natgillin/translations-raw huggingface dataset:
Imatinib givet i kombination med kemoterapi-induktion (se Tabel 3) resulterede i en komplet hæmatologisk responsrate på 93 % (147 ud af 158 evaluerbare patienter), og i en væsentlig cytogenetisk responsrate på 90 % (19 ud af 21 evaluerbare patienter).
Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93 % (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90 % (19 out of 21 evaluable patients).
Bærere af HBV, hvor behandling med imatinib er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt.
Carriers of HBV who require treatment with imatinib should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Colitis, ileus, inflammatorisk tarmsygdom
Colitis, ileus, inflammatory bowel disease
Køn har ingen betydning for imatinibs kinetik.
There is no effect of gender on the kinetics of imatinib.
• Kraftigt nedsat urinmængde, følelse af tørst (tegn på nyreproblemer).
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Hedeture, kulderystelser eller natlig svedtendens.
• Hot flushes, chills or night sweats.
Imatinib og dets metabolitter udskilles kun i ubetydelig grad via nyrerne.
Imatinib and its metabolites are not excreted via the kidney to a significant extent.
Disse er sygdomme i blodet, i hvilke visse blodlegemer (kaldet eosinofile celler) begynder at vokse ukontrolleret.
These are blood diseases in which some blood cells (named eosinophils) start growing out of control.
3 På patientårsbasis blev kardielle hændelser, herunder hjerteinsufficiens, observeret oftere hos patienter med transformeret CML end hos patienter med kronisk CML.
3) On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
I dette studie indgik 7 patienter med MDS/MPD, som blev behandlet med 400 mg imatinib dagligt.
This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Må ikke opbevares ved temperaturer over 30 °C.
Do not store above 30 ºC.
Den cirkulerende hovedmetabolit i mennesker er N-demethyl-piperazinderivatet, som udviser samme potens in vitro som det stof, den er afledt af.
The main circulating metabolite in humans is the N-demethylated piperazine derivative, which shows similar in vitro potency to the parent.
Disse tilfælde blev sædvanligvis behandlet ved midlertidigt at tilbageholde behandling med imatinib, og behandle med diuretika og andre relevante, understøttende tiltag.
These reactions can usually be managed by withholding imatinib temporarily and with diuretics and other appropriate supportive care measures.
Bedring blev rapporteret for: hjerte, nervesystem, hud/subkutant væv, respiratoriske/ thorakale/ mediastinale, muskuloskeletale/bindevævs/kar og gastrointestinale organsystemer.
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Behandlingsvarighed: I det eneste kliniske studie, der er udført indtil nu, fortsattes behandlingen med imatinib indtil sygdomsprogression (se pkt.
Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Imatinibs 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 DFSP.
In adult and paediatric patients, the effectiveness of imatinib 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 DFSP.
Der er ingen kontrollerede forsøg med pædiatriske patienter med DFSP.
There are no controlled trials in paediatric patients with DFSP.
Niveauet for ingen observeret effekt (NOEL) var 15 mg/kg/dag.
The no observed effect level (NOEL) was 15 mg/kg/day.
Da imatinib blev givet som ”salvage therapy” til patienter, som ikke responderede eller som responderede dårligt på kemoterapi, opnåedes komplet hæmatologisk respons hos 9 (81,8 %) ud af 11 patienter.
When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8 %) out of 11 achieving a complete haematological response.
(2 timer, q 12 timer), dag 2-3 (total af 8 omgange)
(2 h, q 12 h), days 2-3 (total of 8 courses)
Derudover angav investigatorerne symptomatisk bedring af andre organdysfunktioner i kasuistikkerne.
Additionally, improvements in symptomatology and other organ dysfunction abnormalities were reported by the investigators in the case reports.
Der er ingen kontrollerede forsøg med pædiatriske patienter med MDS/MPD.
There are no controlled trials in paediatric patients with MDS/MPD.
9/l) og trombocytopeni (trombocyttal <50 x 10 9/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 % 9/l) og trombopeni neutropeni og 8,9 % trombocytopeni).
9/l) 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).
Sammenligningen af AUC(0-24) på dag 8 og dag 1 ved 340 mg/m²/dag dosisniveauet viste en 1,7 gang højere lægemiddelakkumulering efter gentagen dosering, én gang dagligt.
The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold accumulation after repeated once-daily dosing.
Histopatologiske undersøgelser af de afdøde rotter afslørede kardiomyopati (begge køn), kronisk progressiv nefropati (hunner) og papillomaer på forhuden som hovedårsag til død eller begrundelse for aflivning.
Histopathological examination of decedents revealed cardiomyopathy (both sexes), chronic progressive nephropathy (females) and preputial gland papilloma as principal causes of death or reasons for sacrifice.
Tidligere gastrointestinale indgrebs påvirkning af imatinibabsorptionen er ikke undersøgt.
The effect of prior gastrointestinal surgery on imatinib absorption has not been investigated.
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST, oplevede 7 (5 %) af patienterne CTC grad 3-4: gastrointestinale blødninger (3 patienter), intratumorale blødninger (3 patienter) eller begge dele (1 patient).
In the study in patients with unresectable and/or metastatic GIST, 7 (5 %) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
Baseret på in vitro undersøgelser, bindes, ved kliniske relevante koncentrationer af imatinib, ca. 95 % til plasmaproteiner, hovedsagelig albumin og alfa-syre-glycoprotein, med en mindre binding til lipoproteiner.
At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95 % on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Plasmaeksponeringen synes at være højere hos patienter med nedsat nyrefunktion end hos patienter med normal nyrefunktion, formentlig på grund af forhøjede plasmaniveauer af alpha-acid glucoprotein (AGP), et imatinib-bindende protein, hos disse patienter.
In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
Der sås forhøjet se-carbamid og se-creatinin hos adskillige af disse dyr.
Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Når imatinib kombineres med højdosis kemoterapi, ses en øget forekomst af alvorlige leverreaktioner.
When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected.
Niveauet for ingen observeret effekt (NOEL) var 30 mg/kg/dag.
The no observed effect level (NOEL) was 30 mg/kg/day.
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST rapporteredes anæmi grad 3 og 4 hos henholdsvis 5,4 % og 0,7% af patienterne, hvilket kan hænge sammen med gastrointestinal eller intra-tumoral blødning, i hvert fald hos enkelte af patienterne.
In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4 % and 0.7 % of patients, respectively, and may have been related to gastrointestinal or intratumoural bleeding in at least some of these patients.
• Hævelse, som fx af anklerne eller omkring øjnene.
• Swelling such as round your ankles or puffy eyes.
Kronisk nyresvigt Det reproduktive system og mammae
Renal failure chronic Reproductive system and breast disorders
6400 mg (enkeltdosis): Der er beskrevet et tilfælde i litteraturen om en patient, der fik kvalme, opkastning, abdominalsmerter, feber, hævelse af ansigt, nedsat neutrofiltal, stigning i transaminaser.
6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Imatinib medac 400 mg hårde kapsler EU/1/13/876/002
Imatinib medac 400 mg hard capsules EU/1/13/876/002
Udskillelse af fri imatinib er sandsynligvis sammenlignelig for patienter med nedsat nyrefunktion og dem med 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 patients with 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).
Imatinib medac 100 mg hårde kapsler EU/1/13/876/001
Imatinib medac 100 mg hard capsules EU/1/13/876/001
Disse patienters alder varierede fra 20 til 72 år.
The age of these patients ranged from 20 to 72 years.
Den anbefalede dosis af imatinib er 600 mg/dag til voksne patienter i blastkrise.
The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
I dette studie blev 14 patienter med HES/CEL behandlet med 100 mg1.000 mg imatinib dagligt.
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
Der fandtes i en 39-ugers undersøgelse med aber ingen NOAEL (no observed adverse effect level/niveau ved ingen observeret bivirkningseffekt) ved den laveste dosis på 15 mg/kg, ca. 1/3 af den maksimale humane dosis på 800 mg baseret på legemsoverfladeareal.
In a 39-week monkey study, no NOAEL (no observed adverse effect level) was established at the lowest dose of 15 mg/kg, approximately one-third the maximum human dose of 800 mg based on body surface.
Imatinib medac er indiceret til behandling af
Imatinib medac is indicated for the treatment of
1200 mg til 1600 mg (varighed varierer mellem 1 og 10 dage): Kvalme, opkastning, diarré, rødme, erytem, ødem, hævelse, træthed, muskelkramper, trombocytopeni, pancytopeni, abdominalsmerter, hovedpine, nedsat appetit.
1200 mg to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Ileus/intestinal obstruktion*, gastrointestinal perforation*, diverticulitis*,
Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric Hepatobiliary disorders
Der var ingen særlige sikkerhedsmæssige fund i kliniske undersøgelser med børn.
There were no special safety findings in paediatric clinical trials.
Pakningen må ikke anvendes, hvis den er beskadiget, eller der er tegn på, at pakningen har været åbnet.
Do not use any pack that is damaged or shows signs of tampering.
Behandlingsskema: Eksisterende data har vist, at imatinib er effektiv og sikker ved administration af 600 mg/dag i kombination med kemoterapi i induktionsfasen, i konsoliderings- og vedligeholdelsesfaser af kemoterapi (se pkt.
Treatment schedule: On the basis of the existing data, imatinib 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 patients with newly diagnosed Ph+ ALL.
(3 timer, q 12 timer), dag 5
(3 h, q 12 h), day 5
I et 2-års carcinogenicitetsstudie i rotter resulterede administration af imatinib på 15, 30 og 60 mg/kg/dag i en signifikant reduktion i levetiden ved 60 mg/kg/dag for hanner og for hunner ved ≥ 30 mg/kg/dag.
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥ 30 mg/kg/day.
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 Cmax and 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).
Crospovidon (type A) Lactosemonohydrat Magnesiumstearat
Crospovidone (type A) Lactose monohydrate Magnesium stearate
Baseret på den poolede farmakokinetiske populationsanalyse hos børn med hæmatologiske sygdomme (CML, Ph+ ALL eller andre hæmatologiske sygdomme behandlet med imatinib) stiger imatinibclearance med stigende legemsoverflade.
Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
Alle patienter opnåede komplet hæmatologisk respons, komplet cytogenetisk repons og/eller komplet molekylært respons.
All patients achieved complete haematological response, complete cytogenetic response and/or complete molecular response.
Vedligeholdelse (8-ugers cykler) Cyklus 6-12
Maintenance (8-week cycles) Cycles 6-12
• Kombination af omfattende svært udslæt, følelse af at være syg, feber, højt indhold af visse hvide blodlegemer eller gul hud eller øjne (tegn på gulsot) med stakåndethed, brystsmerter/ubehag, svært nedsat urinproduktion og tørst osv. (tegn på en behandlingsrelateret allergisk reaktion).
• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
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.
Active substances that may have their plasma concentration altered by imatinib 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.
• Føle sig svimmel eller besvime (tegn på lavt blodtryk).
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
Imatinibs 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.
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.
Selvom resultaterne fra en farmakokinetisk analyse viste, at der var en betydelig variation mellem forsøgspersoner, øgede den gennemsnitlige eksponering af imatinib sig ikke hos patienter med varierende grad af nedsat leverfunktion, sammenlignet med patienter med normal leverfunktion (se pkt.
Although the results of pharmacokinetic analysis showed that there is considerable inter-subject variation, the mean exposure to imatinib did not increase in patients with varying degrees of liver dysfunction as compared to patients with normal liver function (see sections 4.2, 4.4 and 4.8).
Der skal udvises forsigtighed, når imatinib gives samtidig med CYP3A4-familien.
Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Imatinib medac hæmmer væksten af disse celler i en vis undergruppe af disse sygdomme.
Imatinib medac inhibits the growth of these cells in a certain subtype of these diseases.
Alle patienter opnåede komplet hæmatologisk respons, cytogenetisk repons og/eller klinisk respons.
All patients achieved complete haematological response, cytogenetic response and/or clinical response.
Der er ingen kontrollerede forsøg med pædiatriske patienter med HES/CEL.
There are no controlled trials in paediatric patients with HES/CEL.
Der er kun begrænset erfaring med imatinib hos patienter med MDS/MPD forbundet med PDGFR-omlejring (se pkt 5.1).
The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Nedsat leverfunktion: Imatinib metaboliseres primært i leveren.
Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
• Symptomer på infektioner såsom feber, kraftige kulderystelser, ondt i halsen eller sår i munden.
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
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.
Analysen bekræftede, at imatinib-eksponeringen hos børn, som fik 260 mg/m² en gang dagligt (højst 400 mg en gang dagligt) eller 340 mg/m² en gang dagligt (højst 600 mg en gang dagligt), svarede til eksponeringen hos voksne, som fik imatinib 400 mg eller 600 mg en gang dagligt.
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.
Hvis en af disse undersøgelser viser abnormalitet, bør det overvejes at kombinere imatinib med profylaktisk brug af systemisk steroid (1-2 mg/kg) i en til to uger ved behandlingsstart.
If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
FREMSTILLERENS BATCHNUMMER Lot
BATCH NUMBER Lot:
Plasmafarmakokinetik
Plasma pharmacokinetics
5 Pleural effusion blev observeret oftere hos patienter med GIST og hos patienter med transformeret CML (CML-AP og CML-BC) end hos patienter med kronisk CML.
5) Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML.
• Philadelphia-kromosom-positiv akut lymfoblastær leukæmi (Ph-positiv ALL).
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
I den kliniske Philadelphia-kromosom-positiv (Ph undersøgelse var 38 % af patienterne ≥60 år, og 12 % af patienterne var ≥70 år.
In the clinical study 38 % of patients were ≥ 60 years of age and 12 % of patients were ≥ 70 years of age.
Der anbefales en dosis på 340 mg/m² dagligt 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).
Det er en potent protein-kinasehæmmer, der hæmmer aktiviteten af BcrAbl-tyrosinkinase (TK) såvel som adskillige TK-receptorer: Kit, receptoren for stamcellefaktoren (SCF) kodet for af c-kit proto-onkogenet, discoidin-domænereceptorerne (DDR1 og DDR2), receptoren for den kolonistimulerende faktor (CSF-1R) og receptorerne for trombocytafledte vækstfaktorer alfa og beta (PDGFR-alfa og PDGFR-beta).
Imatinib is a small molecule protein kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Pakninger indeholdende 30 hårde kapsler.
Packs containing 30 hard capsules.
1, sinuitis, cellulitis, infektioner i øvre luftveje, influenza, urinvejsinfektion, gastroenteritis, sepsis
1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Palmoplantar erytrodysæstesi syndrom*, lichenoid keratosis*, lichen planus*, toksisk epidermal nekrolyse*, medikamentelt udslæt med eosinofili
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
• voksne og børn med nydiagnosticeret Philadelphia-kromosom-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.
• voksne patienter med refraktært hypereosiniphil syndrom (HES) og/eller kronisk eosinofil leukæmi (CEL) med FIP1L1-PDGFRα-omlejring.
• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Imatinib medac hæmmer væksten af disse celler.
Imatinib medac inhibits the growth of these cells.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) eller sjældne (kan forekomme hos op til 1 ud af 1.000 personer):
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Der anbefales en dosering på 340 mg/m² dagligt til børn med CML i kronisk fase og i accelereret fase (må ikke overskride en total dosering på 800 mg).
340 mg/m daily is recommended for paediatric patients with chronic phase CML and accelerated phase CML (not to exceed the total dose of 800 mg).
Derudover erfaringer der efter markedsføring er rapporteret gastric antral vascular ecstasia (GAVE), en sjælden form for gastrointestinal blødning, hos patienter med CML, ALL og andre sygdomme (se pkt.
In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).
Pakninger indeholdende 60 hårde kapsler.
Packs containing 60 hard capsules.
Vedligeholdelse (8-ugers cykler) Cyklus 1-4
Maintenance (8-week cycles) Cycles 1-4
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 grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Musklesvaghed, arthritis, rabdomyolyse/myopati
Muscular weakness, arthritis, rhabdomyolysis/myopathy