FrancophonIA/ELRC3.0 huggingface dataset:
English: 9/l, then resume treatment at 200 mg/m
Danish: 9l og genoptag behandling med 200 mg/m
English: The doctor will tell you how many tablets of Glivec to give to your child.
Danish: Lægen vil fortælle dig, hvor mange Glivec-tabletter, du skal give dit barn.
English: Table 3 Response in adult CML studies
Danish: Tabel 3 Respons hos voksne CML-patienter
English: EU/1/01/198/009 10 tablets EU/1/01/198/010 30 tablets EU/1/01/198/013 90 tablets
Danish: EU/1/01/198/009 10 tabletter EU/1/01/198/010 30 tabletter EU/1/01/198/013 90 tabletter
English: In adult and paediatric patients, the effectiveness of Glivec 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.
Danish: Glivecs 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.
English: 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 10
Danish: CLM i kronisk fase defineres ved, at alle følgende kriterier er opfyldt: blaster <15% i blod og knoglemarv, perifere blodbasofiltal <20%, trombocyttal >100 x 10
English: • 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.
Danish: • voksne og børn med nydiagnosticeret Philadelphia-kromosom (bcr-abl) positiv (Ph+) kronisk myeloid leukæmi (CML), for hvilke knoglemarvstransplantation ikke anses for førstevalgsbehandling.
English: If you are being treated for HES/CEL:
Danish: Hvis du behandles for HES/CEL:
English: • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement.
Danish: • voksne patienter med refraktært hypereosiniphil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL) med FIP1L1-PDGFR-omlejring.
English: Glivec administration to patients without the genetic translocation generally results in no improvement.
Danish: Der ses generelt ingen bedring ved indgift af Glivec til patienter uden genetisk translokation.
English: Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Danish: Glivecs farmakokinetik er evalueret i dosisintervallet: 25-1.000 mg. Plasmafarmakokinetiske profiler blev analyseret på dag 1 og på enten dag 7 eller dag 28, hvor plasmakoncentrationerne havde nået steady-state.
English: They are supplied in packs containing 10, 30 or 90 tablets, but these may not all be available in your country.
Danish: De findes i pakninger med 10, 30 eller 90 tabletter, men ikke alle pakningsstørrelser er nødvendigvis tilgængelige i dit land.
English: Treatment schedule: On the basis of the existing data, Glivec 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.
Danish: Behandlingsskema: Eksisterende data har vist, at Glivec er effektiv og sikker ved administration af 600 mg/dag i kombination med kemoterapi i induktionsfasen, i konsoliderings- og vedligeholdelsesfaser af kemoterapi (se pkt.
English: Active substances that may have their plasma concentration altered by Glivec 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: Use in adults Your doctor will tell you exactly how many capsules of Glivec to take.
Danish: Brug til voksne Din læge vil fortælle dig, præcis hvor mange Glivec-kapsler, du skal tage.
English: • the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
Danish: • behandling af voksne patienter med Kit (CD 117) positiv, inoperable og/eller metastaserende maligne gastrointestinale bindevævstumorer (GIST).
English: The doctor will tell you how many capsules of Glivec to give to your child.
Danish: Lægen vil fortælle dig, hvor mange Glivec-kapsler, du skal give dit barn.
English: Glivec may cause your body to retain water (severe fluid retention).
Danish: Glivec kan forårsage, at din krop begynder at ophobe væske (svær væskeretention).
English: Table 1 Tabulated summary of adverse reactions
Danish: Tabel 1 Opsummering af bivirkninger
English: The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Danish: Den totale daglige dosis til børn må ikke overstige 800 mg for CML-patienter og 600 mg for Ph+ALL-patienter.
English: To conduct an observational registry collecting efficacy and safety data in newly diagnosed paediatric Ph+ Acute Lymphoblastic Leukaemia (ALL) patients treated with chemotherapy + imatinib ± HSCT.
Danish: Gennemføre et observations-registerstudie med henblik på at indsamle sikkerhedsog virkningsdata hos nyligt diagnostiserede pædiatriske patienter med Ph+ akut lymfoblastær leukæmi (ALL) behandlet med kemoterapi + imatinib ± HSCT.
English: EU/1/01/198/002 24 capsules EU/1/01/198/003 48 capsules EU/1/01/198/004 96 capsules EU/1/01/198/005 120 capsules EU/1/01/198/006 180 capsules
Danish: EU/1/01/198/002 24 kapsler EU/1/01/198/003 48 kapsler EU/1/01/198/004 96 kapsler EU/1/01/198/005 120 kapsler EU/1/01/198/006 180 kapsler
English: Glivec 50 mg hard capsules Packs containing 30 capsules.
Danish: Glivec 50 mg hårde kapsler Pakninger indeholdende 30 kapsler.
English: Glivec significantly prolonged RFS, with 75% of patients being recurrence-free at 38 months in the Glivec group vs. 20 months in the placebo group (95% CIs, [30 - non-estimable]; [14 - nonestimable], respectively); (hazard ratio = 0.398 [0.259-0.610], p<0.0001).
Danish: Glivec forlængede signifikant RFS, idet 75% af patienterne var recidivfrie efter 38 måneder i Glivecgruppen 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).
English: (24 h), days 1, 15;
Danish: (24 timer), dag 1, 15;
English: Study AJP01 Induction therapy CP 1.2 g/m i.v.
Danish: Studie AJP01 Induktionsbehandling CP 1,2 g/m i.v.
English: Posology for GIST
Danish: Dosering ved GIST
English: They are supplied in packs containing 24, 48, 96, 120 or 180 capsules, but these may not all be available in your country.
Danish: De findes i pakninger med 24, 48, 96, 120 eller 180 kapsler, men ikke alle pakningsstørrelser er nødvendigvis tilgængelige i dit land.
English: How to take Glivec
Danish: Sådan skal du tage Glivec
English: (1 h) day 1; Ara-C 60 mg/m i.v., days 22-25, 29-32
Danish: (1 time) dag 1; Ara-C 60 mg/m i.v., dag 22-25, 29-32
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-kromosom-positiv (Ph CML og hos patienter med akut lymfoblastisk leukæmi (ALL).
English: The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m once daily (not exceeding 400 mg once daily) or 340 mg/m 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.
Danish: Analysen bekræftede, at imatinib-eksponeringen hos børn, som fik 260 mg/m en gang daglig (højst 400 mg en gang daglig) eller 340 mg/m 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.
English: 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.
Danish: 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.
English: The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Danish: Der er kun begrænset erfaring med Glivec hos patienter med MDS/MPD forbundet med PDGFRomlejring (se pkt 5.1).
English: For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg divisible tablet is available.
Danish: Ved andre doser end 400 mg og 800 mg (se anbefalede doser nedenfor) er en 100 mg tablet med delekærv tilgængelig.
English: IDA 9 mg/m oral, days 1-28;
Danish: IDA 9 mg/m oral, dag 1-28;
English: 8, hepatic necrosis
Danish: 8, levernekrose
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 10
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 10
English: Study 0110 37-month data Chronic phase, IFN failure (n=532)
Danish: Undersøgelse 0110 37 måneders data Kronisk fase, IFNsvigt (n=532)
English: (1 h), days 26, 46; Ara-C 75 mg/m i.v.
Danish: (1 time), dag 26, 46; Ara-C 75 mg/m i.v.
English: Glivec may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
Danish: Glivec kan øge plasmakoncentrationen af andre CYP3A4metaboliserede lægemidler (for eksempel triazol-benzodiazepiner, dihydropyridincalciumantagonister, visse HMG-CoA reduktasehæmmere, såsom statiner osv.).
English: The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the Glivec arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Danish: Den estimerede frekvens af patienter fri for progressions til fremskreden fase eller blastkrise efter 84 måneder var signifikant højere i Glivec-armen end i IFN-armen (92,5% vs. 85,1%, p<0,001).
English: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
Danish: Kvalme, diarré, opkast, dyspepsi, abdominalsmerter
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 1-20
English: Daunorubicin 30 mg/m i.v., days 1-3, 15-16;
Danish: Daunorubicin 30 mg/m i.v., dag 1-3, 15-16;
English: 20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets
Danish: 20 filmovertrukne tabletter 60 filmovertrukne tabletter 120 filmovertrukne tabletter 180 filmovertrukne tabletter
English: Major response at 84 months (%) * p<0.001, Fischer's exact test ** molecular response percentages are based on available samples Haematological response criteria (all responses to be confirmed after  4 weeks): WBC < 10 x 10
Danish: Major respons ved 84 måneder (%) * p<0,001, Fischers exact test ** Procentvise molekylære respons er baseret på tilgængelige prøver.
English: In addition, thirty-six (36) months of Glivec treatment significantly prolonged overall survival (OS) compared to 12 months of Glivec treatment (HR = 0.45 [0.22, 0.89], p=0.0187) (Table 8, Figure 2).
Danish: Derudover forlængede 36 måneders Glivec-behandling signifikant den totale overlevelse (OS) sammenlignet med 12 måneders Glivec-behandling (HR = 0,45 [0,22-0,89], p = 0,0187) (Tabel 8, Figur 2).
English: The dose of 340 mg/m daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Danish: 340 mg/m daglig til børn med CML i kronisk fase og i fremskredne faser (må ikke overskride en total dosering på 800 mg).
English: If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC  1 x 10
Danish: Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Glivecbehandling indtil ANC 1,0 x 10
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: Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m i.v.
Danish: Vinkristin 2 mg i.v., dag 4, 11; Doxorubicin 50 mg/m i.v.
English: The dose of 340 mg/m daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Danish: Der anbefales en dosis på 340 mg/m daglig til børn med Ph+ ALL (totaldosis på 600 mg må ikke overskrides).
English: 6-MP 25 mg/m oral, days 1-20
Danish: 6-MP 25 mg/m oral, dag 1-20
English: Other medicines and Glivec
Danish: Brug af anden medicin sammen med Glivec
English: In the juvenile toxicology study, effects upon growth, delay in vaginal opening and preputial separation were observed at approximately 0.3 to 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
Danish: I det juvenile toksikologistudie blev der set effekt på vækst samt forsinket vaginalåbning og præputial separation ved ca. 0,3 til 2 gange den gennemsnitlige pædiatriske eksponering ved den højst anbefalede dosis på 340 mg/m Derudover blev der set mortalitet hos juvenile dyr (omkring fravænningsfase) ved ca. 2 gange den gennemsnitlige pædiatriske eksponering ved den højst anbefalede dosis på 340 mg/m
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 100 patienter) til sjældne (kan forekomme hos op til 1 ud af 1.000 patienter):
English: Chronic phase CML, MDS/MPD and GIST (starting dose 400 mg) HES/CEL (at dose 400 mg)
Danish: CML i kronisk fase, MDS/MPD og GIST (startdosis 400 mg)
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common:
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: If you are being treated for DFSP:
Danish: Hvis du behandles for DSFP:
English: Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with Glivec (see section 4.5).
Danish: Kliniske tilfælde af hypotyroidisme er rapporteret hos patienter, der har fået foretaget tyroidektomi, og som er i levothyroxin-erstatningsterapi samtidig med Glivec-behandling (se pkt.
English: 29.7 16/84 vs. 39/81 0.27 (0.15; 0.48) 98.7 vs. 56.1 79.9 vs. 41.5 * Full follow-up period; NE - Not estimable
Danish: 29,7 16/84 vs. 39/81 0,27 (0,15; 0,48) 98,7 vs. 56,1 79,9 vs. 41,5 * Fuldstændig opfølgningsperiode; IE - Ikke estimerbar
English: Therefore, caution is recommended when administering Glivec with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Danish: Forsigtighed tilrådes derfor, når Glivec administreres sammen med CYP3A4-substrater med snævert terapeutisk interval (f.eks. ciclosporin, pimozid, tacrolimus, sirolimus, ergotamin, dihydroergotamin, fentanyl, alfentanil, terfenadin, bortezomib, docetaxel og quinidin).
English: days 2, 3, 16, and 17
Danish: 6 doser)iii: dag 2, 3, 16, og 17
English: Packs containing 10, 30 or 90 film-coated tablets
Danish: Pakninger indeholdende 10, 30 eller 90 filmovertrukne tabletter.
English: These patients received Glivec for a median of 47 months (range 24 days - 60 months).
Danish: Disse patienter fik Glivec i en periode varierende mellem 24 dage og 60 måneder (median 47 måneder).
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: Thirty-six (36) months of Glivec treatment significantly prolonged RFS compared to 12 months of Glivec treatment (with overall Hazard Ratio (HR) = 0.46 [0.32, 0.65], p<0.0001) (Table 8, Figure 1).
Danish: Glivec-behandling i 36 måneder forlængede signifikant RFS sammenlignet med 12 måneders Glivecbehandling (samlet hazard ratio (HR) = 0,46 [0,32-0,65], p<0,0001) (Tabel 8, Figur 1).
English: (3 h), days 1-4; Mitoxantrone 10 mg/m i.v.
Danish: (3 timer), dag 1-4; Mitoxantron 10 mg/m i.v.
English: Haemolytic anaemia, thrombotic microangiopathy Metabolism and nutrition disorders Common:
Danish: Hæmolytisk anæmi, trombotisk mikroangiopati Metabolisme og ernæring Almindelig:
English: Posology for Ph+ ALL in children Dosing for children should be on the basis of body surface area (mg/m2).
Danish: Dosering ved Ph+ ALL hos børn Dosering hos børn bør baseres på legemsoverflade (mg/m2).
English: For adult patients with relapsed or refractory Ph+ALL Glivec monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Danish: Glivec 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: MTX 15 mg intrathecal, days 1, 8, 15, 22; Ara-C 40 mg intrathecal, days 1, 8, 15, 22; Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Danish: MTX 15 mg intrathecal, dag 1, 8, 15, 22; Ara-C 40 mg intrathecal, dag 1, 8, 15, 22; Methylprednisolon 40 mg intrathecal, dag 1, 8, 15, 22
English: Pharmacokinetics in GIST patients
Danish: Farmakokinetik hos GIST-patienter
English: Partial 1 Haematological response criteria (all responses to be confirmed after  4 weeks): CHR: Study 0110 [WBC < 10 x 10 9/l, platelets < 450 x 10
Danish: Delvist Hæmatologiske responskriterier (hvert respons skal bekræftes ≥4 uger): CHR: Undersøgelse 0110 [leukocytter <10 x 10
English: Treatment duration: In clinical trials in GIST patients, treatment with Glivec was continued until disease progression.
Danish: Behandlingsvarighed: I kliniske undersøgelser med GIST-patienter, blev behandling med Glivec fortsat indtil sygdomsprogression.
English: One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with Glivec 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 Glivec 800 mg daglig.
English: Patients were treated at doses of Glivec of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Danish: 340 mg/m 2/dag (n=9), 440 mg/m 2/dag (n=7) og 570 mg/m 2/dag (n=5).
English: In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m 2/day subcutaneously in combination with subcutaneous Ara-C
Danish: I IFN-armen blev patienterne behandlet med en måldosis IFN på 5 MIE/m2/dag subkutant i kombination med subkutant Ara-C 20 mg/m 2/dag i 10 dage/måned.
English: 9/l, platelet < 450 x 10
Danish: 9/l, trombocytter <450 x 10
English: The effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival.
Danish: Kliniske undersøgelser vedrørende kronisk myeloid leukæmi Glivecs effekt er baseret på generelle hæmatologiske og cytogene responsrater og progressionsfri overlevelse.
English: Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Danish: Børn med CML i accelereret fase og blastkrise (startdosis 340 mg/m
English: Paediatric chronic phase CML (at dose 340 mg/m
Danish: Børn med CML i kronisk fase (ved en dosis på 340 mg/m2)
English: The recommended dose of Glivec is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST.
Danish: Den anbefalede dosis af Glivec er 400 mg/dag for adjuverende behandling af voksne efter resektion af GIST.
English: (3 h), day 1; Daunorubicin 60 mg/m i.v.
Danish: (3 timer), dag 1; Daunorubicin 60 mg/m i.v.
English: Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Danish: Målorganerne for neoplastiske ændringer var nyrerne, urinblæren, urinrøret, fedtkirtlerne på forhuden og klitoris, tyndtarmen, biskjoldbruskkirtlerne, binyrererne og den ikke-kirtellignende del af maven.
English: 9/l unrelated to therapy.
Danish: 9/l uafhængigt af behandlingen.
English: • Muscle cramps or joint, muscle or bone pain, during Glivec treatment or after you have stopped taking Glivec.
Danish: • Muskelkramper eller led-, muskel- eller knoglesmerter mens du er i behandling med Glivec,
English: (1 h) days 4-5;
Danish: (1 time) dag 4-5;
English: Packs containing 20, 60, 120 or 180 film-coated tablets
Danish: Pakninger indeholdende 20, 60, 120 eller 180 filmovertrukne tabletter.
English: (2) Imatinib 36 MO: │││ Censored observations
Danish: (2) Imatinib 36 mdr.
English: The recommended dose of Glivec is 400 mg/day for adult patients with unresectable and/or metastatic malignant GIST.
Danish: Den anbefalede dosis af Glivec er 400 mg/dag til voksne patienter med inoperable og/eller metastaserende maligne GIST.
English: Treatment duration: In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1).
Danish: Behandlingsvarighed: I det eneste kliniske studie, der er udført indtil nu, fortsattes behandlingen med Glivec indtil sygdomsprogression (se pkt.
English: Treatment duration: In clinical trials, treatment with Glivec was continued until disease progression.
Danish: Behandlingsvarighed: I kliniske undersøgelser fortsattes behandling med Glivec indtil sygdomsprogression.