FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you experience severe upper stomach pain (pancreatitis), stop taking this medicine and tell your doctor straight away.
Danish: • Hvis du oplever voldsomme mavesmerter (pancreatitis), stop med at tage dette lægemiddel og fortæl det til lægen med det samme.
English: This imbalance occurred because patients on deferoxamine were allowed to remain on their pre-study dose even if it was higher than the protocol specified dose.
Danish: Denne ubalance opstod, fordi patienter på deferoxamin fik tilladelse til at blive på deres før-studiedosering, selvom denne dosis var højere end den protokolspecificerede dosis.
English: It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio.
Danish: Det er en trident ligand, der binder jern med høj affinitet i et forhold på 2:1.
English: They should be monitored closely by their doctor for side effects that may require a dose adjustment.
Danish: De skal følges tæt af deres læge for at opdage bivirkninger, der kan kræve dosisjusteringer.
English: Interruption
Danish: Afbrydelse
English: The primary efficacy parameter was the change in liver iron concentration (LIC) from baseline after 12 months of treatment.
Danish: Den primære effektparameter var ændringen i jernkoncentrationen i leveren (LIC) fra baseline efter 12 måneders behandling.
English: In 250 patients who were followed for up to five years, no further decrease in mean creatinine clearance levels was observed.
Danish: Hos 250 patienter, der blev fulgt i op til fem år, blev der ikke observeret yderligere fald i det gennemsnitlige kreatininclearance-niveau.
English: Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3.
Danish: Ved gentagen dosering øgedes eksponeringen med en akkumulationsfaktor på 1,3 til 2,3.
English: 1, neutropenia
Danish: 1, neutropeni
English: Creatinine clearance and/or plasma cystatin C Prior to therapy.
Danish: Kreatinin-clearance og/eller plasma-cystatin C Inden behandlingsstart.
English: • Disturbance in urine test (protein in the urine) If any of these affects you severely, tell your doctor.
Danish: • Afvigelser i urinanalyser (protein i urinen) Hvis nogen af disse bivirkninger påvirker dig alvorligt, så fortæl det til din læge.
English: One of the secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter.
Danish: En af de sekundære effektparametre var ændringen i serumferritin mellem baseline og fjerde kvartal.
English: The dose should be immediately and completely consumed, and not stored for future use.
Danish: Dosen bør indtages med det samme og fuldstændigt og bør ikke gemmes til senere brug.
English: Do not use any pack that is damaged or shows signs of tampering.
Danish: Brug ikke pakninger, der er beskadiget eller viser tegn på at være i stykker eller at have været åbnet.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet eller cancerogent potentiale.
English: Adverse reactions are ranked below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Bivirkninger er opstillet herunder ud fra følgende konventioner: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • Tear in stomach or intestine wall that can be painful and cause nausea
Danish: • Flænge i mave eller tarmvæg, som kan være smertefuldt og give kvalme
English: Cases of serious acute pancreatitis were observed without documented underlying biliary conditions.
Danish: Der er rapporteret om tilfælde af alvorlig akut pancreatitis uden dokumenterede underliggende biliære tilstande.
English: Patients with estimated creatinine clearance <60 ml/min.
Danish: Patienter med estimeret kreatinin-clearance < 60 ml/min.
English: The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends.
Danish: Resultaterne af tests for serum-kreatinin, serumferritin og serum-transaminaser bør registreres og vurderes regelmæssigt for tendenser.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Treatment may be reinitiated depending on the individual clinical circumstances.
Danish: Behandling kan, afhængigt af den enkelte patients omstændigheder, genoptages.
English: • The recommended doses and the rules for starting treatment
Danish: • De anbefalede doser og retningslinjer for opstart af behandling
English: The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, as required, to reduce the existing iron burden.
Danish: Målene med kelatbehandling er at fjerne mængden af jern, der administreres i transfusioner og, om nødvendigt, at reducere den eksisterende jernbelastning.
English: Other considerations
Danish: Andre overvejelser
English: The Cmax was increased by 30% (90% CI: 20.3% - 40.0%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Danish: Cmax blev forøget med 30 % (90 % CI: 20,3 % - 40,0 %), men den kliniske dosis-respons-analyse viste intet tegn på klinisk relevant effekt af en sådan stigning.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen og æsken efter EXP og Udløbsdato.
English: Table 3 Dose adjustment and interruption of treatment for renal monitoring
Danish: Tabel 3 Dosisjustering og afbrydelse af behandling ved monitorering af nyrefunktionen
English: If any of these apply to you, tell your doctor straight away.
Danish: Hvis noget af dette gælder for dig, så fortæl det til din læge med det samme.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel, samt affald heraf, skal bortskaffes i henhold til lokale retningslinjer.
English: In some cases, only a stabilisation of the serum creatinine values has been observed after dose reduction.
Danish: I nogle tilfælde sås kun en stabilisering af serum-kreatinin niveauet efter dosisreduktion.
English: The absolute bioavailability of the film-coated tablet formulation has not been determined.
Danish: Den absolutte biotilgængelighed af den filmovertrukne tabletformulering er ikke fastlagt.
English: 1, anaemia aggravated
Danish: 1, forværret anæmi
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: At the time of prescription, patients should be advised of the signs and symptoms of severe skin reactions, and be closely monitored.
Danish: I forbindelse med receptudskrivelse bør patienter informeres om tegn og symptomer på alvorlige hudreaktioner samt overvåges nøje.
English: The Guide for healthcare professionals shall contain the following key elements:
Danish: Vejledningen til sundhedspersoner skal indeholde følgende nøgleelementer:
English: Similar findings were observed in neonatal and juvenile animals.
Danish: Lignende fund er set hos neonatale og unge dyr.
English: (acquired Fanconi syndrome), glycosuria
Danish: (erhvervet Fanconis syndrom), glukosuri
English: If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, deferasirox should be interrupted.
Danish: Hvis der er en vedholdende og progressiv forøgelse af serum-transaminase-niveauer, der ikke kan henføres til andre årsager, bør behandling med deferasirox afbrydes.
English: Gallstones and related biliary disorders were reported in about 2% of patients.
Danish: Galdesten og relaterede biliære sygdomme blev rapporteret hos omkring 2 % af patienterne.
English: 9/l) (see section 4.5).
Danish: 9/l) (se pkt.
English: You may also have MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver.
Danish: Du får måske også foretaget MR-scanninger (magnetisk resonans) for at bestemme mængden af jern i din lever.
English: Creatinine clearance
Danish: Kreatinin-clearance
English: Weekly and Weekly
Danish: Ugentligt og Ugentligt
English: At these same doses, the ratios of iron excretion: iron intake were 1.02 (indicating net iron balance) and 1.67 (indicating net iron removal), respectively.
Danish: Ved de samme doser var ratioen af jernudskillelse: jernindtag henholdsvis 1,02 (hvilket indikerer netto-jernbalance) og 1,67 (hvilket indikerer netto-jernudskillelse).
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret i {MM/ÅÅÅÅ}.
English: Annually in paediatric patients.
Danish: Årligt hos pædiatriske patienter.
English: Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3.
Danish: Deferasirox bliver primært glucoronideret af UGT1A1 og i mindre grad af UGT1A3.
English: • Proteinuria (test should be performed prior to therapy and monthly thereafter)
Danish: • Proteinuri (test bør foretages inden behandlingsstart, og efterfølgende månedligt)
English: About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment.
Danish: Omkring to tredjedele af patienterne med forøget serum-kreatinin vendte tilbage til niveauet under 33 % uden dosisjustering.
English: However, the role of deferasirox as a contributing or aggravating factor cannot be excluded (see section 4.8).
Danish: Deferasirox' rolle som bidragende eller forværrende faktor kan dog ikke udelukkes (se pkt.
English: Manufacturer Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Danish: Fremstiller Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Storbritannien
English: Of the paediatric patients 52 were aged 2 to 5 years.
Danish: 52 af de pædiatriske patienter var 2 til 5 år gamle.
English: In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption.
Danish: Hos den sidste tredjedel reagerede forøgelsen af serum-kreatinin ikke altid på en dosisreduktion eller dosisafbrydelse.
English: Alternative starting doses
Danish: Alternativ startdosis
English: Fifty-six patients under the age of 6 years participated in this pivotal study, 28 of them receiving deferasirox dispersible tablets.
Danish: 56 patienter under 6 år deltog i dette pivotalstudie, 28 af dem modtagende deferasirox dispergible tabletter.
English: Deferasirox did not cause other effects on fertility or reproduction.
Danish: Deferasirox forårsagede ikke andre effekter på fertilitet eller reproduktion.
English: Concomitant administration of deferasirox and busulfan resulted in an increase of busulfan exposure (AUC), but the mechanism of the interaction remains unclear.
Danish: Samtidig administration af deferasirox og busulfan resulterede i øget eksponering (AUC) for busulfan, men mekanismen bag denne interaktion er ikke kendt.
English: Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
Danish: Kvinder har en moderat mindre påviselig clearance (med 17,5 %) for deferasirox sammenlignet med mænd.
English: The tests will also monitor your kidney function (blood level of creatinine, presence of protein in the urine) and liver function (blood level of transaminases).
Danish: Prøverne vil også vise nyrefunktionen (kreatinin-niveau i blodet, tilstedeværelse af protein i urinen) og leverfunktionen (transaminase-niveau i blodet).
English: Your doctor will take these tests into consideration when deciding on the dose of Deferasirox Mylan most suitable for you and will also use these tests to decide when you should stop taking Deferasirox Mylan.
Danish: Din læge vil tage disse prøver med i betragtning, når han/hun afgør, hvilken dosis Deferasirox Mylan, der passer bedst til dig, og vil også bruge disse prøver til at afgøre, hvornår du skal stoppe med at tage Deferasirox Mylan.
English: The transporters MRP2 and MXR (BCRP) are involved in the biliary excretion of deferasirox.
Danish: Transportproteinerne MRP2 og MXR (BCRP) er involveret i den biliære udskillelse af deferasirox.
English: If you think you may be allergic, ask your doctor for advice.
Danish: Hvis du har mistanke om, at du kan være allergisk, skal du spørge lægen til råds.
English: It is not known if deferasirox is secreted into human milk.
Danish: Det vides ikke, om deferasirox udskilles i human mælk.
English: Metabolic acidosis
Danish: Metabolisk acidose
English: Hypromellose Titanium dioxide (E171) Macrogol/PEG (6000) Talc
Danish: Hypromellose Titandioxid (E171) Macrogol/PEG (6000) Talkum
English: Date of first authorisation:
Danish: Dato for første markedsføringstilladelse:
English: In some post-marketing cases, renal function deterioration has led to renal failure requiring temporary or permanent dialysis.
Danish: Der er efter markedsføringen set tilfælde, hvor forværring af nyrefunktionen har ført til nyresvigt, som har krævet midlertidig eller permanent dialyse.
English: • Take Deferasirox Mylan once a day, every day, at about the same time each day with some water.
Danish: • Tag Deferasirox Mylan sammen med noget vand, én gang daglig, hver dag, på cirka samme tidspunkt.
English: One third of deferoxamine dose
Danish: En tredjedel af deferoxamindosis
English: Serum transaminases, bilirubin, alkaline phosphatase
Danish: Serum-aminotransferaser, bilirubin, alkalisk fosfatase
English: For substances that are predominantly metabolised by CYP1A2 and that have a narrow therapeutic index (e.g. clozapine, tizanidine), the same recommendations apply as for theophylline.
Danish: For substanser, som primært metaboliseres af CYP1A2, og som har et snævert terapeutisk indeks (fx clozapin, tizanidin), gælder de samme anbefalinger som for theofyllin.
English: Dose reduction or interruption may be also considered if abnormalities occur in levels of markers of renal tubular function and/or as clinically indicated:
Danish: Dosisreduktion eller afbrydelse kan også overvejes, hvis uregelmæssigheder opstår i niveauer for markører af nyretubulær funktion og/eller som klinisk indiceret:
English: Patients should be referred to a renal specialist, and further specialised investigations (such as renal biopsy) may be considered if the following occur despite dose reduction and interruption:
Danish: Patienter bør henvises til en nyrespecialist og yderligere specialiserede undersøgelser (så som renal biopsi) bør overvejes, hvis følgende opstår på trods af reduktion i dosis og afbrydelse af behandling:
English: Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/− heterozygous mice in a 6-month study.
Danish: Deferasirox var ikke carcinogent, når det blev administreret til rotter i et 2-års studie og transgene p53+/− heterozygote mus i et 6-måneders studie.
English: Adverse reactions reported during post-marketing experience.
Danish: Bivirkninger indberettet fra erfaringer efter markedsføring.
English: Contraindicated
Danish: Kontraindiceret
English: However, a contributory or aggravating role cannot be excluded.
Danish: Det kan dog ikke udelukkes, at der er en medvirkende eller forværrende effekt.
English: Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5).
Danish: Kombination med andre jernkelator-behandlinger, da sikkerheden af sådanne kombinationer ikke er klarlagt (se pkt.
English: Deferasirox Mylan can be used by people aged 65 years and over at the same dose as for other adults.
Danish: Deferasirox Mylan kan anvendes af folk i alderen 65 år og derover med samme dosis som for andre voksne.
English: An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment.
Danish: En fejlagtig administration, af en enkelt dosis på 90 mg/kg, resulterede i Fanconis syndrom, som forsvandt efter behandlingen.
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03
Danish: Farmakoterapeutisk klassifikation: Jernkelerende præparat, ATC-kode: V03AC03
English: ◦ The need to consider renal biopsy:
Danish: ◦ Nødvendigheden af at overveje nyrebiopsi:
English: The patient's serum ferritin should be monitored during and after the combination, and the dose of Deferasirox Mylan adjusted if necessary.
Danish: Patientens serumferritin bør monitoreres under og efter kombinationen, og dosis af Deferasirox Mylan skal om nødvendigt justeres.
English: Single events of increase in ALT and aspartate aminotransferase were reported in 20.0% and 8.3%, respectively, of the 145 patients who completed the study.
Danish: Der blev rapporteret enkeltstående tilfælde af stigning i ALAT og aspartat-aminotransferase hos henholdsvis 20,0 % og 8,3 % af de 145 patienter, som gennemførte studiet.
English: The MAH shall ensure that, at launch, in each Member State where Deferasirox Mylan is marketed, all healthcare professionals and patients who are expected to prescribe, dispense and use Deferasirox Mylan are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at ved lancering i hvert medlemsland, hvor Deferasirox Mylan er markedsført, vil alt sundhedspersonale og patienter, som forventes at udskrive, udlevere og anvende Deferasirox Mylan få udleveret følgende uddannelsespakke
English: A comparable safety profile for film-coated and dispersible tablets was observed.
Danish: Der blev observeret en sammenlignelig sikkerhedsprofil for filmovertrukne tabletter og dispergible tabletter.
English: >33% above pretreatment average and Decreases <LLN
Danish: > 33 % over gennemsnittet fra før behandling og Faldende < LLN
English: Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%).
Danish: Transaminaseniveauer, der var mere end 10 gange over normalområdets øverste grænse, hvilket indikerer hepatitis, var usædvanlige (0,3 %).
English: Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
Danish: Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Ungarn
English: • The rules for treatment dose adjustments and interruption when target serum ferritin +/− liver iron concentration are reached.
Danish: • Retningslinjerne for dosisjustering og seponering, når målet for serum-ferritin +/jernkoncentrationen i leveren er nået.
English: Close clinical monitoring is required when deferasirox is combined with these substances.
Danish: Der kræves tæt monitorering, når deferasirox kombineres med disse substanser.
English: Elderly patients may experience more side effects (in particular diarrhoea) than younger patients.
Danish: Ældre patienter kan opleve flere bivirkninger (specielt diarré) end yngre patienter.
English: CYP450-catalysed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%).
Danish: CYP450katalyseret (oxidativ) metabolisme af deferasirox er tilsyneladende mindre i mennesker (8 %).
English: Deferasirox (dispersible tablet formulation) is absorbed following oral administration with a median time to maximum plasma concentration (tmax) of about 1.5 to 4 hours.
Danish: Deferasirox (dispergibel tablet-formulering) bliver absorberet efter oral administration med en mediantid til maksimum plasmakoncentration (tmax) på omkring 1,5 til 4 timer.
English: However, as a general precautionary measure in the management of paediatric patients with transfusional iron overload, body weight, height and sexual development should be monitored prior to therapy and at regular intervals (every 12 months).
Danish: Som en generel forholdsregel for varetagelse af pædiatriske patienter med transfusionsbetinget jernophobning bør kropsvægt, højde og kønsudvikling imidlertid monitoreres inden behandlingsstart og med regelmæssige intervaller (hver 12. måned).
English: Doses above 14 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassaemia syndromes.
Danish: Doser over 14 mg/kg anbefales ikke, da der ikke er nogen erfaring med doser over dette niveau hos patienter med ikke-transfusionsafhængige talassæmi-syndromer.
English: Decreases in mean creatinine clearance have been observed in both paediatric and adult patients with beta-thalassemia and iron overload during the first year of treatment, but there is evidence that this does not decrease further in subsequent years of treatment.
Danish: Fald i gennemsnitlig kreatininclearance er observeret hos både pædiatriske og voksne patienter med beta-talassæmi og jernophobning i det første år af behandlingen, men der er tegn på, at dette ikke falder yderligere i de efterfølgende år af behandlingen.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Danish: Lægemiddelreaktioner med eosinofili og systemiske symptomer (DRESS)
English: Patients with pre-existing renal conditions and patients who are receiving medicinal products that depress renal function may be more at risk of complications.
Danish: Patienter med forud bestående nyresygdom eller patienter, som får lægemidler, der nedsætter nyrefunktionen, kan have en større risiko for komplikationer.
English: Since the interaction has not been established with dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should be avoided.
Danish: Da interaktionen ikke er blevet påvist med doser højere end 0,5 mg for repaglinid, bør samtidig brug af deferasirox og repaglinid undgås.
English: Deferasirox Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Deferasirox Mylan indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, dvs. den er i alt væsentligt ”natriumfri”.
English: or >1,000μg/l
Danish: eller > 1.000 μg/l
English: The patient information pack should contain:
Danish: Informationspakken til patienten skal indeholde:
English: Do not take Deferasirox Mylan - if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Deferasirox Mylan - hvis du er allergisk over for deferasirox eller et af de øvrige indholdsstoffer i denne medicin (angivet i punkt 6).
English: Your eyesight and hearing will be tested each year during treatment as a precautionary measure.
Danish: Som en sikkerhedsforanstaltning vil dit syn og hørelse blive testet hvert år.
English: • A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in the number of all kinds of blood cells (pancytopenia)
Danish: • Et fald i antallet af celler, der er involveret i blodets evne til at størkne (trombocytopeni), i antallet af røde blodlegemer (forværret anæmi), i antallet af hvide blodlegemer (neutropeni) eller i antallet af alle slags blodlegemer (pancytopeni)
English: The safety of deferasirox in combination with other iron chelators has not been established.
Danish: Sikkerheden af deferasirox i kombination med andre jernkelatorer er ikke blevet klarlagt.