natgillin/translations-raw huggingface dataset:
Følgende kan alle være tegn på alvorlige bivirkninger: hvis du har brystsmerter, vejrtrækningsbesvær, hoste, eller hvis du besvimer hvis du får uventet blødning eller blå mærker uden at du har slået dig hvis du har blod i opkast, afføring eller urin, eller sortfarvet afføring hvis du får tegn på infektion, som for eksempel feber eller voldsomme kulderystelser hvis du får feber, ømhed i munden eller halsen, blæredannelse eller afskalning af huden og/eller slimhinderne Kontakt straks lægen, hvis du får en eller flere af ovenstående bivirkninger. 
The following can all be signs of serious side effects: if you have chest pain, difficulty breathing, coughing and fainting if you experience unexpected bleeding or bruising without having an injury if you find blood in your vomit, stools or urine, or have black stools if you get signs of infections such as fever, severe chills if you get fever, sore mouth or throat, blistering or peeling of your skin and/or mucous membranes Contact your doctor immediately if you notice any of the above.
Dosering én gang dagligt viste sammenlignelig effekt (non-inferioritet) med dosering 2 gange dagligt med hensyn til det primære effektendepunkt (forskel i MaHR 0,8%; 95% konfidensinterval [-7,1% - 8,7%]); behandling med 140 mg én gang dagligt viste imidlertid forbedret sikkerhed og tolerabilitet. 
The once daily schedule demonstrated comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MaHR 0.8%; 95% confidence interval [-7.1% - 8.7%]); however, the 140 mg once daily regimen demonstrated improved safety and tolerability.
Følgende kan alle være tegn på alvorlige bivirkninger: hvis du har brystsmerter, vejrtrækningsbesvær, hoste, eller hvis du besvimer hvis du får uventet blødning eller blå mærker uden at du har slået dig hvis du har blod i opkast, afføring eller urin, eller sortfarvet afføring hvis du får tegn på infektion, som for eksempel feber eller voldsomme kulderystelser hvis du får feber, ømhed i munden eller halsen, blæredannelse eller afskalning af huden og/eller slimhinderne 
The following can all be signs of serious side effects: if you have chest pain, difficulty breathing, coughing and fainting if you experience unexpected bleeding or bruising without having an injury if you find blood in your vomit, stools or urine, or have black stools if you get signs of infections such as fever, severe chills if you get fever, sore mouth or throat, blistering or peeling of your skin and/or mucous membranes
• 20 mg dagligt for patienter, der tager SPRYCEL 100 mg dagligt. 
• 20 mg daily for patients taking SPRYCEL 100 mg tablet daily.
Forekomsten er tidligere og hyppigere hos patienter med CML eller Ph+ ALL i fremskreden fase end med CML i kronisk fase. 
Their occurrence is earlier and more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML.
c Betydeligt molekylært respons (til enhver tid) er defineret som BCR-ABL forhold ≤ 0,1% ved RQ-PCR i perifere blodprøver, som er standardiseret efter den internationale skala. 
c Major molecular response (at any time) was defined as BCR ABL ratios ≤ 0.1% by RQ PCR in peripheral blood samples standardised on the International scale.
Hos pædiatriske patienter med CML-CP med ikke-hæmatologiske bivirkninger bør anbefalingerne for dosisreduktion for hæmatologiske bivirkninger beskrevet ovenfor følges. 
In CML-CP paediatric patients with non-haematologic adverse reactions, the dose reduction recommendations for haematologic adverse reactions that are described above should be followed.
Der forekom svær væskeretention hos 32 patienter (6%) ud af alle patienter med CML i kronisk fase, der fik SPRYCEL ved den anbefalede dosis (n=548). 
In all SPRYCEL treated patients with chronic phase CML, severe fluid retention occurred in 32 patients (6%) receiving SPRYCEL at the recommended dose (n=548).
Der er gennemført 2 randomiserede, åbne fase III-studier for at evaluere effekten af dasatinib, administreret én gang dagligt sammenlignet med dasatinib, administreret 2 gange dagligt. 
Two randomised, open-label Phase III studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily.
I det pædiatriske fase-II-studie med patienter, der fik tabletformuleringen, var den estimerede 24måneders PFS blandt de 51 patienter med nydiagnosticeret CML-CP 94,0% (82,6; 98,0) og 81,7% (61,4; 92,0) blandt de 29 patienter med imatinib resistent/intolerant CML-CP. 
In the Phase II paediatric study, in patients receiving the tablet formulation, estimated 24-month PFS rate among the 51 patients with newly diagnosed CML-CP was 94.0% (82.6, 98.0), and 81.7% (61.4, 92.0) among the 29 patients with imatinib-resistant/intolerant CML-CP. After 24 months of follow-up, OS in newly diagnosed patients was 100%, and 96.6% in imatinib-resistant or intolerant patients.
Ikke almindelig nyreinsufficiens (inklusive nyresvigt), hyppig vandladning, proteinuri 
Uncommon renal impairment (including renal failure), urinary frequency, proteinuria
Ved år 5 p<0,0251 
By 5 years 42%, p<.0251
Der er gennemført et åbent, enkeltarms-, multicenter-studie med patienter med intolerans eller resistens over for imatinib. 
An open-label, single-arm, multicentre study was conducted in patients intolerant or resistant to imatinib.
Langvarig suppression af mavesyresekretion ved H2-antagonister eller protonpumpe-hæmmere (fx famotidin og omeprazol) vil sandsynligvis reducere eksponeringen af dasatinib. 
Long-term suppression of gastric acid secretion by H2 antagonists or proton pump inhibitors (e.g. famotidine and omeprazole) is likely to reduce dasatinib exposure.
MMR (95% CI) Nydiagnosticeret (N = 51)a 
MMR (95% CI) Newly diagnosed (N = 51)a
Fordøjelsesproblemer: tab af vigtige næringsstoffer som f.eks. protein fra fordøjelseskanalen, forstoppelse, fistel i endetarmen (unormal åbning fra endetarmen til huden omkring endetarmen), nedsat nyrefunktion, sukkersyge 
Digestive problems: loss of vital nutrients such as protein from your digestive tract, bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus), impairment of kidney function, diabetes
SPRYCEL 80 mg, SPRYCEL 100 mg og SPRYCEL 140 mg filmovertrukne tabletter Alu/Alu blistere (perforerede enkeltdosisblistere). 
SPRYCEL 80 mg, SPRYCEL 100 mg and SPRYCEL 140 mg film-coated tablets Alu/Alu blisters (perforated unit dose blisters).
Smerter: årebetændelse, som kan medføre rødme, ømhed og hævelse, senebetændelse Hjerne: hukommelsestab 
Pain: inflammation of vein which can cause redness, tenderness and swelling, inflammation of the tendon
Hvis du har taget for meget SPRYCEL 
If you take more SPRYCEL than you should
SPRYCEL filmovertrukne tabletter 
SPRYCEL film-coated tablets
MR4.5-rater over tid var konsekvent højere hos dasatinib behandlede patienter sammenlignet med imatinib behandlede patienter. 
Rates of MR4.5 over time were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) Hjerte og lunger: forstørret højre hjertekammer, betændelse i hjertemusklen, en række tilstande, der skyldes blokering af blodtilførslen til hjertemusklen (akut koronarsyndrom), hjertestop, sygdom i kranspulsåren, betændelse i det væv, der omgiver hjertet og lungerne, blodpropper, blodpropper i lungerne 
Rare side effects (may affect up to 1 in 1,000 people) Heart and lungs: enlargement of the right ventricle in the heart, inflammation of the heart muscle, collection of conditions resulting from blockage of blood supply to the heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from the heart), coronary (heart) artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
Lymfoid blast (n= 48) 
Lymphoid blast (n= 48)
I studiet vedrørende nyligt diagnosticeret CML i kronisk fase blev grad 3 eller 4 hypofosfatæmi rapporteret hos 4% af de patienter, der fik SPRYCEL, og grad 3 eller 4 forhøjelse af aminotransferase, kreatinin og bilirubin blev rapporteret hos ≤ 1% af patienterne efter mindst 12 måneders opfølgning. 
In the newly diagnosed chronic phase CML study, grade 3 or 4 hypophosphataemia was reported in 4% of SPRYCEL-treated patients, and grade 3 or 4 elevations of transaminases, creatinine, and bilirubin were reported in ≤ 1% of patients after a minimum of 12 months follow-up.
c MCyR kombinerer både fuldstændigt (0% Ph+metafaser) og delvist (> 0%-35%) respons. 
c MCyR combines both complete (0% Ph+ metaphases) and partial (> 0%-35%) responses.
Sådan skal du tage SPRYCEL 
How to take SPRYCEL
Der blev opnået effekt på tværs af alle dasatinib behandlingsgrupper med dosering én gang dagligt med sammenlignelig effekt (non-inferior) i forhold til dosering 2 gange dagligt for det primære effektendepunkt (forskel i MCyR 1,9%; 95% konfidensinterval [-6,8% - 10,6%]); behandling med 100 mg 1 gang dagligt viste imidlertid forbedret sikkerhed og tolerabilitet. 
Efficacy was achieved across all dasatinib treatment groups with the once daily schedule demonstrating comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MCyR 1.9%; 95% confidence interval [-6.8% - 10.6%]); however, the 100 mg once daily regimen demonstrated improved safety and tolerability.
SPRYCEL 20 mg, SPRYCEL 50 mg, SPRYCEL 70 mg filmovertrukne tabletter Alu/Alu blistere (kalender-blistere eller perforerede enkeltdosisblistere). 
SPRYCEL 20 mg, SPRYCEL 50 mg and SPRYCEL 70 mg film-coated tablets Alu/Alu blisters (calendar blisters or perforated unit dose blisters).
Den anbefalede daglige startdosis af SPRYCEL pulver til oral suspension til pædiatriske patienter med Ph+ CML-CP eller Ph+ ALL og voksne patienter med Ph+ CML-CP, der ikke er i stand til at synke tabletter, er vist i Tabel 1. 
The recommended starting daily dosage of SPRYCEL powder for oral suspension for paediatric patients with Ph+ CML-CP or Ph+ ALL and adult patients with Ph+ CML-CP who cannot swallow tablets is shown in Table 1.
Almindelig vægttab, vægtøgning 
Common weight decreased, weight increased
Lymfoid blast (n= 33) 
Lymphoid blast (n= 33)
Fase-III kliniske studier hos patienter med CML i kronisk, accelereret eller myeloid blastfase og Ph+ ALL, som var resistente eller intolerante over for imatinib 
Phase III clinical studies in patients with CML in chronic, accelerated, or myeloid blast phase, and Ph+ ALL who were resistant or intolerant to imatinib
Anbefalet startdosis ved accelereret, myeloid eller lymfoid blastfase CML (fremskreden fase) eller Ph+ ALL er 140 mg én gang dagligt (se pkt. 
The recommended starting dose for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL is 140 mg once daily (see section 4.4).
Den anbefalede startdosis til voksne patienter med accelereret CML eller CML med blastkrise eller Ph+ ALL er 140 mg 1 gang dagligt. 
The starting dose recommended for adult patients with accelerated or blast crisis CML or Ph+ ALL is 140 mg once a day.
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). 
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).
Ialt 387 patienter fik dasatinib 70 mg 2 gange dagligt (288 resistente og 99 intolerante). 
A total of 387 patients received dasatinib 70 mg twice daily (288 resistant and 99 intolerant).
Medianbehandlingsvarigheden hos 1.618 voksne patienter med CML i kronisk fase var 29 måneder (interval 0 til 92,9 måneder). 
The median duration of therapy in 1,618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months).
Tabel 6b: Udvalgte bivirkninger, der blev indberettet i et fase III-dosisoptimeringsstudie: CML i fremskreden fase og Ph+ALLa 
Table 6b: Selected adverse reactions reported in phase III dose-optimisation study: Advanced phase CML and Ph+ ALLa
Hvis grad ≥3 neutropeni eller trombocytopeni recidiverer under komplet hæmatologisk respons (CHR) hos pædiatriske patienter med Ph+ CML-CP, bør SPRYCEL pauseres og kan senere genoptages ved en lavere dosis. 
For paediatric patients with Ph+ CML-CP, if Grade ≥3 neutropaenia or thrombocytopaenia recurs during complete haematologic response (CHR), SPRYCEL should be interrupted, and may be subsequently resumed at a reduced dose.
SPRYCEL indeholder natrium 
SPRYCEL contains sodium
SPRYCEL indeholder: 
What SPRYCEL contains
SPRYCEL er indiceret til behandling af pædiatriske patienter med: nydiagnosticeret Ph+CML i den kroniske fase (Ph+CML-CP) eller Ph-CML-CP som er resistent eller intolerant overfor tidligere behandlinger, herunder imatinib. 
SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
Hos patienter, som oplevede myelosuppression grad 3 eller 4, svandt dette som regel efter korte dosisafbrydelser og/eller -reduktioner. 
In patients who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 5% of patients.
Dasatinib administreres oralt en gang dagligt i form af enten SPRYCEL filmovertrukne tabletter eller SPRYCEL pulver til oral suspension 
Dasatinib is administered orally once daily in the form of either SPRYCEL film-coated tablets or SPRYCEL
Hyppigheden af major molekylært respons (vurderet hos 41 patienter med CCyR) ved 24 måneder var 46%. 
The rate of major molecular response (assessed in 41 patients with a CCyR) was 46% at 24 months.
Tabel 11: Effekt i fase 2 enkeltarms- kliniske studier med SPRYCELa Kronisk 
Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic
5 til mindre end 10 kg 
5 to less than 10 kg
Hver ml oral suspension indeholder 10 mg dasatinib (som monohydrat). 
Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate).
Disse reducerede doser af SPRYCEL forventes at justere arealet under kurven (AUC) svarende til, hvad der observeres uden CYP3A4-hæmmere. 
These reduced doses of SPRYCEL are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data are not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors.
Blandt 865 patienter med leukæmi, der i kliniske fase II-studier blev behandlet med dasatinib, var de gennemsnitlige ændringer fra baseline i QTc-intervallet ved Fridericias' metode (QTcF) 4-6 msek. 
In 865 patients with leukaemia treated with dasatinib in Phase II clinical studies, the mean changes from baseline in QTc interval using Fridericia's method (QTcF) were 4 - 6 msec; the upper 95% confidence intervals for all mean changes from baseline were < 7 msec (see section 4.8).
Sjælden cerebrovaskulært attak, transitorisk cerebral iskæmi, krampe, optikusneuritis, paralyse af 7. nerve, demens, ataksi 
Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth nerve paralysis, dementia, ataxia
Meget almindelig diarré, opkastning, kvalme, mavesmerter 
Very common diarrhoea, vomiting, nausea, abdominal pain
Medianbehandlingsvarigheden hos 1.094 voksne patienter med CML eller Ph+ ALL i fremskreden fase var 6,2 måneder (interval 0 til 93,2 måneder). 
The median duration of therapy in 1,094 adult patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0 to 93.2 months).
Undersøgelser kan vise: væske omkring hjertet, væske i lungerne, uregelmæssigt hjerteslag, alt for få hvide blodlegemer i blodet forbundet med feber, mave-tarmblødning, stor mængde urinsyre i blodet 
Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropaenia, gastrointestinal bleeding, high uric acid levels in the blood
Koncentrationsdata hos 32 pædiatriske patienter behandlet med pulveret til oral suspension ved dosis 72 mg/m2 blev puljet med data fra en populationsfarmakokinetisk (PPK)-analyse med tabletten og dette viste, at eksponeringen for pulveret til oral suspension (målt som tidsgennemsnitlig koncentration ved steady-state [Cavgss]) ved dosis 72 mg/m2 var ca. 30% lavere end den for tabletten ved dosis 60 mg/m2. 
(PPK) analysis, which showed that the exposure of the powder for oral suspension (as measured by time-averaged concentration at steady state [Cavgss]) at 72 mg/m2 was approximately 30% lower than that of the tablet at 60 mg/m2.
CCyR (95% CI) Nydiagnosticeret (N = 51)a 
CCyR (95% CI) Newly diagnosed (N = 51)a
SPRYCEL 20 mg filmovertrukne tabletter SPRYCEL 50 mg filmovertrukne tabletter SPRYCEL 70 mg filmovertrukne tabletter SPRYCEL 80 mg filmovertrukne tabletter SPRYCEL 100 mg filmovertrukne tabletter SPRYCEL 140 mg filmovertrukne tabletter dasatinib 
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets dasatinib
SPRYCEL indeholder 0,017 mg benzylalkohol pr. ml oral suspension. 
SPRYCEL contains 0.017 mg benzyl alcohol in each mL of oral suspension.
I det kliniske fase III-studie med patienter med nyligt diagnosticeret CML i kronisk fase sås væskeretention grad 3 eller 4 hos 13 patienter (5%) i dasatanib behandlingsgruppen og hos 2 patienter (1%) i imatinib behandlingsgruppen efter mindst 60 måneders opfølgning (se pkt. 
In the Phase III clinical study in patients with newly diagnosed chronic phase CML, grade 3 or 4 fluid retention was reported in 13 patients (5%) in the dasatinib-treatment group and in 2 patients (1%) in the imatinib-treatment group after a minimum of 60 months follow-up (see section 4.8).
I delmængden af 130 pædiatriske patienter med CML i kronisk fase behandlet med SPRYCEL var medianbehandlingsvarigheden 42,3 måneder (interval 0,1 til 99,6 måneder). 
In the subset of 130 chronic phase CML SPRYCEL-treated paediatric patients, the median duration of therapy was 42.3 months (range 0.1 to 99.6 months).
Almindelig hypertension, rødmen Ikke almindelig hypotension, tromboflebitis, trombose 
Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis
Andelen af patienter, som opretholdt MCyR i 18 måneder, var 90% (95% CI: [82%-98%]) for dasatinib (CCyR 94%, 95% CI: [87%-100%]) og 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%). 
The proportion of patients who maintained MCyR for 18 months was 90% (95% CI: [82%-98%]) for dasatinib (CCyR 94%, 95% CI: [87%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%).
MCyR (95% CI) Nydiagnosticeret (N = 51)a 
MCyR (95% CI) Newly diagnosed (N = 51)a
Forekomsten er tidligere og hyppigere hos patienter med CML eller Ph+ ALL i fremskreden fase end med CML i kronisk fase (se pkt. 
Their occurrence is earlier and more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML (see section 4.4).
SPRYCEL 20 mg filmovertrukne tabletter SPRYCEL 50 mg filmovertrukne tabletter SPRYCEL 70 mg filmovertrukne tabletter SPRYCEL 80 mg filmovertrukne tabletter SPRYCEL 100 mg filmovertrukne tabletter SPRYCEL 140 mg filmovertrukne tabletter 
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets
Hos 2.712 patienter med enten CML i kronisk fase, CML i fremskreden fase eller Ph+ ALL var medianbehandlingsvarigheden 19,2 måneder (interval 0 til 93,2 måneder). 
In the 2,712 adult patients with either chronic phase CML, advanced phase CML or Ph+ ALL, the median duration of therapy was 19.2 months (range 0 to 93.2 months).
AUC for dasatinib forventes at blive reduceret med cirka 25% ved samtidig brug af dexamethason, hvilket sandsynligvis ikke vil være klinisk betydningsfuldt. 
Concomitant use of dexamethasone, a weak CYP3A4 inducer, with dasatinib is allowed; dasatinib AUC is predicted to decrease approximately 25% with concomitant use of dexamethasone, which is not likely to be clinically meaningful.
Undersøgelser kan vise: unormale blodprøveresultater og risiko for nedsat nyrefunktion på grund af affaldsstoffer fra den døende svulst (tumorlysesyndrom), lavt indhold af albumin i blodet, lavt indhold af lymfocytter (en slags hvide blodceller) i blodet, højt indhold af kolesterol i blodet, hævede lymfekirtler, blødninger i hjernen, forstyrrelser i hjertets elektriske aktivitet, forstørret hjerte, leverbetændelse, protein i urinen, forhøjet kreatinkinase (et enzym, der hovedsageligt findes i hjertet, hjernen og skeletmusklerne), forhøjet troponin (et enzym, der hovedsageligt findes i hjerte- og skeletmuskulaturen), forhøjet gamma-glutamyltransferase (et enzym, der hovedsageligt findes i leveren) 
Tests may show: abnormal blood test results and possibly impaired kidney function caused by the waste products of the dying tumour (tumour lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell) in the blood, high level of cholesterol in the blood, swollen lymph nodes, bleeding in the brain, irregularity of the electrical activity of the heart, enlarged heart, inflammation of the liver, protein in the urine, raised creatine phosphokinase (an enzyme mainly found in the heart, brain and skeletal muscles), raised troponin (an enzyme mainly found in the heart and skeletal muscles), raised gamma-glutamyltransferase (an enzyme mainly found in the liver)
SPRYCEL indeholder benzoesyre og natriumbenzoat SPRYCEL indeholder 0,25 mg benzoesyre pr. ml oral suspension og 0,25 mg natriumbenzoat pr. ml oral suspension. 
SPRYCEL contains benzoic acid and sodium benzoate SPRYCEL contains 0.25 mg benzoic acid in each mL of oral suspension and 0.25 mg sodium benzoate in each mL of oral suspension.
Bemærk: Hvis du skal rekonstituere mere end én flaske, færdiggør da én flaske ad gangen. 
SPRYCEL powder for oral suspension is to be constituted as follows: Note: If you have to constitute more than one bottle, complete one bottle at a time.
Pulver Opbevares ved temperaturer under 25 °C. 
Powder Store below 25°C.
I alt 174 patienter fik 70 mg dasatinib 2 gange dagligt (161 resistente og 13 intolerante over for imatinib). 
A total of 174 patients received dasatinib 70 mg twice daily (161 resistant and 13 intolerant to imatinib).
SPRYCEL indeholder saccharose 
SPRYCEL contains sucrose
I alt 611 patienter blev randomiseret til dasatinib 140 mg én gang dagligt eller 70 mg 2 gange dagligt. 
A total of 611 patients were randomised to either the dasatinib 140 mg once daily or 70 mg twice daily group.
Blandt imatinib resistente patienter var den estimerede hyppighed af PFS 88% (95% CI: [84%-92%]) efter et år og 75% (95% CI: [69%-81%]) efter to år. 
Among imatinib-resistant patients, the estimated rate of PFS was 88% (95% CI: [84%-92%]) at 1 year and 75% (95% CI: [69%-81%]) at 2 years.
Hud, hår, øjne, generelt: kramper, betændelse i synsnerven, hvilket kan medføre fuldstændig eller delvis blindhed, blålilla, spættet misfarvning af huden, unormal høj funktion af skjoldbruskkirtlen, betændelse i skjoldbruskkirtlen, ataksi (en tilstand med nedsat muskelkoordinering), vanskelighed ved at gå, spontan abort, betændelse i hudens blodkar, hudfibrose 
Skin, hair, eye, general: convulsion, inflammation of the optic nerve that may cause a complete or partial loss of vision, blue-purple mottling of the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (a condition associated with lack of muscular coordination), difficulty walking, miscarriage, inflammation of the skin blood vessels, skin fibrosis
(n= 165)b Accelereret fase (n= 157)c 
Accelerated phase (n= 157)c