natgillin/translations-raw huggingface dataset:
Hud, hår, øjne, generelt: allergisk reaktion herunder ømme, røde knuder under huden (erythema nodosum), angst, forvirring, humørsvingninger, nedsat seksuallyst, besvimelse, rysten, øjenbetændelse som medfører røde øjne eller smerter i øjnene, en hudsygdom karakteriseret ved ømt, rødt, afgrænset udslæt med skjolder med pludselig feber og forhøjet antal hvide blodlegemer (neutrofil dermatose), høretab, øget lysfølsomhed, nedsat syn, tåreflåd, misfarvning af huden, betændelse i fedtvævet under huden, sår på huden, blæredannelse på huden, neglesygdom, hårsygdom, hånd-fod-syndrom, nyresvigt, hyppig vandladning, brystforstørrelse hos mænd, menstruationsforstyrrelser, generel svækkelse og utilpashed, nedsat funktion af skjoldbruskkirtlen, balancetab, mens man går, osteonekrose (en sygdom med nedsat blodtilførsel til knoglerne, som kan medføre knogletab og knogledød), leddegigt, hævelse af huden hvor som helst på kroppen 
Heart and lungs: heart attack (including fatal outcome), inflammation of the lining (fibrous sack) surrounding the heart, irregular heartbeat, chest pain due to lack of blood supply to the heart (angina), low blood pressure, narrowing of airway that may cause breathing difficulties, asthma, increased blood pressure in the arteries (blood vessels) of the lungs Digestive problems: inflammation of the pancreas, peptic ulcer, inflammation of the food pipe, swollen tummy (abdomen), tear in the skin of the anal canal, difficulty in swallowing, inflammation of the gallbladder, blockage of bile ducts, gastro-oesophageal reflux (a condition where acid and other stomach contents come back up into the throat) Skin, hair, eye, general: allergic reaction including tender, red lumps on the skin (erythema nodosum), anxiety, confusion, mood swings, lower sexual drive, fainting, tremor, inflammation of the eye which causes redness or pain, a skin disease characterized by tender, red, well-defined blotches with the sudden onset of fever and raised white blood cell count (neutrophilic dermatosis), loss of hearing, sensitivity to light, visual impairment, increased eye tearing, disturbance in skin colour, inflammation of fatty tissue under the skin, skin ulcer, blistering of the skin, nail disorder, hair disorder, hand-foot disorder, renal failure, urinary frequency, breast enlargement in men, menstrual disorder, general weakness and discomfort, low thyroid function, losing balance while walking, osteonecrosis (a disease of reduced blood flow to the bones, which can cause bone loss and bone death), arthritis, skin swelling anywhere in the body
Figur 2: MMR-rater over tid - alle randomiserede patienter i et fase 3-studie med patienter med nyligt diagnosticeret CML i kronisk fase 
Figure 2: MMR rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML
SPRYCEL 80 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, trekantet med “BMS 80” printet på den ene side og “855” på den anden. 
SPRYCEL 80 mg: the film-coated tablet is white to off-white, biconvex, triangular with “BMS 80” debossed on one side and “855” on the other side.
84% - 92,4%) for både dasatinib og imatinib armene. 
The estimated 60-month PFS rate was 88.9% (CI: 84% - 92.4%) for both the dasatinib and imatinib treatment groups.
SPRYCEL 70 mg tabletter dasatinib 
SPRYCEL 70 mg tablets dasatinib
Ydre karton: sprycel 80 mg 
Outer Carton: sprycel 80 mg
SKIL IKKE SPRØJTEN AD 
DO NOT TAKE APART THE SYRINGE
En PPK-modelbaseret simulation forudsagde at den anbefalede dosering efter legemsvægt, der er beskrevet for pulveret til oral suspension i pkt. 
A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the powder for oral suspension, in section 4.2 of the Summary of Product Characteristics for the powder for oral suspension, is expected to provide similar exposure to a tablet dose of 60 mg/m2.
SPRYCEL 140 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, rund med “BMS 140” printet på den ene side og “857” på den anden. 
SPRYCEL 140 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS 140” debossed on one side and “857” on the other side.
SPRYCEL 70 mg filmovertrukne tabletter 
SPRYCEL 70 mg film-coated tablets
SPRYCEL 140 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 140 mg dasatinib (som monohydrat). 
SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Mediantiden fra diagnose til start af behandling var 18 måneder. 
The median time from diagnosis to start of treatment was 18 months.
inden for 24 måneder (95% CI) 
within 24 months (95% CI)
Ved år 4 p<0,0055 
By 4 years 34%, p<.0055
SPRYCEL 20 mg tabletter dasatinib 
SPRYCEL 20 mg tablets dasatinib
Almindelig alopeci, dermatitis (inklusive eksem), pruritus, akne, tør hud, urticaria, hyperhidrose Ikke almindelig neutrofil dermatosis, fotosensitivitet, pigmenteringsforstyrrelse, panniculitis, hudsår, bulløse tilstande, neglelidelser, palmoplantar erytrodysæstesisyndrom, hårlidelser 
Uncommon neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthesia syndrome, hair disorder
SPRYCEL 50 mg tabletter dasatinib 
SPRYCEL 50 mg tablets dasatinib
inden for 48 måneder (95% CI) 
within 48 months (95% CI)
Lungebetændelse 
Inflammation of the lungs
inden for 36 måneder (95% CI) 
within 36 months (95% CI)
SPRYCEL 50 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, oval med “BMS” printet på den ene side og “528” på den anden. 
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS” debossed on one side and “528” on the other side.
SPRYCEL 70 mg filmovertrukne tabletter EU/1/06/363/006 
SPRYCEL 70 mg film-coated tablets EU/1/06/363/006
k Væskeophobning, væskeretention, gastrointestinalt ødem, generaliseret ødem, perifær hævelse, ødem, ødem på grund af hjertesygdom, perirenal effusion, ødem efter indgreb, visceralt ødem. 
k Fluid overload, fluid retention, gastrointestinal oedema, generalised oedema, peripheral swelling, oedema, oedema due to cardiac disease, perinephric effusion, post procedural oedema, visceral oedema.
Ikke kendt trombotisk mikroangiopati Luftveje, thorax og mediastinum 
Not known thrombotic microangiopathy Respiratory, thoracic and mediastinal disorders Very common pleural effusion*, dyspnoea
Medianbehandlingsvarighed med dasatinib var 24 måneder med 51% af patienterne behandlet i > 24 måneder til dato. 
Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date.
SPRYCEL 100 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, oval med “BMS 100” printet på den ene side og “852” på den anden. 
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side.
SPRYCEL 80 mg filmovertrukne tabletter EU/1/06/363/013 
SPRYCEL 80 mg film-coated tablets EU/1/06/363/013
Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS 140" printet på den ene side og "857" på den anden. 
White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side.
SPRYCEL 140 mg filmovertrukne tabletter EU/1/06/363/015 
SPRYCEL 140 mg film-coated tablets EU/1/06/363/015
SPRYCEL 70 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, rund med “BMS” printet på den ene side og “524” på den anden. 
SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “524” on the other side.
Medianbehandlingsvarighed med dasatinib var 3 måneder med 2% behandlet i > 24 måneder til dato. 
Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date.
Gennemsnitstid fra diagnose til start af behandling var 82 måneder. 
The median time from diagnosis to start of treatment was 82 months.
Medianbehandlingsvarighed med dasatinib var 14 måneder med 31% af patienterne behandlet i > 24 måneder til dato. 
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
Skade på blodkar kendt som trombotisk mikroangiopati (TMA), inklusive nedsat antal røde blodlegemer, nedsat antal blodplader og dannelse of blodpropper. 
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
SPRYCEL 50 mg filmovertrukne tabletter EU/1/06/363/005 
SPRYCEL 50 mg film-coated tablets EU/1/06/363/005
Responsrate (95% CI) 
Response rate (95% CI)
Ikke kendt interstitiel lungesygdom Mave-tarm-kanalen 
Not known interstitial lung disease
Hver filmovertrukket tablet indeholder 70 mg dasatinib (som monohydrat). 
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Medianbehandlingsvarighed med dasatinib var 3,5 måneder med 12% af patienterne behandlet i > 24 måneder til dato. 
Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
SPRYCEL 140 mg tabletter dasatinib 
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg tablets dasatinib
Hvide til gråligt hvide, bikonvekse, ovale filmovertrukne tabletter med "BMS 100" printet på den ene side og "852" på den anden. 
White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side.
Hver filmovertrukket tablet indeholder 20 mg dasatinib (som monohydrat). 
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
SPRYCEL 20 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 20 mg dasatinib (som monohydrat). 
SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Pleuraeffusion 
Pleural effusion
SPRYCEL 80 mg filmovertrukne tabletter 
SPRYCEL 80 mg film-coated tablets
Perikardie-effusion 
Breast-feeding
SPRYCEL 100 mg filmovertrukne tabletter EU/1/06/363/011 
SPRYCEL 100 mg film-coated tablets EU/1/06/363/011
Tidligere fuldstændigt hæmatologisk respons (CHR) på 
Prior complete haematologic response (CHR) to imatinib was
SPRYCEL 50 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 50 mg dasatinib (som monohydrat). 
SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
SPRYCEL 70 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 70 mg dasatinib (som monohydrat). 
SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
inden for 60 måneder (95% CI) 
within 60 months (95% CI)
SPRYCEL 70 mg filmovertrukne tabletter dasatinib 
SPRYCEL 70 mg film-coated tablets dasatinib
Hvide til gråligt hvide, bikonvekse, trekantede filmovertrukne tabletter med "BMS 80" printet på den ene side og "855" på den anden. 
White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Det reproduktive system og mammae Ikke almindelig gynækomasti, menstruationsforstyrrelser Almene symptomer og reaktioner på administrationsstedet 
Reproductive system and breast disorders Uncommon gynecomastia, menstrual disorder General disorders and administration site conditions Very common peripheral oedemai, fatigue, pyrexia, face oedemaj
Ved år 3 p<0,0055 
By 3 years 67%, p<.0055
MEDIAN (95% CI) HAZARD RATIO (95% CI) 
HAZARD RATIO (95% CI)
SPRYCEL 80 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 80 mg dasatinib (som monohydrat). 
SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Medianbehandlingsvarighed med dasatinib var 3 måneder med 7% af patienterne behandlet i > 24 måneder til dato. 
Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
4.2 i Produktresuméet for pulveret til oral suspension, forventes at give en eksponering, der er sammenlignelig med en tabletdosis på 60 mg/m2. 
A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the tablet, in section 4.2, is expected to provide similar exposure to a tablet dose of 60 mg/m2.
SPRYCEL 100 mg filmovertrukne tabletter 
SPRYCEL 100 mg film-coated tablets
Patienter, som får mere end den anbefalede dosis, skal monitoreres tæt for myelosuppression, eftersom dasatinib er forbundet med myelosuppression grad 3 eller 4 (se pkt. 
Since dasatinib is associated with grade 3 or 4 myelosuppression (see section 4.4), patients who ingest more than the recommended dose should be closely monitored for myelosuppression and given appropriate supportive treatment.
SPRYCEL 20 mg filmovertrukne tabletter 
SPRYCEL 20 mg film-coated tablets
Ikke kendt artrieflimren/hjerteflimren Vaskulære sygdomme 
Not known atrial fibrillation/atrial flutter Vascular disorders
Hver filmovertrukket tablet indeholder 50 mg dasatinib (som monohydrat). 
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
l Genital hævelse, ødem ved incisionsstedet, genitalt ødem, penilt ødem, penil hævelse, skrotalt ødem, hævelser på huden, hævede testikler, vulvovaginal hævelse. 
l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling, testicular swelling, vulvovaginal swelling.
Grad 3- eller 4-stigninger af aminotransferaser eller bilirubin blev indberettet hos 1% af patienterne med CML i kronisk fase (resistens eller intolerans over for imatinib). 
Grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% of patients with chronic phase CML (resistant or intolerant to imatinib), but elevations were reported with an increased frequency of 1 to 7% of patients with advanced phase CML and Ph+ ALL.
Forekomsten af pleuraeffusion og kongestivt hjertesvigt/hjerteinsufficiens var lavere blandt de patienter, der blev behandlet med SPRYCEL 100 mg én gang dagligt, end blandt de patienter, der blev behandlet med SPRYCEL 70 mg 2 gange dagligt i fase III-studiet vedrørende dosisoptimering hos patienter med CML i kronisk fase og med resistens eller intolerans over for tidligere behandling med imatinib (medianbehandlingsvarigheden var 30 måneder). 
In the Phase III dose-optimisation study in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy (median duration of treatment of 30 months), the incidence of pleural effusion and congestive heart failure/cardiac dysfunction was lower in patients treated with SPRYCEL 100 mg once daily than in those treated with SPRYCEL 70 mg twice daily.
SPRYCEL 50 mg filmovertrukne tabletter 
SPRYCEL 50 mg film-coated tablets
Dosis (maksimum daglig dosis) Stardosis 
Dose (maximum dose per day)
Vinsyre Trinatriumcitrat, vandfrit Natriumbenzoat (E211) 
Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)]
CHR (fremskreden CML/Ph+ ALL): WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering. 
CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
SPRYCEL 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg dasatinib (som monohydrat). 
SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
CHR: WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering. 
CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Ved år 3 p<0,0013 
By 3 years 24%, p<.0013
Meget almindelig hududslæte 
Rare diabetes mellitus
Neutropeni 
Headache
EU/1/06/363/004 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/007 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/001 - 60 filmovertrukne tabletter (flaske) 
EU/1/06/363/004 - 56 film-coated tablets (blisters) EU/1/06/363/007 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/001 - 60 film-coated tablets (bottle)
SPRYCEL 50 mg filmovertrukne tabletter dasatinib 
SPRYCEL 50 mg film-coated tablets dasatinib
EU/1/06/363/005 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/008 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/002 - 60 filmovertrukne tabletter (flaske) 
EU/1/06/363/005 - 56 film-coated tablets (blisters) EU/1/06/363/008 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/002 - 60 film-coated tablets (bottle)
Hvide til gråligt hvide, bikonvekse, ovale filmovertrukne tabletter med "BMS" printet på den ene side og "528" på den anden. 
White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side.
Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS" printet på den ene side og "527" på den anden. 
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side.
EU/1/06/363/006 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/009 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/003 - 60 filmovertrukne tabletter (flaske) 
EU/1/06/363/006 - 56 film-coated tablets (blisters) EU/1/06/363/009 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/003 - 60 film-coated tablets (bottle)
Ved år 4 p<0,0021 
By 4 years 73%, p<.0021
CHR (kronisk CML): WBC ≤ institutionel ULN, trombocytter < 450.000/mm3, ingen blaster eller promyelocytter i perifert blod, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering. 
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.
Ettrins dosisreduktion 
One-level dose reduction
EU/1/06/363/015 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/014 - 30 filmovertrukne tabletter (flaske) 
EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 140 mg dasatinib (som monohydrat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
EU/1/06/363/011 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/010 - 30 filmovertrukne tabletter (flaske) 
EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle)
Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS" printet på den ene side og "524" på den anden. 
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Bristol-Myers Squibb Pharma EEIG Plaza 254 
Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Systemisk administration af en potent CYP3A4-hæmmer frarådes derfor til patienter, der får dasatinib (se pkt. 
Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended (see section 4.2).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 80 mg dasatinib (som monohydrat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
21 patienter (1%) havde QTcF > 500 msek. 
Twenty-one patients (1%) experienced a QTcF > 500 msec (see section 4.4).
Totrins dosisreduktion 
Two-level dose reduction
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 100 mg dasatinib (som monohydrat). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
SPRYCEL 20 mg filmovertrukne tabletter dasatinib 
SPRYCEL 20 mg film-coated tablets dasatinib
EU/1/06/363/013 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/012 - 30 filmovertrukne tabletter (flaske) 
EU/1/06/363/013 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/012 - 30 film-coated tablets (bottle)
Under disse undersøgelser bør dosis af dasatinib reduceres eller behandlingen afbrydes i overensstemmelse med anbefalingerne for behandling af ikke-hæmatologiske bivirkninger (se pkt. 
In accordance with recommendations for management of non-haematologic adverse reactions (see section 4.2) the dose of dasatinib should be reduced or therapy interrupted during this evaluation.
SPRYCEL 20 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, rund med “BMS” printet på den ene side og “527” på den anden. 
What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “527” on the other side.
Ved alle post-dosis tidspunkter på dag 8 var medianændringerne fra baseline i QTcF-intervaller 4-6 msek., med tilhørende øvre 95% konfidensintervaller < 7 msek. 
At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
2% af patienterne med CML i fremskreden fase oplevede andre grad 3 eller 4 blødninger. 
Other grade 3 or 4 haemorrhage occurred in 2% of patients with advanced phase CML.
Tabel 2: Dosiseskaleringer for patienter med Ph+ CML-CP. 
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Virkning og anvendelse 2. 
What SPRYCEL is and what it is used for 2.
SPRYCEL findes også som tabletter til brug hos voksne og børn fra 1 år og som vejer mere 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. 
SPRYCEL is also available as tablets for use in adults and children from one year of age and weighing more than 10 kg.
Ved år 1 p<0,0001 
By 1 year 46%, p<.0001
Retningslinjer for pædiatriske patienter med Ph+ ALL behandlet i kombination med kemoterapi kan ses i et særskilt afsnit efter tabellen. 
Guidelines for dose modifications in paediatric patients with CML-CP are summarised in Table 3.Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the table.
Anæmi a Resultater fra fase 3-dosisoptimeringsstudie rapporteret ved studieopfølgning ved år 2. b CA180-034 studieresultater ved anbefalet startdosis på 100 mg én gang dagligt. 
Pericardial effusion Pulmonary oedema Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported at the recommended starting dose of 140 mg once daily (n=304) population at 2 year final study follow up.
SPRYCEL 100 mg tabletter dasatinib 
NAME OF THE MEDICINAL PRODUCT SPRYCEL 100 mg tablets dasatinib
Ved år 2 p<0,0001 
By 2 years 64%, p<.0001