natgillin/translations-raw huggingface dataset:
After a minimum of 12 months of follow-up in the mITT population, discontinuations due to disease progression to AP or BP CML for bosutinib-treated patients were 0.4% compared to 1.7% for imatinib-treated patients.
Po najmanj 12 mesecih spremljanja v populaciji mITT je bila stopnja prekinitev zdravljenja zaradi napredovanja bolezni v pospešeno ali blastno fazo KML pri bolnikih, ki so se zdravili z bosutinibom, 0,4 % v primerjavi z 1,7 % pri bolnikih, ki so se zdravili z imatinibom.
Includes patients (N) who attained or maintained CHR for CP patients and OHR for AP and BP patients.
Vključuje bolnike (n), ki so dosegli ali ohranili CHR (pri bolnikih v kronični fazi) in OHR (pri bolnikih v pospešeni in blastni fazi).
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.
V študiji škodljivih vplivov na razvoj pri kuncih so pri odmerku, toksičnem za mater, opazili anomalije zarodka (fuzija prsnice, 2 zarodka sta imela številne visceralne nepravilnosti) in rahlo zmanjšanje telesne mase zarodka.
A 200 mg dose of bosutinib administered with food was evaluated in a cohort of 18 hepatically impaired subjects (Child-Pugh classes A, B, and C) and 9 matched healthy subjects.
Zaužitje 200 mg odmerka bosutiniba skupaj s hrano so ocenjevali v kohorti 18 preskušancev z okvaro jeter (razred A, B, in C po Child-Pughu) ter pri 9 primerljivih zdravih preskušancih.
- This medicine does not require any special storage conditions.
- Za shranjevanje zdravila niso potrebna posebna navodila.
It is used to treat adult patients who have a type of leukaemia called Philadelphia chromosome-positive (Ph-positive) Chronic Myeloid Leukaemia (CML) and are newly-diagnosed or for whom previous medicines to treat CML have either not worked or are not suitable.
Uporablja se za zdravljenje odraslih bolnikov, ki imajo vrsto levkemije, imenovano kronična mieloična levkemija s prisotnim kromosomom Philadelphia (Ph-pozitivna KML), in imajo novo odkrito bolezen ali pri katerih predhodno zdravljenje KML ni bilo uspešno ali pa je bilo neustrezno.
Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of bosutinib (see section 4.8).
Zaradi možnosti pojava sindroma lize tumorja (TLS - Tumour Lysis Syndrome) je pred začetkom zdravljenja z bosutinibom priporočljivo korigirati klinično pomembno dehidracijo in visoke ravni sečne kisline (glejte poglavje 4.8).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Bosulif:
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Bosulif se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - Če imate ali ste v preteklosti imeli težave z jetri.
Based on a population pharmacokinetic analysis increasing exposure (AUC) in patients with moderate and severe renal impairment at initiation of treatment during studies was observed (see sections 4.2 and
S populacijsko farmakokinetično analizo so med študijami pri bolnikih z zmerno in hudo okvaro ledvic na začetku zdravljenja opazili povečanje izpostavljenosti (AUC) (glejte poglavji 4.2 in 5.2).
In case lipase elevations are accompanied by abdominal symptoms, bosutinib should be interrupted and appropriate diagnostic measures considered to exclude pancreatitis (see section 4.2).
V primeru, da povečane vrednosti lipaze spremljajo tudi trebušni simptomi, je treba z jemanjem bosutiniba prekiniti in z ustreznimi diagnostičnimi metodami izključiti pankreatitis (poglavje 4.2).
Proarrhythmic potential
Proaritmični potencial
If you stop taking Bosulif
Če ste prenehali jemati zdravilo Bosulif
In vitro studies indicate that bosutinib has a low potential to inhibit breast cancer resistance protein (BCRP, systemically), organic anion transporting polypeptide (OATP)1B1, OATP1B3, organic anion transporter (OAT)1, OAT3, organic cation transporter (OCT)2 at clinically relevant concentrations, but may have the potential to inhibit BCRP in the gastrointestinal tract and OCT1.
Študije in vitro so pokazale, da ima bosutinib pri klinično pomembnih koncentracijah majhen potencial za zaviranje beljakovine odpornosti pri raku dojke (BCRP - Breast Cancer Resistance Protein, sistemsko), polipeptidnega prenašalca organskih anionov (OATP - Organic Anion Transporting Polypeptide)1B1, OATP1B3, prenašalca organskih anionov (OAT - Organic Anion Transporter)1, OAT3, prenašalca organskih kationov (OCT - Organic Cation Transporter)2, vendar pa ima lahko potencial za zaviranje BCRP v prebavilih in OCT1.
In these patients, the maximum toxicity of Grade 1 or 2 was experienced in 174 (58%) patients, Grade 3 in 96 patients (32%), and Grade 4 in 27 (9%) patients.
Pri teh bolnikih je do največje toksičnosti stopnje 1 ali 2 prišlo pri 174 (58 %) bolnikih, stopnje 3 pri 96 (32 %) bolnikih in stopnje 4 pri 27 (9 %) bolnikih.
Doses less than 300 mg/day have been used; however, efficacy has not been established.
Uporabljali so odmerke, manjše od 300 mg na dan, vendar učinkovitosti niso dokazali.
Patients with transaminase elevations should be managed by withholding bosutinib temporarily (with consideration given to dose reduction after recovery to Grade 1 or baseline), and/or discontinuation of bosutinib.
Pri bolnikih s povečanimi vrednostmi transaminaz je treba začasno prekiniti zdravljenje z bosutinibom (pri tem je treba upoštevati zmanjšanje odmerka po izboljšanju na stopnjo 1 ali na izhodiščno vrednost) in/ali dokončno ukiniti zdravljenje z bosutinibom.
In healthy subjects given a single intravenous dose of 120 mg bosutinib, the mean (%CV) terminal elimination half-life was 35.5 (24) hours, and the mean (%CV) clearance was 61.9 (26) L/h.
Pri zdravih preskušancih, ki so jim dali enkraten intravenski 120 mg odmerek bosutiniba, je povprečni (% CV) končni razpolovni čas izločanja znašal 35,5 (24) ur, povprečni (% CV) očistek pa 61,9 (26) l/h.
If you get any side effects, talk to your doctor or pharmacist or nurse.
Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Other efficacy endpoints include transformation to AP/BP, progression free survival and OS for all cohorts.
Drugi opazovani dogodki so vključevali transformacijo v pospešeno/blastno fazo, preživetje brez napredovanja bolezni ter OS v vseh kohortah.
Among patients with reports of adverse reactions of elevations in either ALT or AST (all grades), the median time of onset observed was 29 days with a range of onset 1 to 2,465 days for ALT and AST.
Pri bolnikih, pri katerih so poročali o neželenih učinkih povečanih vrednosti ALT ali AST (vse stopnje), je bil opaženi mediani čas do pojava 29 dni, z razponom 1 do 2.465 dni za ALT ter AST.
Median, weeks (95% CI)
mediana, tedni (95 % IZ)
Do not take Bosulif - if you are allergic to bosutinib or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Bosulif - če ste alergični na bosutinib ali katerokoli sestavino tega zdravila (navedeno v poglavju 6); - če vam je zdravnik povedal, da so vaša jetra poškodovana in ne delujejo pravilno.
Treatment with bosutinib is associated with myelosuppression, defined as anaemia, neutropenia, and thrombocytopenia.
Zdravljenje z bosutinibom je povezano z mielosupresijo, ki je opredeljena kot anemija, nevtropenija in trombocitopenija.
You should ask your doctor if use of your treatment for vomiting may result in a greater risk of heart arrhythmias.
Vprašajte zdravnika za nasvet glede uporabe zdravil proti bruhanju, kajti uporaba le-teh lahko poveča tveganje za srčne aritmije.
Bosulif with food and drink Do not take Bosulif with grapefruit or grapefruit juice, as it may increase the risk of side effects.
Zdravila Bosulif ne jemljite skupaj z grenivkami ali grenivkinim sokom, ker se zaradi tega lahko poveča tveganje za pojav neželenih učinkov.
The trial randomised 536 patients (268 in each treatment group) with Ph+ or Ph- newly-diagnosed CP CML (intent-to-treat population [ITT]) including 487 patients with Ph+ CML harbouring b2a2 and/or b3a2 transcripts and baseline BCR-ABL copies > 0 (modified intent-to-treat [mITT] population).
V preskušanju so randomizirali 536 bolnikov (po 268 v vsako skupino zdravljenja) z novo odkrito Ph+ ali Ph- KML v kronični fazi (populacija, ki so jo nameravali zdravili [ITT - Intent-To-Treat]), vključno s 487 bolniki s Ph+ KML, ki so imeli prepise b2a2 in/ali b3a2 ter število kopij BCR-ABL ob izhodišču > 0 (modificirana populacija, ki so jo nameravali zdraviti [mITT - Modified Intent-ToTreat]).
Women of childbearing potential should be advised to use effective contraception during treatment with bosutinib and for at least 1 month after the last dose and to avoid becoming pregnant while receiving bosutinib.
Ženskam v rodni dobi je treba svetovati, da med zdravljenjem z bosutinibom in še vsaj 1 mesec po zadnjem odmerku uporabljajo učinkovito kontracepcijo in naj med zdravljenjem ne zanosijo.
Monitoring for an effect on the QTc is advisable and a baseline electrocardiogram (ECG) is recommended prior to initiating therapy with bosutinib and as clinically indicated.
Priporočajo spremljanje vpliva na QTc ter elektrokardiogram (EKG) pred začetkom zdravljenja z bosutinibom in kadar je to klinično potrebno.
Anti-arrhythmic medicinal products and other substances that may prolong QT Bosutinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, domperidone, haloperidol, methadone, and moxifloxacin (see section 4.4).
Antiaritmiki in druge učinkovine, ki lahko podaljšujejo interval QT Bosutinib je treba uporabljati previdno pri bolnikih, ki imajo podaljšan interval QT ali pa lahko pri njih do tega pride, vključno z bolniki, ki jemljejo antiaritmike, kot so amiodaron, dizopiramid, prokainamid, kinidin in sotalol, ali druga zdravila, ki lahko povzročijo podaljšanje intervala QT, kot so klorokin, halofantrin, klaritromicin, domperidon, haloperidol, metadon in moksifloksacin (glejte poglavje 4.4).
Maximal exposure Cmax increased by 28% and 34% in the moderate and severe groups, respectively.
V skupini z zmerno okvaro ledvic se je največja izpostavljenost Cmax povečala za 28 %, v skupini s hudo okvaro ledvic pa za 34 %.
The tablet film-coating contains polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) and iron oxide yellow (E172, for Bosulif 100 mg and 400 mg) or iron oxide red (E172, for Bosulif 400 mg and 500 mg).
Filmska obloga tablete vsebuje polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec (E553b) in rumeni železov oksid (E172, 100 mg in 400 mg tablete) ali rdeči železov oksid (E172, 400 mg in 500 mg tablete).
If you accidentally take too many Bosulif tablets or a higher dose than you need, contact a doctor for advice right away.
Če ste vzeli večji odmerek zdravila Bosulif, kot bi smeli Če ste pomotoma vzeli preveč tablet zdravila Bosulif ali če ste vzeli večji odmerek, kot ga potrebujete, nemudoma obvestite zdravnika.
The evaluable population includes patients who had a valid baseline disease assessment.
Populacija, ki jo je bilo mogoče oceniti, vključuje bolnike z veljavno oceno bolezni na začetku študije.
- if you have diarrhoea and vomiting.
- Če imate drisko in bruhate.
Repeated-dose toxicity
Toksičnost pri ponavljajočih odmerkih
Following administration of a single intravenous dose of 120 mg bosutinib to healthy subjects, bosutinib had a mean (% coefficient of variation [CV]) volume of distribution of 2,331 (32) L, suggesting that bosutinib is extensively distributed to extra vascular tissue.
Po dajanju enkratnega intravenskega 120 mg odmerka bosutiniba zdravim preskušancem je povprečni (% koeficient variance [CV]) volumen porazdelitve bosutiniba znašal 2.331 (32) l, kar kaže na to, da se bosutinib v veliki meri porazdeli v ekstravaskularno tkivo.
It is important that renal function is assessed prior to treatment initiation and closely monitored during therapy with bosutinib, with particular attention in those patients who have pre-existing renal compromise or in those patients exhibiting risk factors for renal dysfunction, including concomitant use of medicinal products with potential for nephrotoxicity, such as diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Pred začetkom zdravljenja z bosutinibom je pomembno oceniti delovanje ledvic in ga med zdravljenjem pozorno spremljati, zlasti pri bolnikih z obstoječo okvaro ledvic ali bolnikih z dejavniki tveganja za motnjo delovanja ledvic, vključno s sočasno uporabo potencialno nefrotoksičnih zdravil, kot so diuretiki, zaviralci ACE, antagonisti angiotenzinskih receptorjev in nesteroidna protivnetna zdravila (NSAID).
Of these patients, 268 (400 mg starting dose) and 248 (500 mg starting dose) are from the 2 Phase 3 studies in previously untreated CML patients, 570 and 63 are from 2 Phase 1/2 studies in previously treated Ph+ leukaemias, and 123 patients from a Phase 4 study in previously treated CML.
Od teh bolnikov jih je 268 (začetni odmerek 400 mg) in 248 (začetni odmerek 500 mg) iz 2 kliničnih študij 3. faze pri predhodno nezdravljenih bolnikih s KML, 570 in 63 jih je iz 2 kliničnih študij 1./2.
Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
Preglednica 6 - Odziv glede na status mutacij BCR-ABL ob začetku študije pri KML v kronični fazi (populacija, ki jo je bilo mogoče oceniti): pred zdravljenjem z imatinibom in dasatinibom in/ali nilotinibom (tretja linija)
In CML patients at steady state, Cmax (geometric mean, coefficient of variation [CV]%) was 145 (14) ng/mL, and AUCss (geometric mean, CV%) was 2,700 (16) ng•h/mL after daily administration of bosutinib at 400 mg with food.
Pri bolnikih s KML v stanju dinamičnega ravnovesja je Cmax (geometrična sredina, koeficient variacije [KV] %) znašala 145 (14) ng/ml, AUCss (geometrična sredina, KV %) pa je znašala 2.700 (16) ng*h/ml po jemanju bosutiniba 400 mg na dan s hrano.
Newly-diagnosed CP Ph+ CML The recommended dose is 400 mg bosutinib once daily.
Novo odkrita Ph+ KML v kronični fazi Priporočeni odmerek je 400 mg bosutiniba enkrat na dan.
The primary efficacy endpoint was the proportion demonstrating a major molecular response (MMR) at 12 months (48 weeks) in the bosutinib treatment group compared with that in the imatinib treatment group in the mITT population.
Primarni opazovani dogodek učinkovitosti je bil delež populacije mITT, ki je dosegla pomembni molekularni odziv (MMR - Major Molecular Response) po 12 mesecih (48 tednih) v skupini, ki se je zdravila z bosutinibom, v primerjavi s skupino, ki se je zdravila z imatinibom.
In vitro and in vivo studies indicated that bosutinib (parent compound) undergoes predominantly hepatic metabolism in humans.
Študije in vitro ter in vivo so pokazale, da je bosutinib (izhodna spojina) pri ljudeh pretežno podvržen presnovi v jetrih.
The median time to first event was 59 days (range: 27 to 505 days), and the median duration per event was 15 days (range: 1 to 913 days).
Mediani čas do prvega dogodka je bil 59 dni (razpon: 27 do 505 dni), mediano trajanje dogodka pa je bilo 15 dni (razpon: 1 do 913 dni).
The effect of bosutinib 500 mg administration on corrected QTc was evaluated in a randomised, single-dose, double-blind (with respect to bosutinib), crossover, placebo- and open-label moxifloxacin-controlled study in healthy subjects.
Učinek uporabe 500 mg bosutiniba na QTc so ocenili v randomizirani, dvojno slepi (glede na bosutinib), navzkrižni, s placebom ter moksifloksacinom (uporabljenim odprto) nadzorovani študiji z enkratnim odmerkom pri zdravih preskušancih.
Automated machine-read QTc prolongation without accompanying arrhythmia has been observed.
Opazili so podaljšanje QTc brez spremljajoče aritmije, ocenjeno z avtomatskim čitalcem.
Time to OHR for responders only, weeks (95% CI)
čas do OHR, samo pri odzivnih bolnikih, tedni (95 % IZ)
The median duration of an event was 18 days (range: 1 to 775 days), and 15 days (range: 1 to 803 days) for ALT and AST, respectively.
Mediano trajanje dogodka je znašalo 18 dni (razpon: 1 do 775 dni) za ALT in 15 dni (razpon: 1 do 803 dni) za AST.
If clinically significant moderate or severe non-haematological toxicity develops, bosutinib should be interrupted, and may be resumed at a dose reduced by 100 mg taken once daily after the toxicity has resolved.
Če pride do klinično pomembne zmerne ali hude nehematološke toksičnosti, je treba zdravljenje z bosutinibom prekiniti; ko toksični učinki izzvenijo, se sme zdravljenje nadaljevati z odmerkom, zmanjšanim za 100 mg, enkrat na dan.
A delayed increase in heart rate was observed.
Opazili so zapoznelo pospešeno bitje srca.
The t½ of bosutinib increased in hepatic impaired patients as compared to the healthy subjects.
Vrednost t1/2 bosutiniba se je pri bolnikih z okvaro jeter v primerjavi z zdravimi preskušanci povečala.
Hold bosutinib until ANC  1.0 × 109/L and platelets 9/L.
Zdravljenje z bosutinibom prekinite, dokler ni ANC  1,0 x 10
Tell your doctor if you have a heart disorder, such as an abnormal electrical signal called “prolongation of the QT interval”, or if you faint (loss of consciousness) or have an irregular heart beat while taking Bosulif.
Težave s srcem: Obvestite zdravnika, če imate težave s srcem, kot je nepravilnost električne aktivnosti, ki se imenuje “podaljšanje intervala QT“ ali če med jemanjem zdravila Bosulif omedlite (izgubite zavest) ali imate nereden srčni utrip.
MCyR attained or maintained Resp/Eval b
MCyR dosežen ali ohranjen odzivni bolniki/je mogoče oceniti b (%) n = 112
Of the 994 (78%) patients that experienced diarrhoea, 10 patients discontinued bosutinib due to this event.
Od 994 (78 %) bolnikov, ki so imeli diarejo, je 10 bolnikov zaradi diareje prekinilo zdravljenje z bosutinibom.
Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Pri bolnikih s klinično pomembnimi srčnimi boleznimi je potrebna previdnost (glejte poglavje 4.4).
Complete cytogenetic response was defined as the absence of Ph+ metaphases in chromosome banding analysis of ≥ 20 metaphases derived from bone marrow aspirate or MMR if an adequate cytogenetic assessment was unavailable.
Popolni citogenetski odziv so opredelili kot odsotnost Ph+ metafaz pri analizi proganja kromosomov ≥ 20 metafaz, ki so jih pridobili iz aspirata kostnega mozga, ali MMR, če ustrezna citogenetska ocena ni bila na voljo.
Dose and method of administration
Odmerek in način uporabe
Following administration of single or multiple doses of bosutinib (400 or 500 mg) to humans, the major circulating metabolites appeared to be oxydechlorinated (M2) and N-desmethylated (M5) bosutinib, with bosutinib N-oxide (M6) as a minor circulating metabolite.
Po zaužitju enkratnega ali večkratnih odmerkov bosutiniba (400 ali 500 mg) pri ljudeh so bili poglavitni presnovki v obtoku oksidekloriniran (M2) in N-demetiliran (M5) bosutinib, skupaj z bosutinib N-oksidom (M6) kot manj pomembnim presnovkom v obtoku.
Diarrhoea: For NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade 3-4 diarrhoea, bosutinib should be interrupted and may be resumed at 400 mg once daily upon recovery to grade ≤ 1 (see section 4.4).
Diareja: Če se pojavi diareja stopnje 3-4 po merilih NCI za poenoteno terminologijo neželenih dogodkov (NCI CTCAE - National Cancer Institute Common Terminology Criteria for Adverse Events), je treba zdravljenje z bosutinibom prekiniti; ko pride do izboljšanja na stopnjo ≤ 1, se sme zdravljenje nadaljevati z odmerkom 400 mg enkrat na dan (glejte poglavje 4.4).
A 2-arm, Phase 3, open-label, multicentre superiority trial was conducted to investigate the efficacy and safety of bosutinib 400 mg once daily alone compared with imatinib 400 mg once daily alone in adult patients with newly-diagnosed Ph+ CP CML.
Izvedli so odprto, multicentrično preskušanje superiornosti z dvema skupinama, v katerem so preučevali učinkovitost in varnost samega bosutiniba 400 mg enkrat na dan v primerjavi s samim imatinibom 400 mg enkrat na dan pri odraslih bolnikih z novo odkrito Ph+ KML v kronični fazi.
Bosutinib 400 mg study
Študija z bosutinibom 400 mg
Heart problems.
Srčne bolezni
Whereas, in the Phase 3 study in patients with newly-diagnosed CP CML treated with bosutinib 400 mg, dose escalations by 100 mg increments to a maximum of 600 mg once daily with food were permitted if the patient failed to demonstrate breakpoint cluster region-Abelson (BCR-ABL) transcripts ≤ 10% at Month 3, did not have a Grade 3 or 4 adverse reaction at the time of escalation, and all Grade 2 non-haematological toxicities were resolved to at least Grade 1.
V študiji 3. faze pri bolnikih z novo odkrito KML v kronični fazi, ki so se zdravili z bosutinibom 400 mg, pa so dovolili povečanje odmerka v korakih po 100 mg do največ 600 mg enkrat na dan s hrano, če pri bolniku po 3 mesecih niso dokazali prepisov gena ''Breakpoint Cluster RegionAbelson'' (BCR-ABL) ≤ 10 %, če v času povečanja ni imel neželenih učinkov stopnje 3 ali 4 in če so vse nehematološke toksičnosti izzvenele do vsaj stopnje 1.
If transaminase elevations ≥ 3 × ULN occur concurrently with bilirubin elevations > 2 × ULN and alkaline phosphatase < 2 × ULN, bosutinib should be discontinued (see section 4.4).
Če pride do povečanja vrednosti transaminaz ≥ 3-kratnik ZMN ob sočasnem povečanju vrednosti bilirubina > 2-kratnik ZNM in alkalne fosfataze za < 2-kratnik ZMN, je treba zdravljenje z bosutinibom prekiniti (glejte poglavje 4.4).
Doses less than 300 mg/day have been used in patients; however, efficacy has not been established.
Pri bolnikih so uporabljali tudi odmerke, manjše od 300 mg na dan, vendar učinkovitosti niso dokazali.
What Bosulif contains - The active substance is bosutinib.
Kaj vsebuje zdravilo Bosulif - Učinkovina je bosutinib.
Bosutinib should be administered with caution to patients who have a history of or predisposition for QTc prolongation, who have uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia, or who are taking medicinal products that are known to prolong the QTc (e.g., anti-arrhythmic medicinal products and other substances that may prolong QTc [see section 4.5]).
Bosutinib je treba uporabljati previdno pri bolnikih z anamnezo ali predispozicijo za podaljšanje QTc, pri bolnikih z nenadzorovano ali klinično pomembno srčno boleznijo (vključno z nedavnim miokardnim infarktom, kongestivnim srčnim popuščanjem, nestabilno angino pektoris ali klinično pomembno bradikardijo) ali pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšujejo QTc (npr. antiaritmiki in druge učinkovine, ki lahko podaljšajo QTc [poglavje 4.5]).
Elevated liver transaminases: If elevations in liver transaminases > 5 × institutional upper limit of normal (ULN) occur, bosutinib should be interrupted until recovery to ≤ 2.5 × ULN and may be resumed at 400 mg once daily thereafter.
Povečane vrednosti jetrnih transaminaz: Če pride do povečanja vrednosti jetrnih transaminaz, ki presega 5-kratnik zgornje meje normale (ZMN), je treba zdravljenje z bosutinibom prekiniti, dokler ne pride do izboljšanja na ≤ 2,5-kratnik ZMN; nato se sme zdravljenje nadaljevati z odmerkom 400 mg enkrat na dan.
Tell your doctor if you develop any of the following signs and symptoms of fluid retention during Bosulif treatment such as swelling of the ankles, feet or legs; difficulty breathing chest pain or a cough (these may be signs of fluid retention in the lungs or chest).
Obvestite zdravnika, če se vam pojavijo naslednji znaki in simptomi zastajanja tekočine med zdravljenjem z zdravilom Bosulif: otekanje gležnjev, stopal ali nog, težko dihanje, bolečine v prsnem košu ali kašelj (to so lahko znaki zastajanja tekočine v pljučih ali prsnem košu).