English: It is not known whether ferric citrate coordination complex/metabolites are excreted in human milk.
Danish: Det er ukendt, om koordinationskompleks af jerncitrat/metabolitter udskilles i human mælk.
English: The following medicines can affect or be affected by Fexeric: Fexeric contains iron and your doctor may need to adjust the dose of your other iron-containing
Danish: Følgende lægemidler kan påvirke eller blive påvirket af Fexeric: Fexeric indeholder jern, og lægen vil muligvis skulle justere dosis af andre jernholdige
English: Patients with active, symptomatic inflammatory bowel disease were excluded from clinical trials.
Danish: Patienter med aktiv inflammatorisk tarmsygdom var udelukket fra kliniske forsøg.
English: Keeping the phosphorus level normal is important to maintain healthy bones and blood vessels and to prevent itchy skin, red eyes, bone pain or bone fractures.
Danish: Det er vigtigt at opretholde et normalt fosforniveau af hensyn til knoglernes og blodkarrenes sundhed og for at forebygge hudkløe, røde øjne, knoglesmerter eller knoglebrud.
English: Patients receiving this medicine should adhere to their prescribed low phosphate diets.
Danish: Patienter, der er i behandling med dette lægemiddel, skal overholde den ordinerede diæt med lavt fosfatindhold.
English: < 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000).
Danish: 000 til <1/1 000) og meget sjælden (<1/10 000).
English: severe abdominal pain or constipation (uncommon)
Danish: kraftige mavesmerter eller forstoppelse (ikke almindeligt)
English: Do not store above 25°C Keep the bottle tightly closed in order to protect from moisture.
Danish: Må ikke opbevares ved temperaturer over 25 °C Hold glasset tæt tillukket for at beskytte mod fugt.
English: Fexeric did not alter the bioavailability of the following medicinal products when concomitantly administered: clopidogrel, digoxin, diltiazem, glimepiride, losartan.
Danish: Fexeric ændrede ikke følgende lægemidlers biotilgængelighed ved samtidig administration: clopidogrel, digoxin, diltiazem, glimepirid, losartan.
English: Talk to your doctor or pharmacist before taking Fexeric if you have: too much iron in your body bowel inflammation
Danish: Kontakt lægen eller apotekspersonalet, før du tager Fexeric, hvis du har: - for meget jern i kroppen - tarmbetændelse
English: Fexeric 1 g film-coated tablets
Danish: Fexeric 1 g filmovertrukne tabletter
English: In drug-drug interaction studies in healthy male and female subjects, Fexeric decreased the bioavailability of concomitantly administered ciprofloxacin (as measured by the area under the curve [AUC]) by approximately 45%.
Danish: I lægemiddelinteraktionsstudier hos raske mandlige og kvindelige forsøgspersoner nedsatte Fexeric biotilgængeligheden af samtidigt administreret ciprofloxacin (målt som arealet under kurven [AUC]) med cirka 45 %.
English: Shelf-life after first opening of the bottle: 60 days
Danish: Opbevaringstid efter første åbning af flasken: 60 dage
English: Adverse reactions reported in CKD 5D and CKD ND patients are presented in Tables 1 and 2, respectively.
Danish: De bivirkninger, der blev indberettet hos CKD 5D- og CKD ND-patienter, præsenteres henholdsvis i tabel 1 og 2 herunder.
English: Since citrate is known to increase aluminium absorption, aluminium-based compounds should be avoided while patients receive Fexeric.
Danish: Eftersom citrat vides at øge optagelsen af aluminium, skal aluminiumsbaserede stoffer undgås, mens patienten er i behandling med Fexeric.
English: Reductions in intravenous iron and erythropoiesis-stimulating agent (ESA) use with this medicine have been observed.
Danish: Der er observeret et fald i brugen af intravenøst jern og erytropoiese-stimulerende stoffer (ESA) under anvendelse af dette lægemiddel.
English: The non clinical programme was based on 7 repeat dose toxicology studies in rats and dogs.
Danish: Det prækliniske program var baseret på 7 toksikologistudier med gentagne doser hos rotter og hunde.
English: It is unknown whether Fexeric may pass through breast milk and affect your baby.
Danish: Det vides ikke, om Fexeric udskilles i modermælken og om dette kan påvirke dit barn.
English: Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney
Danish: Fexeric er indiceret til kontrol af hyperfosfatæmi hos voksne patienter med kronisk nyresygdom
English: - if you have haemochromatosis, a condition causing the body to absorb too much iron from the diet - if you have any other disorder associated with too much iron
Danish: - hvis du lider af hæmokromatose, en tilstand der gør, at kroppen optager for meget jern fra kosten - hvis du har andre lidelser, der har at gøre med for meget jern
English: Information on genotoxicity, carcinogenic potential, toxicity to reproduction and development of ferric citrate was bridged from scientific literature.
Danish: Oplysninger om jerncitrats genotoksicitet, carcinogene potentiale, reproduktions- og udviklingstoksicitet stammer fra den videnskabelige litteratur.
English: Pharmacotherapeutic group: Drugs for treatment of hyperkalemia and hyperphosphatemia
Danish: Farmakoterapeutisk klassifikation: Lægemidler til behandling af hyperkaliæmi og hyperfosfatæmi
English: What you need to know before you take Fexeric
Danish: Det skal du vide, før du begynder at tage Fexeric
English: Patients treated with Fexeric should not receive concomitant treatment with other oral iron
Danish: Patienter, der er i behandling med Fexeric, må ikke behandles samtidig med andre orale
English: No data are available on the potential influence of Fexeric on fertility.
Danish: Der foreligger ingen data for Fexerics potentielle indvirkning på fertilitet.
English: Fexeric increases iron levels in your body.
Danish: Fexeric øger kroppens indhold af jern.
English: Since iron-based preparations are known to reduce the absorption of levothyroxine (thyroxine), physicians should consider monitoring suitable markers or clinical signs of efficacy if these medicinal products are concomitantly administered with Fexeric.
Danish: Eftersom jernbaserede præparater vides at nedsætte optagelsen af levothyroxin (thyroxin), skal lægen overveje monitorering af passende markører eller kliniske tegn på virkning, hvis disse lægemidler
English: This blood test may be part of your routine tests for your kidney disease.
Danish: Disse blodprøver kan udgøre en del af de rutinemæssige prøver, du får taget på grund af din nyresygdom.
English: Patients with kidneys that do not work properly are not able to eliminate phosphorus from their body adequately.
Danish: Patienter med nedsat nyrefunktion er ikke i stand til på passende måde at udskille fosfor fra kroppen.
English: Data on primary and secondary pharmacodynamics, safety pharmacology and pharmacokinetics of Fexeric were derived from the repeat dose toxicology studies, and did not reveal safety concerns for humans.
Danish: Data vedrørende Fexerics primære og sekundære farmakodynamik, sikkerhedsfarmakologi og farmakokinetik blev udledt fra toksikologistudier med gentagne doser og afslørede ingen
English: The safety of Fexeric for the treatment of hyperphosphataemia has been investigated in 18 clinical trials involving a total of 1388 CKD 5D patients with treatment duration of up to 2 years and 145 CKD ND patients with treatment duration of 12 weeks to 1 year.
Danish: Fexerics sikkerhed ved behandling af hyperfosfatæmi er blevet undersøgt i 18 kliniske forsøg, der involverede i alt 1388 CKD 5D-patienter med en behandlingsvarighed på op til 2 år og 145 CKD NDpatienter med en behandlingsvarighed på fra 12 uger til 1 år.
English: Effects of other medicinal products on Fexeric
Danish: Andre lægemidlers indvirkning på Fexeric
English: Do not take a double dose to make up for a forgotten
Danish: Du må ikke tage en dobbeltdosis som
English: Patients with elevated ferritin levels receiving intravenous iron may require a reduction in dose or discontinuation of intravenous iron therapy.
Danish: Patienter med forhøjet ferritin der får intravenøst jern, kan have behov for dosisreduktion eller seponering af behandlingen med intravenøst jern.
English: Effects of Fexeric on other medicinal products
Danish: Fexerics indvirkning på andre lægemidler
English: There was no evidence of hepatic impairment or significant alteration of hepatic enzymes across the clinical studies with Fexeric, including the long-term studies.
Danish: Der var ingen tegn på leverinsufficiens eller signifikant ændring i leverenzymer på tværs af de kliniske studier med Fexeric heller ikke i langtidsstudierne.
English: Serum phosphorus concentrations should be monitored within 2 to 4 weeks of starting or changing the dose of Fexeric, and approximately every 2-3 months when stable.
Danish: Koncentrationen af fosfor i serum skal kontrolleres inden for 2 til 4 uger efter påbegyndelse af behandling med Fexeric eller ændring af dosis, og cirka hver 2. til 3. måned, når koncentrationen har stabiliseret sig.
English: Following completion of the 52-week active-controlled period, patients were eligible to enter a 4-week placebo-controlled period in which they were re-randomized to receive Fexeric (n=96)
Danish: Efter afslutningen af den 52 uger lange aktiv-kontrollede periode kunne patienterne deltage i en 4-ugers placebo-kontrolleret periode, hvor de igen blev randomiseret til at få Fexeric (n=96)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Fexeric in in one or more subsets of the paediatric population in the treatment of hyperphosphataemia related to chronic kidney disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Fexeric i en eller flere undergrupper af den pædiatriske population ved behandling for hyperfosfatæmi relateret til kronisk nyresygdom (se pkt.
English: Tablets are 19 mm long,
Danish: Tabletterne er 19 mm lange, 7,2 mm
English: Non-interventional post-authorisation safety study (PASS): prospective, observational, multicentre study in CKD patients treated with Fexeric in order to gain long-term (2 years) safety data (including iron overload events, infective and gastrointestinal events) particularly in EU patients, elderly and very elderly patients, dialysed (HD, PD) and non-dialysed patients, and in addition reflecting the specific risks in subgroups of serum ferritin levels > 500 ng/ml and in patients
Danish: Ikke-interventionssikkerhedstudie efter tilladelse til markedsføring: en prospektiv, multicenterbaseret observationsundersøgelse af CKD patienter behandlet med Fexeric for at indhente oplysninger på lang sigt (over 2 år) om sikkerheden (herunder jernophobningshændelser, infektiøse og gastrointestinale hændelser), navnlig hos ældre og gamle patienter i EU, dialysepatienter (HD, PD) og patienter, der ikke er i dialyse, og derudover afspejle den specifikke risiko hos undergrupper for serumferritinniveauer > 500 ng/ml og hos patienter i intervallet 200 til < 500 ng/ml.
English: In CKD 5D patients, the primary evaluation of safety is based on the integrated analysis of data from 4 studies involving 557 CKD 5D patients treated with Fexeric for up to 1 year.
Danish: For så vidt angår CDK 5D-patienterne, baseres den primære sikkerhedsevaluering på den integrerede analyse af data fra 4 studier, der involverede 557 CKD 5D-patienter, der blev behandlet med Fexeric i op til 1 år.
English: Treatment with Fexeric may lead to elevations in iron stores, particularly in patients receiving concomitant intravenous iron therapy.
Danish: Behandling med Fexeric kan føre til forhøjet ophobning af jern, særligt hos patienter der er i samtidig intravenøs behandling med jern.
English: How to take Fexeric
Danish: Sådan skal du tage Fexeric
English: The Fexeric-bound phosphorus is then excreted from your body in faeces.
Danish: Det Fexeric-bundne fosfor udskilles derefter fra kroppen i afføringen.
English: Active severe gastrointestinal disorders (e.g. gastrointestinal bleeding) Haemochromatosis or laboratory tests indicating possible haemochromatosis Other iron overload (primary or secondary) syndromes
Danish: Aktive alvorlige gastrointestinale lidelser (f.eks. gastrointestinal blødning) Hæmokromatose eller laboratorieanalyser der tyder på mulig hæmokromatose Andre tilstande, der involverer (primære eller sekundære) jernophobningssyndromer
English: The dose can be increased or decreased by 1 to 2 g (1 to 2 tablets) per day at 2- to 4-week intervals as needed to maintain serum phosphorus at recommended target levels up to a maximum of 12 g (12 tablets) per day.
Danish: Dosis kan efter behov øges eller nedsættes med 1 til 2 g (1 til 2 tabletter) om dagen med et interval på 2 til 4 uger for at fastholde koncentrationen af fosfor i serum på det anbefalede målniveau op til maksimalt 12 g (12 tabletter) om dagen.
English: There are no data regarding the use of ferric citrate coordination complex in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af koordinationskompleks af jerncitrat til gravide kvinder.
English: Fexeric film-coated tablets are peach-coloured, oval-shaped tablets embossed with “KX52” on one side.
Danish: Fexeric filmovertrukne tabletter er ferskenfarvede, ovale tabletter med "KX52" præget på den ene side.
English: Results from subgroup analyses in the pivotal clinical study in dialysis patients show that the concomitant use of frequently co-prescribed medications in CKD patients (fluoroquinolones, tetracyclines, proton pump inhibitors, thyroid hormones, sertraline, Vitamin D, warfarin, acetylsalicylic acid) do not affect the efficacy of Fexeric with respect to its ability to lower serum
Danish: Resultater fra undergruppeanalyser i det pivotale kliniske studie med dialysepatienter viser, at samtidig anvendelse af lægemidler, som ofte ordineres sammen til CKD patienter (fluoroquinoloner, tetracykliner, protonpumpehæmmere, thyreoideahormoner, sertralin, Vitamin D, warfarin, acetylsalicylsyre) ikke påvirker Fexerics virkning for så vidt angår dets evne til at reducere fosfor i
English: Formal pharmacokinetic studies have not been performed due to the medicine's predominantly localised primary mechanism of action in the GI tract.
Danish: Der er ikke udført egentlige farmakokinetiske studier på grund af lægemidlets virkningsmekanisme, der fortrinsvis er lokal i mave-tarm-kanalen.
English: Fexeric must be taken in divided doses with or immediately after meals of the day.
Danish: Fexeric skal tages i opdelte doser sammen med eller umiddelbart efter dagens måltider.
English: This medicine should be used only in the absence of iron overload syndromes and with caution if serum ferritin rises above 500 ng/ml.
Danish: Dette lægemiddel må kun anvendes i fravær af jernophobningssyndromer og med forsigtighed, hvis serumferritin stiger til over 500 ng/ml.
English: Urinary phosphorus excretion and FGF-23 were also significantly decreased relative to baseline in the CKD ND patients treated with Fexeric compared to patients treated with placebo.
Danish: Udskillelsen af fosfor og FGF-23 i urinen var også signifikant lavere i forhold til baseline hos CKD ND-patienter behandlet med Fexeric sammenlignet med patienter
English: Take the tablets whole, with one glass of water, with or immediately after meals.
Danish: Tabletterne skal synkes hele med et glas vand sammen med eller umiddelbart efter måltiderne.
English: Ferric citrate was neither mutagenic in the bacterial reverse mutation assay (Ames test) nor clastogenic in the chromosomal aberration test in Chinese hamster fibroblasts.
Danish: Jerncitrat var hverken mutagent i den bakterielle tilbagemutationsmåling (Ames' test) eller klastogent i kromosomaberrationstesten i fibroblaster fra kinesiske hamstere.
English: All patients receiving this medicine require at least quarterly monitoring of serum iron storage parameters (serum ferritin and TSAT).
Danish: Alle patienter, der får dette lægemiddel, skal have deres serumjerndepotparametre (serumferritin og TSAT) undersøgt mindst hver tredje måned.
English: Fexeric is not recommended during pregnancy and in women of childbearing potential not using contraceptive
Danish: Fexeric bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker
English: Patients must take Fexeric with or immediately after meals.
Danish: Patienten skal tage Fexeric sammen med eller umiddelbart efter måltiderne.
English: Temporarily discontinue Fexeric if the serum phosphorus is < 3 mg/dl and resume at a lower dose once the serum phosphorus has returned to the target range.
Danish: Fexeric skal seponeres midlertidigt, hvis fosfor i serum er < 3 mg/dl, og genoptages med en lavere dosering, når koncentrationen af fosfor i serum igen ligger inden for det tilsigtede interval.
English: In CKD ND patients, the primary evaluation of safety is based on data from the pivotal study (Study 204), where 75 patients were treated with Fexeric for 12 weeks.
Danish: For så vidt angår CKD ND-patienterne, baseres den primære sikkerhedsevaluering på data fra det pivotale studie (Studie 204), hvor 75 patienter blev behandlet med Fexeric i 12 uger.