natgillin/translations-raw huggingface dataset:
21 af disse patienter (1%) havde QTcF > 500 msek. 
Twenty-one of these patients (1%) experienced a QTcF > 500 msec.
Tabel 14: Effekt af SPRYCEL i fase 3 dosisoptimeringsstudie: CML og Ph+ ALL i fremskreden fase (resultater efter 2 år)a 
Table 14: Efficacy of SPRYCEL in phase III dose-optimisation study: advanced phase CML and Ph+ ALL (2 year results)a
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN BRISTOL-MYERS SQUIBB PHARMA EEIG 3. 
NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG 3.
Hos forsøgspersoner med alvorlig leverinsufficiens var den gennemsnitlige Cmax og AUC, justeret for 70 mg dosen, nedsat med henholdsvis 43% og 28% sammenlignet med forsøgspersoner med normal leverfunktion (se pkt. 
In severely hepatic-impaired subjects, the mean Cmax and AUC adjusted for the 70 mg dose were decreased by 43% and 28%, respectively, compared to subjects with normal hepatic function (see sections 4.2 and 4.4).
30 til mindre end 45 kg 
30 to less than 45 kg
Andelen af patienter med PFS efter to år var 86% (95% CI: [78%-93%]) for dasatinib og 65% (95% CI: [43%-87%]) for imatinib. 
The proportion of patients who had PFS at 2 years was 86% (95% CI: [78%-93%]) for dasatinib and 65% (95% CI: [43%-87%]) for imatinib.
SPRYCEL er indiceret til behandling af pædiatriske patienter med: nydiagnosticeret Philadelphia kromosom-positiv myelogen leukæmi i den kroniske fase (Ph+ CML-CP) eller Ph+ CML-CP, der var resistent overfor forudgående behandling, herunder imatinib. 
SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
Baseret på Kaplan-Meier-estimater var andelen af patienter med progressionsfri overlevelse (PFS) i et år 91% (95% CI: [85%-97%]) for dasatinib og 73% (95% CI: [54%-91%]) for imatinib. 
Based on the Kaplan-Meier estimates, the proportion of patients who had progression-free survival (PFS) for 1 year was 91% (95% CI: [85%-97%]) for dasatinib and 73% (95% CI: [54%-91%]) for imatinib.
Udvalgte bivirkninger, der blev rapporteret ved den anbefalede startdosis på 140 mg én gang dagligt, er vist i Tabel 6b. 
Selected adverse reactions that were reported in the recommended starting dose of 140 mg once daily are shown in Table 6b.
Derudover fik 46 patienter med Ph+ ALL dasatinib 70 mg 2 gange dagligt (44 resistente og 2 intolerante over for imatinib). 
In addition, 46 patients with Ph+ ALL received dasatinib 70 mg twice daily (44 resistant and 2 intolerant to imatinib).
Almindelig asteni, smerter, smerter i brystet, generaliseret ødem*k, kulderystelser Ikke almindelig utilpashed, andet superficielt ødem,l 
Common asthenia, pain, chest pain, generalised oedema*k, chills Uncommon malaise, other superficial oedemal
I alt 48 patienter med CML i lymfoid blastfase fik 70 mg dasatinib 2 gange dagligt (42 resistente og 6 intolerante over for imatinib). 
A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib).
I fase III-studiet med patienter med nyligt diagnosticeret CML i kronisk fase havde 1 patient (< 1%) af de patienter, der blev behandlet med SPRYCEL, QTcF > 500 msek. 
In the Phase III study in patients with newly diagnosed chronic phase CML, one patient (< 1%) of the SPRYCEL-treated patients had a QTcF > 500 msec after a minimum of 12 months follow-up (see section 4.4).
Æske der indeholder 60 × 1 filmovertrukne tabletter i perforerede enkeltdosisblistere. 
Carton containing 60 x 1 film-coated tablets in perforated unit dose blisters.
En reaktion med feber, blærer på huden og sår på slimhinderne Sygdom i nyrerne med symptomer, herunder ødem og unormale laboratorietestresultater, såsom protein i urinen og lavt proteinniveau i blodet 
A reaction with fever, blisters on the skin, and ulceration of the mucous membranes Disease of the kidneys with symptoms including oedema and abnormal laboratory test results such as protein in the urine and low protein level in the blood Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelets, and formation of blood clots
Sjælden gastroenteropati med proteintab, ileus, analfistler 
Rare protein-losing gastroenteropathy, ileus, anal fistula
SPRYCEL indeholder 0,25 mg benzoesyre pr. ml oral suspension og 0,25 mg natriumbenzoat pr. ml oral suspension. 
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.
Blandt imatinib intolerante patienter var den estimerede hyppighed af PFS 98% (95% CI: [95%-100%]) efter et år og 94% (95% CI: [88%-99%]) efter to år. 
Among imatinib-intolerant patients, the estimated rate of PFS was 98% (95% CI: [95%-100%]) at 1 year and 94% (95% CI: [88%-99%]) at 2 years.
Lægen har ordineret SPRYCEL til dig personligt. 
This medicine has been prescribed for you.
Raten for MMR var konsekvent højere hos dasatinib behandlede patienter sammenlignet med imatinib behandlede patienter. 
Rates of MMR were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Hyppigheden af major molekylært respons (vurderet hos 19 patienter med CCyR) ved 24 måneder var 68%. 
The rate of major molecular response (assessed in 19 patients with a CCyR) was 68% at 24 months.
Diarré Væskeretention Superficielt ødem Pleuraeffusion Generaliseret ødem Kongestivt hjertesvigt/hjerte-insufficiensb 
Fluid retention Superficial oedema Pleural effusion Generalised oedema Congestive heart failure /cardiac dysfunctionb
Der skal tages CBC'er hver anden dag indtil restitution under konsolideringsserierne af kemoterapi (se pkt. 
During the consolidation blocks of chemotherapy, CBCs should be performed every 2 days until recovery (see sections 4.2 and 4.8).
Mindst 2 års opfølgning 
Minimum of 2 years follow up
For at minimere risikoen for optagelse gennem huden og for at opretholde konsistens i doseringen må de filmovertrukne tabletter ikke knuses, deles eller tygges, men skal synkes hele. 
The film-coated tablets must not be crushed, cut or chewed in order to maintain dosing consistency and minimise the risk of dermal exposure; they must be swallowed whole.
Æske der indeholder 30×1 filmovertrukne tabletter i perforerede enkeltdosisblistere. 
Carton containing 30 x 1 film-coated tablets in perforated unit dose blisters.
Den kumulative rate for udvalgte bivirkninger, som blev rapporteret ved den anbefalede startdosis på 100 mg én gang dagligt, er vist i Tabel 6a. 
Cumulative rates of selected adverse reactions that were reported in the 100 mg once daily recommended starting dose are shown in Table 6a.
Ikke kendt reaktivering af hepatitis B Blod og lymfesystem 
Not known hepatitis B reactivation
Med længere behandling og opfølgning (middelværdi på 24 måneder) opnåedes MCyR hos 53% af de dasatinib behandlede patienter (CCyR hos 44%) og 33% af de imatinib behandlede patienter (CCyR hos 18%) inden crossover. 
Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm. With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover.
Ikke kendt letal gastrointestinal blødning* 
Not known fatal gastrointestinal haemorrhage* Hepatobiliary disorders
Hjælpestoffer: indeholder lactosemonohydrat. 
Excipients: contains lactose monohydrate.
Hos patienter med Ph+ ALL, som blev behandlet med 140 mg én gang dagligt, var medianvarigheden af MaHR 5 måneder, median PFS var 4 måneder, og den samlede medianoverlevelse var 7 måneder. 
In patients with Ph+ ALL treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months the median PFS was 4 months, and the median overall survival was 7 months.
Hæmatologisk responsrateb (%) MaHR (95% CI) 
Haematologic response rateb (%) MaHR (95% CI)
Baseret på Kaplan-Meier-estimater var andelen af patienter som opretholdt MCyR i et år 92% (95% CI: [85%-100%]) for dasatinib (CCyR 97%, 95% CI: [92%-100%]) og 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%). 
Based on the Kaplan-Meier estimates, the proportion of patients who maintained MCyR for 1 year was 92% (95% CI: [85%-100%]) for dasatinib (CCyR 97%, 95% CI: [92%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%).
Hjerte og lunger: hjertebanken, uregelmæssig hjerterytme (puls), hjertesvigt med ophobning af blod, svag hjertemuskel, højt blodtryk, forhøjet blodtryk i lungerne, hoste Fordøjelsesproblemer: appetitforstyrrelser, smagsforstyrrelser, opsvulmet eller oppustet mave (abdomen), betændelseslignende tilstand i tarmen, forstoppelse, halsbrand, sår i munden, vægtøgning, vægttab, irriteret maveslimhinde 
Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, increased blood pressure in the lungs, cough Digestive problems: appetite disturbances, taste disturbance, bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis
(se Produktresumé for SPRYCEL pulver til oral suspension). 
powder for oral suspension (see Summary of Product Characteristics for SPRYCEL powder for oral suspension).
Samtidig brug af dasatinib og lægemidler, der inducerer CYP3A4 (fx dexamethason, phenytoin, carbamazepin, rifampicin, phenobarbital eller naturlægemidler, der indeholder Hypericum perforatum, også kendt som perikon) kan i betydelig grad reducere eksponeringen af dasatinib og dermed øge risikoen for behandlingssvigt. 
Concomitant use of dasatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John's Wort) may substantially reduce exposure to dasatinib, potentially increasing the risk of therapeutic failure.
Ved år 5 p<0,0022 
By 5 years 76%, p<.0022
Tabel 13: Langvarig virkning af SPRYCEL i fase 3 dosisoptimeringsstudie: imatinib resistente eller intolerante patienter med CML i kronisk fasea Mindste opfølgningsperiode 
Table 13: Long term efficacy of SPRYCEL in phase 3 dose optimisation study: imatinib resistant or intolerant chronic phase CML patientsa Minimum follow-up period
Tabel 6a: Udvalgte bivirkninger, der blev indberettet i et fase 3-dosisoptimeringsstudie (imatinib intolerant eller resistent CML i kronisk fase)a 
Table 6a: Selected adverse reactions reported in a phase 3 dose optimisation study (imatinib intolerant or resistant chronic phase CML)a
Hos patienter med CML i accelereret fase, som blev behandlet med 140 mg én gang dagligt, blev medianvarigheden af MaHR og den samlede medianoverlevelse ikke nået; median PFS var 25 måneder. 
In patients with accelerated phase CML treated with the 140 mg once daily regimen, the median duration of MaHR and the median overall survival was not reached and the median PFS was 25 months.
Der er gennemført et åbent, enkeltarms-, multicenter-studie med patienter med CML i lymfoid blastfase eller Ph+ ALL, som var resistente eller intolerante over for tidligere imatinibbehandling. 
An open-label, single-arm, multicentre study was conducted in patients with lymphoid blast phase CML or Ph+ ALL who were resistant or intolerant to prior imatinib therapy.
Effektresultaterne er angivet i Tabel 11. 
Efficacy results are reported in Table 11.
SPRYCEL indeholder: Aktivt stof: Dasatinib. 
What SPRYCEL contains The active substance is dasatinib.
I alt 109 patienter fik 70 mg dasatinib 2 gange dagligt (99 resistente og 10 intolerante over for imatinib). 
A total of 109 patients received dasatinib 70 mg twice daily (99 resistant and 10 intolerant to imatinib).
Det skal tilsikres, at adapteren er sat godt fast i flasken. 
Make sure bottle adapter is firmly pressed.
Almindelig gastrointestinal blødning*, colitis (inklusive neutropenisk colitis), gastritis, inflammation i slimhinderne (inklusive mucositis/stomatitis), dyspepsi, abdominal distension, obstipation, forstyrrelser i bløddele i munden Ikke almindelig pankreatitis (inklusive akut pankreatitis), øvre gastrointestinalt ulcus, esophagitis, ascites*, analfissur, dysfagi, gastroøsofageal reflukssygdom 
Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorder
b Inkluderer blødning i centralnervessystemet, cerebralt hæmatom, cerebral blødning, ekstradural hæmatom, intrakraniel blødning, hæmoragisk apopleksi, subaraknoidal blødning, subdural hæmatom og subdural blødning. 
b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma, haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural haemorrhage.
Medianændringerne i QTcF fra baseline var 3,0 msek. 
The median changes in QTcF from baseline were 3.0 msec in dasatinib-treated patients compared to 8.2 msec in imatinib-treated patients.
Gør følgende hjælpemidler klar, før du klargør en dosis SPRYCEL oral suspension til administration til patienten: 
Before you prepare a dose of SPRYCEL oral suspension for administration to the patient, get the following supplies ready:
Ydre karton: sprycel 70 mg 
Outer Carton: sprycel 70 mg
Hyppigheden af major molekylært respons (alle 25 behandlede patienter med CCyR) ved 24 måneder var 52%. 
The rate of major molecular response (all 25 treated patients with a CCyR) was 52% at 24 months.
Ydre karton: sprycel 140 mg 
Outer Carton: sprycel 140 mg
20 til mindre end 30 kg 
20 to less than 30 kg
Hos patienter med nyligt diagnosticeret CML i kronisk fase, som fik SPRYCEL, og som fik myelosuppression grad 3 eller 4, svandt dette som regel efter korte dosisafbrydelser og/ellerreduktioner. 
In SPRYCEL-treated patients with newly diagnosed chronic phase CML who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 1.6% of patients after a minimum of 12 months follow-up.
Hyppigheden af major molekylært respons (alle 22 behandlede patienter med CCyR) ved 24 måneder var 50%. 
The rate of major molecular response (all 22 treated patients with a CCyR) was 50% at 24 months.
Mediantiden fra diagnose til start af behandling var 61 måneder. 
The median time from diagnosis to start of treatment was 61 months.
Antal patienter (%) Transformation efter 60 måneder, n/N 
Number of patients (%) Transformation at 60 months, n/N (%) Rate of PFS at 60 months (95% CI) Rate of OS at 60 months (95% CI)
Hos forsøgspersoner med moderat leverinsufficiens var dasatinibs gennemsnitlige Cmax og AUC, justeret for 70 mg dosen, nedsat med henholdsvis 47% og 8% sammenlignet med forsøgspersoner med normal leverfunktion. 
The mean Cmax and AUC of dasatinib adjusted for the 70 mg dose were decreased by 47% and 8%, respectively, in subjects with moderate hepatic impairment compared to subjects with normal hepatic function.
Hver filmovertrukket tablet indeholder 67,5 mg lactosemonohydrat. 
Each film-coated tablet contains 67.5 mg of lactose monohydrate.
Hver filmovertrukket tablet indeholder 189 mg lactosemonohydrat. 
Each film-coated tablet contains 189 mg of lactose monohydrate.
Stevens-Johnsons syndromf Knogler, led, muskler og bindevæv 
Stevens-Johnson syndromef Musculoskeletal and connective tissue disorders Very common musculoskeletal paing
Hver filmovertrukket tablet indeholder 135,0 mg lactosemonohydrat. 
Each film-coated tablet contains 135.0 mg of lactose monohydrate.
Hud, hår, øjne, generelt: prikken i huden, kløe, tør hud, akne, betændelseslignende tilstand i huden, vedvarende ringen for ørerne, hårtab, voldsom svedtendens, synsforstyrrelser (sløret syn og nedsat syn), tørre øjne, blå mærker, depression, søvnløshed, ansigtsrødme, svimmelhed, sår (blå mærker), appetitmangel, søvnighed, ophobning af vand i kroppen Smerter: ledsmerter, muskelsvaghed, brystsmerter, smerter i hænder og fødder, kulderystelser, stive muskler og led, muskeltrækninger 
Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflammation of the skin, persistent noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, bruise, depression, insomnia, flushing, dizziness, contusion (bruising), anorexia, somnolence, generalised oedema Pain: pain in joints, muscular weakness, chest pain, pain around hands and feet, chills, stiffness in muscles and joints, muscle spasm
Ved år 2 p<0,0008 
By 2 years 19%, p<.0008
I fase III-dosisoptimeringsstudiet i CML i fremskreden fase og Ph+ ALL, blev grad 3 og 4 forhøjelse af aminotransferaser eller bilirubin indberettet hos 1% til 5% af patienterne. 
In the Phase III dose-optimisation study in advanced phase CML and Ph+ALL, grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% to 5% of patients across treatment groups.
Tabel 1: Dosering af SPRYCEL tabletter til patienter med Ph+ CML-CP eller Ph+ ALL. 
Table 1: Dosage of SPRYCEL tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL Body weight (kg)a
e Inkluderer lægemiddeludslæt, erytem, erythema multiforme, erythrosis, eksfoliativt udslæt, generaliseret erytem, genitalt udslæt, varmeudslæt, milia, miliaria, pustuløs psoriasis, udslæt, erytematøst udslæt, follikulært udslæt, generaliseret udslæt, makulært udslæt, makulopapuløst udslæt, papuløst udslæt, kløende udslæt, pustuløst udslæt, vesikulært udslæt, hudeksfoliation, hudirritation, toksisk huderuption, urticaria vesiculosa og vaskulitisk udslæt. 
e Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalised erythema, genital rash, heat rash, milia, miliaria, pustular psoriaisis, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, toxic skin eruption, urticaria vesiculosa, and vasculitic rash.
Mens sprøjtespidsen holdes godt på plads i flasken, vendes flasken om, så sprøjten har bunden i vejret. 
Holding the syringe tip firmly into the bottle, turn the bottle with the syringe upside down.
Ydre karton: sprycel 20 mg 
Outer Carton: sprycel 20 mg
10 til mindre end 20 kg 
10 to less than 20 kg
I fase III-studier vedrørende dosisoptimering ved CML i kronisk fase blev grad 3 og 4 forhøjelse i aminotransferaser eller bilirubin indberettet hos ≤ 1% af patienterne med ensartet lav forekomst i de 4 behandlingsgrupper. 
In the Phase III dose-optimisation study in chronic phase CML, grade 3 or 4 elevations of transaminases or bilirubin were reported in ≤ 1% of patients with similar low incidence in the four treatment groups.
Samtidig brug af dasatinib og lægemidler eller stoffer, der er potente CYP3A4-hæmmere (fx ketoconazol, itraconazol, erythromycin, clarithromycin, ritonavir, telithromycin, grapefrugtjuice), kan øge eksponeringen for dasatinib. 
Concomitant use of dasatinib and medicinal products or substances which potently inhibit CYP3A4 (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, grapefruit juice) may increase exposure to dasatinib.
Hjertebivirkninger 
Cardiac adverse reactions
Figur 3: MR4.5-rater over tid - alle randomiserede patienter i et fase 3-studie med patienter med nyligt diagnosticeret CML i kronisk fase 
Figure 3: MR4.5 rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML
Mediantiden fra diagnose til start af behandling var 28 måneder. 
The median time from diagnosis to start of treatment was 28 months.
b Hæmatologiske responskriterier (alle responser blev bekræftet efter 4 uger): Komplet hæmatologisk respons (CHR) (kronisk CML): WBC ≤ gældende ULN, trombocytter <450.000/mm3, ingen blastceller eller promyelocytter i perifert blod, <5% myelocytter plus metamyelocytter i perifert blod, basofile celler i perifert blod <20% og ingen ekstramedullær involvering. 
b Haematologic response criteria (all responses confirmed after 4 weeks): Complete haematologic response (CHR) (chronic CML): WBC ≤ institutional ULN, platelets <450,000/mm3, no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <20%, and no extramedullary involvement.
Hos patienterne med CML i myeloid blastfase, som blev behandlet med 140 mg én gang dagligt, var medianvarighed af MaHR 8 måneder, median PFS var 4 måneder, og den samlede medianoverlevelse var 8 måneder. 
In patients with myeloid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 8 months, the median PFS was 4 months, and the median overall survival was 8 months.
SPRYCEL tabletter anbefales ikke til patienter, der vejer mindre end 10 kg. Pulveret til oral suspension bør bruges til patienter, der vejer mindre end 10 kg og patienter, der ikke er i stand til at synke tabletter. 
The powder for oral suspension should be used for patients weighing less than 10 kg and patients who cannot swallow tablets.
Hver filmovertrukket tablet indeholder 27 mg lactosemonohydrat. 
Each film-coated tablet contains 27 mg of lactose monohydrate.
Hos nogle patienter med PAH blev der observeret bedring af de hæmodynamiske og kliniske parametre efter ophør af dasatinib behandling. 
Improvements in haemodynamic and clinical parameters have been observed in patients with PAH following discontinuation of dasatinib.
Ydre karton: sprycel 100 mg 
Outer Carton: sprycel 100 mg
Tabel 12: Effekt af SPRYCEL i fase 3-studie vedrørende dosisoptimering: imatinib resistent eller -intolerant CML i kronisk fase (resultater ved år 2)a 
Table 12: Efficacy of SPRYCEL in phase III dose-optimization study: imatinib resistant or intolerant chronic phase CML (2-year results)a
Hver filmovertrukket tablet indeholder 94,5 mg lactosemonohydrat. 
Each film-coated tablet contains 94.5 mg of lactose monohydrate.
Kontakt lægen for råd, hvis du har mistanke om, at du eller dit barn er allergisk. 
If you or your child could be allergic, ask your doctor for advice.
c Cytogenetiske responskriterier: fuldstændigt (0% Ph+ metafaser) eller delvist (> 0%-35%). 
c Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial (>0%-35%).
Ydre karton: sprycel 50 mg 
Outer Carton: sprycel 50 mg
Hver filmovertrukket tablet indeholder 108 mg lactosemonohydrat. 
Each film-coated tablet contains 108 mg of lactose monohydrate.
Gastrointestinal blødning a Resultater, som blev rapporteret i populationen med den anbefalede startdosis på 100 mg 1 gang dagligt (n=165) i fase IIIdosisoptimeringsstudiet 
Diarrhoea Fluid retention Superficial oedema Pleural effusion Generalised oedema Pericardial effusion Pulmonary hypertension Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported in recommended starting dose of 100 mg once daily (n=165) population
Baseret på Kaplan-Meier-estimater var antallet af patienter, som opretholdt MCyR i 18 måneder, 93% (95% CI: [88%-98%]) for de patienter, der blev behandlet med dasatinib 100 mg én gang dagligt. 
Based on the Kaplan-Meier estimates, the proportion of patients treated with dasatinib 100 mg once daily who maintained MCyR for 18 months was 93% (95% CI: [88%-98%]).
Mediantiden fra diagnose til start af behandling var 48 måneder. 
The median time from diagnosis to start of treatment was 48 months.
Hos patienterne med CML i lymfoid blastfase, som blev behandlet med 140 mg én gang dagligt, var medianvarigheden af MaHR 5 måneder, median PFS var 5 måneder, og den samlede medianoverlevelse var 11 måneder. 
In patients with lymphoid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months, the median PFS was 5 months, and the median overall survival was 11 months.
Tabletterne må ikke knuses, deles eller tygges. 
Do not crush, cut or chew them.
SPRYCEL 140 mg filmovertrukne tabletter 
SPRYCEL 140 mg film-coated tablets