natgillin/translations-raw huggingface dataset:
Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL expressed in murine myeloid cell lines.
Bosutinib je zaviral 16 od 18 oblik BCR-ABL, odpornih na imatinib, izraženih v mieloidnih celičnih linijah glodavcev.
Do not breast-feed during treatment with Bosulif as it could harm your baby.
Med zdravljenjem z zdravilom Bosulif ne smete dojiti, kajti to lahko škoduje vašemu otroku.
Bosutinib (N=246)
odziv bosutinib (n = 246)
All 3 metabolites exhibited activity that was  5% that of bosutinib in a Src-transformed fibroblast anchorage-independent proliferation assay.
Vsi 3 presnovki so izkazovali aktivnost, ki je znašala  5 % aktivnosti bosutiniba pri Src-preoblikovanem preskusu sidriščno neodvisnega razraščanja fibroblastov.
Cytochrome P-450 (CYP)3A inhibitors
Zaviralci citokroma P-450 (CYP)3A
Bosutinib activity in vitro in hERG assays suggested a potential for prolongation of cardiac ventricular repolarisation (QTc).
Aktivnost bosutiniba pri hERG testih in vitro kaže na možnost podaljšanja repolarizacije srčnih ventriklov (QTc).
Paediatric population Bosulif has not yet been studied in children and adolescents less than 18 years of age.
Pediatrična populacija Zdravila Bosulif še niso raziskovali pri otrocih in mladostnikih, mlajših od 18 let.
Bosulif will only be prescribed to you by a doctor with experience in medicines to treat leukaemia.
Zdravilo Bosulif vam lahko predpiše le zdravnik, ki ima izkušnje z zdravili za zdravljenje levkemije.
If dose is missed by less than 12 hours, take your recommended dose.
Če ste pozabili vzeti odmerek in je minilo manj kot 12 ur, vzemite priporočeni odmerek.
Elevations of transaminases, particularly in the setting of concomitant increases in bilirubin, may be an early indication of drug-induced liver injury and these patients should be managed appropriately (see sections 4.2 and 4.8).
Povečane vrednosti transaminaz, še zlasti ob sočasnem povečanju vrednosti bilirubina, so lahko zgodnji znak z zdravilom povzročenih poškodb jeter; te bolnike je treba ustrezno obravnavati (glejte poglavji 4.2 in 4.8).
The percentage is based on number of patients with baseline mutation assessment.
Odstotek temelji na številu bolnikov z oceno mutacij na začetku študije.
Other medicines and Bosulif
Druga zdravila in zdravilo Bosulif
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.
Do prekinitev zaradi suboptimalnega odziva ali neuspešnega zdravljenja po presoji raziskovalca je prišlo pri 2,0 % bolnikov v skupini, ki se je zdravila z bosutinibom, v primerjavi s 6,3 % bolnikov iz skupine, ki se je zdravila z imatinibom.
The median time to CCyR (responders only) was 23.9 weeks in the bosutinib group compared to the 24.3 weeks imatinib group.
Mediani čas do CCyR (samo odzivni bolniki) je bil 23,9 tedna v skupini z bosutinibom v primerjavi s 24,3 tedna v skupini z imatinibom.
Following administration of a single dose of bosutinib (500 mg) with food in healthy subjects, the absolute bioavailability was 34%.
Po zaužitju enkratnega odmerka bosutiniba (500 mg) skupaj s hrano pri zdravih preskušancih je bila absolutna biološka uporabnost 34 %.
Vomiting or diarrhoea may reduce the effectiveness of oral contraceptives.
Bruhanje in driska lahko zmanjšata učinkovitost peroralnih kontraceptivov.
Bosulif is not to be used during pregnancy, unless clearly necessary, because Bosulif could harm an unborn baby.
Zdravila Bosulif se ne sme uporabljati med nosečnostjo, razen če je to nujno potrebno, saj lahko škoduje nerojenemu otroku.
Short-acting antacids should be considered as an alternative to PPIs and administration times of bosutinib and antacids should be separated (i.e. take bosutinib in the morning and antacids in the evening) whenever possible.
Razmisliti je treba o uporabi kratkodelujočih antacidov kot alternativi za PPIs; če je le mogoče, mora biti čas jemanja bosutiniba in antacidov ločen (npr. bosutinib zjutraj in antacidi zvečer).
Bosutinib inhibits the abnormal BCR-ABL kinase that promotes CML.
Bosutinib zavira nenormalno kinazo BCR-ABL, ki pospešuje KML.
The antiemetic agent, domperidone, has the potential to increase QT interval (QTc) prolongation and to induce “torsade de pointes”- arrhythmias; therefore, co-administration with domperidone should be avoided.
Antiemetik domperidon lahko podaljša interval QT (QTc) in povzroči aritmijo “torsade de pointes”, zato se je treba sočasni uporabi z domperidonom izogibati.
Bosutinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity, reproductive toxicity, and photoxicity studies.
Zdravilo Bosulif so ocenjevali v študijah farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, vpliva na sposobnost razmnoževanja in fototoksičnosti.
Grapefruit products, including grapefruit juice and other foods that are known to inhibit CYP3A should be avoided (see section 4.5).
Izogibati se je treba izdelkom iz grenivke, vključno z grenivkinim sokom, ter drugi hrani, za katero je znano, da zavira CYP3A (glejte poglavje 4.5).
Very common Lipase increased (including Hyperlipasaemia) Common
Preiskave zelo pogosti povečane vrednosti lipaze (vključno s hiperlipazemijo)
Patients with uncontrolled or significant cardiovascular disease including QTc prolongation, at baseline, were not included in clinical studies (see sections 5.1 and 5.3).
Bolniki, ki so imeli na začetku študije nenadzorovano ali hudo bolezen srca, vključno s podaljšanjem QTc, niso bili vključeni v klinične študije (glejte poglavji 5.1 in 5.3).
Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17
Imetnik dovoljenja za promet z zdravilom Pfizer Europe MA EEIG Boulevard de la Plaine 17
Reactivation of hepatitis B (HBV) in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL TKIs.
Pri bolnikih, ki so kronični prenašalci tega virusa, se je pojavila reaktivacija hepatitisa B (HBV), potem ko so ti bolniki prejeli zaviralce tirozin-kinaze BCR-ABL.
In in vitro studies, bosutinib inhibits proliferation and survival of established CML cell lines, Ph+ ALL cell lines, and patient-derived primary primitive CML cells.
V študijah in vitro bosutinib zavira proliferacijo in preživetje trajnih celičnih linij KML, celičnih linij Ph+ ALL in primarnih, primitivnih celic KML, pridobljenih od bolnikov.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE14.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz; oznaka ATC: L01XE14
Bosulif film-coated tablets come in different strengths.
Bosulif filmsko obložene tablete so na voljo v različnih jakostih.
Mutation assessed No mutation At least 1 mutation Dasatinib resistant mutations E255K/V F317L Nilotinib resistant mutations c
mutacija ocenjena ni mutacije vsaj 1 mutacija mutacije, neodzivne na dasatinib E255K/V F317L mutacije, neodzivne na nilotinib Y253H E255K/V F359C/I/V
Table 2 - Adverse reactions for bosutinib
Preglednica 2 - Neželeni učinki bosutiniba
Bosutinib was highly bound to human plasma proteins in vitro (94%) and ex vivo in healthy subjects (96%), and binding was not concentration-dependent.
Bosutinib se je in vitro (94 %) ter ex vivo pri zdravih preskušancih (96 %) v veliki meri vezal na človeške plazemske beljakovine; vezava ni bila odvisna od koncentracije.
Cytogenetic responses were based on the percentage of Ph+ metaphases among ≥ 20 metaphase cells in each bone marrow sample.
Citogenetski odzivi so temeljili na odstotku Ph+ metafaz med ≥ 20 metafaznih celic v vsakem vzorcu kostnega mozga.
Chest pain (including Chest discomfort), Pain
pogosti bolečina v prsnem košu (vključno s tiščanjem v prsnem košu), bolečina
Bosutinib belongs to a pharmacological class of medicinal products known as kinase inhibitors.
Bosutinib sodi v farmakološko skupino zdravil, imenovanih zaviralci kinaze.
The data from this study indicate that bosutinib does not prolong the QTc in healthy subjects at the dose of 500 mg daily with food, and under conditions that give rise to supratherapeutic plasma concentrations.
Podatki iz študije kažejo, da bosutinib pri zdravih preskušancih, ki so prejemali odmerek 500 mg na dan skupaj s hrano, in v okoliščinah, ki povzročijo supraterapevtske plazemske koncentracije, ne podaljša QTc.
Women taking Bosulif will be advised to use effective contraception during treatment and for at least 1 month after the last dose.
Ženskam, ki jemljejo zdravilo Bosulif, je treba svetovati, naj med zdravljenjem in še vsaj 1 mesec po zadnjem odmerku uporabljajo učinkovito metodo kontracepcije.
This finding was in a study of bosutinib in combination with letrozole in a patient with metastatic breast cancer.
Do te ugotovitve je prišlo v študiji bosutiniba v kombinaciji z letrozolom pri bolnici z metastatskim rakom dojk.
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.
V študiji masne porazdelitve peroralno zaužitega bosutiniba se je povprečno 94,6 % celotnega odmerka izločilo v 9 dneh; glavna pot izločanja je bila blato (91,3 %), medtem ko se je z urinom izločilo 3,29 % odmerka.
It is unknown whether bosutinib and its metabolites are excreted in human milk.
Dojenje Ni znano, ali se bosutinib in njegovi presnovki izločajo v materino mleko.
Bosutinib treatment reduced the size of CML tumours growing in nude mice and inhibited growth of murine myeloid tumours expressing imatinib-resistant forms of BCR-ABL. Bosutinib also inhibits receptor tyrosine kinases c-Fms, EphA and B receptors, Trk family kinases, Axl family kinases, Tec family kinases, some members of the ErbB family, the non-receptor tyrosine kinase Csk, serine/threonine kinases of the Ste20 family, and 2 calmodulin-dependent protein kinases.
Zdravljenje z bosutinibom je zmanjšalo velikost tumorjev KML, ki so rasli na golih miših, ter pri glodavcih zaviralo rast mieloidnih tumorjev, ki so izražali na imatinib odporne oblike BCR-ABL. Bosutinib zavira tudi receptorske tirozin-kinaze c-Fms, receptorje EphA in EphB, kinaze iz družine Trk, kinaze iz družine Axl, kinaze iz družine Tec, nekatere člane družine ErbB, nereceptorske tirozin-kinaze Csk, serin/treonin-kinaze iz družine Ste20 in 2 proteinski kinazi, odvisni od kalmodulina.
Statistically significant comparison at the pre-specified significance level; based on CMH test stratified by geographical region and Sokal score at randomisation.
Statistično pomembna primerjava pri vnaprej določeni stopnji pomembnosti; na osnovi testa CMH, stratificiranega po geografski regiji in oceni po Sokalu ob randomizaciji.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
In particular, you should ask your doctor if you want to use a medicine containing domperidone for the treatment of nausea and/or vomiting.
Še zlasti se posvetujte z zdravnikom, če želite jemati zdravilo proti siljenju na bruhanje in/ali bruhanju, ki vsebuje domperidon.
Females were observed with increased embryonic resorptions, and decreases in implantations and viable embryos.
Pri samicah so opazili povečanje resorpcije zarodkov in zmanjšanje števila implantacij in zarodkov, sposobnih za življenje.
Men being treated with bosutinib are advised to seek advice on conservation of sperm prior to treatment because of the possibility of decreased fertility due to therapy with bosutinib.
Moškim, ki se zdravijo z bosutinibom, je treba svetovati, naj se pred začetkom zdravljenja posvetujejo glede shranjevanja sperme, ker obstaja možnost zmanjšanja plodnosti zaradi zdravljenja z bosutinibom.
In a study in liver impaired subjects, an increasing frequency of QTc prolongation > 450 ms with declining hepatic function was observed.
V študiji pri preskušancih z okvarjenim delovanjem jeter so opazili povečano pogostnost podaljšanja QTc za > 450 ms skupaj z zmanjševanjem delovanja jeter.
Caution is recommended in patients with previous history of pancreatitis.
Pri bolnikih z anamnezo pankreatitisa priporočajo previdnost.
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).
Po 3, 6 in 9 mesecih je bil delež bolnikov z MMR večji v skupini, ki se je zdravila z bosutinibom, kot v skupini, ki se je zdravila z imatinibom (preglednica 4).
The median duration of therapy was 14.1 months (range: 0.3 to 24.7 months), 61.6 months (0.03 to 99.6 months), 11.1 months (range: 0.03 to 123.3 months), 30.2 months (range: 0.3 to 85.6 months), and 5.7 months (range: 0.07 to 17.8 months), respectively.
Mediano trajanje zdravljenja je bilo 14,1 meseca (razpon: 0,3 do 24,7 meseca), 61,6 meseca (0,03 do 99,6 meseca), 11,1 meseca (razpon: 0,03 do 123,3 meseca), 30,2 meseca (razpon: 0,3 do 85,6 meseca) in 5,7 meseca (razpon: 0,07 do 17,8 meseca), upoštevajoč vrstni red študij v prejšnjem stavku.
Based on the large reduction in bosutinib exposure that occurred when bosutinib was co-administered with rifampicin, increasing the dose of bosutinib when co-administering with strong or moderate CYP3A inducers is unlikely to sufficiently compensate for the loss of exposure.
Na podlagi velikega zmanjšanja izpostavljenosti bosutinibu, do katerega je prišlo pri sočasni uporabi z rifampicinom, povečanje odmerka bosutiniba pri sočasni uporabi z močnimi ali zmernimi induktorji CYP3A najverjetneje ne bo v zadostni meri nadomestilo zmanjšane izpostavljenosti.
Tell your doctor if you have a heart disorders, such as arrhythmias or an abnormal electrical signal called “prolongation of the QT interval”.
Obvestite zdravnika, če imate bolezen srca, kot so aritmije ali nepravilnost električne aktivnosti srca, imenovano „podaljšanje intervala QT“.
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.
V študiji pre- in postnatalnega razvoja pri podganah so pri odmerku ≥ 30 mg/kg/dan ugotovili zmanjšano število skotenih mladičev, pri odmerku 70 mg/kg/dan pa se je povečala incidenca popolne izgube legla in zmanjšala rast mladičev po skotitvi.
Toxicities were characterised by an increase in liver weights in correlation with hepatocellular hypertrophy which occurred in the absence of elevated liver enzymes or microscopic signs of hepatocellular cytotoxicity, and is of unknown relevance to humans.
Toksičnost je vključevala povečanje mase jeter v povezavi s hipertrofijo jeter, do katere je prišlo brez povečanih vrednosti jetrnih encimov ali mikroskopskih znakov hepatocelularne citotoksičnosti; pomen za človeka ni znan.
These medicines should be taken with caution during your treatment with Bosulif.
Ta zdravila je treba med zdravljenjem z zdravilom Bosulif jemati previdno.
Blood creatinine increased, Amylase increased, Blood creatine phosphokinase increased
pogosti povečane vrednosti kreatinina v krvi, povečane vrednosti amilaze, povečane vrednosti kreatin-fosfokinaze v krvi
Following a single oral (10 mg/kg) administration of [
Po zaužitju enkratnega peroralnega odmerka (10 mg/kg) [
What Bosulif is and what it is used for What you need to know before you take Bosulif How to take Bosulif
Kaj je zdravilo Bosulif in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Bosulif Kako jemati zdravilo Bosulif Možni neželeni učinki
Your doctor should do blood tests to check your liver function prior to your starting treatment with Bosulif and for the first 3 months of treatment with Bosulif, and as clinically indicated.
Zdravnik vas mora poslati na preiskave krvi za ugotavljanje delovanja jeter pred začetkom zdravljenja z zdravilom Bosulif, prve 3 mesece zdravljenja ter kot je klinično indicirano.
Dose reduction is recommended for patients with moderate or severe renal impairment (see sections 4.2 and 5.2).
Pri bolnikih z zmerno ali hudo okvaro ledvic je priporočljivo zmanjšati odmerek (glejte poglavji 4.2 in 5.2).
- The other ingredients are: microcrystalline cellulose (E460), croscarmellose sodium (E468), poloxamer 188, povidone (E1201) and magnesium stearate (E470b).
- Druge sestavine zdravila so: mikrokristalna celuloza (E460), premreženi natrijev karmelozat (E468), poloksamer 188, povidon (E1201) in magnezijev stearat (E470b).
Among the 994 patients with diarrhoea, 180 patients (18%) were managed with treatment interruption and of these 170 (94%) were rechallenged with bosutinib.
Med 994 bolniki z diarejo je bilo pri 180 (18 %) bolnikih zdravljenje prekinjeno; od teh jih je 170 (94 %) ponovno začelo jemati bosutinib.
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.
Če imate zmerne ali hude težave z ledvicami, vam bo zdravnik odmerek zmanjšal za 100 mg enkrat na dan, če so vaše težave z ledvicami zmerne, ali za dodatnih 100 mg enkrat na dan, če so vaše težave z ledvicami hude.
Infections Bosutinib may predispose patients to bacterial, fungal, viral, or protozoan infections.
Bosutinib lahko poveča nagnjenost bolnikov k bakterijskim, glivičnim, virusnim ali protozojskim okužbam.
Renal impairment was based on CLCr (calculated by the Cockcroft-Gault formula) of < 30 mL/min (severe renal impairment), 30  CLCr  50 mL/min (moderate renal impairment), or 50 < CLCr  80 mL/min (mild renal impairment).
Okvara ledvic je bila opredeljena kot vrednost očistka kreatinina CLCr (izračunana po Cockcroft-Gaultovi formuli) < 30 ml/min (huda okvara ledvic), 30  CLCr  50 ml/min (zmerna okvara ledvic) ali 50 < CLCr  80 ml/min (blaga okvara ledvic).
These medicines should be avoided during your treatment with Bosulif.
Tem zdravilom se je treba med zdravljenjem z zdravilom Bosulif izogibati.
Concomitant medicinal products were given to treat diarrhoea in 662 (66%) patients.
662 (66 %) bolnikov so sočasno zdravili z zdravili za zdravljenje diareje.
Clinical study in CP previously untreated CML
Klinična študija pri predhodno nezdravljeni KML v kronični fazi
Excretion of unchanged bosutinib in urine was low with approximately 1% of the dose in both healthy subjects and those with advanced malignant solid tumours.
Izločanje nespremenjenega bosutiniba v urin je bilo majhno tako pri zdravih preskušancih kot pri tistih z napredovalimi malignimi čvrstimi tumorji, in sicer približno 1 % odmerka.
No metabolism of bosutinib was observed with CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A5.
Presnavljanja bosutiniba s CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ali 3A5 niso ugotovili.
Carcinogenicity Bosutinib was not carcinogenic in the 2-year rat carcinogenicity study.
Kancerogenost V dveletni študiji kancerogenosti na podganah bosutinib ni bil kancerogen.
Patients receiving bosutinib should have liver function tests prior to treatment initiation and monthly for the first 3 months of treatment, and as clinically indicated.
Bolniki, ki prejemajo bosutinib, morajo opraviti teste delovanja jeter, in sicer pred začetkom zdravljenja, enkrat na mesec v prvih 3 mesecih zdravljenja, potem pa kot je klinično indicirano.
The solubility of bosutinib is pH-dependent and absorption is reduced when gastric pH is increased (see section 4.5).
Topnost bosutiniba je odvisna od pH, absorpcija pa je zmanjšana pri povečanih vrednostih pH v želodcu (glejte poglavje 4.5).
In faeces, bosutinib and N-desmethyl bosutinib were the major drug-related components.
V blatu sta bila bosutinib in N-demetiliran bosutinib glavni z zdravilom povezani sestavini.
If a strong or moderate CYP3A inhibitor must be administered during bosutinib treatment, an interruption of bosutinib therapy or a dose reduction in bosutinib should be considered.
Če je treba med zdravljenjem z bosutinibom uporabiti močan ali zmeren zaviralec CYP3A, je treba razmisliti o prekinitvi zdravljenja z bosutinibom ali o zmanjšanju odmerka bosutiniba.
If possible, show the doctor the pack, or this leaflet.
Če je mogoče, zdravniku pokažite škatlo zdravila Bosulif ali to navodilo za uporabo.
This medicine has been given “conditional approval”.
Zdravilo je pridobilo tako imenovano “pogojno dovoljenje za promet”.
Diarrhoea and vomiting
Diareja in bruhanje
Rare side effects (may affect up to 1 in 1,000 people): - severe skin disorder (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative (scaly, peeling) rash.
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): - huda bolezen kože (multiformni eritem, Stevens-Johnsonov sindrom, toksična epidermalna nekroliza) zaradi alergijske reakcije, eksfoliativni izpuščaj (z luskasto kožo in luščenjem)
- If you get any side effects, talk to your doctor.
- Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom.
Treatment with bosutinib may be associated with fluid retention including pericardial effusion, pleural effusion, pulmonary oedema and/or peripheral oedema.
Zdravljenje z bosutinibom je lahko povezano z zastajanjem tekočine, vključno s perikardialnim izlivom, plevralnim izlivom, pljučnim edemom in/ali perifernim edemom.
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.
V nekaterih primerih je prišlo do akutne odpovedi jeter ali fulminantnega hepatitisa in posledično do presaditve jeter ali smrtnega izida.
In vitro studies with human liver microsomes indicated that the major cytochrome P450 isozyme involved in the metabolism of bosutinib is CYP3A4 and drug interaction studies have shown that ketoconazole and rifampicin had marked effect on the pharmacokinetics of bosutinib (see section 4.5).
Študije in vitro z mikrosomi človeških jeter so pokazale, da je glavni izoencim citokroma P450, ki je udeležen pri presnovi bosutiniba, CYP3A4, študije medsebojnega delovanja zdravil pa so pokazale, da imata ketokonazol in rifampicin izrazit vpliv na farmakokinetiko bosutiniba (glejte poglavje 4.5).
If you forget to take Bosulif
Če ste pozabili vzeti zdravilo Bosulif
The Kaplan-Meier estimates of OS at 48 weeks for bosutinib and imatinib patients in the mITT population were 99.6% (95% CI: 97.1%, 99.9%) and 97.9% (95% CI: 95.0%, 99.1%), respectively.
Oceni OS po Kaplan-Meierju po 48 tednih za bolnike na bosutinibu in bolnike na imatinibu v populaciji mITT sta bili 99,6 % (95 % IZ: 97,1 %; 99,9 %) oziroma 97,9 % (95 % IZ: 95,0 %;
In the entire development program, concurrent elevation in transaminases ≥ 3 × ULN and bilirubin > 2 × ULN with alkaline phosphatase < 2 × ULN occurred without alternative causes in 1/1,611 (< 0.1%) subjects treated with bosutinib.
V celotnem razvojnem programu je do sočasnega povečanja vrednosti transaminaz ≥ 3-kratnik ZMN ter bilirubina > 2-kratnik ZMN z alkalno fosfatazo < 2-kratnik ZMN brez drugega vzroka prišlo pri 1/1.611 (< 0,1 %) preskušancev, ki so se zdravili z bosutinibom.
There are limited amount of data in pregnant women from the use of bosutinib.
Podatki o uporabi bosutiniba pri nosečnicah so omejeni.
The systemic exposure of N-desmethylated metabolite was 25% of the parent compound, while the oxydechlorinated metabolite was 19% of the parent compound.
Sistemska izpostavljenost N-demetiliranemu presnovku je znašala 25 % izhodne spojine, izpostavljenost oksidekloriniranemu presnovku pa 19 % izhodne spojine.
If you experience dizziness, have blurred vision or feel unusually tired, do not drive or operate machines until these side effects have gone away.
Vpliv na sposobnost upravljanja vozil in strojev Če se vam pojavi omotica, zamegljen vid ali nenavadna utrujenost, ne upravljajte vozil ali strojev, dokler ti neželeni učinki ne minejo.
After 500 mg bosutinib daily with food, Cmax was 200 (6) ng/mL and AUCss was 3,640 (12) ng•h/mL.
Po odmerku bosutiniba 500 mg na dan s hrano je vrednost Cmax znašala 200 (6) ng/ml, vrednost AUCss pa je znašala 3.640 (12) ng*h/ml.