natgillin/translations-raw huggingface dataset:
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).
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).
(24 timer), dag 1, 15;
(24 h), days 1, 15;
Studie AJP01 Induktionsbehandling CP 1,2 g/m i.v.
Study AJP01 Induction therapy CP 1.2 g/m i.v.
Dosering ved GIST
Posology for GIST
De findes i pakninger med 24, 48, 96, 120 eller 180 kapsler, men ikke alle pakningsstørrelser er nødvendigvis tilgængelige i dit land.
They are supplied in packs containing 24, 48, 96, 120 or 180 capsules, but these may not all be available in your country.
Sådan skal du tage Glivec
How to take Glivec
(1 time) dag 1; Ara-C 60 mg/m i.v., dag 22-25, 29-32
(1 h) day 1; Ara-C 60 mg/m i.v., days 22-25, 29-32
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).
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.
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.
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.
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.
Der er kun begrænset erfaring med Glivec hos patienter med MDS/MPD forbundet med PDGFRomlejring (se pkt 5.1).
The experience with Glivec in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Ved andre doser end 400 mg og 800 mg (se anbefalede doser nedenfor) er en 100 mg tablet med delekærv tilgængelig.
For doses other than 400 mg and 800 mg (see dosage recommendation below) a 100 mg divisible tablet is available.
IDA 9 mg/m oral, dag 1-28;
IDA 9 mg/m oral, days 1-28;
8, levernekrose
8, hepatic necrosis
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
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
Undersøgelse 0110 37 måneders data Kronisk fase, IFNsvigt (n=532)
Study 0110 37-month data Chronic phase, IFN failure (n=532)
(1 time), dag 26, 46; Ara-C 75 mg/m i.v.
(1 h), days 26, 46; Ara-C 75 mg/m i.v.
Glivec kan øge plasmakoncentrationen af andre CYP3A4metaboliserede lægemidler (for eksempel triazol-benzodiazepiner, dihydropyridincalciumantagonister, visse HMG-CoA reduktasehæmmere, såsom statiner osv.).
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.).
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).
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).
Kvalme, diarré, opkast, dyspepsi, abdominalsmerter
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
(24 timer), dag 1, 15; 6-MP 25 mg/m2 oral, dag 1-20
(24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
Daunorubicin 30 mg/m i.v., dag 1-3, 15-16;
Daunorubicin 30 mg/m i.v., days 1-3, 15-16;
20 filmovertrukne tabletter 60 filmovertrukne tabletter 120 filmovertrukne tabletter 180 filmovertrukne tabletter
20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets
Major respons ved 84 måneder (%) * p<0,001, Fischers exact test ** Procentvise molekylære respons er baseret på tilgængelige prøver.
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
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).
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).
340 mg/m daglig til børn med CML i kronisk fase og i fremskredne faser (må ikke overskride en total dosering på 800 mg).
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).
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Glivecbehandling indtil ANC 1,0 x 10
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC  1 x 10
= 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
Vinkristin 2 mg i.v., dag 4, 11; Doxorubicin 50 mg/m i.v.
Vincristine 2 mg i.v., days 4, 11; Doxorubicine 50 mg/m i.v.
Der anbefales en dosis på 340 mg/m daglig til børn med Ph+ ALL (totaldosis på 600 mg må ikke overskrides).
The dose of 340 mg/m daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
6-MP 25 mg/m oral, dag 1-20
6-MP 25 mg/m oral, days 1-20
Brug af anden medicin sammen med Glivec
Other medicines and Glivec
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
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.
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):
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
CML i kronisk fase, MDS/MPD og GIST (startdosis 400 mg)
Chronic phase CML, MDS/MPD and GIST (starting dose 400 mg) HES/CEL (at dose 400 mg)
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 (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common:
Hvis du behandles for DSFP:
If you are being treated for DFSP:
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.
Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with Glivec (see section 4.5).
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
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
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).
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).
6 doser)iii: dag 2, 3, 16, og 17
days 2, 3, 16, and 17
Pakninger indeholdende 10, 30 eller 90 filmovertrukne tabletter.
Packs containing 10, 30 or 90 film-coated tablets
Disse patienter fik Glivec i en periode varierende mellem 24 dage og 60 måneder (median 47 måneder).
These patients received Glivec for a median of 47 months (range 24 days - 60 months).
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.
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).
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).
(3 timer), dag 1-4; Mitoxantron 10 mg/m i.v.
(3 h), days 1-4; Mitoxantrone 10 mg/m i.v.
Hæmolytisk anæmi, trombotisk mikroangiopati Metabolisme og ernæring Almindelig:
Haemolytic anaemia, thrombotic microangiopathy Metabolism and nutrition disorders Common:
Dosering ved Ph+ ALL hos børn Dosering hos børn bør baseres på legemsoverflade (mg/m2).
Posology for Ph+ ALL in children Dosing for children should be on the basis of body surface area (mg/m2).
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.
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.
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
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
Farmakokinetik hos GIST-patienter
Pharmacokinetics in GIST patients
Delvist Hæmatologiske responskriterier (hvert respons skal bekræftes ≥4 uger): CHR: Undersøgelse 0110 [leukocytter <10 x 10
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
Behandlingsvarighed: I kliniske undersøgelser med GIST-patienter, blev behandling med Glivec fortsat indtil sygdomsprogression.
Treatment duration: In clinical trials in GIST patients, treatment with Glivec was continued until disease progression.
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.
One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with Glivec 800 mg daily.
340 mg/m 2/dag (n=9), 440 mg/m 2/dag (n=7) og 570 mg/m 2/dag (n=5).
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).
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.
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
9/l, trombocytter <450 x 10
9/l, platelet < 450 x 10
Kliniske undersøgelser vedrørende kronisk myeloid leukæmi Glivecs effekt er baseret på generelle hæmatologiske og cytogene responsrater og progressionsfri overlevelse.
The effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival.
Børn med CML i accelereret fase og blastkrise (startdosis 340 mg/m
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
Børn med CML i kronisk fase (ved en dosis på 340 mg/m2)
Paediatric chronic phase CML (at dose 340 mg/m
Den anbefalede dosis af Glivec er 400 mg/dag for adjuverende behandling af voksne efter resektion af GIST.
The recommended dose of Glivec is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST.
(3 timer), dag 1; Daunorubicin 60 mg/m i.v.
(3 h), day 1; Daunorubicin 60 mg/m i.v.
Målorganerne for neoplastiske ændringer var nyrerne, urinblæren, urinrøret, fedtkirtlerne på forhuden og klitoris, tyndtarmen, biskjoldbruskkirtlerne, binyrererne og den ikke-kirtellignende del af maven.
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
9/l uafhængigt af behandlingen.
9/l unrelated to therapy.
• Muskelkramper eller led-, muskel- eller knoglesmerter mens du er i behandling med Glivec,
• Muscle cramps or joint, muscle or bone pain, during Glivec treatment or after you have stopped taking Glivec.
(1 time) dag 4-5;
(1 h) days 4-5;
Pakninger indeholdende 20, 60, 120 eller 180 filmovertrukne tabletter.
Packs containing 20, 60, 120 or 180 film-coated tablets
(2) Imatinib 36 mdr.
(2) Imatinib 36 MO: │││ Censored observations
Den anbefalede dosis af Glivec er 400 mg/dag til voksne patienter med inoperable og/eller metastaserende maligne GIST.
The recommended dose of Glivec is 400 mg/day for adult patients with unresectable and/or metastatic malignant GIST.
Behandlingsvarighed: I det eneste kliniske studie, der er udført indtil nu, fortsattes behandlingen med Glivec indtil sygdomsprogression (se pkt.
Treatment duration: In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1).
Behandlingsvarighed: I kliniske undersøgelser fortsattes behandling med Glivec indtil sygdomsprogression.
Treatment duration: In clinical trials, treatment with Glivec was continued until disease progression.
Medianvarigheden af førstevalgsbehandling var henholdsvis 82 og 8 måneder i Glivec- og INFarmene 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 Glivec and IFN arms, respectively.
Der er klinisk erfaring med administration af Glivec 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 Glivec with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
3, lungeødem
3, pulmonary oedema
Du skal straks fortælle din læge, hvis du meget hurtigt tager på i vægt, mens du er i behandling med Glivec.
During treatment with Glivec, tell your doctor straight away if you put on weight very quickly.
Jernoxid, rød (E 172) Shellac
Iron oxide, red (E172) Shellac
Dosering ved MDS/MPD Den anbefalede dosis af Glivec er 400 mg/dag til voksne patienter med MDS/MPD.
Posology for MDS/MPD The recommended dose of Glivec is 400 mg/day for adult patients with MDS/MPD.
Den anbefalede dosis af Glivec er 600 mg/dag til voksne patienter med Ph+ ALL.
The recommended dose of Glivec is 600 mg/day for adult patients with Ph+ ALL.
DEX (6 mg/m2/dag, p.o.): dag 1-5; 29-33 6-MP (75 mg/m2/dag, p.o.): dag 11-56 (tilbagehold 6-MP i de 6-10 dage med kraniebestråling med start dag 1 i cyklus 5.
DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
Hvis cytopeni ikke er leukæmirelateret, reducér Glivec-dosis til 260 mg/m 3.
If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 260 mg/m 3.
Høj
High
DEX 10 mg/m oral, dag 1-5;
DEX 10 mg/m oral, days 1-5;
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%) drugrelated adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
De findes i pakninger med 20, 60, 120 eller 180 tabletter, men ikke alle pakningsstørrelser er nødvendigvis tilgængelige i dit land.
They are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Aktive stoffer, der kan øge plasmakoncentrationen af imatinib Stoffer, der hæmmer CYP3A4-aktiviteten (f.eks. proteasehæmmere som f.eks. indinavir, lopinavir/ritonavir, ritonavir, saquinavir, teleprevir, nelfinavir, boceprevir; azol-antimykotika inklusive ketoconazol, itraconazol, posaconazol, voriconazol; visse makrolider som f.eks. erythromycin, clarithromycin og telithromycin), kan nedsætte metaboliseringen 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, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
VCR 2 mg i.v., dag 6, 13, 20; Daunorubicin 45 mg/m i.v., dag 6-7, 13-14
VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14
Startdosis er 600 mg, som skal tages som én tablet af 400 mg plus 2 tabletter af 100 mg én gang daglig.
The starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
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):
(3 timer, q 12 timer), dag 1-3;
(3 h, q 12 h), days 1-3;
Glivec indeholder: - Aktivt stof: imatinibmesilat.
What Glivec contains - The active substance is imatinib mesilate.
Dosering ved CML hos børn Dosering til børn bør baseres på legemsoverfladeareal (mg/m2).
Posology for CML in children Dosing for children should be on the basis of body surface area (mg/m2).
Muskelspasmer og kramper, muskuloskeletale smerter herunder myalgi artralgi, knoglesmerter
Muscle spasm and cramps, musculoskeletal pain including myalgia arthralgia, bone pain
VCR 2 mg total dose i.v., dag 1, 8, 15, 22; CP 750 mg/m i.v., dag 1, 8; Prednison 60 mg/m oral, dag 1-7, 15-21;
VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m i.v., days 1, 8; Prednisone 60 mg/m oral, days 1-7, 15-21;
Hvis cytopeni ikke er leukæmirelateret, reducér Glivec-dosis til 400 mg. 3.
If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 400 mg. 3.
Børn: I studie I2301 blev der inkluderet i alt 93 børn, unge og yngre voksne (fra 1 til 22 år) med Ph+ ALL i et åbent, multicenter, ikke-radomiseret fase III sekventielt kohorte-forsøg.
Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, nonrandomised phase III trial, and were treated with Glivec (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Hvis du har taget for meget Glivec
If you take more Glivec than you should
Glivec 400 mg filmovertrukne tabletter PVDC/alu blister.
Glivec 400 mg film-coated tablets PVDC/alu blisters
(24 timer), dag 1; Etoposid 250 mg/m i.v.
(24 h), day 1; Etoposide 250 mg/m i.v.
- Filmovertrækket består af rød jernoxid (E 172), gul jernoxid (E 172), macrogol, talcum og hypromellose.
- The tablet coating is made of red iron oxide (E172), yellow iron oxide (E172), macrogol, talc and hypromellose.
Der er udført et åbent multicenter, klinisk fase II-studie (studie B2225) med henblik på vurdering af Glivec i en blandet patientpopulation med livstruende sygdomme forbundet med Abl, Kit eller PDGFR protein-tyrosinkinaser.
One open label, multicentre, phase II clinical trial (study B2225) was conducted testing Glivec in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
Palpitationer, takykardi, hjerteinsufficiens
Palpitations, tachycardia, cardiac failure congestive
Glivec 100 mg hårde kapsler EU/1/01/198/002-006
Glivec 100 mg hard capsules EU/1/01/198/002-006
(q 12 timer), dag 2-3, i
(q 12 h), days 2-3, for
(2 timer, q 12 timer), dag 2-3 (total af
(2 h, q 12 h), days 2-3 (total of 8 courses)
Glivec 100 mg hårde kapsler Kapselindhold: Cellulose, mikrokrystallinsk Crospovidon
Glivec 100 mg hard capsules Capsule content: Cellulose microcrystalline Crospovidone
Dosering ved HES/CEL Den anbefalede dosis af Glivec er 100 mg/dag til voksne patienter med HES/CEL.
Posology for HES/CEL The recommended dose of Glivec is 100 mg/day for adult patients with HES/CEL.
Glivec 100 mg filmovertrukne tabletter PVC/alu blister.
Glivec 100 mg film-coated tablets PVC/alu blisters
Samtidig anvendelse af imatinib og lægemidler, der inducerer CYP3A4 (f.eks. dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital eller Hypericum perforatum, også kendt som prikbladet perikum) kan signifikant reducere følsomheden over for Glivec, og dermed potientielt øge risikoen for terapeutisk svigt.
Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.