natgillin/translations-raw huggingface dataset:
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
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.