FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 6 Kinase profile of nilotinib (phosphorylation IC50 nM)
Danish: Tabel 6 Nilotinibs kinaseprofil (fosforylation IC50 nM)
English: There is a limited amount of data on pregnancies in patients while attempting treatment-free remission (TFR).
Danish: Der er begrænset data vedrørende graviditet hos patienter, der er i behandlingsfri remission (TFR).
English: The primary endpoint was the percentage of patients in MMR at 48 weeks after starting the TFR phase (considering any patient who required re-initiation of treatment as non-responder).
Danish: Det primære endepunkt var procentdelen af patienter i MMR 48 uger efter start på TFR-fasen (hvor alle patienter, som genoptog behandlingen, ansås for at være ikke-respondenter).
English: In patients with CML, a change in DNA (genetic material) triggers a signal that tells the body to produce abnormal white blood cells.
Danish: Hos patienter med CML udløser en ændring i DNA (arvematerialet) et signal, der fortæller kroppen, at den skal producere unormale hvide blodlegemer.
English: The median highest prior imatinib dose had been 600 mg/day.
Danish: Den mediane højeste tidligere imatinib-dosis havde været 600 mg/dag.
English: Ventricular repolarisation abnormalities may have been contributory factors.
Danish: Abnormaliteter i ventrikulær repolarisering kan have været medvirkende faktorer.
English: Most responders achieved their MCyR rapidly within 3 months (median 2.8 months) of starting nilotinib treatment and these were sustained.
Danish: De fleste respondenter opnåede MCyR hurtigt inden for 3 måneder (median 2,8 måneder) efter start af nilotinib-behandlingen, og det blev opretholdt.
English: Nilotinib did not induce teratogenicity, but did show embryo- and foetotoxicity at doses that also showed maternal toxicity.
Danish: Nilotinib inducerede ikke teratogenicitet, men viste embryo- og føtotoksicitet ved doser, der også viste maternel toksicitet.
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a mutagenic potential of nilotinib.
Danish: Genotoksicitetsstudier i bakterielle in vitro-systemer og i in vitro- og in vivo-systemer hos pattedyr med og uden metabolisk aktivering viste ingen tegn på mutagent potentiale hos nilotinib.
English: The MCyR rate in 321 CP patients was 51%.
Danish: MCyR-raten hos 321 CP-patienter var 51 %.
English: No effects on sperm count/motility or on fertility were noted in male and female rats up to the highest tested dose, approximately 5 times the recommended dosage for humans.
Danish: Der er ikke observeret effekt på spermatozotælling/motilitet eller på fertilitet i han- og hunrotter op til den højest testede dosis, ca. 5 gange højere end den anbefalede dosis for mennesker.
English: Isolated reports of intentional overdose with nilotinib were reported, where an unspecified number of Tasigna hard capsules were ingested in combination with alcohol and other medicinal products.
Danish: Der er indrapporteret isolerede tilfælde af tilsigtet overdosering med nilotinib, hvor et ukendt antal Tasigna hårde kapsler blev indtaget i kombination med alkohol og andre lægemidler.
English: Forty patients (58.0%) had relative dose intensity superior to 90%.
Danish: 40 patienter (58,0 %) havde en relativ dosisintensitet på over 90 %.
English: - if you are being treated with medicines that affect the heart beat (anti-arrhythmics) or the liver (see Other medicines and Tasigna).
Danish: - hvis du bliver behandlet med medicin, der påvirker hjerterytmen (antiarytmika) eller leveren (se Brug af anden medicin sammen med Tasigna).
English: Cochran-Mantel-Haenszel (CMH) test p-value for response rate (vs. imatinib 400 mg) <0.0001 Only patients who were in MMR at a specific time point are included as responders for that time point.
Danish: Cochran-Mantel-Haenszel (CMH) test p-værdi for responsrate (vs. imatinib 400 mg) <0,0001 Kun patienter, der var i MMR på et bestemt tidspunkt, er inkluderet som respondenter for det pågældende tidspunkt.
English: Table 5 Grade 3-4 laboratory abnormalities*
Danish: Tabel 5 Laboratorieabnormiteter, grad 3-4*
English: Tasigna is a treatment for children and adolescents with CML.
Danish: Tasigna er en behandling til børn og unge med CML.
English: - the level of sugar and fats in the blood.
Danish: - Sukker- og fedtindholdet i blodet.
English: Chronic phase
Danish: Kronisk fase
English: Table 3 Non-haematological adverse reactions (≥5% of all patients)*
Danish: Tabel 3 Ikke-hæmatologiske bivirkninger (≥5 % af alle patienter)*
English: Gastrointestinal haemorrhage, regardless of causality, was reported in 3% of these patients.
Danish: Gastrointestinal blødning blev, uanset kausalitet, rapporteret hos 3 % af disse patienter.
English: If clinically significant moderate or severe non-haematological toxicity develops, dosing should be interrupted, and patients should be monitored and treated accordingly.
Danish: Hvis der udvikles klinisk signifikant moderat eller svær ikke-hæmatologisk toksicitet, afbrydes behandlingen, og patienter skal overvåges og behandles derefter.
English: Imatinib intolerance included patients who discontinued imatinib because of toxicity and were not in major cytogenetic response at time of study entry.
Danish: Imatinibintolerans omfattede patienter, som ophørte med imatinib på grund af toksicitet, og som ikke havde større cytogenetisk respons ved rekruttering til studiet.
English: Since nilotinib and its metabolites are not renally excreted, a decrease in total body clearance is not anticipated in patients with renal impairment.
Danish: Da nilotinib og dets metabolitter ikke udskilles via nyrerne, forventes et fald i total-clearance ikke hos patienter med nedsat nyrefunktion.
English: The median time to achieve CCyR was just past 3 months (median 3.4 months).
Danish: Mediantiden til CCyR var lige godt 3 måneder (median 3,4 måneder).
English: Table 10 Duration of exposure with nilotinib
Danish: Tabel 10 Eksponeringsvarighed med nilotinib
English: Complete haematological response (CHR) in CP patients was evaluated as a secondary endpoint.
Danish: CHR (komplet hæmatologisk respons) hos CP-patienter blev evalueret som et sekundært endepunkt.
English: The heart rate will also be checked using a machine that measures electrical activity of the heart (a test called an “ECG”).
Danish: Hjerterytmen vil også blive undersøgt ved at bruge et apparat, der måler hjertets elektriske aktivitet (EKG-undersøgelse).
English: The cardiovascular status of patients should be evaluated and cardiovascular risk factors monitored and actively managed during nilotinib therapy according to standard guidelines.
Danish: Patientens kardiovaskulære status skal evalueres og kardiovaskulære risikofaktorer monitoreres og håndteres aktivt under nilotinib-behandling i henhold til gældende retningslinjer.
English: This study suggests that a clinically meaningful drug-drug interaction between nilotinib and warfarin is less likely up to a dose of 25 mg of warfarin.
Danish: Dette studie tyder på, at en klinisk relevant lægemiddelinteraktion mellem nilotinib og warfarin er mindre sandsynlig op til en dosis på 25 mg warfarin.
English: Rifampicin, a potent CYP3A4 inducer, decreases nilotinib Cmax by 64% and reduces nilotinib AUC by 80%.
Danish: Rifampicin, en potent CYP3A4-inducer, nedsætter nilotinib Cmax med 64 % og reducerer nilotinib AUC med 80 %.
English: In 11 AP patients, evaluated for efficacy, treatment induced a 36% overall HR rate.
Danish: Hos 11 AP-patienter, der blev evalueret med henblik på virkning, inducerede behandlingen en overordnet HR-rate på 36 %.
English: Complete cytogenetic response (CCyR) was defined as 0% Ph+ metaphases in the bone marrow based on a minimum of 20 metaphases evaluated.
Danish: Komplet cytogenetisk respons (CCyR) var defineret som 0 % Ph+ metafaser i knoglemarven baseret på et minimum af 20 evaluerede metafaser.
English: Patients should be tested for HBV infection before initiating treatment with nilotinib.
Danish: Patienten bør testes for HBV-infektion før initiering af behandling med nilotinib.
English: There was no evidence of carcinogenicity upon administration of nilotinib at 5, 15 and 40 mg/kg/day.
Danish: Der var ikke bevis for karcinogenicitet ved administration af 5, 15 og 40 mg nilotinib/kg/dag.
English: Patients who lose MMR must re-initiate treatment within 4 weeks of when loss of remission is known to have occurred.
Danish: Patienter, der ikke kan opretholde MMR, skal genoptage behandlingen indenfor 4 uger, når tab af remission er blevet konstateret.
English: 230 mg/m once daily, and recovery to Grade 1 takes longer than 28 days, treatment should be discontinued.
Danish: 1 gang daglig, og tilbagevenden til grad  1 tager længere tid end 28 dage, bør behandlingen seponeres.
English: Tasigna may be given in combination with haematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) if clinically indicated.
Danish: Tasigna kan gives i kombination med hæmatopoietiske vækstfaktorer som erythropoietin eller granulocytkoloni-stimulerende faktor (G-CSF), hvis dette er klinisk indiceret.
English: It is therefore crucial to perform frequent monitoring of BCR-ABL transcript levels and complete blood count with differential in order to detect possible loss of remission (see section 4.2).
Danish: Det er derfor vigtigt at udføre hyppig monitorering af BCR-ABL-transkriptniveauer og fuldstændig blodtælling med differentialtælling for at påvise eventuelt tab af remission (se pkt.
English: Progression to accelerated phase (AP) or blast crisis (BC) on treatment is defined as the time from the date of randomisation to the first documented disease progression to accelerated phase or blast crisis or CML-related death.
Danish: Progression til accelereret fase eller blastkrise i behandling er defineret som tiden, der går fra randomiseringsdatoen til den første dokumenterede sygdomsprogression til accelereret fase eller blastkrise eller til CML-relateret død.
English: Your doctor may consider discontinuing your treatment with Tasigna based on specific criteria.
Danish: Din læge kan beslutte at afbryde din behandling med Tasigna ud fra bestemte kriterier.
English: The following adverse reactions have been derived from post-marketing experience with Tasigna via spontaneous case reports, literature cases, expanded access programmes, and clinical studies other than the global registration trials.
Danish: Følgende bivirkninger stammer fra spontane rapporter efter markedsføringen af Tasigna, litteraturen, expanded access programmer og kliniske forsøg ud over de globale registreringsforsøg.
English: Increased post-implantation loss was observed in both the fertility study, which involved treatment of both males and females, and the embryotoxicity study, which involved treatment of females.
Danish: Øget postimplantationstab blev observeret i både fertilitetsstudiet, som involverede behandling af både hanner og hunner, og embryotoksicitetsstudiet, som involverede behandling af hunner.
English: Tasigna demonstrated efficacy in patients harboring a variety of BCR-ABL mutations associated with imatinib resistance, except T315I.
Danish: Tasigna viste virkning hos patienter med forskellige BCR-ABL-mutationer, der associeres med imatinib-resistens, undtagen T315I.
English: These tests will monitor: - the amount of blood cells (white blood cells, red blood cells and platelets) in the body to see how Tasigna is tolerated.
Danish: Blodprøverne vil vise: - mængden af blodceller (hvide blodlegemer, røde blodlegemer og blodplader) i kroppen, så man kan se, hvordan du tåler Tasigna.
English: * Percentages are rounded to integer for presentation in this table.
Danish: *Procenter er rundet op til hele tal i denne tabel.
English: None of the metabolites contribute significantly to the pharmacological activity of nilotinib.
Danish: Ingen af metabolitterne bidrager signifikant til nilotinibs farmakologiske aktivitet.
English: Inter-patient variability in nilotinib pharmacokinetics was moderate to high.
Danish: Patientvariationerne i nilotinib-farmakokinetikken var moderat til høj.
English: The hard capsules are red.
Danish: De hårde kapsler er røde.
English: In a pre- and postnatal development study in rats, maternal exposure to nilotinib caused reduced pup body weight with associated changes in physical development parameters as well as reduced mating and fertility indices in the offspring.
Danish: I et præ- og postnatalt udviklingsstudie hos rotter forårsagede maternal eksponering over for nilotinib reduceret kropsvægt hos ungerne og deraf følgende forandringer i de fysiske udviklingsparametre samt nedsat parring og fertilitet hos afkommet.
English: H2 blockers should be taken approximately 10 hours before and approximately 2 hours after you take Tasigna; - antacids such as those containing aluminium hydroxide, magnesium hydroxide and simethicone, which neutralise high acidity in the stomach.
Danish: H2-blokkere skal tages ca. 10 timer før og ca. 2 timer efter, du har taget Tasigna; - Syreneutraliserende midler såsom medicin, der indeholder aluminiumhydroxid, magnesiumhydroxid og simethicon, som neutraliserer et højt syreindhold i maven.
English: The long-term effects of treating children with Tasigna for long periods of time are not known.
Danish: De langsigtede påvirkninger ved behandling af børn med Tasigna i længere tid kendes ikke.
English: Patients with a CHR at baseline achieved a MCyR faster (1.9 versus 2.8 months).
Danish: Patienter med CHR ved baseline opnåede MCyR hurtigere (1,9 vs. 2,8 måneder).
English: Main metabolic pathways identified in healthy subjects are oxidation and hydroxylation.
Danish: De vigtigste metaboliseringsveje hos raske forsøgspersoner er oxidering og hydroxylering.
English: Hypokalaemia or hypomagnesaemia must be corrected prior to Tasigna administration and should be monitored periodically during therapy.
Danish: Hypokaliæmi eller hypomagnesiæmi skal korrigeres, før Tasigna administreres og skal monitoreres periodisk under behandling.
English: Clinically relevant or severe abnormalities of routine haematological or biochemistry laboratory values in adult patients are presented in Table 5.
Danish: Klinisk relevante eller alvorlige abnormaliteter ved rutinemæssige hæmatologiske eller biokemiske laboratorieværdier hos voksne patienter er vist i tabel 5.
English: If your doctor recommends that you discontinue treatment with Tasigna Your doctor will regularly evaluate your treatment with a specific diagnostic test and decide whether you should continue to take this medicine.
Danish: Hvis din læge anbefaler, at du holder op med at tage Tasigna Din læge vil regelmæssigt evaluere din behandling med en særlige diagnostisk test og beslutte, om du skal fortsætte med at tage dette lægemiddel.
English: Due to lack of steady-state data, control of warfarin pharmacodynamic markers (INR or PT) following initiation of nilotinib therapy (at least during the first 2 weeks) is recommended.
Danish: På grund af mangel på steady-state data anbefales det at kontrollere warfarins farmakodynamiske markører (INR eller PT) efter påbegyndelse af behandling med nilotinib (i det mindste i løbet af de første 2 uger).
English: Resistance to imatinib included failure to achieve a complete haematological response (by 3 months), cytogenetic response (by 6 months) or major cytogenetic response (by 12 months) or progression of disease after a previous cytogenetic or haematological response.
Danish: Resistens over for imatinib inkluderede manglende fuldstændig hæmatologisk respons (ved 3 måneder), cytogenetisk respons (ved 6 måneder) eller større cytogenetisk respons (ved 12 måneder) eller sygdomsprogression efter en tidligere cytogenetisk eller hæmatologisk respons.
English: In paediatric patients, treatment must be interrupted until the event returns to Grade 1.
Danish: Hos pædiatriske patienter skal behandlingen afbrydes, indtil hændelsen vender tilbage til grad  1.
English: Carcinogenicity studies
Danish: Karcinogenicitetsstudier
English: Patients with BCR-ABL levels ≤10% at 3 months of treatment show a greater overall survival at 72 months compared to those who did not achieve this molecular response level (94.5% vs. 77.1% respectively [p=0.0005]).
Danish: Patienter med BCR-ABL niveauer ≤10 % efter 3 måneders behandling viser en større total overlevelse ved 72 måneder sammenlignet med dem, der ikke opnåede dette molekylære respons-niveau (hhv. 94,7 % vs. 77,1 % [p=0,0005]).
English: No deaths were reported on treatment or after treatment discontinuation in both studies.
Danish: I de to studier blev der ikke rapporteret om dødsfald ved behandling eller efter seponering af behandlingen.
English: Efficacy was based on 321 CP patients and 137 AP patients enrolled.
Danish: Virkningen var baseret på 321 rekrutterede CP-patienter og 137 rekrutterede AP-patienter.
English: 24-month analysis
Danish: 24 måneders analyse
English: It may be given with hydroxyurea or anagrelide if clinically indicated.
Danish: Det kan gives med hydroxyurea eller anagrelid, hvis dette er klinisk indiceret.
English: Do not use more than one teaspoon of apple sauce for each hard capsule and do not use any food other than apple sauce.
Danish: Du må ikke tage mere end én teske æblemos for hver hård kapsel, og du må ikke bruge andet end æblemos.
English: Most responders achieved a HR early with nilotinib treatment (median 1.0 months) and these have been durable (median duration of confirmed HR was 24.2 months).
Danish: De fleste respondenter nåede et HR tidligt med nilotinib-behandling (median 1,0 måned), og de har været vedvarende (medianvarighed på den bekræftede HR var 24,2 måneder).
English: After a single dose of radiolabelled nilotinib in healthy subjects, more than 90% of the dose was eliminated within 7 days, mainly in faeces (94% of the dose).
Danish: Efter en enkeltdosis af radioaktivt mærket nilotinib hos raske forsøgspersoner var mere end 90 % af dosis elimineret inden 7 dage, hovedsageligt i fæces (94 % af dosis).
English: Anti-arrhythmic medicinal products and other substances that may prolong the QT interval
Danish: Antiarytmika og andre lægemidler, der kan forlænge QT-intervallet
English: How to take Tasigna - Swallow the hard capsules whole with water.
Danish: Sådan skal du tage Tasigna - Synk de hårde kapsler hele med vand.
English: No episodes of torsade de pointes were observed in clinical studies.
Danish: Ingen episoder med Torsade de Pointes blev observeret i kliniske studier.
English: There is no experience with treatment of paediatric patients below 2 years of age.
Danish: Der er ingen erfaring med behandling af pædiatriske patienter under 2 år.
English: The AUC of imatinib was increased by 18% to 39%, and the AUC of nilotinib was increased by 18% to 40%.
Danish: AUC for imatinib steg med 18-39 %, og AUC for nilotinib steg med 18-40 %.
English: In murine models of CML, as a single agent nilotinib reduces tumour burden and prolongs survival following oral administration.
Danish: I murine modeller af CML reducerer nilotinib som enkeltstående stof tumorbyrden og forlænger overlevelsen efter oral administration.
English: You should also tell your doctor if you are already taking Tasigna and you are prescribed a new medicine that you have not taken previously during Tasigna treatment.
Danish: Du skal fortælle det til lægen, hvis du allerede tager Tasigna, og du får ordineret et nyt lægemiddel, du ikke tidligere har taget under behandlingen med Tasigna.
English: Prior interferon
Danish: Tidligere interferon
English: If you think you may be allergic, tell your doctor before taking Tasigna.
Danish: Hvis du mener, at du kan være overfølsom, skal du fortælle det til din læge, før du tager Tasigna.
English: Among the 53 patients who discontinued the TFR phase due to confirmed loss of MR4.0 or loss of MMR, 51 patients restarted nilotinib and 2 patients discontinued the study.
Danish: Af de 53 patienter som udgik af TFR fasen, på grund af bekræftet tab af MR4.0 eller tab af MMR, genstartede 51 patienter på nilotinib og 2 patienter udgik af studiet.
English: Tasigna should be taken twice daily approximately 12 hours apart and must not be taken with food.
Danish: Tasigna tages to gange dagligt med ca. 12 timers interval og må ikke indtages sammen med mad.
English: In vitro cardiac safety studies demonstrated a preclinical signal for QT prolongation, based upon block of hERG currents and prolongation of the action potential duration in isolated rabbit hearts by nilotinib.
Danish: In vitro-hjertesikkerhedsstudier viste et præklinisk signal for QT-forlængelse baseret på blokering af hERG-kanalen og forlængelse af aktionspotentialets varighed i isolerede kaninhjerter med nilotinib.
English: What Tasigna is Tasigna is a medicine containing an active substance called nilotinib.
Danish: Hvad Tasigna er Tasigna er et lægemiddel, der indeholder et aktivt stof kaldet nilotinib.
English: Caution is recommended in patients with previous history of pancreatitis.
Danish: Der rådes til forsigtighed hos patienter med tidligere kendt pankreatit.
English: Therefore, absorption and subsequent elimination of systemically absorbed nilotinib may be influenced by substances that affect CYP3A4 and/or P-gp.
Danish: Derfor kan absorption og efterfølgende elimination af systemisk absorberet nilotinib påvirkes af lægemidler, der påvirker CYP3A4 og/eller P-gp.
English: None of the 21 resistant or intolerant CML patients who were in MMR on treatment had confirmed loss of MMR.
Danish: Ingen af de 21 resistente eller intolerante CML-patienter, som var i MMR ved behandling, havde et bekræftet tab af MMR.
English: In vitro, nilotinib is a relatively strong inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1, with Ki value being lowest for CYP2C9 (Ki=0.13 microM).
Danish: In vitro er nilotinib en relativt stærk hæmmer af CYP3A4, CYP2C8, CYP2C9, CYP2D6 og UGT1A1, hvor CYP2C9 har den laveste Ki-værdi (Ki=0,13 mikroM).
English: Table 7 MMR rate
Danish: Tabel 7 MMR-rate
English: The bioavailability of nilotinib is increased by food.
Danish: Nilotinibs biotilgængelighed øges af mad.
English: Nilotinib absorption (relative bioavailability) might be reduced by approximately 48% and 22% in patients with total gastrectomy and partial gastrectomy, respectively.
Danish: Absorptionen (relativ biotilgængelig) af nilotinib kan blive reduceret med ca. 48 % og 22 % hos patienter med henholdsvis total gastrektomi og partiel gastrektomi.
English: It may increase the amount of Tasigna in the blood, possibly to a harmful level.
Danish: Det kan øge mængden af Tasigna i blodet, hvilket kan være skadeligt.
English: During treatment with Tasigna - if you faint (loss of consciousness) or have an irregular heart beat while taking this medicine, tell your doctor immediately as this may be a sign of a serious heart condition.
Danish: Under behandlingen med Tasigna - hvis du besvimer (mister bevidstheden) eller har en uregelmæssig hjerterytme, mens du tager dette lægemiddel, skal du fortælle det til din læge med det samme, da det kan være et tegn på en alvorlig hjertelidelse.
English: Frequency All grades
Danish: Frekvens Alle grader
English: Treatment with nilotinib is associated with (National Cancer Institute Common Toxicity Criteria grade 3-4) thrombocytopenia, neutropenia and anaemia.
Danish: Behandling med nilotinib er associeret med (National Cancer Institute Common Toxicity Criteria grad 3-4) trombocytopeni, neutropeni og anæmi.
English: In healthy volunteers, Cmax and area under the serum concentration-time curve (AUC) of nilotinib are increased by 112% and 82%, respectively, compared to fasting conditions when Tasigna is given with food.
Danish: Hos raske frivillige forsøgspersoner er Cmax og arealet under serumkoncentrationstidskurven (AUC) for nilotinib øget med henholdsvis 112 % og 82 % sammenlignet med fastende, når Tasigna gives sammen med mad.
English: The highest prior imatinib dose was 600 mg/day in 74% of all patients, with 40% of patients receiving imatinib doses 800 mg/day.
Danish: Den højeste tidligere imatinib-dosis var 600 mg/dag hos 74 %, hvor 40 % af patienterne modtog imatinib-doser 800 mg/dag.