FrancophonIA/ELRC3.0 huggingface dataset:
English: When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17 (64.7%), respectively.
Danish: Hvis responsraten beregnes ud fra patienter med mindst en valid parametervurdering er reponsraten for CHR, CCyr og MR henholdvis 20/22 (90,9 %), 9/9 (100 %) og
English: Maximal plasma concentrations of imatinib in patients are 2-4 μmol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered medicinal products is possible.
Danish: Maksimale plasmakoncentrationer af imatinib er hos patienter 2-4 µmol/l, og hæmning af CYP2D6 og/eller CYP3A4/5-medieret metabolisme af samtidigt administrerede lægemidler er derfor mulig.
English: Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ ALL below 1 year of age (see section 5.1).
Danish: Anvendelse til børn: Der er ingen erfaring med behandling af børn under 2 år med CML, og børn under 1 år med Ph+ ALL (se pkt.
English: • paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
Danish: • børn med Ph+ CML i kronisk fase efter manglende effekt af alfa-interferonbehandling, eller i
English: Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Danish: Med undtagelse af nyligt diagnosticerede patienter med CML i kronisk fase, er der ikke gennemført kontrollerede undersøgelser, der har vist klinisk bedring eller øget overlevelse ved disse sygdomme.
English: imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Danish: imatinib blev administreret periodisk i kohorte 1-5 med stigende varighed og tidligere start med imatinib fra kohorte til kohorte; kohorte 1 fik den mindst intensive imatinibbehandling og kohorte 5 den mest intensive (længste varighed i dage med kontinuerlig, daglig imatinibdosering i de første kemobehandlingsforløb).
English: • adult and paediatric patients with Ph+ CML in blast crisis.
Danish: • voksne og børn med Ph+ CML i blastkrise.
English: Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka Józefa Piłsudskiego 5
Danish: Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka Józefa Piłsudskiego 5 Str. 95-200 Pabianice
English: The age of these patients ranged from 2 to 79 years.
Danish: Alderen hos disse patienter varierede fra 2 til 79 år.
English: In eleven patients PDGFR gene rearrangements were detected, 9 of them achieved a CHR and 1 PHR.
Danish: Der blev set PDGFRomlejring hos 11 patienter, 9 af disse opnåede CHR og 1 PHR.
English: These are a group of blood diseases in which some blood cells start growing out of control.
Danish: Disse er en gruppe af sygdomme i blodet, hvor nogle blodlegemer begynder at vokse ukontrolleret.
English: • Chest pain, irregular heart rhythm (signs of heart problems).
Danish: • Brystsmerter, uregelmæssig hjerterytme (tegn på hjerteproblemer).
English: A total of 51 paediatric patients with newly diagnosed and untreated CML in chronic phase have been enrolled in an open-label, multicentre, single-arm phase II trial.
Danish: I alt 51 børn med nydiagnosticeret og ubehandlet CML i kronisk fase blev inkluderet i en åben, multicenter, enkeltarmet fase II-undersøgelse.
English: Imatinib is a protein kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Danish: Imatinib er en protein-kinasehæmmer, som potent hæmmer Bcr-Abl tyrosinkinasen in vitro, in vivo og på cellulært niveau.
English: In 61 of these 117 patients FIP1L1-PDGFRα fusion kinase was identified.
Danish: Af disse 117 patienter var 61 positive for FIP1L1-PDGFRα fusionkinase.
English: When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Danish: Når imatinib blev kombineret med højdosis kemoterapi hos Ph+ ALL patienter, sås forbigående levertoksicitet i form af forhøjet transaminase og hyperbilirubinæmi.
English: There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.
Danish: Der har efter markedsføring været rapporter om spontane aborter og medfødte abnormaliteter hos spædbørn født af kvinder, som har taget Imatinib medac.
English: In patients with hypereosinophilic syndrome (HES) with occult infiltration of HES cells within the myocardium, isolated cases of cardiogenic shock/left ventricular dysfunction have been associated with HES cell degranulation upon the initiation of imatinib therapy.
Danish: Hos patienter med hypereosinofilt syndrom (HES) med skjult infiltration af HES-celler i myokardiet, har der været isolerede tilfælde af kardiogent shock/dysfunktion af venstre ventrikel i forbindelse med HES-celledegranulering ved initiering af imatinibterapi.
English: As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Danish: Da der er rapporteret tilfælde af hjertebivirkninger med imatinib, bør der foretages en nøje benefit/risk-vurdering hos HES/CEL-populationen før påbegyndelse af behandling.
English: Renal insufficiency: Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Danish: Nyreinsufficiens: Patienter med nedsat nyrefunktion eller i dialyse bør gives den mindste anbefalede dosis på 400 mg dagligt som startdosis.
English: There have been case reports of growth retardation occurring in children and pre-adolescents receiving imatinib.
Danish: Der har været case-rapporter med væksthæmning hos børn og præ-teenagere, der fik imatinib.
English: Caution is recommended in thyroidectomy patients receiving levothyroxine and imatinib.
Danish: Forsigtighed anbefales hos thyreoidektomerede patienter, som får levothyroxin og imatinib.
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 medac.
English: When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11 % decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4 %) compared to fasting conditions.
Danish: Når imatinib indtages i forbindelse med et måltid med høj fedtprocent, reduceres absorptionen af imatinib minimalt (11 %'s fald i Cmax og forlængelse af tmax med 1,5 time), med et lille fald i AUC (7,4 %) sammenlignet med fastende.
English: The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med imatinib i alle undergrupper af den pædiatriske population med Philadelphia-kromosom (bcr-abl translokation)-positiv kronisk myeloid leukæmi (se pkt.
English: Treatment can be given as a once daily dose or alternatively the daily dose may be split into two administrations - one in the morning and one in the evening.
Danish: Behandlingen kan gives én gang dagligt eller alternativt deles i to - én dosis om morgenen og én om aftenen.
English: Capsule shell
Danish: Kapselskal Gelatine
English: Liver dysfunction classification:
Danish: Klassificering af nedsat leverfunktion:
English: • Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Danish: • Hypereosinofil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL).
English: Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered.
Danish: Undersøgelse hos en kardiolog, optagelse af ekkokardiogram og bestemmelse af serumtroponin bør derfor overvejes hos patienter med MDS/MPD, som har høje eosinofiltal, før der gives imatinib.
English: This clinical effect was associated with a higher reduction in bcr-abl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p = 0.02).
Danish: Denne kliniske effekt var efter 2 ugers behandling forbundet med en højere reduktion i bcr-abl transskriptionen hos de imatinibbehandlede patienter end i kemoterapiarmen (p = 0,02).
English: Treatment duration: In clinical trials, treatment with imatinib was continued until disease progression.
Danish: Behandlingsvarighed: I kliniske undersøgelser fortsattes behandling med imatinib indtil sygdomsprogression.
English: The 23 patients enrolled in this registry received imatinib at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
Danish: De 23 patienter som var inkluderet i registerstudiet, fik Imatinib medac med en daglig mediandosis på 264 mg (dosisområde: 100 til 400 mg) med en median varighed på 7,2 år (behandlingstid 0,1 til 12,7 år).
English: In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Danish: In vitro hæmmer imatinib aktiviteten fra cytochrom-P450-isoenzymet CYP2D6 ved koncentrationer svarende til dem, der påvirker CYP3A4-aktivitet.
English: In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Danish: In vitro hæmmer imatinib O-glucuronidationen af paracetamol med en Ki-værdi på 58,5 mikromol/l.
English: Accelerated phase is an intermediate phase among the chronic phase and the onset of the blast crisis; it is considered as the first manifestation of resistance to therapy.
Danish: Den accelererede fase er en mellemfase mellem den kroniske fase og indtræden af blastkrisen og anses som det første tegn på resistens over for behandlingen.
English: Metabolism of imatinib is mainly hepatic, and only 13 % of excretion is through the kidneys.
Danish: Imatinib metaboliseres primært i leveren, og kun 13 % udskilles via nyrerne.
English: Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)
Danish: CML i accelereret fase og blastkrise og Ph+ ALL (startdosis 600 mg)
English: Patients with cardiac disease
Danish: Patienter med hjertesygdom
English: The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg).
Danish: Niveauet for ingen observeret effekt (NOEL) var 15 mg/kg/dag for både moderdyr og F1 generation (en ¼ af den maksimale humane dosis på 800 mg).
English: Consolidation (de novo Ph+ ALL)
Danish: Konsoliderende behandling (de novo Ph+ ALL)
English: Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
Danish: Imatinib var teratogent hos rotter ved administration under organgenese ved doser ≥ 100 mg/kg, ca. svarende til den maksimale kliniske dosis på 800 mg/dag, baseret på legemsoverfladeareal.
English: The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Danish: Øgningen i gennemsnitlig AUC ved dosisøgning efter oral administration var lineær og dosisproportional i intervallet 25-1.000 mg imatinib.
English: Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “fluid retention”.
Danish: Diverse bivirkninger, som for eksempel pleuraekssudat, ascites, lungeødem og hurtig vægtstigning med eller uden overfladiske ødemer, kan kollektivt betegnes som ”væskeretention”.
English: Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib.
Danish: Tilfælde af leverskade, inklusive leversvigt og levernekrose er blevet observeret med imatinib.
English: See package leaflet for further information.
Danish: Se indlægssedlen for nærmere oplysninger.
English: There is no experience in children with CML below 2 years of age.
Danish: Der er ingen erfaring med behandling af CML hos børn under 2 år.
English: • Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of
Danish: • Muskelkramper med feber, rød-brun urin, smerter eller svaghed i dine muskler (tegn på
English: Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see section 4.8).
Danish: På grund af den mulige forekomst af tumorlysesyndrom (TLS) anbefales korrektion af klinisk signifikant dehydrering og behandling af forhøjede urinsyreniveauer før påbegyndelse af behandling med imatinib (se pkt.
English: Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6 % vs. 31.6 %, respectively).
Danish: Kontinuerlig daglig eksponering for imatinib tidligt i behandlingsforløbet i kombination med kemoterapi hos kohorte 5-patienter (n=50) forbedrede den 4-årige hændelsesfri overlevelse (EFS) sammenlignet med en historisk kontrolgruppe (n=120), der fik standard-kemoterapi uden imatinib (hhv. 69,6 % vs. 31,6 %).
English: Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Danish: Doser på 400 mg og 600 mg bør administreres 1 gang dagligt, mens daglige doser på 800 mg bør administreres som 400 mg 2 gange dagligt, én dosis om morgenen og én dosis om aftenen.
English: Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93 % (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90 % (19 out of 21 evaluable patients).
Danish: Imatinib givet i kombination med kemoterapi-induktion (se Tabel 3) resulterede i en komplet hæmatologisk responsrate på 93 % (147 ud af 158 evaluerbare patienter), og i en væsentlig cytogenetisk responsrate på 90 % (19 ud af 21 evaluerbare patienter).
English: Carriers of HBV who require treatment with imatinib 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 imatinib 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: Colitis, ileus, inflammatory bowel disease
Danish: Colitis, ileus, inflammatorisk tarmsygdom
English: There is no effect of gender on the kinetics of imatinib.
Danish: Køn har ingen betydning for imatinibs kinetik.
English: • Severely decreased urine output, feeling thirsty (signs of kidney problems).
Danish: • Kraftigt nedsat urinmængde, følelse af tørst (tegn på nyreproblemer).
English: • Hot flushes, chills or night sweats.
Danish: • Hedeture, kulderystelser eller natlig svedtendens.
English: Imatinib and its metabolites are not excreted via the kidney to a significant extent.
Danish: Imatinib og dets metabolitter udskilles kun i ubetydelig grad via nyrerne.
English: These are blood diseases in which some blood cells (named eosinophils) start growing out of control.
Danish: Disse er sygdomme i blodet, i hvilke visse blodlegemer (kaldet eosinofile celler) begynder at vokse ukontrolleret.
English: 3) On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
Danish: 3 På patientårsbasis blev kardielle hændelser, herunder hjerteinsufficiens, observeret oftere hos patienter med transformeret CML end hos patienter med kronisk CML.
English: This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Danish: I dette studie indgik 7 patienter med MDS/MPD, som blev behandlet med 400 mg imatinib dagligt.
English: Do not store above 30 ºC.
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: The main circulating metabolite in humans is the N-demethylated piperazine derivative, which shows similar in vitro potency to the parent.
Danish: Den cirkulerende hovedmetabolit i mennesker er N-demethyl-piperazinderivatet, som udviser samme potens in vitro som det stof, den er afledt af.
English: These reactions can usually be managed by withholding imatinib temporarily and with diuretics and other appropriate supportive care measures.
Danish: Disse tilfælde blev sædvanligvis behandlet ved midlertidigt at tilbageholde behandling med imatinib, og behandle med diuretika og andre relevante, understøttende tiltag.
English: Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Danish: Bedring blev rapporteret for: hjerte, nervesystem, hud/subkutant væv, respiratoriske/ thorakale/ mediastinale, muskuloskeletale/bindevævs/kar og gastrointestinale organsystemer.
English: Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Danish: Behandlingsvarighed: I det eneste kliniske studie, der er udført indtil nu, fortsattes behandlingen med imatinib indtil sygdomsprogression (se pkt.
English: In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP.
Danish: Imatinibs effekt er hos voksne og børn baseret på generelle hæmatologiske og cytogene responsrater og progressionsfri overlevelse ved CML, på hæmatologiske og cytogenetiske responsrater ved Ph+ ALL, MDS/MPD, på hæmatologiske responsrater ved HES/CEL, på objektive responsrater hos voksne med inoperabel og/eller metastaserende DFSP.
English: There are no controlled trials in paediatric patients with DFSP.
Danish: Der er ingen kontrollerede forsøg med pædiatriske patienter med DFSP.
English: The no observed effect level (NOEL) was 15 mg/kg/day.
Danish: Niveauet for ingen observeret effekt (NOEL) var 15 mg/kg/dag.
English: When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8 %) out of 11 achieving a complete haematological response.
Danish: Da imatinib blev givet som ”salvage therapy” til patienter, som ikke responderede eller som responderede dårligt på kemoterapi, opnåedes komplet hæmatologisk respons hos 9 (81,8 %) ud af 11 patienter.
English: (2 h, q 12 h), days 2-3 (total of 8 courses)
Danish: (2 timer, q 12 timer), dag 2-3 (total af 8 omgange)
English: Additionally, improvements in symptomatology and other organ dysfunction abnormalities were reported by the investigators in the case reports.
Danish: Derudover angav investigatorerne symptomatisk bedring af andre organdysfunktioner i kasuistikkerne.
English: There are no controlled trials in paediatric patients with MDS/MPD.
Danish: Der er ingen kontrollerede forsøg med pædiatriske patienter med MDS/MPD.
English: 9/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64 % and 44-63 % for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7 % neutropenia and 8.9 % thrombocytopenia).
Danish: 9/l) og trombocytopeni (trombocyttal <50 x 10 9/l) var 4-6 gange højere ved blastkrise og accelereret fase (59-64 % og 44-63 % for henholdsvis neutropeni og trombopeni) end ved sammenligning med nydiagnosticerede patienter med kronisk fase CML (16,7 % 9/l) og trombopeni neutropeni og 8,9 % trombocytopeni).
English: The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold accumulation after repeated once-daily dosing.
Danish: Sammenligningen af AUC(0-24) på dag 8 og dag 1 ved 340 mg/m²/dag dosisniveauet viste en 1,7 gang højere lægemiddelakkumulering efter gentagen dosering, én gang dagligt.
English: Histopathological examination of decedents revealed cardiomyopathy (both sexes), chronic progressive nephropathy (females) and preputial gland papilloma as principal causes of death or reasons for sacrifice.
Danish: Histopatologiske undersøgelser af de afdøde rotter afslørede kardiomyopati (begge køn), kronisk progressiv nefropati (hunner) og papillomaer på forhuden som hovedårsag til død eller begrundelse for aflivning.
English: The effect of prior gastrointestinal surgery on imatinib absorption has not been investigated.
Danish: Tidligere gastrointestinale indgrebs påvirkning af imatinibabsorptionen er ikke undersøgt.
English: In the study in patients with unresectable and/or metastatic GIST, 7 (5 %) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
Danish: I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST, oplevede 7 (5 %) af patienterne CTC grad 3-4: gastrointestinale blødninger (3 patienter), intratumorale blødninger (3 patienter) eller begge dele (1 patient).
English: At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95 % on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Danish: Baseret på in vitro undersøgelser, bindes, ved kliniske relevante koncentrationer af imatinib, ca. 95 % til plasmaproteiner, hovedsagelig albumin og alfa-syre-glycoprotein, med en mindre binding til lipoproteiner.
English: In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Danish: Plasmaeksponeringen synes at være højere hos patienter med nedsat nyrefunktion end hos patienter med normal nyrefunktion, formentlig på grund af forhøjede plasmaniveauer af alpha-acid glucoprotein (AGP), et imatinib-bindende protein, hos disse patienter.
English: Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Danish: Der sås forhøjet se-carbamid og se-creatinin hos adskillige af disse dyr.
English: When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected.
Danish: Når imatinib kombineres med højdosis kemoterapi, ses en øget forekomst af alvorlige leverreaktioner.
English: The no observed effect level (NOEL) was 30 mg/kg/day.
Danish: Niveauet for ingen observeret effekt (NOEL) var 30 mg/kg/dag.
English: In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4 % and 0.7 % of patients, respectively, and may have been related to gastrointestinal or intratumoural bleeding in at least some of these patients.
Danish: I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST rapporteredes anæmi grad 3 og 4 hos henholdsvis 5,4 % og 0,7% af patienterne, hvilket kan hænge sammen med gastrointestinal eller intra-tumoral blødning, i hvert fald hos enkelte af patienterne.