natgillin/translations-raw huggingface dataset:
Ved tredje episode reduceres dosis til 50 mg én gang dagligt (hos nyligt diagnosticerede patienter) eller seponeres (hos patienter, der har været resistente eller intolerante over for tidligere behandling, inklusive imatinib). 
For third episode, further reduce dose to 50 mg once daily (for newly diagnosed patients) or discontinue (for patients resistant or intolerant to prior therapy including imatinib).
Sjælden spontan abort 
Rare abortion
Hvis der opstår laboratoriefund eller kliniske fund associeret med TMA hos patienter, som modtager SPRYCEL, skal behandling med SPRYCEL seponeres, og der skal udføres en grundig evaluering for TMA, inklusive ADAMTS13aktivitet og anti-ADAMTS13-antistoffer. 
If laboratory or clinical findings associated with TMA occur in a patient receiving SPRYCEL, treatment with SPRYCEL should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Efter mindst 60 måneders opfølgning var den kumulative rate 2,3% for permanent seponering på grund af myelosuppression grad 3 eller 4. 
After a minimum of 60 months follow-up the cumulative rate of permanent discontinuation due to grade 3 or 4 myelosuppression was 2.3%.
Forbered omhyggeligt SPRYCEL oral suspension til administration, afmål dosen og fyld sprøjten som vist: 
Carefully prepare the SPRYCEL oral suspension for administration, measure the dose, and fill the syringe, like this:
n/a = ikke relevant; CI = konfidensinterval; ULN = øvre normalgrænse. 
n/a = not applicable; CI = confidence interval; ULN = upper limit of normal range.
Medianvarigheden af dasatinib relateret pleuraeffusion (alle grader) var 283 dage (~40 uger). 
The median duration of dasatinib-related pleural effusion (all grades) was 283 days (~40 weeks).
CI = konfidensinterval; ULN = øvre normalgrænse. 
CI = confidence interval; ULN = upper limit of normal range.
Medianbehandlingsvarigheden for alle patienter i fortsat behandling med en opfølgningsperiode på mindst 5 år (n=205) var 59 måneder (28-66 måneder). 
The median duration of treatment for all patients still on therapy with a minimum of 5 years of follow-up (n=205) was 59 months (range 28-66 months).
Patienter, der rapporterede PAH under dasatinib behandling, tog ofte andre lægemidler eller havde komorbiditet i tillæg til den underliggende malignitet. 
Patients with PAH reported during dasatinib treatment were often taking concomitant medicinal products or had co-morbidities in addition to the underlying malignancy.
* Se afsnittet ”Beskrivelse af udvalgte bivirkninger” for yderligere oplysninger. 
* For additional details, see section "Description of selected adverse reactions"
Efter opklaring bør der foretages en funktionel vurdering, inden behandlingen med dasatinib genoptages. 
After resolution, a functional assessment should be performed prior to resuming treatment with dasatinib.
3 Hvis cytopeni recidiverer, gentages trin 1, og behandlingen genoptages med reduceret dosis på 100 mg én gang dagligt (anden episode) eller 80 mg én gang dagligt (tredje episode). 
3 If recurrence of cytopaenia, repeat step 1 and resume treatment at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
Varighed af cCCyR 
Durability of cCCyR
Sjælden lungeemboli, acute respiratory distress syndrome 
Rare pulmonary embolism, acute respiratory distress syndrome
Dasatinib aktivitet in vitro i hERG- og Purkinje-fiberassays tydede på et potentiale for forlængelse af kardiel ventrikelrepolarisering (QT-interval). 
Dasatinib activity in vitro in hERG and Purkinje fiber assays suggested a potential for prolongation of cardiac ventricular repolarisation (QT interval).
I separate eksperimenter med murine modeller af CML, forebyggede dasatinib in-vivo progression af kronisk CML til blastfase og forlængede overlevelsen hos mus med patient-deriverede CMLcellelinjer placeret forskellige steder, inklusive centralnervesystemet. 
In vivo, in separate experiments using murine models of CML, dasatinib prevented the progression of chronic CML to blast phase and prolonged the survival of mice bearing patient-derived CML cell lines grown at various sites, including the central nervous system.
Oprindelig dosis 
Original dose
Behandlingen genoptages med samme dosis, hvis det er første tilfælde og med reduceret dosis, hvis bivirkningen er tilbagevendende. 
The same dose should be resumed if this is the first occurrence and the dose should be reduced if this is a recurrent adverse reaction.
Data beskrevet i tabellen er fra studier, hvor der blev anvendt en startdosis på 70 mg to gange dagligt. 
Data described in this table are from studies using a starting dose of 70 mg twice daily.
Et dosisregime med 70 mg to gange dagligt blev ligeledes undersøgt. 
A 70 mg twice daily regimen was also studied.
Hos patienter, der rapporterede sygdomsprogression eller som seponerede dasatinib eller imatinib behandling, blev der udført BCR-ABL sekventering af patienternes blodprøver, hvor disse er tilgængelige. 
In patients who report disease progression or discontinue dasatinib or imatinib therapy, BCR-ABL sequencing was performed on blood samples from patients where these are available.
• Hvis mængden, der er behov for, overstiger 11 ml, skal den deles i 2 doser, som angivet i 
• If the amount needed is greater than 11 mL, it must be split into 2 doses as indicated in Table 16.
Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket. 
If you get any side effects , talk to your doctor or pharmacist.
Disse data bør tages med i overvejelserne, hvis patienter skal skifte fra tabletter til pulver til oral suspension eller omvendt. 
These data should be considered if patients are to switch from tablets to powder for oral suspension or vice versa.
Bruges med forsigtighed hos patienter med lever- eller nyreinsufficiens, da benzylalkohol kan akkumuleres over tid og forårsage metabolisk acidose. 
Use with caution in patients with hepatic or renal impairment, as benzyl alcohol may accumulate over time and cause metabolic acidosis.
Ved klinisk relevante koncentrationer af dasatinib var binding til plasmaproteiner ca. 96%, på basis af in vitro- eksperimenter. 
At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments.
MCyR Alle patienter Imatinib resistente patienter CCyR Alle patienter Imatinib resistente patienter Major molekulært respons hos patienter der opnår CCyRd (%) (95% CI) 
MCyR All patients Imatinib-resistant patients CCyR All patients Imatinib-resistant patients Major molecular response in patients achieving CCyRd (%) (95% CI)
Dosisstigning eller -reduktion anbefales på baggrund af patientens respons og tolerabilitet. 
Dose increase or reduction is recommended based on patient response and tolerability.
CTC-grader: neutropeni (grad 3 ≥ 0,5-< 1,0 × 109/l, grad 4 < 0,5 × 109/l); trombocytopeni (grad 3 ≥ 25-< 50 × 109/l, grad 4 < 25 × 109/l); anæmi (hæmoglobin grad 3 ≥ 65-< 80 g/l, grad 4 < 65 g/l). 
CTC grades: neutropaenia (Grade 3 ≥ 0.5- < 1.0 × 109/l, Grade 4 < 0.5 × 109/l); thrombocytopaenia (Grade 3 ≥ 25 - < 50 × 109/l, Grade 4 < 25 × 109/l); anaemia (haemoglobin Grade 3 ≥ 65 - < 80 g/l, Grade 4 < 65 g/l).
Trin 1: Bank forsigtigt på bunden af hver flaske (indeholdende 33 g SPRYCEL pulver til oral suspension) for at løsne pulveret. 
Step 1: Tap bottom of each bottle (containing 33 g SPRYCEL powder for oral suspension) gently to loosen the powder.
In vitro data tyder på, at dasatinib har potentiale til at forlænge kardiel ventrikulær repolarisering (QTintervallet) (se pkt. 
In vitro data suggest that dasatinib has the potential to prolong cardiac ventricular repolarisation (QT Interval) (see section 5.3).
Fortæl det til lægen, hvis du tager blodfortyndende medicin, eller medicin, der forebygger blodpropper. 
Tell your doctor if you are taking medicines to thin the blood or prevent clots.
Ved 60 måneder forekom transformation til accelereret fase eller blastfase hos færre patienter, der blev behandlet med dasatinib (n = 8; 3%), i forhold til patienter, der blev behandlet med imatinib (n = 15; 5,8%). 
At 60 months, transformation to accelerated or blast phase occurred in fewer dasatinib-treated patients (n=8; 3%) compared with imatinib-treated patients (n=15; 5.8%).
Meget almindelig myelosuppression (inklusive anæmi, neutropeni, trombocytopeni) 
Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia)
MCyR forekom hyppigere i dasatinib armen (36%) end i imatinib armen (29%) efter 3 måneder. 
At 3 months, a MCyR occurred more often in the dasatinib arm (36%) than in the imatinib arm (29%).
12 måneder p< 0,00003* 
12 months p< 0.00003*
Der er i fase I-studier observeret hæmatologisk og cytogenetisk respons i alle faser af CML og Ph+ ALL hos de første 84 behandlede patienter, som blev fulgt i op til 27 måneder. 
In the Phase I study, haematologic and cytogenetic responses were observed in all phases of CML and in Ph+ ALL in the first 84 patients treated and followed for up to 27 months.
Sjælden gangforstyrrelser 
Rare gait disturbance
I kliniske studier er myelosuppression blevet behandlet med dosisafbrydelse, dosisreduktion eller seponering af forsøgsbehandling. 
In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy.
Denne medicin anvendes til behandling af kronisk myeloid leukæmi (CML) hos voksne, unge og børn på mindst 1 år. 
This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children at least 1 year of age.
b Progression blev defineret som øget WBC-tal, tab af CHR eller MCyR, ≥ 30% stigning i Ph+ metafaser, bekræftet AP/BPsygdom eller død. 
b Progression was defined as increasing WBC count, loss of CHR or MCyR, ≥30% increase in Ph+ metaphases, confirmed AP/BP disease or death.
a Bekræftet cCCyR (confirmed complete cytogenetic response) defineres som et respons noteret ved to på hinanden følgende lejligheder (med mindst 28 dages mellemrum). 
a Confirmed complete cytogenetic response (cCCyR) is defined as a response noted on two consecutive occasions (at least
Lymfoid blastfase og Ph+ ALL (n= 168)c 
Lymphoid blast phase and Ph+ ALL (n= 168)c
Accelereret (n= 158) 
Accelerated (n= 158)
H2-antagonister og protonpumpe-hæmmere frarådes derfor, og aluminiumhydroxid/magnesiumhydroxid-produkter skal administreres op til 2 timer inden eller 2 timer efter administration af dasatinib (se pkt. 
Thus, H2 antagonists and proton pump inhibitors are not recommended and aluminium hydroxide/magnesium hydroxide products should be administered up to 2 hours prior to, or 2 hours following the administration of dasatinib (see section 4.5).
Før hver brug skal det tilsikres, at sprøjtens stempel er skubbet helt i bund i sprøjtens cylinder. 
Before each use, make sure the syringe plunger is pushed to the bottom of the syringe barrel.
Rekonstitution på denne måde giver 90 ml (volumen, der kan administreres) 10 mg/ml SPRYCEL oral suspension. 
Constitution in this way produces 90 mL (deliverable volume) of 10 mg/mL SPRYCEL oral suspension.
Retningslinjer for dosisreduktion for pædiatriske patienter, som skal have SPRYCEL pulver til oral suspension administreret sammen med en potent CYP3A4-hæmmer, vises i Tabel 4. 
Guidelines for dose reduction for paediatric patients in whom SPRYCEL powder for oral suspension must be administered with a strong CYP3A4 inhibitor are shown in Table 4.
Spørg din læge eller apotekspersonalet til råds, hvis du er gravid eller ammer. 
Ask your doctor or pharmacist for advice if you are pregnant or breast feeding.
BCR-ABL-tyrosinkinasehæmmere har været associeret med trombotisk mikroangiopati (TMA), inklusive enkelte indberetningstilfælde for SPRYCEL (se pkt. 
BCR-ABL tyrosine kinase inhibitors have been associated with thrombotic microangiopathy (TMA), including individual case reports for SPRYCEL (see section 4.8).
Hos raske frivillige, der fik 100 mg [14C]-mærket dasatinib, udgjorde uomdannet dasatinib 29% af den cirkulerende radioaktivitet i plasma. 
In healthy subjects administered 100 mg of [14C]-labelled dasatinib, unchanged dasatinib represented 29% of circulating radioactivity in plasma.
2 års opfølgning 
2 year follow-up
Dasatinibs farmakokinetik er evalueret hos 229 voksne, raske frivillige og hos 84 patienter. 
The pharmacokinetics of dasatinib were evaluated in 229 adult healthy subjects and in 84 patients.
Efter oral administration er stigningen i gennemsnitlig eksponering (AUCτ) ca. proportional med dosisstigningen over et dosisspænd på 25-120 mg 2 gange dagligt. 
Following oral administration, the increase in the mean exposure (AUCτ) is approximately proportional to the dose increment across doses ranging from 25 mg to 120 mg twice daily.
Det bør bemærkes, at der hurtigt blev opnået større hæmatologisk respons (MaHR) (de fleste inden for 35 dage efter første administration af dasatinib til patienter med CML i lymfoid blastfase, og inden for 55 dage for patienter med Ph+ ALL). 
Of note, major haematologic responses (MaHR) were achieved quickly (most within 35 days of first dasatinib administration for patients with lymphoid blast CML, and within 55 days for patients with Ph+ ALL).
Hos voksne og pædiatriske patienter med CML i kronisk fase bør der tages fuldstændigt blodbillede hver anden uge i 12 uger, derefter hver tredje måned eller som klinisk indiceret. 
In adult and paediatric patients with chronic phase CML, complete blood counts should be performed every 2 weeks for 12 weeks, then every 3 months thereafter or as clinically indicated.
SPRYCEL pulver til oral suspension indeholder ca. 0,29 g/ml saccharose efter rekonstitution med vand. 
SPRYCEL powder for oral suspension contains approximately 0.29 g/mL of sucrose upon constitution with water.
Hvis neutropeni og/eller trombocytopeni medfører en udsættelse af den næste behandlingsserie på mere end 14 dage, skal behandlingen med SPRYCEL afbrydes og genoptages på samme dosisniveau, når næste behandlingsserie påbegyndes. 
If neutropaenia and/or thrombocytopaenia result in delay of the next block of treatment by more than 14 days, SPRYCEL should be interrupted and resumed at the same dose level once the next block of treatment is started.
Toogfyrre procent af de imatinib resistente patienter uden tidligere MCyR med imatinib (n= 188) opnåede MCyR med dasatinib. 
Forty-two percent of the imatinib-resistant patients with no prior MCyR to imatinib (n= 188) achieved a MCyR with dasatinib.
Startdosis af SPRYCEL til børn beregnes efter legemsvægten som vist nedenfor: 
The starting dose of SPRYCEL for children is calculated by body weight as shown below:
Medianbehandlingsvarighed var ca. 6 måneder (0,03-31 måneder interval). 
Median duration of treatment was approximately 6 months (range 0.03-31 months).
Disse data bør tages med i overvejelserne, hvis patienter skal skifte fra oral suspension til tabletter eller omvendt. 
These data should be considered if patients are to switch from powder for oral suspension to tablets or vice versa.
d Eksklusive gastrointestinal blødning og CNS-blødning; disse bivirkninger er indberettet under organklasserne henholdsvis mave-tarmkanalen og nervesystemet. 
d Excludes gastrointestinal bleeding and CNS bleeding; these adverse reactions are reported under the gastrointestinal disorders system organ class and the nervous system disorders system organ class, respectively.
I den samlede population på 2.712 patienter, der blev behandlet med SPRYCEL, oplevede 520 (19%) bivirkninger, der medførte seponering. 
In the overall population of 2,712 SPRYCEL-treated adult subjects, 520 (19%) experienced adverse reactions leading to treatment discontinuation.
Blandt de dasatanib behandlede patienter, som fik pleuraeffusion (n=73), fik 45 (62%) afbrudt behandlingen og 30 (41%) fik dosis reduceret. 
Among dasatinib-treated patients with drug-related pleural effusion (n=73), 45 (62%) had dose interruptions and 30 (41%) had dose reductions.
Immunsystemet Ikke almindelig overfølsomhed (inklusive erythema nodosum) 
Uncommon hypersensitivity (including erythema nodosum)
Hjertebivirkninger forekom hyppigere hos patienter med risikofaktorer eller hjertesygdom i anamnesen. 
Cardiac adverse reactions were more frequent in patients with risk factors or a history of cardiac disease.
I en yderligere analyse opnåede flere patienter behandlet med dasatinib (84%) tidlig molekylært respons (defineret som BCR-ABL-niveauer ≤ 10% efter 3 måneder) sammenlignet med patienter behandlet med imatinib (64%). 
In an additional analysis, more dasatinib-treated patients (84%) achieved early molecular response (defined as BCR-ABL levels ≤ 10% at 3 months) compared with imatinib-treated patients (64%).
Der var desuden to studier med i alt 161 pædiatriske patienter med Ph+ ALL, som fik SPRYCEL administreret i kombination med kemoterapi. 
In addition, there were two studies in a total of 161 paediatric patients with Ph+ ALL in which SPRYCEL was administered in combination with chemotherapy.
Raten for MMR til enhver tid for hver risikogruppe, defineret ved Hasford-score, var større i SPRYCEL gruppen end i imatinib gruppen (lav risiko: henholdsvis 90% og 69%; middel risiko: henholdsvis 71% og 65%; høj risiko: 67% og 54%). 
The rate of MMR at any time in each risk group determined by Hasford score was higher in the SPRYCEL group compared with the imatinib group (low risk: 90% and 69%; intermediate risk: 71% and 65%; high risk: 67% and 54%, respectively).
Tabel 7: Bivirkninger rapporteret hos ≥10% af pædiatriske patienter med Ph+ ALL behandlet med SPRYCEL i et kontinuerligt dosisregime i kombination med kemoterapi (N=126)a 
Table 7: Adverse reactions reported in ≥10% of paediatric patients with Ph+ ALL treated with SPRYCEL on a continuous dosing regimen in combination with chemotherapy (N=126)a
Tabel 5: Tabeloversigt over bivirkninger 
Table 5: Tabulated summary of adverse reactions
Risikopatienter 
Patients at risk
Aktive substanser der kan reducere plasmakoncentration af dasatinib Når dasatinib administreredes efter 8 daglige aften-administrationer af 600 mg rifampicin, der er en potent CYP3A4-induktor, faldt AUC af dasatinib med 82%. 
Active substances that may decrease dasatinib plasma concentrations When dasatinib was administered following 8 daily evening administrations of 600 mg rifampicin, a potent CYP3A4 inducer, the AUC of dasatinib was decreased by 82%.
SPRYCEL bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med dasatinib. 
SPRYCEL should not be used during pregnancy unless the clinical condition of the woman requires treatment with dasatinib.
Blandt de dasatinib behandlede patienter med pleuraeffusion opnåede 96% cytogenetisk respons (cCCyR), 82% opnåede MMR, og 50% opnåede MR4.5 på trods af afbrydelser i behandlingen eller dosisjusteringer. 
Among the dasatinib-treated patients with pleural effusion, 96% achieved a cCCyR, 82% achieved a MMR, and 50% achieved a MR4.5 despite dose interruptions or dose adjustment.
imatinib sås hos 93% af den overordnede patientpopulation. 
achieved in 93% of the overall patient population.
Det er ikke undersøgt, hvilken effekt det på lang sigt har på sygdomsforløbet at seponere behandlingen, efter der er opnået cytogenetisk eller molekylært respons [herunder fuldstændigt cytogenetisk respons (CCyR), major molekylært respons (MMR) og MR4,5]. 
The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic or molecular response [including complete cytogenetic response (CCyR), major molecular response (MMR) and MR4.5] has not been investigated.
YDRE KARTON OG ETIKET TIL FLASKE YDRE KARTON TIL BLISTERPAKNING 
OUTER CARTON AND LABEL FOR BOTTLE PACK OUTER CARTON FOR BLISTER PACK
NEL: samme kriterier som for CHR, men ANC ≥ 500/mm3 og < 1.000/mm3 eller trombocytter ≥ 20.000/mm3 og 
NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and
82 patienter fik udelukkende dasatinib tabletter, og 24 patienter fik dasatinib pulver til oral suspension mindst én gang, ud af dem fik 8 patienter udelukkende dasatinib pulver til oral suspension. 
Eighty-two patients received dasatinib tablets exclusively and 24 patients received dasatinib powder for oral suspension at least once, 8 of whom received dasatinib powder for oral suspension exclusively.
Behandling med dasatinib kan genoptages ved den oprindelige dosis for milde/moderate bivirkninger (≤ grad 2) og genoptages ved en reduceret dosis ved svære bivirkninger (≥ grad 3) (se pkt. 
Dasatinib may be resumed at the original dose for mild/moderate adverse reactions (≤ grade 2) and resumed at a dose level reduction for severe adverse reactions (≥ grade 3) (see section 4.2).
Startdosis af SPRYCEL beregnes ud fra legemsvægt som vist nedenfor: 
The starting dose of SPRYCEL is calculated by body weight as shown below:
Amning skal ophøre under behandling med SPRYCEL. 
Breast-feeding should be stopped during treatment with SPRYCEL.
mindst 45 kg 
at least 45 kg
Ved baseline var fordelingen af Hasford-scores den samme for SPRYCEL og imatinib behandlingsgrupperne (lavrisiko: 33% og 34%; middelrisiko 48% og 47%; højrisiko: 19% og 19%). 
At baseline, the distribution of Hasford Scores was similar in the SPRYCEL and imatinib treatment groups (low risk: 33% and 34%; intermediate risk 48% and 47%; high risk: 19% and 19%, respectively).
Pleuraeffusion var sædvanligvis reversibel og blev håndteret ved at seponere behandlingen med SPRYCEL og ved at anvende diuretika eller anden passende støttende behandling (se pkt. 
Pleural effusion was usually reversible and managed by interrupting SPRYCEL treatment and using diuretics or other appropriate supportive care measures (see sections 4.2 and 4.4).
YDRE KARTON OG ETIKET TIL FLASKE 
OUTER CARTON AND LABEL FOR BOTTLE PACK
Sjælden diabetes mellitus Psykiske forstyrrelser 
Rare diabetes mellitus Psychiatric disorders
nydiagnosticeret Ph+ ALL i kombination med kemoterapi. 
newly diagnosed Ph+ ALL in combination with chemotherapy.
Effektresultaterne er vist i tabel 12 og 13. 
Efficacy results are presented in Tables 12 and 13.
Dette lægemiddel indeholder 2,1 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. ml SPRYCEL oral suspension. 
This medicinal product contains 2.1 mg sodium (main component of cooking/table salt) per mL of SPRYCEL oral suspension.
Patienter med sjældne arvelige problemer med galactoseintolerans, total lactasemangel eller glucose-/galactose-malabsorption bør ikke tage dette lægemiddel. 
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Farmakokinetikken for tabletformuleringen af dasatinib blev evalueret i 72 pædiatriske patienter med recidiv eller refraktær leukæmi eller solide tumorer ved orale doser, der strækker sig fra 60 til 120 mg/m2 én gang dagligt og 50 til 110 mg/m2 to gange dagligt. 
Pharmacokinetics of the tablet formulation of dasatinib were evaluated for 72 paediatric patients with relapsed or refractory leukaemia or solid tumours at oral doses ranging from 60 to 120 mg/m2 once daily and 50 to 110 mg/m2 twice daily.
Øvrige indholdsstoffer: Tabletkerne: lactosemonohydrat (se punkt 2 ”SPRYCEL indeholder lactose”); mikrokrystallinsk cellulose; croscarmellosenatrium; hydroxypropylcellulose; magnesiumstearat Filmovertræk: hypromellose; titandioxid (E171); macrogol 400 
The other ingredients are: Tablet core: lactose monohydrate (see section 2 "SPRYCEL contains lactose"); microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide (E171); macrogol 400
Udskillelse finder primært sted gennem fæces, mest i form af metabolitter. 
Elimination is predominantly in the faeces, mostly as metabolites.
Bærere af HBV, hvor behandling med SPRYCEL er nødvendig, skal overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter behandlingsophør (se pkt. 
Carriers of HBV who require treatment with SPRYCEL should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
70 mg mindst 45 kg 
70 mg at least 45 kg