natgillin/translations-raw huggingface dataset:
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.
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.
Bivirkningsdatabasen for børn med Ph+ALL er meget begrænset, med der er ikke identificeret nye bivirkninger.
The safety database for children with Ph+ALL is very limited though no new safety concerns have been identified.
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%.
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%.
Dette vil hjælpe med at beskytte dig mod maveproblemer, når du tager Imatinib Teva.
This will help protect you from stomach problems when taking Imatinib Teva.
Grad 3 og 4 neutropeni sås hos henholdsvis 7,5% og 2,7% af patienterne og grad 3 trombocytopeni hos 0,7% af patienterne.
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.
Hæmatologisk og cytogenetisk respons er bibeholdt i en periode varende fra henholdsvis 19-60 måneder (median 49 måneder) og 16-59 måneder (median 47 måneder).
Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19-60) and 47 months (range 16-59), respectively.
(3 timer, q 12
(2 h, q 12
Yderligere seks patienter, behandlet med Imatinib Teva, er blevet beskrevet i 5 publicerede kasuistikker, alderen varierede fra 18 måneder til 49 år.
A further 6 DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Imatinibs effekt er baseret på generelle hæmatologiske og cytogene responsrater og progressionsfri overlevelse.
The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Det er vigtigt, at du tager det så længe, lægen eller apotekspersonalet fortæller dig, at du skal.
It is important that you do this as long as your doctor, pharmacist or nurse tells you to.
Samtidig anvendelse af rifampicin eller andre stærke CYP3A4induktorer og imatinib bør undgås.
Concomitant use of rifampicin or other strong CYP3A4 inducers and imatinib should be avoided.
Major respons ved 24 måneder (%)
Major response at 24 months (%)
Kontakt lægen, før du tager Imatinib Teva: hvis du har eller har haft lever-, nyre- eller hjerteproblemer.
Talk to your doctor before taking Imatinib Teva: - if you have or have ever had a liver, kidney or heart problem.
Nogle lægemidler kan påvirke virkningen af Imatinib Teva, når de bruges samtidigt.
Some medicines can interfere with the effect of Imatinib Teva when taken together.
Undersøgelse 0102 38 måneders data Myeloid blastkrise (n=260)
Study 0102 38-month data Myeloid blast crisis (n=260)
I alt døde 71 (12,8%) og 85 (15,4%) patienter i henholdsvis imatinib- og IFN+Ara-C-grupperne.
A total of 71 (12.8%) and 85 (15.4%) patients died in the imatinib and IFN+Ara-C groups, respectively.
Din læge kan beslutte at nedsætte eller øge dosis afhængig af, hvordan du responderer på behandlingen.
Your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
I imatinib-armen blev patienterne behandlet med 400 mg daglig.
In the imatinib arm, patients were treated with 400 mg daily.
Større cytogenetisk respons, hæmatologisk respons, molekulær respons (evaluering af minimal tilbageværende sygdom), tid til accelereret fase eller blastkrise samt overlevelse er de sekundære hovedeffektmål.
Major cytogenetic response, haematological response, molecular response (evaluation of minimal residual disease), time to accelerated phase or blast crisis and survival are main secondary endpoints.
Diameteren af den filmovertrukne tablet er ca. 9 mm.
The diameter of the film-coated tablet is approximately 9 mm.
På grund af kendt øget risiko for blødning i forbindelse med brug af imitanib (f.eks. hæmoragi) bør patienter med behov for antikoagulantia have heparin med lav molekylevægt eller standardheparin i stedet for coumarinderivater som warfarin.
Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterpakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Antallet af Imatinib Teva-kapsler afhænger af barnets tilstand, kropsvægt og højde.
The amount of Imatinib Teva given will depend on your child's condition, body weight and height.
1800 mg til 3200 mg (så høj som 3200 mg daglig i 6 dage): Svaghed, myalgi, øget kreatininfosfokinase, øget bilirubin, gastrointestinale smerter.
1800 mg to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Patienten bør testes for HBV-infektion før initiering af behandling med Imatinib Teva.
Patients should be tested for HBV infection before initiating treatment with Imatinib Teva.
Af disse 11 patienter, blev 4 patienter optrappet til 800 mg daglig, hvoraf 2 af dem genopnåede cytogenetisk respons (1 delvist og 1 fuldstændigt, og den sidst nævnte opnåede også et molekulær respons), mens kun 1 af de 7 patienter, som ikke fik større dosis genopnåede et fuldstændigt cytogenetisk respons.
Of these 11 patients, 4 patients escalated up to 800 mg daily, 2 of whom regained a cytogenetic response (1 partial and 1 complete, the latter also achieving a molecular response), while of the 7 patients who did not escalate the dose, only one regained a complete cytogenetic response.
Behandling med Imatinib Teva kan da genoptages ved reduceret daglig dosis.
Treatment with imatinib may then be continued at a reduced daily dose.
Der var i samme publikation oplysning om længere varende opfølgningsdata fra 12 MDS/MPD-patienter med PDGFRomlejring (5 patienter fra studie B2225).
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR gene rearrangements (5 patients from study B2225).
9 Muskuloskeletale smerter under behandling med imatinib eller efter seponering er blevet observeret efter markedsføring.
9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
Kapslen indeholder et hvidt til gulligt granuleret pulver.
The content of the capsule is white to light yellow granulated powder.
Uomdannet imatinib er ansvarlig for ca. 25% af dosis (5% urin og 20% fæces), resten er metabolitter.
Unchanged imatinib accounted for 25% of the dose (5% urine, 20% faeces), the remainder being metabolites.
Farmakoterapeutisk klassifikation: Protein-kinasehæmmer, ATC-kode: L01XE01
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
21 patienter blev behandlet med 400 mg Imatinib Teva daglig, mens 3 patienter fik en lavere dosis.
21 patients were treated with imatinib 400 mg daily, while the other 3 patients received lower doses.
Tabel 5 Kemoterapi-regime anvendt i kombination med imatinib i studie I2301
Table 5 Chemotherapy regimen used in combination with imatinib in study I2301
Et hovedrespons kombinerer både fuldstændig og partiel respons: Fuldstændig (0% Ph+ metafaser), delvis (1-35%)
A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Imatinib Tevas effekt på resultatet af knoglemarvstransplantation er ikke blevet bestemt.
The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
Ved brug af denne metode øgedes den estimerede kumulative responsfrekvens for førstevalgsbehandling med imatinib fra 12 måneders behandling til 84 måneders behandling som følgende: hhv. CHR fra 96,4% til 98,4% og CCyR fra 69,5% til 87,2%.
Using this approach, the estimated cumulative response rates for first-line treatment with imatinib improved from 12 months of therapy to 84 months of therapy as follows: CHR from 96.4% to 98.4% and CCyR from 69.5% to 87.2%, respectively.
Hvis laboratorie- eller kliniske fund associeret med TMA forekommer hos en patient, som er i behandling med Imatinib Teva, skal behandlingen seponeres og der skal foretages en grundig undersøgelse for TMA, inklusiv ADAMTS13-aktivitet og anti-ADAMTS13-antistofbestemmelse.
If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Teva , treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Du kan blive mere følsom overfor sollys, når du tager Imatinib Teva.
You may become more sensitive to the sun while taking Imatinib Teva.
Hos voksne bør dosis reduceres fra 400 mg til 300 mg eller fra 600 mg til 400 mg, eller fra 800 mg til 600 mg, og hos børn fra 340 til 260 mg/m2/dag.
In adults the dose should be reduced from 400 mg to 300 mg or from 600 mg to 400 mg or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Behandlingen kan enten gives til dit barn som én daglig dosis eller alternativt kan den daglige dosis deles og gives to gange (halvdelen om morgenen og den anden halvdel om aftenen).
The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).
Prilaz baruna Filipovica 25 10000 Zagreb Kroatien
PLIVA Croatia Ltd. Prilaz baruna Filipovica 25 10000 Zagreb Croatia
• Brug ca. 50 ml til hver 100 mg tablet.
• Use about 50 ml for each 100 mg tablet.
I IFN-armen blev patienterne behandlet med en måldosis IFN på 5 MIE/m2/dag subkutant i kombination med subkutant Ara-C 20 mg/m2/dag i 10 dage/måned.
In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m2/day subcutaneously in combination with subcutaneous Ara-C 20 mg/m2/day for 10 days/month.
I denne retrospektive analyse af total overlevelse blev imatinibs overlegenhed vist i forhold til IFN+Ara-C (p<0,001); inden for 42 måneder var 47 (8,5%) imatinib-patienter og 63 (19,4%) IFN+Ara-C-patienter døde.
In this retrospective analysis, the superiority of imatinib over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
De mere hyppige bivirkninger var gastrointestinalblødning, konjunktivitis og stigning i transaminase eller bilirubin.
The more frequent adverse reactions included gastrointestinal haemorrhages, conjunctivitis and elevation of transaminases or bilirubin.
Alle patienter blev efter induktion behandlet med imatinib og standard kemoterapi (se Tabel 3), og bcr-abl transkriptionerne var identiske i de to arme efter 8 ugers behandling.
All patients received imatinib and consolidation chemotherapy (see Table 4) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
In vitro resultater viste, at CYP3A4 var det primære CYP-enzym som katalysator af biotransformationen af imatinib.
The in vitro results showed that CYP3A4 was the major human P450 enzyme catalysing the biotransformation of imatinib.
Undersøgelsens primære effektvariable var graden af det cytogenetiske hovedrespons (fuldstændigt plus partielt respons, 0-35% Ph+-metafaser i knoglemarven).
The primary efficacy variable of the study was the rate of major cytogenetic response (complete plus partial response, 0 to 35% Ph+ metaphases in the bone marrow).
De voksne patienter, som er beskrevet i publiceret litteratur blev behandlet med enten 400 mg (fire tilfælde) eller 800 mg (et tilfælde) Imatinib Teva daglig.
The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
• behandling af voksne patienter med inoperabel dermatofibrosarkom protuberans (DFSP) og voksne patienter med residiverende og/eller metastaserende DFSP som ikke er tilgængelig for kirurgi.
• The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
400 mg imatinib to gange daglig havde en inhibitorisk effekt på CYP2D6-medieret metoprololmetabolisme, som gav en stigning af Cmax og AUC for metoprolol på cirka 23% (90%CI [1,16-1,30]).
Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Der er gennemført en større, åben, international, randomiseret, fase III multicenterundersøgelse med patienter med nydiagnosticeret Ph+ CML.
One large, open-label, multicentre, international randomised phase III study has been conducted in patients with newly diagnosed Ph+ CML.
Imatinib Teva anvendes også til behandling af voksne med: - Myelodysplastiske/myeloproliferative sygdomme (MDS/MDP).
Imatinib Teva is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Der blev set PDGFR-omlejring hos 11 patienter, 9 af disse opnåede CHR og 1 PHR.
In eleven patients PDGFR gene rearrangements was detected, 9 of them achieved a CHR and 1 PHR.
Årlige frekvenser af enhver type progression blev reduceret over tid med imatinib.
The yearly rates of progression of any type for imatinib also decreased over time.
2 Hovedpine var hyppigst hos GIST-patienter.
2 Headache was the most common in GIST patients.
Ved 7-års opfølgning var der 93 (16,8%) progressionshændelser i imatinib-armen: 37 (6,7%) omhandlede progression til accelereret fase/blastkrise, 31 (5,6%) tab af MCyR, 15 (2,7%) tab af CHR eller stigning i leukocytter, og 10 (1,8%) dødsfald ikke relateret til CML.
With 7 years follow-up, there were 93 (16.8%) progression events in the imatinib arm: 37 (6.7%) involving progression to accelerated phase/blast crisis, 31 (5.6%) loss of MCyR, 15 (2.7%) loss of CHR or increase in WBC, and 10 (1.8%) CML unrelated deaths.
Den estimerede progressionsfri overlevelse efter 84 måneder var 81,2% i imatinib-armen og 60,6% i kontrolarmen (p<0,001).
The estimated rate of progression-free survival at 84 months was 81.2% in the imatinib arm and 60.6% in the control arm (p<0.001).
Calciumhydrogenphosphat Crospovidon
Calcium hydrogen phosphate Crospovidone
Patienter med nedsat nyrefunktion eller i dialyse bør gives den mindste anbefalede dosis på 400 mg dagligt som startdosis.
Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Lymfoid blastkrise
Lymphoid blast crisis
Frekvenskategorier er defineret ved brug af følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000),
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Præbehandling med gentagne doser af rifampicin 600 mg efterfulgt af enkeltdosis imatinib 400 mg resulterede i fald i Cmax og AUC(0-∞) på mindst 54% og 74% af værdierne uden rifampicinbehandling.
Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Ialt 26 pædiatriske patienter i alderen <18 år med enten CML i kronisk fase (n=11) eller CML i blastkrise eller Ph+ akut leukæmi (n=15) blev inkluderet i en fase I undersøgelse med dosiseskalering.
A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
Hæmatologisk respons1 Fuldstændigt hæmatologisk respons (CHR) Intet tegn på leukæmi (NEL)
Haematological response1 Complete haematological response (CHR) No evidence of leukaemia (NEL)
Undersøgelse 0110 37 måneders data Kronisk fase, IFN-svigt (n=532)
Study 0110 37-month data Chronic phase, IFN failure (n=532)
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).
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).
• Brug ca. 200 ml til hver 400 mg tablet.
• Use about 200 ml for each 400 mg tablet.
Behandlingsvarighed: I kliniske undersøgelser fortsattes behandling med Imatinib indtil sygdomsprogression.
Treatment duration: In clinical trials, treatment with imatinib was continued until disease progression.
Hvor estimeret 96% (93%) af patienterne med CCyR (PCyR) ved 12 måneder var fri for progression til accelereret fase/blastkrise ved 84 måneder, var kun 81% af patienterne uden CCyR ved 12 måneder fri for progression til fremskreden CML ved 84 måneder (p<0,001 samlet, p=0,25 mellem CCyR og PCyR).
Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
• Voksne og pædiatriske patienter med Ph+ CML i kronisk fase efter manglende effekt af alfainterferonbehandling, eller i accelereret fase eller blastkrise.
• Adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
305 CZ-74770 Opava - Komárov Tjekkiet
CZ-74770 Opava - Komárov
BCR-ABL-tyrosinkinasehæmmere (TKI'er) er blevet associeret med trombotisk mikroangiopati (TMA), herunder enkeltstående rapporter for Imatinib Teva (se pkt.
BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Teva (see section 4.8).
Patienter, der ikke viste respons (manglende fuldstændig hæmatologisk respons (CHR) efter 6 måneder, øget leukocyttal, intet større cytogenetisk respons (MCyR) efter 24 måneder), tab af respons (tab af CHR eller MCyR) eller svær intolerance over for behandling, fik lov at krydse over til den anden behandlingsarm.
Patients showing lack of response (lack of complete haematological response (CHR) at 6 months, increasing WBC, no major cytogenetic response (MCyR) at 24 months), loss of response (loss of CHR or MCyR) or severe intolerance to treatment were allowed to cross over to the alternative treatment arm.
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.
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 drugs is possible.
CML i kronisk fase, MDS/MPD (startdosis 400 mg) HES/CEL (ved 400 mg dosis)
Chronic phase CML, MDS/MPD (starting dose 400 mg) HES/CEL (at dose 400 mg)
Ved en konservativ antagelse af at patienter med manglende data er ikke respondenter, blev CHR observeret hos 20/23 (87 %), CCyR hos 9/23 (39,1 %) og MR hos 11/23(47,8 %) af patienterne.
When assuming conservatively that patients with missing data were non-responders, CHR was observed in 20/23 (87%) patients, CCyR in 9/23 (39.1%) patients, and MR in 11/23 (47.8%) patients, respectively.
Kliniske undersøgelser vedrørende kronisk myeloid leukæmi
Clinical studies in chronic myeloid leukaemia
• Voksne patienter med myelodysplastisk syndrom/myeloproliferative sygdomme (MDS/MPD) som er forbundet med platelet-derived growth factor receptor-omlejring (PDGFR-omlejring).
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
Kronisk fase; manglende effekt med Interferon
Chronic phase, Interferon failure
Behandlingen bør initieres af en læge med erfaring i behandling af patienter med maligne hæmatologiske lidelser og maligne sakromer som passende.
Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
Komplet CyR n (%) Delvis CyR n (%)
Complete CyR n (%) Partial CyR n (%)
Elimination Baseret på fremkomne stof(fer) efter oral dosis af 14C-mærket imatinib, genfandtes ca. 81% af dosis inden for 7 dage i fæces (68% af dosis) og urin (13% af dosis).
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81% of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Køn har ingen betydning for imatinib's kinetik.
There is no effect of gender on the kinetics of imatinib.
Imatinib Teva hæmmer væksten af disse celler.
Imatinib Teva inhibits the growth of these cells.
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.
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.
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).
Imatinib in combination with chemotherapy induction (see Table 4) 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).
Denne kliniske effekt var efter 2 ugers behandling forbundet med en højere reduktion i bcr-abl transkriptionen hos de imatinibbehandlede patienter end i kemoterapiarmen (p=0,02).
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).
Ved en dosis på 60 mg/kg, havde hunrotterne et signifikant føtaltab efter implantation og et reduceret antal levende fostre.
At a dose of 60 mg/kg, female rats had significant post-implantation foetal loss and a reduced number of live foetuses.
Hvis der opstår stigninger i bilirubin >3 x IULN (institutional upper limit of normal) eller i levertransaminaser >5 x IULN, skal Imatinib Teva seponeres indtil bilirubinniveauerne er faldet til <1,5 x IULN og transaminaseniveauer til <2,5 x IULN.
If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Hepatotoksicitet imatinib metaboliseres primært i leveren, og kun 13% udskilles via nyrerne.
Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
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