natgillin/translations-raw huggingface dataset:
Efter resektion af primær GIST blev patienterne randomiseret til en af de to behandlingsarme: imatinib 400 mg/dag eller tilsvarende placebo i et år. 
After resection of primary GIST, patients were randomised to one of the two arms: imatinib at 400 mg/day or matching placebo for one year.
Imatinibs sikkerhed og virkning hos børn under 18 år med MDS/MPD, DFSP, GIST og HES/CEL er ikke klarlagt i kliniske studier. 
The safety and efficacy of imatinib in children with MDS/MPD, DFSP, GIST and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Men hvis det næsten er tid til at tage den næste dosis, skal du springe den glemte dosis over. 
However if it is nearly time for the next dose, - Then continue with your normal schedule.
- Hvis du er kvinde og er gravid eller planlægger at blive gravid, skal du være forsigtig, når du åbner kapslerne og håndterer indholdet for at undgå hud- og øjenkontakt eller indånding af pulveret. 
- If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
En 3-årig dreng, der fik en enkelt dosis på 400 mg, oplevede opkastning, diarré og appetitløshed, og en anden 3-årig dreng, der fik en enkelt dosis på 980 mg, oplevede nedsat antal hvide blodlegemer og 
One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count
Effekt af seponering af behandling efter opnåelse af komplet cytogenetisk 
The effect of stopping treatment after the achievement of a complete cytogenetic response has not been
Genoptag behandling med imatinib 600 mg. 3. 
Resume treatment with imatinib at 600 mg. 3.
På grund af den øgede risiko for blødning ved brug af imatinib (f.eks. hæmoragi) bør patienter med behov for antikoagulantia have lavmolekylært heparin eller standardheparin i stedet for 
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.
Der bør udvises forsigtighed, når imatinib tages sammen med proteasehæmmere, azol-antimykotika, visse makrolider (se pkt. 
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides
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. 
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.
De 23 patienter, som var inkluderet i registerstudiet, fik imatinib 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). 
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).
I to kliniske undersøgelser (studie B2222 og et mellemgruppe studie S0033) blev den daglige dosis af imatinib optrappet til 800 mg hos patienter, hvis sygdom fremskrider ved de lavere daglige doser på 400 mg eller 600 mg. 
In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of imatinib was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.
Ara-C: cytosin arabinosid; CP: cyclophosphamid; DEX: dexamethason; MTX: methotrexat; 6-MP: 6mercaptopurin; VM26: teniposid; VCR: vinkristin; IDA: idarubicin; i.v. 
Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs 
Detailed information on this medicine is available on the European Medicines Agency
Undersøg om cytopeni er relateret til leukæmi (marv-aspirant eller biopsi). 
Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).
Der er begrænset erfaring hos børn og Ph-positiv ALL og meget begrænset erfaring med børn med MDS/MPD, DFSP, GIST og HEL/CEL. 
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Patienter med hjertesygdom, risikofaktorer for hjerteinsufficiens eller nyreinsufficiens i anamnesen skal monitoreres omhyggeligt, og alle patienter, som har symptomer forenelige med hjerte- eller nyreinsufficiens, bør undersøges og behandles. 
Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated
Ved præliminær populationsfarmakokinetikanalyse hos GIST-patienter fandtes 3 variable (albumin, leukocytter og bilirubin) at have statistisk signifikant indflydelse på imatinibs farmakokinetik. 
Based on preliminary population pharmacokinetic analysis in GIST patients, there were three variables (albumin, WBC and bilirubin) found to have a statistically significant relationship with imatinib pharmacokinetics.
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 
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 drug accumulation after repeated once-daily dosing.
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 
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
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 7 4% 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.
- Hævelse, som fx af anklerne eller omkring øjnene. 
• Swelling such as round your ankles or puffy eyes.
Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi9, 
Musculoskeletal and connective tissue disorders Muscle spasm and cramps, musculoskeletal pain including myalgia9,
Dosering ved CML hos børn 
Posology for CML in children
GIST er en kræftform i mavesækken og tarmen. 
GIST is a cancer of the stomach and bowels.
Kapslens længde er mellem 23,0 og 23,6 mm, og bredden er 8,53 mm. 
The length of the capsule is from 23.0 mm to 23.6 mm and the width is 8.53 mm.
SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30°C. 
SPECIAL STORAGE CONDITIONS Store below 30°C
Kapslens længde er mellem 19,1 og 19,7 mm, og bredden er 6,91 mm. 
The length of the capsule is from 19.1 mm to 19.7 mm and the width is 6.91 mm.
- Muskelkramper med feber, rød-brun urin, smerter eller svaghed i dine muskler (tegn på 
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle
Børn med CML i accelereret fast og blastkrise (startdosis 340 mg/m2) 
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Tilfælde af leverskade, inklusive leversvigt og levernekrose, er blevet observeret med imatinib. 
Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib.
Tabel 7 12 måneders og 36 måneders imatinib-behandling (SSGXVIII/AIO forsøg) 
Table 7 12-month and 36-month imatinib treatment (SSGXVIII/AIO Trial)
Den totale daglige dosis til børn må ikke overstige 800 mg for CML-patienter og 600 mg for Ph+ ALL-patienter. 
The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
- Brystsmerter, uregelmæssig hjerterytme (tegn på hjerteproblemer). 
• Chest pain, irregular heart rhythm (signs of heart problems).
En stor, international, åben, ikke-kontrolleret fase II undersøgelse blev udført med patienter med Philadelphia-kromosom-positiv (Ph+) CML i blastkrisefase af sygdommen. 
A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in blast crisis phase of the disease.
Om nødvendigt kan det overvejes at ophøre med Imatinib Teva B.V.-behandling. 
When needed, discontinuation of Imatinib Teva B.V. treatment may be considered.
Disse tilfælde blev sædvanligvis behandlet ved midlertidigt at tilbageholde behandling med imatinib og behandle med diuretika og andre relevante, understøttende tiltag. 
These reactions can usually be managed by withholding imatinib temporarily and with diuretics and other appropriate supportive care measures.
EU/1/17/1243/025 30 filmovertrukne tabletter EU/1/17/1243/026 30x1 filmovertrukne tabletter EU/1/17/1243/027 90 filmovertrukne tabletter EU/1/17/1243/028 90x1 filmovertrukne tabletter EU/1/17/1243/029 30 filmovertrukne tabletter EU/1/17/1243/030 30x1 filmovertrukne tabletter EU/1/17/1243/031 90 filmovertrukne tabletter EU/1/17/1243/032 90x1 filmovertrukne tabletter 
EU/1/17/1243/025 30 film-coated tablets EU/1/17/1243/026 30x1 film-coated tablets EU/1/17/1243/027 90 film-coated tablets EU/1/17/1243/028 90x1 film-coated tablets EU/1/17/1243/029 30 film-coated tablets EU/1/17/1243/030 30x1 film-coated tablets EU/1/17/1243/031 90 film-coated tablets EU/1/17/1243/032 90x1 film-coated tablets imatinib teva b.v. 400 mg film-coated tablets
- Genopblussen (reaktivering) af hepatitis B-infektion, hvis du tidligere har haft hepatitis B (leverbetændelse type B). 
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver
• behandling af voksne patienter med inoperabel dermatofibrosarkom protuberans (DFSP) og voksne patienter med residiverende og/eller metastaserende DFSP som ikke er tilgængelig for 
• 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.
Der er ingen kontrollerede forsøg med pædiatriske patienter med c-Kit-positiv GIST. 
There are no controlled trials in paediatric patients with c-Kit positive GIST.
Der findes begrænsede data vedrørende effekt af dosisøgning fra 400 mg til 600 mg eller 800 mg hos patienter, der oplever bedring ved den lavere dosis (se pkt. 
Limited data exist on the effect of dose increases from 400 mg to 600 mg or 800 mg in patients progressing at the lower dose (see section 5.1).
Total-bilirubin: >3-10 ULN ASAT: alt 
Total bilirubin: >3-10 ULN AST: any
- Kraftigt nedsat urinmængde, følelse af tørst (tegn på nyreproblemer). 
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
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. 
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).
- Hvis du behandles for Ph-positiv ALL: 
- If you are being treated for DFSP:
- 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. 
- 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.
EU/1/17/1243/001 20x1 filmovertrukne tabletter EU/1/17/1243/002 60 filmovertrukne tabletter EU/1/17/1243/003 60x1 filmovertrukne tabletter EU/1/17/1243/004 120 filmovertrukne tabletter EU/1/17/1243/005 120x1 filmovertrukne tabletter EU/1/17/1243/006 180x1 filmovertrukne tabletter EU/1/17/1243/007 20x1 filmovertrukne tabletter EU/1/17/1243/008 60 filmovertrukne tabletter EU/1/17/1243/009 60x1 filmovertrukne tabletter EU/1/17/1243/010 120 filmovertrukne tabletter EU/1/17/1243/011 120x1 filmovertrukne tabletter EU/1/17/1243/012 180x1 filmovertrukne tabletter 
EU/1/17/1243/001 20x1 film-coated tablets EU/1/17/1243/002 60 film-coated tablets EU/1/17/1243/003 60x1 film-coated tablets EU/1/17/1243/004 120 film-coated tablets EU/1/17/1243/005 120x1 film-coated tablets EU/1/17/1243/006 180x1 film-coated tablets EU/1/17/1243/007 20x1 film-coated tablets EU/1/17/1243/008 60 film-coated tablets EU/1/17/1243/009 60x1 film-coated tablets EU/1/17/1243/010 120 film-coated tablets EU/1/17/1243/011 120x1 film-coated tablets EU/1/17/1243/012 180x1 film-coated tablets imatinib teva b.v. 100 mg film-coated tablets
Der udførtes rutinemæssigt immunohistokemi med Kit antistof (A-4502, polyklonalt kaninserum, 1:100; DAKO Corporation, Carpinteria, CA) i overensstemmelse med analyse ved avidin-biotinperoxidasekompleksmetode efter antigengenfinding. 
Immunohistochemistry was routinely performed with Kit antibody (A-4502, rabbit polyclonal antiserum, 1:100; DAKO Corporation, Carpinteria, CA) according to analysis by an avidin-biotin-peroxidase complex method after antigen retrieval.
I dette studie blev 14 patienter med HES/CEL behandlet med 100 mg-1.000 mg imatinib daglig. 
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Bedring blev rapporteret for: hjerte, nervesystem, hud/subkutant væv, respiratoriske/ thorakale/mediastinale, muskuloskeletale/bindevævs/kar og gastroentestinale organsystemer. 
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Udskilning af fri imatinib er sandsynligvis sammenlignelig for patienter med nedsat nyrefunktion og dem med normal nyrefunktion, eftersom udskillelse via nyren kun udgør en mindre elimineringsvej for imatinib (se pkt. 
The free drug clearance of imatinib is probably similar between patients with renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
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 Teva B.V. 
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
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 GIST og DFSP samt på recidivfri overlevelse i adjuverende GIST. 
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 GIST and DFSP and on recurrence-free survival in adjuvant GIST.
Længere behandlingsvarighed (>36 måneder) kan muligvis forsinke yderligere tilbagefald. 
Longer duration of the treatment (> 36 months) may delay the onset of further recurrences; however the impact of this finding on the overall survival remains unknown.
- Have kvalme med tab af appetitten, mørk urin, gul hud eller øjne (tegn på leverproblemer). 
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
Nogle lægemidler kan påvirke virkningen af Imatinib Teva B.V., når de bruges samtidigt. 
Some medicines can interfere with the effect of Imatinib Teva B.V. when taken together.
(0,5 time), dag 7, 8, 14, 15; i.v. 
(0.5 h), days 7, 8, 14, 15;
- 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
• børn med nydiagnosticeret Philadelphia-kromosom (bcr-abl) positiv (Ph+) kronisk myeloid leukæmi (CML), for hvilke knoglemarvstransplantation ikke anses for førstevalgsbehandling. 
• 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
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.
Imatinib forlængede signifikant RFS, idet 75% af patienterne var recidivfrie efter 38 måneder i Imatinib-gruppen i forhold til efter 20 måneder i placebo-gruppen (95% konfidensinterval, [30 - ikke estimerbare]; [14 - ikke estimerbare]); (hazard ratio = 0,398 [0,259-0,610], p<0,0001). 
Imatinib significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the imatinib group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - non- estimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
• behandling af voksne patienter med Kit (CD117) positiv, inoperabel og/eller metastaserende maligne gastrointestinale bindevævstumorer (GIST). 
• The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Alle patienter opnåede komplet hæmatologisk respons, komplet cytogenetisk respons og/eller komplet molekylært respons. 
All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Ved andre doser end 400 mg og 800 mg (se anbefalede doser nedenfor) er en 100 mg filmovertrukken 
For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg film-coated tablet is
• voksne og børn med nydiagnosticeret Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph+ ALL) integreret med kemoterapi. 
• Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
9 Muskuloskeletale smerter under behandling med imatinib eller efter seponering er blevet 
9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in
a ANC < 0,5 x 109/l og/eller trombocytter < 10 x 109/l 
a ANC < 0.5 x 109/l and/or platelets < 10 x 109/l
Stoffet hæmmer selektivt proliferationen og inducerer apoptosis i Bcr-Abl-positive cellelinjer såvel som i friske leukæmiceller fra Philadelphia-kromosom-positiv (Ph+) CML og hos patienter med akut lymfoblastisk leukæmi (ALL). 
The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
• 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.
Total-bilirubin: >1,5-3,0 ULN ASAT: alt 
Total bilirubin: >1.5-3.0 ULN AST: any
In vitro hæmmer imatinib CYP2D6-aktiviteten ved koncentrationer svarende til dem, der påvirker CYP3A4-aktivitet. 
In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Der er meget begrænset erfaring hos børn med MDS/MPD, DFSP, 
There is very limited experience in children with MDS/MPD, DFSP, GIST
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). 
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).
Induktions-konsoliderende behandling Hyper-CVAD regimen: CP 300 mg/m2 i.v. 
Study AUS01 Induction-consolidation therapy Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Der bør vaskes hænder straks efter 
Hands should be washed immediately after handling open capsules.
Selvom resultaterne fra en farmakokinetisk analyse viste, at der var en betydelig variation mellem forsøgspersoner, øgede den gennemsnitlige eksponering af imatinib sig ikke hos patienter med varierende grad af nedsat leverfunktion, sammenlignet med patienter med normal leverfunktion (se 
Although the results of pharmacokinetic analysis showed that there is considerable inter-subject variation, the mean exposure to imatinib did not increase in patients with varying degrees of liver dysfunction as compared to patients with normal liver function (see sections 4.2, 4.4 and 4.8).
Vincristin 2 mg i.v., dag 4, 11; Doxorubicin 50 mg/m i.v. 
Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m2 i.v.
1 Pneumoni blev oftest observeret hos patienter med transformeret CML og hos patienter med 
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with
Ved doser >6 mg/kg sås hos rotter i 13-ugers undersøgelsen hyperplasi af det transitoriske epithel i nyrepapillerne og i urinblæren, uden ændringer i serum- eller urinparametre. 
In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses ≥ 6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
6 patienter opnåede delvist respons og 21 patienter opnåede stabilisering af deres sygdom efter optrapning af dosis med et overordnede klinisk fordel på 26%. 
The daily dose was escalated to 800 mg in a total of 103 patients; 6 patients achieved a partial response and 21 stabilisation of their disease after dose escalation for an overall clinical benefit of 26%.
I syv publikationer var der rapporteret om sytten (17) patienter med GIST (med eller uden Kit og PDGFRmutationer). 
Seventeen (17) patients with GIST (with or without Kit and PDGFR mutations) were reported in 7 publications.
- Symptomer på infektioner såsom feber, kraftige kulderystelser, ondt i halsen eller sår i munden. 
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
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 
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.