natgillin/translations-raw huggingface dataset:
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). 
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).
Kontakt din læge eller apoteket, før du tager ascorbinsyre (C-vitamin) sammen med Ferriprox. 
Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.
I tilfælde af jerninduceret hjertesvigt bør Ferriprox med 75-100 mg/kg/dag tilføjes til behandlingen med deferoxamin. 
In the case of iron-induced heart failure, Ferriprox at 75-100 mg/kg/day should be added to deferoxamine therapy.
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". 
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".
Ledsmerte og hævelse spændende fra let smerte i et eller flere led til alvorlig funktionsnedsættelse. 
Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability.
Dosis (mg, tre gange daglig) 
Dose (mg, three times/day)
Abdominalsmerter Opkastning 
Abdominal Pain Vomiting
Du må ikke tage Ferriprox, hvis du er gravid, eller hvis du forsøger at blive gravid. 
Do not take Ferriprox if you are pregnant or if you are trying to become pregnant.
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. 
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.
Tag den anden dosis midt på dagen. 
Take your second dose midday.
- Graviditet (se pkt. 
- Pregnancy (see section 4.6).
Hydroxypropylcellulose 
Hydroxypropyl cellulose
Afbrydelse af behandling med deferipron bør overvejes, hvis serumferritin falder under 500 µg/l. 
Interruption of therapy with deferiprone should be considered if serum ferritin falls below 500 µg/l.
Hvis behandling ikke kan undgås, skal amningen stoppes (se pkt. 
If treatment is unavoidable, breast-feeding must be stopped (see section 4.3).
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). 
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).
Agranulocytose og neutropeni forsvinder normalt, når behandlingen med Ferriprox seponeres, men der har været rapporter om tilfælde af agranulocytose med dødelig udgang. 
Agranulocytosis and neutropenia usually resolve upon discontinuation of Ferriprox, but fatal cases of agranulocytosis have been reported.
Nyre- og leverfunktion bør overvåges hos disse patientpopulationer, mens de er i behandling med deferipron. 
Renal and hepatic function should be monitored in these patient populations during deferiprone therapy.
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. 
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.
Studierne LA16-0102, LA-01 og LA08-9701 sammenlignede Ferriprox' virkning med deferoxamins virkning til styring af serumferritin hos transfusionsafhængige talassæmi-patienter. 
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.
Anvendelse af deferipron bør ophøre, hvis der observeres neurologiske forstyrrelser (se pkt. 
Deferiprone use should be discontinued if neurological disorders are observed (see sections 4.8 and
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). 
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).
Samtidig brug af jernkelerende stoffer frarådes hos patienter, hvis serumferritin falder under 500 µg/l på grund af risikoen for overdreven jernfjernelse. 
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.
En total daglig dosis på over 100 mg/kg kropsvægt kan ikke anbefales, da der muligvis er en øget risiko for bivirkninger (se pkt. 
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).
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). 
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).
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. 
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).
KONTROL AF HVIDE BLODCELLETAL VED BEHANDLING MED FERRIPROX 
MONITORING YOUR WHITE BLOOD CELL COUNT WITH FERRIPROX
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 250 ml oral opløsning 
PHARMACEUTICAL FORM AND CONTENTS 250 ml oral solution
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). 
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).
Hver pakning indeholder en flaske med 250 ml eller 500 ml oral opløsning. 
Each pack contains one bottle of 250 ml or 500 ml oral solution.
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. 
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.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Anvendes inden/EXP. 
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.
− de alvorligste bivirkninger, som kan fremkomme, mens du tager Ferriprox, er et meget lavt antal hvide blodlegemer (neutrofiler)). 
− the most serious side effect that may occur while taking Ferriprox is a very low white blood cell (neutrophil) count.
Deferipron seponeres omgående, hvis patienten får en infektion. 
Immediately interrupt deferiprone if the patient experience infection.
Du skal benytte effektive præventionsmidler, mens du tager Ferriprox. 
You must use effective contraception while you are taking Ferriprox.
Myokardial MRI T2*-værdier på mindre end 20 ms indikerer jernophobning i hjertet. 
Myocardial MRI T2* values of less than 20 ms represent iron overload in the heart.
Deferipron-3-O-glucuronids AUC var 10 % lavere og Cmax 20 % lavere hos forsøgsdeltagere med let eller moderat leverinsufficiens sammenlignet med raske frivillige. 
Deferiprone-3-O-glucuronide AUC was decreased by 10% and Cmax by 20% in mildly and moderately impaired subjects compared with healthy volunteers.
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. 
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.
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede): - mavesmerter - kvalme - opkastning - rødbrun misfarvning af urinen 
Very common side effects (may affect more than 1 in 10 people): - abdominal pain - nausea - vomiting - reddish/brown discoloration of urine
For at opnå en dosis på ca. 75 mg/kg/dag anvendes den mængde oral opløsning, der foreslås i følgende skema for patientens legemsvægt. 
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.
Disse symptomer forsvandt, når børnene ophørte med at tage Ferriprox. 
The children recovered from these symptoms after Ferriprox discontinuation.
Ferriprox oral opløsning indeholder Sunset yellow (E110) Sunset yellow (E110) er et farvestof, som kan forårsage allergiske reaktioner. 
Ferriprox oral solution contains Sunset Yellow (E110) Sunset Yellow (E110) is a colouring agent which may cause allergic reactions.
− hvis du har haft agranulocytose (et meget lavt antal hvide blodlegemer (neutrofiler)). 
− if you have a history of agranulocytosis (very low white blood cell (neutrophil) count).
Deferipron indgives som regel oralt med 25 mg/kg legemsvægt tre gange dagligt for en total daglig dosis på 75 mg/kg legemsvægt. 
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.
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). 
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).
Den alvorligste bivirkning ved Ferriprox er et meget lavt antal hvide blodlegemer (neutrofiler). 
The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count.
Hvis De ønsker yderligere oplysninger om Ferriprox, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen: 
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Ud fra resultaterne af dette studie er justering af Ferriprox-dosisregimet ikke nødvendig hos patienter med nyreinsufficiens. 
Based on the results of this study, no adjustment of the Ferriprox dosage regimen is required in patients with impaired renal function.
I studiets 12-måneders-forløb var Ferriprox superior til deferoxamin mht. reduktion af kardial jernophobning. 
Over the 12-month duration of the study, Ferriprox was superior to deferoxamine in decreasing cardiac iron load.
Svær leverinsufficiens' indflydelse på deferiprons og deferipron 3-O-glucuronids farmakokinetik er ikke evalueret. 
The influence of severe hepatic impairment on the pharmacokinetics of deferiprone and deferiprone 3-O-glucuronide has not been evaluated.
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). 
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).
Hvis du har glemt at tage Ferriprox 
If you forget to take Ferriprox
Ferriprox oral opløsning indeholder farvestoffet Sunset Yellow (E110), som kan forårsage allergiske reaktioner. 
Ferriprox oral solution contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions.
Sunset yellow (E110) Sucralose (E955) 
Sucralose (E955)
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. 
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.
LISTE OVER HJÆLPESTOFFER Indeholder Sunset Yellow (E110); se yderligere oplysninger i indlægssedlen. 
LIST OF EXCIPIENTS Contains Sunset Yellow (E110); see leaflet for further information.
Kombinationsterapi med deferoxamin frarådes, når monoterapi med et af de kelerende stoffer er tilstrækkelig, eller når serumferritin falder under 500 µg/l. 
Combination therapy with deferoxamine is not recommended when monotherapy with either chelator is adequate or when serum ferritin falls below 500 µg/l.
Der foreligger ingen tilgængelige informationer om anvendelsen af deferipron hos patienter med nyresygdom i slutstadiet eller svær leverinsufficiens (se pkt. 
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).
Skal anvendes inden 50 dage efter første åbning. 
After first opening use within 50 days.
Skal anvendes inden 35 dage efter første åbning. 
After first opening use within 35 days.
Hvis patienten udvikler en infektion under behandlingen med deferipron, skal behandlingen omgående seponeres, og det absolutte neutrofiltal skal kontrolleres hurtigst muligt. 
If the patient develops an infection while on deferiprone, therapy should be immediately interrupted, and an ANC obtained without delay.
FLASKE MED 50 TABLETTER 
BOTTLE OF 50 TABLETS
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. 
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).
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. 
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.
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. 
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.
Ferriprox er pakket i glas med 50 tabletter. 
Ferriprox is packaged in bottles of 50 tablets.
Ferriprox er pakket i glas med 100 tabletter. 
Ferriprox is packaged in bottles of 100 tablets.
− hvis du er overfølsom over for deferipron eller et af de øvrige indholdsstoffer i denne medicin 
− if you are allergic to deferiprone or any of the other ingredients of this medicine (listed in section 6).
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). 
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).
Tag ikke Ferriprox 
Do not take Ferriprox
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. 
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).
Ud fra resultaterne af dette studie er der ikke behov for justering af Ferriprox-dosisregimet hos patienter med let eller moderat leverinsufficiens. 
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.
Ferriprox 1000 mg filmovertrukne tabletter EU/1/99/108/004 
Ferriprox 1000 mg film-coated tablets EU/1/99/108/004
Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin, har brugt det for nylig eller evt. tager anden medicin. 
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Hver 500 mg tablet indeholder 500 mg deferipron. 
Each 500 mg tablet contains 500 mg deferiprone.
FLASKE MED 100 TABLETTER 
BOTTLE OF 100 TABLETS
Hvor effektiv Ferriprox er til at reducere kroppens jernophobning påvirkes direkte af doseringen, og hvor stor jernophobningen er. 
The effect of Ferriprox in decreasing the body iron is directly influenced by the dose and the degree of iron overload.
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). 
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).
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. 
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.
Der blev også anvendt en MR-skanningsmetode, T2*, til at kvantificere myokardial jernophobning. 
A magnetic resonance imaging (MRI) method, T2*, was also used to quantify myocardial iron load.
Tag ikke aluminiumbaserede syreneutraliserende midler, samtidig med at du tager Ferriprox. 
Do not take aluminium-based antacids at the same time as taking Ferriprox.
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. 
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.
Hjælpestof, som behandleren skal være opmærksom på Hver ml oral opløsning indeholder 0,4 mg Sunset yellow (E110). 
Each ml of oral solution contains 0.4 mg Sunset Yellow (E110).
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. 
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.
“Anden medicin og Ferriprox”). 
Other medicines and Ferriprox
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Ferriprox 500 mg filmovertrukne tabletter Hver tablet indeholder 500 mg deferipron. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Ferriprox 500 mg film-coated tablets Each tablet contains 500 mg deferiprone.
Et åbent, ikke-randomiseret klinisk studie med parallelle grupper blev udført med henblik på at vurdere effekten af leverinsufficiens på sikkerhed, tolerabilitet og farmakokinetik for en enkelt oral dosis på 33 mg/kg Ferriprox. 
An open-label, non-randomized, parallel group clinical study was conducted to evaluate the effect of impaired renal function on the safety, tolerability, and pharmacokinetics of a single 33 mg/kg oral dose of Ferriprox.
Der skal udvises forsigtighed hos patienter med nyresygdom i slutstadiet eller svær nyreinsufficiens. 
Caution must be exercised in patients with end stage renal disease or severe hepatic dysfunction.
− Sammen med denne folder finder du et informationskort til patient/plejer. 
− Attached to this leaflet you will find a patient/carer reminder card. You should detach,
Maksimal serumkoncentration ses 45 til 60 minutter efter en enkeltdosis hos fastende patienter, men kan være forsinket til 2 timer hos patienter, der har indtaget føde. 
Peak serum concentration occurs 45 to 60 minutes following a single dose in fasted patients.
Se nedenstående skema for anbefalede doser for legemsvægt i 10 kg trin. 
See table below for recommended doses for body weights at 10 kg increments.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter 
PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets