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