natgillin/translations-raw huggingface dataset:
I studiet vedrørende nyligt diagnosticeret CML i kronisk fase omfattede dasatinib relaterede væskeretentionsbivirkninger efter mindst 60 måneders opfølgning pleuraeffusion (28%), superficielt ødem (14%), pulmonal hypertension (5%), generaliseret ødem (4%) og perikardie-effusion (4%). 
In the newly diagnosed chronic phase CML study after a minimum of 60 months follow-up, dasatinib-related fluid retention adverse reactions included pleural effusion (28%), superficial oedema (14%), pulmonary hypertension (5%), generalised oedema (4%), and pericardial effusion (4%).
Voksne med accelereret og blastfase CML og Ph+ ALL (startdosis 140 mg én gang dagligt) 
Adults with accelerated and blast phase CML and Ph+ ALL (starting dose 140 mg once daily)
I fase III-dosisoptimeringsstudiet med patienter med CML i fremskreden fase og Ph+ ALL var medianbehandlingsvarigheden 14 måneder for CML i accelereret fase, 3 måneder for CML i myeloid blastfase, 4 måneder for CML i lymfoid blastfase og 3 måneder for Ph+ ALL. 
In the Phase III dose-optimisation study in patients with advanced phase CML and Ph+ ALL, the median duration of treatment was 14 months for accelerated phase CML, 3 months for myeloid blast CML, 4 months for lymphoid blast CML and 3 months for Ph+ ALL.
Patienter med BCR-ABL ≤ 10% efter 3 måneder 
Patients with BCR-ABL ≤ 10% at 3 months
6.6 Regler for bortskaffelse og anden håndtering SPRYCEL pulver til oral suspension skal rekonstitueres af apotekspersonalet eller en kvalificeret sundhedsperson, før det udleveres til patienten. 
SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient.
Raten for MMR på specifikke tidspunkter er vist grafisk i Figur 2. 
MMR rates by specific time point are displayed graphically in Figure 2.
I et konventionelt rottefertilitetsstudie og i et studie vedrørende tidlig embryoudvikling påvirkede dasatinib ikke fertiliteten hos han- eller hunrotter, men inducerede embryoletalitet ved dosisniveauer omtrent svarende til human klinisk eksponeringer. 
Dasatinib did not affect male or female fertility in a conventional rat fertility and early embryonic development study, but induced embryolethality at dose levels approximating human clinical exposures.
I kliniske studier er behandling med SPRYCEL hos pædiatriske patienter med Ph+ ALL administreret kontinuerligt som supplement til successive serier af standardkemoterapi i højst to år. 
In clinical studies, treatment with SPRYCEL in paediatric patients with Ph+ ALL was administered continuously, added to successive blocks of backbone chemotherapy, for a maximum duration of two years.
Første dosis (ml) 
First dose (mL)
Der bør derfor udvises forsigtighed, når dasatinib administreres samtidigt med CYP3A4-substrater med snævert terapeutisk indeks, som fx astemizol, terfenadin, cisaprid, pimozid, quinidin, bepridil eller sekalealkaloider (ergotamin, dihydroergotamin) (se pkt. 
Therefore, caution is warranted when dasatinib is coadministered with CYP3A4 substrates of narrow therapeutic index, such as astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine) (see section 4.5).
Samlet overlevelsesrate på specifikke tidspunkter er vist grafisk i Figur 4. 
The OS rate by specific time point is displayed graphically in Figure 4.
Kumulative grad 3 eller 4 cytopenier hos patienter, der fik 100 mg én gang dagligt, var ens ved år 2 og år 5 og omfattede: neutropeni (35% versus 36%), trombocytopeni (23% versus 24%) og anæmi (13% 
Cumulative grade 3 or 4 cytopaenias among patients treated with 100 mg once daily were similar at 2 and 5 years including: neutropaenia (35% vs. 36%), thrombocytopaenia (23% vs. 24%) and anaemia (13% vs. 13%).
Derudover hæmmer dasatinib kinaser i SRC-kinasefamilien ved subnanomolære koncentrationer. 
Additionally, dasatinib inhibits SRC family kinases at subnanomolar concentrations.
Voksne med CML i kronisk fase (startdosis 100 mg én gang dagligt) 
Adults with chronic phase CML (starting dose 100 mg once daily)
Mens flasken holdes lodret indsættes sprøjtens spids fast i flaskens adapter. 
With the bottle in an upright position, insert the tip of the syringe firmly into the bottle adapter.
Det anbefales at anvende latex- eller nitrilhandsker til hensigtsmæssig bortskaffelse af tabletter, der utilsigtet knuses eller knækkes for at minimere risikoen for optagelse gennem huden. 
The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended, to minimise the risk of dermal exposure.
10 til under 20 
10 to less than 20
ANC < 0,5 × 109/l og/eller trombocytter < 50 × 109/l 
ANC < 0.5 x 109/L and/or platelets < 50 x 109/L
Hvis der udvikles alvorlige, grad 3 eller 4, ikke-hæmatologiske bivirkninger med dasatinib, afbrydes behandlingen, indtil bivirkningen er forsvundet. 
If a severe grade 3 or 4, non-haematologic adverse reaction develops with dasatinib, treatment must be withheld until the adverse reaction has resolved.
Æske der indeholder en flaske med 60 filmovertrukne tabletter. 
Carton containing one bottle with 60 film-coated tablets.
Hos disse patienter var CCyR og MMR hhv. 87,9% [95%CI: (71,8-96,6)] og 45,5% [95% CI: (28,1-63,6)] ved 12 måneder. 
In these patients, CCyR and MMR were CCyR: 87.9% [95% CI: (71.8-96.6)] and MMR: 45.5% [95% CI: (28.1-63.6)] at 12 months.
Derudover er der udført et åbent, randomiseret komparativt fase III-studie med voksne patienter med nyligt diagnosticeret CML i kronisk fase. 
In addition, one open-label, randomised, comparative Phase III study was conducted in adult patients with newly diagnosed chronic phase CML.
PAH (præ-kapillær pulmonal arteriel hypertension diagnosticeret med højresidig hjertekateterisation) er blevet rapporteret i forbindelse med dasatinib behandling. 
PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib exposure.
Pulver: Opbevares ved temperaturer under 25 °C. 
Powder: Store below 25°C.
Blandt 258 dasatinib behandlede patienter og 258 imatinib behandlede patienter med mindst 60 måneders opfølgning i fase III-studiet vedrørende nyligt diagnosticeret CML i kronisk fase rapporteredes QTc-forlængelse som en bivirkning hos 1 patient (< 1%) i hver gruppe. 
In 258 dasatinib-treated patients and 258 imatinib-treated patients with a minimum of 60 months follow-up in the Phase III study in newly diagnosed chronic phase CML, 1 patient (< 1%) in each group had QTc prolongation reported as an adverse reaction.
I fase III-studiet vedrørende nyligt diagnosticeret CML i kronisk fase er følgende grad 3 eller 4 afvigelser i laboratorieundersøgelser rapporteret efter mindst 12 måneders opfølgning hos patienter, der tog SPRYCEL: neutropeni (21%), trombocytopeni (19%) og anæmi (10%). 
In the Phase III newly diagnosed chronic phase CML study, the following grade 3 or 4 laboratory abnormalities were reported after a minimum of 12 months follow-up in patients taking SPRYCEL: neutropaenia (21%), thrombocytopaenia (19%), and anaemia (10%).
Ikke almindelig angst, konfusion, affektlabilitet, nedsat libido Nervesystemet 
Uncommon anxiety, confusional state, affect lability, libido decreased Nervous system disorders
Til patienter, der får dasatinib, bør der derfor vælges alternative midler, der har mindre potentiale for CYP3A4-induktion (se pkt. 
Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5).
Ikke-hæmatologiske bivirkninger 
Non-haematologic adverse reactions
Yderligere effektresultater fremgår af Tabel 11. 
Further efficacy results are reported in Table 11.
c Inkluderer forhøjet natriuretisk peptid i hjernen, ventrikel dysfunktion, venstre ventrikel dysfunktion, højre ventrikel dysfunktion, hjertesvigt, akut hjertesvigt, kronisk hjertesvigt, kongestiv hjertesvigt, kardiomyopati, kongestiv kardiomyopati, diastolisk dysfunktion, nedsat uddrivningsfraktion og ventrikelsvigt, venstre ventrikelsvigt, højre ventrikelsvigt og ventrikel-hypokinesi. 
c Includes brain natriuretic peptide increased, ventricular dysfunction, left ventricular dysfunction, right ventricular dysfunction, cardiac failure, cardiac failure acute, cardiac failure chronic, cardiac failure congestive, cardiomyopathy, congestive cardiomyopathy, diastolic dysfunction, ejection fraction decreased and ventricular failure, left ventricular failure, right ventricular failure, and ventricular hypokinesia.
Efter mindst 60 måneders opfølgning blev der ikke rapporteret om yderligere patienter med QTcF > 500 msek. 
No additional patients were reported to have QTcF > 500 msec after a minimum of 60 months follow-up.
Opkastning Mavesmerter Diarré 
Abdominal pain Diarrhoea
Øvrige indholdsstoffer: saccharose, carmellosenatrium, simeticonemulsion (bestående af simeticon, polyethylenglycolsorbitantristearat, polyethoxylatstearat, glycerider, methylcellulose, xanthangummi, benzoesyre, sorbinsyre, svovlsyre), vinsyre, vandfrit trinatriumcitrat, natriumbenzoat (E211), hydrofobisk silicakolloid, blandet bærsmag (indeholder: benzylalkohol, svovldioxid) (se afsnit 2 "Det skal du vide, før du begynder at tage SPRYCEL"). 
The other ingredients are: sucrose, carmellose sodium, simethicone emulsion (consisting of simeticone, polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides, methylcellulose, xanthan gum, benzoic acid, sorbic acid, sulfuric acid), tartaric acid, trisodium citrate anhydrous, sodium benzoate (E211), silica hydrophobic colloidal, mixed berry flavour (containing: benzyl alcohol, sulphur dioxide) (see section 2 "What you need to know before you take SPRYCEL").
Blandt de 2.182 patienter med resistens eller intolerans over for tidligere behandling med imatinib, som fik dasatinib i kliniske studier, blev QTc-forlængelse indberettet som bivirkning hos 15 (1%) patienter. 
Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received dasatinib in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
CYP3A4-substrater, der vides at have et snævert terapeutisk indeks (fx astemizol, terfenadin, cisaprid, pimozid, quinidin, bepridil eller sekalealkaloider [ergotamin, dihydroergotamin]), skal derfor administreres med forsigtighed til patienter, der får dasatinib (se pkt. 
Therefore, CYP3A4 substrates known to have a narrow therapeutic index (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving dasatinib (see section 4.4).
Der foreligger resultater for 150 patienter: 101 var randomiseret til dasatinib og 49 til imatinib (alle imatinib resistente). 
101 were randomised to dasatinib and 49 to imatinib (all imatinib-resistant).
d Major molekylære responskriterier: Defineret som BCR-ABL/kontroltranskriptioner ≤0,1% ved RQ-PCR i perifere blodprøver. 
d Major molecular response criteria: Defined as BCR-ABL/control transcripts ≤0.1% by RQ-PCR in peripheral blood samples
Forudgående imatinib (N = 46)b a Patienter fra fase-II pædiatrisk studie i nydiagnosticeret CML-CP, som får oral tabletformulering b Patienter fra fase-I og fase-II pædiatriske studier i imitanib resistent eller -intolerant CML-CP, som får oral tabletformulering 
Prior imatinib (N = 46)b a Patients from Phase II paediatric study of newly diagnosed CML-CP receiving oral tablet formulation b Patients from Phase I and Phase II paediatric studies of imatinib-resistant or intolerant CML-CP receiving oral tablet formulation
• 40 mg dagligt for patienter, der tager SPRYCEL 140 mg dagligt. 
• 40 mg daily for patients taking SPRYCEL 140 mg tablet daily.
Mindst 7 års opfølgning 
Minimum of 7 years follow up
Mens sprøjtespidsen holdes godt på plads i flasken, vend flasken med sprøjten om, så den holdes lodret igen. 
Holding the syringe tip firmly in the bottle, turn the bottle with the syringe upright again.
Samtidig brug af dasatinib og en histamin-2 (H2)-antagonist (fx famotidin), protonpumpe-hæmmer (fx omeprazol) eller aluminiumhydroxid/magnesiumhydroxid kan reducere eksponeringen af dasatinib. 
The concomitant use of dasatinib and a histamine-2 (H2) antagonist (e.g. famotidine), proton pump inhibitor (e.g. omeprazole), or aluminium hydroxide/magnesium hydroxide may reduce the exposure to dasatinib.
Hvis cytopeni ikke er relateret til leukæmi stoppes behandlingen indtil ANC ≥ 1,0 × 109/l og trombocytter ≥ 75 × 109/l og genoptages derefter med den oprindelige startdosis eller ved en nedsat dosis. 
If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥1.0 × 109/L and platelets ≥75 × 109/L and resume at the original starting dose or at a reduced dose.
Tabel 1: Dosering af SPRYCEL pulver til oral suspension for patienter med Ph+ CML-CP og pædiatriske patienter med Ph+ ALL (10 mg/ml suspension efter rekonstitution) Legemsvægt (kg) 
Table 1: Dosage of SPRYCEL powder for oral suspension for patients with Ph+ CML-CP and paediatric patients with Ph+ ALL (10 mg/mL suspension upon constitution) Body weight (kg)
Én flaske med pulver til oral suspension indeholder 990 mg dasatinib (som monohydrat). 
One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate).
PAH (præ-kapillær pulmonal arteriel hypertension diagnosticeret med højresidig hjertekateterisation) er blevet rapporteret i forbindelse med dasatinib behandling (se pkt. 
PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib treatment (see section 4.8).
Imatinib resistente patienter 
Imatinib-resistant patients
Ydre karton: sprycel 10 mg/ml 
Outer Carton: sprycel 10 mg/mL
• 20 mg dagligt for patienter, der tager SPRYCEL 70 mg dagligt. 
• 20 mg daily for patients taking SPRYCEL 70 mg tablet daily.
SPRYCEL pulver til oral suspension er også tilgængeligt til pædiatriske patienter med Ph+ CML-CP og Ph+ ALL samt voksne patienter med CML-CP, der ikke kan synke tabletter. 
SPRYCEL powder for oral suspension is also available for paediatric Ph+ CML-CP and Ph+ ALL patients, and adult CML-CP patients, who cannot swallow tablets.
I en undersøgelse med 14 raske forsøgspersoner, resulterede administration af en enkeldosis på 100 mg SPRYCEL 22 timer efter en dosis på 40 mg omeprazol i 4 dage, ved steady state i en reduktion af AUC for dasatinib på 43% og Cmax for dasatinib på 42%. 
In a study of 14 healthy subjects, administration of a single 100-mg dose of SPRYCEL 22 hours following a 4-day, 40-mg omeprazole dose at steady state reduced the AUC of dasatinib by 43% and the Cmax of dasatinib by 42%.
Anbefalet startdosis ved CML i kronisk fase er 100 mg dasatinib én gang dagligt. 
The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily.
Den anbefalede startdosis til voksne patienter med CML i kronisk fase er 100 mg 1 gang dagligt. 
The starting dose recommended for adult patients with chronic phase CML is 100 mg once a day.
SPRYCEL 20 mg, 50 mg eller 70 mg filmovertrukne tabletter fås i æsker med 56 filmovertrukne tabletter i 4 kalender-blisterkort, der hver indeholder 14 filmovertrukne tabletter, samt i æsker med 60 × 1 filmovertrukne tabletter i perforerede engangsdosis-blisterkort. 
SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each, and in cartons containing 60 x 1 film-coated tablets in perforated unit dose blisters.
En patient (< 1%) i hver gruppe havde QTcF > 500 msek. 
One patient (< 1%) in each group experienced a QTcF > 500 msec.
Almindelig artralgi, myalgi, muskelsvaghed, muskulosketal stivhed, muskelspasmer Ikke almindelig rabdomyolyse, osteonekrose, muskelinflammation, tendonitis, artritis 
Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm Uncommon rhabdomyolysis, osteonecrosis, muscle inflammation, tendonitis, arthritis
Daglig dosis, ml (mg) 
Daily Dose, mL (mg)
Hos pædiatriske patienter med Ph+ ALL med ikke-hæmatologiske bivirkninger bør dosis reduceres ét niveau efter behov i henhold til anbefalingerne for dosisreduktion for hæmatologiske bivirkninger beskrevet ovenfor. 
In Ph+ ALL paediatric patients with non-haematologic adverse reactions, if needed, one level of dose reduction should be followed, according to the dose reduction recommendations for haematologic adverse reactions that are described above.
Afvigelser i laboratorieundersøgelser Hæmatologi 
Laboratory test abnormalities Haematology
Effekter på vækst og udvikling hos pædiatriske patienter I pædiatriske studier med SPRYCEL hos imatinib resistente/intolerante pædiatriske patienter med Ph+ CML-CP og behandlingsnaive pædiatriske patienter med Ph+ CML-CP efter mindst 2 års behandling blev behandlingsrelaterede bivirkninger associeret med knoglevækst og -udvikling rapporteret hos 6 (4,6%) patienter, hvoraf én var svær i intensitet (grad 3 væksthæmning). 
Effects on growth and development in paediatric patients In paediatric trials of SPRYCEL in imatinib-resistant/intolerant Ph+ CML-CP paediatric patients and treatment-naive Ph+ CML-CP paediatric patients after at least 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 6 (4.6%) patients, one of which was severe in intensity (Growth Retardation Grade 3).
MÅ IKKE VASKES I OPVASKEMASKINE 
DO NOT USE A DISHWASHER
Data fra raske frivillige, der fik enkeltdosis dasatinib 100 mg 30 minutter efter et fedtrigt måltid, viste en 14% stigning i gennemsnitligt AUC for dasatinib. 
Data from healthy subjects administered a single 100 mg dose of dasatinib 30 minutes following a high-fat meal indicated a 14% increase in the mean AUC of dasatinib.
Baseret på in vitro-data synes dasatinib ikke at være aktiv over for T315I-mutationen. 
A different spectrum of mutation was detected in the imatinib treatment arm. Dasatinib does not appear to be active against the T315I mutation, based on in vitro data.
CML i kronisk fase - resistens eller intolerans over for tidligere imatinib behandling 
Chronic phase CML - Resistance or intolerance to prior imatinib therapy
Andre lægemidler, der inducerer CYP3A4-aktivitet (fx dexamethason, phenytoin, carbamazepin, phenobarbital eller naturlægemidler, der indeholder Hypericum perforatum, også kendt som perikon), kan øge metabolismen og reducere plasmakoncentrationer af dasatinib. 
Other medicinal products that induce CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John´s Wort) may also increase metabolism and decrease dasatinib plasma concentrations.
Uåbnet flaske 
Unopened bottle 2 years.
Hjerne: slagtilfælde, midlertidig episode med neurologiske forstyrrelser på grund af nedsat blodtilførsel, lammelse af ansigtsnerverne, demens Immunsystemet: alvorlig allergisk reaktion 
Brain: stroke, temporary episode of neurologic dysfunction caused by loss of blood flow, facial nerve paralysis, dementia
SPRYCEL indeholder lactose 
SPRYCEL contains lactose
Fjern sprøjten fra flasken uden at trykke stemplet ned. 
Remove the syringe from the bottle being careful not to depress the plunger.
Der blev observeret en klinisk signifikant stigning i den samlede hyppighed af planocellulært karcinom og papillomer i uterus og cervix i høj-dosis hunrotter og prostataadenom i lav-dosis hanrotter. 
A statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose females and of prostate adenoma in low-dose males was noted.
Almindelig febril neutropeni Ikke almindelig lymfadenopati, lymfopeni 
Common febrile neutropaenia Uncommon lymphadenopathy, lymphopaenia
I pædiatriske studier med SPRYCEL i kombination med kemoterapi hos nydiagnosticerede pædiatriske patienter med Ph+ ALL blev der, efter maksimalt 2 års behandling, rapporteret behandlingsrelaterede bivirkninger associeret med knoglevækst og udvikling hos 1 (0,6%) patient. 
In paediatric trials of SPRYCEL in combination with chemotherapy in newly diagnosed Ph+ ALL paediatric patients after a maximum of 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 1 (0.6%) patient.
SPRYCEL 80 mg, 100 mg eller 140 mg filmovertrukne tabletter fås i æsker med 30 × 1 filmovertrukne tabletter i perforerede engangsdosis-blisterkort. 
SPRYCEL 80 mg, 100 mg or 140 mg film-coated tablets are available in cartons containing 30 x 1 film-coated tablets in perforated unit dose blisters.
Baseret på Kaplan-Meier-estimaterne opretholdt 95% (95% CI: [92%-98%]) af patienterne MCyR i et år og 88% (95% CI: [83%-93%]) opretholdt MCyR i to år. 
Based on the Kaplan-Meier estimates, 95% (95% CI: [92%-98%]) of the patients maintained MCyR for 1 year and 88% (95% CI: [83%-93%]) maintained MCyR for 2 years.
Andelen af patienter som opretholdt CCyR i et år var 97% (95% CI: [94%-99%]) og 90% (95% CI: [86%-95%]) i to år. 
The proportion of patients who maintained CCyR for 1 year was 97% (95% CI: [94%-99%]) and for 2 years was 90% (95% CI: [86%-95%]).
Lægemiddelrelaterede blødningsbivirkninger spændende fra petekkier og epistaxis til grad 3 eller 4 gastrointestinal blødning og blødning i centralnervesystemet (CNS) er rapporteret hos patienter, der tager SPRYCEL (se pkt. 
Bleeding drug-related adverse reactions, ranging from petechiae and epistaxis to grade 3 or 4 gastrointestinal haemorrhage and CNS bleeding, were reported in patients taking SPRYCEL (see section 4.4).
Der er gennemført 2 randomiserede, åbne studier for at evaluere effekten af dasatinib administreret én gang dagligt, sammenlignet med dasatinib administreret 2 gange dagligt. 
Two randomised, open-label studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily.
Fordøjelsesproblemer: diarré, kvalme eller opkastning Hud, hår, øjne, generelt: udslæt, feber, hævelse af ansigt, hænder og fødder, hovedpine, følelse af træthed eller svaghed, blødning 
Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting) Skin, hair, eye, general: skin rash, fever, swelling around the face, hands and feet, headache, feeling tired or weak, bleeding
Almindelig appetitforstyrrelsera, hyperurikæmi Ikke almindelig tumorlysesyndrom, dehydrering, hypoalbuminæmi, hyperkolesterolæmi 
Common appetite disturbancesa, hyperuricaemia Uncommon tumour lysis syndrome, dehydration, hypoalbuminemia, hypercholesterolemia
Tabel 9: Effektresultater fra et fase 3-studie hos patienter med nyligt diagnosticeret CML i kronisk fase 
Table 9: Efficacy results from a phase 3 study of newly diagnosed patients with chronic phase CML
b Hæmatologiske responskriterier (alle responser blev bekræftet efter 4 uger): Større hæmatologisk respons: (MaHR) 
b Haematologic response criteria (all responses confirmed after 4 weeks): Major haematologic response (MaHR) = complete haematologic response (CHR) + no evidence of leukaemia (NEL).
20 til under 30 
20 to less than 30
2 Hvis cytopeni ikke er relateret til leukæmi stoppes behandlingen, indtil ANC ≥ 1,0 × 109/l og trombocytter ≥ 20 × 109/l og genoptages med den oprindelige startdosis. 
2 If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 20 x 109/L and resume at the original starting dose.
Tid til MMR var konsekvent kortere hos dasatinib behandlede patienter sammenlignet med imatinib behandlede patienter. 
The time to MMR was consistently shorter in dasatinib-treated patients compared with imatinib-treated patients.