FrancophonIA/ELRC3.0 huggingface dataset:
English: Packaging Content Package size Withdrawal Period
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: June 2021
Danish: Juni 2021
English: • Then wait at least 30 minutes before eating any food.
Danish: • Vent derefter mindst 30 minutter, før du spiser.
English: Date of first authorisation: 28 August 2006 Date of latest renewal: 18 April 2016
Danish: Dato for første markedsføringstilladelse: 28. august 2006 Dato for seneste fornyelse: 18. april 2016
English: “NVR” on the other.
Danish: ”NVR” på den anden side.
English: This is a long-term treatment, possibly lasting for months or years.
Danish: Dette er en længerevarende behandling, der muligvis kan vare måneder eller år.
English: Urgent medical treatment may be necessary.
Danish: Akut medicinsk behandling kan være nødvendig.
English: White to almost white granules
Danish: Hvidt til næsten hvidt granulat
English: The potential for toxicity to reproduction was assessed in rats and rabbits.
Danish: Potentialet for reproduktionstoksicitet blev vurderet i rotter og kaniner.
English: If you miss a dose, take it as soon as you remember on that day.
Danish: Hvis du glemmer en dosis, så tag den så snart du husker det den samme dag.
English: • Pharmacists - a detailed letter explaining the switch between formulations
Danish: • Farmaceuter - et detaljeret brev, der forklarer skiftet mellem formuleringer
English: Frequency not known (cannot be estimated from the available data).
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Liver iron concentration (LIC)*
Danish: Jernkoncentration i lever (LIC)*
English: The safety profile was consistent with previous studies in adult MDS patients.
Danish: Sikkerhedsprofilen var i overensstemmelse med tidligere studier hos voksne MDS patienter.
English: You will have regular blood and urine tests during treatment.
Danish: Du vil få taget regelmæssige blod- og urinprøver under behandlingen.
English: The study enrolled 145 adult and 21 paediatric patients.
Danish: Studiet indrullerede 145 voksne og 21 pædiatriske patienter.
English: The liquid in the glass will look cloudy.
Danish: Væsken i glasset vil se uklar ud.
English: • If you experience partial loss of vision,
Danish: • Hvis du oplever delvist tab af dit syn
English: Twice (2x)
Danish: To gange (2x)
English: Acid-base balance should be monitored as clinically indicated in these populations.
Danish: Syre-base balance, bør overvåges som klinisk indiceret i disse populationer.
English: EXJADE is not recommended for children aged under 2 years.
Danish: EXJADE anbefales ikke til børn under 2 år.
English: *LLN: lower limit of the normal range **ULN: upper limit of the normal range
Danish: *LLN: nedre grænse af normalområdet **ULN: øvre grænse af normalområdet
English: 1, alopecia
Danish: 1, alopeci
English: If you have questions about how long to take EXJADE, talk to your doctor.
Danish: Hvis du har spørgsmål om, hvor lang tid du skal tage EXJADE, så tal med din læge.
English: and Once (1x)
Danish: En gang (1x)
English: The safety and efficacy of EXJADE in children from birth to 23 months of age have not been established.
Danish: EXJADEs sikkerhed og virkning hos børn i alderen fra fødsel til 23 måneder er ikke klarlagt.
English: The mean elimination half-life (t1/2) ranged from 8 to 16 hours.
Danish: Den gennemsnitlige eliminationshalveringstid (t1/2) varierede fra 8 til 16 timer.
English: EXJADE can be used by people aged 65 years and over at the same dose as for other adults.
Danish: EXJADE kan anvendes af folk i alderen 65 år og derover med samme dosis som for andre voksne.
English: The corresponding doses for the different formulations are shown in the table below.
Danish: Den tilsvarende dosis for de forskellige formuleringer er vist i tabellen nedenfor.
English: Monitoring your EXJADE treatment
Danish: Kontrol af din EXJADE-behandling
English: • Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
Danish: • Alt efter hvordan du reagerer på behandlingen, kan din læge senere justere din behandling til højere eller lavere doser.
English: Creatinine clearance and/or plasma cystatin C
Danish: Kreatinin-clearance og/eller plasmacystatin C
English: Your doctor will take these tests into consideration when deciding on the dose of EXJADE most suitable for you and will also use these tests to decide when you should stop taking EXJADE.
Danish: Din læge vil tage disse prøver med i betragtning, når han/hun afgør, hvilken dosis EXJADE, der passer bedst til dig, og vil også bruge disse prøver til at afgøre, hvornår du skal stoppe med at tage EXJADE.
English: In severe cases this reintroduction could be conducted in combination with a short period of oral steroid administration.
Danish: I alvorlige tilfælde kan denne behandling påbegyndes igen i kombination med en kort periode af oralt administreret steroid.
English: This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions.
Danish: Dette skyldes, at blod indeholder jern, og at din krop ikke har en naturlig måde at fjerne det overskydende jern, du får med blodtransfusionerne, på.
English: Then add a little water or juice to what is left in the glass, swirl the liquid around and drink that too.
Danish: Du skal derefter hælde lidt vand eller juice ned i det, der er tilbage i glasset, hvirvle væsken rundt og drikke det.
English: Do not stop taking EXJADE unless your doctor tells you to.
Danish: Hold ikke op med at tage EXJADE, medmindre din læge giver dig besked på det.
English: • Proteinuria (test should be performed prior to therapy and monthly thereafter)
Danish: • Proteinuria (test bør foretages inden behandlingsstart, og efterfølgende månedligt)
English: If possible, evaluation of the pharmacokinetics (AUC, clearance) of a busulfan test dose should be performed to allow dose adjustment.
Danish: Hvis muligt skal farmakokinetikken (AUC, clearance) af en busulfan testdosis evalueres for at muliggøre dosisjustering.
English: If such reactions occur, EXJADE should be discontinued and appropriate medical intervention instituted.
Danish: Hvis sådanne reaktioner indtræffer bør EXJADE seponeres, og passende medicinsk behandling iværksættes.
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: There are no data available on the retreatment of patients who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment cannot be recommended.
Danish: Der er ingen tilgængelige data for genoptagelse af behandlingen hos patienter, der genophober jern efter at have opnået et tilfredsestillende jernniveau i kroppen, og derfor kan det ikke anbefales at genoptage behandlingen.
English: Similar findings were observed in neonatal and juvenile animals.
Danish: Lignende fund er set i neonatale og unge dyr.
English: In children younger than 6 years old exposure was about 50% lower than in adults.
Danish: Hos børn under 6 år var eksponeringen omkring 50% lavere end hos voksne.
English: Gastrointestinal perforation 1, acute pancreatitis
Danish: Gastrointestinal perforation 1, akut pancreatitis
English: Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively.
Danish: Opløsning i kulsyreholdige drikke eller mælk er ikke anbefalet grundet henholdsvis skumning og langsom opløsning.
English: EXJADE has minor influence on the ability to drive and use machines.
Danish: EXJADE påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you feel dizzy after taking EXJADE, do not drive or operate any tools or machines until you are feeling normal again.
Danish: Hvis du føler dig svimmel, efter at du har taget EXJADE, må du ikke køre bil eller betjene værktøj eller maskiner før du har det godt igen.
English: The dosing recommendations for elderly patients are the same as described above.
Danish: Dosisrekommendationer for ældre patienter er de samme som ovenfor.
English: It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio.
Danish: Det er en tridentat ligand, der binder jern med høj affinitet med en ratio på 2:1.
English: Women of childbearing potential are recommended to use additional or alternative non-hormonal methods of contraception when using EXJADE.
Danish: Kvinder i den fødedygtige alder anbefales at bruge yderligere eller alternative ikke-hormonale præventionsmidler når de tager EXJADE.
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: Continue taking EXJADE every day for as long as your doctor tells you.
Danish: Fortsæt med at tage EXJADE hver dag så længe lægen beder dig om det.
English: • Stir until the tablet(s) dissolve completely.
Danish: • Rør rundt indtil tablet(terne) er helt opløst.
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, serum-ferritin og serum-transaminaser bør registreres og vurderes regelmæssigt for tendenser.
English: The clinical study report should be submitted by
Danish: Den kliniske forsøgsrapport skal indsendes inden
English: If this applies to you, tell your doctor before taking EXJADE.
Danish: Hvis dette gælder for dig, skal du fortælle det til lægen, inden du tager EXJADE.
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 magnetisk resonans-skanninger (MRI) for at bestemme mængden af jern i din lever.
English: Before initiating treatment Serum creatinine at Day - X
Danish: Før påbegyndelse af behandling Serum-kreatinin ved Dag X
English: If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, EXJADE 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 EXJADE afbrydes.
English: Do not take a double dose on the next day to make up for the forgotten granules.
Danish: Du må ikke tage en dobbeltdosis den næste dag som erstatning for det glemte granulat.
English: • Additional risk minimisation measures The MAH must inform the European Medicines Agency and the CHMP of the results of the surveillance programme in each Member State.
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal informere Det Europæiske Lægemiddelagentur og CHMP om resultater af overvågningsprogrammet i hvert Medlemsland.
English: EXJADE is not recommended - if you are at an advanced stage of myelodysplastic syndrome (MDS; decreased production of blood cells by the bone marrow) or have advanced cancer.
Danish: EXJADE er ikke anbefalet - hvis du er på et fremskredent stadie af myelodysplastisk syndrom (MDS; nedsat produktion af blodceller i knoglemarven) eller har fremskreden kræft.
English: • Take EXJADE granules either with or without a light meal.
Danish: • Tag EXJADE granulat enten med eller uden et let måltid.
English: o The need to consider renal biopsy:
Danish: o Nødvendigheden af at overveje nyrebiopsi:
English: Treatment may be reinitiated depending on the individual clinical circumstances.
Danish: Behandling kan, afhængigt af den enkelte patients kliniske omstændigheder, genoptages.
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: Bivirkningerne er opstillet nedenfor med følgende opdeling: 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: Take this medicine on an empty stomach.
Danish: Tag medicinen på tom mave.
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, blev der ikke observeret yderligere fald i det gennemsnitlige kreatininclearance-niveau.
English: • Take EXJADE once a day, every day, at about the same time each day with some water.
Danish: • Tag EXJADE én gang daglig, hver dag, på cirka samme tidspunkt med noget vand.
English: • Drop the tablet(s) into a glass of water, or apple or orange juice (100 to 200 ml).
Danish: • Put tablet(terne) i et glas vand eller æble- eller appelsinjuice (100 til 200 ml).
English: Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3.
Danish: Deferasirox bliver primært gluconideret af UGT1A1 og i mindre grad af UGT1A3.
English: After the suspension has been swallowed, any residue must be resuspended in a small volume of water or juice and swallowed.
Danish: Når suspensionen er drukket, skal den tilbageværende rest opslæmmes i en lille mængde vand eller juice og drikkes.
English: Optic neuritis
Danish: Optisk neuritis
English: Disperse tablets in water or fruit juice before swallowing.
Danish: Opløs tabletterne i vand eller frugtjuice før indtagelse.
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 samme doser var ratioen for jernudskillelse: jernindtag henholdsvis 1,02 (hvilket indikerer netto-jernbalance) og 1,67 (hvilket indikerer netto-jernudskillelse).
English: The patient's serum ferritin should be monitored during and after the combination, and the dose of EXJADE adjusted if necessary.
Danish: Patientens serum-ferritin bør monitoreres under og efter kombinationen, og EXJADE-dosis skal om nødvendigt justeres.
English: Do not dissolve the tablets in fizzy drinks or milk.
Danish: Du må ikke opløse tabletterne i kulsyreholdige drikke eller mælk.
English: However, the role of deferasirox as a contributing or aggravating factor cannot be excluded (see section 4.8).
Danish: Deferasiroxs rolle som bidragende eller forværrende faktor kan dog ikke udelukkes (se pkt.
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: Cardiac dysfunction is a known complication of severe iron overload.
Danish: Kardiel dysfunktion er en kendt komplikation ved alvorlig jernoverbelastning.
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: 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: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
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: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet eller karcinogenicitet.
English: Show the doctor the pack of granules.
Danish: Vis lægen pakningen med granulat.
English: If any SCAR is suspected, EXJADE should be discontinued immediately and should not be reintroduced.
Danish: Hvis der er mistanke om SCAR, skal EXJADE seponeres øjeblikkeligt, og behandlingen bør ikke genoptages.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 2: “Monitoring your EXJADE treatment”).
Danish: Din læge vil regelmæssigt holde øje med din tilstand for at kontrollere, at behandlingen har den ønskede effekt (se også pkt.
English: • Take EXJADE once a day, every day, at about the same time each day.
Danish: • Tag EXJADE én gang daglig, hver dag, på cirka samme tidspunkt.
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 afgørende studie, 28 af dem modtagende deferasirox dispergible tabletter.
English: Do not take EXJADE - if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke EXJADE - hvis du er allergisk over for deferasirox eller et af de øvrige indholdsstoffer i EXJADE (angivet i punkt 6).
English: Show the doctor the pack of tablets.
Danish: Vis lægen pakken med tabletter.
English: Maximum dose
Danish: Maksimal dosis
English: • Drink everything in the glass.
Danish: • Drik indtil glasset er helt tomt.
English: The film-coated tablets are ovaloid and biconvex.
Danish: De filmovertrukne tabletter er ovale og bikonvekse.
English: LIC is the preferred method of iron overload determination and should be used wherever available.
Danish: LIC er den foretrukne metode til bestemmelse af jernoverskud og bør anvendes, når den er tilgængelig.
English: Deferasirox is an orally active chelator that is highly selective for iron (III).
Danish: Deferasirox er en oralt aktiv kelator, der er stærkt selektiv for jern (III).
English: As a consequence, treatment with EXJADE is not recommended in these patients.
Danish: Som konsekvens af dette kan det ikke anbefales at behandle disse patienter med EXJADE.
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: 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 serumkreatinin vendte tilbage til niveauet under 33% uden dosisjustering.
English: It is not known if deferasirox is secreted into human milk.
Danish: Det vides ikke, om deferasirox uskilles i human mælk.
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 defirasirox og busulfan resulterede i øget eksponering (AUC) for busulfan, men mekanismen bag denne interaktion er ikke kendt.
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: 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: Patiener 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: 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: Of the paediatric patients 52 were aged 2 to 5 years.
Danish: Af de pædiatriske patienter var 52 af disse 2 til 5 år gamle.
English: If deferasirox and theophylline are used concomitantly, monitoring of theophylline concentration and theophylline dose reduction should be considered.
Danish: Hvis deferasirox og theophyllin anvendes samtidig, bør theophyllin-koncentrationen monitoreres, og reduktion af theophyllindosis bør overvejes.
English: CYP450-catalysed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%).
Danish: CYP450-katalyseret (oxidativ) metabolisme af deferasirox er tilsyneladende mindre i mennesker (8%).
English: The safety of deferasirox in combination with other iron chelators has not been established.
Danish: Sikkerheden af deferasirox i kombination med andre jernkelatorerer er ikke blevet klarlagt.
English: Lactose content The dispersible tablets contain lactose.
Danish: Lactoseindhold De dispergible tabletter indeholder lactose.
English: • The maximum recommended daily dose for EXJADE film-coated tablets is:
Danish: • Den maksimale anbefalede daglige dosis af EXJADE filmovertrukne tabletter er:
English: Monthly thereafter.
Danish: Månedligt herefter.
English: Gastrointestinal haemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis
Danish: Gastrointestinal blødning, gastrisk ulcus (inklusive multiple ulcura), ulcus duodeni, gastritis
English: After a high-fat meal, only AUC was mildly increased (by 18%).
Danish: Efter indtagelse af et måltid med højt fedtindhold steg kun AUC svagt (18%).
English: Physicians and patients should remain alert for signs and symptoms of gastrointestinal ulceration and haemorrhage during EXJADE therapy and promptly initiate additional evaluation and treatment if a serious gastrointestinal adverse reaction is suspected.
Danish: Læger og patienter skal være på vagt for tegn og symptomer på gastrointestinal ulceration og blødning under behandling med EXJADE, og umiddelbart initiere yderligere undersøgelser og behandling, hvis en alvorlig gastrointestinal utilsigtet hændelse er mistænkt.
English: When the granules were administered with apple sauce or yogurt, a food effect was absent.
Danish: Da granulatet blev indgivet sammen med æblegrød eller yoghurt, var der ingen effekt af maden.
English: If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom), as EXJADE may reduce the effectiveness of oral and patch contraceptives.
Danish: Hvis du i øjeblikket tager et oralt præventionsmiddel (p-piller) eller bruger præventionsplaster for at forebygge graviditet, bør du bruge en supplerende eller anden type prævention (fx kondom), da EXJADE kan nedsætte virkningen af orale præventionsmidler og præventionsplaster.
English: If you stop taking it, the excess iron will no longer be removed from your body (see also above section “How long to take EXJADE”).
Danish: Hvis du stopper med at tage EXJADE, vil det overskydende jern ikke længere blive fjernet fra din krop (se også ovenstående pkt.