FrancophonIA/ELRC3.0 huggingface dataset:
English: Five bosutinib patients and 7 imatinib patients transformed to AP CML or BP CML.
Croatian: U pet bolesnika liječenih bosutinibom i 7 bolesnika liječenih imatinibom bolest se transformirala u KML u ubrzanoj fazi ili KML u blastičnoj fazi.
English: In the Phase 1/2 clinical study in patients with previously treated Ph+ leukaemias, QTcF interval changes > 60 ms from baseline were observed in 6 (1.1%) of 562 patients.
Croatian: U kliničkom ispitivanju faze 1/2 u bolesnika s prethodno liječenim Ph+ leukemijama promjene QTcF intervala > 60 ms u odnosu na početne vrijednosti zapažene su u 6 (1,1%) od 562 bolesnika.
English: Doses less than 300 mg/day have been used in patients; however, efficacy has not been established.
Croatian: Bolesnici su primali doze manje od 300 mg na dan, međutim njihova djelotvornost nije utvrđena.
English: Maximum Grade 1 or 2 events were experienced by 63 (32%) patients.
Croatian: Događaji maksimalne toksičnosti 1. ili 2. stupnja pojavile su se u 63 (32%) bolesnika.
English: How to store Bosulif
Croatian: Kako čuvati Bosulif
English: BCR-ABL mutation status at baseline
Croatian: Status mutacije BCR-ABL-a na početku
English: Tell your doctor right away if you have any of these symptoms: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area or fever.
Croatian: Odmah obavijestite svog liječnika ako imate bilo koji od sljedećih simptoma: svrbež, žutu boju bjeloočnica ili kože, tamnu boju mokraće i bol ili nelagodu u gornjem desnom dijelu trbuha ili vrućicu.
English: Minimum follow-up time (time from last patient first dose to data snapshot date) of 60 months for CP treated with imatinib only and, 48 months for CP treated with imatinib and at least 1 other TKI, AP and BP.
Croatian: Minimalno vrijeme praćenja (vrijeme od prve doze zadnjem bolesniku do datuma podataka prikazanog stanja) od 60 mjeseci u bolesnika u CP-u liječenih samo imatinibom i 48 mjeseci u bolesnika u CP-u liječenih imatinibom i najmanje 1 drugim TKI-om, u bolesnika u AP-u i u bolesnika u BP-u.
English: Cumulative haematological responsed
Croatian: Kumulativni hematološki odgovor d
English: Tell your doctor if you develop any of the following signs and symptoms: an increase in the number of stools (bowel movements) per day over normal, an increase in episodes of vomiting, blood in your vomit, stools (bowel movements) or urine, or have black stools (tarry black bowel movements).
Croatian: Obavijestite svog liječnika ako imate bilo koji od sljedećih znakova i simptoma: porast u dnevnom broju stolica (pražnjenja crijeva) u odnosu na uobičajeno, porast epizoda povraćanja, krv u povraćenom sadržaju, stolici (pražnjenju crijeva) ili mokraći, ili ako imate crne stolice (boje katrana).
English: Myalgia
Croatian: Mialgija
English: Of the 297 (23%) patients with reports of adverse reactions of anaemia, 3 patients discontinued bosutinib due to anaemia.
Croatian: Od 297 (23%) bolesnika s prijavljenim nuspojavama anemije, 3 bolesnika prekinula su liječenje bosutinibom zbog anemije.
English: In the Phase 3 clinical study in patients with newly-diagnosed CP CML treated with bosutinib 400 mg, there were no patients in the bosutinib treatment group with an increase of > 60 ms from baseline when the QT interval was corrected using Fridericia's formula (QTcF).
Croatian: U kliničkom ispitivanju faze 3 u bolesnika s novodijagnosticiranim KML-om u kroničnoj fazi liječenih bosutinibom u dozi od 400 mg, nijedan bolesnik u skupini liječenoj bosutinibom nije imao zabilježen porast od > 60 ms u odnosu na početne vrijednosti kada je QT interval korigiran prema Fridericijinoj formuli (QTcF).
English: The concomitant use of bosutinib with strong or moderate CYP3A inducers should be avoided as a decrease in bosutinib plasma concentration will occur (see section 4.5).
Croatian: Nužno je izbjegavati istodobnu primjenu bosutiniba sa snažnim ili umjerenim induktorima CYP3A jer će doći do smanjenja koncentracije bosutiniba u plazmi (vidjeti dio 4.5).
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A inhibition potential, if possible, is recommended.
Croatian: Ako je moguće, preporučuje se odabir zamjenskog istodobnog lijeka bez ili s minimalnim potencijalom inhibiranja CYP3A.
English: Dose adjustments for adverse reactions
Croatian: Prilagođavanja doze zbog nuspojava
English: Leukopenia (including White blood cell count decreased) Uncommon Febrile neutropenia, Granulocytopenia Immune system disorders
Croatian: Leukopenija (uključujući smanjenje broja leukocita) Manje često Febrilna neutropenija, granulocitopenija
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A enzyme inhibition potential, if possible, is recommended.
Croatian: Ako je moguće, preporučuje se odabir zamjenskog istodobnog lijeka bez ili s minimalnim potencijalom inhibiranja enzima CYP3A.
English: In vitro studies indicate that clinical drug-drug interactions are unlikely to occur at therapeutic doses as a result of inhibition by bosutinib on the metabolism of medicinal products that are substrates for CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5.
Croatian: In vitro ispitivanja pokazuju da pri terapijskim dozama nije izgledna pojava kliničkih interakcija između lijekova kao posljedica inhibicijskog učinka bosutiniba na metabolizam lijekova koji su supstrati za CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, ili CYP3A4/5.
English: Tell your doctor if you are urinating more frequently and producing larger amounts of urine with a pale colour or if you are urinating less frequently and producing smaller amounts of urine with a dark colour.
Croatian: Obavijestite svog liječnika ako mokrite češće i u povećanim količinama, a mokraća je blijede boje ili ako mokrite rjeđe i u smanjenim količinama, a mokraća je tamne boje.
English: - headache.
Croatian: Glavobolja
English: At Month 12, the MR4 rate (defined as ≤ 0.01% BCR-ABL [corresponding to ≥ 4 log reduction from standardised baseline] with a minimum of 9,800 ABL transcripts) was higher in the bosutinib treatment group compared to the imatinib treatment group in the mITT population (20.7% [95% CI: 15.7%, 25.8%] versus 12.0% [95% CI: 7.9%, 16.1%], respectively, 1-sided p-value=0.0052).
Croatian: 4 (definirana kao ≤ 0,01% BCR-ABL [što odgovara smanjenju za ≥ 4 log od standardizirane početne vrijednosti] s najmanje 9800 ABL transkripata) bila je veća u skupini koja je liječena bosutinibom u usporedbi sa skupinom koja je liječena imatinibom u mITT populaciji (20,7% [95% CI: 15,7%; 25,8%] naspram 12,0% [95% CI: 7,9%; 16,1%], jednostrana p-vrijednost = 0,0052).
English: Complete haematological response (CHR for AP and BP CML: WBC less than or equal to institutional upper limit of normal (ULN), platelets greater than or equal to 100,000/mm and less than 450,000/mm 3, absolute neutrophil count (ANC) greater than or equal to 1.0×10
Croatian: Potpuni hematološki odgovor (CHR) za AP i BP KML: broj leukocita manji ili jednak institucionalnoj gornjoj granici normale (GGN), broj trombocita veći ili jednak 100 000/mm
English: An in vitro study indicates that drug-drug interactions are unlikely to occur at therapeutic doses as a result of induction by bosutinib on the metabolism of medicinal products that are substrates for CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4.
Croatian: Jedno in vitro ispitivanje pokazuje da pri terapijskim dozama nije izgledna pojava interakcija između lijekova kao posljedica indukcijskog učinka bosutiniba na metabolizam lijekova koji su supstrati za CYP1A2, CYP2B6, CYP2C9, CYP2C19 i CYP3A4.
English: To conduct a single-arm open-label, multi-centre efficacy and safety study of bosutinib in patients with Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Croatian: Provođenje otvorenog, multicentričnog ispitivanja djelotvornosti i sigurnosti bosutiniba s jednom skupinom bolesnika u bolesnika s kroničnom mijeloičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ KML) koji su prethodno liječeni s jednim ili više inhibitora tirozin kinaze te kod kojih se imatinib, nilotinib i dasatinib ne smatraju prikladnim opcijama liječenja.
English: Clinical study in CP previously untreated CML
Croatian: Kliničko ispitivanje prethodno neliječenog KML-a u kroničnoj fazi
English: In the Phase 3 study in patients with newly-diagnosed CP CML who started bosutinib treatment at 400 mg, a total of 46 patients (17.2%) received dose escalations to 500 mg.
Croatian: U ispitivanju faze 3 na bolesnicima s novodijagnosticiranim KML-om u u kroničnoj fazi, koji su započeli liječenje bosutinibom u dozi od 400 mg, doza je postupno povećavana do 500 mg u ukupno 46 bolesnika (17,2%).
English: Tell your doctor right away if you have any of these symptoms: painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g. mouth and lips).
Croatian: Odmah obavijestite svog liječnika ako imate ijedan od ovih simptoma: bolni osip crvene ili ljubičaste boje koji se širi i mjehuriće i/ili druge ranice koje se počinju javljati na sluznicama (primjerice, usta i usnice).
English: Dose escalation to 400 mg once daily with food for patients with moderate renal impairment or to 300 mg once daily for patients with severe renal impairment may be considered if they do not experience severe or persistent moderate adverse reactions and if they do not achieve an adequate haematological, cytogenetic, or molecular response.
Croatian: Povećavanje doze na 400 mg jedanput na dan s hranom u bolesnika s umjerenim oštećenjem bubrega ili na 300 mg jedanput na dan u bolesnika s teškim oštećenjem bubrega, može se razmotriti ako se u njih ne pojave teške ili ustrajne umjerene nuspojave i ako ne postignu odgovarajući hematološki, citogenetski ili molekularni odgovor.
English: Fluid retention
Croatian: Zadržavanje tekućine
English: These represent an evaluation of the adverse reaction data from 1,272 patients with either newly-diagnosed CP CML or with chronic, accelerated, or blast phase CML resistant or intolerant to prior therapy or Ph+ ALL who have received at least 1 dose of single-agent bosutinib.
Croatian: One predstavljaju procjenu podataka o nuspojavama u 1272 bolesnika s bilo novodijagnosticiranim KML-om u kroničnoj fazi ili s KML-om u kroničnoj, ubrzanoj ili blastičnoj fazi rezistentnim ili intolerantnim na prethodno liječenje ili s Ph+ ALL-om koji su primili najmanje jednu dozu bosutiniba kao jedinog lijeka.
English: Pfizer Ελλάς A.E. Τλ: +30 210 6785 800
Croatian: Τλ: +30 210 6785 800
English: The concomitant use of bosutinib with strong CYP3A inducers (including, but not limited to carbamazepine, phenytoin, rifampicin, St. John's Wort), or moderate CYP3A inducers (including, but not limited to bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided, as a decrease in bosutinib plasma concentration will occur.
Croatian: Nužno je izbjegavati istodobnu primjenu bosutiniba sa snažnim induktorima CYP3A (uključujući, između ostalog karbamazepin, fenitoin, rifampicin, gospinu travu) ili umjerenim induktorima CYP3A (uključujući, između ostalog bosentan, efavirenz, etravirin, modafinil, nafcilin) jer će doći do smanjenja koncentracije bosutiniba u plazmi.
English: Increasing exposure (area under curve [AUC]) in patients with moderate and severe renal impairment during studies was observed.
Croatian: Tijekom ispitivanja zapaženo je povećanje izloženosti (površina ispod krivulje, [engl. area under the curve, AUC]) u bolesnika s umjerenim i teškim oštećenjem bubrega.
English: Histopathologically, luminal dilation, goblet cell hyperplasia, haemorrhage, erosion, and oedema of the intestinal tract, and sinus erythrocytosis and haemorrhage in the mesenteric lymph nodes, were observed.
Croatian: Opažene histopatološke promjene bile su dilatacija lumena, hiperplazija vrčastih stanica, krvarenje, erozija i edem intestinalnog trakta te sinusna eritrocitoza i krvarenje u mezenterijalnim limfnim čvorovima.
English: EU/1/13/818/001 (28 film-coated tablets) EU/1/13/818/002 (30 film-coated tablets) EU/1/13/818/005 (112 film-coated tablets)
Croatian: EU/1/13/818/001 (28 filmom obloženih tableta) EU/1/13/818/002 (30 filmom obloženih tableta) EU/1/13/818/005 (112 filmom obloženih tableta)
English: The cumulative incidence of CCyR adjusted for the competing risk of treatment discontinuation without CCyR was higher in the bosutinib treatment group compared to the imatinib treatment group in the mITT population (79.1% [95% CI: 73.4%, 83.7%] versus 67.3% [95% CI: 60.9%, 72.8%] at Week 48; HR: 1.38, [95% CI: 1.13, 1.68]; 1-sided p-value=0.0003).
Croatian: Kumulativna incidencija CCyR-a prilagođena za konkurentni rizik od prekida liječenja bez CCyR-a bila je veća u skupini liječenoj bosutinibom nego u skupini liječenoj imatinibom u mITT populaciji (79,1% [95% CI: 73,4%; 83,7%] naspram 67,3% [95% CI: 60,9%; 72,8%] u 48. tjednu; HR: 1,38; [95% CI: 1,13; 1,68]; jednostrana p-vrijednost = 0,0003).
English: Dose escalation to 500 mg once daily for patients with moderate renal impairment or to 400 mg once daily in patients with severe renal impairment may be considered in those who did not experience severe or persistent moderate adverse reactions, and if they do not achieve an adequate haematological, cytogenetic, or molecular response.
Croatian: Povećanje doze na 500 mg jedanput dnevno u bolesnika s umjerenim oštećenjem bubrega ili na 400 mg jedanput dnevno u bolesnika s teškim oštećenjem bubrega može se razmotriti u bolesnika koji nisu imali teške ili ustrajne umjerene nuspojave i ako ne postignu odgovarajući hematološki, citogenetski ili molekularni odgovor.
English: Median, weeks (95% CI)
Croatian: Medijan, mjeseci (95% CI)
English: In an intravenous study in dogs, transient increases in heart rate and decreases in blood pressure and minimal prolongation of the QTc (< 10 msec) were observed at exposures ranging from approximately 6-times to 20-times the human exposure resulting from the clinical dose of 400 mg and 4-times to 15-times the human exposure resulting from the clinical dose of 500 mg (based on unbound Cmax in the respective species).
Croatian: U ispitivanju intravenske primjene u pasa, zapaženi su prolazni porast srčane frekvencije i smanjenje krvnog tlaka te minimalno produljenje QTc (<10 msek) kod izloženosti u rasponu približno 6 do 20 puta većoj od izloženosti u ljudi nakon kliničke doze od 400 mg i 4 do 15 puta većoj od izloženosti u ljudi nakon kliničke doze od 500 mg (na temelju Cmax nevezanog spoja u odgovarajućim vrstama).
English: Years 2 (Month 24) and 5 (60 months) for CP treated with imatinib only and Years 1 (Month 12) and 4 (48 months) for CP treated with imatinib and at least 1 other TKI, AP, and BP.
Croatian: 2. godina (24. mjesec) i 5. godina (60 mjeseci) za kroničnu fazu liječenu samo imatinibom i 1. godina (12. mjesec) i 4 godina (48 mjeseci) za kroničnu fazu liječenu imatinibom i najmanje jednim drugim TKI-om u ubrzanoj i blastičnoj fazi.
English: In the Phase 3 clinical study in patients with newly diagnosed Ph+ CP CML treated with bosutinib 500 mg, QTcF interval changes > 60 ms from baseline were observed in 2 (0.8%) of 248 patients receiving bosutinib.
Croatian: U kliničkom ispitivanju faze 3 u bolesnika s novodijagnosticiranim Ph+ KML-om u kroničnoj fazi, liječenih bosutinibom u dozi od 500 mg, promjene QTcF intervala > 60 ms u odnosu na početne vrijednosti zapažene su u 2 (0,8%) od 248 bolesnika koja su primala bosutinib.
English: In faeces, bosutinib and N-desmethyl bosutinib were the major drug-related components.
Croatian: U fecesu su glavne komponente povezane uz lijek bile bosutinib i N-desmetil bosutinib.
English: Tell your doctor if you develop abdominal pain or discomfort.
Croatian: Obavijestite svog liječnika ako osjetite bol ili nelagodu u trbuhu.
English: Baseline characteristics for the mITT population were well balanced between the 2 treatment groups with respect to age (median age was 52 years for the bosutinib group and 53 years for the imatinib group with 19.5% and 17.4% of patients 65 years of age or older, respectively); gender (women 42.3% and 44.0%, respectively); and race (Caucasian 77.6% and 77.2%, Asian 12.2% and
Croatian: Početne karakteristike mITT populacije bile su uravnotežene između 2 liječene skupine s obzirom na dob (medijan dobi bio je 52 godine za skupinu koja je primala bosutinib i 53 godine za skupinu koja je primala imatinib, s tim da je 19,5% odnosno 17,4% bolesnika imalo 65 ili više godina), spol (žene 42,3% odnosno 44,0%) i rasu (bijelci 77,6% odnosno 77,2%, osobe azijskog porijekla 12,2%, odnosno 12,4%, crnci ili Afroamerikanci 4,1% odnosno 4,1% i ostali 5,7% odnosno 5,8% te 1 osoba nepoznate rase u svakoj skupini).
English: The cumulative incidence of MMR adjusting for competing risk of treatment discontinuation without MMR was higher in the bosutinib treatment group compared to the imatinib treatment group in the mITT population (45.1% [95% CI: 38.8%, 51.2%] versus 33.7% [95% CI: 27.8%, 39.6%] at Week 48; hazard ratio [HR] from a stratified proportional subdistributional hazards model: 1.35 [95% CI: 1.07, 1.70], 1-sided p-value = 0.0086).
Croatian: Kumulativna incidencija MMR-a prilagođena za konkurentni rizik od prekida liječenja bez MMR-a bila je veća u skupini liječenoj bosutinibom nego u skupini liječenoj imatinibom u mITT populaciji (45,1% [95% CI: 38,8%; 51,2%] naspram 33,7% [95% CI: 27,8%; 39,6%] u 48. tjednu; omjer hazarda dobiven iz raslojenog modela proporcionalnih hazarda za podraspodjelu: 1,35 [95% CI: 1,07; 1,70], jednostrana p-vrijednost = 0,0086).
English: Clinical study in imatinib-resistant or intolerant CML in CP, AP, and BP A single-arm, Phase 1/2 open-label, multicentre trial was conducted to evaluate the efficacy and safety of bosutinib 500 mg once daily in patients with imatinib-resistant or -intolerant CML with separate cohorts for chronic, accelerated, and blast phase disease previously treated with 1 prior TKI (imatinib) or more than 1 TKI (imatinib followed by dasatinib and/or nilotinib).
Croatian: Provedeno je otvoreno, multicentrično ispitivanje faze 1/2, s jednom skupinom bolesnika zbog procjene djelotvornosti i sigurnosti bosutiniba 500 mg jedanput dnevno u bolesnika s KML-om i rezistencijom ili intolerancijom na imatinib, s odvojenim kohortama za kroničnu, ubrzanu i blastičnu fazu bolesti, a koji su prethodno liječeni s 1 inhibitorom tirozin kinaze (TKI-om) (imatinib) ili više od 1 TKI-a (imatinib nakon kojeg je slijedio dasatinib i/ili nilotinib).
English: Newly-diagnosed CP Ph+ CML
Croatian: Novodijagnosticirani Ph+ KML u kroničnoj fazi
English: A no observed effect level (NOEL) for pupil size was not established, but the NOEL for impaired gait occurred at exposures approximately 11-times the human exposure resulting from the clinical dose of 400 mg and 8-times the human exposure resulting from the clinical dose of 500 mg (based on unbound Cmax in the respective species).
Croatian: Razina kod koje se ne opaža učinak (engl. no observed effect level, NOEL) na veličinu zjenice nije ustanovljena, ali NOEL za poremećaj hoda pojavio se kod izloženosti približno 11 puta većoj od izloženosti u ljudi nakon kliničke doze od 400 mg i 8 puta većoj od izloženosti u ljudi nakon kliničke doze od 500 mg (na temelju Cmax nevezanog spoja u odgovarajućim vrstama).
English: Modeling studies indicate that bosutinib binds the kinase domain of BCR-ABL. Bosutinib is also an inhibitor of Src family kinases including Src, Lyn and Hck.
Croatian: Bosutinib također inhibira obitelj Src kinaza, uključujući Src, Lyn i Hck.
English: Cumulative cytogenetic responsea MCyR, % (95% CI) CCyR, % (95% CI)
Croatian: MCyR, % (95% CI) CCyR, % (95% CI)
English: Of the 197 (15%) patients with reports of adverse reactions of neutropenia, 15 patients discontinued bosutinib due to neutropenia.
Croatian: Od 197 (15%) bolesnika s prijavljenim nuspojavama neutropenije, 15 bolesnika prekinulo je liječenje bosutinibom zbog neutropenije.
English: Tell your doctor if you develop any of the following signs and symptoms of painful red or purplish rash that spreads and blisters and/or other lesions begin to appear in the mucous membrane (e.g., mouth and lips).
Croatian: Obavijestite svog liječnika ako razvijete bilo koji od sljedećih znakova i simptoma: bolni osip crvene ili ljubičaste boje koji se širi i mjehuriće i/ili druge ranice koje se počinju javljati na sluznicama (primjerice, usta i usnice).
English: Dose and method of administration
Croatian: Doziranje i način primjene
English: Yellow oval (width: 5.6 mm; length: 10.7 mm) biconvex, film-coated tablet debossed with “Pfizer” on one side and “100” on the other side.
Croatian: Žuta, ovalna (širina: 5,6 mm; duljina: 10,7 mm), bikonveksna, filmom obložena tableta s utisnutom oznakom "Pfizer" na jednoj strani i "100" na drugoj strani.
English: Adverse reaction identified post marketing.
Croatian: Nuspojava identificirana nakon stavljanja lijeka u promet.
English: In addition, diarrhoea and vomiting can also be managed by withholding bosutinib temporarily, dose reduction, and/or discontinuation of bosutinib (see sections 4.2 and 4.8).
Croatian: Nadalje, proljev i povraćanje se mogu također zbrinuti privremenim prekidom bosutiniba, smanjivanjem doze i/ili trajnim prekidom liječenja bosutinibom (vidjeti dijelove 4.2 i 4.8).
English: Orange oval (width: 8.8 mm; length: 16.9 mm) biconvex, film-coated tablet debossed with “Pfizer” on one side and “400” on the other side.
Croatian: Narančasta, ovalna (širina: 8,8 mm; duljina: 16,9 mm), bikonveksna, filmom obložena tableta s utisnutom oznakom „Pfizer“ na jednoj strani i „400“ na drugoj strani.
English: Automated machine-read QTc prolongation without accompanying arrhythmia has been observed.
Croatian: Zapaženo je produljenje QTc-a bez popratne aritmije, a očitano je automatskim uređajem.
English: - damage to the liver.
Croatian: Oštećenje jetre
English: Among patients with thrombocytopenia reactions, the median time to first event was 28 days (range: 1 to 1,688 days), and median duration per event was 15 days (range: 1 to 1,762 days).
Croatian: Među bolesnicima s nuspojavama u obliku trombocitopenije, medijan vremena do prvog događaja bio je 28 dana (raspon: 1 do 1688 dana), a medijan trajanja po događaju bio je 15 dana (raspon: 1 do 1762 dana).
English: EU/1/13/818/006 (28 film-coated tablets) EU/1/13/818/007 (30 film-coated tablets)
Croatian: EU/1/13/818/006 (28 filmom obloženih tableta) EU/1/13/818/007 (30 filmom obloženih tableta)
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Pfizer Europe MA EEIG
English: Tell your doctor if you develop any of the following signs and symptoms such as fever, problems with urine such as burning on urination, a new cough, or a new sore throat.
Croatian: Obavijestite svog liječnika ako imate bilo koji od sljedećih znakova i simptoma kao što su vrućica, problemi s mokraćom poput pečenja za vrijeme mokrenja, novonastali kašalj, ili novonastala grlobolja.
English: Following concomitant administration of a single dose bosutinib with 6 daily doses of 600 mg rifampicin, in 24 healthy subjects in fed state bosutinib exposure (Cmax and AUC in plasma) decreased to 14% and 6%, respectively, of the values when bosutinib 500 mg was administered alone.
Croatian: Nakon istodobne primjene jedne doze bosutiniba i 6 dnevnih doza od 600 mg rifampicina u 24 zdrava ispitanika u stanju sitosti, izloženost bosutinibu (Cmax i AUC u plazmi) smanjila se na 14% odnosno 6% vrijednosti u odnosu na primjenu 500 mg samog bosutiniba.
English: Among patients with diarrhoea, the median time to first event was 2 days (range: 1 to 2,415 days) and the median duration of any grade of diarrhoea was 2 days (range: 1 to 2,511 days).
Croatian: Među bolesnicima s proljevom medijan vremena do prvog događaja bio je 2 dana (raspon: 1 do 2415 dana), a medijan trajanja proljeva bilo kojeg stupnja bio je 2 dana (raspon: 1 do 2511 dana).