natgillin/translations-raw huggingface dataset:
10 filmovertrukne tabletter 30 filmovertrukne tabletter 90 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 60 x 1 filmovertrukne tabletter 90 x 1 filmovertrukne tabletter 
10 film-coated tablets 30 film-coated tablets 90 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets
De hyppigst observerede alvorlige bivirkninger hos børn med CML var grad 3 eller 4 cytopenier med neutropeni, trombocytopeni og anæmi. 
In paediatric CML patients the most frequent toxicities observed were grade3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Dosering ved CML hos børn og unge 
Posology for CML in children and adolescents
20 filmovertrukne tabletter 60 filmovertrukne tabletter 120 filmovertrukne tabletter 180 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 60 x 1 filmovertrukne tabletter 90 x 1 filmovertrukne tabletter 120 x 1 filmovertrukne tabletter 180 x 1 filmovertrukne tabletter 
20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets 120x1 film-coated tablets 180x1 film-coated tablets
Nøje monitoring af leverfunktionen skal udføres i tilfælde, hvor imatinib kombineres med kemoterapiregimer, som også vides at være forbundet med leverdysfunktion (se pkt. 
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8).
Din læge kan beslutte at øge dosis til 400 mg, som skal tages som 4 tabletter à 100 mg eller én tablet à 400 mg én gang daglig afhængig af, hvordan du responderer på behandlingen. 
Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets of 100 mg or one tablet of 400 mg once a day, depending on how you respond to treatment.
- Du må ikke amme, mens du er i behandling med Imatinib Accord. 
- Do not breast-feed during the treatment with Imatinib Accord.
Hvis dette gælder for dig, skal du fortælle din læge det, før du tager Imatinib Accord. 
If this applies to you, tell your doctor without taking Imatinib Accord.
Der bør anvendes mindste startdosis til patienter med nedsat nyrefunktion. 
Patients with Renal impairment should be given the minimum starting dose.
Hvor længe skal du tage Imatinib Accord Bliv ved med at tage Imatinib Accord hver dag, så længe som din læge har foreskevet det. 
Keep taking Imatinib Accord every day for as long as your doctor tells you.
Imatinib hæmmer også receptortyrosinkinaserne for trombocytafledte vækstfaktorer (PDGF), PDGF-R og PDGF-medierede cellulære signaler. 
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events.
Meget almindelig Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi9, artralgi, knoglesmerter10 
Musculoskeletal and connective tissue disorders Very common Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia,
Pædiatrisk population: Der er ingen erfaring med behandling af børn under 2 år med CML og 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).
Accelereret fase defineres som tilstedeværelse af én eller flere af følgende: blaster 15 %, men <30 % i blod eller knoglemarv, blaster plus promyelocytter 30 % i blod eller knoglemarv (hvilket giver <30 % blaster), perifere blodbasofiltal 20 %, trombocyttal <100 x 109/l uafhængigt af behandlingen. 
Accelerated phase is defined by the presence of any of the following: blasts ≥ 15% but < 30% in blood or bone marrow, blasts plus promyelocytes ≥ 30% in blood or bone marrow (providing < 30% blasts), peripheral blood basophils ≥ 20%, platelets < 100 x 109/l unrelated to therapy.
- Når tabletten/tabletterne er opløst, skal opløsningen drikkes med det samme. 
• Once the tablet has dissolved, drink everything in the glass straight away.
Imatinib Accord 100 mg filmovertrukne tabletter leveres i pakker, der indeholder 20, 60, 120 eller 180 tabletter, men ikke alle pakningsstørrelser fås nødvendigvis i dit land. 
Imatinib Accord 100 mg film-coated tablets are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Det skal du vide, før du begynder at tage Imatinib Accord 
What you need to know before you take Imatinib Accord
Dosisøgning fra 340 mg/m2 daglig til 570 mg/m2 daglig (uden at overstige total dosis på 800 mg) kan overvejes hos børn og unge ved fravær af alvorlige bivirkninger og svær ikke-leukæmirelateret neutropeni eller trombocytopeni ved følgende omstændigheder: sygdomsprogression (på ethvert tidspunkt); hvis der ikke er opnået tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling; hvis der ikke er opnået cytogenetisk respons efter 12 måneders behandling; eller ved tab af tidligere opnået hæmatologisk og/eller cytogenetisk respons. 
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children and adolescents in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Forsigtighed tilrådes derfor, når Imatinib administreres sammen med CYP3A4-substrater med snævert terapeutisk interval (f.eks. ciclosporin, pimozid, tacrolimus, sirolimus, ergotamin, diergotamin, fentanyl, alfentanil, terfenadin, bortezomib, docetaxel og quinidin). 
Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Der anbefales en dosis på 340 mg/m2 daglig til børn og unge med Ph+ ALL (totaldosis på 600 mg må ikke overskrides). 
The dose of 340 mg/m2 daily is recommended for children and adolescents with Ph+ ALL (not to exceed the total dose of 600 mg).
Dosisøgninger fra 400 mg til 600 mg eller 800 mg til patienter med CML i kronisk fase, eller fra 600 mg til maksimalt 800 mg (givet som 400 mg 2 gange daglig) til patienter i accelereret fase eller i blastkrise kan, hvis der ikke opstår svære bivirkninger og svær ikke-leukæmirelateret neutropeni eller trombocytopeni, overvejes i følgende tilfælde: Sygdomsprogression (til enhver tid), udeblivende tilfredsstillende hæmatologisk respons efter mindst 3 måneders behandling, udeblivende opnåelse af cytogenetisk respons efter 12 måneders behandling, samt hvis tidligere hæmatologisk og/eller cytogenetisk respons ikke genopnås. 
Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Af en række potentielt samtidigt administrerede lægemidler (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabin, erythromycin, fluconazol, hydroxyurea, norfloxacin, phenoxymethylpenicillin) hæmmede kun erythromycin (IC50 50 µm) og fluconazol (IC50 118 µm) imatinib-metabolismen i et omfang, der kunne have klinisk betydning. 
Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance.
Ara-C 1.000 mg/m2/12 timer i.v. 
Ara-C 1,000 mg/m2/12h i.v.
Brug til voksne Din læge vil fortælle dig, præcis hvor mange Imatinib Accord-tabletter, du skal tage. 
Your doctor will tell you exactly how many tablets of Imatinib Accord to take.
Stoffet hæmmer selektivt proliferationen og inducerer apoptosis i BcrAbl-positive cellelinier såvel som i friske leukæmiceller fra Philadelphia-kromosompositiv (Ph+) CML 
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.
VCR 1,3 g/m2 i.v., dag 1; prednisolon 60 mg/m2 oral, dag 1-5 
VCR 1.3 g/ m2 i.v., day 1; Prednisolone 60 mg/m2 oral, days 1-5
Avaskulær nekrose/hoftenekrose*, væksthæmning hos børn og unge* 
Avascular necrosis/hip necrosis*, growth retardation in children and adolescents* Renal and urinary disorders
= intramuskulær, ARA-C = cytarabin, CPM = cyclophosphamid, VCR = vinkristin, DEX = dexamethason, DAUN = daunorubicin, 6-MP = 6-mercaptopurin, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2mercaptoethan-natriumsulfonat, iii= eller indtil MTX-niveauet er <0,1 µM, Gy= Gray 
G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 μM, q6h = every 6 hours, Gy= Gray
Hos børn og unge, der er i behandling med imatinib, anbefales tæt monitorering af væksten (se pkt. 
Close monitoring of growth in children and adolescents under imatinib treatment is recommended (see section 4.8).
2Cytogenetiske responskriterier: 
Cytogenetic response
ingen blaster og promyelocytter i blod, basofile < 20%, ingen ekstramedullær påvirkning Cytogenetiske responskriterier: fuldstændig (0 % Ph+ metafaser), delvis (1-35 %), mindre (36- 65 %) eller minimal (66-95 %). 
Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Hvis cytopeni ikke er leukæmirelateret, reducér Imatinib Accord-dosis til 400 mg. 3. 
If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accordto 400 mg. 3.
Hvis cytopeni ikke er leukæmirelateret, reducér Imatinib Accord-dosis til 260 mg/m2. 
If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accord to 260 mg/m2.
Ikke almindelige (kan forekomme hos op til 1 ud af 10 patienter) til sjældne (kan forekomme hos op til 1 ud af 1.000 patienter) 
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people)
(1 time), dag 1-5; VM26 60 mg/m2 i.v. 
(1 h), days 1-5; VM26 60 mg/ m2 i.v.
Akut respirationssvigt11*, interstitiel lungesygdom* 
Acute respiratory failure11*, interstitial lung disease* Gastrointestinal disorders
Der er udført et åbent multicenter fase II-klinisk forsøg (studie B2225) med inklusion af 12 patienter med DFSP, som blev behandlet med imatinib 800 mg daglig. 
One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
- Philadelphia kromosom positiv akut lymfoblast leukæmi (Ph-positiv ALL). 
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Aktive stoffer der kan øge plasmakoncentrationen af imatinib Stoffer der hæmmer cytochrom P450 isoenzym CYP3A4-aktivitet (f.eks. proteasehæmmere som f.eks. indinavir, lopinavir/ritonavir, ritonavir, saquinavir, teleprevir, nelfinavir, boceprevir; azolantimykotika inklusiv ketoconazol, itraconazol, posaconazol, voriconazol; bestemte makrolider som f.eks. erythromycin, clarithromycin og telithromycin) kan nedsætte metabolismen og øge koncentrationen af imatinib. 
Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycinand telithromycin) could decrease metabolism and increase imatinib concentrations.
Methotrexat (5 g/m2 over 24 timer, i.v. 
Methotrexate (5 g/m2 over 24 hours, IV): day 1
Der er ingen erfaring med behandling af CML hos børn under 2 år og unge. 
There is no experience in children and adolescents with CML below 2 years of age.
(24 timer), dag 1, 15; 6-MP 25 mg/m2 oral, dag 1 
(24 h), days 1, 15; 6-MP 25 mg/ m2 oral, days 1-20
Fuldstændigt (Bekræftet3) [95% CI] Delvist 1Hæmatologiske responskriterier (hvert respons skal bekræftes ≥ 4 uger): CHR: Undersøgelse 0110 [leukocytter <10 x 109/l, trombocytter < 450 x 109/l, myelocyt + metamyelocyt < 5% i blodet, ingen blaster eller promyelocytter i blodet, basophiler < 20%, ingen ekstramedullær involvering] og i undersøgelse 0102 and 0109 [ANC 1,5 x 109/l, trombocytter 100 x 109/l, ingen blaster i blodet, BM-blaster < 5 % og ingen ekstramedullær sygdom]. 
Partial Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): CHR: Study 0110 [WBC < 10 x 109/l, platelets < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
Der ses generelt ingen bedring ved indgift af Imatinib til patienter uden genetisk translokation. 
Imatinib administration to patients without the genetic translocation generally results in no improvement.
Startdosis er 100 mg, som skal tages som én tablet à 100 mg én gang daglig. 
The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Dosering ved Ph+ ALL hos børn og unge 
Posology for Ph+ ALL in children and adolescents
Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) eller almindelige (kan forekomme hos op til 1 ud af 10 patienter) 
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people)
Nydiagnostiseret Ph+ ALL: 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 55newly 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).
• Muskelkramper eller led-, muskel- eller knoglesmerter mens du er i behandling med Imatinib 
• Muscle cramps or joint, muscle or bone pain, during Imatinib Accord treatment or after you have stopped taking Imatinib Accord.
Papillomaer/carcinomer i fedtkirtlerne på forhuden/klitoris blev set fra 30 mg/kg/dag og højere, som svarer til cirka 0,5 eller 0,3 gange den daglige humane eksponering (baseret på AUC) på henholdsvis 400 mg/dag eller 800 mg/dag. 
Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children and adolescents (based on AUC) at 340 mg/m2/day.
De mest almindelige rapporterede (10%) lægemiddelrelaterede bivirkninger var i begge patientgrupper: let kvalme, opkastning, diarré, abdominalsmerter, træthed, myalgi og muskelkramper samt udslæt. 
The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Denne hæmning er ikke observeret in vivo efter administrationen af 400 mg Imatinib og 1 g paracetamol. 
Thisinhibition has not been observed in vivoafter the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Der var i samme publikation oplysning om længere varende opfølgningsdata fra 12 MDS/MPD-patienter med PDGFR-omlejring (5 patienter fra studie B2225). 
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR
Der er ingen kontrollerede undersøgelser, undtagen hos nyligt diagnosticerede kronisk fase CML-patienter, der har vist klinisk bedring såsom forbedring af sygdomsrelaterede symptomer eller øget overlevelse. 
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) 
Very common (may affect more than 1 in 10 people)
Der er klinisk erfaring med administration af Imatinib sammen med kemoterapi til patienter med Ph+ ALL, men specifikke interaktionsstudier mellem imatinib og kemoterapiregimer er ikke tilstrækkeligt karakteriseret. 
In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
Den høje rate af CHR er ledsaget af udvikling af komplet cytogenetisk respons (CCyR) 
The high rate of CHR is accompanied by the development of a completecytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Silica, kolloid vandfri Magnesiumstearat 
Silica colloidal, anhydrous Magnesium stearate
INFORMATION I BRAILLESKRIFT Imatinib Accord 100 mg 
INFORMATION IN BRAILLE Imatinib Accord 100 mg
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Imatinib Accord-behandling indtil ANC 1,0 x 109/l og trombocytter 20 x 109/l og genoptag herefter behandlingen med 300 mg. 
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1 x 109/1 and platelets ≥ 20 x 109/1, then resume treatment at 300 mg.
Imatinib monoterapi med 600 mg/dag er sikker og effektiv hos voksne patienter med recidiverende eller refraktiv Ph+ALL, og kan gives indtil der sker sygdomsprogression. 
For adult patients with relapsed or refractory Ph+ALL Imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Stop Imatinib Accord indtil ANC 1,5 x 109/l og trombocytter 75 x 109/l. 
Stop Imatinib Accord until ANC ≥ 1.5x109/l and platelets ≥ 75x109/l.
Undersøgelse 0110 37 måneders data Kronisk fase, IFNsvigt (n=532) 
Table 3 Response in adult CML studies Study 0110 37-month data Chronic phase, IFN failure (n=532)
• Kronisk nyresvigt. 
• Chronic renal failure
Medianvarigheden af førstevalgsbehandling var henholdsvis 82 og 8 måneder i Imatinibog INF-armene syv år efter, at den sidste patient var rekrutteret. 
Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the Imatinib and IFN arms, respectively.
Den anbefalede dosis af Imatinib er 600 mg/dag til voksne patienter med Ph+ ALL. 
The recommended dose of Imatinib is 600 mg/day for adults patients with Ph+ ALL.
Hvis du har glemt at tage Imatinib Accord - Hvis du glemmer at tage en dosis, så tag den, så snart du kommer i tanker om det. 
- If you forget a dose, take it as soon as you remember.
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. 
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.
Recidiverendet/refraktær Ph+ ALL: 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%.
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Imatinib Accord-behandlingen indtil ANC 1,0 x 109l og trombocytter 20 x 109l og genoptag behandling med 200 mg/m2. 
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1x109/1 and platelets ≥ 20x109/1, then resume treatment at 200 mg/m2.
INFORMATION I BRAILLESKRIFT Imatinib Accord 400 mg 
INFORMATION IN BRAILLE Imatinib Accord 400 mg
(3 timer), dag 1-4; mitoxantron 10 mg/m2 i.v. 
(3h), days1-4; Mitoxantrone 10 mg/m2 i.v.
Palmoplantar erytrodysæstesi syndrom*, lichenoid keratosis*, lichen planus*, toksisk epidermal nekrolyse*, medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS)*, pseudoporfyri* Knogler, led, muskler og bindevæv 
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Derudover er der efter markedsføring rapporteret gastric antral vascular ecstasia (GAVE), en sjælden form for gastrointestinal blødning, hos patienter med CML, ALL og andre sygdomme (se pkt. 
In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).When needed,discontinuation of Imatinib treatment may be considered.
Tabel 3 Respons hos voksne CML-patienter 
Posology for CML in adult patients
(24 timer), dag 1, Ara-C 1 g/m2 i.v. 
(24 h), day 1, Ara-C 1 g/ m2 i.v.
(24 timer), dag 1, og Ara-C 2 g/m2 i.v. 
(24 h), day 1, and Ara-C 2 g/ m2 i.v.
Vedligeholdelse (8-ugers cykler) Cyklus 1-4 
Maintenance (8-week cycles) Cycles 1cy
Imatinib Accord kan føre til, at din krop kan begynde at ophobe væske 
Imatinib Accord may cause your body to retain water (severe fluid retention).
(24 timer), dag 4; DEX 40 mg/dag på dag 1-4 og 11-14, supplerende med MTX 1 g/m2 i.v. 
DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/ m2 i.v.
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). 
of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 100 mg imatinib (som mesilat). 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate).
C. ANDRE FORHOLD OG BETINGELSER FOR 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
• PVC/PVdC/alu-blister: Må ikke opbevares ved temperaturer over 30°C. 
• For PVC/PVdC/Alu blisters Do not store above 30C.
Den anbefalede dosis af Imatinib er 600 mg/dag til voksne patienter i accelereret fase. 
The recommended dosage of Imatinib Accord is 600 mg/day for adult patients in accelerated phase.
Den anbefalede dosis af Imatinib er 600 mg/dag til voksne patienter i blastkrise. 
The recommended dose of Imatinib is 600 mg/day for adult patients in blast crisis.
(1 time) dag 1; Ara-C 60 mg/m2 i.v., dag 22-25, 29-32 
Ara-C 60 mg/ m2 i.v., days 22-25, 29-32