FrancophonIA/ELRC3.0 huggingface dataset:
English: If any infusion-related ADRs are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2).
Slovenian: Če pride do kakršnihkoli z infundiranjem povezanih neželenih učinkov zdravila, je treba infundiranje prekiniti in ga znova začeti, ko je bolnikovo stanje stabilno (glejte poglavje 4.2).
English: For the first and second infusion, administer over 6.5 hours (see section 4.2), through a peripheral line or indwelling catheter, according to the schedule below:
Slovenian: Prvo in drugo infundiranje zdravila morata trajati 6,5 ure (glejte poglavje 4.2); infuziji je treba dati po perifernem kanalu ali stalnem katetru in po naslednjem časovnem razporedu:
English: ORR (%) 95% CI P value p<0.001
Slovenian: Vrednost p p < 0,001
English: • Withdraw and discard 50 ml from a 1000 ml bag of sodium chloride 9 mg/ml (0.9%) solution for injection;
Slovenian: • Iz 1.000-ml vrečke 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje potegnite 50 ml
English: For the first infusion, administer over 4.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below:
Slovenian: Prvo infuzijo je treba dati v 4,5 ure (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila) po periferni liniji ali stalnem katetru in po naslednjem časovnem razporedu:
English: (Primary) endpoint
Slovenian: (Primarni) opazovani dogodek
English: Ask your doctor for advice if you are planning to become pregnant after this period.
Slovenian: Če želite po tem obdobju zanositi, se posvetujte z zdravnikom.
English: Chlorambuci + Chl
Slovenian: Limfadenopatija c
English: Small intestinal obstruction
Slovenian: • mišični krči.
English: Immune system disorders
Slovenian: Redčenje raztopine za infundiranje
English: Chlorambucil
Slovenian: Zapora črevesa
English: If any infusion-related adverse reactions are observed, infusion should be interrupted and restarted when the patient's condition is stable (see section 4.2 of the SmPC).
Slovenian: Če pride do kakršnih koli neželenih učinkov, povezanih z infundiranjem, je treba infundiranje prekiniti in ga znova začeti, ko je bolnikovo stanje stabilno (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila).
English: For the first and second infusion, administer over 6.5 hours (see section 4.2 of the SmPC), through a peripheral line or indwelling catheter, according to the schedule below:
Slovenian: Prvo in drugo infundiranje zdravila morata trajati 6,5 ure (glejte poglavje 4.2 povzetka glavnih značilnosti zdravila); infuziji je treba dati po perifernem kanalu ali stalnem katetru in po naslednjem časovnem razporedu:
English: All responses were confirmed after 4 weeks.
Slovenian: Vsi odzivi so bili potrjeni po 4 tednih.
English: 31 May 2022
Slovenian: 31. maj 2022
English: It should only be used, if other medicinal products are not efficacious.
Slovenian: Uporablja se lahko le, če druga zdravila niso učinkovita.
English: No additional deaths or transformations occurred in the ITT population.
Slovenian: V populaciji ITT ni prišlo do dodatnih smrti ali transformacij.
English: Date of first authorisation: 27 March 2013 Date of latest renewal: 18 February 2019
Slovenian: Datum prve odobritve: 27. marec 2013 Datum zadnjega podaljšanja: 18. februar 2019
English: 2 patients had more than 1 mutation in this category.
Slovenian: 2 bolnika sta imela več kot eno mutacijo v tej kategoriji.
English: No formal studies have been performed to assess the effects of these demographic factors.
Slovenian: Formalnih študij, ki bi ocenile vpliv teh demografskih faktorjev, niso opravili.
English: The safety analyses included data from an ongoing extension study.
Slovenian: Analize varnosti so vključevale podatke iz potekajoče podaljšane študije.
English: The efficacy results are summarised in Table 3.
Slovenian: Rezultati učinkovitosti so povzeti v preglednici 3.
English: Therefore, clinical activity in patients with these mutations is not expected.
Slovenian: Klinične aktivnosti pri bolnikih s temi mutacijami torej ni pričakovati.
English: Seventy-five percent of the dose was recovered within 96 hours.
Slovenian: Petinsedemdeset odstotkov odmerka se je izločilo v 96 urah.
English: Final Clinical Study Report:
Slovenian: Končno poročilo o klinični študiji:
English: Do not take a double dose to make up for the forgotten tablets.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili pozabljene tablete.
English: This is always important, but especially if you are experiencing frequent or prolonged diarrhoea as described above.
Slovenian: To je vedno pomembno, še zlasti pa, če imate pogoste in dolgotrajne driske, kot je opisano zgoraj.
English: Take the tablet(s) in the morning with food.
Slovenian: Tableto (tablete) vzemite zjutraj skupaj s hrano.
English: A potential risk to the breast-feeding infant cannot be excluded.
Slovenian: Možnega tveganja za dojenega otroka ne moremo izključiti.
English: Note: Percentages were based on number of patients in each treatment group.
Slovenian: Opomba: Odstotki temeljijo na številu bolnikov v vsaki skupini zdravljenja.
English: Concentration of radioactivity in milk was up to 8-fold higher than in plasma.
Slovenian: Koncentracija radioaktivnosti v mleku je bila do 8-krat večja kot v plazmi.
English: * For efficacy results in the subgroup of patients corresponding to the approved indication, see text above.
Slovenian: * Za rezultate učinkovitosti pri podskupini bolnikov, zajeti v odobreni indikaciji, glejte besedilo zgoraj.
English: ANC = absolute neutrophil count
Slovenian: ANC = absolutno število nevtrofilcev (Absolute Neutrophil Count)
English: The presence of hypokalaemia and hypomagnesaemia may further enhance this effect.
Slovenian: Prisotnost hipokaliemije in hipomagneziemije lahko ta učinek še okrepi.
English: - if you have an infection.
Slovenian: - Če imate okužbo.
English: Patients should be monitored and managed using standard-of-care treatment.
Slovenian: Bolnike je treba spremljati in obravnavati z uporabo standardnega zdravljenja.
English: When your disease is very severe, your body may not be able to clear all the waste products from the dying cancer cells.
Slovenian: Če je vaša bolezen zelo huda, vaše telo morda ni sposobno odstraniti vseh odpadnih snovi propadajočih rakavih celic.
English: 9/L and less than 1.0×10
Slovenian: 9/l in manjše od 1,0 x 10
English: Age, gender and race
Slovenian: Starost, spol in rasa
English: Since there is limited information in the elderly, caution should be exercised in these patients.
Slovenian: Ker so podatki glede uporabe pri starejših omejeni, je pri teh bolnikih potrebna previdnost.
English: Your doctor will be aware of this and may ensure you are adequately hydrated and give you other medicines to help prevent it.
Slovenian: Zdravnik je s tem seznanjen in lahko zagotovi, da ste ustrezno hidrirani, ter vam da druga zdravila za preprečevanje tega sindroma.
English: Some medicines can affect the levels of Bosulif in your body.
Slovenian: Nekatera zdravila lahko vplivajo na raven zdravila Bosulif v vašem telesu.
English: Number (%) of subjects with MMR
Slovenian: čas število (%) preskušancev z MMR
English: Women of childbearing potential/Contraception
Slovenian: Ženske v rodni dobi/kontracepcija
English: Bosutinib has no or negligible influence on the ability to drive and use machines.
Slovenian: Bosutinib nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The relationship between the observed effects and medicinal product treatment were inconclusive.
Slovenian: O povezavi med opaženimi učinki in uporabo zdravila ni dokončnih zaključkov.
English: In these situations an individual benefit-risk assessment is mandatory and patients should be monitored for occurrence of QTc prolongation.
Slovenian: V tem primeru je obvezna individualna ocena razmerja med koristjo in tveganjem, bolnike pa je treba spremljati glede pojava podaljšanja QTc.
English: Includes patients (N) who attained or maintained MCyR.
Slovenian: Vključuje bolnike (n), ki so dosegli ali ohranili MCyR.
English: Including patients (N) who received at least 1 dose of bosutinib.
Slovenian: Vključno z bolniki (n), ki so prejeli vsaj 1 odmerek bosutiniba.
English: If you are taking any of them, tell your doctor.
Slovenian: Če jemljete katerokoli izmed njih, obvestite zdravnika.
English: - if you have heart problems.
Slovenian: - Če imate težave s srcem.
English: - if you have been told that you have problems with your kidneys.
Slovenian: - Če so vam povedali, da imate težave z ledvicami.
English: If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor right away.
Slovenian: Če zdravila niste sposobni jemati tako, kot je predpisal zdravnik, ali če imate občutek, da ga ne potrebujete več, nemudoma obvestite zdravnika.
English: Frequency categories are defined as: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena na naslednji način: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Bosulif is indicated for the treatment of adult patients with:
Slovenian: Zdravilo Bosulif je indicirano za zdravljenje odraslih bolnikov:
English: You must immediately contact your doctor if you experience any of those serious side effects (see also section 2 “What you need to know before you take Bosulif”):
Slovenian: Nemudoma se posvetujte z zdravnikom, če opazite kateregakoli od naslednjih resnih neželenih učinkov (glejte tudi poglavje 2 “Kaj morate vedeti, preden boste vzeli zdravilo Bosulif”):
English: An effect on male fertility cannot be excluded (see section 4.6).
Slovenian: Učinka na plodnost pri moških ni mogoče izključiti (glejte poglavje 4.6).
English: The medicines listed here may not be the only ones that could interact with Bosulif.
Slovenian: Našteta zdravila morda niso edina, ki bi lahko medsebojno delovala z zdravilom Bosulif.
English: Patients who take an overdose of bosutinib should be observed and given appropriate supportive treatment.
Slovenian: Bolnike, ki so vzeli prevelik odmerek bosutiniba, je treba spremljati in uvesti ustrezno podporno zdravljenje.
English: A proarrhythmic potential of bosutinib cannot be ruled out.
Slovenian: Proaritmičnega potenciala bosutiniba ni mogoče izključiti.
English: This is called tumour lysis syndrome and can cause kidney failure and heart problems within 48 hours of the first dose of Bosulif.
Slovenian: To se imenuje sindrom lize tumorja in lahko povzroči odpoved ledvic in težave s srcem v 48 urah po prejemu prvega odmerka zdravila Bosulif.
English: Bosulif should be taken orally once daily with food (see section 5.2).
Slovenian: Zdravilo Bosulif je treba jemati peroralno, enkrat na dan, s hrano (glejte poglavje 5.2).
English: If recovery takes longer than 4 weeks, discontinuation of bosutinib should be considered.
Slovenian: Če okrevanje traja dlje kot 4 tedne, je treba razmisliti o prekinitvi zdravljenja z bosutinibom.
English: The p-values for endpoints other than MMR at 12 months and CCyR by 12 months have not been adjusted for multiple comparisons.
Slovenian: Vrednosti p za druge opazovane dogodke, razen MMR po 12 mesecih in CCyR po 12 mesecih, niso prilagodili za večkratne primerjave.
English: Severe skin reactions
Slovenian: Hude kožne reakcije
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.
Slovenian: Obvestite zdravnika, če urinirate bolj pogosto in proizvajate večje količine urina blede barve ali če urinirate manj pogosto in proizvajate manjše količine urina temne barve.
English: One patient on bosutinib and 7 patients on imatinib died while on study.
Slovenian: En bolnik na bosutinibu in 7 bolnikov na imatinibu je med študijo umrlo.
English: One patient with the E255V mutation previously treated with nilotinib achieved CHR as best response.
Slovenian: En bolnik z mutacijo E255V, ki je bil predhodno zdravljen z nilotinibom, je kot najboljši odziv dosegel CHR.
English: Do not stop taking Bosulif unless your doctor tells you to do so.
Slovenian: Ne prenehajte z jemanjem zdravila Bosulif, razen če vam to naroči zdravnik.
English: Absorption was relatively slow, with a median time-to-peak concentration (tmax) reached after 6 hours.
Slovenian: Absorpcija je bila relativno počasna, z medianim časom do največje koncentracije (tmax) 6 ur.
English: Ph-positive CML is a cancer of the blood which makes the body produce too many of a specific type of white blood cell called granulocytes.
Slovenian: Ph-pozitivna kronična mieloična levkemija je krvni rak, zaradi katerega telo izdeluje preveliko količino določenih belih krvnih celic, imenovanih granulociti.
English: Bosutinib did not have effects on respiratory functions.
Slovenian: Bosutinib ni vplival na dihalne funkcije.
English: The safety and efficacy of bosutinib in children and adolescents less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost bosutiniba pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: If you have any questions about how Bosulif works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate kakršnakoli vprašanja o tem, kako zdravilo Bosulif deluje, ali zakaj vam je bilo to zdravilo predpisano, se posvetujte z zdravnikom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, vitamins, and herbal medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, vključno z zdravili brez recepta, vitamini in zdravili rastlinskega izvora.
English: Serum lipase
Slovenian: Serumska lipaza
English: Doses greater than 600 mg/day have not been studied and, therefore, should not be given.
Slovenian: Odmerkov, večjih od 600 mg na dan, niso preučevali in se jih zato ne sme uporabljati.
English: Swallow the tablet(s) whole with water.
Slovenian: Tableto (tablete) pogoltnite celo (cele) z vodo.
English: Your doctor may change the dose of these medicines, change the dose of Bosulif, or switch you to a different medicine.
Slovenian: Zdravnik bo morda spremenil odmerek teh zdravil, odmerek zdravila Bosulif ali pa vam bo predpisal drugo zdravilo.
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.
Slovenian: Klinični znaki toksičnosti so vključevali spremembe blata in so bili povezani z zmanjšanim vnosom hrane in zmanjšanjem telesne mase, kar je občasno privedlo do smrti ali elektivne evtanazije.
English: You should inform your doctor if you are taking medicines containing active substances such as those listed below:
Slovenian: Obvestite zdravnika, če jemljete zdravila, ki vsebujejo učinkovine, navedene v nadaljevanju:
English: Snapshot date: 02Oct2015
Slovenian: Datum zajema podatkov: 2. oktober 2015
English: What Bosulif is and what it is used for
Slovenian: Kaj je zdravilo Bosulif in za kaj ga uporabljamo
English: Effects of bosutinib on other medicinal products
Slovenian: Vpliv bosutiniba na druga zdravila
English: No specific dose recommendation is necessary in the elderly.
Slovenian: Pri starejših niso potrebna posebna priporočila glede odmerjanja.
English: Your doctor may adjust the dose using the 100 mg tablets depending upon your medical conditions, upon your response to treatment and/or on any side effect you may experience.
Slovenian: Zdravnik bo morda prilagodil odmerek z uporabo 100 mg tablet, odvisno od vašega stanja, odziva na zdravljenje in/ali pojava neželenih učinkov.
English: Hepatic impairment (see sections 5.1 and 5.2).
Slovenian: Okvara jeter (glejte poglavji 5.1 in 5.2).
English: Bosutinib can induce severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
Slovenian: Bosutinib lahko povzroči hude kožne reakcije, kot sta Stevens-Johnsonov sindrom in toksična epidermalna nekroliza.
English: - if you have any of these symptoms: serious skin rashes.
Slovenian: - Če se vam pojavi kateri od simptomov resnih kožnih izpuščajev.
English: Table 4 - Comparison of MMR at Months 3, 6, and 9 by treatment in the mITT population
Slovenian: Preglednica 4 - Primerjava MMR po 3, 6 in 9 mesecih glede na vrsto zdravljenja v populaciji mITT
English: This allowed measurable concentrations of radioactivity to appear in the plasma of nursing pups.
Slovenian: To je omogočilo, da so se v plazmi dojenih mladičev pojavile merljive koncentracije radioaktivnosti.
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.
Slovenian: Prilagajanje odmerka pri okvari ledvic temelji na rezultatih te študije in znane linearne farmakokinetike bosutiniba v razponu odmerkov od 200 do 600 mg.
English: Elevation in serum lipase has been observed.
Slovenian: Opazili so povečane vrednosti serumske lipaze.
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.
Slovenian: V študijah genotoksičnosti na bakterijskih sistemih in vitro ter na sistemih sesalcev in vitro in in vivo, z metabolično aktivacijo ali brez nje, niso zasledili nobenega dokaza za mutageni potencial bosutiniba.
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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Bosulif za eno ali več podskupin pediatrične populacije pri zdravljenju KML (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The study results indicate that bosutinib does not exhibit clinically relevant P-gp inhibitory effects.
Slovenian: Rezultati študije kažejo, da bosutinib ne kaže klinično pomembnih zaviralnih učinkov P-gp.
English: Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Slovenian: Reaktivacija hepatitisa B: Ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba jeter).
English: There is a risk that treatment with Bosulif will lead to decreased fertility and you may wish to seek advice about sperm storage before the treatment starts.
Slovenian: Obstaja tveganje, da bo zdravljenje z zdravilom Bosulif povzročilo zmanjšanje plodnosti, zato se boste pred začetkom zdravljenja morda želeli posvetovati glede shranjevanja sperme.
English: In clinical trials for both indications, treatment with bosutinib continued until disease progression or intolerance to therapy.
Slovenian: V kliničnih preskušanjih za obe indikaciji se je zdravljenje z bosutinibom nadaljevalo do napredovanja bolezni ali neprenašanja zdravljenja.
English: Treatment of nausea or vomiting with such medicines together with Bosulif may result in a greater risk of dangerous heart arrhythmias.
Slovenian: Zdravljenje siljenja na bruhanje ali bruhanja s temi zdravili skupaj z zdravilom Bosulif lahko povzroči večje tveganje za pojav nevarnih srčnih aritmij.
English: - if you have or have had pancreas problems.
Slovenian: - Če imate ali ste imeli težave s trebušno slinavko.
English: If clinically appropriate, re-escalation to the dose prior to the dose reduction taken once daily should be considered (see section 4.4).
Slovenian: Če je to klinično primerno, je treba razmisliti o ponovnem povečanju odmerka na odmerek, kakršen je bil pred zmanjšanjem, ki ga je treba jemati enkrat na dan (glejte poglavje 4.4).
English: The liver was also identified as a target organ in rats.
Slovenian: Pri podganah se je pokazalo, da so ciljni organ tudi jetra.
English: Treatment with bosutinib is associated with elevations in serum transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]).
Slovenian: Zdravljenje z bosutinibom je povezano s povečanjem vrednosti serumskih transaminaz (alaninaminotransferaza [ALT], aspartat-aminotransferaza [AST]).
English: The median duration of therapy was 13.8 months (range: 0.03 to 123.3 months).
Slovenian: Mediano trajanje zdravljenja je bilo 13,8 meseca (razpon: 0,03 do 123,3 meseca).
English: In addition, 5.6% of patients in the bosutinib treatment group had further dose escalations to 600 mg.
Slovenian: Poleg tega so pri 5,6 % bolnikov iz skupine, ki se je zdravila z bosutinibom, odmerek nadalje povečali na 600 mg.
English: Overall haematological response (OHR)=major haematological response (complete haematological response + no evidence of leukaemia) or return to chronic phase (RCP).
Slovenian: Celokupni hematološki odziv (OHR) = pomembni hematološki odziv (popolni hematološki odziv + ni nobenega dokaza za levkemijo) ali vrnitev v kronično fazo.
English: In addition, the patient should be advised that vomiting or diarrhoea may reduce the efficacy of oral contraceptives by preventing full absorption.
Slovenian: Bolnice je treba obvestiti, da lahko bruhanje in diareja zmanjšata učinkovitost peroralnih kontraceptivov, saj preprečujeta popolno absorbcijo.
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.
Slovenian: Bosutinib je pokazal sposobnost za absorpcijo svetlobe v območjih UV-B in UV-A; porazdeli se v kožo in uvealni trakt pigmentiranih podgan.
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.
Slovenian: Študije toksičnosti pri ponavljajočih odmerkih, ki so na podganah trajale do 6 mesecev in na psih do 9 mesecev, so pokazale, da je primarni ciljni organ toksičnosti bosutiniba prebavni sistem.
English: Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML.
Slovenian: Zdravljenje mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolnikov s KML.
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.
Slovenian: Populacijske farmakokinetične analize pri bolnikih s Ph+ levkemijo ali z malignimi čvrstimi tumorji so pokazale, da starost, spol, telesna masa in rasa nimajo klinično pomembnih vplivov.
English: Experience with bosutinib overdose in clinical studies was limited to isolated cases.
Slovenian: Izkušnje s prevelikim odmerjanjem bosutiniba v kliničnih študijah so omejene le na posamezne primere.
English: If blood counts remain low for > 2 weeks, upon recovery reduce dose by 100 mg and resume treatment.
Slovenian: Če število krvnih celic ostane majhno > 2 tedna, je po izboljšanju treba odmerek zmanjšati za 100 mg in nadaljevati z zdravljenjem.
English: Complete blood counts should be performed weekly for the first month and then monthly thereafter, or as clinically indicated.
Slovenian: Popolno krvno sliko je treba preveriti enkrat na teden v prvem mesecu zdravljenja, potem pa enkrat na mesec ali kot je klinično indicirano.
English: - if you notice any of these symptoms: pain in your side, blood in your urine or reduced amount of urine.
Slovenian: - Če opazite katerega od simptomov: bolečine v ledvenem predelu, kri v urinu ali zmanjšana količina urina.