FrancophonIA/ELRC3.0 huggingface dataset:
English: The estimated 60-month PFS rate was 88.9% (CI: 84% - 92.4%) for both the dasatinib and imatinib treatment groups.
Danish: 84% - 92,4%) for både dasatinib og imatinib armene.
English: SPRYCEL 70 mg tablets dasatinib
Danish: SPRYCEL 70 mg tabletter dasatinib
English: Outer Carton: sprycel 80 mg
Danish: Ydre karton: sprycel 80 mg
English: DO NOT TAKE APART THE SYRINGE
Danish: SKIL IKKE SPRØJTEN AD
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.
Danish: En PPK-modelbaseret simulation forudsagde at den anbefalede dosering efter legemsvægt, der er beskrevet for pulveret til oral suspension i pkt.
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.
Danish: 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.
English: SPRYCEL 70 mg film-coated tablets
Danish: SPRYCEL 70 mg filmovertrukne tabletter
English: SPRYCEL 140 mg film-coated tablets Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Danish: SPRYCEL 140 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 140 mg dasatinib (som monohydrat).
English: The median time from diagnosis to start of treatment was 18 months.
Danish: Mediantiden fra diagnose til start af behandling var 18 måneder.
English: within 24 months (95% CI)
Danish: inden for 24 måneder (95% CI)
English: By 4 years 34%, p<.0055
Danish: Ved år 4 p<0,0055
English: SPRYCEL 20 mg tablets dasatinib
Danish: SPRYCEL 20 mg tabletter dasatinib
English: Uncommon neutrophilic dermatosis, photosensitivity, pigmentation disorder, panniculitis, skin ulcer, bullous conditions, nail disorder, palmar-plantar erythrodysesthesia syndrome, hair disorder
Danish: 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
English: SPRYCEL 50 mg tablets dasatinib
Danish: SPRYCEL 50 mg tabletter dasatinib
English: within 48 months (95% CI)
Danish: inden for 48 måneder (95% CI)
English: Inflammation of the lungs
Danish: Lungebetændelse
English: within 36 months (95% CI)
Danish: inden for 36 måneder (95% CI)
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.
Danish: 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.
English: SPRYCEL 70 mg film-coated tablets EU/1/06/363/006
Danish: SPRYCEL 70 mg filmovertrukne tabletter EU/1/06/363/006
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.
Danish: k Væskeophobning, væskeretention, gastrointestinalt ødem, generaliseret ødem, perifær hævelse, ødem, ødem på grund af hjertesygdom, perirenal effusion, ødem efter indgreb, visceralt ødem.
English: Not known thrombotic microangiopathy Respiratory, thoracic and mediastinal disorders Very common pleural effusion*, dyspnoea
Danish: Ikke kendt trombotisk mikroangiopati Luftveje, thorax og mediastinum
English: Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date.
Danish: Medianbehandlingsvarighed med dasatinib var 24 måneder med 51% af patienterne behandlet i > 24 måneder til dato.
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.
Danish: SPRYCEL 100 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, oval med “BMS 100” printet på den ene side og “852” på den anden.
English: SPRYCEL 80 mg film-coated tablets EU/1/06/363/013
Danish: SPRYCEL 80 mg filmovertrukne tabletter EU/1/06/363/013
English: White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side.
Danish: Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS 140" printet på den ene side og "857" på den anden.
English: SPRYCEL 140 mg film-coated tablets EU/1/06/363/015
Danish: SPRYCEL 140 mg filmovertrukne tabletter EU/1/06/363/015
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.
Danish: SPRYCEL 70 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, rund med “BMS” printet på den ene side og “524” på den anden.
English: Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date.
Danish: Medianbehandlingsvarighed med dasatinib var 3 måneder med 2% behandlet i > 24 måneder til dato.
English: The median time from diagnosis to start of treatment was 82 months.
Danish: Gennemsnitstid fra diagnose til start af behandling var 82 måneder.
English: Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
Danish: Medianbehandlingsvarighed med dasatinib var 14 måneder med 31% af patienterne behandlet i > 24 måneder til dato.
English: 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: Skade på blodkar kendt som trombotisk mikroangiopati (TMA), inklusive nedsat antal røde blodlegemer, nedsat antal blodplader og dannelse of blodpropper.
English: SPRYCEL 50 mg film-coated tablets EU/1/06/363/005
Danish: SPRYCEL 50 mg filmovertrukne tabletter EU/1/06/363/005
English: Response rate (95% CI)
Danish: Responsrate (95% CI)
English: Not known interstitial lung disease
Danish: Ikke kendt interstitiel lungesygdom Mave-tarm-kanalen
English: Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder 70 mg dasatinib (som monohydrat).
English: Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
Danish: Medianbehandlingsvarighed med dasatinib var 3,5 måneder med 12% af patienterne behandlet i > 24 måneder til dato.
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg tablets dasatinib
Danish: SPRYCEL 140 mg tabletter dasatinib
English: White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side.
Danish: Hvide til gråligt hvide, bikonvekse, ovale filmovertrukne tabletter med "BMS 100" printet på den ene side og "852" på den anden.
English: Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder 20 mg dasatinib (som monohydrat).
English: SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Danish: SPRYCEL 20 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 20 mg dasatinib (som monohydrat).
English: Pleural effusion
Danish: Pleuraeffusion
English: SPRYCEL 80 mg film-coated tablets
Danish: SPRYCEL 80 mg filmovertrukne tabletter
English: Breast-feeding
Danish: Perikardie-effusion
English: SPRYCEL 100 mg film-coated tablets EU/1/06/363/011
Danish: SPRYCEL 100 mg filmovertrukne tabletter EU/1/06/363/011
English: Prior complete haematologic response (CHR) to imatinib was
Danish: Tidligere fuldstændigt hæmatologisk respons (CHR) på
English: SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Danish: SPRYCEL 50 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 50 mg dasatinib (som monohydrat).
English: SPRYCEL 70 mg film-coated tablets Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Danish: SPRYCEL 70 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 70 mg dasatinib (som monohydrat).
English: within 60 months (95% CI)
Danish: inden for 60 måneder (95% CI)
English: SPRYCEL 70 mg film-coated tablets dasatinib
Danish: SPRYCEL 70 mg filmovertrukne tabletter dasatinib
English: White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side.
Danish: Hvide til gråligt hvide, bikonvekse, trekantede filmovertrukne tabletter med "BMS 80" printet på den ene side og "855" på den anden.
English: Reproductive system and breast disorders Uncommon gynecomastia, menstrual disorder General disorders and administration site conditions Very common peripheral oedemai, fatigue, pyrexia, face oedemaj
Danish: Det reproduktive system og mammae Ikke almindelig gynækomasti, menstruationsforstyrrelser Almene symptomer og reaktioner på administrationsstedet
English: By 3 years 67%, p<.0055
Danish: Ved år 3 p<0,0055
English: HAZARD RATIO (95% CI)
Danish: MEDIAN (95% CI) HAZARD RATIO (95% CI)
English: SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Danish: SPRYCEL 80 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 80 mg dasatinib (som monohydrat).
English: Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
Danish: Medianbehandlingsvarighed med dasatinib var 3 måneder med 7% af patienterne behandlet i > 24 måneder til dato.
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.
Danish: 4.2 i Produktresuméet for pulveret til oral suspension, forventes at give en eksponering, der er sammenlignelig med en tabletdosis på 60 mg/m2.
English: SPRYCEL 100 mg film-coated tablets
Danish: SPRYCEL 100 mg filmovertrukne tabletter
English: Since dasatinib is associated with grade 3 or 4 myelosuppression (see section 4.4), patients who ingest more than the recommended dose should be closely monitored for myelosuppression and given appropriate supportive treatment.
Danish: Patienter, som får mere end den anbefalede dosis, skal monitoreres tæt for myelosuppression, eftersom dasatinib er forbundet med myelosuppression grad 3 eller 4 (se pkt.
English: SPRYCEL 20 mg film-coated tablets
Danish: SPRYCEL 20 mg filmovertrukne tabletter
English: Not known atrial fibrillation/atrial flutter Vascular disorders
Danish: Ikke kendt artrieflimren/hjerteflimren Vaskulære sygdomme
English: Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder 50 mg dasatinib (som monohydrat).
English: l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling, testicular swelling, vulvovaginal swelling.
Danish: l Genital hævelse, ødem ved incisionsstedet, genitalt ødem, penilt ødem, penil hævelse, skrotalt ødem, hævelser på huden, hævede testikler, vulvovaginal hævelse.
English: Grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% of patients with chronic phase CML (resistant or intolerant to imatinib), but elevations were reported with an increased frequency of 1 to 7% of patients with advanced phase CML and Ph+ ALL.
Danish: Grad 3- eller 4-stigninger af aminotransferaser eller bilirubin blev indberettet hos 1% af patienterne med CML i kronisk fase (resistens eller intolerans over for imatinib).
English: In the Phase III dose-optimisation study in patients with chronic phase CML with resistance or intolerance to prior imatinib therapy (median duration of treatment of 30 months), the incidence of pleural effusion and congestive heart failure/cardiac dysfunction was lower in patients treated with SPRYCEL 100 mg once daily than in those treated with SPRYCEL 70 mg twice daily.
Danish: Forekomsten af pleuraeffusion og kongestivt hjertesvigt/hjerteinsufficiens var lavere blandt de patienter, der blev behandlet med SPRYCEL 100 mg én gang dagligt, end blandt de patienter, der blev behandlet med SPRYCEL 70 mg 2 gange dagligt i fase III-studiet vedrørende dosisoptimering hos patienter med CML i kronisk fase og med resistens eller intolerans over for tidligere behandling med imatinib (medianbehandlingsvarigheden var 30 måneder).
English: SPRYCEL 50 mg film-coated tablets
Danish: SPRYCEL 50 mg filmovertrukne tabletter
English: Dose (maximum dose per day)
Danish: Dosis (maksimum daglig dosis) Stardosis
English: Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)]
Danish: Vinsyre Trinatriumcitrat, vandfrit Natriumbenzoat (E211)
English: CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Danish: CHR (fremskreden CML/Ph+ ALL): WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering.
English: SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Danish: SPRYCEL 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg dasatinib (som monohydrat).
English: CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Danish: CHR: WBC ≤ institutionel ULN, ANC ≥ 1.000/mm3, trombocytter ≥ 100.000/mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering.
English: By 3 years 24%, p<.0013
Danish: Ved år 3 p<0,0013
English: Rare diabetes mellitus
Danish: Meget almindelig hududslæte
English: Headache
Danish: Neutropeni
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)
Danish: EU/1/06/363/004 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/007 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/001 - 60 filmovertrukne tabletter (flaske)
English: SPRYCEL 50 mg film-coated tablets dasatinib
Danish: SPRYCEL 50 mg filmovertrukne tabletter dasatinib
English: EU/1/06/363/005 - 56 film-coated tablets (blisters) EU/1/06/363/008 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/002 - 60 film-coated tablets (bottle)
Danish: EU/1/06/363/005 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/008 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/002 - 60 filmovertrukne tabletter (flaske)
English: White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side.
Danish: Hvide til gråligt hvide, bikonvekse, ovale filmovertrukne tabletter med "BMS" printet på den ene side og "528" på den anden.
English: White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side.
Danish: Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS" printet på den ene side og "527" på den anden.
English: EU/1/06/363/006 - 56 film-coated tablets (blisters) EU/1/06/363/009 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/003 - 60 film-coated tablets (bottle)
Danish: EU/1/06/363/006 - 56 filmovertrukne tabletter (blistere) EU/1/06/363/009 - 60 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/003 - 60 filmovertrukne tabletter (flaske)
English: By 4 years 73%, p<.0021
Danish: Ved år 4 p<0,0021
English: 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.
Danish: CHR (kronisk CML): WBC ≤ institutionel ULN, trombocytter < 450.000/mm3, ingen blaster eller promyelocytter i perifert blod, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering.
English: One-level dose reduction
Danish: Ettrins dosisreduktion
English: EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle)
Danish: EU/1/06/363/015 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/014 - 30 filmovertrukne tabletter (flaske)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 140 mg dasatinib (som monohydrat).
English: EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle)
Danish: EU/1/06/363/011 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/010 - 30 filmovertrukne tabletter (flaske)
English: White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side.
Danish: Hvide til gråligt hvide, bikonvekse, runde filmovertrukne tabletter med "BMS" printet på den ene side og "524" på den anden.
English: Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Bristol-Myers Squibb Pharma EEIG Plaza 254
English: Therefore, in patients receiving dasatinib, systemic administration of a potent CYP3A4 inhibitor is not recommended (see section 4.2).
Danish: Systemisk administration af en potent CYP3A4-hæmmer frarådes derfor til patienter, der får dasatinib (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 80 mg dasatinib (som monohydrat).
English: Twenty-one patients (1%) experienced a QTcF > 500 msec (see section 4.4).
Danish: 21 patienter (1%) havde QTcF > 500 msek.
English: Two-level dose reduction
Danish: Totrins dosisreduktion
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 100 mg dasatinib (som monohydrat).
English: SPRYCEL 20 mg film-coated tablets dasatinib
Danish: SPRYCEL 20 mg filmovertrukne tabletter dasatinib
English: EU/1/06/363/013 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/012 - 30 film-coated tablets (bottle)
Danish: EU/1/06/363/013 - 30 × 1 filmovertrukket tablet (enkeltdosisblistere) EU/1/06/363/012 - 30 filmovertrukne tabletter (flaske)
English: In accordance with recommendations for management of non-haematologic adverse reactions (see section 4.2) the dose of dasatinib should be reduced or therapy interrupted during this evaluation.
Danish: Under disse undersøgelser bør dosis af dasatinib reduceres eller behandlingen afbrydes i overensstemmelse med anbefalingerne for behandling af ikke-hæmatologiske bivirkninger (se pkt.
English: What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “527” on the other side.
Danish: SPRYCEL 20 mg: Den filmovertrukne tablet er hvid til gråligt hvid, bikonveks, rund med “BMS” printet på den ene side og “527” på den anden.
English: At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Danish: Ved alle post-dosis tidspunkter på dag 8 var medianændringerne fra baseline i QTcF-intervaller 4-6 msek., med tilhørende øvre 95% konfidensintervaller < 7 msek.
English: Other grade 3 or 4 haemorrhage occurred in 2% of patients with advanced phase CML.
Danish: 2% af patienterne med CML i fremskreden fase oplevede andre grad 3 eller 4 blødninger.
English: Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP
Danish: Tabel 2: Dosiseskaleringer for patienter med Ph+ CML-CP.
English: What SPRYCEL is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: SPRYCEL is also available as tablets for use in adults and children from one year of age and weighing more than 10 kg.
Danish: SPRYCEL findes også som tabletter til brug hos voksne og børn fra 1 år og som vejer mere 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.
English: By 1 year 46%, p<.0001
Danish: Ved år 1 p<0,0001
English: Guidelines for dose modifications in paediatric patients with CML-CP are summarised in Table 3.Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the table.
Danish: Retningslinjer for pædiatriske patienter med Ph+ ALL behandlet i kombination med kemoterapi kan ses i et særskilt afsnit efter tabellen.
English: Pericardial effusion Pulmonary oedema Haemorrhage Gastrointestinal bleeding a Phase 3 dose optimisation study results reported at the recommended starting dose of 140 mg once daily (n=304) population at 2 year final study follow up.
Danish: Anæmi a Resultater fra fase 3-dosisoptimeringsstudie rapporteret ved studieopfølgning ved år 2. b CA180-034 studieresultater ved anbefalet startdosis på 100 mg én gang dagligt.
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 100 mg tablets dasatinib
Danish: SPRYCEL 100 mg tabletter dasatinib
English: By 2 years 64%, p<.0001
Danish: Ved år 2 p<0,0001
English: grade 3 or 4 elevations of transaminases or bilirubin were reported in ≤ 1% of patients with similar low incidence in the four treatment groups.
Danish: I fase III-dosisoptimeringsstudiet i 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.
English: PROPORTION RESPONDERS
Danish: Leverinsufficiens
English: Very common skin rashe Common alopecia, dermatitis (including eczema), pruritus, acne, dry skin, urticaria, hyperhidrosis
Danish: Meget almindelig perifert ødemi, udmattelse, pyreksi, ansigtsødemj
English: Gastrointestinal disorders
Danish: Hæmatologisk parameter
English: Hepatic impairment
Danish: Meget almindelig hovedpine
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg film-coated tablets dasatinib
Danish: SPRYCEL 140 mg filmovertrukne tabletter dasatinib
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 80 mg tablets dasatinib
Danish: SPRYCEL 80 mg tabletter dasatinib
English: If you are breast-feeding, tell your doctor.
Danish: Fortæl det til din læge, hvis du ammer.
English: Hepatic and renal impairment
Danish: Lever- og nyreinsufficiens
English: Blood and lymphatic system disorders
Danish: Hydrofobisk silicacolloid
English: Talk to your doctor if you are not sure you can drive.
Danish: Tal med din læge, hvis du ikke er sikker på, at du kan køre.
English: • spread to other parts of the body or cannot be removed by surgery.
Danish: • spredt sig til andre dele af kroppen eller ikke kan fjernes ved operation.