natgillin/translations-raw huggingface dataset:
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.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton
Bærere af HBV, hvor behandling med Imatinib Teva er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt. 
Carriers of HBV who require treatment with Imatinib Teva 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).
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%). 
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (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).
• Rødmen og/eller hævelse af håndflader eller fodsåler, hvilket kan være ledsaget af en prikkende følelse eller brændende smerte. 
• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
Hvis der opstår alvorlige ikke-hæmatologiske bivirkninger ved behandling med Imatinib Teva, skal behandlingen seponeres, indtil bivirkningerne er ophørt. 
If a severe non-haematological adverse reaction develops with imatinib use, treatment must be withheld until the event has resolved.
18 Gy i 10 fraktioner for patienter, som er CNS3 ved diagnosticering VCR (1,5 mg/m2/dag, i.v. 
18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza Spanien 
C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza Spain
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. 
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.
Imatinib Teva hæmmer væksten af disse celler i en vis undergruppe af disse sygdomme. 
Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.
Yderligere 4 HES patienter blev fundet FIP1L1-PDGFRα positive i 3 andre publicerede kasuistikker. 
FIP1L1-PDGFRα-positive in other 3 published reports.
Der er meget begrænset erfaring hos børn med MDS/MPD, DFSP og HES/CEL. 
There is very limited experience in children with MDS/MPD, DFSP and HES/CEL.
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). 
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).
Den totale daglige dosis til børn og teenagere må ikke overstige 800 mg med CML og 600 mg med Ph+ ALL. 
The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Patienter, der bekymrer sig om deres fertilitet under imatinib-behandling, bør konsultere deres læge. 
Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
I et 2-års karcinogenicitetsstudie i rotter resulterede administration af imatinib på 15, 30 og 60 mg/kg/dag i en signifikant reduktion i levetiden ved 60 mg/kg/dag for hanner og for hunner ved ≥30 mg/kg/dag. 
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥30 mg/kg/day.
Dette tid-til-hændelse effektmål er stærkt påvirket af det høje antal skift fra IFN+Ara-C-armen til imatinib-armen. 
This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to imatinib.
Imatinib Teva er indiceret til behandling af 
Imatinib Teva is indicated for the treatment of
I kliniske undersøgelser i CML blev der hos 2% af nydiagnosticerede patienter, hos 2,4% af patienterne i sen kronisk fase efter svigtende interferonbehandling, hos 4% af patienterne i accelereret fase efter svigtende interferonbehandling og hos 5% af patienterne i blastkrise efter svigtende interferonbehandling observeret seponering af undersøgelsesmedicinen på grund af lægemiddelrelaterede bivirkninger. 
In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
De første 77 patienter startede med en dosis på 400 mg, protokollen blev efterfølgende ændret og tillod højere doser, hvorefter de resterende 158 patienter startede med en dosis på 600 mg. 
The first 77 patients were started at 400 mg, the protocol was subsequently amended to allow higher dosing and the remaining 158 patients were started at 600 mg.
I dette studie indgik 7 patienter med MDS/MPD, som blev behandlet med 400 mg Imatinib Teva daglig. 
This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Imatinib Tevas 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 og på objektive responsrater hos voksne med DFSP. 
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 DFSP.
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. 
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.
Der er i kliniske undersøgelser set øget incidens af disse hændelser hos ældre og hos patienter med hjertesygdom i anamnesen. 
In clinical trials, there was an increased incidence of these events in the elderly and those with a prior history of cardiac disease.
Baseret på den poolede farmakokinetiske populationsanalyse hos børn med hæmatologiske sygdomme (CML, Ph+ ALL eller andre hæmatologiske sygdomme behandlet med imatinib), stiger imatinibclearance med stigende legemsoverflade. 
Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
I dette studie var dosisoptrapning tilladt fra 400 mg daglig til 600 mg daglig og derefter fra 600 mg daglig til 800 mg daglig. 
In this study, dose escalations were allowed from 400 mg daily to 600 mg daily, then from 600 mg daily to 800 mg daily.
Kapslen er fra 23,0 mm til 23,6 mm lang og 8,53 mm bred. 
The length of the capsule is from 23.0 mm to 23.6 mm and the width is 8.53 mm.
Der er udført 3 store, internationale, åbne, ikke-kontrollerede fase II undersøgelser med patienter med Philadelphia-kromosompositiv (Ph+) CML i fremskreden blastkrise eller accelereret fase, andre Ph+leukæmier eller med CML i kronisk fase men tidligere behandlet med alfa-interferonbehandling (IFN) uden effekt. 
Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced, blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
Der sås signifikant øgning i følsomhed for imatinib (gennemsnitlig Cmax og AUC for imatinib steg med henholdsvis 26% og 40%) hos raske frivillige ved samtidig administration af enkeltdosis ketoconazol (en CYP3A4-hæmmer). 
There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
• Muskelkramper med feber, rød-brun urin, smerter eller svaghed i dine muskler (tegn på muskelproblemer). 
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
Behandlingsvarighed: I det eneste kliniske studie, der er udført indtil nu, fortsattes behandlingen med Imatinib Teva indtil sygdomsprogression (se pkt. 
Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
• Bleghed, føle sig træt og stakåndet og have mørk urin (tegn på lavt antal røde blodceller). 
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
Den primære effektvariable var graden af hæmatologisk hovedrespons, rapporteret enten som fuldstændigt hæmatologisk respons, intet tegn på leukæmi (dvs. clearance af blaster fra knoglemarv og blod, men uden fuldstændig restitution i perifert blod som ved fuldstændigt respons) eller remission til CML i kronisk fase. 
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
• Voksne og pædiatriske patienter med nydiagnosticeret Philadelphiakromosom (bcr-abl) positiv (Ph+) kronisk myeloid leukæmi (CML), for hvilke knoglemarvstransplantation ikke anses for førstevalgsbehandling. 
• Adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
CLM i kronisk fase defineres ved, at alle følgende kriterier er opfyldt: blaster <15% i blod og knoglemarv, perifere blodbasofiltal <20%, trombocyttal >100 x 109/l. 
Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and bone marrow, peripheral blood basophils < 20%, platelets > 100 x 109/l.
• Muskelsvaghed, kramper og en unormal hjerterytme (tegn på ændringer i mængden af kalium i dit blod). 
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
I dette studie blev 14 patienter med HES/CEL behandlet med 100 mg - 1.000 mg Imatinib Teva daglig. 
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Imatinib Teva bruges også til behandling af børn med CML. 
Imatinib Teva is also a treatment for children and adolescents with CML.
3 Fuldstændigt cytogenetisk respons bekræftet ved endnu en cytogenetisk knoglemarvsundersøgelse udført mindst 1 måned efter den initiale knoglemarvsundersøgelse 
3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Længden af den filmovertrukne tablet er ca. 20 mm og bredden er ca. 10 mm. 
The length of the film-coated tablet is approximately 20 mm and the width is approximately 10 mm.
Undersøg om cytopeni er relateret til leukæmi (marvaspirat eller biopsi). 
Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).
(1 time), dag 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, dag 26-46 
(1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/m2 oral, days 26-46
Total bilirubin: > 1,5-3,0 ULN AST: alt 
Total bilirubin: > 1.5-3.0 ULN AST: any
Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi9, artralgi, knoglesmerter 
Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
• Voksne patienter med refraktært hypereosiniphil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL) med FIP1L1-PDGFRα-omlejring. 
• Adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
- Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel. 
Pregnancy, breast-feeding and fertility - If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Aktive stoffer hvis plasmakoncentration kan ændres af imatinib Imatinib øger gennemsnitligt Cmax og AUC af simvastatin (et CYP3A4-substrat) henholdsvis 2 og 3,5 gange, hvilket indikerer, at imatinib hæmmer CYP3A4. 
Active substances that may have their plasma concentration altered by imatinib Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Den estimerede frekvens af patienter fri for progressions til fremskreden fase eller blastkrise efter 84 måneder var signifikant højere i imatinib-armen end i IFN-armen (92,5% vs. 85,1%, p<0,001). 
The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the imatinib arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Da imatinib blev brugt som enkeltstofbehandling ved recidiverende/refraktær Ph+ ALL var resultatet hos 53 ud af 411 evaluerbare patienter en hæmatologisk responsrate på 30% (9% komplet) og en væsentlig cytogenetisk responsrate på 23%. 
When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
• Kraftig hovedpine, svækkelse eller lammelser af lemmer eller ansigt, talebesvær, pludseligt bevidsthedstab (tegn på problemer med nervesystemet såsom blødning eller hævelse i kranie/hjerne). 
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
Der er ingen erfaring med behandling af børn under 2 år med CML og ved behandling af børn under 1 år med Ph+ALL (se pkt. 
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).
Analysen bekræftede, at imatinib-eksponeringen hos børn, som fik 260 mg/m2 en gang daglig (højst 400 mg en gang daglig) eller 340 mg/m2 en gang daglig (højst 600 mg en gang daglig), svarede til eksponeringen hos voksne, som fik imatinib 400 mg eller 600 mg en gang daglig. 
The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
I et kontrolleret studie (ADE10) hvor imatinib blev sammenlignet med kemoterapi-induktion hos 55 nydiagnostiserede patienter i alderen 55 år og derover, gav imatinib brugt som monoterapi anledning til en signifikant højere ratio af hæmalogisk respons end kemopterapi (96,3% vs. 50%, p=0,0001). 
In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Pleuralgi, pulmonær fibrose, pulmonær hypertension, pulmonær blødning 
Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Denne fase III undersøgelse hos voksne patienter sammenlignede enkeltstof-behandling med imatinib med behandling med en kombination af interferon-alfa (IFN) og cytarabin (Ara-C). 
Chronic phase, newly diagnosed This phase III study in adult patients compared treatment with either single-agent imatinib or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
Imatinib Teva 100 mg hårde kapsler Til doser på 400 mg og derover (se anbefalede doser nedenfor) er en 400 mg hård kapsel tilgængelig. 
Imatinib Teva 100 mg hard capsules For doses of 400 mg and above (see dose recommendation below) a 400 mg hard capsule is available.
• Bækkensmerter, nogle gange med kvalme og opkastninger med uventet vaginalblødning, føle sig svimmel eller besvime pga. nedsat blodtryk (tegn på problemer med dine æggestokke eller livmoder). 
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
Behandlingsskema: Eksisterende data har vist, at Imatinib Teva er effektiv og sikker ved administration af 600 mg/dag i kombination med kemoterapi i induktionsfasen, i konsoliderings- og vedligeholdelsesfaser af kemoterapi (se pkt. 
Treatment schedule: On the basis of the existing data, imatinib has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL.
• Kvalme, åndenød, uregelmæssig hjerterytme (puls), uklar urin, træthed og/eller ubehag forbundet med abnorme resultater af laboratorieprøver (f.eks. højt indhold af kalium, urinsyre og calcium i blodet og lavt indhold af fosfor i blodet). 
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).