natgillin/translations-raw huggingface dataset:
I de ikke- sammenlignende undersøgelser af behandling af CML, ALL og GIST reagerede mellem 26% og 96% af patienterne positivt på behandlingen.
In the non-comparative studies of CML, ALL and GIST, between 26% and 96% of patients showed a response to treatment.
På grund af sygdommenes sjældenhed forelå der kun begrænsede oplysninger vedrørende andre sygdomme, men ca. to tredjedele af patienterne udviste minimum en delvis positiv reaktion på Glivec.
Due to their rarity, limited data were available for the other diseases, but around two thirds of the patients showed at least a partial response to Glivec.
De hyppigste bivirkninger ved Glivec (der ses hos flere end 1 ud af 10 patienter) er for lavt antal hvide blodlegemer (neutropeni), for lavt antal blodplader (thrombocytopeni) og for lavt antal røde blodlege - mer (anæmi), hovedpine, kvalme, opkastning, diarré, vrøvl med maven (dyspepsi), mavesmerter, væ - skeansamling, udslæt, muskeltrækninger og - kramper, muskel - og ledsmerter samt træthed.
The most common side effects with Glivec (seen in more than 1 in 10 patients) are neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, oedema (fluid retention), rash, muscle spasm and cramps, muscle and joint pain, and fatigue (tiredness).
Den fuld - stændige liste over de indberettede bivirkninger for Glivec fremgår af indlægssedlen.
For the full list of all side effects reported with Glivec, see the Package Leaflet.
Glivec bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for imatinib eller andre af indholdsstofferne.
Glivec should not be used in people who may be hypersensitive (allergic) to imatinib or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Glivec er større end risiciene ved behandling af ovenstående sygdomme, også dem, for hvilke der kun foreligger be - grænsede oplysninger.
The Committee for Medicinal products for Human Use (CHMP) decided that Glivec’ s benefits are greater than its risks for the treatment of the conditions listed above, including those for which limited data were available.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Glivec.
Glivec has been authorised under ‘ exceptional circumstances’.
Det firma, der fremstiller Glivec, vil foretage yderligere undersøgelser af Glivec, herunder dets vek - selvirkning med andre lægemidler, dets indvirkning på resultatet af fremtidige knoglemarvstransplan - tationer og dets virkning hos patienter med GIST, navnlig ved høje doser.
The company that makes Glivec will carry out further studies into Glivec, including an examination of its interactions with other medicines, its effects on the outcome of future bone marrow transplants and its effectiveness in patients with GIST, particularly at high dosages.
Andre oplysninger om Glivec:
Other information about Glivec:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Glivec til Novartis Europharm Limited den 7. november 2001.
The European Commission granted a marketing authorisation valid throughout the European Union, for Glivec on 7 November 2001 to Novartis Europharm Limited.
Denne markedsføringstilla - delse blev fornyet den 7. november 2006.
The marketing authorisation was renewed on 7 November 2006.
Sammendragene af udtalelserne fra Udvalget til Lægemidler til Sjældne Sygdomme for Glivec kan ses her (CML: den 14. februar 2001), her (GIST: den 20. november 2001), her (ALL: den 26. august 2005), her (DFSP: den 26. august 2005), her (HES og CEL: den 28. oktober 2005) og her (MD/ MPD: den 23. december 2005.
23 December 2005).
Den fuldstændige EPAR for Glivec findes her.
The full EPAR for Glivec can be found here.
EU Nummer EU/ 1/ 01/ 198/ 001 EU/ 1/ 01/ 198/ 002 EU/ 1/ 01/ 198/ 003 EU/ 1/ 01/ 198/ 004 EU/ 1/ 01/ 198/ 005 EU/ 1/ 01/ 198/ 006 EU/ 1/ 01/ 198/ 007
EU/ 1/ 01/ 198/ 001 EU/ 1/ 01/ 198/ 002 EU/ 1/ 01/ 198/ 003 EU/ 1/ 01/ 198/ 004 EU/ 1/ 01/ 198/ 005 EU/ 1/ 01/ 198/ 006 EU/ 1/ 01/ 198/ 007 EU/ 1/ 01/ 198/ 008 EU/ 1/ 01/ 198/ 009 EU/ 1/ 01/ 198/ 010 EU/ 1/ 01/ 198/ 011 EU/ 1/ 01/ 198/ 012 EU/ 1/ 01/ 198/ 013
Særnavn Glivec Glivec Glivec Glivec Glivec Glivec Glivec
Glivec Glivec Glivec Glivec Glivec Glivec Glivec Glivec Glivec Glivec Glivec Glivec Glivec
Styrke 50 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg
50 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 100 mg 400 mg 400 mg 100 mg 100 mg 400 mg
Lægemiddelform Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde Filmovertrukne tabletter
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Administrationvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Emballage Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu) Blister (PVC/ alu)
blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVDC/ alu) blister (PVDC/ alu) blister (PVC/ alu) blister (PVC/ alu) blister (PVDC/ alu)
Pakningsstørrelse 30 kapsler 24 kapsler 48 kapsler 96 kapsler 120 kapsler 180 kapsler 20 filmovertrukne tabletter
30 capsules 24 capsules 48 capsules 96 capsules 120 capsules 180 capsules 20 film-coated tablets 60 film-coated tablets 10 film-coated tablets 30 film-coated tablets 120 film-coated tablets 180 film-coated tablets 90 film-coated tablets
Oral anvendelse
CHMP/ 2418/ 01
Hvidt/ gult pulver i en lysegul/ orangegul, uigennemsigtig kapsel, præget med ” NVR SH ”.
White to yellow powder in a light yellow to orange-yellow opaque capsule, marked “ NVR SH”.
Glivec er indiceret til behandling af • voksne og børn med nydiagnosticeret Philadelphiakromosom (bcr- abl) positiv (Ph+) kronisk myeloid leukæmi (CML), for hvilke knoglemarvstransplantation ikke anses for førstevalgsbehandling. • voksne og børn med Ph+ CML i kronisk fase efter manglende effekt af alfa - interferonbehandling, eller i accelereret fase eller blastkrise. • voksne patienter med nydiagnosticeret Philadelphiakromosom positiv akut lymfoblastær leukæmi (Ph+ ALL) integreret med kemoterapi. • voksne patienter med Ph+ ALL med tilbagefald eller refraktær sygdom som monoterapi. • voksne patienter med myelodysplastisk syndrom/ myeloproliferative sygdomme (MDS/ MPD) som er forbundet med platelet- derived growth factor receptor- omlejring (PDGFR- omlejring). • voksne patienter med refraktært hypereosiniphil syndrom (HES) og/ eller kronisk eosinofil leukæmi (CEL) uden FIP1L1- PDGFRα- omlejring.
Glivec is indicated for the treatment of • 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. • adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. • adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. • adult patients with relapsed or refractory Ph+ ALL as monotherapy. • adult patients with myelodysplastic/ myeloproliferative diseases (MDS/ MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. • adult patients with advanced hypereosinophilic syndrome (HES) and/ or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Glivec er også indiceret til behandling af • voksne patienter med Kit (CD 117) positiv, inoperable og/ eller metastaserende maligne gastrointestinale bindevævstumorer (GIST). • voksne patienter med inoperabel dermatofibrosarkom protuberans (DFSP) og voksne patienter med residiverende og/ eller metastaserende DFSP som ikke er tilgængelig for kirurgi.
Glivec is also indicated for the treatment of • adult patients with Kit (CD 117) positive unresectable and/ or metastatic malignant gastrointestinal stromal tumours (GIST). • adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/ or metastatic DFSP who are not eligible for surgery.
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 og på objektive responsrater hos voksne med GIST og DFSP.
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 GIST and DFSP.
Der er kun begrænset erfaring med Glivec hos patienter med MDS/ MPD forbundet med PDGFR- omlejring (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).
Behandlingen bør initieres af en læge med erfaring i behandling af patienter med maligne
Therapy should be initiated by a physician experienced in the treatment of patients with
2 hæmatologiske lidelser og/ eller maligne sarkomer eller som passende.
2 haematological malignancies and malignant sarcomas, as appropriate.
4. 6).
Since studies in animals have shown reproductive toxicity, and the potential risk for the human foetus is unknown, women of child-bearing potential who open capsules should be advised to handle the contents with caution and avoid skin-eye contact or inhalation (see section 4.6).
Dosering ved CML hos voksne patienter Den anbefalede dosis af Glivec er 400 mg/ dag til patienter med CML i kronisk fase.
Posology for CML in adult patients The recommended dosage of Glivec is 400 mg/ day for patients in chronic phase CML.
CLM i kronisk fase defineres ved at alle følgende kriterier er opfyldt: blaster < 15% i blod og knoglemarv, perifere blodbasofiltal < 20%, thrombocyttal > 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.
Den anbefalede dosis af Glivec er 600 mg/ dag til patienter i accelereret fase.
The recommended dosage of Glivec is 600 mg/ day for patients in accelerated phase.
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%, thrombocyttal < 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.
Den anbefalede dosis af Glivec er 600 mg/ dag til patienter i blastkrise.
The recommended dose of Glivec is 600 mg/ day for patients in blast crisis.
Blastkrise defineres som ≥30% blaster i blod eller knoglemarv eller ekstramedullær sygdom ud over hepatosplenomegali.
Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Behandlingsvarighed:
Treatment duration:
I kliniske undersøgelser fortsattes behandling med Glivec indtil sygdomsprogression.
In clinical trials, treatment with Glivec was continued until disease progression.
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 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.
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).
Der anbefales en dosering på 340 mg/ m2 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/ m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Dosisøgning fra 340 mg/ m2 daglig til 570 mg/ m2 daglig (uden at overstige total dosis på 800 mg) kan overvejes hos børn ved fravær af alvorlige bivirkninger og svær ikke- leukæmirelateret neutropeni eller thrombocytopeni 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 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.
Dosering ved Ph+ ALL Den anbefalede dosis af Glivec er 600 mg/ dag til patienter med Ph+ ALL.
Posology for Ph+ ALL The recommended dose of Glivec is 600 mg/ day for patients with Ph+ ALL.
3 Behandlingsskema:
3 Treatment schedule:
5. 1) brugt i behandlingen af voksne patienter med nydiagnosticeret Ph+ALL.
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.
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.
Dosering ved MDS/ MPD Den anbefalede dosis af Glivec er 400 mg/ dag til patienter med MDS/ MPD.
Posology for MDS/ MPD The recommended dose of Glivec is 400 mg/ day for patients with MDS/ MPD.
5. 1).
In the only clinical trial performed up to now, treatment with Glivec was continued until disease progression (see section 5.1).
Dosering ved HES/ CEL Den anbefalede dosis af Glivec er 100 mg/ dag til patienter med HES/ CEL.
Posology for HES/ CEL The recommended dose of Glivec is 100 mg/ day for patients with HES/ CEL.
Dosering ved GIST Den anbefalede dosis af Glivec er 400 mg/ dag til patienter med inoperable og/ eller metastaserende maligne GIST.
Posology for GIST The recommended dose of Glivec is 400 mg/ day for patients with unresectable and/ or metastatic malignant GIST.
5. 1).
Limited data exist on the effect of dose increases from 400 mg to 600 mg or 800 mg in patients progressing at the lower dose (see section 5.1).
Der er aktuelt ingen data, der støtter specifikke dosisanbefalinger for GIST- patienter, der tidligere har fået udført gastrointestinal resektion.
There are currently no data available to support specific dosing recommendations for GIST patients based on prior gastrointestinal resection.
5. 2) havde tidligere fået udført resektion.
The majority (98%) of patients in the clinical trial (see section 5.2) had had prior resection.
For alle patienterne i undersøgelsen, var der mindst 2 uger mellem resektionen og første administration af Glivec; yderligere anbefalinger kan dog ikke baseres på denne undersøgelse.
For all patients on the study, there was at least a two-week interval between resection and the first dose of Glivec administered; however, no additional recommendations can be made based on this study.
I kliniske undersøgelser med GIST- patienter, blev behandling med Glivec fortsat indtil sygdomsprogression.
In clinical trials in GIST patients, treatment with Glivec was continued until disease progression.
Dosering ved DFSP Den anbefalede dosis af Glivec er 800 mg/ dag til patienter med DSFP.
Posology for DFSP The recommended dose of Glivec is 800 mg/ day for patients with DFSP.
Hvis der opstår alvorlige ikke- hæmatologiske bivirkninger ved behandling med Glivec, skal behandlingen seponeres, indtil bivirkningerne er ophørt.
Dose adjustment for adverse reactions Non-haematological adverse reactions If a severe non-haematological adverse reaction develops with Glivec use, treatment must be withheld until the event has resolved.
Hvis der opstår stigninger i bilirubin > 3 x IULN (institutional upper limit of normal) eller i levertransaminaser > 5 x IULN, skal Glivec seponeres indtil bilirubinniveauerne er faldet til < 1, 5 x IULN og transaminaseniveauer til < 2, 5 x IULN.
If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, Glivec should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Hos voksne bør dosis reduceres fra 400 til 300 mg eller fra 600 til 400 mg, eller fra 800 mg til 600 mg, og hos børn fra 340 til 260 mg/ m2/ dag.
In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/ m2/ day.
I tilfælde af svær neutropeni og thrombocytopeni anbefales dosisreduktion eller seponering af behandlingen, som angivet i nedenstående tabel:
Haematological adverse reactions Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are 4 recommended as indicated in the table below.
Dosisjusteringer på grund af neutropeni og thrombocytopeni:
Dose adjustments for neutropenia and thrombocytopenia:
HES/ CEL (start dosering 100 mg)
HES/ CEL (starting dose
ANC < 1, 0 x 109/ l og/ eller thrombocytter < 50 x 109/ l
and/ or platelets < 50 x 109/ l
Seponer Glivec indtil ANC ≥1, 5 x 109/ l og thrombocytter ≥75 x 109/ l.
platelets ≥ 75 x 109/ l.
Genoptag Glivec- behandlingen ved den tidligere dosis (dvs. før svære bivirkninger).
Resume treatment with Glivec at previous dose (i. e. before severe adverse reaction).
CML i kronisk fase, MDS/ MPD og
Chronic phase CML, MDS/ MPD and GIST
ANC < 1, 0 x 109/ l og/ eller
ANC < 1.0 x 109/ l and/ or
Seponer Glivec indtil ANC ≥1, 5 x 109/ l og thrombocytter ≥75 x 109/ l.
Stop Glivec until ANC ≥ 1.5 x 109/ l and platelets ≥ 75 x 109/ l.
GIST (startdosis 400 mg) HES/ CEL
(starting dose 400 mg) HES/ CEL (at dose 400 mg)
thrombocytter < 50 x 109/ l
platelets < 50 x 109/ l
I tilfælde af recidiverende ANC < 1, 0 x 109/ l og/ eller thrombocytter < 50 x 109/ l, gentag trin 1 og genoptag behandling med Glivec i en reduceret dosis på 300 mg.
In the event of recurrence of ANC < 1.0 x 109/ l and/ or platelets < 50 x 109/ l, repeat step 1 and resume Glivec at reduced dose of 300 mg.
Børn med CML i kronisk fase
Paediatric chronic phase CML
(ved en dosis på 340 mg/ m2)
(at dose 340 mg/ m2)
I tilfælde af recidiverende ANC < 1, 0 x 109/ l og/ eller thrombocytter < 50 x 109/ l, gentag trin 1 og genoptag behandling med Glivec i en reduceret dosis på 260 mg/ m2.
In the event of recurrence of ANC < 1.0 x109/ l and/ or platelets < 50 x109/ l, repeat step 1 and resume Glivec at reduced dose of 260 mg/ m2.
CML i accelereret fase og blastkrise
Accelerated phase CML and blast crisis and Ph+
ANC < 0, 5 x 109/ l og/ eller
ANC < 0.5 x 109/ l and/ or
Undersøg om cytopeni er relateret til leukæmi (marv- aspirat eller biopsi).
Check whether cytopenia is related to leukaemia (marrow aspirate or biopsy).
og Ph+ ALL (startdosis 600 mg)
ALL (starting dose 600 mg)
thrombocytter < 10 x 109/ l
platelets < 10 x 109/ l
Hvis cytopeni ikke er leukæmirelateret, reducér Glivec- dosis til 400 mg.
If cytopenia is unrelated to leukaemia, reduce dose of Glivec to 400 mg.
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Glivec - behandling indtil ANC ≥1, 0 x 109/ l og thrombocytter ≥20 x 109/ l og genoptag herefter behandlingen med 300 mg.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC ≥ 1 x 109/ l and platelets ≥ 20 x 109/ l, then resume treatment at 300 mg.
Børn med CML i accelereret fase og blastkrise (startdosis
Paediatric accelerated phase CML and blast
ANC < 0, 5 x 109/ l og/ eller thrombocytter < 10 x 109l
ANC < 0.5 x 109/ l and/ or
340 mg/ m2)
crisis (starting dose 340 mg/ m2)
Hvis cytopeni vedvarer i 2 uger, reducér dosis yderligere til 200 mg/ m2.
If cytopenia persists for 2 weeks, reduce further to 200 mg/ m2.
Hvis cytopeni vedvarer i 4 uger og stadig ikke er leukæmirelateret, seponér Glivec - behandlingen indtil ANC ≥1, 0 x 109l og thrombocytter ≥20 x 109l og genoptag behandling med 200 mg/ m2.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Glivec until ANC ≥ 1 x 109/ l and platelets ≥ 20 x 109/ l, then resume treatment at 200 mg/ m2.
DFSP (ved 800 mg dosis)
(at dose 800 mg)
Stop Glivec indtil ANC ≥1, 5 x 109/ l og thrombocytter ≥75 x 109/ l.
platelets ≥ 75 x 109/ l.
600 mg.
Resume treatment with Glivec at 600 mg.
I tilfælde af tilbagevenden af ANC < 1, 0 x 109/ l og/ eller thrombocytter < 50 x 109/ l, gentages trin 1 og Glivec reintroduceres med nedsat dosering på 400 mg.
In the event of recurrence of ANC < 1.0 x 109/ l and/ or platelets < 50 x 109/ l, repeat step 1 and resume Glivec at reduced dose of 400 mg.
Anvendelse til børn:
Paediatric use:
5. 1).
There is no experience in children with CML below 2 years of age (see section 5.1).
Der er begrænset erfaring med børn og Ph+ ALL og meget begrænset erfaring hos børn med MDS/ MPD og DFSP.
There is limited experience in children with Ph+ ALL and very limited experience in children with MDS/ MPD and DFSP.
Der er ingen erfaring med behandling af børn og unge med GIST og HES/ CEL.
There is no experience in children or adolescents with GIST and HES/ CEL.
4. 4, 4. 8 og 5. 2).
The dose can be reduced if not tolerated (see sections 4.4, 4.8 and 5.2).
Nedsat leverfunktion Mild
Liver dysfunction Mild
Leverfunktionstest Total bilirubin: = 1, 5 ULN AST: > ULN (kan være normal eller < ULN hvis total bilirubin er > ULN)
Liver function tests Total bilirubin: = 1.5 ULN AST: > ULN (can be normal or< ULN if total bilirubin is > ULN)
Total bilirubin: > 1, 5– 3, 0 ULN AST: alt
Total bilirubin: > 1.5– 3.0 ULN AST: any
Total bilirubin: > 3– 10 ULN AST: alt
Total bilirubin: > 3– 10 ULN AST: any
Da nyreudskillelsen af imatinib er negligeabel, forventes det ikke, at ubundet imatinib- clearance falder hos patienter med nyreinsufficiens.
Since the renal clearance of imatinib is negligible, a decrease in free imatinib clearance is not expected in patients with renal insufficiency.