FrancophonIA/ELRC3.0 huggingface dataset:
English: - Patients who are no longer benefiting from previous treatment for CML: The recommended dose is 800 mg per day.
Danish: - Patienter, der ikke længere har gavn af tidligere behandling af CML: Den anbefalede dosis er 800 mg dagligt.
English: The primary endpoint in the AP patients was overall confirmed haematological response (HR), defined as either a complete haematological response, no evidence of leukaemia or return to chronic phase.
Danish: Det primære endepunkt hos AP-patienterne var overordnet bekræftet hæmatologisk respons (HR) defineret som enten CHR, ingen tegn på leukæmi eller tilbagevenden til kronisk fase.
English: Patients must have typical BCR-ABL transcripts to allow quantitation of BCR-ABL, evaluation of the depth of molecular response, and determination of a possible loss of molecular remission after discontinuation of treatment with nilotinib.
Danish: Patienten skal have typiske BCR-ABL-transkripter for at give mulighed for kvantificering af BCR-ABL, evaluering af dybden af molekylært respons og bestemmelse af muligt tab af molekylær remission efter seponering af behandling med nilotinib.
English: Patients who maintain BCR-ABL levels between MMR and MR4 for a minimum of 4 consecutive measurements can return to the original monitoring schedule.
Danish: Patienter, som opretholder BCR-ABL niveauerne mellem MMR og MR4 i minimum 4 fortløbende målinger, kan vende tilbage den til originale monitoreringsplan.
English: The primary endpoint in the CP patients was major cytogenetic response (MCyR), defined as elimination (CCyR, complete cytogenetic response) or significant reduction to <35% Ph+ metaphases (partial cytogenetic response) of Ph+ haematopoietic cells.
Danish: Det primære endepunkt hos CP-patienterne var MCyR (major cytogenetisk respons) defineret som elimination (CCyR, complete cytogenetisk respons) eller signifikant reduktion til <35 % Ph+ metafaser (partiel cytogenetisk respons) af Ph+ hæmatopoietiske celler.
English: The KM estimate of median treatment-free survival (TFS) has not yet been reached (Figure 4); 99 of 190 patients (52.1%) did not have a TFS event.
Danish: Den estimerede KM mediantid for behandlingsfri overlevelse (TFS) er endnu ikke nået (figur 4); 99 af 190 patienter (52,1 %) havde ikke en TFS-hændelse
English: Discontinuation due to adverse drug reactions was observed in 16% of chronic phase and 10% of accelerated phase patients.
Danish: Seponerering på grund af bivirkninger blev observeret hos 16 % af patienterne i kronisk fase og hos 10 % af patienterne i accelereret fase.
English: If you have questions about when to take this medicine, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvornår du skal tage dette lægemiddel, skal du tale med din læge eller apoteket.
English: Tasigna with food and drink Do not take Tasigna with food.
Danish: Brug af Tasigna sammen med mad og drikke
English: If you stop taking Tasigna
Danish: Hvis du holder op med at tage Tasigna
English: Eighty-eight patients (46.3%) discontinued the TFR phase due to loss of MMR, and 1 (0.5%), 1 (0.5%), and 3 patients (1.6%) due to death from unknown cause, physician decision and subject decision, respectively.
Danish: Otteogfirs patienter (46,3 %) kunne ikke opretholde TFR-fasen på grund af tab af MMR, og 1 (0,5 %), 1 (0,5 %) og 3 patienter (1,6 %) på grund af henholdsvis dødsfald af ukendte årsager, lægens beslutning og patientens beslutning.
English: Myelosuppression - Neutropenia - Thrombocytopenia - Anaemia
Danish: Myelosuppression - Neutropeni - Trombocytopeni - Anæmi
English: Safety information from two Tasigna treatment discontinuation studies is also provided.
Danish: Sikkerhedsinformation fra to studier om behandlingsophør med Tasigna er også beskrevet.
English: Significant prolongation of the QT interval may occur when nilotinib is inappropriately taken with strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong the QT interval, and/or food (see section 4.5).
Danish: Signifikant forlængelse af QT-intervallet kan forekomme, når nilotinib uhensigtsmæssigt tages sammen med potente CYP3A4-inhibitorer og/eller lægemidler med kendt potentiale for at forlænge QT-intervallet, og/eller fødeindtag (se pkt 4.5).
English: - taking anti-arrhythmic medicinal products or other substances that lead to QT prolongation.
Danish: - som tager antiarytmika eller andre substanser, der kan føre til QT-forlængelse.
English: If a dose is missed the patient should not take an additional dose, but take the usual prescribed next dose.
Danish: Hvis en dosis glemmes, skal patienten udelade denne dosis og tage næste dosis som ordineret.
English: Therefore, when the concurrent use of a H2 blocker is necessary, it may be administered approximately 10 hours before and approximately 2 hours after the dose of Tasigna.
Danish: Når samtidig brug af en H2-blokker er nødvendig, kan den derfor administreres ca. 10 timer før og ca. 2 timer efter Tasigna.
English: Repeated-dose toxicity studies in dogs of up to 4 weeks' duration and in cynomolgus monkeys of up to 9 months' duration revealed the liver as the primary target organ of toxicity of nilotinib.
Danish: Studier af gentagen dosis-toksicitet hos hunde af op til 4 ugers varighed og hos cynomolgusaber af op til 9 måneders varighed viste leveren som det primære målorgan for nilotinibs toksicitet.
English: Serious cardiovascular events including problems with the blood flow to the leg (peripheral arterial occlusive disease), ischaemic heart disease and problems with the blood supply to the brain (ischaemic cerebrovascular disease) have been reported in patients taking Tasigna.
Danish: Alvorlige kardiovaskulære hændelser, herunder problemer med blodtilførslen til benet (perifer arteriel okklusiv sygdom), iskæmisk hjertesygdom og problemer med blodtilførslen til hjernen (iskæmisk cerebrovaskulær sygdom) er blevet rapporteret hos patienter, der tager Tasigna.
English: Food interactions
Danish: Interaktion med fødevarer
English: If you are pregnant or think that you may be, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.
Danish: eller tror, at du kan være gravid, skal du fortælle det til din læge, og han eller hun vil drøfte med dig, om du kan tage dette lægemiddel under graviditeten.
English: Prior hydroxyurea
Danish: Tidligere hydroxyurea
English: If pregnancy is planned during the TFR phase, the patient must be informed of a potential need to re-initiate nilotinib treatment during pregnancy (see sections 4.2 and
Danish: Hvis graviditet er planlagt i løbet af TFR-fasen, skal patienten informeres om potentielt behov for at genoptage behandlingen med nilotinib under graviditeten (se pkt.
English: For Grade 2 bilirubin elevations or Grade 3 hepatic transaminase elevations in paediatric patients, treatment must be interrupted until the levels return to Grade 1.
Danish: Hvis der ses forhøjede værdier på grad  2 bilirubin eller grad ≥ 3 levertransaminase hos pædiatriske patienter, skal behandlingen afbrydes, indtil niveauerne vender tilbage til grad  1.
English: After imatinib failure, 24 different BCR-ABL mutations were noted in 42% of chronic phase and 54% of accelerated phase CML patients who were evaluated for mutations.
Danish: Efter imatinib-svigt blev 24 forskellige BCR-ABL-mutationer noteret hos 42 % af de CML-CP-patienter og 54 % af de CML-AP-patienter, som blev evalueret med henblik på mutationer.
English: Safety pharmacology studies
Danish: Sikkerhedsfarmakologiske studier
English: There is no experience with the use of Tasigna in newly diagnosed children below 10 years of age and limited experience in patients below 6 years of age who are no longer benefiting from previous treatment for CML.
Danish: Der er ingen erfaring med brug af Tasigna hos nydiagnosticerede børn under 10 år og begrænset erfaring hos patienter under 6 år, som ikke længere har gavn af tidligere behandling af CML.
English: The predicted steady-state Cmax of nilotinib showed an increase of 29%, 18% and 22%, respectively.
Danish: Den forventede steady-state Cmax af nilotinib viste en stigning på henholdsvis 29 %, 18 % og 22 %.
English: Nilotinib may be used concurrently with esomeprazole or other proton pump inhibitors as needed.
Danish: Nilotinib kan anvendes samtidig med esomeprazol eller andre protonpumpehæmmere efter behov.
English: Tasigna is available in a wallet containing 28 hard capsules and in a carton containing 28 or 40 hard capsules.
Danish: Tasigna fås i en folder indeholdende 28 hårde kapsler og i en pakning indeholdende 28 eller 40 hårde kapsler.
English: No food should be consumed for at least one hour after the dose is taken.
Danish: Der må ikke indtages mad i mindst en time efter indtagelse af dosis.
English: - Store in the original package in order to protect from moisture.
Danish: - Opbevares i den originale yderpakning for at beskytte mod fugt.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE08
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE08
English: Median duration of CCyR has not been reached.
Danish: Median varighed af CCyR blev ikke fastlagt.
English: (BCR-ABL/ABL ≤0.0032% IS) during one year.
Danish: (BCR-ABL/ABL ≤0.0032% IS) var opretholdt over et år.
English: Among newly diagnosed patients, the percentage of patients who achieved MR4.0 was 32%, while 28.0% achieved MR4.5.
Danish: Blandt nydiagnosticerede patienter var procentdelen af patienter, der opnåede MR4.0 32 %, imens 28,0 % opnåede MR4.5.
English: Pancreatitis, gastritis, sensitivity of teeth
Danish: Pankreatitis, gastritis, følsomme tænder
English: There is no experience in paediatric patients below 2 years of age or in paediatric patients with Philadelphia chromosome positive CML in accelerated phase or blast crisis.
Danish: Der er ingen erfaring med pædiatriske patienter på under 2 år, eller pædiatriske patienter med Philadelphiakromosom-positiv CML i accelereret fase eller blastkrise.
English: Food effect
Danish: Effekt af mad
English: For a dose of 400 mg once daily (see dose adjustments below), 200 mg hard capsules are available.
Danish: Ved behov for en dosis på 400 mg 1 gang dagligt (se dosisjustering nedenfor), findes hårde kapsler på 200 mg.
English: If you experience side effects (such as dizziness or visual disorders) with a potential impact on the ability to safely drive or use any tools or machines after taking this medicine, you should refrain from these activities until the effect has disappeared.
Danish: Hvis du oplever bivirkninger (f.eks. svimmelhed eller synsforstyrrelser), der kan påvirke din evne til at køre bil forsvarligt eller bruge værktøj eller maskiner, når du har taget dette lægemiddel, skal du afholde dig fra disse aktiviteter, indtil bivirkningen er forsvundet.
English: Gastrointestinal and CNS haemorrhage were reported in 1% and <1% of patients, respectively.
Danish: Gastrointestinal og CNS-blødning blev rapporteret hos hhv. 1 % og <1 % af patienterne.
English: Grapefruit juice and other foods that are known to inhibit CYP3A4 should be avoided.
Danish: Grapejuice og andre madvarer, der vides at hæmme CYP3A4, bør undgås.
English: After discontinuation of nilotinib therapy within the framework of attempting TFR, patients may experience musculoskeletal symptoms more frequently than before treatment discontinuation, e.g., myalgia, pain in extremity, arthralgia, bone pain, spinal pain or musculoskeletal pain.
Danish: Efter seponering af nilotinib inden for rammerne af forsøg på TFR, kan patienterne opleve tilfælde af muskuloskeletale symptomer hyppigere end før seponering af behandlingen, f.eks. myalgi, smerter i ekstremiteterne, artralgi, knoglesmerter, smerter i rygsøjlen eller muskuloskeletale smerter.
English: The median time on treatment with nilotinib was 13.80 months (range: 0.7-30.9 months).
Danish: Mediantiden i behandling med nilotinib var 13,80 måneder (interval: 0,7-30,9 måneder).
English: Clinical studies have excluded patients with alanine transaminase (ALT) and/or aspartate transaminase (AST) >2.5 (or >5, if related to disease) times the upper limit of the normal range and/or total bilirubin >1.5 times the upper limit of the normal range.
Danish: Kliniske studier har ekskluderet patienter med alanin transaminase (ALAT) og/eller aspartat transaminase (ASAT) >2,5 (eller >5, hvis relateret til sygdom) gange den øvre normalgrænse og/eller total bilirubin >1,5 gange den øvre normalgrænse.
English: Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction (see section 4.2).
Danish: Myelosuppression var generelt reversibel og blev normalt håndteret ved midlertidigt at seponere behandlingen med Tasigna eller ved en dosisreduktion (se pkt.
English: The juvenile animals did not exert increased sensitivity to nilotinib relative to adults.
Danish: De unge rotter udviklede ikke en forøget sensitivitet overfor nilotinib set i forhold til voksne rotter.
English: Tasigna must not be taken in conjunction with food (see sections 4.2 and 4.5) and should be taken 2 hours after a meal.
Danish: 4.2 og 4.5) og skal tages 2 timer efter et måltid.
English: For laboratory abnormalities, very common events (1/10) not included in Table 3 are also reported.
Danish: For laboratorieabnormaliteter er meget almindelige bivirkninger (1/10), der ikke er medtaget i tabel 3, også rapporteret.
English: Biochemical adverse drug reactions include alanine aminotransferase increased (24%), hyperbilirubinaemia (16%), aspartate aminotransferase increased (12%), lipase increased (11%), blood bilirubin increased (10%), hyperglycaemia (4%), hypercholesterolaemia (3%) and hypertriglyceridaemia (<1%).
Danish: Biokemiske bivirkninger inkluderer forhøjet alaninaminotransferase (24 %), hyperbilirubinæmi (16 %), forhøjet aspartataminotransferase (12 %), forhøjet lipase (11 %), forhøjet bilirubin i blodet (10 %), hyperglykæmi (4 %), hyperkolesterolæmi (3 %) og hypertriglyceridæmi (<1 %).
English: Clinical studies have not been performed in patients with impaired renal function.
Danish: Der er ikke gennemført kliniske studier med patienter med nedsat nyrefunktion.
English: - the electrolytes in the body (potassium, magnesium).
Danish: - koncentrationen af elektrolytter (kalium, magnesium) i kroppen.
English: Appropriate monitoring and dose adjustment may be necessary for medicinal products that are CYP3A4 substrates and have a narrow therapeutic index (including but not limited to alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, sirolimus and tacrolimus) when co-administered with nilotinib.
Danish: Passende monitorering og dosisjustering kan være nødvendig for lægemidler, der er CYP3A4-substrater og har et snævert terapeutisk indeks (herunder, men ikke begrænset til, alfentanil, ciclosporin, dihydroergotamin, ergotamin, fentanyl, sirolimus og tacrolimus), når de administreres sammen med nilotinib.
English: Pneumonia, urinary tract infection, gastroenteritis, bronchitis, herpes virus infection, candidiasis (including oral candidiasis)
Danish: Pneumoni, urinvejsinfektion, gastroenteritis, bronkitis, herpes virusinfektion, candidiasis (herunder oral candidiasis)
English: Events included neutropenia, vomiting and drowsiness.
Danish: Tilfælde inkluderede neutropeni, opkastning og døsighed.
English: Median time since diagnosis in months (range)
Danish: Mediantid siden diagnose (interval)
English: Median duration of MCyR has not been reached.
Danish: Median varighed af MCyR blev ikke fastlagt.
English: - Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Forty-eight of these 51 patients (94.1%) regained MR4.0 and 47 patients (92.2%) regained MR4.5 by the time of the cut-off date.
Danish: Otteogfyrre af de 51 patienter genvandt (94,1 %) MR4.0 og 47 patienter (92,2 %) MR4.5 inden afskæringsdatoen.
English: Exposures at the lowest dose levels at which the liver effects were seen were lower than the exposure in humans at a dose of 800 mg/day.
Danish: Eksponeringerne ved de laveste dosisniveauer, hvor levervirkningerne sås, var lavere end eksponeringen hos mennesker ved en dosis på 800 mg/dag.
English: Concomitant administration of nilotinib with imatinib (a substrate and moderator of P-gp and CYP3A4), had a slight inhibitory effect on CYP3A4 and/or P-gp.
Danish: Samtidig administration af nilotinib og imatinib (substrat og moderator af P-gp og CYP3A4) havde en svagt hæmmende effekt på CYP3A4 og/eller P-gp.
English: In adult patients with newly diagnosed CML in chronic phase The median duration of exposure was 60.5 months (range 0.1-70.8 months).
Danish: Hos voksne patienter med nydiagnosticeret CML i kronisk fase Den gennemsnitlige eksponeringsvarighed var 60,5 måneder (interval 0,1-70,8 måneder).
English: Figure 5 Kaplan-Meier estimate of treatment-free survival after start of TFR (full analysis set)
Danish: Figure 5 Estimeret Kaplan-Meier behandlingsfri overlevelse efter start af TFR (fuld analyse)
English: Nilotinib has been evaluated in safety pharmacology, repeated-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity (rats and mice) studies.
Danish: Nilotinib er evalueret i studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, reproduktionstoksicitet, fototoksicitet og i karcinogenicitetsstudier (rotter og mus).
English: Eligibility for discontinuation of treatment
Danish: Egnethed til seponering af behandling
English: Tasigna may need to be temporarily withheld and/or dose reduced for haematological toxicities (neutropenia, thrombocytopenia) that are not related to the underlying leukaemia (see Table 2).
Danish: Det kan være nødvendigt midlertidigt at ophøre med Tasigna og/eller reducere dosis af Tasigna på grund af hæmatologiske toksiciteter (neutropeni, trombocytopeni), som ikke er relateret til den underliggende leukæmi (se tabel 2).
English: Elevation in serum lipase has been observed.
Danish: Der er observeret forhøjelser af serumlipase.
English: The median duration of exposure was 60.5 months (range 0.1-70.8 months).
Danish: Den gennemsnitlige eksponeringsvarighed var 60,5 måneder (interval 0,1-70,8 måneder).
English: Oedema peripheral *Percentages are rounded to integer for presentation in this table.
Danish: Perifert ødem *Procenter er rundet op til hele tal i denne tabel.
English: - The other ingredients are lactose monohydrate, crospovidone type A, poloxamer 188, colloidal anhydrous silica, magnesium stearate.
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, crospovidon type A, poloxamer 188, kolloid vandfri silica, magnesiumstearat.
English: Substances that may have their systemic concentration altered by nilotinib
Danish: Substanser, hvis systemiske koncentration kan ændres af nilotinib
English: The proportion of patients who had a molecular response of ≤0.01% and ≤0.0032% by IS at different time points are presented in Table 8 and the proportion of patients who had a molecular response of ≤0.01% and ≤0.0032% by IS by different time points are presented in Figures 2 and 3.
Danish: Andelen af patienter, der fik et molekulært respons på ≤0,01 % og ≤0,0032 % ved IS på forskellige tidspunkter er angivet i tabel 8 og andelen af patienter, der fik et molekylært respons på ≤0,01 % og ≤0,0032 % ved IS på forskellige tidspunkter er angivet i figurene 2 og 3.
English: The safety and efficacy of nilotinib in paediatric patients with Ph+ CML in chronic phase have been investigated in two studies.
Danish: Sikkerhed og effekt af nilotinib hos pædiatriske patienter med Ph+ CML i kronisk fase er blevet undersøgt i to studier.
English: Pleural and pericardial effusions as well as complications of fluid retention occurred in <1% of patients receiving Tasigna.
Danish: Pleural og perikardiel effusion samt komplikationer med væskeretention forekom hos <1 % af de patienter, der fik Tasigna.
English: Figure 4 Kaplan-Meier estimate of treatment-free survival after start of TFR (full analysis set)
Danish: Figur 4 Estimeret Kaplan-Meier behandlingsfri overlevelse efter start af TFR (fuld analyse)
English: - pancreas and liver function in the body to see how Tasigna is tolerated.
Danish: - hvordan bugspytskirtel og lever virker, så man kan se, hvordan du tåler Tasigna.
English: The overall confirmed HR rate in 137 AP patients was 50%.
Danish: Den overordnede, bekræftede HR-rate hos 137 AP-patienter var 50 %.
English: The estimated 24-month overall survival rate in CML-CP patients was 87%.
Danish: Den estimerede 24 måneders totale overlevelse hos CML-CP-patienter var 87 %.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Danish: Din læge holder øje med din tilstand for at kontrollere, at behandlingen virker, som den skal.
English: Should treatment with any of these agents be required, it is recommended that nilotinib therapy be interrupted if possible (see section 4.5).
Danish: Er behandling med et af disse lægemidler nødvendig, anbefales det, at behandlingen med nilotinib afbrydes, hvis det er muligt (se pkt.
English: However, it is recommended that patients experiencing dizziness, fatigue, visual impairment or other undesirable effects with a potential impact on the ability to drive or use machines safely should refrain from these activities as long as the undesirable effects persist (see section 4.8).
Danish: Det anbefales dog, at patienter, der oplever svimmelhed, træthed, synsforstyrrelser eller andre bivirkninger, som kan påvirke evnen til at føre motorkøretøj eller betjene maskiner, skal afholde sig fra disse aktiviteter, så længe bivirkningerne varer ved (se pkt.
English: If you forget to take Tasigna
Danish: Hvis du har glemt at tage Tasigna
English: • Unit packs containing 28 hard capsules in a wallet.
Danish: • Enkeltpakninger indeholdende 28 hårde kapsler i en folder.
English: - if you have symptoms such as easy bruising, feeling tired or short of breath or have experienced repeated infections.
Danish: - hvis du har symptomer såsom tendens til at få blå mærker, træthedsfølelses eller stakåndethed eller har oplevet gentagne infektioner.
English: Resistant (n=226)
Danish: Resistent (n=226)
English: In 22 CP patients evaluated for efficacy nilotinib induced a 32% MCyR rate and a 50% CHR rate.
Danish: Hos 22 CP-patienter, der blev evalueret med henblik på virkning, inducerede nilotinib en MCyR-rate på 32 % og en CHR-rate på 50 %.
English: In resistant or intolerant CML patients, the cumulative MMR rate was 47.7% by cycle 12.
Danish: I resistente eller intolerante CML-patienter var den kumulative MMR-hastighed 47,7 % efter cyklus 12.
English: Tasigna is available in packs containing 28 or 40 hard capsules and in multipacks of 112 hard capsules (comprising 4 cartons, each containing 28 hard capsules), 120 hard capsules (comprising 3 cartons, each containing 40 hard capsules) or 392 hard capsules (comprising 14 cartons, each containing 28 hard capsules).
Danish: Tasigna fås i pakninger indeholdende 28 eller 40 hårde kapsler og i multipakninger indeholdende 112 hårde kapsler (bestående af 4 pakninger, hver indeholdende 28 hårde kapsler), 120 hårde kapsler (bestående af 3 pakninger, hver indeholdende 40 hårde kapsler) eller 392 hårde kapsler (bestående af 14 pakninger, hver indeholdende 28 hårde kapsler).
English: Prior bone marrow transplant * Missing information on imatinib-resistant/intolerant status for one patient.
Danish: Tidligere knoglemarvstransplantation * Der mangler information om imatinibresistens/intoleransstatus for en patient.
English: Close monitoring for an effect on the QTc interval is advisable and a baseline ECG is recommended prior to initiating nilotinib therapy and as clinically indicated.
Danish: Det er tilrådeligt at monitorere tæt om der er effekt på QT-intervallet, og et baseline-EKG er anbefalet før behandlingsstart med nilotinib og som indikeret klinisk.
English: Since a risk to the newborns/infants cannot be excluded, women should not breast-feed during Tasigna treatment and for 2 weeks after the last dose.
Danish: Eftersom en risiko for nyfødte/spædbørn ikke kan udelukkes, må kvinder ikke amme under behandling med Tasigna og i op til 2 uger efter den sidste dosis.