natgillin/translations-raw huggingface dataset:
Tabel 15: Effekt af SPRYCEL hos pædiatriske patienter med CML-CP Kumulativt respons over tid efter minimum opfølgningsperiode 3 måneder
Table 15: Efficacy of SPRYCEL in paediatric patients with CML-CP Cumulative response over time by minimum follow-up period 3 months
Ph+ akut lymfoblastær leukæmi (ALL) og CML i lymfoid blastfase med resistens eller intolerans over for tidligere behandling.
Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Der er ikke gennemført kliniske studier med SPRYCEL hos patienter med nedsat nyrefunktion (patienter med en serumkreatinin-koncentration > 3 gange den øvre normalgrænse blev ekskluderet fra studiet med patienter med nyligt diagnosticeret CML i kronisk fase, og patienter med en serumkreatinin-koncentration > 1,5 gange den øvre normalgrænse blev ekskluderet i studier med patienter med CML i kronisk fase med resistens eller intolerans over for tidligere behandling med imatinib).
No clinical studies were conducted with SPRYCEL in patients with decreased renal function (the study in patients with newly diagnosed chronic phase CML excluded patients with serum creatinine concentration > 3 times the upper limit of the normal range, and studies in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy excluded patients with serum creatinine concentration > 1.5 times the upper limit of the normal range).
Dog bør SPRYCEL anvendes med forsigtighed hos patienter med leverinsufficiens (se pkt.
However, SPRYCEL should be used with caution in patients with hepatic impairment (see section 5.2).
30 til under 45
30 to less than 45
Det skal du vide, før du begynder at tage SPRYCEL
What you need to know before you take SPRYCEL
Efter mindst 12 måneders opfølgning fik 85% af de patienter, der var randomiseret til SPRYCEL gruppen, og 81% af de patienter, der var randomiseret til imatinib gruppen, stadig førstelinjebehandling.
With a minimum of 12 months follow-up, 85% of patients randomised to the SPRYCEL group and 81% of patients randomised to the imatinib group were still receiving first-line treatment.
Hovedpine Nedsat appetit Træthed a I det pivotale studie fik 24 patienter ud af et samlet antal på 106 patienter pulveret til oral suspension mindst én gang, og 8 af dem fik udelukkende pulveret til oral suspension.
Decreased appetite Fatigue a In the pivotal study, among 106 total patients, 24 patients received the powder for oral suspension at least once, 8 of whom received the powder for oral suspension formulation exclusively.
Hos pædiatriske patienter med Ph+ ALL behandlet med dasatinib i kombination med kemoterapi skal der tages CBC før påbegyndelse af hver kemoterapiserie og som klinisk indiceret.
In paediatric patients with Ph+ ALL treated with dasatinib in combination with chemotherapy, CBCs should be performed prior to the start of each block of chemotherapy and as clinically indicated.
Hos patienter med resistent myelosuppression er hæmatopoietisk vækstfaktor blevet anvendt.
Haematopoietic growth factor has been used in patients with resistant myelosuppression.
I det fase-II pædiatriske studie, progredierede 1 nydiagnosticeret patient og 2 imatinib resistente eller intolerante patienter til blastfase CML.
In the Phase II paediatric study, 1 newly diagnosed patient and 2 imatinib-resistant or intolerant patients progressed to blast phase CML.
c CA180-035 studieresultater ved anbefalet startdosis på 140 mg én gang dagligt.
c CA180-035 study results in recommended starting dose of 140 mg once daily.
Behandling med dasatinib er forbundet med anæmi, neutropeni og trombocytopeni.
Treatment with dasatinib is associated with anaemia, neutropaenia and thrombocytopaenia.
Raten for MMR i SPRYCEL og imatinib gruppen inden for 3 måneder (8% og 0,4%), 6 måneder (27% og 8%), 9 måneder (39% og 18%), 12 måneder (46% og 28%), 24 måneder (64% og 46%), 36 måneder (67% og 55%), 48 måneder (73% og 60%) og 60 måneder (76% og 64%) var også i overensstemmelse med det primære endepunkt.
The rates of MMR in the SPRYCEL and imatinib treatment groups, respectively, within 3 months (8% and 0.4%), 6 months (27% and 8%), 9 months (39% and 18%), 12 months (46% and 28%), 24 months (64% and 46%) , 36 months (67% and 55%), 48 months (73% and 60%) and 60 months (76% and 64%)were also consistent with the primary endpoint.
Selvom sikkerhedsprofilen for SPRYCEL hos ældre svarer til den for yngre patienter, er der større sandsynlighed for, at patienter over 65 år oplever de oftest rapporterede bivirkninger som f.eks. træthed, pleuraeffusion, dyspnø, hoste, nedre gastrointestinal blødning og appetitforstyrrelser og de mindre hyppigt rapporterede bivirkninger som f.eks. abdominal distension, svimmelhed, perikardieeffusion, kongestiv hjertesvigt og vægttab og bør derfor monitoreres omhyggeligt (se pkt.
While the safety profile of SPRYCEL in elderly was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions such as fatigue, pleural effusion, dyspnoea, cough, lower gastrointestinal haemorrhage, and appetite disturbance and more likely to experience less frequently reported adverse reactions such as abdominal distention, dizziness, pericardial effusion, congestive heart failure, and weight decrease and should be monitored closely (see section 4.4).
Andelen af patienter, der opnåede en BCR-ABL-ratio på ≤0,01% (4-log-reduktion) til enhver tid, var større i SPRYCEL gruppen end i imatinib gruppen (54,1% versus 45%).
The proportion of patients achieving BCR-ABL ratio of ≤0.01% (4-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (54.1% versus 45%).
For patienter med CML i kronisk fase, som fik 100 mg én gang dagligt, anbefales dosisreduktion til 80 mg én gang dagligt med yderligere reduktion fra 80 mg til 50 mg én gang dagligt, hvis det findes nødvendigt.
For patients with chronic phase CML who received 100 mg once daily, dose reduction to 80 mg once daily with further reduction from 80 mg once daily to 50 mg once daily, if needed, is recommended.
SPRYCEL skal administreres én gang dagligt gennem munden i form af enten SPRYCEL tabletter eller SPRYCEL pulver til oral suspension.
SPRYCEL is administered orally once daily in the form of either SPRYCEL tablets or SPRYCEL powder for oral suspension.
SPRYCEL anvendes også til behandling af Philadelphiakromosom-positiv (Ph+) akut lymfoblastisk leukæmi (ALL) hos voksne, unge og børn i alderen 1 år og derover og CML i lymfoid blastfase hos voksne, som ikke har haft gavn af tidligere behandlinger.
SPRYCEL is also used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents and children at least 1 year of age, and lymphoid blast CML in adults who are not benefiting from prior therapies.
Hjertebivirkningerne kongestiv hjerteinsufficiens / kardiel dysfunktion, perikardie-effusion, arytmier, palpitationer, QT-forlængelse og myokardieinfarkt (herunder letalt) blev rapporteret hos patienter, der tog dasatinib.
The cardiac adverse reactions of congestive heart failure/cardiac dysfunction, pericardial effusion, arrhythmias, palpitations, QT prolongation and myocardial infarction (including fatal) were reported in patients taking dasatinib.
Tabel 10: Dasatinib patienter BCR-ABL ≤ 10% og > 10% efter 3 måneder
Table 10: Dasatinib patients with BCR-ABL ≤ 10% and > 10% at 3 months
Hæmatologisk parameter Neutropeni Trombocytopeni Anæmi a Resultater fra fase III-dosisoptimeringsstudie rapporteret ved studieopfølgning efter 2 år.
Haematology parameters Neutropaenia Thrombocytopaenia Anaemia a Phase 3 dose optimisation study results reported at 2 year study follow up.
Ét randomiseret, ikke-komparativt studie udførtes med patienter i kronisk fase, som oplevede behandlingssvigt ved initial behandling med 400 eller 600 mg imatinib.
One randomised non-comparative study was conducted in chronic phase patients who failed initial treatment with 400 or 600 mg imatinib.
I 5 fase II kliniske studier med patienter med resistens eller intolerans over for tidligere behandling med imatinib blev der taget gentagen ekg ved baseline samt under studiet på præspecificerede tidspunkter på 865 patienter, der fik SPRYCEL 70 mg to gange dagligt.
In 5 Phase II clinical studies in patients with resistance or intolerance to prior imatinib therapy, repeated baseline and on-treatment ECGs were obtained at pre-specified time points and read centrally for 865 patients receiving SPRYCEL 70 mg twice daily.
I dette historisk kontrollerede fase II-multicenterstudie med dasatinib som supplement til standardkemoterapi fik 106 pædiatriske patienter med nydiagnosticeret Ph+ ALL, hvoraf 104 patienter havde bekræftet Ph+ ALL, dasatinib i en daglig dosis på 60 mg/m2 i et kontinuerligt dosisregime i op til 24 måneder i kombination med kemoterapi.
In this multicenter, historically-controlled Phase II study of dasatinib added to standard chemotherapy, 106 paediatric patients with newly diagnosed Ph+ ALL, of whom 104 patients had confirmed Ph+ ALL, received dasatinib at a daily dose of 60 mg/m2 on a continuous dosing regimen for up to
0,58-1,73, p= 0,9800) og PFS (HR 1,00, 95% CI: 0,58-1,72, p = 0,9998) mellem dasatinib og imatinib.
There was no difference in OS (HR 1.01, 95% CI: 0.58-1.73, p= 0.9800) and PFS (HR 1.00, 95% CI: 0.58-1.72, p = 0.9998) between dasatinib and imatinib.
Herefter genoptages behandlingen, eventuelt med reduceret dosis, afhængigt af bivirkningens initiale sværhedsgrad.
Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the adverse reaction.
I kliniske studier med patienter med CML i fremskreden fase, som fik den anbefalede dosis af SPRYCEL (n=304), sås svær blødning i centralenervesystemet (CNS) hos 1% af patienterne.
In clinical studies in patients with advanced phase CML receiving the recommended dose of SPRYCEL (n=304), severe central nervous system (CNS) haemorrhage occurred in 1% of patients.
Seponering inden for 12 måneder på grund af sygdomsprogression forekom hos 3% af de patienter, der blev behandlet med SPRYCEL, og hos 5% af de patienter, der blev behandlet med imatinib.
Discontinuation within 12 months due to disease progression occurred in 3% of SPRYCEL-treated patients and 5% of imatinib-treated patients.
Dosiseskalering frarådes til pædiatriske patienter med Ph+ ALL, da SPRYCEL administreres i kombination med kemoterapi til disse patienter.
Dose escalation is not recommended for paediatric patients with Ph+ ALL, as SPRYCEL is administered in combination with chemotherapy in these patients.
Almindelig neuropati (inklusive perifer neuropati), svimmelhed, dysgeusi, døsighed Ikke almindelig CNS-blødning*b, synkope, tremor, amnesi, balanceforstyrrelser
Very common headache Common neuropathy (including peripheral neuropathy), dizziness, dysgeusia, somnolence Uncommon CNS bleeding*b, syncope, tremor, amnesia, balance disorder
Af de 130 SPRYCEL behandlede pædiatriske forsøgspersoner med CML-CP oplevede 2 (1,5%) bivirkninger, der førte til seponering.
Of the 130 SPRYCEL-treated paediatric subjects with CML-CP, 2 (1.5%) experienced adverse reactions leading to treatment discontinuation.
Dette lægemiddel indeholder 2,1 mg natrium pr. ml SPRYCEL oral suspension.
This medicinal product contains 2.1 mg sodium per mL of SPRYCEL oral suspension.
Primære effektendepunkter var fuldstændigt cytogenetisk respons (CCyR), større cytogenetisk respons (MCyR) og større molekylært respons (MMR).
Key efficacy endpoints were: complete cytogenetic response (CCyR), major cytogenetic response (MCyR) and major molecular response (MMR).
Hvis der opstår en moderat, grad 2, ikke-hæmatologisk bivirkning med dasatinib, skal behandlingen afbrydes, indtil bivirkningen er forsvundet eller vendt tilbage til baseline.
If a moderate, grade 2, non-haematologic adverse reaction develops with dasatinib, treatment should be interrupted until the adverse reaction has resolved or returned to baseline.
SPRYCEL 10 mg/ml pulver til oral suspension dasatinib
SPRYCEL 10 mg/mL powder for oral suspension dasatinib
Sjælden cor pulmonale, myokarditis, akut koronarsyndrom, hjertestop, PR-forlængelse i elektrokardiogram, koronararteriesygdom, pleuroperikarditis
Rare cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest, electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis
CML i lymfoid blastfase og Ph+ ALL
Lymphoid blast phase CML and Ph+ ALL
Æske der indeholder 56 filmovertrukne tabletter i 4 kalender-blistere, som hver indeholder 14 filmovertrukne tabletter.
Carton containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each.
100 mg a Tabletten anbefales ikke til patienter, der vejer mindre end 10 kg; pulveret til oral suspension bør bruges til disse patienter.
100 mg a The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients.
Efter opklaring af en efterfølgende episode bør genintroduktion af dasatinib ved ét dosisniveau lavere overvejes.
Following resolution of a subsequent episode, dasatinib at one dose level reduction should be reintroduced.
Cytogent responsc (%)
Cytogenetic responsec (%)
Det skal tilsikres, at den medfølgende adapter til placering af sprøjten er sat godt fast i flasken.
Make sure the adapter provided on the bottle for syringe placement is firmly pressed into the bottle.
Medianbehandlingsvarigheden var 23 måneder for dasatinib (med 44% af patienterne behandlet i > 24 måneder indtil dato) og 3 måneder for imatinib (med 10% af patienterne behandlet i > 24 måneder til dato).
Median duration of treatment was 23 months for dasatinib (with 44% of patients treated for > 24 months to date) and 3 months for imatinib (with 10% of patients treated for > 24 months to date).
Patienter med BCR-ABL > 10% efter 3 måneder
Patients with BCR-ABL > 10% at 3 months
Hos rotter hæmmede dasatinib trombocytaggregationen in vitro og forlængede overhudsblødning in vivo, men forårsagede ikke spontan blødning.
In rats, dasatinib inhibited platelet aggregation in vitro and prolonged cuticle bleeding time in vivo, but did not invoke spontaneous haemorrhage.
Hos patienter med CML i kronisk fase (n=548) fik 5 patienter (1%), der blev behandlet med dasatinib, grad 3 eller 4 blødning.
In patients with chronic phase CML (n=548), 5 patients (1%) receiving dasatinib had grade 3 or 4 haemorrhage.
Der er udført 4 kliniske, ukontrollerede, åbne, fase II, enkeltarmsstudier for at bestemme sikkerhed og effekt af dasatinib hos patienter med kronisk, accelereret eller myeloid blastfase CML, som enten var resistente eller intolerante over for imatinib.
Four single-arm, uncontrolled, open-label Phase II clinical studies were conducted to determine the safety and efficacy of dasatinib in patients with CML in chronic, accelerated, or myeloid blast phase, who were either resistant or intolerant to imatinib.
SPRYCEL indeholder det aktive stof dasatinib.
SPRYCEL contains the active substance dasatinib.
Hvis du har taget for mange SPRYCEL tabletter Hvis du ved en fejl har taget for mange tabletter, skal du straks kontakte lægen.
If you have accidentally taken too many tablets, talk to your doctor immediately.
Effekten af en enkeltdosis dasatinib på farmakokinetikken ved leverinsufficiens blev undersøgt hos 8 forsøgspersoner med moderat leverinsufficiens, som fik en dosis på 50 mg, og 5 forsøgspersoner med alvorlig leverinsufficiens, som fik en dosis på 20 mg sammenlignet med sammenlignelige raske forsøgspersoner, som fik en dosis på 70 mg dasatinib.
The effect of hepatic impairment on the single-dose pharmacokinetics of dasatinib was assessed in 8 moderately hepatic-impaired subjects who received a 50 mg dose and 5 severely hepatic-impaired subjects who received a 20 mg dose compared to matched healthy subjects who received a 70 mg dose of dasatinib.
Almindelig kongestivt hjertesvigt/hjerteinsufficiens*c, perikardie-effusion*, arytmi (inklusive takykardi), palpitationer
Common congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia (including tachycardia), palpitations
Efter mindst 60 måneders opfølgning var den kumulative rate for grad 3 eller 4 hypofosfatæmi 7%, for grad 3 eller 4 forhøjelse af kreatinin og bilirubin 1%, og for grad 3 eller 4 forhøjelse af aminotransferase forblev frekvensen 1%.
After a minimum of 60 months follow-up the cumulative rate of grade 3 or 4 hypophosphataemia was 7%, grade 3 or 4 elevations of creatinine and bilirubin was 1% and grade 3 or 4 elevations of transaminases remained 1%.
Raten for cCCyR i SPRYCEL og imatinib gruppen inden for 3 måneder (54% og 30%), 6 måneder (70% og 56%), 9 måneder (75% og 63%), 24 måneder (80% og 74%), 36 måneder (83% og 77%), 48 måneder (83% og 79%) og 60 måneder (83% og 79%) var i overensstemmelse med det primære endepunkt.
The rates of cCCyR in the SPRYCEL and imatinib treatment groups, respectively, within 3 months (54% and 30%), 6 months (70% and 56%), 9 months (75% and 63%), 24 months (80% and 74%), 36 months (83% and 77%), 48 months (83% and 79%) and 60 months (83% and 79%) were consistent with the primary endpoint.
SPRYCEL bør ikke tages sammen med grapefrugt eller grapefrugtjuice (se pkt.
SPRYCEL should not be taken with grapefruit or grapefruit juice (see section 4.5).
Der blev indberettet grad 3 eller 4 hypokalcæmi, hypokaliæmi og hypofosfatæmi hos patienter i alle CML-faser, men med øget hyppighed hos patienter med CML i myeloid eller lymfoid blastfase og Ph+ ALL.
Grade 3 or 4 hypocalcaemia, hypokalaemia, and hypophosphataemia were reported in patients with all phases of CML but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML and Ph+ ALL.
SPRYCEL leveres som et hvidt til næsten hvidt pulver til oral suspension, og som bliver til en hvid til gul uigennemsigtig suspension efter blanding.
What SPRYCEL looks like and contents of the pack SPRYCEL is supplied as a white to off-white powder for oral suspension which forms a white to yellow opaque suspension after constitution with water.
Patienterne blev randomiseret til at få enten SPRYCEL 100 mg én gang dagligt eller imatinib 400 mg én gang dagligt.
Patients were randomised to receive either SPRYCEL 100 mg once daily or imatinib 400 mg once daily.
For at opnå den anbefalede dosis findes SPRYCEL som 20 mg, 50 mg, 70 mg, 80 mg, 100 mg og 140 mg filmovertrukne tabletter og pulver til oral suspension (10 mg/ml suspension efter rekonstitution).
To achieve the recommended dose, SPRYCEL is available as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg film-coated tablets and powder for oral suspension (10 mg/mL suspension upon constitution).
Tabletten anbefales ikke til patienter, der vejer mindre end 10 kg; pulveret til oral suspension bør bruges til disse patienter.
The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients.
Dosis (maksimal daglig dosis) Oprindelig startdosis
Dose (maximum dose per day) Original starting dose
Almindelig synsforstyrrelser (inklusive synsforstyrrelser, sløret syn og nedsat syn), tørre øjne Ikke almindelig nedsat syn, konjunktivitis, fotofobi, tåreflåd Øre og labyrint
Common visual disorder (including visual disturbance, vision blurred, and visual acuity reduced), dry eye Uncommon visual impairment, conjunctivitis, photophobia, lacrimation increased Ear and labyrinth disorders
De fås også i flasker med børnesikret lukning, der indeholder 60 filmovertrukne tabletter.
They are also available in bottles with child-resistant closure containing 60 film-coated tablets.
b CA180-034 studieresultater ved anbefalet startdosis på 100 mg én gang dagligt.
b CA180-034 study results in recommended starting dose of 100 mg once daily.
Responsrater er vist i tabel 14.
Response rates are presented in Table 14.
1 Stop behandling indtil ANC ≥ 1,0 × 109/l og trombocytter ≥ 50 × 109/l.
1 Stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L.
Ikke almindelig forhøjet blod-kreatinfosfokinase, forhøjet gammaglutamyltransferase Traumer, forgiftninger og behandlingskomplikationer
Uncommon blood creatine phosphokinase increased, gamma-glutamyltransferase increased Injury, poisoning, and procedural complications
De fås også i flasker med børnesikret lukning, der indeholder 30 filmovertrukne tabletter.
They are also available in bottles with child-resistant closure containing 30 film-coated tablets.
Seponering inden for 60 måneder på grund af sygdomsprogression forekom hos 11% af de patienter, der blev behandlet med SPRYCEL, og hos 14% af de patienter, der blev behandlet med imatinib.
Discontinuation within 60 months due to disease progression occurred in 11% of SPRYCEL-treated patients and 14% of imatinib-treated patients.
Smerter: muskelsmerter (under eller efter ophør af behandling), mavesmerter Undersøgelser kan vise: lavt antal blodplader, lavt antal hvide blodlegemer (neutropeni), blodmangel, væske omkring lungerne
Pain: pain in the muscles (during or after discontinuing treatment), tummy (abdominal) pain Tests may show: low blood platelet count, low white blood cells count (neutropaenia), anaemia, fluid around the lungs
Data beskrevet nedenfor afspejler eksponeringen for SPRYCEL som enkeltstofbehandling ved alle doser testet i kliniske studier (N=2.900), inklusive 324 voksne patienter med nydiagnosticeret CML i kronisk fase, 2.388 voksne patienter med imatinib resistent eller intolerant CML eller Ph+ ALL i kronisk eller fremskreden fase samt 188 pædiatriske patienter.
The data described below reflect the exposure to SPRYCEL as single-agent therapy at all doses tested in clinical studies (N=2,900), including 324 adult patients with newly diagnosed chronic phase CML, 2,388 adult patients with imatinib-resistant or -intolerant chronic or advanced phase CML or Ph+ ALL, and 188 paediatric patients.
Saccharose Natriumcarmellose Simeticonemulsion bestående af: simeticon, polyethylenglycolsorbitantristearat, polyethoxylatstearat, glycerider, methylcellulose, xanthangummi, benzoesyre, sorbinsyre, svovlsyre.
Sucrose Carmellose sodium Simethicone emulsion consisting of: simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides, methylcellulose, xanthan gum, benzoic acid, sorbic acid, sulfuric acid.
SPRYCEL udskrives til voksne og børn på 1 år og derover.
SPRYCEL is prescribed for adults and children at least 1 year of age.
Startdosis af dasatinib var 70 mg, 2 gange dagligt.
The starting dose was 70 mg dasatinib twice daily.
Tabel 4: Dosisreduktion for samtidig brug af potente CYP3A4-hæmmere til pædiatriske patienter
Table 4: Dose reduction for concomitant use of strong CYP3A4 inhibitors in paediatric patients
Andelen af patienter, der opnåede en BCR-ABL-ratio på ≤0,0032% (4,5-log-reduktion) til enhver tid, var større i SPRYCEL gruppen end i imatinib gruppen (44% versus 34%).
The proportion of patients achieving BCR-ABL ratio of ≤0.0032% (4.5-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (44% versus 34%).
Dette lægemiddel bruges til at behandle kronisk myeloid leukæmi (CML) og Philadelphiakromosom-positiv (Ph+) akut lymfoblastisk leukæmi (ALL) hos unge og hos børn på 1 år eller derover.
This medicine is used to treat chronic myeloid leukaemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in adolescents and children from at least one year of age.
Ikke almindelig myokardieinfarkt (inklusive letal udgang)*, forlænget QT i elektrokardiogram*, perikarditis, ventrikulær arytmi (inklusive ventrikulær takykardi), angina pectoris, kardiomegali, abnorme T-takker i elektrokardiogram, forhøjet troponin
Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased
Dasatinib inducerede immunosuppression hos mus, som var dosisrelateret og som effektivt kunne behandles med dosisreduktion og/eller ændringer i dosisskemaet.
In mice, dasatinib induced immunosuppression, which was dose-related and effectively managed by dose reduction and/or changes in dosing schedule.