FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 135.0 mg of lactose monohydrate.
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder 135,0 mg laktosemonohydrat.
English: By 3 years 67%, p<.0055
Norwegian Bokmål: Ved 3 år p<,0055
English: MaHRb
Norwegian Bokmål: MaHRb KI)
English: Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)]
Norwegian Bokmål: Sukrose Karmellosenatrium Simetikonemulsjon bestående av: simetikon polyetylenglykolsorbitantristearat polyetoksylatstearat glyserider metylcellulose xantangummi benzosyre sorbinsyre svovelsyre Vinsyre Trinatriumsitrat, vannfritt Natriumbenzoat (E211) Silika, hydrofob, kolloidal Bærsmak [inneholder benzylalkohol, svoveldioksid (E220)]
English: Table 2: Dose escalation for paediatric patients with Ph+ CML-CP Dose (maximum dose per day) Starting dose
Norwegian Bokmål: Tabell 2: Doseøkning for pediatriske pasienter med Ph+KML-KF Dose (maksimal døgndose) Startdose
English: The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients.
Norwegian Bokmål: Tabletten anbefales ikke for pasienter som veier mindre enn 10 kg. For disse pasientene bør pulver til mikstur, suspensjon brukes.
English: 20 to less than 30 kg
Norwegian Bokmål: 20 til mindre enn 30 kg
English: By 2 years 64%, p<.0001
Norwegian Bokmål: Ved 2 år p<,0001
English: If no explanation is found, or if there is no improvement with dose reduction or interruption, the diagnosis of PAH should be considered.
Norwegian Bokmål: Diagnosen PAH bør vurderes dersom ingen forklaring blir funnet, eller dersom ingen bedring oppnås ved dosereduksjon eller seponering.
English: By 4 years 34%, p<.0055
Norwegian Bokmål: Ved 4 år p<,0055
English: However, when antacids were administered 2 hours prior to a single dose of SPRYCEL, no relevant changes in dasatinib concentration or exposure were observed.
Norwegian Bokmål: Imidlertid ble det ikke sett relevante endringer i konsentrasjonen av eller eksponeringen av dasatinib når antacida ble administrert 2 timer før en enkeltdose av SPRYCEL.
English: Each film-coated tablet contains 108 mg of lactose monohydrate.
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder 108 mg laktosemonohydrat.
English: The median time from diagnosis to start of treatment was 28 months.
Norwegian Bokmål: Median tid fra diagnostisering til behandlingsstart var 28 måneder.
English: Each film-coated tablet contains 94.5 mg of lactose monohydrate.
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder 94,5 mg laktosemonohydrat.
English: 10 to less than 20 kg
Norwegian Bokmål: 10 til mindre enn 20 kg
English: 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.
Norwegian Bokmål: Med lengre behandling og oppfølging (median tid på 24 måneder) ble MCyR oppnådd hos 53 % av de dasatinibbehandlede pasientene (CCyR hos 44 %) og 33 % av de imatinibbehandlede pasientene (CCyR hos 18 %) før behandlingsbytte.
English: 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.
Norwegian Bokmål: Hos pasienter med myeloid blastfase KML som ble behandlet med 140 mg én gang daglig, var median varighet av MaHR henholdsvis 8 måneder.
English: Outer Carton: sprycel 100 mg
Norwegian Bokmål: Ytterkartong: sprycel 100 mg
English: Outer Carton: sprycel 50 mg
Norwegian Bokmål: Ytterkartong: sprycel 50 mg
English: 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
Norwegian Bokmål: Hud, hår, øye, generelt: kribling i huden, kløe, tørr hud, akne, betennelse i huden, vedvarende lyd i ørene, hårtap, betydelig svetting, synspåvirkning (inkluderer tåkesyn, synsforstyrrelser), tørre øyne, blåmerker, depresjon, søvnløshet, hetetokter, svimmelhet, støtskade (blåmerker), spisevegring, søvnighet, generaliserte hevelser
English: Rates of MMR were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Norwegian Bokmål: Andel MMR var gjennomgående høyere hos pasienter som ble behandlet med dasatinib sammenlignet med pasienter som ble behandlet med imatinib.
English: Gastrointestinal toxicity was dose-limiting in rats and monkeys, as the intestine was a consistent target organ.
Norwegian Bokmål: Gastrointestinal toksisitet var den dosebegrensende toksisiteten hos rotter og aper.
English: 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
Norwegian Bokmål: Hud, hår, øye, generelt: allergisk reaksjon inkludert ømme, røde kuler i huden (erythema nodosum), angst, forvirringstilstand, humørsvingninger, lavere seksualdrift, besvimelse, skjelving, øyebetennelse som fører til rødhet eller smerte, en hudsykdom karakterisert av ømme, røde, veldefinerte flekker med plutselig innsettende feber og økt antall hvite blodceller (nøytrofil dermatose), hørselstap, lyssensitivitet, synssvekkelse, økt tåreproduksjon, pigmentforstyrrelse, betennelse i underhudsfett, sår i huden, blemmer i huden, neglesykdom, hårsykdom, hånd-fotsyndrom, nyresvikt, hyppig vannlating, brystforstørrelse hos menn, menstruasjonsforstyrrelser, generell svakhet og ubehag, dårlig funksjon i skjoldbruskkjertelen, mister balansen når du går, osteonekrose (en sykdom som reduserer blodstrømmen til bein, noe som kan føre til beintap og beindød), artritt, opphovnet hud ethvert sted på kroppen Smerter: betennelse i blodårer som kan forårsake rødhet, ømhet og hevelse, senebetennelse Hjerne: hukommelsestap
English: By 3 years 24%, p<.0013
Norwegian Bokmål: Ved 3 år p<,0013
English: Common arthralgia, myalgia, muscular weakness, musculoskeletal stiffness, muscle spasm Uncommon rhabdomyolysis, osteonecrosis, muscle inflammation, tendonitis, arthritis
Norwegian Bokmål: Vanlige artralgi, myalgi, muskelsvakhet, stivhet i muskler og skjelett, muskelkramper Mindre vanlige rabdomyolyse, osteonekrose, muskelbetennelse, tendonitt, artritt
English: SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient.
Norwegian Bokmål: 6.6 Spesielle forholdsregler for destruksjon og annen håndtering SPRYCEL pulver til mikstur, suspensjon må rekonstitueres på apotek eller av kvalifisert helsepersonell før det leveres ut til pasienten.
English: Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting) Skin, hair, eye, general: skin rash, fever, swelling around the face, hands and feet, headache, feeling tired or weak, bleeding
Norwegian Bokmål: Hud, hår, øye, generelt: hudutslett, feber, hevelser rundt ansiktet, hender og føtter, hodepine, kronisk tretthet eller svakhetsfølelse, blødning
English: Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
Norwegian Bokmål: Median varighet av behandling med dasatinib var 3,5 måneder, og 12 % av pasientene har til nå blitt behandlet i > 24 måneder.
English: SPRYCEL 140 mg film-coated tablets
Norwegian Bokmål: SPRYCEL 140 mg tabletter, filmdrasjerte
English: A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the tablet, in section 4.2, is expected to provide similar exposure to a tablet dose of 60 mg/m2.
Norwegian Bokmål: 4.2, forventes å gi lik eksponering som en tablettdose på 60 mg/m2.
English: Haematologic response rateb (%) MaHR (95% CI)
Norwegian Bokmål: Hematologisk responsrateb (%) MaHR (95 % KI)
English: SPRYCEL 70 mg tablets dasatinib
Norwegian Bokmål: SPRYCEL 70 mg tabletter dasatinib
English: Outer Carton: sprycel 80 mg
Norwegian Bokmål: Ytterkartong: sprycel 80 mg
English: 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).
Norwegian Bokmål: Ved milde/moderate bivirkninger (≤ grad 2) kan tidligere dosering med dasatinib gjenopptas.
English: The median time from diagnosis to start of treatment was 48 months.
Norwegian Bokmål: Median tid fra diagnostisering til behandlingsstart var 48 måneder.
English: Tablet core
Norwegian Bokmål: Molekylær hovedresponsc
English: Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate).
Norwegian Bokmål: Hver ml mikstur, suspensjon inneholder 10 mg dasatinib (som monohydrat).
English: The median time from diagnosis to start of treatment was 18 months.
Norwegian Bokmål: Median tid fra diagnostisering til behandlingsstart var 18 måneder.
English: The powder for oral suspension should be used for patients weighing less than 10 kg and patients who cannot swallow tablets.
Norwegian Bokmål: SPRYCEL tabletter anbefales ikke til pasienter som veier mindre enn 10 kg. Pulver til mikstur, suspensjon bør brukes til pasienter som veier mindre enn 10 kg og pasienter som ikke klarer å svelge tabletter.
English: Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date.
Norwegian Bokmål: Median varighet av behandling med dasatinib var 24 måneder, og 51 % av pasientene har til nå blitt behandlet i > 24 måneder.
English: SPRYCEL 50 mg tablets dasatinib
Norwegian Bokmål: SPRYCEL 50 mg tabletter dasatinib
English: Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
Norwegian Bokmål: Median varighet av behandling med dasatinib var 14 måneder, og 31 % av pasientene har til nå blitt behandlet i > 24 måneder.
English: Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5).
Norwegian Bokmål: Det må derfor velges alternative legemidler med mindre potensial for induksjon av CYP3A4 til pasienter som får dasatinib samtidig (se pkt.
English: within 60 months (95% CI)
Norwegian Bokmål: Raten av OS ved 60 måneder (95 % KI)
English: Remove the syringe from the bottle being careful not to depress the plunger.
Norwegian Bokmål: Vær forsiktig så du ikke skyver ned stempelet.
English: Each film-coated tablet contains 27 mg of lactose monohydrate.
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder 27 mg laktosemonohydrat.
English: 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.
Norwegian Bokmål: Hos pasienter med Ph+ ALL som ble behandlet med 140 mg én gang daglig, var median varighet av MaHR 5 måneder.
English: SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “524” on the other side.
Norwegian Bokmål: SPRYCEL 70 mg: den filmdrasjerte tabletten er hvit til off-white, bikonveks, rund, med ”BMS” preget på en side og ”524” på den andre.
English: 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.
Norwegian Bokmål: SPRYCEL 50 mg: den filmdrasjerte tabletten er hvit til off-white, bikonveks, oval, med ”BMS” preget på en side og ”528” på den andre.
English: SPRYCEL 20 mg tablets dasatinib
Norwegian Bokmål: SPRYCEL 20 mg tabletter dasatinib
English: Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended (see section 4.2).
Norwegian Bokmål: Systemisk administrasjon av potente CYP3A4-hemmere er derfor ikke anbefalt til pasienter som får dasatinib (se pkt.
English: By 4 years 73%, p<.0021
Norwegian Bokmål: Ved 4 år p<,0021
English: 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.
Norwegian Bokmål: SPRYCEL 140 mg: den filmdrasjerte tabletten er hvit til off-white, bikonveks, rund, med ”BMS 140” preget på en side og ”857” på den andre.
English: 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.
Norwegian Bokmål: SPRYCEL 80 mg: den filmdrasjerte tabletten er hvit til off-white, bikonveks, trekantet, med ”BMS 80” preget på en side og ”855” på den andre.
English: SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Norwegian Bokmål: SPRYCEL 140 mg tabletter, filmdrasjerte Hver filmdrasjerte tablett inneholder 140 mg dasatinib (som monohydrat).
English: The median time from diagnosis to start of treatment was 82 months.
Norwegian Bokmål: Median tid fra diagnostisering til behandlingsstart var 82 måneder.
English: SPRYCEL 70 mg film-coated tablets EU/1/06/363/006
Norwegian Bokmål: SPRYCEL 70 mg tabletter, filmdrasjerte EU/1/06/363/006
English: SPRYCEL 80 mg film-coated tablets EU/1/06/363/013
Norwegian Bokmål: SPRYCEL 80 mg tabletter, filmdrasjerte EU/1/06/363/013
English: If you have accidentally taken too many tablets, talk to your doctor immediately.
Norwegian Bokmål: Kontakt legen din umiddelbart hvis du ved et uhell har tatt for mange tabletter.
English: White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Norwegian Bokmål: Hvit til off-white, bikonveks, trekantet filmdrasjert tablett med "BMS 80" inngravert på den ene siden og "855" på den andre siden.
English: SPRYCEL 140 mg film-coated tablets EU/1/06/363/015
Norwegian Bokmål: SPRYCEL 140 mg tabletter, filmdrasjerte EU/1/06/363/015
English: SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side.
Norwegian Bokmål: SPRYCEL 100 mg: den filmdrasjerte tabletten er hvit til off-white, bikonveks, oval, med ”BMS 100” preget på en side og ”852” på den andre.
English: Cardiac adverse reactions
Norwegian Bokmål: Hjertebivirkninger
English: k Fluid overload, fluid retention, gastrointestinal oedema, generalised oedema, peripheral swelling, oedema, oedema due to cardiac disease, perinephric effusion, post procedural oedema, visceral oedema.
Norwegian Bokmål: k Væskeoverbelastning, væskeretensjon, gastrointestinalt ødem, generalisert ødem, perifer hevelse, ødem, ødem pga.
English: Cumulative grade 3 or 4 cytopaenias among patients treated with 100 mg once daily were similar at 2 and 5 years including: neutropaenia (35% vs. 36%), thrombocytopaenia (23% vs. 24%) and anaemia (13% vs. 13%).
Norwegian Bokmål: Dette inkluderer nøytropeni (35 % vs. 36 %), trombocytopeni (23 % vs. 24 %) og anemi (13 % vs. 13 %).
English: Pain: pain in the muscles (during or after discontinuing treatment), tummy (abdominal) pain Tests may show: low blood platelet count, low white blood cells count (neutropaenia), anaemia, fluid around the lungs
Norwegian Bokmål: Prøver kan vise: lavt antall blodplater, lavt antall hvite blodceller (nøytropeni), blodmangel (anemi), væskedannelse rundt lungene
English: Second dose (mL)
Norwegian Bokmål: Andre dose (ml)
English: SPRYCEL 50 mg film-coated tablets EU/1/06/363/005
Norwegian Bokmål: SPRYCEL 50 mg tabletter, filmdrasjerte EU/1/06/363/005
English: Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder 20 mg dasatinib (som monohydrat).
English: White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side.
Norwegian Bokmål: Hvit til off-white, bikonveks, rund filmdrasjert tablett med "BMS 140" inngravert på den ene siden og "857" på den andre siden.
English: White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side.
Norwegian Bokmål: Hvit til off-white, bikonveks, oval filmdrasjert tablett med "BMS 100" inngravert på den ene siden og "852" på den andre siden.
English: Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder 70 mg dasatinib (som monohydrat).
English: Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
Norwegian Bokmål: Median varighet av behandling med dasatinib var 3 måneder, og 7 % av pasientene har til nå blitt behandlet i > 24 måneder.
English: SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Norwegian Bokmål: SPRYCEL 20 mg tabletter, filmdrasjerte Hver filmdrasjerte tablett inneholder 20 mg dasatinib (som monohydrat).
English: SPRYCEL 100 mg film-coated tablets EU/1/06/363/011
Norwegian Bokmål: SPRYCEL 100 mg tabletter, filmdrasjerte EU/1/06/363/011
English: 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.
Norwegian Bokmål: e Inkluderer legemiddelerupsjon, erytem, erythema multiforme, rødfarging av hud og slimhinner (erythrose), utslett med sterk avflaking, generalisert erytem, utslett på genitaliene, varmeutslett, milia, miliaria, pustuløs psoriasis, utslett, erytematøst utslett, follikulært utslett, generalisert utslett, makulært utslett, makulopapillært utslett, papillært utslett, kløende utslett, pustulært utslett, vesikuløst utslett, hudavskalling, hudirritasjon, toksisk hudutslett, vesikuløs urticaria og vaskulært utslett.
English: SPRYCEL 70 mg film-coated tablets
Norwegian Bokmål: SPRYCEL 70 mg tabletter, filmdrasjerte
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg tablets dasatinib
Norwegian Bokmål: SPRYCEL 140 mg tabletter dasatinib
English: 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.
Norwegian Bokmål: En PPK-modellbasert simulering beregnet at de kroppsvektbaserte doseringsanbefalingene beskrevet for pulver til mikstur, suspensjon i pkt.
English: But if they do, persons other than the patient should use gloves when handling SPRYCEL.
Norwegian Bokmål: Spesielle forholdsregler ved håndtering av SPRYCEL Det er usannsynlig at tablettene ødelegges, men dersom det skjer, bør andre personer enn pasienten bruke hansker når SPRYCEL håndteres.
English: SPRYCEL 100 mg film-coated tablets
Norwegian Bokmål: SPRYCEL 100 mg tabletter, filmdrasjerte
English: l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling, testicular swelling, vulvovaginal swelling.
Norwegian Bokmål: l Hevelse i genitalier, ødem ved kuttsted, genitalt ødem, penilt ødem, hevelse i penis, ødem i pungen, hevelse i hud, hevelse i testikler, vulvovaginal hevelse.
English: SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Norwegian Bokmål: SPRYCEL 50 mg tabletter, filmdrasjerte Hver filmdrasjerte tablett inneholder 50 mg dasatinib (som monohydrat).
English: 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.
Norwegian Bokmål: Disse bivirkningene er rapportert i organklassesystemet under henholdsvis gastrointestinale sykdommer og nevrologiske sykdommer.
English: CCyR (95% CI) 54% (48-59) 33% (26-41) 27% (19-36) 46% (31-61) 54% (39-69)
Norwegian Bokmål: NA 35 % (41/117) 42 % (50/120) 43 % (51/120)
English: SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Norwegian Bokmål: SPRYCEL 70 mg tabletter, filmdrasjerte Hver filmdrasjerte tablett inneholder 70 mg dasatinib (som monohydrat).
English: SPRYCEL oral suspension may be mixed with milk, yogurt, apple juice, or applesauce.
Norwegian Bokmål: SPRYCEL kan tas med eller uten mat. SPRYCEL mikstur, suspensjon kan blandes med melk, jogurt, eplejuice eller eplesaus.
English: SPRYCEL 70 mg film-coated tablets dasatinib
Norwegian Bokmål: SPRYCEL 70 mg tabletter, filmdrasjerte dasatinib
English: SPRYCEL 80 mg film-coated tablets
Norwegian Bokmål: SPRYCEL 80 mg tabletter, filmdrasjerte
English: SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Norwegian Bokmål: SPRYCEL 80 mg tabletter, filmdrasjerte Hver filmdrasjerte tablett inneholder 80 mg dasatinib (som monohydrat).
English: Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder 50 mg dasatinib (som monohydrat).
English: Two-level dose reduction
Norwegian Bokmål: To-trinns dosereduksjon
English: In 258 dasatinib-treated patients and 258 imatinib-treated patients with a minimum of 60 months follow-up in the Phase III study in newly diagnosed chronic phase CML, 1
Norwegian Bokmål: I fase III-studien av pasienter med nylig diagnostisert kronisk fase KML, fikk 258 pasienter behandling med dasatinib og 258 pasienter behandling med imatinib med minimum 60 måneders oppfølging.
English: EU/1/06/363/004 - 56 film-coated tablets (blisters) EU/1/06/363/007 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/001 - 60 film-coated tablets (bottle)
Norwegian Bokmål: EU/1/06/363/004 - 56 filmdrasjerte tabletter (blisterpakning) EU/1/06/363/007 - 60 x 1 filmdrasjerte tabletter (endosepakning) EU/1/06/363/001 - 60 filmdrasjerte tabletter (tablettboks)