FrancophonIA/ELRC3.0 huggingface dataset:
English: Digestive problems: loss of vital nutrients such as protein from your digestive tract, bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus), impairment of kidney function, diabetes
Danish: Fordøjelsesproblemer: tab af vigtige næringsstoffer som f.eks. protein fra fordøjelseskanalen, forstoppelse, fistel i endetarmen (unormal åbning fra endetarmen til huden omkring endetarmen), nedsat nyrefunktion, sukkersyge
English: SPRYCEL 80 mg, SPRYCEL 100 mg and SPRYCEL 140 mg film-coated tablets Alu/Alu blisters (perforated unit dose blisters).
Danish: SPRYCEL 80 mg, SPRYCEL 100 mg og SPRYCEL 140 mg filmovertrukne tabletter Alu/Alu blistere (perforerede enkeltdosisblistere).
English: Pain: inflammation of vein which can cause redness, tenderness and swelling, inflammation of the tendon
Danish: Smerter: årebetændelse, som kan medføre rødme, ømhed og hævelse, senebetændelse Hjerne: hukommelsestab
English: If you take more SPRYCEL than you should
Danish: Hvis du har taget for meget SPRYCEL
English: SPRYCEL film-coated tablets
Danish: SPRYCEL filmovertrukne tabletter
English: Rates of MR4.5 over time were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Danish: MR4.5-rater over tid var konsekvent højere hos dasatinib behandlede patienter sammenlignet med imatinib behandlede patienter.
English: 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
Danish: 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
English: Lymphoid blast (n= 48)
Danish: Lymfoid blast (n= 48)
English: 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.
Danish: 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.
English: c MCyR combines both complete (0% Ph+ metaphases) and partial (> 0%-35%) responses.
Danish: c MCyR kombinerer både fuldstændigt (0% Ph+metafaser) og delvist (> 0%-35%) respons.
English: How to take SPRYCEL
Danish: Sådan skal du tage SPRYCEL
English: 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.
Danish: 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.
English: SPRYCEL 20 mg, SPRYCEL 50 mg and SPRYCEL 70 mg film-coated tablets Alu/Alu blisters (calendar blisters or perforated unit dose blisters).
Danish: SPRYCEL 20 mg, SPRYCEL 50 mg, SPRYCEL 70 mg filmovertrukne tabletter Alu/Alu blistere (kalender-blistere eller perforerede enkeltdosisblistere).
English: 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.
Danish: 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.
English: Common weight decreased, weight increased
Danish: Almindelig vægttab, vægtøgning
English: Lymphoid blast (n= 33)
Danish: Lymfoid blast (n= 33)
English: 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
Danish: 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
English: 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).
Danish: Anbefalet startdosis ved accelereret, myeloid eller lymfoid blastfase CML (fremskreden fase) eller Ph+ ALL er 140 mg én gang dagligt (se pkt.
English: The starting dose recommended for adult patients with accelerated or blast crisis CML or Ph+ ALL is 140 mg once a day.
Danish: Den anbefalede startdosis til voksne patienter med accelereret CML eller CML med blastkrise eller Ph+ ALL er 140 mg 1 gang dagligt.
English: 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).
Danish: 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).
English: A total of 387 patients received dasatinib 70 mg twice daily (288 resistant and 99 intolerant).
Danish: Ialt 387 patienter fik dasatinib 70 mg 2 gange dagligt (288 resistente og 99 intolerante).
English: The median duration of therapy in 1,618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months).
Danish: Medianbehandlingsvarigheden hos 1.618 voksne patienter med CML i kronisk fase var 29 måneder (interval 0 til 92,9 måneder).
English: Table 6b: Selected adverse reactions reported in phase III dose-optimisation study: Advanced phase CML and Ph+ ALLa
Danish: Tabel 6b: Udvalgte bivirkninger, der blev indberettet i et fase III-dosisoptimeringsstudie: CML i fremskreden fase og Ph+ALLa
English: 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.
Danish: 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.
English: SPRYCEL contains sodium
Danish: SPRYCEL indeholder natrium
English: What SPRYCEL contains
Danish: SPRYCEL indeholder:
English: 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.
Danish: 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.
English: 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.
Danish: Hos patienter, som oplevede myelosuppression grad 3 eller 4, svandt dette som regel efter korte dosisafbrydelser og/eller -reduktioner.
English: Dasatinib is administered orally once daily in the form of either SPRYCEL film-coated tablets or SPRYCEL
Danish: Dasatinib administreres oralt en gang dagligt i form af enten SPRYCEL filmovertrukne tabletter eller SPRYCEL pulver til oral suspension
English: The rate of major molecular response (assessed in 41 patients with a CCyR) was 46% at 24 months.
Danish: Hyppigheden af major molekylært respons (vurderet hos 41 patienter med CCyR) ved 24 måneder var 46%.
English: Table 11: Efficacy in phase II SPRYCEL single-arm clinical studiesa Chronic
Danish: Tabel 11: Effekt i fase 2 enkeltarms- kliniske studier med SPRYCELa Kronisk
English: 5 to less than 10 kg
Danish: 5 til mindre end 10 kg
English: Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate).
Danish: Hver ml oral suspension indeholder 10 mg dasatinib (som monohydrat).
English: 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.
Danish: Disse reducerede doser af SPRYCEL forventes at justere arealet under kurven (AUC) svarende til, hvad der observeres uden CYP3A4-hæmmere.
English: 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).
Danish: 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.
English: Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth nerve paralysis, dementia, ataxia
Danish: Sjælden cerebrovaskulært attak, transitorisk cerebral iskæmi, krampe, optikusneuritis, paralyse af 7. nerve, demens, ataksi
English: Very common diarrhoea, vomiting, nausea, abdominal pain
Danish: Meget almindelig diarré, opkastning, kvalme, mavesmerter
English: 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).
Danish: Medianbehandlingsvarigheden hos 1.094 voksne patienter med CML eller Ph+ ALL i fremskreden fase var 6,2 måneder (interval 0 til 93,2 måneder).
English: Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropaenia, gastrointestinal bleeding, high uric acid levels in the blood
Danish: 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
English: (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.
Danish: 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.
English: CCyR (95% CI) Newly diagnosed (N = 51)a
Danish: CCyR (95% CI) Nydiagnosticeret (N = 51)a
English: 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
Danish: 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
English: SPRYCEL contains 0.017 mg benzyl alcohol in each mL of oral suspension.
Danish: SPRYCEL indeholder 0,017 mg benzylalkohol pr. ml oral suspension.
English: 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).
Danish: 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.
English: 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).
Danish: 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).
English: Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis
Danish: Almindelig hypertension, rødmen Ikke almindelig hypotension, tromboflebitis, trombose
English: 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%).
Danish: 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%).
English: MCyR (95% CI) Newly diagnosed (N = 51)a
Danish: MCyR (95% CI) Nydiagnosticeret (N = 51)a
English: 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).
Danish: Forekomsten er tidligere og hyppigere hos patienter med CML eller Ph+ ALL i fremskreden fase end med CML i kronisk fase (se pkt.
English: 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
Danish: 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
English: 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).
Danish: 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).
English: 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.
Danish: AUC for dasatinib forventes at blive reduceret med cirka 25% ved samtidig brug af dexamethason, hvilket sandsynligvis ikke vil være klinisk betydningsfuldt.
English: 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)
Danish: 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)
English: 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.
Danish: SPRYCEL indeholder benzoesyre og natriumbenzoat SPRYCEL indeholder 0,25 mg benzoesyre pr. ml oral suspension og 0,25 mg natriumbenzoat pr. ml oral suspension.
English: 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.
Danish: Bemærk: Hvis du skal rekonstituere mere end én flaske, færdiggør da én flaske ad gangen.
English: Powder Store below 25°C.
Danish: Pulver Opbevares ved temperaturer under 25 °C.
English: A total of 174 patients received dasatinib 70 mg twice daily (161 resistant and 13 intolerant to imatinib).
Danish: I alt 174 patienter fik 70 mg dasatinib 2 gange dagligt (161 resistente og 13 intolerante over for imatinib).
English: SPRYCEL contains sucrose
Danish: SPRYCEL indeholder saccharose
English: A total of 611 patients were randomised to either the dasatinib 140 mg once daily or 70 mg twice daily group.
Danish: I alt 611 patienter blev randomiseret til dasatinib 140 mg én gang dagligt eller 70 mg 2 gange dagligt.
English: 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.
Danish: 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.
English: 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
Danish: 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
English: Accelerated phase (n= 157)c
Danish: (n= 165)b Accelereret fase (n= 157)c
English: Twenty-one of these patients (1%) experienced a QTcF > 500 msec.
Danish: 21 af disse patienter (1%) havde QTcF > 500 msek.
English: Table 14: Efficacy of SPRYCEL in phase III dose-optimisation study: advanced phase CML and Ph+ ALL (2 year results)a
Danish: Tabel 14: Effekt af SPRYCEL i fase 3 dosisoptimeringsstudie: CML og Ph+ ALL i fremskreden fase (resultater efter 2 år)a
English: NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG 3.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN BRISTOL-MYERS SQUIBB PHARMA EEIG 3.
English: 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).
Danish: 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.
English: 30 to less than 45 kg
Danish: 30 til mindre end 45 kg
English: 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.
Danish: Andelen af patienter med PFS efter to år var 86% (95% CI: [78%-93%]) for dasatinib og 65% (95% CI: [43%-87%]) for imatinib.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Selected adverse reactions that were reported in the recommended starting dose of 140 mg once daily are shown in Table 6b.
Danish: Udvalgte bivirkninger, der blev rapporteret ved den anbefalede startdosis på 140 mg én gang dagligt, er vist i Tabel 6b.
English: In addition, 46 patients with Ph+ ALL received dasatinib 70 mg twice daily (44 resistant and 2 intolerant to imatinib).
Danish: Derudover fik 46 patienter med Ph+ ALL dasatinib 70 mg 2 gange dagligt (44 resistente og 2 intolerante over for imatinib).
English: Common asthenia, pain, chest pain, generalised oedema*k, chills Uncommon malaise, other superficial oedemal
Danish: Almindelig asteni, smerter, smerter i brystet, generaliseret ødem*k, kulderystelser Ikke almindelig utilpashed, andet superficielt ødem,l
English: A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib).
Danish: I alt 48 patienter med CML i lymfoid blastfase fik 70 mg dasatinib 2 gange dagligt (42 resistente og 6 intolerante over for imatinib).
English: 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).
Danish: 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.
English: Carton containing 60 x 1 film-coated tablets in perforated unit dose blisters.
Danish: Æske der indeholder 60 × 1 filmovertrukne tabletter i perforerede enkeltdosisblistere.
English: 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
Danish: 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
English: Rare protein-losing gastroenteropathy, ileus, anal fistula
Danish: Sjælden gastroenteropati med proteintab, ileus, analfistler