FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from the published literature on iron balance studies in patients with thalassaemia major show that the use of Ferriprox concurrently with deferoxamine (coadministration of both chelators during the same day, either simultaneously or sequentially, e.g., Ferriprox during the day and deferoxamine during the night), promotes greater iron excretion than either drug alone.
Danish: Publicerede data om jernbalancestudier hos talassæmi-patienter viser, at brugen af Ferriprox samtidig med deferoxamin (samtidig administration af begge kelerende stoffer på samme dag enten samtidigt eller sekventielt, f.eks. Ferriprox om dagen og deferoxamin om aftenen), fremmer større jernudskillelse end med kun ét af disse lægemidler.
English: Overall, fewer Ferriprox-treated patients than deferoxamine-treated patients showed a worsening of cardiac dysfunction from first assessment to last assessment (4% vs. 20%, p=0.007).
Danish: Generelt viste færre Ferriprox-behandlede patienter end deferoxamin-behandlede patienter en forværring af den kardiale dysfunktion fra første vurdering til sidste vurdering (4% vs. 20%, p=0,007).
English: Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
Danish: Kontakt din læge eller apoteket, før du tager ascorbinsyre (C-vitamin) sammen med Ferriprox.
English: In the case of iron-induced heart failure, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy.
Danish: I tilfælde af jerninduceret hjertesvigt bør Ferriprox med 75-100 mg/kg/dag tilføjes til behandlingen med deferoxamin.
English: Data from the pooled safety database from clinical trials (1343 patient-years exposure to Ferriprox monotherapy and 244 patient-years exposure to Ferriprox and deferoxamine) showed statistically significant (p<0.05) differences in the incidence of adverse reactions based on System Organ Class for “Cardiac disorders", "Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders".
Danish: Data fra den poolede sikkerhedsdatabase fra kliniske studier (1343 patientårs eksponering for Ferriprox-monoterapi og 244 patientårs eksponering for Ferriprox og deferoxamin) viste statistisk signifikante (p<0,05) forskelle i forekomsten af bivirkninger baseret på systemorganklassen “Hjerte", "Knogler, led, muskler og bindevæv” samt "Nyrer og urinveje".
English: Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability.
Danish: Ledsmerte og hævelse spændende fra let smerte i et eller flere led til alvorlig funktionsnedsættelse.
English: Dose (mg, three times/day)
Danish: Dosis (mg, tre gange daglig)
English: Abdominal Pain Vomiting
Danish: Abdominalsmerter Opkastning
English: Do not take Ferriprox if you are pregnant or if you are trying to become pregnant.
Danish: Du må ikke tage Ferriprox, hvis du er gravid, eller hvis du forsøger at blive gravid.
English: The higher rate of “Cardiac disorders" reported during combination therapy than monotherapy was possibly due to the higher incidence of pre-existing cardiac disorders in patients who received combination therapy.
Danish: Den højere forekomst af bivirkninger i systemorganklassen “Hjerte", rapporteret under kombinationsterapi end monoterapi, skyldtes muligvis den højere forekomst af allerede eksisterende hjertesygdomme hos patienter, som fik kombinationsterapi.
English: Take your second dose midday.
Danish: Tag den anden dosis midt på dagen.
English: - Pregnancy (see section 4.6).
Danish: - Graviditet (se pkt.
English: Hydroxypropyl cellulose
Danish: Hydroxypropylcellulose
English: Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 µg/l.
Danish: Afbrydelse af behandling med deferipron bør overvejes, hvis serumferritin falder under 500 µg/l.
English: If treatment is unavoidable, breast-feeding must be stopped (see section 4.3).
Danish: Hvis behandling ikke kan undgås, skal amningen stoppes (se pkt.
English: The maximum difference between the LS means of the therapeutic dose and placebo was 3.01 ms (95% one-sided UCL: 5.01 ms), and between the LS means of the supratherapeutic dose and placebo was 5.23 ms (95% one-sided UCL: 7.19 ms).
Danish: Den maksimale forskel mellem middelværdierne (beregnet ved mindste kvadraters metode) ved den terapeutiske dosis og placebo var 3,01 ms (95% ensidet øvre konfidensgrænse (UCL): 5,01 ms), og mellem middelværdierne (beregnet ved mindste kvadraters metode) ved den supraterapeutiske dosis og placebo var 5,23 ms (95% ensidet UCL: 7,19 ms).
English: Agranulocytosis and neutropenia usually resolve upon discontinuation of Ferriprox, but fatal cases of agranulocytosis have been reported.
Danish: Agranulocytose og neutropeni forsvinder normalt, når behandlingen med Ferriprox seponeres, men der har været rapporter om tilfælde af agranulocytose med dødelig udgang.
English: Renal and hepatic function should be monitored in these patient populations during deferiprone therapy.
Danish: Nyre- og leverfunktion bør overvåges hos disse patientpopulationer, mens de er i behandling med deferipron.
English: The most serious adverse reaction reported in clinical trials with deferiprone was agranulocytosis, defined as an absolute neutrophil count less than 0.5 x 109/l, which occurred in approximately 1% of patients.
Danish: Den alvorligste bivirkning rapporteret i kliniske studier med deferipron var agranulocytose, defineret som et absolut neutrofiltal på mindre end 0,5 x 109/l, som opstod hos ca. 1% af patienterne.
English: Studies LA16-0102, LA-01 and LA08-9701 compared the efficacy of Ferriprox with that of deferoxamine in controlling serum ferritin in transfusion-dependent thalassaemia patients.
Danish: Studierne LA16-0102, LA-01 og LA08-9701 sammenlignede Ferriprox' virkning med deferoxamins virkning til styring af serumferritin hos transfusionsafhængige talassæmi-patienter.
English: Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and
Danish: Anvendelse af deferipron bør ophøre, hvis der observeres neurologiske forstyrrelser (se pkt.
English: Newly diagnosed cardiac dysfunction occurred in 13 (20.6%) deferoxamine-treated patients and in 2 (4.3%) Ferriprox-treated patients who were cardiac disease-free at the first assessment (p=0.013).
Danish: Nyligt diagnosticeret kardial dysfunktion opstod hos 13 (20,6%) deferoxamin-behandlede patienter og hos 2 (4,3%) Ferriprox-behandlede patienter, som var fri for hjertesygdomme ved første vurdering (p=0,013).
English: Concurrent use of iron chelators is not recommended in patients whose serum ferritin falls below 500 µg/l due to the risk of excessive iron removal.
Danish: Samtidig brug af jernkelerende stoffer frarådes hos patienter, hvis serumferritin falder under 500 µg/l på grund af risikoen for overdreven jernfjernelse.
English: A total daily dose above 100 mg/kg body weight is not recommended because of the potentially increased risk of adverse reactions (see sections 4.4, 4.8, and 4.9).
Danish: En total daglig dosis på over 100 mg/kg kropsvægt kan ikke anbefales, da der muligvis er en øget risiko for bivirkninger (se pkt.
English: No effects on fertility or early embryonic development were noted in non-iron-loaded male and female rats that received deferiprone orally at doses of up to 75 mg/kg twice daily for 28 days (males) or 2 weeks (females) prior to mating and until termination (males) or through early gestation (females).
Danish: Der blev ikke observeret nogen virkninger på fertilitet eller tidlig fosterudvikling hos ikke-jernbelastede han- og hunrotter, som fik deferipron oralt i doser på op til 75 mg/kg 2 gange daglig i 28 dage (hanner) eller 2 uger (hunner) før parring og til aflivning (hanner) eller under tidlig drægtighed (hunner).
English: The change from weekly ANC monitoring to at the time of transfusion visits after 12 months of Ferriprox therapy, should be considered on an individual patient basis, according to the physician's assessment of the patient's understanding of the risk minimization measures required during therapy (see section 4.4 below).
Danish: Ændringen fra ugentlig kontrol af det absolutte neutrofiltal til tidspunktet for transfusionsbesøgene efter 12 måneders behandling med Ferriprox skal tilpasses den enkelte patient efter lægens vurdering af patientens forståelse for de nødvendige risikominimeringsforanstaltninger under behandlingen (se pkt.
English: MONITORING YOUR WHITE BLOOD CELL COUNT WITH FERRIPROX
Danish: KONTROL AF HVIDE BLODCELLETAL VED BEHANDLING MED FERRIPROX
English: PHARMACEUTICAL FORM AND CONTENTS 250 ml oral solution
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 250 ml oral opløsning
English: Sixty-one patients with cardiac iron overload, previously treated with deferoxamine, were randomized to continue deferoxamine (average dose 43 mg/kg/day; N=31) or to switch to Ferriprox (average dose 92 mg/kg/day N=29).
Danish: 61 patienter med jernophobning i hjertet, som tidligere blev behandlet med deferoxamin, blev randomiseret til at fortsætte med deferoxamin (gennemsnitlig dosis på 43 mg/kg/dag; N=31) eller skifte til Ferriprox (gennemsnitlig dosis på 92 mg/kg/dag N=29).
English: Each pack contains one bottle of 250 ml or 500 ml oral solution.
Danish: Hver pakning indeholder en flaske med 250 ml eller 500 ml oral opløsning.
English: The most common findings in non-iron-loaded animals at doses of 100 mg/kg/day and above were hematologic effects such as bone marrow hypocellularity, and decreased WBC, RBC and/or platelet counts in peripheral blood.
Danish: Det hyppigste fund hos ikke jernbelastede dyr i doser på 100 mg/kg/dag og derover var hæmatologiske virkninger, såsom hypocellularitet i knoglemarven og nedsat antal hvide og røde blodlegemer og/eller trombocytter i perifert blod.
English: Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. After first opening use within 35 days.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Anvendes inden/EXP.
English: − the most serious side effect that may occur while taking Ferriprox is a very low white blood cell (neutrophil) count.
Danish: − de alvorligste bivirkninger, som kan fremkomme, mens du tager Ferriprox, er et meget lavt antal hvide blodlegemer (neutrofiler)).
English: Immediately interrupt deferiprone if the patient experience infection.
Danish: Deferipron seponeres omgående, hvis patienten får en infektion.
English: You must use effective contraception while you are taking Ferriprox.
Danish: Du skal benytte effektive præventionsmidler, mens du tager Ferriprox.
English: Myocardial MRI T2* values of less than 20 ms represent iron overload in the heart.
Danish: Myokardial MRI T2*-værdier på mindre end 20 ms indikerer jernophobning i hjertet.
English: Deferiprone-3-O-glucuronide AUC was decreased by 10% and Cmax by 20% in mildly and moderately impaired subjects compared with healthy volunteers.
Danish: Deferipron-3-O-glucuronids AUC var 10 % lavere og Cmax 20 % lavere hos forsøgsdeltagere med let eller moderat leverinsufficiens sammenlignet med raske frivillige.
English: In humans, deferiprone is eliminated mainly via the kidneys; 75% to 90% of the ingested dose is reported as being recovered in the urine in the first 24 hours, in the form of free deferiprone, the glucuronide metabolite and the iron-deferiprone complex.
Danish: 75% til 90% af den indtagne dosis rapporteres som værende genfundet i urinen i løbet af de første 24 timer i form af frit deferipron, glucuronidmetabolitten og jerndeferipronkompleks.
English: Very common side effects (may affect more than 1 in 10 people): - abdominal pain - nausea - vomiting - reddish/brown discoloration of urine
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede): - mavesmerter - kvalme - opkastning - rødbrun misfarvning af urinen
English: To obtain a dose of about 75 mg/kg/day, use the volume of oral solution suggested in the following table for the body weight of the patient.
Danish: For at opnå en dosis på ca. 75 mg/kg/dag anvendes den mængde oral opløsning, der foreslås i følgende skema for patientens legemsvægt.
English: The children recovered from these symptoms after Ferriprox discontinuation.
Danish: Disse symptomer forsvandt, når børnene ophørte med at tage Ferriprox.
English: Ferriprox oral solution contains Sunset Yellow (E110) Sunset Yellow (E110) is a colouring agent which may cause allergic reactions.
Danish: Ferriprox oral opløsning indeholder Sunset yellow (E110) Sunset yellow (E110) er et farvestof, som kan forårsage allergiske reaktioner.
English: − if you have a history of agranulocytosis (very low white blood cell (neutrophil) count).
Danish: − hvis du har haft agranulocytose (et meget lavt antal hvide blodlegemer (neutrofiler)).
English: Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight.
Danish: Deferipron indgives som regel oralt med 25 mg/kg legemsvægt tre gange dagligt for en total daglig dosis på 75 mg/kg legemsvægt.
English: Of patients with cardiac dysfunction at first assessment, none treated with deferiprone compared with four (33%) treated with deferoxamine had worsening of their cardiac status (p=0.245).
Danish: Ved første vurdering oplevede ingen af patienterne med kardial dysfunktion, som blev behandlet med deferipron, sammenlignet med fire (33%) behandlet med deferoxamin en forværring af deres kardiale status (p=0,245).
English: The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
Danish: Den alvorligste bivirkning ved Ferriprox er et meget lavt antal hvide blodlegemer (neutrofiler).
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om Ferriprox, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function.
Danish: Ud fra resultaterne af dette studie er justering af Ferriprox-dosisregimet ikke nødvendig hos patienter med nyreinsufficiens.
English: Over the 12-month duration of the study, Ferriprox was superior to deferoxamine in decreasing cardiac iron load.
Danish: I studiets 12-måneders-forløb var Ferriprox superior til deferoxamin mht. reduktion af kardial jernophobning.
English: The influence of severe hepatic impairment on the pharmacokinetics of deferiprone and deferiprone 3-O-glucuronide has not been evaluated.
Danish: Svær leverinsufficiens' indflydelse på deferiprons og deferipron 3-O-glucuronids farmakokinetik er ikke evalueret.
English: A randomized, placebo-controlled, double-blind trial evaluated the effect of concurrent therapy with Ferriprox and deferoxamine in patients with thalassaemia major, who previously received the standard chelation monotherapy with subcutaneous deferoxamine and had mild to moderate cardiac iron loading (myocardial T2* from 8 to 20 ms).
Danish: Et randomiseret, placebokontrolleret, dobbeltblindt studie vurderede effekten af samtidig behandling med Ferriprox og deferoxamin hos talassæmi-patienter, der tidligere havde fået standard kelationsmonoterapi med sukutan deferoxamin og som havde mild til moderat jernophobning i hjertet (myokardial T2* fra 8 til 20 ms).
English: If you forget to take Ferriprox
Danish: Hvis du har glemt at tage Ferriprox
English: Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Danish: Ferriprox oral opløsning indeholder farvestoffet Sunset Yellow (E110), som kan forårsage allergiske reaktioner.
English: Sucralose (E955)
Danish: Sunset yellow (E110) Sucralose (E955)
English: The most common adverse reactions reported during therapy with deferiprone in clinical trials were nausea, vomiting, abdominal pain, and chromaturia, which were reported in more than 10% of patients.
Danish: De bivirkninger, der hyppigst er blevet rapporteret i løbet af behandling med deferipron i kliniske studier var kvalme, opkastning, mavesmerte og kromaturi, som blev rapporteret hos mere end 10 % af patienterne.
English: LIST OF EXCIPIENTS Contains Sunset Yellow (E110); see leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder Sunset Yellow (E110); se yderligere oplysninger i indlægssedlen.
English: Combination therapy with deferoxamine is not recommended when monotherapy with either chelator is adequate or when serum ferritin falls below 500 µg/l.
Danish: Kombinationsterapi med deferoxamin frarådes, når monoterapi med et af de kelerende stoffer er tilstrækkelig, eller når serumferritin falder under 500 µg/l.
English: There are no data available on the use of deferiprone in patients with end stage renal disease or severe hepatic impairment (see section 5.2).
Danish: Der foreligger ingen tilgængelige informationer om anvendelsen af deferipron hos patienter med nyresygdom i slutstadiet eller svær leverinsufficiens (se pkt.
English: After first opening use within 50 days.
Danish: Skal anvendes inden 50 dage efter første åbning.
English: After first opening use within 35 days.
Danish: Skal anvendes inden 35 dage efter første åbning.
English: If the patient develops an infection while on deferiprone, therapy should be immediately interrupted, and an ANC obtained without delay.
Danish: Hvis patienten udvikler en infektion under behandlingen med deferipron, skal behandlingen omgående seponeres, og det absolutte neutrofiltal skal kontrolleres hurtigst muligt.
English: BOTTLE OF 50 TABLETS
Danish: FLASKE MED 50 TABLETTER
English: The most serious adverse reaction reported in clinical trials with deferiprone is agranulocytosis (neutrophils <0.5x109/l), with an incidence of 1.1% (0.6 cases per 100 patient-years of treatment) (see section 4.4).
Danish: De mest alvorlige bivirkninger, der er rapporteret ved kliniske studier med deferipron, er agranulocytose (neutrofiltal < 0,5 x 109/l) med en forekomst på 1,1% (0,6 tilfælde pr. 100 patient-årsbehandling) (se pkt.
English: Study LA16-0102 compared the efficacy of Ferriprox with that of deferoxamine in decreasing cardiac iron overload and in improving cardiac function (as measured by LVEF) in transfusion-dependent thalassaemia patients.
Danish: Studie LA16-0102 sammenlignede Ferriprox' virkning med deferoxamins virkning mht. reduktion af kardial jernophobning og forbedring af hjertefunktionen (som målt med LVEF) hos transfusionsafhængige talassæmi-patienter.
English: The safety profile of combination therapy (deferiprone and deferoxamine) observed in clinical trials, post-marketing experience or published literature was consistent with that characterized for monotherapy.
Danish: Sikkerhedsprofilen for kombinationsterapi (med deferipron og deferoxamin), der er observeret i kliniske studier, erfaring efter markedsføring og publicerede data, stemmer overens med den sikkerhedsprofil, som er karakteristisk for monoterapi.
English: Ferriprox is packaged in bottles of 50 tablets.
Danish: Ferriprox er pakket i glas med 50 tabletter.
English: Ferriprox is packaged in bottles of 100 tablets.
Danish: Ferriprox er pakket i glas med 100 tabletter.
English: − if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6).
Danish: − hvis du er overfølsom over for deferipron eller et af de øvrige indholdsstoffer i denne medicin
English: 60-89 mL/min/1.73m2), moderate renal impairment (eGFR 30-59 mL/min/1.73m2), and severe renal impairment (eGFR 15-29 mL/min/1.73m2).
Danish: 60-89 ml/min/1,73m2), moderat nyreinsufficiens (eGFR 30-59 ml/min/1,73m2) og svær nyreinsufficiens (eGFR 15-29 ml/min/1,73m2).
English: Do not take Ferriprox
Danish: Tag ikke Ferriprox
English: Ferriprox in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2).
Danish: 4.4) er indiceret til behandling af talassæmi-patienter, hvor monoterapi med et andet jernkelerende stof er utilstrækkelig eller hvor forebyggelse eller behandling af livstruende konsekvenser af jernophobning (hovedsagelig i hjertet) kræver hurtig eller intensiv korrektion (se pkt.
English: Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with mildly or moderately impaired hepatic function.
Danish: Ud fra resultaterne af dette studie er der ikke behov for justering af Ferriprox-dosisregimet hos patienter med let eller moderat leverinsufficiens.
English: Ferriprox 1000 mg film-coated tablets EU/1/99/108/004
Danish: Ferriprox 1000 mg filmovertrukne tabletter EU/1/99/108/004
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin, har brugt det for nylig eller evt. tager anden medicin.
English: Each 500 mg tablet contains 500 mg deferiprone.
Danish: Hver 500 mg tablet indeholder 500 mg deferipron.
English: BOTTLE OF 100 TABLETS
Danish: FLASKE MED 100 TABLETTER
English: The effect of Ferriprox in decreasing the body iron is directly influenced by the dose and the degree of iron overload.
Danish: Hvor effektiv Ferriprox er til at reducere kroppens jernophobning påvirkes direkte af doseringen, og hvor stor jernophobningen er.
English: Patients should be aware to contact their physician if they experience any symptoms indicative of infection (such as fever, sore throat and flu-like symptoms).
Danish: Patienterne skal have besked på at henvende sig til deres læge, hvis de oplever symptomer, der kan tyde på infektion (såsom feber, ondt i halsen og influenzalignende symptomer).
English: The incidences of “Musculoskeletal and connective tissue disorders” and "Renal and urinary disorders" were lower during combination therapy than monotherapy, whereas the incidence of “Cardiac disorders" was higher during combination therapy than monotherapy.
Danish: Forekomsten af bivirkninger i systemorganklassen “Knogler, led, muskler og bindevævs” og "Nyrer og urinveje" var lavere under kombinationsterapi end monoterapi, hvorimod forekomsten af bivirkninger i systemorganklassen “Hjerte" var højere under kombinationsterapi end monoterapi.
English: A magnetic resonance imaging (MRI) method, T2*, was also used to quantify myocardial iron load.
Danish: Der blev også anvendt en MR-skanningsmetode, T2*, til at kvantificere myokardial jernophobning.
English: Do not take aluminium-based antacids at the same time as taking Ferriprox.
Danish: Tag ikke aluminiumbaserede syreneutraliserende midler, samtidig med at du tager Ferriprox.
English: Neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years and have also been observed in children with standard doses of deferiprone.
Danish: Nerveforstyrrelser (såsom tremor, gangforstyrrelser, dobbeltsyn, ufrivillige muskelsammentrækninger, problemer med bevægelseskoordination) er rapporteret hos børn, som igennem flere år frivilligt har fået ordineret mere end 2 gange den maksimalt anbefalede dosis på 100 mg/kg/dag, og er også observeret hos børn ved standarddoser af deferipron.
English: Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver ml oral opløsning indeholder 0,4 mg Sunset yellow (E110).
English: Deferiprone AUCs did not differ between treatment groups, but Cmax was decreased by 20% in mildly or moderately hepatically impaired subjects compared with healthy volunteers.
Danish: Deferipron-AUC'erne var de samme i de forskellige behandlingsgrupper, men Cmax var 20 % lavere hos forsøgsdeltagere med let eller moderat leverinsufficiens sammenlignet med raske frivillige.
English: Other medicines and Ferriprox
Danish: “Anden medicin og Ferriprox”).