natgillin/translations-raw huggingface dataset:
Udskilning af fri imatinib er sandsynligvis sammenlignelig for nedsat nyrefunktion og normal nyrefunktion, eftersom udskillelse via nyren kun udgør en mindre elimineringsvej for imatinib (se pkt.
The free drug clearance of imatinib is probably similar between renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
I dette studie blev 14 patienter med HES/CEL behandlet med 100 mg1.000 mg imatinib daglig.
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
CLM i kronisk fase defineres ved, at alle følgende kriterier er opfyldt: blaster <15 % i blod og knoglemarv, perifere blodbasofiltal <20%, trombocyttal > 100 x 109 /l.
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 109/l.
Doser på 260 og 340 mg/m2/dag til børn og unge gav samme optagelse som doser på henholdsvis 400 mg og 600 mg til voksne.
Dosing in children and adolescents at 260 and 340 mg/m2/day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
- Hypereosinofil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL).
Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
• voksne og børn med nydiagnosticeret Philadelphiakromosom (bcr-abl) positiv (Ph+) kronisk myeloid leukæmi (CML), for hvilke knoglemarvstransplantation ikke anses for førstevalgsbehandling.
• 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.
Incidensen af cytopeni hang imidlertid også tydeligt sammen med sygdomsstadiet, idet hyppighed af 3. eller 4. grads neutropeni (ANC <1,0 x 109/l) og trombocytopeni (trombocyttal <50 x 109/l) var 4-6 gange højere ved blastkrise og accelereret fase (59-64% og 44-63% for henholdsvis neutropeni og trombopeni) end ved sammenligning med nydiagnosticerede patienter med kronisk fase CML (16,7% neutropeni og 8,9% trombocytopeni).
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0x109/1) and thrombocytopenias (platelet count < 50x109/1) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Imatinibs sikkerhed og virkning hos børn og unge under 18 år med MDS/MPD, DFSP og HES/CEL er ikke klarlagt i kliniske studier.
The safety and efficacy of imatinib in children and adolescents with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Advarsler og forsigtighedsregler Kontakt lægen, før du tager Imatinib Accord: - hvis du har eller har haft lever-, nyre- eller hjerteproblemer.
Talk to your doctor before taking Imatinib Accord: - if you have or have ever had a liver, kidney or heart problem.
• voksne patienter med refraktært hypereosiniphil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL) med FIP1L1-PDGFR-omlejring.
• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Supplerende kemoterapi omgange: høj-dosis kemoterapi med MTX 1 g/m2 i.v.
Consolidation therapy Alternating chemotherapy course: high dose chemotherapy with MTX 1 g/m2 i.v.
Meget almindelig Kvalme, diarré, opkast, dyspepsi, abdominalsmerter6 Almindelig
Very common Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6 Common
(1 time), dag 2831, 35-38, 42-45; 6-MP 60 mg/m2 oral, dag 26-46
(1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/ m2 oral, days 26-46
Imatinib Accord 400 mg filmovertrukne tabletter leveres i pakker, der indeholder 10, 30 eller 90 tabletter, men ikke alle pakningsstørrelser fås nødvendigvis i dit land.
Imatinib Accord 400 mg film-coated tablets are supplied in packs containing 10, 30, or 90 tablets, but these may not all be available in your country.
• voksne og børn patienter med nydiagnosticeret Philadelphiakromosom positiv akut lymfoblastær leukæmi (Ph+ ALL) integreret med kemoterapi.
• Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
Der er begrænset erfaring hos børn og unge med MDS/MPD, DFSP og HES/CEL.
There is very limited experience in children and adolescents with MDS/MPD, DFSP and HES/CEL.
(0,5 time), dag 7, 8, 14, 15; CP 500 mg/m2 i.v.
(0.5 h), days 7, 8, 14, 15; CP 500 mg/ m2 i.v.
Den estimerede frekvens af patienter fri for progression til fremskreden fase eller blastkrise efter 84 måneder var signifikant højere i Imatinib-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 Imatinib arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Nedsat nyrefunktion: Patienter med nedsat nyrefunktion eller i dialyse bør gives den mindste anbefalede dosis på 400 mg dagligt som startdosis.
Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Der sås signifikant øgning i følsomhed for imatinib (gennemsnitlig Cmax og AUC for imatinib steg med henholdsvis 26% og 40%) hos raske frivillige ved samtidig administration af enkeltdosis ketoconazol (en CYP3A4-hæmmer).
There was a significant increase in exposure to imatinib (the mean Cmaxand AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
Der anbefales en dosering på 340 mg/m2 daglig til børn og unge med CML i kronisk fase og i fremskredne faser (må ikke overskride en total dosering på 800 mg).
The dose of 340 mg/m2 daily is recommended for children and adolescents with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Herpes zoster, herpes simplex, nasopharyngitis, pneumoni1, sinuitis, cellulitis, infektioner i øvre luftveje, influenza, urinvejsinfektion, gastroenteritis, sepsis
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis,cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Hvis noget af det ovenstående gælder for dig, skal du fortælle din læge det, før du tager Imatinib Accord.
If any of these apply to you, tell your doctor before taking Imatinib Accord.
(q 12 timer), dag 2-3, i 4 cyklus
(q 12 h), days 2-3, for 4 cycles
Imatinib Accord anvendes til behandling af voksne med:
Imatinib Accord is a treatment for adults for:
• Kvalme, åndenød, uregelmæssig hjerterytme (puls), uklar urin, træthed og/eller ubehag forbundet med abnorme resultater af laboratorieprøver (f.eks. højt indhold af kalium-, urinsyre og calcium i blodet og lavt indhold af fosfor i blodet).
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
* Denne type bivirkninger er hovedsageligt blevet rapporteret efter markedsføring af Imatinib.
Blood amylase increased * These types of reactions have been reported mainly from post-marketing experience with Imatinib.
Der er begrænset erfaring hos børn og unge og Phpositiv ALL og meget begrænset erfaring med børn og unge med MDS/MPD, DFSP og HEL/CEL.
There is limited experience in children and adolescents with Ph-positive ALL and very limited experience in children and adolescents with MDS/MPD, DFSP and HES/CEL.
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.