FrancophonIA/ELRC3.0 huggingface dataset:
English: Musculoskeletal and connective tissue disorders Very common Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia,
Danish: Meget almindelig Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi9, artralgi, knoglesmerter10
English: There is no experience in children with CML below 2 years of age and with Ph+ ALL below 1 year of age (see section 5.1).
Danish: 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.
English: 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.
Danish: 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.
English: • Once the tablet has dissolved, drink everything in the glass straight away.
Danish: - Når tabletten/tabletterne er opløst, skal opløsningen drikkes med det samme.
English: 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.
Danish: 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.
English: What you need to know before you take Imatinib Accord
Danish: Det skal du vide, før du begynder at tage Imatinib Accord
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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).
Danish: Der anbefales en dosis på 340 mg/m2 daglig til børn og unge med Ph+ ALL (totaldosis på 600 mg må ikke overskrides).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Ara-C 1,000 mg/m2/12h i.v.
Danish: Ara-C 1.000 mg/m2/12 timer i.v.
English: Your doctor will tell you exactly how many tablets of Imatinib Accord to take.
Danish: Brug til voksne Din læge vil fortælle dig, præcis hvor mange Imatinib Accord-tabletter, du skal tage.
English: 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.
Danish: Stoffet hæmmer selektivt proliferationen og inducerer apoptosis i BcrAbl-positive cellelinier såvel som i friske leukæmiceller fra Philadelphia-kromosompositiv (Ph+) CML
English: VCR 1.3 g/ m2 i.v., day 1; Prednisolone 60 mg/m2 oral, days 1-5
Danish: VCR 1,3 g/m2 i.v., dag 1; prednisolon 60 mg/m2 oral, dag 1-5
English: Avascular necrosis/hip necrosis*, growth retardation in children and adolescents* Renal and urinary disorders
Danish: Avaskulær nekrose/hoftenekrose*, væksthæmning hos børn og unge*
English: 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
Danish: = 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
English: Close monitoring of growth in children and adolescents under imatinib treatment is recommended (see section 4.8).
Danish: Hos børn og unge, der er i behandling med imatinib, anbefales tæt monitorering af væksten (se pkt.
English: Cytogenetic response
Danish: 2Cytogenetiske responskriterier:
English: Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Danish: 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 %).
English: If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accordto 400 mg. 3.
Danish: Hvis cytopeni ikke er leukæmirelateret, reducér Imatinib Accord-dosis til 400 mg. 3.
English: If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accord to 260 mg/m2.
Danish: Hvis cytopeni ikke er leukæmirelateret, reducér Imatinib Accord-dosis til 260 mg/m2.
English: Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people)
Danish: 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)
English: (1 h), days 1-5; VM26 60 mg/ m2 i.v.
Danish: (1 time), dag 1-5; VM26 60 mg/m2 i.v.
English: Acute respiratory failure11*, interstitial lung disease* Gastrointestinal disorders
Danish: Akut respirationssvigt11*, interstitiel lungesygdom*
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Danish: 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.
English: Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Danish: - Philadelphia kromosom positiv akut lymfoblast leukæmi (Ph-positiv ALL).
English: 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.
Danish: 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.
English: Methotrexate (5 g/m2 over 24 hours, IV): day 1
Danish: Methotrexat (5 g/m2 over 24 timer, i.v.
English: There is no experience in children and adolescents with CML below 2 years of age.
Danish: Der er ingen erfaring med behandling af CML hos børn under 2 år og unge.
English: (24 h), days 1, 15; 6-MP 25 mg/ m2 oral, days 1-20
Danish: (24 timer), dag 1, 15; 6-MP 25 mg/m2 oral, dag 1
English: 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).
Danish: 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].
English: Imatinib administration to patients without the genetic translocation generally results in no improvement.
Danish: Der ses generelt ingen bedring ved indgift af Imatinib til patienter uden genetisk translokation.
English: The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Danish: Startdosis er 100 mg, som skal tages som én tablet à 100 mg én gang daglig.
English: Posology for Ph+ ALL in children and adolescents
Danish: Dosering ved Ph+ ALL hos børn og unge
English: Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people)
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter) eller almindelige (kan forekomme hos op til 1 ud af 10 patienter)
English: 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).
Danish: 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).
English: • Muscle cramps or joint, muscle or bone pain, during Imatinib Accord treatment or after you have stopped taking Imatinib Accord.
Danish: • Muskelkramper eller led-, muskel- eller knoglesmerter mens du er i behandling med Imatinib
English: 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.
Danish: 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.
English: 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.
Danish: De mest almindelige rapporterede (10%) lægemiddelrelaterede bivirkninger var i begge patientgrupper: let kvalme, opkastning, diarré, abdominalsmerter, træthed, myalgi og muskelkramper samt udslæt.
English: 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.
Danish: Denne hæmning er ikke observeret in vivo efter administrationen af 400 mg Imatinib og 1 g paracetamol.
English: The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR
Danish: Der var i samme publikation oplysning om længere varende opfølgningsdata fra 12 MDS/MPD-patienter med PDGFR-omlejring (5 patienter fra studie B2225).
English: 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.
Danish: 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.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter)
English: 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.
Danish: 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.
English: 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.
Danish: Den høje rate af CHR er ledsaget af udvikling af komplet cytogenetisk respons (CCyR)
English: Silica colloidal, anhydrous Magnesium stearate
Danish: Silica, kolloid vandfri Magnesiumstearat
English: INFORMATION IN BRAILLE Imatinib Accord 100 mg
Danish: INFORMATION I BRAILLESKRIFT Imatinib Accord 100 mg
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Stop Imatinib Accord until ANC ≥ 1.5x109/l and platelets ≥ 75x109/l.
Danish: Stop Imatinib Accord indtil ANC 1,5 x 109/l og trombocytter 75 x 109/l.
English: IFN+Ara-C n=553
Danish: IFN+Ara-C
English: Table 3 Response in adult CML studies Study 0110 37-month data Chronic phase, IFN failure (n=532)
Danish: Undersøgelse 0110 37 måneders data Kronisk fase, IFNsvigt (n=532)
English: • Chronic renal failure
Danish: • Kronisk nyresvigt.
English: 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.
Danish: Medianvarigheden af førstevalgsbehandling var henholdsvis 82 og 8 måneder i Imatinibog INF-armene syv år efter, at den sidste patient var rekrutteret.
English: The recommended dose of Imatinib is 600 mg/day for adults patients with Ph+ ALL.
Danish: Den anbefalede dosis af Imatinib er 600 mg/dag til voksne patienter med Ph+ ALL.
English: - If you forget a dose, take it as soon as you remember.
Danish: 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.
English: 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.
Danish: 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.
English: 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%.
Danish: 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%.
English: 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.
Danish: 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.
English: INFORMATION IN BRAILLE Imatinib Accord 400 mg
Danish: INFORMATION I BRAILLESKRIFT Imatinib Accord 400 mg
English: (3h), days1-4; Mitoxantrone 10 mg/m2 i.v.
Danish: (3 timer), dag 1-4; mitoxantron 10 mg/m2 i.v.
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Danish: Palmoplantar erytrodysæstesi syndrom*, lichenoid keratosis*, lichen planus*, toksisk epidermal nekrolyse*, medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS)*, pseudoporfyri* Knogler, led, muskler og bindevæv
English: 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.
Danish: 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.
English: Posology for CML in adult patients
Danish: Tabel 3 Respons hos voksne CML-patienter
English: (24 h), day 1, Ara-C 1 g/ m2 i.v.
Danish: (24 timer), dag 1, Ara-C 1 g/m2 i.v.
English: (24 h), day 1, and Ara-C 2 g/ m2 i.v.
Danish: (24 timer), dag 1, og Ara-C 2 g/m2 i.v.
English: Maintenance (8-week cycles) Cycles 1cy
Danish: Vedligeholdelse (8-ugers cykler) Cyklus 1-4
English: Imatinib Accord may cause your body to retain water (severe fluid retention).
Danish: Imatinib Accord kan føre til, at din krop kan begynde at ophobe væske
English: DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/ m2 i.v.
Danish: (24 timer), dag 4; DEX 40 mg/dag på dag 1-4 og 11-14, supplerende med MTX 1 g/m2 i.v.
English: of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
Danish: 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).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 100 mg imatinib (som mesilat).
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR
English: • For PVC/PVdC/Alu blisters Do not store above 30C.
Danish: • PVC/PVdC/alu-blister: Må ikke opbevares ved temperaturer over 30°C.
English: The recommended dosage of Imatinib Accord is 600 mg/day for adult patients in accelerated phase.
Danish: Den anbefalede dosis af Imatinib er 600 mg/dag til voksne patienter i accelereret fase.
English: The recommended dose of Imatinib is 600 mg/day for adult patients in blast crisis.
Danish: Den anbefalede dosis af Imatinib er 600 mg/dag til voksne patienter i blastkrise.
English: Ara-C 60 mg/ m2 i.v., days 22-25, 29-32
Danish: (1 time) dag 1; Ara-C 60 mg/m2 i.v., dag 22-25, 29-32
English: DEX 10 mg/ m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3-5; MTX 15mg intrathecal, day 1
Danish: DEX 10 mg/m2 oral, dag 1-5; CP 200 mg/m2 i.v., dag 3-5; MTX 15 mg intrathecal, dag 1
English: In newly diagnosed chronic phase CML grade 4neutropenia (ANC < 0.5x109/1) and thrombocytopenia (platelet count < 10x109/1) were observed in 3.6% and < 1% of patients, respectively.
Danish: Der sås 4. grads neutropeni (ANC <0,5 x 109/l) og trombopeni (trombocyttal <10 x 109/l) hos henholdsvis 3,6% og 1% af patienterne med nydiagnosticeret CML i kronisk fase.
English: Haemorrhagic corpus luteum/haemorrhagic ovarian cyst General disorders and administrative site conditions Very common Fluid retention and oedema, fatigue Common
Danish: Hæmoragisk corpus luteum/ hæmoragisk ovariecyste Almene symptomer og reaktioner på administrationsstedet Meget almindelig Væskeretention og ødem, træthed Almindelig
English: - Take Imatinib Accord with a meal.
Danish: Hvornår og hvordan skal du tage Imatinib Accord - Tag Imatinib Accord sammen med et måltid.
English: Vitreous haemorrhage* Ear and labyrinth disorders Uncommon
Danish: Øre og labyrint Ikke almindelig