FrancophonIA/ELRC3.0 huggingface dataset:
English: Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
Danish: Behandling skal initieres af en læge med erfaring i diagnosticering og behandling af patienter med leukæmi.
English: Secondary endpoints included time in cCCyR (measure of durability of response), time to cCCyR, major molecular response (MMR) rate, time to MMR, progression free survival (PFS) and overall survival (OS).
Danish: Sekundære endepunkter omfattede tid i cCCyR (måling af responsvarighed), tid til cCCyR, major molekylært respons (MMR), tid til MMR, progressionsfri overlevelse (PFS) og samlet overlevelse (OS).
English: • Shake well before each use.
Danish: • Omryst grundigt før hver brug.
English: CYP3A4 is a major enzyme responsible for the metabolism of dasatinib.
Danish: CYP3A4 er i høj grad ansvarlig for metabolismen af dasatinib.
English: The mutations detected among the dasatinib-treated patients were T315I, F317I/L and V299L.
Danish: Hos dasatinib behandlede patienter var de observerede mutationer T315I, F317I/L og V299L.
English: The outcome of patients with bone marrow transplantation after dasatinib treatment has not been fully evaluated.
Danish: Resultater for patienter med knoglemarvstransplantation efter behandling med dasatinib er endnu ikke fuldt evalueret.
English: SPRYCEL can be taken with or without a meal and should be taken consistently either in the morning or in the evening (see section 5.2).
Danish: SPRYCEL kan tages med eller uden mad og bør tages konsekvent enten om morgenen eller om aftenen (se pkt.
English: Time-to cCCyR Time-to MMR Durability of cCCyR
Danish: Tid-til cCCyR Tid-til MMR Varighed af cCCyR
English: However, in an in vivo single-dose study in conscious telemetered monkeys, there were no changes in QT interval or ECG wave form.
Danish: I et in vivo enkeltdosisstudie med telemetri-monitorerede aber, der var ved bevidsthed, er der dog ikke set ændringer i QT-interval eller formen af ekg-takker.
English: Rare deep vein thrombosis, embolism, livedo reticularis
Danish: Sjælden dyb venetrombose, emboli, livedo reticularis
English: Myelosuppression is generally reversible and usually managed by withholding dasatinib temporarily or by dose reduction.
Danish: Myelosuppression er almindeligvis reversibel og kan oftest håndteres ved midlertidigt at afbryde dasatinib eller ved dosisreduktion.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Hydroxypropylcellulose Magnesiumstearat
English: The non-clinical safety profile of dasatinib was assessed in a battery of in vitro and in vivo studies in mice, rats, monkeys, and rabbits.
Danish: Dasatinibs ikke-kliniske sikkerhedsprofil er vurderet i mange in vitro og in vivo-studier med mus, rotter, aber og kaniner.
English: Thus, antacids may be administered up to 2 hours prior to or 2 hours following SPRYCEL (see section 4.4).
Danish: Antacida kan derfor administreres i op til 2 timer inden eller 2 timer efter SPRYCEL (se pkt.
English: Your pharmacist or qualified healthcare professional will constitute (mix to form a liquid) SPRYCEL powder for oral suspension to form SPRYCEL oral suspension before dispensing to you.
Danish: Apotekspersonalet eller en kvalificeret sundhedsperson vil rekonstituere (blande for at få en væske) SPRYCEL pulver til oral suspension for at få en SPRYCEL oral suspension, før den bliver udleveret til dig.
English: An echocardiography should be performed at treatment initiation in every patient presenting symptoms of cardiac disease and considered in patients with risk factors for cardiac or pulmonary disease.
Danish: Ekkokardiografi bør foretages ved behandlingsstart hos alle patienter med symptomer på hjertesygdom og bør overvejes hos patienter med risikofaktorer for hjerte- eller lungesygdom.
English: In the study in chronic phase CML, the primary endpoint was MCyR in imatinib-resistant patients.
Danish: I studiet med CML i kronisk fase, var det primære endepunkt MCyR hos imatinib resistente patienter.
English: Changes in the gastrointestinal, haematopoietic and lymphoid systems were reversible following cessation of treatment.
Danish: Forandringer i de gastrointestinale, hæmatopoietiske og lymfoide systemer var reversible efter behandlingsophør.
English: Among dasatinib-treated CML-CP paediatric patients previously exposed to imatinib, the mutations detected at the end of treatment were: T315A, E255K and F317L.
Danish: Blandt dasatinib behandlede CML-CP pædiatriske patienter tidligere eksponeret over for imatinib blev følgende mutationer påvist ved behandlingens afslutning: T315A, E255K og F317L.
English: The efficacy of dasatinib is based on haematological and cytogenetic response rates.
Danish: Effekten af dasatinib er baseret på hæmatologiske og cytogenetiske responsrater.
English: In a paediatric pharmacokinetics study, dose-normalized dasatinib exposure (Cavg, Cmin and Cmax) appears similar between 21 patients with CP-CML and 16 patients with Ph+ ALL.
Danish: I et pædiatrisk farmakokinetisk studie er den dosisnormaliserede eksponering af dasatinib (Cavg, Cmin og Cmax) sammenlignelig mellem 21 patienter med CP-CML og 16 patienter med Ph+ ALL.
English: Pregnant or breast-feeding women should avoid exposure to SPRYCEL powder for oral suspension.
Danish: Gravide eller ammende kvinder bør undgå eksponering for SPRYCEL pulver til oral suspension.
English: Gastrointestinal toxicity was dose-limiting in rats and monkeys, as the intestine was a consistent target organ.
Danish: Gastrointestinal toksicitet var dosisbegrænsende hos rotter og aber, da tarmen vedvarende var et målorgan.
English: Congestive heart failure/cardiac dysfunction and pulmonary oedema were reported in < 2% of patients.
Danish: Kongestivt hjertesvigt/hjerteinsufficiens og lungeødem blev rapporteret hos < 2% af patienterne.
English: In people with CML, white cells called granulocytes start growing out of control.
Danish: Hos patienter med CML er de hvide blodlegemer, der kaldes granulocytter, begyndt at vokse uden kontrol.
English: Dasatinib was considered to be non-phototoxic in vivo after a single oral administration to female hairless mice at exposures up to 3-fold the human exposure following administration of the recommended therapeutic dose (based on AUC).
Danish: Dasatinib anses for at være ikke-fototoksisk in vivo efter en enkelt oral administration til hårløse hunmus ved eksponeringer op til 3 gange større end de humane eksponeringer efter administration af den anbefalede terapeutiske dosis (baseret på AUC).
English: Patients who develop dyspnoea and fatigue after initiation of therapy should be evaluated for common etiologies including pleural effusion, pulmonary oedema, anaemia, or lung infiltration.
Danish: Patienter, som udvikler dyspnø og træthed efter initiering af behandlingen, bør undersøges for almindelig ætiologi inklusive pleuraeffusion, pulmonal ødem, anæmi eller lungeinfiltration.
English: Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating dasatinib therapy.
Danish: Patienter bør undersøges for tegn og symptomer på underliggende kardiopulmonal sygdom før initiering af dasatinib behandling.
English: Other relevant efficacy results included CCyR and complete molecular response (CMR) rates.
Danish: Andre relevante virkningsresultater omfattede CCyR og samlet molekylært respons (CMR).
English: • 12-mL oral syringe provided with the bottle.
Danish: • 12 ml oral sprøjte der fulgte med flasken.
English: Following resolution of a severe (grade 3 or 4) episode, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the adverse reaction.
Danish: Efter opklaring af en alvorlig (grad 3 eller 4) episode kan behandlingen genoptages efter behov ved en reduceret dosis afhængig af bivirkningens initiale sværhedsgrad.
English: The time to MMR is displayed graphically in Figure 1.
Danish: Tid til MMR er vist grafisk i Figur 1.
English: Baseline characteristics were well balanced between the two treatment groups with respect to age (median age was 46 years for the SPRYCEL group and 49 years for the imatinib group with 10% and 11% of patients 65 years of age or older, respectively), gender (women 44% and 37%, respectively), and race (Caucasian 51% and 55%; Asian 42% and 37%, respectively).
Danish: Baseline-karakteristika var ligeligt fordelt mellem de to behandlingsgrupper med hensyn til alder (gennemsnitslader var 46 år for SPRYCEL gruppen og 49 år for imatinib gruppen med henholdsvis 10% og 11% af patienterne på 65 år eller derover), køn (henholdsvis 44% og 37% kvinder) og race (kaukasisk 51% og 55%, asiatisk 42% og 37%).
English: A total of 46 dasatinib-treated patients had recurrent pleural effusions.
Danish: I alt 46 dasatinib behandlede patienter havde recidiverende pleuraeffusion.
English: The following adverse reactions, excluding laboratory abnormalities, were reported in patients treated with SPRYCEL used as single-agent therapy in clinical studies and post-marketing experience (Table 5).
Danish: Følgende bivirkninger, eksklusive unormale laboratorieprøver, indberettedes hos patienter behandlet med SPRYCEL brugt som enkeltstofbehandling i kliniske studier og efter markedsføring (Tabel 5).
English: Due to the limitations of this clinical study, caution is recommended when administering dasatinib to patients with hepatic impairment.
Danish: På grund af begrænsningerne ved dette studie bør der udvises forsigtighed ved administration af dasatinib til patienter med leverinsufficiens.
English: The cumulative rate of dasatinib-related pleural effusion (all grades) over time was 10% at 12 months, 14% at 24 months, 19% at 36 months, 24% at 48 months and 28% at 60 months.
Danish: Den kumulative rate for dasatanib relateret pleuraeffusion (alle grader) over tid var 10% ved 12 måneder, 14% ved 24 måneder, 19% ved 36 måneder, 24% ved 48 måneder og 28% ved 60 måneder.
English: The rates of MCyR at 2 years were similar whether patients had any baseline BCR-ABL mutation, P-loop mutation, or no mutation (63%, 61% and 62%, respectively).
Danish: Hyppigheden af MCyR efter to år var ens for patienter med BCR-ABL-mutation, P-loop-mutation eller ingen mutation ved baseline (henholdsvis 63%, 61% og 62%).
English: Physico-chemical and available pharmacodynamic/toxicological data on dasatinib point to excretion in breast milk and a risk to the suckling child cannot be excluded.
Danish: Fysisk-kemiske og tilgængelige farmakodynamiske/toksikologiske data vedrørende dasatinib peger mod, at stoffet udskilles i modermælk, og det kan ikke udelukkes, at der er en risiko for det ammende barn.
English: Two clinical studies were conducted in patients resistant or intolerant to imatinib; the primary efficacy endpoint in these studies was Major Cytogenetic Response (MCyR).
Danish: Der er udført 2 kliniske studier med patienter, der er resistente eller intolerante over for imatinib; det primære effektendepunkt i disse studier var MCyR (Major Cytogenetic Response).
English: Dose adjustment for adverse reactions Myelosuppression
Danish: Dosisjustering ved bivirkninger Myelosuppression
English: For third episode, further reduce dose to 50 mg once daily (for newly diagnosed patients) or discontinue (for patients resistant or intolerant to prior therapy including imatinib).
Danish: Ved tredje episode reduceres dosis til 50 mg én gang dagligt (hos nyligt diagnosticerede patienter) eller seponeres (hos patienter, der har været resistente eller intolerante over for tidligere behandling, inklusive imatinib).
English: Rare abortion
Danish: Sjælden spontan abort
English: If laboratory or clinical findings associated with TMA occur in a patient receiving SPRYCEL, treatment with SPRYCEL should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Danish: Hvis der opstår laboratoriefund eller kliniske fund associeret med TMA hos patienter, som modtager SPRYCEL, skal behandling med SPRYCEL seponeres, og der skal udføres en grundig evaluering for TMA, inklusive ADAMTS13aktivitet og anti-ADAMTS13-antistoffer.
English: After a minimum of 60 months follow-up the cumulative rate of permanent discontinuation due to grade 3 or 4 myelosuppression was 2.3%.
Danish: Efter mindst 60 måneders opfølgning var den kumulative rate 2,3% for permanent seponering på grund af myelosuppression grad 3 eller 4.
English: Carefully prepare the SPRYCEL oral suspension for administration, measure the dose, and fill the syringe, like this:
Danish: Forbered omhyggeligt SPRYCEL oral suspension til administration, afmål dosen og fyld sprøjten som vist:
English: n/a = not applicable; CI = confidence interval; ULN = upper limit of normal range.
Danish: n/a = ikke relevant; CI = konfidensinterval; ULN = øvre normalgrænse.
English: The median duration of dasatinib-related pleural effusion (all grades) was 283 days (~40 weeks).
Danish: Medianvarigheden af dasatinib relateret pleuraeffusion (alle grader) var 283 dage (~40 uger).
English: CI = confidence interval; ULN = upper limit of normal range.
Danish: CI = konfidensinterval; ULN = øvre normalgrænse.
English: The median duration of treatment for all patients still on therapy with a minimum of 5 years of follow-up (n=205) was 59 months (range 28-66 months).
Danish: Medianbehandlingsvarigheden for alle patienter i fortsat behandling med en opfølgningsperiode på mindst 5 år (n=205) var 59 måneder (28-66 måneder).
English: Patients with PAH reported during dasatinib treatment were often taking concomitant medicinal products or had co-morbidities in addition to the underlying malignancy.
Danish: Patienter, der rapporterede PAH under dasatinib behandling, tog ofte andre lægemidler eller havde komorbiditet i tillæg til den underliggende malignitet.
English: * For additional details, see section "Description of selected adverse reactions"
Danish: * Se afsnittet ”Beskrivelse af udvalgte bivirkninger” for yderligere oplysninger.
English: After resolution, a functional assessment should be performed prior to resuming treatment with dasatinib.
Danish: Efter opklaring bør der foretages en funktionel vurdering, inden behandlingen med dasatinib genoptages.
English: 3 If recurrence of cytopaenia, repeat step 1 and resume treatment at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
Danish: 3 Hvis cytopeni recidiverer, gentages trin 1, og behandlingen genoptages med reduceret dosis på 100 mg én gang dagligt (anden episode) eller 80 mg én gang dagligt (tredje episode).
English: Durability of cCCyR
Danish: Varighed af cCCyR
English: Rare pulmonary embolism, acute respiratory distress syndrome
Danish: Sjælden lungeemboli, acute respiratory distress syndrome
English: Dasatinib activity in vitro in hERG and Purkinje fiber assays suggested a potential for prolongation of cardiac ventricular repolarisation (QT interval).
Danish: Dasatinib aktivitet in vitro i hERG- og Purkinje-fiberassays tydede på et potentiale for forlængelse af kardiel ventrikelrepolarisering (QT-interval).
English: In vivo, in separate experiments using murine models of CML, dasatinib prevented the progression of chronic CML to blast phase and prolonged the survival of mice bearing patient-derived CML cell lines grown at various sites, including the central nervous system.
Danish: I separate eksperimenter med murine modeller af CML, forebyggede dasatinib in-vivo progression af kronisk CML til blastfase og forlængede overlevelsen hos mus med patient-deriverede CMLcellelinjer placeret forskellige steder, inklusive centralnervesystemet.
English: Original dose
Danish: Oprindelig dosis
English: The same dose should be resumed if this is the first occurrence and the dose should be reduced if this is a recurrent adverse reaction.
Danish: Behandlingen genoptages med samme dosis, hvis det er første tilfælde og med reduceret dosis, hvis bivirkningen er tilbagevendende.
English: Data described in this table are from studies using a starting dose of 70 mg twice daily.
Danish: Data beskrevet i tabellen er fra studier, hvor der blev anvendt en startdosis på 70 mg to gange dagligt.
English: A 70 mg twice daily regimen was also studied.
Danish: Et dosisregime med 70 mg to gange dagligt blev ligeledes undersøgt.
English: In patients who report disease progression or discontinue dasatinib or imatinib therapy, BCR-ABL sequencing was performed on blood samples from patients where these are available.
Danish: Hos patienter, der rapporterede sygdomsprogression eller som seponerede dasatinib eller imatinib behandling, blev der udført BCR-ABL sekventering af patienternes blodprøver, hvor disse er tilgængelige.
English: • If the amount needed is greater than 11 mL, it must be split into 2 doses as indicated in Table 16.
Danish: • Hvis mængden, der er behov for, overstiger 11 ml, skal den deles i 2 doser, som angivet i
English: If you get any side effects , talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.
English: These data should be considered if patients are to switch from tablets to powder for oral suspension or vice versa.
Danish: Disse data bør tages med i overvejelserne, hvis patienter skal skifte fra tabletter til pulver til oral suspension eller omvendt.
English: Use with caution in patients with hepatic or renal impairment, as benzyl alcohol may accumulate over time and cause metabolic acidosis.
Danish: Bruges med forsigtighed hos patienter med lever- eller nyreinsufficiens, da benzylalkohol kan akkumuleres over tid og forårsage metabolisk acidose.
English: At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments.
Danish: Ved klinisk relevante koncentrationer af dasatinib var binding til plasmaproteiner ca. 96%, på basis af in vitro- eksperimenter.
English: MCyR All patients Imatinib-resistant patients CCyR All patients Imatinib-resistant patients Major molecular response in patients achieving CCyRd (%) (95% CI)
Danish: MCyR Alle patienter Imatinib resistente patienter CCyR Alle patienter Imatinib resistente patienter Major molekulært respons hos patienter der opnår CCyRd (%) (95% CI)
English: Dose increase or reduction is recommended based on patient response and tolerability.
Danish: Dosisstigning eller -reduktion anbefales på baggrund af patientens respons og tolerabilitet.
English: CTC grades: neutropaenia (Grade 3 ≥ 0.5- < 1.0 × 109/l, Grade 4 < 0.5 × 109/l); thrombocytopaenia (Grade 3 ≥ 25 - < 50 × 109/l, Grade 4 < 25 × 109/l); anaemia (haemoglobin Grade 3 ≥ 65 - < 80 g/l, Grade 4 < 65 g/l).
Danish: CTC-grader: neutropeni (grad 3 ≥ 0,5-< 1,0 × 109/l, grad 4 < 0,5 × 109/l); trombocytopeni (grad 3 ≥ 25-< 50 × 109/l, grad 4 < 25 × 109/l); anæmi (hæmoglobin grad 3 ≥ 65-< 80 g/l, grad 4 < 65 g/l).
English: Step 1: Tap bottom of each bottle (containing 33 g SPRYCEL powder for oral suspension) gently to loosen the powder.
Danish: Trin 1: Bank forsigtigt på bunden af hver flaske (indeholdende 33 g SPRYCEL pulver til oral suspension) for at løsne pulveret.
English: In vitro data suggest that dasatinib has the potential to prolong cardiac ventricular repolarisation (QT Interval) (see section 5.3).
Danish: In vitro data tyder på, at dasatinib har potentiale til at forlænge kardiel ventrikulær repolarisering (QTintervallet) (se pkt.
English: Tell your doctor if you are taking medicines to thin the blood or prevent clots.
Danish: Fortæl det til lægen, hvis du tager blodfortyndende medicin, eller medicin, der forebygger blodpropper.
English: At 60 months, transformation to accelerated or blast phase occurred in fewer dasatinib-treated patients (n=8; 3%) compared with imatinib-treated patients (n=15; 5.8%).
Danish: Ved 60 måneder forekom transformation til accelereret fase eller blastfase hos færre patienter, der blev behandlet med dasatinib (n = 8; 3%), i forhold til patienter, der blev behandlet med imatinib (n = 15; 5,8%).
English: Very Common myelosuppression (including anaemia, neutropaenia, thrombocytopaenia)
Danish: Meget almindelig myelosuppression (inklusive anæmi, neutropeni, trombocytopeni)
English: At 3 months, a MCyR occurred more often in the dasatinib arm (36%) than in the imatinib arm (29%).
Danish: MCyR forekom hyppigere i dasatinib armen (36%) end i imatinib armen (29%) efter 3 måneder.
English: 12 months p< 0.00003*
Danish: 12 måneder p< 0,00003*
English: In the Phase I study, haematologic and cytogenetic responses were observed in all phases of CML and in Ph+ ALL in the first 84 patients treated and followed for up to 27 months.
Danish: Der er i fase I-studier observeret hæmatologisk og cytogenetisk respons i alle faser af CML og Ph+ ALL hos de første 84 behandlede patienter, som blev fulgt i op til 27 måneder.
English: Rare gait disturbance
Danish: Sjælden gangforstyrrelser
English: In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy.
Danish: I kliniske studier er myelosuppression blevet behandlet med dosisafbrydelse, dosisreduktion eller seponering af forsøgsbehandling.
English: This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children at least 1 year of age.
Danish: Denne medicin anvendes til behandling af kronisk myeloid leukæmi (CML) hos voksne, unge og børn på mindst 1 år.
English: b Progression was defined as increasing WBC count, loss of CHR or MCyR, ≥30% increase in Ph+ metaphases, confirmed AP/BP disease or death.
Danish: b Progression blev defineret som øget WBC-tal, tab af CHR eller MCyR, ≥ 30% stigning i Ph+ metafaser, bekræftet AP/BPsygdom eller død.
English: a Confirmed complete cytogenetic response (cCCyR) is defined as a response noted on two consecutive occasions (at least
Danish: a Bekræftet cCCyR (confirmed complete cytogenetic response) defineres som et respons noteret ved to på hinanden følgende lejligheder (med mindst 28 dages mellemrum).
English: Lymphoid blast phase and Ph+ ALL (n= 168)c
Danish: Lymfoid blastfase og Ph+ ALL (n= 168)c
English: Accelerated (n= 158)
Danish: Accelereret (n= 158)
English: Thus, H2 antagonists and proton pump inhibitors are not recommended and aluminium hydroxide/magnesium hydroxide products should be administered up to 2 hours prior to, or 2 hours following the administration of dasatinib (see section 4.5).
Danish: H2-antagonister og protonpumpe-hæmmere frarådes derfor, og aluminiumhydroxid/magnesiumhydroxid-produkter skal administreres op til 2 timer inden eller 2 timer efter administration af dasatinib (se pkt.
English: Before each use, make sure the syringe plunger is pushed to the bottom of the syringe barrel.
Danish: Før hver brug skal det tilsikres, at sprøjtens stempel er skubbet helt i bund i sprøjtens cylinder.
English: Constitution in this way produces 90 mL (deliverable volume) of 10 mg/mL SPRYCEL oral suspension.
Danish: Rekonstitution på denne måde giver 90 ml (volumen, der kan administreres) 10 mg/ml SPRYCEL oral suspension.
English: Guidelines for dose reduction for paediatric patients in whom SPRYCEL powder for oral suspension must be administered with a strong CYP3A4 inhibitor are shown in Table 4.
Danish: Retningslinjer for dosisreduktion for pædiatriske patienter, som skal have SPRYCEL pulver til oral suspension administreret sammen med en potent CYP3A4-hæmmer, vises i Tabel 4.
English: Ask your doctor or pharmacist for advice if you are pregnant or breast feeding.
Danish: Spørg din læge eller apotekspersonalet til råds, hvis du er gravid eller ammer.
English: BCR-ABL tyrosine kinase inhibitors have been associated with thrombotic microangiopathy (TMA), including individual case reports for SPRYCEL (see section 4.8).
Danish: BCR-ABL-tyrosinkinasehæmmere har været associeret med trombotisk mikroangiopati (TMA), inklusive enkelte indberetningstilfælde for SPRYCEL (se pkt.
English: In healthy subjects administered 100 mg of [14C]-labelled dasatinib, unchanged dasatinib represented 29% of circulating radioactivity in plasma.
Danish: Hos raske frivillige, der fik 100 mg [14C]-mærket dasatinib, udgjorde uomdannet dasatinib 29% af den cirkulerende radioaktivitet i plasma.