FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have a liver or pancreas disorder.
Danish: - hvis du har en sygdom i leveren eller bugspytkirtlen.
English: No food should be consumed for 2 hours before the dose is taken and no food should be consumed for at least one hour after the dose is taken.
Danish: Der må ikke indtages mad i 2 timer før, dosen tages, og der må ikke indtages mad i mindst 1 time efter, at dosen er taget.
English: Cardiovascular events were reported in a randomised Phase III study in newly diagnosed CML patients and observed in post-marketing reports.
Danish: Kardiovaskulære hændelser blev rapporteret i et randomiseret fase III-studie hos nydiagnosticerede CML-patienter og er blevet rapporteret post- marketing.
English: Nilotinib is a potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein both in cell lines and in primary Philadelphia-chromosome positive leukaemia cells.
Danish: Nilotinib er en potent hæmmer af BCR-ABL-onkoproteinets ABL-tyrosinkinaseaktivitet både i cellelinjerne og i primære Philadelphia-kromosompositive leukæmiceller.
English: How long to take Tasigna
Danish: Hvor længe du skal tage Tasigna
English: Patients with hepatic impairment might therefore have increased exposure to nilotinib and should be treated with caution (see section 4.2).
Danish: Patienter med nedsat leverfunktion kan derfor have øget eksponering for nilotinib og bør behandles med forsigtighed (se pkt.
English: If a woman who is being treated with nilotinib is considering pregnancy, treatment discontinuation may be considered based on the eligibility criteria for discontinuing treatment as described in sections 4.2 and 4.4.
Danish: Hvis en kvinde i behandling med nilotinib overvejer at blive gravid, kan seponering af behandlingen overvejes i henhold til kriterierne for seponering, som beskrevet i pkt.
English: Table 4 Adverse reactions in adult patients in Tasigna clinical studies (<5% of all patients)
Danish: Tabel 4 Bivirkninger hos voksne patienter i kliniske studier af Tasigna (<5 % af alle patienter)
English: For laboratory abnormalities, very common adverse reactions not included in Table 3 are also reported.
Danish: For laboratorieabnormaliteter er meget almindelige bivirkninger, der ikke er medtaget i tabel 3, også rapporteret.
English: The hard capsules are red/light yellow.
Danish: De hårde kapsler er røde/lysegule.
English: Available toxicological data in animals have shown excretion of nilotinib in milk (see section 5.3).
Danish: De tilgængelige toksikologiske data fra dyreforsøg viser, at nilotinib udskilles i mælk (se pkt.
English: In a healthy subjects study, no significant change in nilotinib pharmacokinetics was observed when a single 400 mg dose of nilotinib was administered 10 hours after and 2 hours before famotidine.
Danish: Hos raske frivillige forsøgspersoner blev der ikke observeret nogen signifikant ændring i nilotinibs farmakokinetik, når en enkelt 400 mg dosis af nilotinib blev administreret 10 timer efter og 2 timer før famotidin.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Tasigna: - if you have suffered prior cardiovascular events such as a heart attack, chest pain (angina), problems with the blood supply to your brain (stroke) or problems with the blood flow to your leg (claudication) or if you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes or problems with the level of fats in your blood (lipid disorders).
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Tasigna: - hvis du tidligere har oplevet kardiovaskulære hændelser såsom hjerteanfald, brystsmerter (angina), problemer med blodtilførslen til din hjerne (slagtilfælde) eller problemer med blodtilførslen til dit ben (claudicatio), eller hvis du har risikofaktorer for hjerte-kar-sygdomme såsom forhøjet blodtryk (hypertension), sukkersyge (diabetes) eller problemer med niveauet af fedt i blodet.
English: One hard capsule contains 117.08 mg lactose monohydrate.
Danish: En hård kapsel indeholder 117,08 mg lactosemonohydrat.
English: Folliculitis, upper respiratory tract infection (including pharyngitis, nasopharyngitis, rhinitis)
Danish: Follikulitis, infektion i de øvre luftveje (herunder faryngitis, nasofaryngitis, rhinitis)
English: The estimated 24-month overall survival rate in CML-AP patients was 70%.
Danish: Den estimerede 24 måneders totale overlevelse hos CML-AP patienter var 70 %.
English: Severe forms of drug-related fluid retention such as pleural effusion, pulmonary oedema, and pericardial effusion were uncommonly (0.1 to 1%) observed in a Phase III study of newly diagnosed CML patients.
Danish: Alvorlige lægemiddelrelaterede former for væskeretention såsom pleuraeffusion, lungeødem og perikardieeffusion blev observeret med en hyppighed svarende til ikke almindelig (0,1 til 1 %) i et fase III-studie hos nydiagnosticerede CML-patienter.
English: Therefore, if necessary, an antacid may be administered approximately 2 hours before or approximately 2 hours after the dose of Tasigna.
Danish: Hvis det er nødvendigt, kan et antacidum derfor administreres ca. 2 timer før eller efter Tasigna.
English: In a juvenile development study, nilotinib was administered via oral gavage to juvenile rats from the first week post partum through young adult (day 70 post partum) at doses of 2, 6 and 20 mg/kg/day.
Danish: I et ungdomsudviklingsstudie blev nilotinib administreret oralt til spæde rotter fra den første uge efter fødslen indtil de var unge rotter (dag 70 efter fødslen) i doser på 2, 6 og 20 mg/kg/dag.
English: Nilotinib was shown to absorb light in the UV-B and UV-A range, is distributed into the skin and showed a phototoxic potential in vitro, but no effects have been observed in vivo.
Danish: Nilotinib fordeles ind i huden og viste et fototoksisk potentiale in vitro, men der er ikke observeret nogen virkninger in vivo.
English: Cardiac failure was observed in <1% of patients.
Danish: Hjertesvigt observeredes hos <1 % af patienterne.
English: Laboratory abnormalities of mild to moderate transient elevations of aminotransferases and total bilirubin have been observed in children at a higher frequency than in adults, indicating a higher risk of hepatotoxicity in the paediatric population (see section 4.8).
Danish: Anormale laboratorierværdier som milde til moderate, forbigående, forhøjede aminotransferaser og totalt bilirubin er observeret hos børn med højere frekvens end hos voksne, hvilket indikerer en højere risiko for hepatotoksicitet hos den pædiatriske population (se pkt.
English: An increase in serum exposure to nilotinib between the first dose and steady state was approximately 2-fold for daily dosing and 3.8-fold for twice-daily dosing.
Danish: Stigningen i serumeksponering for nilotinib mellem den første dosis og steady state var ca. 2 gange for en daglig dosering og 3,8 gange for dosering to gange daglig.
English: The substance binds with high affinity to the ATP-binding site in such a manner that it is a potent inhibitor of wild-type BCR-ABL and maintains activity against 32/33 imatinib-resistant mutant forms of BCR-ABL. As a consequence of this biochemical activity, nilotinib selectively inhibits the proliferation and induces apoptosis in cell lines and in primary Philadelphia-chromosome positive leukaemia cells from CML patients.
Danish: Stoffet binder sig med høj affinitet til ATP-bindingsstedet på en sådan måde, at det er en potent hæmmer af vildtype BCR-ABL og opretholder aktivitet mod 32/33-imatinibresistente muterede former af BCR-ABL. Som følge af denne biokemiske aktivitet hæmmer nilotinib selektivt proliferationen og inducerer apoptose i cellelinjer og i primære Philadelphia-kromosompositive leukæmiceller fra CML-patienter.
English: Median duration of therapy in days (25th-75th percentiles)
Danish: Mediane behandlingsvarighed i dage (25- og 75-percentil)
English: In paediatric patients, the frequency, type and severity of adverse reactions observed have been generally consistent with those observed in adults, with the exception of the laboratory abnormalities hyperbilirubinaemia (Grade 3/4: 13.0%) and transaminase elevation (AST Grade 3/4: 1.4%, ALT Grade 3/4: 8.7%) which were reported at a higher frequency than in adult patients.
Danish: Frekvensen, typen og sværhedsgraden af de observerede bivirkninger hos pædiatriske patienter har generelt været i overensstemmelse med det, der er observeret hos voksne patienter, med undtagelse af anormale laboratorieværdier som hyperbilirubinæmi (grad 3/4: 13,0 %) og transaminaseforhøjelse (ASAT grad 3/4: 1,4 %, ALAT grad 3/4: 8,7 %), der blev rapporteret med en højere frekvens end hos voksne patienter.
English: Among the 17 newly diagnosed CML patients who achieved MMR, one patient had confirmed loss of MMR (the patient lost CHR due to an increase in basophil count, however did not progress to AP/BC).
Danish: Blandt de 17 nydiagnosticerede CML-patienter, der opnåede MMR, havde en patient et bekræftet tab af MMR (patienten tabte CHR på grund af en stigning i basofilantallet, men udviklede ikke AP/BC).
English: BCR-ABL transcript levels must be assessed prior to and during treatment discontinuation (see sections 4.2 and 5.1).
Danish: BCR-ABL-transkriptniveauer skal vurderes før og under seponering af behandlingen (se pkt.
English: Elevations of bilirubin and hepatic transaminases should be managed by withholding nilotinib temporarily, dose reduction and/or discontinuation of nilotinib (see section 4.2).
Danish: Forhøjet bilirubin og levertransaminaser bør håndteres ved midlertidigt at tilbageholde nilotinib, reducere dosis og/eller seponering af nilotinib (se pkt.
English: There are no data in newly diagnosed paediatric patients below 10 years of age and limited data in imatinib-resistant or intolerant paediatric patients below 6 years of age.
Danish: Der er ingen data fra nydiagnosticerede pædiatriske patienter på under 10 år, og begrænsede data fra imatinib-resistente eller intolerante pædiatriske patienter på under 6 år.
English: A single-dose drug-drug interaction study in healthy volunteers with 25 mg warfarin, a sensitive CYP2C9 substrate, and 800 mg nilotinib did not result in any changes in warfarin pharmacokinetic parameters or warfarin pharmacodynamics measured as prothrombin time (PT) and international normalised ratio (INR).
Danish: Et enkeltdosis lægemiddelinteraktionsstudie hos raske forsøgspersoner med 25 mg warfarin, et sensitivt CYP2C9-substrat, og 800 mg nilotinib resulterede ikke i nogle forandringer i warfarins farmakokinetiske parametre eller warfarins farmakodynamiske målinger såsom protrombintid (PT) og international normaliseret ratio (INR).
English: Pleural and pericardial effusions, regardless of causality, occurred in 2% and <1% of patients, respectively, receiving nilotinib 300 mg twice daily.
Danish: Pleura- og perikardie-effusion, uanset kausalitet, forekom hos henholdsvis 2 % og <1 % af de patienter, der fik nilotinib 300 mg 2 gange dagligt.
English: What you need to know before you take Tasigna
Danish: Det skal du vide, før du begynder at tage Tasigna
English: Blood glucose levels should be assessed prior to initiating nilotinib therapy and monitored during treatment.
Danish: Blodglucosenivauet skal vurderes før behandlingsstart med nilotinib og monitoreres under behandlingen.
English: Plasma protein binding is approximately 98% on the basis of in vitro experiments.
Danish: Plasmaproteinbindingen er ud fra in vitro-eksperimenter ca.
English: Increased exposure to nilotinib might also be expected with moderate CYP3A4 inhibitors.
Danish: Øget eksponering for nilotinib kan muligvis også forventes med moderate CYP3A4-hæmmere.
English: If blood counts remain low, a dose reduction to 400 mg once daily may be required.
Danish: Hvis tallene fortsat er lave, kan en dosisreduktion til 400 mg 1 gang dagligt være nødvendig.
English: Eighty-five of these 86 patients (98.8%) regained MMR, (one patient discontinued study permanently due to subject decision) and 76 patients (88.4%) regained MR4.5 by the time of the cut-off date.
Danish: Femogfirs af de 86 patienter (98,8 %) genvandt MMR (én patient valgte at udtræde permanent af studiet), og 76 patienter (88,4 %) genvandt MR4.5 inden afskæringsdatoen.
English: Nilotinib is mainly metabolised in the liver with CYP3A4 expected to be the main contributor to the oxidative metabolism.
Danish: Nilotinib metaboliseres hovedsageligt i leveren, og det formodes at CYP3A4 er den væsentligste bidragsyder til den oxidative metabolisme.
English: The major target organs for non-neoplastic lesions were the skin (epidermal hyperplasia), the growing teeth (degeneration/atrophy of the enamel organ of upper incisors and inflammation of the gingiva/odontogenic epithelium of incisors) and the thymus (increased incidence and/or severity of decreased lymphocytes).
Danish: De overordnede målorganer for ikke-neoplastiske læsioner var huden (epidermal hyperplasi), voksende tænder (degeneration/atrofi af emaljeorganet på de øvre fortænder og inflammation i gingivalt/odontogent epitel af fortænderne) og thymus (øget incidens og/eller sværhedsgrad af nedsat lymfocyttal).
English: Table 11 CML disease history characteristics
Danish: Tabel 11 CML-sygdomskarakteristika
English: Hyperthyroidism, hypothyroidism
Danish: Hyperthyroidisme, hypothyroidisme
English: CMH test p-value for response rate (versus imatinib 400 mg once daily)
Danish: CMH test p-value for responsrate (vs. imatinib 400 mg 1 gang dagligt)
English: What Tasigna contains - The active substance is nilotinib.
Danish: Tasigna indeholder - Aktivt stof: nilotinib.
English: - Breast-feeding is not recommended during treatment with Tasigna and for two weeks after the last dose.
Danish: - Amning frarådes under behandling med Tasigna og i 2 uger efter den sidste dosis.
English: By 1 year
Danish: Ved 1 år
English: In case lipase elevations are accompanied by abdominal symptoms, nilotinib therapy should be interrupted and appropriate diagnostic measures considered to exclude pancreatitis.
Danish: I tilfælde af mavesymptomer i forbindelse med forhøjede lipaseværdier bør behandling med nilotinib afbrydes, og nødvendige diagnostiske test bør overvejes for at udelukke pankreatitis.
English: Resistant (n=109)
Danish: Resistent (n=109)
English: Administration of Tasigna 30 minutes or 2 hours after food increased bioavailability of nilotinib by 29% or 15%, respectively (see sections 4.2, 4.4 and 4.5).
Danish: Administration af Tasigna 30 minutter eller 2 timer efter mad øgede nilotinibs biotilgængelighed med henholdsvis 29 % og 15 % (se pkt.
English: Cardiac failure, cyanosis
Danish: Hjertesvigt, cyanose
English: In CML patients, nilotinib administered at 400 mg twice daily for 12 days increased the systemic exposure (AUC and Cmax) of oral midazolam (a substrate of CYP3A4) 2.6-fold and 2.0-fold, respectively.
Danish: I CML-patienter øger nilotinib 400 mg to gange dagligt i 12 dage den systemiske eksponering (AUC og Cmax) af oral midazolam (substrat af CYP3A4) henholdsvis 2,6 gange og 2,0 gange.
English: The bioavailability of nilotinib might be reduced in patients with total gastrectomy (see section 5.2).
Danish: Biotilgængeligheden af nilotinib kan blive reduceret hos patienter med total gastrektomi (se pkt.
English: The primary endpoint was the proportion of patients without confirmed loss of MR4.0 or loss of MMR within 48 weeks following treatment discontinuation.
Danish: Det primære endepunkt var procentdelen af patienter der opretholdt MR4.5 eller MMR i 48 uger efter behandlingsophør.
English: Hyperparathyroidism secondary
Danish: Sekundær hyperparathyroidisme
English: Of the 126 patients who entered the TFR phase, 73 patients (57.9%, [95% CI: 48.8, 66.7]) had no loss of MMR, no confirmed loss of MR4.0, and no re-initiation of nilotinib within 48 weeks.
Danish: Af de 126 patienter, som indgik i TFR fasen, havde 73 patienter (57,9 %, [95 % CI: 48,8; 66,7]) ikke noget tab af MMR, ikke noget bekræftet tab af MR4.0 og ingen genopstart af nilotinib inden for 48 uger.
English: In newly diagnosed CML patients, the cumulative MMR rate was 64.0% by cycle 12.
Danish: Ved nydiagnosticerede CML-patienter var den kumulative MMR-hastighed 64,0 % efter cyklus 12.
English: Alternative concomitant medicinal products with no or minimal CYP3A4 inhibition should be considered.
Danish: Samtidig behandling med alternative lægemidler uden eller med minimal CYP3A4-hæmning bør overvejes.
English: Nilotinib therapy should be re-initiated at 300 mg twice daily or at a reduced dose level of 400 mg once daily if the patient had a dose reduction prior to discontinuation of therapy.
Danish: Behandlingen med nilotinib skal genoptages med 300 mg to gange dagligt eller med en reduceret dosis på 400 mg en gang dagligt, hvis patientens dosis var blevet reduceret før seponering af behandlingen.
English: Steady-state nilotinib exposure was dose-dependent, with less than dose-proportional increases in systemic exposure at dose levels higher than 400 mg given as once-daily dosing.
Danish: Nilotinib-eksponeringen ved steady state var dosisafhængig med mindre end dosisproportionale stigninger i den systemiske eksponering ved dosisniveauer på over 400 mg givet som 1 daglig dosis.
English: Dose adjustment is not considered necessary in patients with hepatic impairment.
Danish: Det vurderes, at dosisjustering ikke er nødvendig hos patienter med nedsat leverfunktion.
English: The dose was 400 mg twice daily and dose escalation to 600 mg twice daily was allowed.
Danish: Dosis var 400 mg 2 gange dagligt, og dosisskalering til 600 mg 2 gange dagligt var tilladt.
English: In clinical studies, patients with uncontrolled or significant cardiac disease (e.g., recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia) were excluded.
Danish: I kliniske studier blev patienter med ukontrolleret eller væsentlig hjertesygdom (f.eks. nylig myokardieinfarkt, kronisk venstresidig hjerteinsufficiens, ustabil angina eller klinisk signifikant bradykardi) ekskluderet.
English: Nilotinib is a moderate CYP3A4 inhibitor.
Danish: Nilotinib er en moderat CYP3A4-hæmmer.
English: Carriers of HBV who require treatment with nilotinib should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Danish: Bærere af HBV, hvor behandling med nilotinib er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt.
English: Hepatic impairment has a modest effect on the pharmacokinetics of nilotinib.
Danish: Nedsat leverfunktion har en beskeden effekt på farmakokinetikken af nilotinib.
English: Single dose administration of 200 mg of nilotinib resulted in increases in AUC of 35%, 35% and 19% in subjects with mild, moderate and severe hepatic impairment, respectively, compared to a control group of subjects with normal hepatic function.
Danish: Administration af en enkelt dosis på 200 mg nilotinib resulterede i en stigning i AUC på henholdsvis 35 %, 35 % og 19 % hos personer med mildt, moderat og svært nedsat leverfunktion, sammenlignet med en kontrolgruppe af personer med normal leverfunktion.
English: NEL = no evidence of leukaemia/marrow response 114 CP patients had a CHR at baseline and were therefore not assessable for complete haematological response * Missing information on imatinib-resistant/intolerant status for one patient.
Danish: 114 CP-patienter havde en CHR ved baseline og kunne derfor ikke vurderes med henblik på fuldstændig hæmatologisk respons * Der mangler information om imatinibresistens/intoleransstatus hos en patient.
English: Lactose monohydrate Crospovidone Type A Poloxamer 188
Danish: Lactosemonohdyrat Crospovidon type A Poloxamer 188
English: Occurrence is more frequent in patients with imatinib-resistant or intolerant CML, in particular in patients with accelerated-phase CML.
Danish: Forekomsten er hyppigere hos imatinib-resistente eller intolerante patienter med kronisk og accelereret CML, specielt hos patienter med accelereret CML.
English: Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid leukaemia (Ph-positive CML).
Danish: Tasigna bruges til at behandle en form for leukæmi, der hedder Philadelphia-kromosompositiv kronisk myeloid leukæmi (Ph-positiv CML).
English: Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Danish: Forsigtighed bør udvises hos patienter med relevante hjertelidelser (se pkt 4.4).
English: In a retrospective analysis, 91% (234/258) of patients on nilotinib 300 mg twice daily achieved BCR-ABL levels ≤10% at 3 months of treatment compared to 67% (176/264) of patients on imatinib 400 mg once daily.
Danish: I en retrospektiv analyse opnåede 91 % (234/258) af patienterne, der fik nilotinib 300 mg 2 gange dagligt, BCR-ABL-niveauer ≤10 % efter 3 måneders behandling sammenlignet med 67 % (176/264) af de patienter, der fik imatinib 400 mg 1 gang dagligt.
English: Table 4 Adverse reactions in adult patients in the Tasigna Phase III study (<5% of all patients)
Danish: Tabel 4 Bivirkninger hos voksne patienter i fase III-studiet med Tasigna (<5 % af alle patienter)
English: There was no relevant increase in exposure to nilotinib when the dose was increased from 400 mg twice daily to 600 mg twice daily.
Danish: Der var ingen relevant stigning i eksponeringen for nilotinib, når dosis blev øget fra 400 mg 2 gange dagligt til 600 mg 2 gange dagligt.
English: Nilotinib therapy should be re-initiated at either 300 mg or 400 mg twice daily.
Danish: Behandlingen med nilotinib skal genoptages med enten 300 mg eller 400 mg to gange dagligt.
English: Approximately 12% of subjects in the Phase III study in patients with newly diagnosed CML in chronic phase and approximately 30% of subjects in the Phase II study in patients with imatinib-resistant or intolerant CML in chronic phase and accelerated phase were 65 years of age or over.
Danish: Cirka 12 % af deltagerne i et fase III studie med patienter med nydiagnosticeret CML i kronisk fase og ca. 30 % af deltagerne i et fase II studie med imatinib-resistente eller intolerante patienter med kronisk og accelereret CML var 65 år eller derover.
English: Among resistant or intolerant CML patients, the percentage of patients who achieved BCR-ABL/ABL ≤0.01% IS (MR4.0) by the cut-off date was 11.4%, while 4.5% of the patients achieved BCR-ABL/ABL ≤0.0032% IS (MR4.5).
Danish: Blandt resistente eller intolerante CML-patienter var procentdelen af patienter, der opnåede BCR-ABL/ABL ≤0,01 % IS (MR4,0) ved cut-off datoen 11,4 %, imens 4,5 % af patienterne opnåede BCR-ABL/ABL ≤0,0032 % IS (MR4.5).
English: Alterations included increased alanine aminotransferase and alkaline phosphatase activity and histopathology findings (mainly sinusoidal cell or Kupffer cell hyperplasia/hypertrophy, bile duct hyperplasia and periportal fibrosis).
Danish: Ændringer inkluderede øget alaninaminotransferase og alkalifosfataseaktivitet og histopatologiske fund (hovedsageligt sinusoidecelle- eller Kupffer-cellehyperplasi/hypertrofi, galdegangshyperplasi og periportal fibrose).
English: Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML.
Danish: Behandling skal initieres af en læge med erfaring i diagnostisering og behandling af patienter med CML.
English: Use in adults - Patients newly diagnosed with CML: The recommended dose is 600 mg per day.
Danish: Anvendelse til voksne - Nydiagnosticerede patienter med CML: Den anbefalede dosis er 600 mg pr. dag.
English: Insomnia, depression, anxiety
Danish: Søvnløshed, depression, angst
English: The long-term effects of prolonged treatment with nilotinib in paediatric patients are unknown.
Danish: Langtidseffekterne ved langvarig behandling af den pædiatriske population med nilotinib er ukendt.