natgillin/translations-raw huggingface dataset:
Dette vil hjælpe med at beskytte dig mod maveproblemer, når du tager Imatinib Accord.
This will help protect you from stomach problems when taking Imatinib Accord.
Dosering hos og unge børn bør baseres på legemsoverflade (mg/m2).
Dosing for children and adolescents should be on the basis of body surface area (mg/m2).
Ældre: Imatinibs farmakokinetik er ikke specifikt undersøgt hos ældre.
Imatinib pharmacokinetics have not been specifically studied in elderly.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Ved en konservativ antagelse af at patienter med manglende data er ikkerespondenter, blev CHR observeret hos 20/23 (87 %), CCyR hos 9/23 (39,1 %) og MR hos 11/23 (47,8 %) af patienterne.
When assuming conservatively that patients with missing data were non-responders, CHR was observed in 20/23 (87%) patients, CCyR in 9/23 (39.1%) patients, and MR in 11/23 (47.8%) patients, respectively.
• 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.
Graviditet, amning og frugtbarhed - Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Imatinib Accord er et lægemiddel, der indeholder et aktivt stof kaldet imatinib.
Imatinib Accord is a medicine containing an active substance called imatinib.
Tabel 2 Respons i undersøgelsen vedrørende nydiagnosticeret CML (84 måneders data) Imatinib
Table 2 Response in newly diagnosed CML Study (84-month data)
Yderligere seks patienter, behandlet med imatinib, er blevet beskrevet i 5 publicerede kasuistikker, alderen varierede fra 18 måneder til 49 år.
A further 6DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Imatinib Accord er indiceret til behandling af
Imatinib Accord is indicated for the treatment of
Lignende resultater blev observeret hos patienter med maligne gliomer behandlet med Imatinib samtidig med indtagelse af enzyminducerende antiepileptiske lægemidler (EIAEDs) som carbamazepin, oxcarbazepin og phenytoin.
Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic drugs (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Effekten af Imatinib-behandling på overlevelse i kronisk fase, nyligt diagnostiseret CML er blevet yderligere undersøgt i en retrospektiv analyse af ovenstående rapporterede Imatinib-data med primærdata fra et andet fase III-studie, hvor IFN+Ara-C (n=325) blev anvendt i et tilsvarende behandlingsregime.
The effect of Imatinib treatment on survival in chronic phase, newly diagnosed CML has been further examined in a retrospective analysis of the above reported Imatinib data with the primary data from another Phase III study using IFN+Ara-C (n=325) in an identical regimen.
Der blev hos GIST patienter (studie B2222) observeret stigning i grad 3 eller 4 ALAT (alaninaminotransferase) hos 6,8% og stigning i grad 3 eller 4 ASAT (aspartataminotransferase) hos 4,8%.
In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
Der er ikke udført studier med patienter, der fik Imatinib Accord, og dets virkning på fertilitet og gametogenese.
Studies on patients receiving Imatinib Accord and its effect on fertility and gametogenesis have not been performed.
På grund af kendt øget risiko for blødning i forbindelse med brug af Imatinib (f.eks. hæmoragi) bør patienter med behov for antikoagulantia have heparin med lav molekylevægt eller standardheparin i stedet for coumarinderivater som warfarin.
Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
Imatinib Accord bruges også til behandling af børn og unge med CML.
Imatinib Accord is also a treatment for children and adolescents with CML.
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Farmakokinetik hos børn og unge
Pharmacokinetics in children and adolescents
Hvis du er i behandling for CML
If you are being treated for CML
I alt døde 71 (12,8 %) og 85 (15,4 %) patienter i henholdsvis Imatinib- og IFN+Ara-C-grupperne.
A total of 71 (12.8%) and 85 (15.4%) patients died in the Imatinib and IFN+Ara-C groups, respectively.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Anvendes som foreskrevet af lægen.
OTHER SPECIAL WARNING(S), IF NECESSARY Use only as directed by a doctor.
Hypromellose 6 cps (E464) Mikrokrystallinsk cellulose ph 102 Crospovidon
Hypromellose 6 cps (E464) Microcrystalline cellulose pH 102 Crospovidone
Hvis laboratorie- eller kliniske fund associeret med TMA forekommer hos en patient, som er i behandling med Imatinib Accord, skal behandlingen seponeres og der skal foretages en grundig undersøgelse for TMA, inklusiv ADAMTS13-aktivitet og anti-ADAMTS13-antistofbestemmelse.
If laboratory or clinical findings associated with TMA occur in a patient receiving Imatinib Accord, treatment should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and anti-ADAMTS13antibody determination, should be completed.
Større cytogenetisk respons, hæmatologisk respons, molekulær respons (evaluering af minimal tilbageværende sygdom), tid til accellereret fase eller blastkrise samt overlevelse er de sekundære hovedeffektmål.
Major cytogenetic response, haematological response, molecular response (evaluation of minimal residual disease), time to accelerated phase or blast crisis and survival are main secondary endpoints.
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 og unge 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 and adolescents from 340 to 260 mg/m2/day.
• Usædvanligt hårtab eller udtyndning af håret.
• Unusual hair loss or thinning.
- Myelodysplastiske/myeloproliferative sygdomme (MDS/MDP).
Myelodysplastic/myeloproliferative diseases (MDS/MPD).
I Imatinib-armen blev patienterne behandlet med 400 mg daglig.
In the Imatinib arm, patients were treated with 400 mg daily.
Cytopeni hos CML-patienter, særligt neutropeni og trombocytopeni, har været gennemgående fund i alle undersøgelser med tegn på større hyppighed ved doser 750 mg (fase I undersøgelse).
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study).
Dette tid-til-hændelse effektmål er stærkt påvirket af det høje antal skift fra IFN+Ara-C-armen til Imatinib-armen.
This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to Imatinib.
Imatinib Accord hæmmer væksten af disse celler.
Imatinib Accord inhibits the growth of these cells.
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, protein-tyrosinkinasehæmmer, ATC-kode: L01XE01
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Ileus/intestinal obstruktion*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)* Hepatobiliary disorders Common
Der er i kliniske undersøgelser set øget incidens af disse hændelser hos ældre og hos patienter med hjertesygdom i anamnesen.
In clinical trials, there was an increased incidence of these events in elderly and those with a prior history of cardiac disease.
Ved 7-års opfølgning var der 93 (16,8 %) progressionshændelser i Imatinib -armen: 37 (6,7 %) omhandlede progression til accelereret fase/blastkrise, 31 (5,6 %) tab af MCyR, 15 (2,7 %) tab af CHR eller stigning i WBC, og 10 (1,8 %) dødsfald ikke relateret til CML.
With 7 years follow-up, there were 93 (16.8%) progression events in the Imatinib arm: 37 (6.7%) involving progression to accelerated phase/blast crisis, 31 (5.6%) loss of MCyR, 15 (2.7%) loss of CHR or increase in WBC, and 10 (1.8%) CML unrelated deaths.
Du kan blive mere følsom overfor sollys, når du tager Imatinib Accord.
You may become more sensitive to the sun while taking Imatinib Accord.
Patienter med hjertesygdom, risikofaktorer for hjerteinsufficiens eller nyreinsufficiens i anamnesen skal monitoreres omhyggeligt, og alle patienter, som har symptomer forenelige med hjerte- eller nyreinsufficiens, bør undersøges og behandles.
Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure or renal failure should be evaluated and treated.
6 doser)iii: dag 2, 3, 16, og 17
6 doses)iii: days 2, 3, 16, and 17
Total bilirubin: >3-10 ULN ASAT: alt ULN = laboratoriets øvre normalgrænse ASAT = aspartataminotransferase
Total bilirubin: > 3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Undersøgelsens primære effektvariabel var graden af det cytogenetiske hovedrespons (fuldstændigt plus partielt respons, 0-35 % Ph+-metafaser i knoglemarven).
The primary efficacy variable of the study was the rate of major cytogenetic response (complete plus partial response, 0 to 35% Ph+ metaphases in the bone marrow).
doses)iii: dag 2 og 3
doses)iii: days 2 and 3
Ara-C: cytosin arabinosid; CP: cyclophosphamid; DEX: dexamethason; MTX: methotrexat; 6MP: 6-mercaptopurin; VM26: teniposid; VCR: vinkristin; IDA: idarubicin; i.v.
Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Kontakt din læge med det samme, hvis du oplever nogle af de følgende bivirkninger
Tell your doctor straight away if you get any of the following
Denne fase III undersøgelse hos voksne patienter sammenlignede enkeltstof-behandling med Imatinib med behandling med en kombination af interferon-alfa (IFN) og cytarabin (Ara-C).
This phase III study in adult patients compared treatment with either single-agent Imatinib or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
In vitro hæmmer Imatinib cytochrom P450 isoenzym CYP2D6-aktivitet ved koncentrationer svarende til dem, der påvirker CYP3A4-aktivitet.
In vitro imatinib inhibits the cytochrome P450 isoenzyme CYP2D6 activity at concentrations similar to those that affect CYP3A4 activity.
Total bilirubin: >1,5-3,0 ULN ASAT: alt
Total bilirubin: > 1.5-3.0 ULN AST: any
Den pædiatriske patient fik 400 mg/m2/daglig, hvilket efterfølgende blev øget til 520 mg/m2/daglig.
The paediatric patient received 400 mg/m2/daily, subsequently increased to 520 mg/m2/daily.
Pakninger indeholdende 10, 30 eller 90 filmovertrukne tabletter.
Packs containing 10, 30, or 90 film-coated tablets.
Ved brug af denne metode øgedes den estimerede kumulative responsfrekvens for førstevalgsbehandling med Imatinib fra 12 måneders behandling til 84 måneders behandling som følgende: CHR fra 96,4 % til 98,4 % og CCyR fra 69,5 % til 87,2 %).
Using this approach, the estimated cumulative response rates for first-line treatment with Imatinib improved from 12 months of therapy to 84 months of therapy as follows: CHR from 96.4% to 98.4% and CCyR from 69.5% to 87.2%, respectively.
Kronisk myeloid leukæmi (CML).
Chronic myeloid leukaemia (CML).
Til patienter (børn), der ikke er i stand til at synke tabletterne, kan indholdet opløses i et glas almindeligt vand eller æblejuice.
For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of mineral water or apple juice.
Den estimerede progressionsfri overlevelse efter 84 måneder var 81,2 % i Imatinib-armen og 60,6 % i kontrolarmen (p<0,001).
The estimated rate of progression-free survival at 84 months was 81.2% in the Imatinib arm and 60.6% in the control arm (p<0.001).
ASAT: >ULN (kan være normal eller <ULN hvis total bilirubin er >ULN)
Total bilirubin: = 1.5 ULN AST: > ULN (can be normal or < ULN if total bilirubin is > ULN)
Sikkerhedsdatabasen for børn og unge med Ph+ ALL er meget begrænset.
The safety database for children and adolescents with Ph+ALL is very limited though no new safety concerns have been identified.
Maksimale plasmakoncentrationer af imatinib er hos patienter 2-4 mol/l, og hæmning af CYP2D6 og/eller CYP3A4/5-medieret metabolisme af samtidigt administrerede lægemidler er derfor mulig.
Maximal plasma concentrations of imatinib in patients are 2-4 µmol/l, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered drugs is possible.
• voksne patienter med inoperabel dermatofibrosarkom protuberans (DFSP) og voksne patienter med residiverende og/eller metastaserende DFSP som ikke er tilgængelig for kirurgi.
• adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Årlige frekvenser af enhver type progression blev reduceret over tid med Imatinib.
The yearly rates of progression of any type for Imatinib also decreased over time.
Imatinib blev administreret periodisk i kohorte 1-5 med stigende varighed og tidligere start med imatinib fra kohorte til kohorte; kohorte 1 fik den mindst intensive imatinibbehandling og kohorte 5 den mest intensive (længste varighed i dage med kontinuerlig, daglig imatinib-dosering i de første kemobehandlingsforløb).
Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
• Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
• Do not use this medicine after the expiry date which is stated on the carton and blister after
Hvor estimeret 96 % (93 %) af patienterne med CCyR (PCyR) ved 12 måneder var fri for progression til accelereret fase/blastkrise ved 84 måneder, var kun 81 % af patienterne uden CCyR ved 12 måneder fri for progression til fremskreden CML ved 84 måneder (p<0,001 samlet, p=0,25 mellem CCyR og PCyR).
Whereas an estimated 96% (93%) of patients with CCyR (PCyR) at 12 months were free of progression to accelerated phase/blast crisis at 84 months, only 81% of patients without MCyR at 12 months were free of progression to advanced CML at 84 months (p<0.001 overall, p=0.25 between CCyR and PCyR).
9 Muskuloskeletale smerter under behandling med imatinib eller efter seponering er blevet observeret efter markedsføring.
Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
Pakninger indeholdende 20, 60, 120 eller 180 filmovertrukne tabletter.
Packs containing 20, 60, 120 or 180 film-coated tablets.
I denne retrospektive analyse af total overlevelse blev Imatinibs overlegenhed vist i forhold til IFN+AraC (p<0,001); inden for 42 måneder var 47 (8,5 %) Imatinib-patienter og 63 (19,4 %) IFN+Ara-Cpatienter døde.
In this retrospective analysis, the superiority of Imatinib over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) Imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
Bærere af HBV, hvor behandling med Imatinib Accord 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 Accord 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).
BCR-ABL-tyrosinkinasehæmmere (TKI'er) er blevet associeret med trombotisk mikroangiopati (TMA), herunder enkeltstående rapporter for imatinib (se pkt.
BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Accord (see section 4.8).
Imatinib Accord hæmmer væksten af disse celler i en vis undergruppe af disse sygdomme.
Imatinib Accord inhibits the growth of these cells in a certain subtype of these diseases.
Imatinib metaboliseres primært i leveren, og kun 13% udskilles via nyrerne.
Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
Præbehandling med gentagne doser af rifampicin 600 mg efterfulgt af enkeltdosis Imatinib 400 mg resulterede i fald i Cmax og AUC(0-∞) på mindst 54% og 74% af værdierne uden rifampicinbehandling.
Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose ofimatinibresulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
However, always take this medicine exactly as your doctor or pharmacist has told you.
Patienter, får behandling med Imatinib Accord og er bekymrede for deres fertilitet, bør konsultere deres læge.
Patients on imatinib treatment who are concerned about their fertility should consult with their physician.
Imatinib var teratogent hos rotter ved administration under organgenese ved doser ≥100 mg/kg, ca. svarende til den maksimale kliniske dosis på 800 mg/dag, baseret på legemsoverfladeareal.
Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
• voksne og børn med Ph+ CML i kronisk fase efter manglende effekt af alfainterferonbehandling, eller i accelereret fase eller blastkrise.
• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
In vitro hæmmer Imatinib O-glucuronidationen af paracetamol med en Ki-værdi på 58,5 mikromol/l.
In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/l.
Kvinder i den fertile alder Kvinder i den fertile alder skal tilrådes at anvende sikker kontraception under behandlingen.
Women of childbearing potential must be advised to use effective contraception during treatment.
• voksne patienter med myelodysplastisk syndrom/myeloproliferative sygdomme (MDS/MPD) som er forbundet med platelet-derived growth factor receptor-omlejring (PDGFR-omlejring).
• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
I undersøgelsen med patienter med inoperabel og/eller metastaserende GIST, oplevede 7 (5%) af patienterne CTC grad 3-4: gastrointestinale blødninger (3 patienter), intra-tumorale 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).
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, hypromellose 6 cps (E464), magnesiumstearat og vandfri kolloid silica.Tabletovertrækket består af hypromellose 6 cps (E464), talkum (E553b), polyethylenglycol, gul jernoxid (E172) og rød jernoxid (E172).
- The other ingredients are microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate and anhydrous colloidal silica.The tablet coating is made of hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, iron oxide yellow (E172) and iron oxide red (E172).
Tabel 4 Kemoterapiregime anvendt i kombination med imatinib
Table 4 Chemotherapy regimen used in combination with imatinib
Cytogenetisk respons Major respons n (%) [95 % CI]
Major response n (%) [95% CI]
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med imatinib i alle undergrupper af den pædiatriske population med Philadelphiakromosom (bcr-abl translokation)-positiv kronisk myeloid leukæmi (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)-positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
ANC = fuldstændigt antal neutrofilocytter aopstået efter mindst 1 måneds behandling
ANC = absolute neutrophil count aoccurring after at least 1 month of treatment Special populations Hepatic insufficiency
Pædiatriske patienter: Ialt 26 pædiatriske patienter i alderen <18 år med enten CML i kronisk fase (n=11) eller CML i blastkrise eller Ph+ akut leukæmi (n=15) blev inkluderet i en fase I undersøgelse med dosis-eskalering.
A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
Imatinib Accord er en behandling til voksne og børn og unge mod:
Imatinib Accord is a treatment for adults and children and adolescents for:
Hvis dosis tolereres, kan den øges ved manglede effekt (se pkt.
If tolerated, the dose can be increased for lack of efficacy (see sections 4.4 and
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 intra-tumoural bleeding in at least some of these patients.
Der er udført tre store, internationale, åbne, ikke-kontrollerede fase II-undersøgelser med patienter med Philadelphia-kromosompositiv (Ph+) CML i fremskreden blastkrise eller accelereret fase, andre Ph+ - leukæmier eller med CML i kronisk fase men tidligere behandlet med alfa-interferonbehandling (IFN) uden effekt.
Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
I et 2-års karcinogenicitetsstudie 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.
Hvis du behandles for DSFP
If you are being treated for DFSP
Genoptag behandling med Imatinib Accord 600 mg.
Resume treatment with Imatinib Accord at 600 mg.
PVC/PVdC/aluminium-blister eller alu/alu-blister.
PVC/PVdC/Alu or Alu/Alu blisters.
Den totale daglige dosis til børn og unge må ikke overstige 800 mg for CML-patienter og 600 mg for Ph+ALL-patienter.
The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.