FrancophonIA/ELRC3.0 huggingface dataset:
English: Take Farydak once a day at the same time each day only on the scheduled days.
Danish: Tag Farydak én gang om dagen på samme tidspunkt hver dag og kun på de angivne dage.
English: During Farydak treatment, you should also tell your doctor or your pharmacist if you are prescribed another medicine that you have not already been taking.
Danish: Under behandlingen med Farydak skal du også fortælle det til din læge eller apotekspersonalet, hvis du får ordineret andre lægemidler, som du ikke tog i forvejen.
English: Anticipated pharmacodynamic interactions
Danish: Forventede farmakodynamiske interaktioner
English: After a single oral dose of [14C] panobinostat in patients, 29 to 51% of administered radioactivity is excreted in the urine and 44 to 77% in the faeces.
Danish: Efter en enkelt dosis [14C] panobinostat hos patienter udskilles 29 til 51 % af den administrerede radioaktivitet i urinen og 44 til 77 % i fæces.
English: Gastrointestinal toxicity is very common in patients treated with panobinostat.
Danish: Gastrointestinal toksicitet er meget almindeligt hos patienter, der behandles med panobinostat.
English: The treatment was discontinued in 2.9% of patients due to fatigue and asthenia.
Danish: Behandlingen blev seponeret hos 2,9% af patienter på grund af træthed og asteni.
English: Patients who experience diarrhoea and nausea or vomiting may require temporary dose discontinuation or dose reduction as outlined in Table 4.
Danish: Patienter, der oplever diarré og kvalme eller opkastning kan have behov for midlertidig dosisafbrydelse eller dosisreduktion som beskrevet i tabel 4.
English: Therefore, physicians and patients should be aware of the increased risk of thrombocytopenia and the potential for haemorrhage, especially in patients with coagulation disorders or in those who are receiving chronic anti-coagulation therapy.
Danish: Derfor bør læger og patienter være opmærksomme på den øgede risiko for trombocytopeni og muligheden for blødninger, særlig hos patienter med koagulationssygdomme eller hos dem, som får fast antikoagulerende behandling.
English: Adverse drug reactions are listed according to system organ classes in MedDRA.
Danish: Bivirkningerne er anført efter systemorganklasserne i MedDRA.
English: Patients over 65 years of age had a higher frequency of selected adverse events and of discontinuation of treatment because of adverse events.
Danish: Patienter over 65 år havde en højere forekomst af udvalgte bivirkninger og af behandlings-seponering på grund af bivirkninger.
English: Fatigue and asthenia were reported in 41.2% and 22.0% of patients, respectively.
Danish: Træthed og asteni blev indberettet hos henholdsvis 41,2 % og 22,0 % af patienterne.
English: No patient had an absolute QTcF >500 msec.
Danish: Der var ingen patienter med et absolut QTcF >500 msek.
English: - check the amount of electrolytes (such as potassium, magnesium, phosphate) in your body.
Danish: - undersøge mængden af salte (fx kalium, magnesium, fosfat) i din krop.
English: Your doctor will discuss with you the possible risks of taking Farydak during pregnancy.
Danish: Din læge vil drøfte de mulige risici, der er ved at tage Farydak under graviditet med dig.
English: • If QT prolongation is resolved within 7 days, resume treatment at prior dose for initial occurrence or at reduced dose if QT prolongation is recurrent.
Danish: • Hvis QT-forlængelsen forbedres i løbet af 7 dage, skal behandlingen genoptages med den tidligere dosis ved første forekomst eller med nedsat dosis, hvis QT-forlængelsen er tilbagevendende.
English: In the event of grade 3 nausea or grade 3 or 4 vomiting despite administration of an anti-emetic, panobinostat should be temporarily discontinued and resumed at a reduced dose on recovery to grade 1.
Danish: I tilfælde af kvalme grad 3, eller opkastning grad 3 eller 4 trods administration af et antiemetikum bør panobinostat seponeres midlertidigt og genoptages med en nedsat dosis ved bedring til grad 1.
English: Your doctor may need to change your dose, temporarily stop or completely stop your treatment with Farydak in case you experience side effects.
Danish: Din læge skal måske ændre din dosis, midlertidigt afbryde eller helt stoppe behandlingen med Farydak, hvis du oplever nogle bivirkninger.
English: Please refer to Table 1 for cycles 1 to 8 and Table 2 for cycles 9-16.
Danish: Se venligst tabel 1 for cyklus 1 til 8 og tabel 2 for cyklus 9-16.
English: • blood in urine (a sign of a kidney problem)
Danish: • blod i urinen (tegn på et nyreproblem)
English: Panobinostat is extensively metabolised, and a large fraction of the dose is metabolised before reaching the systemic circulation.
Danish: Panobinostat metaboliseres i udstrakt grad, og en stor fraktion af dosis metaboliseres, før den når den systemiske cirkulation.
English: Refractoriness to bortezomib was defined as disease progression on or within 60 days of the last bortezomib-containing line of therapy.
Danish: Tilstanden behandlingsrefraktær over for bortezomib blev defineret som sygdomsprogression på eller inden for 60 dage efter sidste bortezomib-indeholdende behandlingslinje.
English: Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics of panobinostat.
Danish: Lægemidler, der kan påvirke CYP3A4-enzymaktiviteten, kan derfor ændre panobinostats farmakokinetik.
English: Adverse reactions leading to permanent discontinuation occurred in 30%, 44% and 47% of patients aged <65 years, 65-75 years and ≥75 years, respectively.
Danish: Bivirkninger, som førte til permanent seponering af behandlingen forekom hos henholdsvis 30 %, 44 % og 47 % af patienterne i alderen <65 år, 65-75 år og ≥75 år.
English: Medicinal products with laxative properties should be used with caution because of the potential for exacerbation of diarrhoea.
Danish: Laksantia skal anvendes med forsigtighed på grund af muligheden for forværring af diarréen.
English: The MAH shall ensure that in each Member State where Farydak is marketed, all patients/carers who are expected to use Farydak have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre at alle patienter/sundhedspersonale, der forventes at anvende Farydak, i hvert medlemsland, hvor Farydak er markedsført, har adgang til/ er forsynet med følgende uddannelsespakke:
English: You will have regular blood tests during treatment with Farydak.
Danish: Du vil få taget regelmæssige blodprøver under behandlingen med Farydak.
English: The volume of distribution of panobinostat at steady state (Vss) is approximately 1,000 litres based on final parameter estimates in the population pharmacokinetic analysis.
Danish: Panobinostats fordelingsvolumen i steady state (Vss) er ca. 1.000 liter baseret på endelige parameterestimater i den farmakokinetiske populationsanalyse.
English: It is unknown whether panobinostat is excreted in human milk.
Danish: Det er ukendt, om panobinostat udskilles i human mælk.
English: Treatment with Farydak should be initiated by a physician experienced in the use of anti-cancer therapies.
Danish: Behandlingen med Farydak skal initieres af en læge med erfaring i anvendelse af anticancerbehandlinger.
English: Additional blood counts should be considered during the “rest period” - e.g. on days 15 and/or 18, especially in patients ≥65 years and patients with a baseline platelet count below 150 x 109/l.
Danish: Det bør overvejes at udføre yderligere blodtællinger i løbet af ”hvileperioden” - fx på dag 15 og/eller 18, især hos patienter ≥65 år og patienter med en baseline for trombocyttallet på under 150 x 109/l.
English: Fatalities involving either pneumonia or sepsis were reported.
Danish: Der blev indberettet fatale tilfælde i forbindelse med pneumoni eller sepsis.
English: Multiple myeloma is a disorder of plasma cells (a type of blood cell) that grow out of control in the bone marrow.
Danish: Myelomatose er en forstyrrelse i plasmacellerne (en slags blodceller), som vokser ukontrolleret i knoglemarven.
English: Tell your doctor straight away if your partner becomes pregnant while you are taking Farydak or during the six months following your treatment with Farydak.
Danish: Fortæl det straks til din læge, hvis din partner bliver gravid, mens du tager Farydak, eller i løbet af de første seks måneder efter behandlingen med Farydak.
English: - Do not take this medicine after the expiry date, which is stated on the carton and blister foil.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter EXP.
English: Cytochrome P450 3A4 (CYP3A4) is the main oxidation enzyme, with potential minor involvement of CYP2D6 and 2C19.
Danish: Cytokrom P450 3A4 (CYP3A4) er det vigtigste oxidationsenzym, og CYP2D6 og 2C19 indgår eventuelt i mindre grad.
English: Strong CYP3A4 inducers
Danish: Stærke CYP3A4 inducere
English: Pertinent metabolic pathways involved in the biotransformation of panobinostat are reduction, hydrolysis, oxidation and glucuronidation processes.
Danish: Relevante metaboliske signalveje, der indgår i biotransformationen af panobinostat, er reduktions-, hydrolyse-, oxidations- og glucuronidationsprocesser.
English: - if you have blood clotting problems (coagulation disorder).
Danish: - hvis du har problemer med at få blodet til at størkne (koagulationsforstyrrelse).
English: - Do not take this medicine if you notice any damage to the packaging or if there are any signs of tampering.
Danish: • Tag ikke lægemidlet, hvis du bemærker, at pakningen er beskadiget på nogen måde, eller hvis der er tegn på, at den er forsøgt åbnet.
English: Packs containing 6, 12 or 24 capsules.
Danish: Pakninger med 6, 12 eller 24 kapsler.
English: In the phase III study, thrombocytopenia typically recovered to baseline by the start of the next 21-day cycle (see Figure 1).
Danish: I fase III-forsøget bedredes trombocytopenien typisk til baseline-niveau inden starten på den næste 21dages cyklus (se figur 1).
English: However, treatment discontinuation due to these reactions was reported in a relatively small proportion of patients, with diarrhoea at 4.5% and nausea and vomiting at 0.5% each.
Danish: Behandlingsseponering som følge af disse reaktioner er dog blevet indberettet hos en relativt lille andel patienter, med henholdsvis diarré på 4,5 % og kvalme og opkastning på 0,5 %.
English: Therefore a complete blood count must be performed before initiating therapy with panobinostat, with frequent monitoring during treatment (in particular before each injection of bortezomib as per bortezomib SmPC).
Danish: Der skal derfor udføres en komplet blodcelletælling, før opstart af behandlingen med panobinostat, med hyppig monitorering under behandlingen (særlig før hver injektion med bortezomib som angivet i produktresuméet for bortezomib).
English: The bortezomib and dexamethasone prescribing information should be consulted prior to the start of the combination treatment to assess whether a dose reduction is required.
Danish: Produktresuméerne for bortezomib og dexamethason bør gennemses, før kombinationsbehandlingen startes, for at vurdere om der er behov for en dosisreduktion.
English: Adverse drug reactions from the phase III study (Panorama 1) are shown in Table 7.
Danish: Bivirkninger fra fase III-forsøget (Panorama 1) er vist i tabel 7.
English: Farydak is an anti-cancer medicine that contains the active substance panobinostat, which belongs to a group of medicines called pan-deacetylase inhibitors.
Danish: Farydak er et lægemiddel mod kræft, der indeholder det aktive stof panobinostat, og tilhører en gruppe af lægemidler, som kaldes pan-deacetylase-hæmmere.
English: Overall panobinostat exposure and inter-patient variability remained unchanged with or without food, whereas Cmax was reduced by <45% and Tmax prolonged by 1 to 2.5 hours with food (i.e. both normal and high-fat breakfasts).
Danish: Den samlede eksponering for panobinostat og variabiliteten fra patient til patient forblev uændret med eller uden mad, mens Cmax faldt med <45 %, og Tmax blev forlænget med 1 til 2,5 timer med mad (dvs. både normale og fedtrige morgenmåltider).
English: Gastrointestinal toxicity, primarily diarrhoea, nausea and vomiting, is among the most frequently reported adverse reactions.
Danish: Gastrointestinal toksicitet, primært diarré, kvalme og opkastning, er blandt de hyppigst indberettede bivirkninger.
English: • If any QTcF value is above 500 msec, Farydak therapy should be permanently discontinued.
Danish: • Hvis der forekommer en QTcF-værdi over 500 msek., skal behandlingen med Farydak seponeres permanent.
English: Metabolism via CYP2D6 and 2C19 was minor.
Danish: Metabolismen fandt sted i mindre grad via CYP2D6 og 2C19.
English: Panobinostat should not be administered in patients with severe hepatic impairment due to lack of experience and safety data in this population.
Danish: Panobinostat bør ikke administreres til patienter med svær leverinsufficiens, da der mangler erfaring og sikkerhedsdata for denne population.
English: Clinical judgement on how to continue the treatment should be exercised when a patient experiences an adverse drug reaction.
Danish: Der skal anvendes klinisk vurdering med hensyn til, hvordan behandlingen skal fortsættes, når en patient oplever bivirkninger.
English: itraconazole, voriconazole or posaconazole) and some bacterial infections (such as antibiotics like clarithromycin or telithromycin).
Danish: voriconazol eller posaconazol) og visse bakterieinfektioner (fx antibiotika som clarithromycin og telithromycin).
English: Tell a doctor or a pharmacist straight away if you notice any of these side effects:
Danish: Fortæl det straks til lægen eller apotekspersonalet, hvis du bemærker en eller flere af disse bivirkninger:
English: Bortezomib may be started at 1.3 mg/m2 once weekly on days 1 and 8, and dexamethasone at 20 mg on days 1 and 8.
Danish: Bortezomib kan påbegyndes med 1,3 mg/m2 én gang ugentligt på dag 1 og 8, og dexamethason med 20 mg på dag 1 og 8.
English: In vitro, panobinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells.
Danish: In vitro forårsagede panobinostat akkumulering af acetylerede histoner og andre proteiner, hvilket inducerede standsning af cellecyklus og/eller apoptose af nogle transformerede celler.
English: Farydak is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations.
Danish: Farydak er en histon-deacetylase (HDAC)-hæmmer, der hæmmer den enzymatiske aktivitet af HDAC´er ved nanomolære koncentrationer.
English: Some of these infections (e.g. pneumonia) have been severe (e.g. leading to sepsis, or respiratory or multi-organ failure) and have had fatal outcomes (see section 4.8).
Danish: Nogle af disse infektioner (f.eks. pneumoni) har været svære (f.eks. medført sepsis eller respirations- eller multiorgansvigt) og har haft fatale følger (se pkt.
English: grade ≤1 and resume treatment at a reduced dose.
Danish: CTC grad ≤1, og genoptag behandlingen med nedsat dosis.
English: In addition, it is currently unknown whether panobinostat may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should additionally use a barrier method of contraception.
Danish: Desuden er det i øjeblikket uvist, om panobinostat kan nedsætte virkningen af hormonale kontraceptiva,og kvinder, der bruger hormonale kontraceptiva skal derfor tillige anvende en kontraceptiv barrieremetode.
English: Of note, whereas grade 3 and grade 4 neutropenia were observed in 28% and 7% of patients, respectively, febrile neutropenia was observed in 1% of patients (see section 4.8).
Danish: Det skal især bemærkes, at mens neutropeni grad 3 og grad 4 blev observeret hos henholdsvis 28 % og 7 % af patienterne, blev febril neutropeni observeret hos 1 % af patienterne (se pkt.
English: The median duration of exposure in the study was 5.0 months.
Danish: Eksponeringens mediane varighed i forsøget var 5,0 måneder.
English: Hepatic function abnormal, hyperbilirubinaemia a
Danish: Leverfunktion abnorm, hyperbilirubinæmi a
English: Frequency of monitoring of these patients should be increased during treatment with panobinostat, particularly during the dose escalation phase.
Danish: Disse patienter bør monitoreres hyppigere under behandling med panobinostat, særlig i dosiseskaleringsfasen.
English: Therefore an ECG should be recorded prior to the start of therapy and repeated periodically before each treatment cycle.
Danish: Der skal derfor optages et EKG før behandlingsstart og derefter periodisk før hver behandlingscyklus.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: • swollen ankles (a sign of a low level of albumin in the blood which is known as hypoalbuminaemia)
Danish: • hævede ankler (tegn på en lav mængde albumin i blodet, hvilket kaldes hypoalbuminæmi)
English: These medicines should be used with care or may need to be avoided during your treatment with Farydak.
Danish: Disse lægemidler skal anvendes med forsigtighed eller skal måske helt undgås under behandlingen med Farydak.
English: It is currently unknown whether panobinostat may reduce the effectiveness of hormonal contraceptives.
Danish: Det er på nuværende tidspunkt uvist om panobinostat kan reducere effekten af hormonale kontraceptiva.
English: Very common Hypotension Common
Danish: Meget almindelig Hypotension Almindelig
English: Panobinostat may be started at a dose of 15 mg, and if tolerated in the first cycle escalated to 20 mg in the second cycle.
Danish: Panobinostat kan påbegyndes med en dosis på 15 mg, og, hvis det tåles i 1. cyklus, eskaleres til 20 mg i 2. cyklus.
English: Panobinostat has not been studied in patients with end-stage renal disease (ESRD) or patients on dialysis (see section 5.2).
Danish: Panobinostat er ikke undersøgt hos patienter med nyresygdom i sidste stadie (ESRD) eller patienter i dialyse (se pkt.
English: Farydak should only be used during pregnancy if the expected benefits outweigh the potential risks to the foetus.
Danish: Farydak bør kun anvendes under graviditet, hvis de forventede fordele opvejer den potentielle risiko for fosteret.
English: However, thrombocytopenia is reversible (median time to recovery of 12 days) and can usually be managed by dose adjustment and interruption with or without platelet transfusion (see section 4.4).
Danish: Trombocytopeni er imidlertid reversibel (mediantid til bedring på 12 dage) og kan som regel håndteres med dosisjustering og -afbrydelse med eller uden trombocyttransfusion (se pkt.
English: Replacement intravenous fluids and electrolytes may be used as appropriate.
Danish: Intravenøs væske- og elektrolyterstatning kan anvendes efter behov.
English: If patients experience thrombocytopenia, panobinostat may need to be temporarily withheld and the subsequent dose may need to be reduced (see Table 3).
Danish: Hvis patienter oplever trombocytopeni, skal panobinostat muligvis seponeres midlertidigt, og den efterfølgende dosis kan blive nødvendig at nedsætte (se tabel 3).
English: If you have questions about how long to take Farydak, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor længe du skal tage Farydak, skal du tale med din læge eller apotekspersonalet.
English: • light-headedness, particularly when standing up (a sign of low blood pressure)
Danish: • svimmelhed, især når du rejser dig op (tegn på lavt blodtryk)
English: Monitoring during your treatment with Farydak
Danish: Overvågning under behandlingen med Farydak
English: Very common Insomnia
Danish: Meget almindelig Søvnløshed
English: Discontinuation of treatment may be considered if thrombocytopenia does not improve despite the treatment modifications described below and/or the patient requires repeated platelet transfusions.
Danish: Det kan overvejes, at afbryde behandlingen, hvis trombocytopenien ikke forbedres på trods af de nedenfor beskrevne behandlingsjusteringer, og/eller hvis patienten får behov for gentagne trombocyttransfusioner.
English: The primary endpoint of the study was to assess overall response rate (ORR) after 8 cycles of therapy
Danish: Forsøgets primære endepunkt var vurdering af den overordnede responsrate (ORR) efter 8 behandlingscyklusser ifølge mEBMT-kriterierne.
English: Increased levels of acetylated histones were observed in xenografts from mice that were treated with panobinostat.
Danish: Der blev observeret øgede niveauer af acetylerede histoner i xenografter fra mus, der blev behandlet med panobinostat.
English: Omit dose Resume at reduced dose or change to once weekly
Danish: Udelad dosis Genoptag med nedsat dosis eller skift til én gang ugentligt
English: CTC grade 3 fatigue was reported in 15.7% of the patients, and grade 4 in 1.3%.
Danish: Træthed i CTCgrad 3 blev indberettet hos 15,7 % af patienterne og grad 4 hos 1,3 %.
English: • CTC grade 3 or 4 toxicity recurrence - a further dose reduction may be considered once the adverse event has resolved to CTC grade <1.
Danish: • Recidiv af CTC grad 3 eller 4 toksicitet - en yderligere dosisreduktion kan overvejes, når bivirkningen er forbedret til CTC grad <1.
English: - if you notice any signs of an infection.
Danish: - hvis du bemærker et eller flere tegn på en infektion.
English: All 55 patients were previously treated with bortezomib and at least one IMiD (lenalidomide: 98.2%, thalidomide: 69.1%).
Danish: Alle 55 patienter havde tidligere fået behandling med bortezomib og mindst et IMiD (lenalidomid: 98,2 %, thalidomid: 69,1 %).
English: Instructions for dose interruptions and reductions for panobinostat are outlined in Table 5.
Danish: Anvisninger i dosisafbrydelse ogreduktion for panobinostat er beskrevet i tabel 5.
English: Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval.
Danish: Baseret på prækliniske og kliniske data kan panobinostat potentielt forlænge QT-intervallet.
English: Studies in animals have shown reproductive and embryo-foetal toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet og embryo-føtal toksicitet (se pkt.
English: Panobinostat has demonstrated mutagenic potential in the Ames assay, endo-reduplication effects in human peripheral blood lymphocytes in vitro, and DNA damage in an in vivo COMET study in mouse lymphoma L5178Y cells, that are attributed to the pharmacological mode of action.
Danish: Panobinostat har udvist mutagent potentiale i Ames-assayet, endo-reduplikationsvirkninger i humane perifere blodlymfocytter in vitro og DNA-skader i et in vivo COMET-studie med muselymfom L5178Y-celler, som tilskrives den farmakologiske virkningsmekanisme.
English: Women of child-bearing potential/Contraception in males and females
Danish: Kvinder i den fertile alder/Kontraception hos mænd og kvinder
English: If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Farydak.
Danish: Hvis du tager et eller flere af disse lægemidler, vil din læge måske ordinere et andet lægemiddel til dig, mens du er i behandling med Farydak.
English: Take Farydak on days 1, 3 and 5 and on days 8, 10 and 12.
Danish: Tag Farydak på dag 1, 3 og 5 og på dag 8, 10 og 12.
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis or candidiasis, and viral infections including hepatitis B virus and herpes simplex, have been reported in patients taking panobinostat.
Danish: Lokaliserede og systemiske infektioner, herunder pneumoni, andre bakterieinfektioner, invasive svampeinfektioner, såsom aspergillose eller candidiasis, og virusinfektioner, inklusive hepatitis Bvirus og herpes simplex, er blevet indberettet hos patienter, der tog panobinostat.
English: Grade 3 asthenia was observed in 9.4% of the patients, with no patients experiencing asthenia at CTC grade 4.
Danish: Asteni grad 3 blev observeret hos 9,4 % af patienterne, og ingen patienter oplevede asteni i CTC-grad 4.