FrancophonIA/ELRC3.0 huggingface dataset:
English: If recovery takes longer than 4 weeks, discontinuation of bosutinib should be considered.
Danish: Hvis bedring tager mere end 4 uger, skal det overvejes at seponere bosutinib.
English: Bosutinib did not have effects on respiratory functions.
Danish: Bosutinib påvirkede ikke respirationsfunktionen.
English: Five bosutinib patients and 7 imatinib patients transformed to AP CML or BP CML.
Danish: Fem bosutinib-patienter og 7 imatinib-patienter ændredes til AP CML eller BP CML.
English: Snapshot date: 02Oct2015
Danish: Situationsdato: 2. oktober 2015
English: If you experience dizziness, have blurred vision or feel unusually tired, do not drive or operate machines until these side effects have gone away.
Danish: Hvis du bliver svimmel, får sløret syn eller føler dig usædvanligt træt, skal du undlade at føre motorkøretøj eller betjene maskiner, indtil disse bivirkninger er forsvundet.
English: Includes patients (N) with a valid baseline assessment.
Danish: Inkluderer patienter (N) med en valid baseline-vurdering.
English: Bosulif should be taken orally once daily with food (see section 5.2).
Danish: Bosulif skal tages oralt 1 gang dagligt sammen med føde (se pkt.
English: Food effect
Danish: Virkning af fødevarer
English: Cytochrome P-450 (CYP)3A inhibitors
Danish: Cytochrom P-450 (CYP)3A-hæmmere
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: - domperidone, used to treat nausea and vomiting or to stimulate breast milk production.
Danish: - domperidon, der anvendes til behandling af kvalme og opkastning eller til stimulering af dannelsen af modermælk.
English: Maximal exposure Cmax increased by 28% and 34% in the moderate and severe groups, respectively.
Danish: Maksimal C-eksponering (Cmax) steg med henholdsvis 28 % og 34 % i grupperne med moderat eller svær nyreinsufficiens.
English: 9/L, no blasts or promyelocytes in peripheral blood, less than 5% myelocytes + metamyelocytes in bone marrow, less than 20% basophils in peripheral blood, and no extramedullary involvement.
Danish: 9/l, ingen blaster eller promyelocytter i perifert blod, under 5 % myelocytter + metamyelocytter i knoglemarven, under 20 % basofile i perifert blod og ingen ekstramedullær involvering.
English: If a dose is missed by more than 12 hours, take your next dose at your regular time on the following day.
Danish: Hvis en dosis glemmes i mere end 12 timer, skal du tage den næste dosis på det sædvanlige tidspunkt den følgende dag.
English: Side effects with Bosulif may include:
Danish: Bivirkninger af Bosulif kan omfatte:
English: Your doctor will be aware of this and may ensure you are adequately hydrated and give you other medicines to help prevent it.
Danish: Lægen vil være opmærksom på dette og vil sørge for, at din væskebalance er justeret tilstrækkeligt og muligvis give dig anden forebyggende medicin.
English: The secondary efficacy endpoints included MMR by 18 months, duration of MMR, CCyR by 12 months, duration of CCyR, event-free survival (EFS), and overall survival (OS).
Danish: Det sekundære effektendepunkt omfattede MMR efter 18 måneder, varighed af MMR, CCyR efter 12 måneder, varighed af CCyR, hændelsesfri overlevelse (EFS) og samlet overlevelse (OS).
English: This finding was in a study of bosutinib in combination with letrozole in a patient with metastatic breast cancer.
Danish: Dette fund blev set i et studie med bosutinib i kombination med letrozol hos en patient med metastatisk brystcancer.
English: Table 5 - Efficacy results in previously treated patients with chronic and advanced phase CML*
Danish: Skema 5 - Effektresultater fra tidligere behandlede patienter med CML* i kronisk og avanceret fase
English: Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL expressed in murine myeloid cell lines.
Danish: Bosutinib hæmmede 16 af 18 imatinib-resistente former af BCR-ABL udtrykt i murine myeloide cellelinjer.
English: The study results indicate that bosutinib does not exhibit clinically relevant P-gp inhibitory effects.
Danish: Studiets resultater tyder på, at bosutinib ikke udviser klinisk relevante P-gp-hæmmende virkninger.
English: Treatment with bosutinib may result in a clinically significant decline in renal function in CML patients.
Danish: Behandling med bosutinib kan resultere i en klinisk signifikant nedsættelse af nyrefunktionen hos CML-patienter.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om dette lægemiddel, og denne indlægsseddel vil om nødvendigt blive ajourført
English: Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML.
Danish: Behandlingen skal initieres af en læge med erfaring i diagnosticering og behandling af CML.
English: Abbreviations: BCR-ABL=breakpoint cluster region-Abelson; CI=confidence interval;
Danish: Forkortelser: BCR-ABL=breakpoint cluster region-Abelson; CI=konfidensinterval;
English: If you faint (loss of consciousness) or have an irregular heartbeat while taking Bosulif, tell your doctor immediately, as this may be a sign of a serious heart condition.
Danish: Hvis du besvimer (mister bevidstheden) eller får uregelmæssig puls, mens du tager Bosulif, skal du straks kontakte lægen, da det kan være et tegn på en alvorlig hjertesygdom.
English: 1-sided p-value
Danish: 1-sidet p-værdi
English: Proton pump inhibitors (PPIs)
Danish: Protonpumpehæmmere (PPI'er)
English: All 3 metabolites exhibited activity that was  5% that of bosutinib in a Src-transformed fibroblast anchorage-independent proliferation assay.
Danish: Alle 3 metabolitter udviste aktivitet, der var  5 % af bosutinibs aktivitet, i en Src-transformeret fibroblastforankringsuafhængig proliferationsanalyse.
English: FISH analysis (≥ 200 cells) could be used for post-baseline cytogenetic assessments if ≥ 20 metaphases were not available.
Danish: FISH-analyse (≥ 200 celler) kunne anvendes til post-baseline cytogenetisk vurdering, hvis ≥ 20 metafaser ikke var tilgængelige.
English: The systemic exposure of N-desmethylated metabolite was 25% of the parent compound, while the oxydechlorinated metabolite was 19% of the parent compound.
Danish: Den systemiske eksponering af den N-demetylerede metabolit var 25 % af moderstoffet, mens den oxydechlorinerede metabolit udgjorde 19 % af moderstoffet.
English: Bosutinib belongs to a pharmacological class of medicinal products known as kinase inhibitors.
Danish: Bosutinib tilhører en farmakologisk klasse af lægemidler, der kaldes kinasehæmmere.
English: Adverse reaction identified post marketing.
Danish: Bivirkning identificeret efter markedsføringen.
English: Subjects with moderate and severe renal impairment had an increase in AUC over healthy volunteers of 35% and 60%, respectively.
Danish: Deltagere med moderat eller svær nyreinsufficiens havde stigninger i AUC på henholdsvis 35 % og 60 %
English: - if you have or have had pancreas problems.
Danish: - hvis du har eller har haft problemer med bugspytkirtlen.
English: Bosutinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity, reproductive toxicity, and photoxicity studies.
Danish: Bosutinib er blevet vurderet i studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, reproduktionstoksicitet og fototoksicitet.
English: Repeated-dose toxicity studies in rats of up to 6 months in duration and in dogs up to 9 months in duration revealed the gastrointestinal system to be the primary target organ of toxicity of bosutinib.
Danish: Forsøg vedrørende toksicitet efter gentagne doser hos rotter af op til 6 måneders varighed og hos hunde af op til 9 måneders varighed viste, at det gastrointestinale system er bosutinibs primære målorgan, hvad angår toksicitet.
English: Clinical signs of toxicity included foecal changes and were associated with decreased food consumption and body weight loss which occasionally led to death or elective euthanasia.
Danish: De kliniske tegn på toksicitet omfattede fækale forandringer og var forbundet med nedsat fødeindtagelse og vægttab, der i nogle tilfælde medførte død eller elektiv eutanasi.
English: Very common Lipase increased (including Hyperlipasaemia) Common
Danish: Forhøjet lipase (herunder hyperlipasæmi)
English: In a rat pre- and postnatal development study, there were reduced number of pups born at ≥ 30 mg/kg/day, and increased incidence of total litter loss and decreased growth of offspring after birth occurred at 70 mg/kg/day.
Danish: I et præ- og postnatalt udviklingsforsøg hos rotter blev der født færre unger ved ≥ 30 mg/kg/dag, og forekomsten af totalt kuldtab og nedsat vækst hos afkommet efter fødslen var forøget ved 70 mg/kg/dag.
English: Four patients (0.3%) experienced QTcF interval prolongation (greater than 500 ms).
Danish: Fire patienter (0,3 %) oplevede forlængelse af QTcF-intervallet (over 500 msek.).
English: The recommended dose is 500 mg once daily for patients whose previous medicines to treat CML have either not worked or are not suitable.
Danish: Den anbefalede dosis er 500 mg 1 gang dagligt for patienter, hvis tidligere lægemidler til behandling af CML enten ikke har virket eller ikke har været velegnede.
English: Newly-diagnosed CP Ph+ CML
Danish: Nydiagnosticeret CP Ph+ CML
English: Bosutinib can induce severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
Danish: Bosutinib kan fremkalde alvorlige hudreaktioner såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
English: Population pharmacokinetic analyses in patients with Ph+ leukaemia or malignant solid tumour indicate that there are no clinically relevant effects of age, gender, body weight, race.
Danish: Populationsfarmakokinetiske analyser hos patienter med Ph+ leukæmi eller maligne solide tumorer tyder på, at alder, køn, legemsvægt og race ikke har nogen klinisk relevante effekter.
English: The recommended dose is 400 mg once daily for patients with newly-diagnosed CML.
Danish: Den anbefalede dosis er 400 mg 1 gang dagligt for patienter med nydiagnosticeret CML.
English: Transaminase elevations generally occurred early in the course of treatment (of the patients who experienced transaminase elevations of any grade, > 80% experienced their first event within the first 3 months).
Danish: Aminotransferasestigninger indtræder som regel tidligt i behandlingsforløbet (blandt de patienter, der fik aminotransferasestigning af en hvilken som helst grad, fik > 80 % det første gang inden for de første 3 måneder).
English: Pericardial effusion, Electrocardiogram QTc prolonged (including Long
Danish: Almindelig Perikardieeffusion, QTc-forlængelse på elektrokardiogram (herunder langt
English: In the event that you have moderate or severe kidney problems, your doctor will reduce your dose by 100 mg once daily for moderate kidney problems and by an additional 100 mg once daily for severe kidney problems.
Danish: Hvis du har moderate eller alvorlige nyreproblemer, vil lægen nedsætte din dosis med 100 mg 1 gang dagligt ved moderate nyreproblemer og med yderligere 100 mg 1 gang dagligt ved alvorlige nyreproblemer.
English: The safety and efficacy of bosutinib in children and adolescents less than 18 years of age have not been established.
Danish: Bosutinibs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Bosulif film-coated tablets come in different strengths.
Danish: Bosulif filmovertrukne tabletter fås i forskellige styrker.
English: Dose reductions are recommended for severe or persistent neutropenia and thrombocytopenia as described in Table 1:
Danish: Det anbefales at reducere dosis i tilfælde af svær eller vedvarende neutropeni og trombocytopeni, som beskrevet i skema 1:
English: Patients should be tested for HBV infection before initiating treatment with bosutinib.
Danish: Patienten bør testes for HBV-infektion før initiering af behandlingen med bosutinib.
English: - modafinil, used to treat certain types of sleep disorders.
Danish: - modafinil, der anvendes til behandling af visse typer søvnforstyrrelser.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE14.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, proteinkinasehæmmere, ATC-kode: L01XE14.
English: - boceprevir and telaprevir, used to treat hepatitis C. - aprepitant, used to prevent and control nausea (feeling sick) and vomiting.
Danish: - boceprevir og telaprevir, der anvendes til behandling af hepatitis C. - aprepitant, der anvendes til at forebygge og behande kvalme og opkastning.
English: In a mass-balance study with oral bosutinib, an average of 94.6% of the total dose was recovered in 9 days; faeces (91.3%) was the major route of excretion, with 3.29% of the dose recovered in urine.
Danish: I et massebalancestudie med oral bosutinib blev der i gennemsnit genfundet 94,6 % af den totale dosis i løbet af 9 dage: fæces (91,3 %) var den primære udskillelsesvej, mens 3,29 % af dosis blev genfundet i urin.
English: Pfizer Manufacturing Deutschland GmbH Betriebsstӓtte Freiburg Mooswaldallee 1
Danish: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1
English: In vitro testing indicated that bosutinib had limited activity against the T315I or the V299L mutation.
Danish: In vitro test antyder, at bosutinib har begrænset aktivitet ved T315I- og V299L-mutationer.
English: Bosulif is not to be used during pregnancy, unless clearly necessary, because Bosulif could harm an unborn baby.
Danish: Du må ikke tage Bosulif under graviditet, medmindre det er strengt nødvendigt, det er fordi Bosulif kan skade dit ufødte barn.
English: However, if a patient taking bosutinib experiences dizziness, fatigue, visual impairment or other undesirable effects with a potential impact on the ability to drive or use machines safely, the patient should refrain from these activities for as long as the undesirable effects persist.
Danish: Hvis en patient, der tager bosutinib, oplever svimmelhed, træthed, synsforstyrrrelser eller andre bivirkninger, der potentielt kan påvirke evnen til at føre motorkøretøj eller betjene maskiner på sikker vis, skal patienten dog afstå fra sådanne aktiviteter, så længe bivirkningen varer ved.
English: Bosutinib should be permanently discontinued in patients who experience a severe skin reaction during treatment.
Danish: Bosutinib skal seponeres permanent hos patienter, som får en alvorlig hudreaktion under behandlingen.
English: Automated machine-read QTc prolongation without accompanying arrhythmia has been observed.
Danish: Der er set QTc-forlængelse uden ledsagende arytmi.
English: Paediatric population Bosulif has not yet been studied in children and adolescents less than 18 years of age.
Danish: Pædiatrisk population Bosulif er ikke blevet undersøgt hos børn og unge under 18 år.
English: Women taking Bosulif will be advised to use effective contraception during treatment and for at least 1 month after the last dose.
Danish: Kvinder, der får Bosulif, vil blive anbefalet at bruge sikker prævention under behandlingen og i mindst 1 måned efter den sidste dosis.
English: Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a mutagenic potential of bosutinib.
Danish: Genotoksicitetsforsøg i bakterielle in vitro-systemer og i in vitro- og in vivo-pattedyrssystemer med og uden metabolisk aktivering viste ingen evidens for, at bosutinib har mutagent potentiale.
English: Grapefruit products, including grapefruit juice and other foods that are known to inhibit CYP3A should be avoided (see section 4.5).
Danish: Grapefrugt-produkter, herunder grapefrugtjuice, og andre fødemidler, der vides at hæmme CYP3A, skal undgås (se pkt.
English: Based on the limited clinical information from the Phase 1/2 study, some evidence of clinical activity was observed in patients with BCR-ABL mutations (see Table 6).
Danish: Baseret på begrænset klinisk information fra fase I/II studier tyder det på, at der er nogen klinisk aktivitet hos patienter med BCR-ABL-mutationer (se skema 6).
English: Overall haematological response (OHR)=major haematological response (complete haematological response + no evidence of leukaemia) or return to chronic phase (RCP).
Danish: Samlet hæmatologisk respons (OHR) = major hæmatologisk respons (komplet hæmatologisk respons + ingen evidens for leukæmi) eller tilbagevenden til kronisk fase (RCP).
English: - if you have diarrhoea and vomiting.
Danish: - hvis du har diarré og opkastning.
English: - nefazodone, used to treat depression.
Danish: - nefazodon, der anvendes til behandling af depression.
English: Dose adjustments for renal impairment were based on the results of this study, and the known linear pharmacokinetics of bosutinib in the dose range of 200 to 600 mg.
Danish: Dosisjusteringer for nedsat nyrefunktion er baseret på resultaterne i dette studie og den kendte lineære farmakokinetik for bosutinib i dosisintervallet 200-600 mg.
English: Bosutinib 400 mg study
Danish: Bosutinib 400 mg-studie
English: White opaque 3-ply PVC/Polychlorotrifluoroethene/PVC blister sealed with push-through foil backing containing either 14 or 15 tablets.
Danish: Hvid, uigennemsigtig 3-lags blisterkort af PVC/polychlortrifluorethylen/PVC forseglet med gennemtrykkelig foliebeklædning indeholdende enten 14 eller 15 tabletter.
English: This allowed measurable concentrations of radioactivity to appear in the plasma of nursing pups.
Danish: Det muliggjorde målbare koncentrationer af radioaktivitet i plasma hos diende unger.
English: At Months 3, 6, and 9, the proportion of patients with MMR was higher in the bosutinib treatment group compared to the imatinib treatment group (Table 4).
Danish: Ved måned 3, 6 og 9 var andelen af patienter med MMR højere i bosutinib-behandlingsgruppen sammenlignet med imatinib-behandlingsgruppen (skema 4).
English: If dose is missed by less than 12 hours, take your recommended dose.
Danish: Hvis en dosis glemmes i mindre end 12 timer, skal du tage den anbefalede dosis.
English: Includes patients (N) who attained or maintained CHR for CP patients and OHR for AP and BP patients.
Danish: Inkluderer patienter (N), der opnåede eller fastholdt CHR (CP-patienter) eller, OHR(AP- og BPpatienter).
English: The median duration of therapy was 13.8 months (range: 0.03 to 123.3 months).
Danish: Den mediane behandlingsvarighed var 13,8 måneder (interval: 0,03-123,3 måneder).
English: Bosulif contains the active substance bosutinib.
Danish: Bosulif indeholder det aktive stof bosutinib.
English: Note: Baseline mutations were identified before the patient's first dose of study drug.
Danish: Situationsdato: 2. oktober 2015 Bemærk: Baseline-mutationer blev identificeret før patientens første dosis studiemedicin.
English: Cytogenetic Response criteria: Major Cytogenetic Response included Complete [0% Ph+ metaphases from bone marrow or < 1% positive cells from fluorescent in situ hybridisation (FISH)] or partial (1%-35%) cytogenetic responses.
Danish: Kriterier for cytogenetisk respons: Major cytogenetisk respons omfattede komplet (0 % Ph+ metafaser fra knoglemarven eller < 1 % positive celler fra fluorescens-in situ-hybridisering (FISH)) eller delvist (1-35 %) cytogenetisk respons.
English: - methadone, used to treat pain.
Danish: - methadon, der anvendes til behandling af smerter.
English: Swallow the tablet(s) whole with water.
Danish: Tabletterne skal synkes hele sammen med vand.
English: Bosulif will only be prescribed to you by a doctor with experience in medicines to treat leukaemia.
Danish: Du vil kun få ordineret Bosulif af en læge med erfaring med lægemidler til behandling af leukæmi.
English: In a study of the central nervous system (CNS), bosutinib treated rats displayed decreased pupil size and impaired gait.
Danish: I et studie af centralnervesystemet (CNS) udviste bosutinibbehandlede rotter nedsat pupilstørrelse og nedsat gang.
English: Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML.
Danish: Bosutinib hæmmer den abnorme BCR-ABL-kinase, der fremmer CML.
English: Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Poloxamer 188
Danish: Mikrokrystallinsk cellulose (E460) Croscarmellosenatrium (E468) Poloxamer 188
English: Do not breast-feed during treatment with Bosulif as it could harm your baby.
Danish: Du må ikke amme under behandlingen med Bosulif, da det kan skade dit barn.
English: An effect on male fertility cannot be excluded (see section 4.6).
Danish: Påvirkning af hanners fertilitet kan ikke udelukkes (se pkt.
English: In a rabbit developmental toxicity study at the maternally toxic dose, there were foetal anomalies observed (fused sternebrae, and 2 foetuses had various visceral observations), and a slight decrease in foetal body weight.
Danish: I et forsøg vedrørende udviklingstoksicitet hos kaniner ved den maternelle toksiske dosis blev der set fosterabnormiteter (sammensmeltede sternebrae, og 2 fostre havde forskellige viscerale observationer) og et let fald i den føtale legemsvægt.
English: Bosutinib has demonstrated the ability to absorb light in the UV-B and UV-A range and is distributed into the skin and uveal tract of pigmented rats.
Danish: Det er påvist, at bosutinib kan absorbere lys i UV-B- og UV-A-området, og at det fordeles i huden og tractus uvealis hos pigmenterede rotter.
English: Bosulif with food and drink Do not take Bosulif with grapefruit or grapefruit juice, as it may increase the risk of side effects.
Danish: Tag ikke Bosulif sammen med grapefrugt eller grapefrugtjuice, da det kan øge risikoen for bivirkninger.
English: The median time to CCyR (responders only) was 23.9 weeks in the bosutinib group compared to the 24.3 weeks imatinib group.
Danish: Mediantiden til CCyR (kun respondenter) var 23,9 uger i bosutinib-gruppen sammenlignet med 24,3 uger i imatinib-gruppen.
English: Clinical data are very limited (n = 3) for CML patients with moderate renal impairment receiving an escalated dose of 600 mg bosutinib.
Danish: Kliniske data er meget begrænsede (n = 3) for CML-patienter med moderat nyreinsufficiens, som fik en øget dosis på 600 mg bosutinib.
English: Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Danish: Genopblussen (reaktivering) af infektion med hepatitis B, når du tidligere har haft leverbetændelse af typen hepatitis B.
English: - efavirenz and etravirine, used to treat HIV infections/AIDS.
Danish: - efavirenz og etravirin, der anvendes til behandling af hiv/aids.
English: There are limited amount of data in pregnant women from the use of bosutinib.
Danish: Der er utilstrækkelige data fra anvendelse af bosutinib til gravide kvinder.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Bosulif in one or more subsets of the paediatric population in CML (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med bosutinib hos en eller flere undergrupper af den pædiatriske population med CML (se pkt.
English: Bosutinib displays pH-dependent aqueous solubility in vitro.
Danish: Bosutinib udviser pH-afhængig vandopløselighed in vitro.
English: Discontinuations due to suboptimal response or treatment failure as assessed by the investigator occurred for 2.0% of patients in the bosutinib-treated group compared to 6.3% of patients in the imatinib-treated group.
Danish: Seponering på grund af suboptimalt respons eller manglende terapeutisk virkning i henhold til investigators vurdering forekom for 2,0 % af patienterne i bosutinib-behandlingsgruppen sammenlignet med 6,3 % af patienterne i imatinib-behandlingsgruppen.
English: Blood creatinine increased, Amylase increased, Blood creatine phosphokinase increased
Danish: Almindelig Forhøjet blodkreatinin, forhøjet amylase, Forhøjet serumkreatin-fosfokinase