FrancophonIA/ELRC3.0 huggingface dataset:
English: These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).
Danish: Disse bivirkninger er ikke almindelige (kan påvirke op til 1 ud af 100 patienter) eller sjældne (kan påvirke op til 1 ud af 1.000 patienter).
English: ULN: upper limit of the normal range
Danish: ULN: øvre grænse af normalområdet
English: The kidney toxicity is considered mainly due to iron deprivation in animals that were not previously overloaded with iron.
Danish: Nyretoksiciteten menes primært at skyldes jernmangel hos dyr, der ikke tidligere havde ophobning af jern.
English: Hertfordshire EN6 1TL
Danish: EN6 1TL
English: If you have questions about how long to take Deferasirox Mylan, talk to your doctor.
Danish: Hvis du har spørgsmål om, hvor lang tid du skal tage Deferasirox Mylan, så tal med din læge.
English: There is no specific antidote for deferasirox.
Danish: Der findes ingen specifik antidot for deferasirox.
English: , tubulointerstitial nephritis
Danish: , tubulo-interstitial nefritis
English: It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the initiation of treatment, every 2 weeks during the first month and monthly thereafter.
Danish: Det anbefales, at serum-transaminaser, bilirubin og alkalisk fosfatase måles inden initiering af behandling, hver 2. uge i den første måned og derefter månedligt.
English: Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, France
Danish: Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, Frankrig
English: Deferasirox has low affinity for zinc and copper, and does not cause constant low serum levels of these metals.
Danish: Deferasirox har lav affinitet for zink og kobber, og forårsager ikke lave serum-niveauer for disse metaller.
English: Abnormal serum creatinine and creatinine clearance values were reported in 5.5% and 1.8% of patients, respectively.
Danish: Unormale værdier for serumkreatinin og kreatininclearance blev indberettet hos henholdsvis 5,5 % og 1,8 % patienterne.
English: Adult patients
Danish: Voksne patienter
English: If you are switching from the dispersible tablets to these film-coated tablets, you will need an adjustment of the dose.
Danish: Hvis du skal skifte fra dispergible tabletter til disse filmovertrukne tabletter, skal din dosis justeres.
English: Deferasirox Mylan 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: Deferasirox Mylan anbefales ikke - hvis du er på et fremskredent stadie af myelodysplastisk syndrom (MDS; nedsat produktion af blodceller i knoglemarven) eller har fremskreden kræft.
English: All references to the dispersible tablet formulation throughout the SmPC refer to the reference medical product dispersible tablets.
Danish: Alle referencer til den dispergible tablet-formulering i produktresumeet refererer til det medicinske referenceprodukt dispergible tabletter.
English: After a high-fat meal, AUC and Cmax were increased (by 18% and 29%, respectively).
Danish: Efter indtagelse af et måltid med højt fedtindhold steg AUC og Cmax (henholdsvis 18 % og 29 %).
English: Monthly and Monthly
Danish: Månedligt og Månedligt
English: Hepatic function in all patients should be monitored before treatment, every 2 weeks during the first month and then every month (see section 4.4).
Danish: Leverfunktionen bør monitoreres hos alle patienter før behandling, hver 2. uge i løbet af den første måned og derefter hver måned (se pkt.
English: Immune system disorders Not known:
Danish: Lidelser i immunsystemet Ikke kendt:
English: • That deferasirox causes rises in serum creatinine in some patients ◦ The need to monitor serum creatinine On two occasions prior to initiation of treatment Every week during the first month of initiation of treatment or after therapy modification
Danish: • At deferasirox forårsager stigninger i serum-kreatinin hos visse patienter ◦ Nødvendigheden af at monitorere serum-kreatinin To gange før påbegyndelse af behandling Hver uge den første måned ved påbegyndelse af behandling eller efter ændring af behanding
English: Your doctor may require you to undergo a kidney biopsy, if he/she suspects significant kidney damage.
Danish: Din læge kan kræve, at du får foretaget en nyrebiopsi, hvis han/hun mistænker alvorlig nyreskade.
English: - if you experience frequent heartburn.
Danish: - hvis du ofte oplever halsbrand.
English: It is recommended that serum creatinine be assessed in duplicate before initiating therapy.
Danish: Det anbefales, at serum-kreatinin dobbeltbestemmes før påbegyndelse af behandling.
English: Reduction of daily dose by 7 mg/kg/day (film-coated tablet formulation), if following renal parameters are observed at two consecutive visits and cannot be attributed to other causes
Danish: Reduktion af daglig dosis med 7 mg/kg/dag (filmovertrukken tablet), hvis følgende renale parametre er set ved to på hinanden følgende kontrolbesøg og ikke kan forklares af andre årsager
English: Elevations of liver transaminases greater than 2 times the baseline and 5 times the upper limit of normal were reported in 1.8% of patients.
Danish: Stigninger i leveraminotransferaser til over 2 gange baseline og 5 gange den øvre grænse for normalværdien blev rapporteret hos 1,8 % af patienterne.
English: During clinical studies dose-dependent increases in serum creatinine occurred in about 36% of patients, though most remained within the normal range.
Danish: Under kliniske studier forekom dosisafhængige forhøjelser af serum-kreatinin hos omkring 36 % af patienterne, selvom de fleste blev inden for normalområdet.
English: Prior to launch of Deferasirox Mylan in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Indehaveren af markedsføringstilladelsen skal inden lancering af Deferasirox Mylan i hvert medlemsland komme til enighed med nationale myndighed om indholdet og formatet af uddannelsesprogrammet, inklusive kommunikationsmedia, distributionsmetode og et hvert andet aspekt af programmet.
English: Care should be taken to maintain adequate hydration in patients who develop diarrhoea or vomiting.
Danish: Der bør udvises opmærksomhed omkring opretholdelse af passende hydrering af patienter, som udvikler diarré eller opkastning.
English: Physicians and patients should remain alert for signs and symptoms of gastrointestinal ulceration and haemorrhage during Deferasirox Mylan therapy and promptly initiate additional evaluation and treatment if a serious gastrointestinal adverse reaction is suspected.
Danish: Læger og patienter skal være på vagt over for tegn og symptomer på gastrointestinal ulceration og blødning under behandling med Deferasirox Mylan, og umiddelbart initiere yderligere undersøgelser og behandling, hvis der er mistanke om en alvorlig gastrointestinal utilsigtet hændelse.
English: Liver iron concentration (LIC)
Danish: Filmovertrukne tabletter Jernkoncentration i lever (LIC)
English: At a starting dose of 10 mg/kg/day, deferasirox dispersible tablets led to reductions in indicators of total body iron.
Danish: Ved en startdosis på 10 mg/kg/dag medførte deferasirox dispergible tabletter reduktioner i indikatorer for total-jern i kroppen.
English: The overall exposure of adolescents (12 to ≤17 years) and children (2 to <12 years) to deferasirox after single and multiple doses was lower than that in adult patients.
Danish: Den samlede eksponering af unge (12 til ≤ 17 år) og børn (2 til ≤ 12 år) for deferasirox efter enkelte og gentagne doser var lavere end for voksne patienter.
English: Elevations of liver transaminases have been reported.
Danish: Forhøjelser af levertransaminaser er blevet rapporteret.
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: In clinical studies, elderly patients experienced a higher frequency of adverse reactions than younger patients (in particular, diarrhoea) and should be monitored closely for adverse reactions that may require a dose adjustment.
Danish: I kliniske studier har ældre patienter oplevet en højere frekvens af bivirkninger end yngre patienter (specielt diarré) og bør monitoreres tæt for bivirkninger, der kan kræve dosisjustering.
English: The absolute bioavailability (AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose.
Danish: Den absolutte biotilgængelighed (AUC) af deferasirox (dispergibel tablet-formulering) er omkring 70 % sammenlignet med en intravenøs dosis.
English: Cardiac dysfunction is a known complication of severe iron overload.
Danish: Kardiel dysfunktion er en kendt komplikation ved alvorlig jernophobning.
English: If deferasirox and theophylline are used concomitantly, monitoring of theophylline concentration and theophylline dose reduction should be considered.
Danish: Hvis deferasirox og theofyllin anvendes samtidig, bør theofyllin-koncentrationen monitoreres, og reduktion af theofyllindosis bør overvejes.
English: If this applies to you, tell your doctor before taking Deferasirox Mylan.
Danish: Hvis dette gælder for dig, skal du fortælle det til lægen, inden du tager Deferasirox Mylan.
English: The concomitant administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal haemorrhage.
Danish: Samtidig administration af deferasirox med antikoagulantia kan muligvis også øge risikoen for gastrointestinal blødning.
English: Gastrointestinal haemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis
Danish: Ikke almindelig: Gastrointestinal blødning, gastrisk ulcus (inklusive multiple ulcera), ulcus duodeni, gastritis
English: • The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
Danish: • Nødvendigheden af et vejledende skema der fremhæver målinger før behandling af serumkreatinin, kreatinin-clearance, proteinuri, leverenzymer, ferritin, som fx:
English: In addition to monthly serum ferritin assessments, LIC should be monitored every three months when serum ferritin is ≤800 µg/l.
Danish: I tillæg til månedlige serumferritin-målinger skal LIC monitoreres hver 3. måned, når serumferritin er ≤ 800 µg/l.
English: For adults not assessed and ≤2,000 µg/l
Danish: Ikke vurderet og ≤ 2.000 µg/l
English: In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk.
Danish: I dyrestudier blev det konstateret, at deferasirox hurtigt og i udstrakt grad blev udskilt i mælken.
English: The safety and efficacy of Deferasirox Mylan in children from birth to 23 months of age have not been established.
Danish: Deferasirox Mylans sikkerhed og virkning hos børn i alderen fra fødsel til 23 måneder er ikke klarlagt.
English: If you feel dizzy after taking Deferasirox Mylan, 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 Deferasirox Mylan, må du ikke køre bil eller betjene værktøj eller maskiner før du har det godt igen.
English: Serum creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to therapy, weekly in the first month after initiation or modification of therapy with deferasirox (including switch of formulation), and monthly thereafter.
Danish: Serumkreatinin, kreatinin-clearance (estimeret med Cockcroft-Gault eller MDRD-formlen hos voksne og med Schwartz-formlen for børn) og/eller plasma-cystatin C bør monitoreres inden behandlingsstart, ugentligt den første måned efter påbegyndelse eller ændring af behandling med deferasirox (inklusive skift til anden formulering).
English: Weekly during first month of therapy or after dose modification (including switch of formulation).
Danish: Ugentligt under den første måned af behandlingen eller efter dosisjustering (inklusive skift til anden formulering).
English: Auditory (decreased hearing) and ocular (lens opacities) disturbances are uncommon, and yearly examinations are also recommended (see section 4.4).
Danish: Auditive (nedsat hørelse) og visuelle (uklarheder i linsen) forstyrrelser er ikke almindelige, og årlige undersøgelser anbefales også (se pkt.
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 Deferasirox Mylan may reduce the effectiveness of oral and patch contraceptives.
Danish: Hvis du i øjeblikket tager et oralt præventionsmiddel (p-piller) eller bruger p-plaster for at forebygge graviditet, bør du bruge en supplerende eller anden type prævention (fx kondom), da Deferasirox Mylan kan nedsætte virkningen af orale præventionsmidler og p-plaster.
English: If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
Danish: Hvis kombinationen er nødvendig, bør der udføres nøje klinisk overvågning samt monitorering af blodglukose (se pkt.
English: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Danish: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irland
English: Women of childbearing potential are recommended to use additional or alternative non-hormonal methods of contraception when using Deferasirox Mylan.
Danish: Kvinder i den fødedygtige alder anbefales at bruge yderligere eller alternative ikke-hormonale præventionsmidler, når de tager Deferasirox Mylan.
English: The increases in Cmax due to the change in formulation and due to the effect of a high-fat meal may be additive and therefore, it is recommended that the film-coated tablets should be taken either on an empty stomach or with a light meal.
Danish: Ændring af formuleringen og effekten af måltider med højt fedtindhold kan have en forstærkende effekt på stigningen i Cmax, hvorfor det anbefales, at de filmovertrukne tabletter tages på tom mave eller med et let måltid.
English: Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level (see section 5.1).
Danish: Doser over 28 mg/kg anbefales ikke, da der kun er begrænset erfaring med doser over dette niveau (se pkt.
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 jernophobning og bør anvendes, når den er tilgængelig.
English: - First month after start of therapy or dose modification (including switch of formulation)
Danish: - Første måned efter behandlingsstart eller dosisjustering (inklusive skift til anden formulering)
English: Deferasirox Mylan has minor influence on the ability to drive and use machines.
Danish: Deferasirox Mylan påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: The physician educational material should contain:
Danish: Undervisningsmaterialet til lægen skal indeholde:
English: If no satisfactory control is achieved at doses above 21 mg/kg, treatment at such doses should not be maintained and alternative treatment options should be considered whenever possible.
Danish: Hvis der ikke opnås tilfredsstillende kontrol ved doser over 21 mg/kg, bør behandlingen ikke opretholdes, og når det er muligt, bør alternative behandlingsmuligheder overvejes.
English: In post-marketing reports, a high proportion of cases of metabolic acidosis occurred in children in the context of Fanconi syndrome.
Danish: I rapporter efter markedsføring, blev det set at en stor del af tilfældene af metabolisk acidose forekom hos børn i forbindelse med Fanconis syndrom.
English: Deferasirox Mylan is not recommended for children aged under 2 years.
Danish: Deferasirox Mylan anbefales ikke til børn under 2 år.
English: Adjustment Steps (every 3
Danish: Korrektionstrin (hver 3.
English: • Disturbance in kidney function tests.
Danish: • Forstyrrelse i nyrefunktionstests.
English: Elderly patients The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older).
Danish: Ældre patienter Farmakokinetikken for deferasirox er ikke undersøgt for ældre patienter (65 år eller derover).
English: Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of treatment and at regular intervals thereafter (every 12 months).
Danish: Det anbefales at foretage auditive tests og synstests (inklusive fundoskopi) før påbegyndelse af behandling, og de skal derefter udføres med regelmæssige mellemrum (hver 12. måned).
English: • Swelling of arms or legs
Danish: • Hævelse af arme eller ben
English: Cholestyramine significantly reduced the deferasirox exposure in a mechanistic study to determine the degree of enterohepatic recycling (see section 5.2).
Danish: Cholestyramin reducerede signifikant deferasirox-eksponeringen i et mekanistisk studie for at bestemme graden af enterohepatisk recirkulation (se pkt.
English: Most of these patients had pre-existing haematological disorders that are frequently associated with bone marrow failure.
Danish: De fleste af disse patienter havde præ-eksisterende hæmatologiske lidelser, der ofte forbindes med knoglemarvsdepression.
English: Deferasirox metabolism depends on UGT enzymes.
Danish: Deferasirox-metabolisme afhænger af UGT-enzymer.
English: If such reactions occur, Deferasirox Mylan should be discontinued and appropriate medical intervention instituted.
Danish: Hvis sådanne reaktioner indtræffer, bør Deferasirox Mylan seponeres, og passende medicinsk behandling iværksættes.
English: • A warning on the risk of overchelation and on the necessity of close monitoring of serum ferritin levels and renal and hepatic function.
Danish: • En advarsel om risikoen for overkelering og nødvendigheden af en hyppig monotorering af serum-ferritinniveauer og nyre- og leverfunktion.
English: Hypersensitivity reactions (including anaphylactic reactions and angioedema) Metabolism and nutrition disorders Not known:
Danish: Allergiske reaktioner (inklusive anafylaktiske reaktioner og angioødem) Metaboliske og ernæringsmæssige lidelser Ikke kendt:
English: It is recommended that serum ferritin be monitored every month and that the dose of Deferasirox be adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin.
Danish: Det anbefales, at serumferritin monitoreres hver måned, og at dosis af Deferasirox justeres, hvis nødvendigt, hver 3. til 6. måned, ud fra udviklingen i serumferritin.
English: The principal analysis of the pivotal comparative study in 586 patients suffering from betathalassaemia and transfusional iron overload did not demonstrate non-inferiority of deferasirox dispersible tablets to deferoxamine in the analysis of the total patient population.
Danish: Hovedanalysen af det afgørende sammenligningsstudie hos 586 patienter med beta-talassæmi og transfusionsbetinget jernophobning viste ikke non-inferioritet af deferasirox dispergible tabletter sammenlignet med deferoxamin i analysen af den totale patientpopulation.
English: Cellulose, microcrystalline Crospovidone (Type A) Povidone (K30) Magnesium stearate Silica, colloidal anhydrous Poloxamer (P188)
Danish: Cellulose, mikrokrystallisk Crospovidon (type A) Polyvidon (K30) Magnesiumstearat Silica, kolloid vandfri Poloxamerer (P188)
English: The single dose Cmax was not affected, but an increase of theophylline Cmax is expected to occur with chronic dosing.
Danish: Efter enkeltdosis-behandling var Cmax ikke påvirket, men en øget theofyllin-Cmax kan forventes ved kronisk dosering.
English: Deferasirox Mylan contains an active substance called deferasirox.
Danish: Deferasirox Mylan indeholder et aktivt stof, der kaldes deferasirox.
English: Film-coated tablet (tablet)
Danish: Filmovertrukket (tablet)
English: When serum creatinine is elevated and if another abnormality has been detected (e.g. proteinuria, signs of Fanconi syndrome).
Danish: Når serum-kreatinin er forhøjet og hvis der er set andre abnormaliteter (såsom proteinuri, tegn på Fanconi's Syndrom)
English: Deferasirox has been investigated in 411 adult (age ≥16 years) and 292 paediatric patients (aged 2 to <16 years) with chronic iron overload due to blood transfusions.
Danish: Deferasirox er undersøgt hos 411 voksne (alder ≥ 16 år) og 292 pædiatriske patienter (alder 2 til < 16 år) med kronisk jernophobning forårsaget af blodtransfusioner.
English: • Physician educational material
Danish: • Uddannelsesmateriale til læger
English: The Cmax of deferasirox film-coated tablets was increased (by 29%) when taken with a high-fat meal.
Danish: Cmax for deferasirox filmovertrukne tabletter blev øget (med 29 %), når de blev indtaget samtidigt med mad med et højt fedtindhold.
English: In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 7 mg/kg.
Danish: Hos pædiatriske patienter med ikke-transfusionsafhængige talassæmi-syndromer bør dosis ikke overstige 7 mg/kg.
English: Deferasirox has been studied only in patients with baseline serum creatinine within the ageappropriate normal range.
Danish: Deferasirox er kun blevet undersøgt hos patienter med baseline serum-kreatinin inden for det aldersbestemte normalområde.
English: Characteristics in patients
Danish: Karakteristika hos patienter
English: The patient's response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1).
Danish: Patientens respons skal monitoreres, og dosisøgninger bør overvejes, hvis der ikke opnås tilstrækkelig virkning (se pkt.
English: Interruption of deferasirox therapy should be considered in patients who develop metabolic acidosis.
Danish: Afbrydelse af behandling med deferasirox bør overvejes hos patienter, der udvikler metabolisk acidose.
English: Therefore, the concomitant use of Deferasirox Mylan with potent UGT inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in Deferasirox Mylan efficacy.
Danish: Derfor kan samtidig anvendelse af Deferasirox Mylan med potente UGT-inducere (fx rifampicin, carbamazepin, phenytoin, phenobarbital, ritonavir) resultere i nedsat effekt af Deferasirox Mylan.
English: An interaction between deferasirox and other CYP1A2 substrates cannot be excluded.
Danish: Interaktion mellem deferasirox og andre CYP1A2-substrater kan ikke udelukkes.
English: Changes in weight of paediatric patients over time must be taken into account when calculating the dose.
Danish: Ved beregning af dosis skal ændringer i vægten for pædiatriske patienter over tid tages i betragtning.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 2: “Monitoring your Deferasirox Mylan treatment”).
Danish: Din læge vil regelmæssigt holde øje med din tilstand for at kontrollere, at behandlingen har den ønskede effekt (se også pkt.
English: Deferasirox Mylan film-coated tablets may be taken either on an empty stomach or with a light meal, preferably at the same time each day (see sections 4.2 and 5.2).
Danish: Deferasirox Mylan filmovertrukne tabletter kan tages på tom mave eller med et let måltid og helst på samme tidspunkt hver dag (se punkterne 4.2 og 5.2).
English: Continue taking Deferasirox Mylan every day for as long as your doctor tells you.
Danish: Fortsæt med at tage Deferasirox Mylan hver dag, så længe lægen beder dig om det.
English: Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children and adolescents, receiving deferasirox.
Danish: Øvre gastrointestinal ulceration og blødning er rapporteret i patienter, inklusive unge og børn, som fik deferasirox.