FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Danish: Mekanismen og betydningen for mennesker af disse resultater i karcinogenicitetsstudiet hos rotter er endnu ikke afklaret.
English: Median age was 51 years (range 18-70 years), with 21.9% of patients ≥ 60 years of age.
Danish: Gennemsnitsalderen var 51 år (range 18-70 år), med 21,9% patienter ≥60 år.
English: A total of 1.106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Danish: I alt randomiseredes 1.106 patienter, 553 til hver arm. Baselinekarakteristika var velafbalancerede mellem de to arme.
English: • Once the tablet has dissolved, drink everything in the glass straight away.
Danish: • Når tabletten er opløst, så drik hele glassets indhold med det samme.
English: 260 patients with myeloid blast crisis were enrolled.
Danish: Der inkluderedes 260 patienter med myeloid blastkrise.
English: 1 Haematological response criteria (all responses to be confirmed after ≥ 4 weeks):
Danish: Hæmatologiske responskriterier (alle respons skal bekræftes efter ≥4 uger):
English: The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Danish: Translokationen t(17:22) [(q22:q13)], eller dets gen-produkt, var til stede i næsten alle respons på Imatinib Teva-behandling.
English: A complete haematological response was achieved in 95% of patients.
Danish: Fuldstændigt hæmatologisk respons opnåedes hos 95% af patienterne.
English: 235 adult patients with accelerated phase disease were enrolled.
Danish: Der inkluderedes 235 voksne patienter med accelereret sygdomsfase.
English: The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Danish: Plasma AUC for denne metabolit blev kun fundet at være 16% af AUC for imatinib.
English: Similar findings were found based on a 18months landmark analysis.
Danish: Lignende resultater fandtes baseret på analysen efter 18 måneder.
English: After 42 months of follow-up, 11 patients experienced a confirmed loss (within 4 weeks) of their cytogenetic response.
Danish: Efter 42 måneders opfølgning fik 11 patienter bekræftet tab (inden for 4 uger) af cytogenetiske respons (inden for 4 uger).
English: 20 out of the 50 (40%) patients in cohort 5 received haematopoietic stem cell transplant.
Danish: 20 ud af 50 (40%) patienter i kohorte 5 fik hæmatopoietisk stamcelletransplantation.
English: 5 patients responded, 3 completely and 2 partially.
Danish: Fem patienter responderede, 3 komplet og 2 partielt.
English: Imatinib Teva may do the same to some other medicines.
Danish: Imatinib Teva kan gøre det samme ved andre lægemidler.
English: Your doctor has prescribed Imatinib Teva because you suffer from a serious condition.
Danish: Din læge har udskrevet Imatinib Teva, fordi du lider af en alvorlig sygdom.
English: The high rate of CHR is accompanied by the development of a complete cytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Danish: Den høje rate af CHR er ledsaget af udvikling af komplet cytogenetisk respons (CCyR) hos 65%, hvilket er sammenligneligt med resultater observeret hos voksne.
English: This is because Imatinib Teva could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Imatinib Teva kan forårsage, at hepatitis B-infektionen bliver aktiv igen, hvilket undertiden kan være dødeligt.
English: While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working.
Danish: Mens du tager Imatinib Teva, vil din læge regelmæssigt kontrollere, om lægemidlet virker.
English: The rate of haematological response was 70% with a duration of 2-3 months.
Danish: Incidensen af hæmatologisk respons var 70% med en varighed på 2-3 måneder.
English: ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Danish: ULN = laboratoriets øvre normalgrænse AST = aspartat aminotransferase
English: The estimated 4-year OS in cohort 5-patients was 83.6% compared to 44.8% in the historical controls.
Danish: Den estimerede 4-års OS hos kohorte 5-patienter var 83,6% sammenlignet med 44,8% i den historiske kontrolgruppe.
English: Mean absolute bioavailability for imatinib is 98%.
Danish: Den gennemsnitlige absolutte biotilgængelighed for imatinib er 98%.
English: Imatinib Teva can help you to fight this condition.
Danish: Imatinib Teva kan hjælpe dig med at bekæmpe denne tilstand.
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 µmol/l, respectively.
Danish: Ki værdier i humane levermikrosomer var henholdsvis 27; 7,5 og 7,9 µmol/l.
English: Not applicable Not applicable
Danish: Ikke relevant Ikke relevant
English: When needed, discontinuation of Imatinib Teva treatment may be considered.
Danish: Om nødvendigt kan det overvejes at ophøre med Imatinib Teva-behandling.
English: Some children and adolescents taking Imatinib Teva may have slower than normal growth.
Danish: Nogle børn og unge, der får Imatinib Teva, kan vokse langsommere end normalt.
English: This medicine does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen specielle opbevaringsforhold.
English: The median duration of second-line treatment with imatinib was 64 months.
Danish: Medianvarigheden af andenvalgsbehandling med imatinib var 64 måneder.
English: - Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Danish: - Imatinib Teva anbefales ikke under graviditeten, medmindre det er strengt nødvendigt, da det kan skade din baby.
English: Importantly, 27.7% of patients also achieved a major cytogenetic response, which was complete in 20.4% (confirmed 16%) of patients.
Danish: Væsentligt er det, at 27,7% af patienterne også opnåede et cytogenetisk hovedrespons, hvilket var fuldstændigt hos 20,4% (bekræftet 16%) af patienterne.
English: The degree of cytogenetic response and molecular response had a clear effect on long-term outcomes in patients on imatinib.
Danish: Graden af cytogenisk respons og molekylært respons havde en klar effekt på langtidsudfaldet for patienter i imatinib-behandling.
English: They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective.
Danish: De kan enten øge eller nedsætte virkningen af Imatinib Teva, hvilket kan resultere i enten flere bivirkninger, eller de kan gøre Imatinib Teva mindre virksomt.
English: Severe elevation of transaminases (<5%) or bilirubin (<1%) was seen in CML patients and was usually managed with dose reduction or interruption (the median duration of these episodes was approximately one week).
Danish: Svære stigninger i transaminaser (<5%) eller bilirubin (<1%) blev observeret hos CML-patienterne og blev sædvanligvis behandlet med dosisreduktion eller seponering (den gennemsnitlige varighed af disse episoder var ca. 1 uge).
English: The annual rate of progression to accelerated phase or blast crisis decreased with time on therapy and was less than 1% annually in the fourth and fifth years.
Danish: Den årlige frekvens for progression til fremskreden fase eller blastkrise aftog, jo længere behandlingen stod på, og var mindre end 1% årlig i fjerde og femte år.
English: For the patients treated at 600 mg, the current estimates for median progression-free-survival and overall survival were 22.9 and 42.5 months, respectively.
Danish: For patienter behandlet med 600 mg, var de nuværende estimater for median progressionsfri overlevelse og overlevelse i det hele taget henholdsvis 22,9 og 42,5 måneder.
English: Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Danish: Bivirkninger Bivirkninger rapporteret med mere end et isoleret tilfælde er listet nedenfor efter organklasse og frekvens.
English: Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Danish: Derudover sås partielt cytogetisk respons (PCyR) hos 16%, dermed MCyR hos 81%.
English: Imatinib pharmacokinetics has not been specifically studied in the elderly.
Danish: Imatinibs farmakokinetik er ikke specifikt undersøgt hos ældre.
English: Do not stop taking Imatinib Teva unless your doctor tells you to.
Danish: Du må ikke stoppe med at tage Imatinib Teva, medmindre din læge fortæller dig det.
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis
Danish: 12 Gy i 8 fraktioner for alle patienter, som er CNS1 og CNS2 ved diagnosticering
English: For patients with reduction in Bcr-Abl transcripts of at least 3 logarithms at 12 months, the probability of remaining free from progression to accelerated phase/blast crisis was 99% at 84 months.
Danish: For patienter med reduktion i Bcr-Abl transkripter på mindst 3 logaritmer ved 12 måneder, var sandsynligheden for at forblive fri for progression til accelereret fase/blastkrise 99% efter 84 måneder.
English: A confirmed haematological response was achieved in 71.5% of patients (Table 3).
Danish: Der opnåedes konfirmeret hæmatologisk respons hos 71,5% af patienterne (Tabel 3).
English: The duration of imatinib therapy can vary with the treatment programme selected, but generally longer exposures to imatinib have yielded better results.
Danish: Varigheden af behandling med Imatinib Teva kan variere med det valgte behandlingsprogram, men generelt har længere eksponering for Imatinib Teva givet de bedste resultater.
English: Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Germany
Danish: Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Tyskland
English: DFSP (at dose 800 mg)
Danish: DFSP (ved 800 mg dosis)
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Danish: • Genopblussen (reaktivering) af hepatitis B-infektion, hvis du tidligere har haft hepatitis B (leverbetændelse type B).
English: Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.
Danish: Imatinib Teva kan nedsætte antallet af hvide blodlegemer, så du lettere kan få infektioner.
English: Polyvinyl alcohol partially hydrolysed Macrogol
Danish: Polyvinylalkohol (delvist hydrolyseret) Macrogol
English: Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Danish: Imatinib-behandling inducerer et hurtigt respons hos nydiagnosticerede pædiatriske CML-patienter med en CHR hos 78% efter 8 ugers behandling.
English: 532 adult patients were treated at a starting dose of 400 mg.
Danish: 532 voksne patienter blev behandlet med en startdosis på 400 mg.
English: Date of latest renewal: 18 September 2017
Danish: Dato for første markedsføringstilladelse: 8. januar 2013 Dato for seneste fornyelse: 18. september 2017
English: In contrast, there were 165 (29.8%) events in the IFN+Ara-C arm, of which 130 occurred during first-line treatment with IFN+Ara-C.
Danish: Til sammenligning var der 165 (29,8%) hændelser i IFN+Ara-C-armen, af hvilke 130 opstod under førstevalgsbehandling med IFN+Ara-C.
English: Table 2 Response in newly diagnosed CML Study (84-month data)
Danish: Tabel 2 Respons i undersøgelsen vedrørende nydiagnosticeret CML (84 måneders data) (Bedste respons)
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Danish: Det aktive stof imatinib udgør en miljørisiko for organismer i sedimenter.
English: • Blood clots in small blood vessels (thrombotic microangiopathy).
Danish: • Blodpropper i små blodkar (trombotisk mikroangiopati).
English: No specific dose recommendation is necessary in the elderly.
Danish: Specifik dosisjustering er ikke nødvendig til ældre.
English: The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Danish: Plasma AUC for imatinib blev reduceret med 73% sammenlignet med patienter som ikke blev behandlet med EIAEDs.
English: There were 59% males and 41% females; 89.9% caucasian and 4.7% black patients.
Danish: 59% var mænd, 41% kvinder; 89,9% var af kaukatisk afstamning og 4,7% af negroid afstamning.
English: Study 0109 40.5-month data Accelerated phase (n=235)
Danish: Undersøgelse 0109 40,5 måneders data Accelereret fase (n=235)
English: Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Danish: Blastkrise defineres som ≥ 30% blaster i blod eller knoglemarv eller ekstramedullær sygdom ud over hepatosplenomegali.
English: If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål om, hvordan Imatinib Teva virker, eller hvorfor du har fået ordineret dette lægemiddel, kontakt din læge.
English: Major molecular response criteria: in the peripheral blood reduction of ≥ 3 logarithms in the amount of Bcr-Abl transcripts (measured by real-time quantitative reverse transcriptase PCR assay) over a standardised baseline.
Danish: Molekylær major responskriterier: I det perifere blod reduktion på ≥3 logariter i antallet af Bcr-Abl-transkriptioner (målt ved real-time kvantitativ reverse transkriptase PCR assay) over for en standardiseret baseline.
English: In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
Danish: I denne undersøgelse opnåede 65% af patienterne et cytogenetisk hovedrespons, som var fuldstændigt hos 53% (bekræftet 43%) af patienterne (Tabel 3).
English: Based on population pharmacokinetic analysis in CML patients, there was a small effect of age on the volume of distribution (12% increase in patients > 65 years old).
Danish: Populationsfarmakokinetiske analyser hos CML-patienter har vist, at alder har en lille effekt på fordelingsvolumen (12% stigning hos patienter >65 år).
English: * These types of reactions have been reported mainly from post-marketing experience with imatinib.
Danish: * Denne type bivirkninger er hovedsageligt blevet rapporteret efter markedsføring af imatinib.
English: The rate of response was also higher in the patients treated at 600 mg (33%) as compared to the patients treated at 400 mg (16%, p=0.0220).
Danish: Hovedresponsniveauet var også større hos patienter behandlet med 600 mg (33%) sammenlignet med patienter behandlet med 400 mg (16%, p=0,0220).
English: The increase is approximately 1.5 to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Danish: Eksponeringen er ca. 1,5- til 2- fold, svarende til en 1,5-gangs stigning af plasma AGP som imatinib binder stærkt til.
English: Mogilska 80, 31-546 Krakow Poland
Danish: Mogilska 80, 31-546 Krakow Polen
English: Myeloid blast crisis
Danish: Myeloid blastkrise
English: A slight to moderate reduction in spermatogenesis was also observed in the dog at oral doses ≥ 30 mg/kg.
Danish: Der sås også en let til moderat reduktion i spermatogenesen hos hunde ved orale doser >30 mg/kg.
English: Imatinib and the N-demethyl metabolite together accounted for about 65% of the circulating radioactivity (AUC(0-48h)).
Danish: Imatinib og N-demethylmetabolitten udgjorde tilsammen ca. 65% af den cirkulerende radioaktivitet (AUC(0-48t)).
English: The percentage of some adverse reactions was higher in the 40 patients in whom the dose was increased to 800 mg daily compared to the population of patients before dose increase (n=551).
Danish: Procentdelen af nogle bivirkninger var højere hos de 40 patienter, hvor dosis blev øget til 800 mg daglig sammenlignet med patientpopulationen inden dosisstigning (n=551).
English: Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Danish: Imatinib Teva vil kun blive ordineret til dig af en læge med erfaring i behandlingen af kræft i blodet eller kræftknuder.
English: In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients).
Danish: I denne undersøgelse opnåede 31% af patienterne et hæmatologisk respons (36% af de tidligere ”ubehandlede patienter” og 22% af de ”tidligere behandlede patienter”).
English: The adverse reactions were similar in all indications, with two exceptions.
Danish: Bivirkningsmønstret var, med 2 undtagelser, det sammme ved alle indikationer.
English: This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
Danish: Det var en population af patienter, der i udtalt grad tidligere havde modtaget anden behandling, eftersom 46% tidligere havde modtaget BMT og 73% tidligere havde modtaget multi-stof kemoterapi.
English: Progression was defined as any of the following events: progression to accelerated phase or blast crisis, death, loss of CHR or MCyR, or in patients not achieving a CHR an increasing WBC despite appropriate therapeutic management.
Danish: Progression blev defineret som enhver af følgende hændelser: progression til accelereret fase eller blastkrise, død, tab af CHR eller MCyR, eller patienter der ikke opnår CHR eller øget leukocyttal på trods af relevant terapeutisk behandling.
English: Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.
Danish: Din læge vil fortælle dig om de mulige risici, der er forbundet med brug af Imatinib Teva under graviditeten.
English: • Painful and/or blistering skin lesions.
Danish: • Smertefulde og/eller blæredannende hudlæsioner.
English: Imatinib Teva is a medicine containing an active substance called imatinib.
Danish: Imatinib Teva er et lægemiddel, der indeholder et aktivt stof kaldet imatinib.
English: The patients were distributed in three main categories: haematological failure (29%), cytogenetic failure (35%), or intolerance to interferon (36%).
Danish: Patienterne blev fordelt i 3 hovedkategorier: Manglende hæmatologisk effekt (29%), manglende cytogenetisk effekt (35%) eller interferonintolerans (36%).
English: Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or < ULN if total bilirubin is > ULN)
Danish: Total bilirubin: = 1,5 ULN AST: >ULN (kan være normal or < ULN hvis total bilirubin er > ULN)
English: Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Danish: En specialist i leversygdomme og i behandling af hepatitis B skal konsulteres, før behandling initieres hos patienter med positiv hepatitis B-serologi (herunder patienter med aktiv sygdom), og hvis patienten testes HBVpositiv under behandlingen.
English: 95 (37%) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63%) had not (“untreated patients”).
Danish: 95 (37%) havde tidligere modtaget kemoterapi til behandling af enten accelereret fase eller blastkrise (”tidligere behandlede patienter”), hvorimod 165 (63%) ikke havde (”ubehandlede patienter”).
English: Experience with imatinib in this indication is very limited and is based on haematological and cytogenetic response rates.
Danish: Der er meget begrænset erfaring med Imatinib Teva ved denne indikation, og den er baseret på hæmatologiske og cytogenetiske responsrater.
English: This Ki value is far higher than the expected plasma levels of imatinib in patients; consequently no interaction is expected upon co-administration of either 5-fluorouracil or paclitaxel and imatinib.
Danish: Denne Ki værdi er langt højere end de forventede plasmaniveauer af imatinib hos patienter, og der forventes derfor ingen interaktion i forbindelse med samtidig administration af hverken 5-fluorouracil eller paclitaxel og imatinib.
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 μM).
Danish: Imatinib interfererede ikke med biotransformationen af 5-fluorouracil, men hæmmede paclitaxelmetabolismen på grund af kompetitiv hæmning af CYP2C8 (Ki = 34,7 μm).
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised imatinib and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Danish: Ved 84 måneder var den estimerede samlede overlevelse 86,4% (83, 90) vs. 83,3% (80, 87) i henholdsvis de randomiserede imatinib- og IFN+Ara-C-grupper (p=0,073, log-rank test).
English: In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Danish: Der blev hos GIST patienter (studie B2222) observeret stigning i grad 3 eller 4 ALT (alaninaminotransferase) hos 6,8% og stigning i grad 3 eller 4 AST (aspartat aminotransferase) hos 4,8%.
English: Major response at 12 months (%)
Danish: Major respons ved 12 måneder (%)
English: Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).
Danish: Genoptag Imatinib Tevabehandlingen ved den tidligere dosis (dvs. før svære bivirkninger).
English: If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Teva should not be resumed.
Danish: Hvis niveauet af ADAMTS13antistoffer er forøget samtidig med lav ADAMTS13-aktivitet, må behandlingen med Imatinib Teva ikke genoptages.
English: ANC < 0.5 x 10
Danish: a ANC < 0.5 x 10
English: ANC = absolute neutrophil count a occurring at least after one month of treatment
Danish: ANC = fuldstændigt antal neutrofilocytter aopstået efter mindst 1 måneds behandling
English: The tablets are approximately 9 mm in diameter.
Danish: Tabletterne er ca. 9 mm i diameter.
English: Patients had received a median of 14 months of prior IFN therapy at doses ≥ 25 x 106 IU/week and were all in late chronic phase, with a median time from diagnosis of 32 months.
Danish: Patienterne havde i gennemsnit tidligere modtaget 14 måneders IFNbehandling med doser ≥2 x 106 IE/uge og var alle i sen kronisk fase med en gennemsnitlig tid siden diagnose på 32 måneder.
English: • Eye pain or deterioration in vision, bleeding in the eyes.
Danish: • Øjensmerter eller svækkelse af dit syn, blødning i øjnene.
English: The effect of imatinib treatment on survival in chronic phase, newly diagnosed CML has been further examined in a retrospective analysis of the above reported imatinib data with the primary data from another Phase III study using IFN+Ara-C (n=325) in an identical regimen.
Danish: Effekten af imatinib-behandling på overlevelse i kronisk fase, nyligt diagnostiseret CML er blevet yderligere undersøgt i en retrospektiv analyse af ovenstående rapporterede imatinib-data med primærdata fra et andet fase III-studie hvor IFN+Ara-C (n=325) blev anvendt i et identisk behandlingsregime.
English: The safety database for children with Ph+ALL is very limited though no new safety concerns have been identified.
Danish: Bivirkningsdatabasen for børn med Ph+ALL er meget begrænset, med der er ikke identificeret nye bivirkninger.
English: Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44%) and 3 (33%) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77%.
Danish: Af 9 patienter med kronisk fase CML og tilgængelige cytogenetiske data opnåede henholdsvis 4 (44%) og 3 (33%) fuldstændigt og delvist cytogenetisk respons, med en McyR-rate på 77%.
English: This will help protect you from stomach problems when taking Imatinib Teva.
Danish: Dette vil hjælpe med at beskytte dig mod maveproblemer, når du tager Imatinib Teva.
English: Grade 3 and 4 neutropenia was seen in 7.5% and 2.7% of patients, respectively, and grade 3 thrombocytopenia in 0.7% of patients.
Danish: Grad 3 og 4 neutropeni sås hos henholdsvis 7,5% og 2,7% af patienterne og grad 3 trombocytopeni hos 0,7% af patienterne.