natgillin/translations-raw huggingface dataset:
Patienter med diarré og opkastning skal behandles med standardbehandling, inklusive antidiarrémidler eller antiemetika og/eller væskesubstitution. 
Patients with diarrhoea and vomiting should be managed using standard-of-care treatment, including an antidiarrhoeal or antiemetic medicinal product and/or fluid replacement.
Lægen bør tage blodprøver for at kontrollere din leverfunktion, før du starter behandling med Bosulif, i de første tre måneder af behandlingen med Bosulif og derefter efter behov. 
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.
Bosutinibs aktivitet in vitro i hERG-analyser tyder på, at det har potentiale til at forlænge den kardiale-ventrikulære repolarisering (QT-intervallet). 
Bosutinib activity in vitro in hERG assays suggested a potential for prolongation of cardiac ventricular repolarisation (QTc).
I forsøget blev 536 patienter (268 i hver behandlingsgruppe) med nydiagnosticeret Ph+ eller Ph- CP CML (intent-to-treat-population (ITT)) randomiseret, herunder 487 patienter med Ph+ CML med b2a2- og/eller b3a2-transskripter og baseline-BCR-ABL-kopier > 0 (modificeret intent-to-treat-population (mITT)). 
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).
Trombocytter < 50 x 10 9/l 
Platelets < 50 × 109/L
Bosutinib hæmmer PDGF-receptoren (platelet derived growth factor) og cKit i minimal grad. 
Bosutinib minimally inhibits platelet-derived growth factor (PDGF) receptor and c-Kit.
I et fertilitetsforsøg med rotter var fertiliteten let nedsat hos handyr. 
In a rat fertility study, fertility was slightly decreased in males.
Sikkerhedsprofil 
Summary of safety profile
Patienter med serumkreatinin > 1,5 x ULN blev udelukket fra CML-studierne. 
Patients with serum creatinine > 1.5 × ULN were excluded from the CML studies.
I analysen tillades baseline-respondenter som fastholdt respons efter baseline. 
The analyses allow baseline responders who maintained response post-baseline to be responders.
Patienter med serumkreatinin > 1,5 x ULN blev udelukket fra CML-studier. 
Patients with serum creatinine > 1.5×ULN were excluded from CML studies.
Blandt de 994 patienter med diarré afbrød 180 patienter (18 %) behandlingen, og 170 af disse patienter (94 %) genoptog senere bosutinib-behandlingen. 
Among the 994 patients with diarrhoea, 180 patients (18%) were managed with treatment interruption and of these 170 (94%) were rechallenged with bosutinib.
Kvinder i den fertile alder skal rådes til at anvende sikker kontraception under behandlingen med bosutinib og i mindst 1 måned efter den sidste dosis for at undgå graviditet under behandlingen med bosutinib. 
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.
I in vitro-studier hæmmer bosutinib proliferationen og overlevelsen af etablerede CML-cellelinjer, Ph+ akut lymfoblastisk leukæmi-cellelinjer og patientderiverede primære primitive CML-celler. 
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.
Tabletternes filmovertræk indeholder polyvinylalkohol, titandioxid (E171), macrogol 3350, talcum (E553b) og gul jernoxid (E172, 100 mg og 400 mg tablet) eller rød jernoxid (E172, 400 mg og 500 mg tablet). 
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).
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter): - alvorlig hudsygdom pga. en allergisk reaktion, (erythema multiforme, Stevens-Johnsons syndrom, toksisk epidermal nekrolyse), udslæt med afstødning af hudens øverste lag. 
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.
Der blev set mindst 1 grad 3- eller 4-bivirkning hos 814 (63,9%) af patienterne. 
At least 1 Grade 3 or Grade 4 adverse reaction was reported for 814 (63.9%) patients.
Skema 6 - Respons efter baseline-BCR-ABL-mutationsstatus hos den CP CML-evaluerbare population: tidligere behandling med imatinib og dasatinib og/eller nilotinib (tredje linie) 
Table 6 - Response by baseline BCR-ABL mutation status in CP CML evaluable population: prior imatinib and dasatinib and/or nilotinib (third-line)
- diarré, opkastning, mavesmerter, kvalme. 
- diarrhoea, vomiting, stomach pain, nausea.
Opløseligheden af bosutinib er pH-afhængig, og absorptionen reduceres i takt med stigende pH (se pkt. 
The solubility of bosutinib is pH-dependent and absorption is reduced when gastric pH is increased (see section 4.5).
Ph+ CP CML tidligere behandlet med imatinib og dasatinib eller nilotinib 
Ph+ CP CML with prior treatment with imatinib and dasatinib or nilotinib
Toksicitet efter gentagne doser 
Repeated-dose toxicity
Nedenstående bivirkninger er set hos patienter i kliniske studie med bosutinib (skema 2). 
The following adverse reactions were reported in patients in bosutinib clinical studies (Table 2).
In vitro- og in vivo-studier tyder på, at bosutinib (moderstoffet) fortrinsvis metaboliseres i leveren hos mennesker. 
In vitro and in vivo studies indicated that bosutinib (parent compound) undergoes predominantly hepatic metabolism in humans.
In vitro-studier tyder på, at bosutinib har lavt potentiale for at hæmme brystcancer-resistensprotein (BCRP, systemisk), organisk anion-transporterende polypeptid (OATP)1B1, OATP1B3, organisk anion-transportør (OAT)1, OAT3, organisk kation-transportør (OCT)2 i klinisk relevante koncentrationer, men har muligvis potentiale for at hæmme BCRP i mave-tarmkanalen og OCT1. 
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.
- phenytoin og carbamazepin, der anvendes til behandling af epilepsi. 
- phenytoin and carbamazepine, used to treat epilepsy.
Det bør overvejes at anvende korttidsvirkende antacida i stedet for PPI'er, og bosutinib og antacida skal om muligt administreres på separate tidspunkter (f.eks. kan bosutinib tages om morgenen og antacida om aftenen). 
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.
Af disse patienter deltog 268 (startdosis på 400 mg) og 248 (startdosis på 500 mg) i de 2 fase 3-studier hos tidligere ikke-behandlede CML-patienter, og 570 henholdsvis 63 deltog i de 2 fase 1/2-studier hos tidligere behandlede patienter med Ph+-leukæmi, og 123 patienter deltog i et fase 4-studie hos tidligere behandlede CML-patienter. 
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.
Diarré og opkastning 
Diarrhoea and vomiting
Der blev set mindst 1 bivirkning af alle grader hos 1.240 (97,5%) af patienterne. 
At least 1 adverse reaction of any toxicity grade was reported for 1,240 (97.5%) patients.
Der blev set histopatologisk luminal dilation, slimcellehyperplasi, hæmoragi, erosion og ødem i tarmkanalen og sinus-erytrocytose og hæmoragi i de mesenteriale lymfeknuder. 
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.
Det primære effektendepunkt var andelen, der udviste major molekylært respons (MMR) efter 12 måneder (48 uger) i bosutinib-behandlingsgruppen, sammenlignet med andelen i imatinibbehandlingsgruppen i mITT-populationen. 
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.
Nydiagnosticeret CP Ph+ CML Den anbefalede dosis er 400 mg bosutinib 1 gang dagligt. 
Newly-diagnosed CP Ph+ CML The recommended dose is 400 mg bosutinib once daily.
Mindst 1 mutation Dasatinib-resistente mutationer E255K/V 
Mutation assessed No mutation At least 1 mutation Dasatinib resistant mutations E255K/V F317L Nilotinib resistant mutations c
Myelosuppression Behandling med bosutinib er forbundet med myelosuppression, defineret som anæmi, neutropeni og trombocytopeni. 
Treatment with bosutinib is associated with myelosuppression, defined as anaemia, neutropenia, and thrombocytopenia.
Hvis du har glemt at tage Bosulif 
If you forget to take Bosulif
Kaplan-Meier-estimaterne af OS efter 48 uger for bosutinib- og imatinib-patienter i mITTpopulationen var henholdsvis 99,6 % (95 % CI: 97,1 %-99,9 %) og 97,9 % (95 % CI: 95,0 %-99,1 %). 
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.
Samlet, % (95 % CI) Major, % (95 % CI) Komplet, % (95 % CI) 
Overall, % (95% CI) Major, % (95% CI) Complete, % (95% CI)
Det frarådes at anvende bosutinib under graviditeten og hos kvinder i den fertile alder, der ikke anvender kontraception. 
Bosutinib is not recommended for use during pregnancy, or in women of childbearing potential not using contraception.
Kontakt lægen, hvis du har spørgsmål om, hvordan Bosulif virker, eller hvorfor du har fået ordineret dette lægemiddel. 
If you have any questions about how Bosulif works or why this medicine has been prescribed for you, ask your doctor.
Mediantiden til MMR for respondenter var 24,7 uger over for 36,3 uger for henholdsvis bosutinib-behandlingsgruppen og imatinib-behandlingsgruppen i mITT-populationen. 
The median time to MMR for responders was 24.7 weeks versus 36.3 weeks for the bosutinib treatment and imatinib treatment groups, respectively, in the mITT population.
Cmax af bosutinib i plasma var 2,4 gange, 2 gange og 1,5 gange højere ved hhv. Child-Pugh-klasse A, B og C, mens AUC af bosutinib var hhv. 2,3 gange, 2 gange og 1,9 gange højere. 
Cmax of bosutinib in plasma increased 2.4-fold, 2-fold, and 1.5-fold, respectively, in Child-Pugh classes A, B, and C; and bosutinib AUC in plasma increased 2.3-fold, 2-fold, and 1.9-fold, respectively.
Baseret på den store reduktion i bosutinib-eksponeringen når det blev administreret sammen med rifampicin, er det sandsynligvis ikke tilstrækkeligt at øge bosutinibdosis for at kompensere for den reducerede eksponering ved administration sammen med potente eller moderate CYP3A-induktorer. 
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.
Medbring om muligt pakningen eller denne indlægsseddel. 
If possible, show the doctor the pack, or this leaflet.
I nogle tilfælde har dette medført akut leversvigt eller fulminant hepatitis, førende til levertransplantation eller fatalt udfald. 
Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.
Det primære effektmål i dette studie var major cytogenetisk respons (MCyR)-rate i uge 24 hos patienter med imatinibresistent CP CML, som forinden kun var blevet behandlet med 1 TKI (imatinib). 
The primary efficacy endpoint of the study was the major cytogenetic response (MCyR) rate at Week 24 in patients with imatinib-resistant CP CML previously treated with only 1 prior TKI (imatinib).
Tid til OHR hos respondenter alene, uger (95 % CI) 
Time to OHR for responders only, weeks (95% CI)
Efter administration af en enkelt dosis bosutinib (500 mg) sammen med føde, var biotilgængeligheden 34% hos raske frivillige. 
Following administration of a single dose of bosutinib (500 mg) with food in healthy subjects, the absolute bioavailability was 34%.
Der blev påvist føtal eksponering for bosutinib-deriveret radioaktivitet under drægtigheden i et placentapassagestudie med drægtige Sprague-Dawley-rotter. 
Foetal exposure to bosutinib-derived radioactivity during pregnancy was demonstrated in a placental transfer study in gravid Sprague-Dawley rats.
Andre effektmål omfattede den kumulative MCyR-rate, tid til og varighed af MCyR og tid til og varighed af CHR hos patienter med CP CML, der forinden kun var blevet behandlet med 1 TKI (imatinib). 
Other efficacy endpoints include the cumulative MCyR rate, time to and duration of MCyR, and time to and duration of CHR, in patients with CP CML previously treated with only 1 prior TKI (imatinib).
In vitro-studier med humane levermikrosomer tyder på, at det CYP-isoenzym, der primært er involveret i bosutinibs metabolisering, er CYP3A4, og interaktionsstudier har vist, at ketoconazol og rifampicin har udtalt effekt på bosutinibs farmakokinetik (se pkt. 
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).
Ingen evidens for leukæmi (NEL): opfylder alle kriterier for CHR, men kan eventuelt have trombocytopeni (trombocyttal over eller lig med 20.000/mm 3 og under 100.000/mm 3) og/eller neutropeni (ANC over eller lige med 0,5 x 10 
No evidence of leukaemia (NEL): Meets all other criteria for CHR except may have thrombocytopenia (platelets greater than or equal to 20,000/mm and less than 100,000/mm 3) and/or neutropenia (ANC greater than or equal to 0.5×10
Det er vigtigt at vurdere nyrefunktionen, inden behandling indledes, og at monitorere den tæt under bosutinib-behandlingen med særlig opmærksomhed hos patienter med eksisterende nyreproblemer, og hos patienter med risiko for renal dysfunktion, herunder samtidig anvendelse af potentielt nefrotoksiske lægemidler, såsom diuretika, ACE-hæmmere, angiotensin receptor-antagonister og non-steroide anti-inflammatoriske lægemidler (NSAID'er). 
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).
Den mediane behandlingsvarighed var henholdsvis 14,1 måneder (interval: 0,3-24,7 måneder), 61,6 måneder (0,0399,6 måneder), 11,1 måneder (interval: 0,03-123,3 måneder), 30,2 måneder (interval: 0,385,6 måneder) og 5,7 måneder (interval: 0,07-17,8 måneder). 
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.
Hos CML-patienter i steady state var Cmax (geometrisk middelværdi, variationskoefficient (CV)%) 145 (14) ng/ml og AUCss (geometrisk middelværdi, CV%) var 2.700 (16) ng•t/ml efter daglig administration af bosutinib på 400 mg sammen med føde. 
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.
I studierne blev der set øget eksponering (AUC - arealet under kurven) hos patienter med moderat eller svær nyreinsufficiens. 
Increasing exposure (area under curve [AUC]) in patients with moderate and severe renal impairment during studies was observed.
Doser under 300 mg/dag har været anvendt, men virkningen er ikke klarlagt. 
Doses less than 300 mg/day have been used; however, efficacy has not been established.
Cytogenetisk respons var baseret på procentdelen af Ph+ metafaser blandt ≥ 20 metafaseceller i hver knoglemarvsprøve. 
Cytogenetic responses were based on the percentage of Ph+ metaphases among ≥ 20 metaphase cells in each bone marrow sample.
Infektioner Bosutinib kan gøre patienterne mere modtagelige for bakterie-, svampe- og protozoinfektioner. 
Infections Bosutinib may predispose patients to bacterial, fungal, viral, or protozoan infections.
Doser under 300 mg/dag har været anvendt til patienter, men virkningen er ikke klarlagt. 
Doses less than 300 mg/day have been used in patients; however, efficacy has not been established.
- markant nedsat antal af en særlig type hvide blodlegemer (granulocytter). 
- a marked decrease in the number of granulocytes (a type of white blood cells).
I alt 1.272 patienter med leukæmi blev behandlet med mindst 1 dosis bosutinib som enkeltstofbehandling. 
A total of 1,272 leukaemia patients received at least 1 dose of single-agent bosutinib.
Mandlige patienter i behandling med bosutinib bør søge råd vedrørende indsamling og opbevaring af sæd inden behandlingen, på grund af muligheden for nedsat fertilitet som følge af behandling med bosutinib. 
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.
Du skal undgå disse lægemidler under behandlingen med Bosulif. 
These medicines should be avoided during your treatment with Bosulif.
Efter administration af en enkelt eller gentagne doser af bosutinib (400 eller 500 mg) til mennesker, var de vigtigste cirkulerende metabolitter tilsyneladende oxydechlorineret (M2) og Ndemetyleret (M5) bosutinib, mens bosutinib-N-oxid (M6) var en minor cirkulerende metabolit. 
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.
Det skal du vide, før du begynder at tage Bosulif 
What do you need to know before you take take Bosulif
Ni patienter (0,8%) fik QTcF-forlængelse i forhold til baseline på mere end 60 ms. 
Nine (0.8%) patients experienced QTcF increase from baseline exceeding 60 ms.
Accelereret fase tidligere behandlet med imatinib som minimum 
Accelerated phase with prior treatment of at least imatinib
I det kliniske fase 1/2-studie med patienter med CML, som var resistente eller intolerante over for tidligere behandling, og som påbegyndte behandling med ≤ 500 mg, fik 93 (93/558; 16,7 %) patienter dosis øget til 600 mg dagligt 
In the Phase 1/2 clinical study in patients with CML who were resistant or intolerant to prior therapy who started treatment at ≤ 500 mg, 93 (93/558; 16.7%) patients had dose escalations to 600 mg daily.
Fortæl det til lægen, hvis du får mavesmerter, halsbrand, diarré, forstoppelse, kvalme og opkastning. 
Tell your doctor if you develop stomach pain, heartburn, diarrhoea, constipation, nausea and vomiting.
Antiarytmika og andre substanser, der kan forlænge QT Bosutinib skal anvendes med forsigtighed hos patienter, der har eller kan udvikle QT-forlængelse, herunder patienter, der tager antiarytmika såsom amiodaron, disopyramid, procainamid, quinidin og sotalol eller andre lægemidler, der kan føre til QT-forlængelse, såsom chloroquin, halofantrin, clarithromycin, domperidon, haloperidol, methadon og moxifloxacin (se pkt. 
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).
I hele udviklingsprogrammet sås samtidig stigning i aminotransferaser ≥ 3 × ULN og bilirubin > 2 × ULN med basisk fosfatase < 2 × ULN uden alternative årsager hos 1 studiedeltager ud af 1.611 behandlet med bosutinib (≤ 0,1%). 
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.
CP, AP eller BP Ph+ CML med resistens eller intolerance over for tidligere behandling Den anbefalede dosis er 500 mg bosutinib 1 gang dagligt. 
CP, AP, or BP Ph+ CML with resistance or intolerance to prior therapy The recommended dose is 500 mg bosutinib once daily.
Toksiciteterne var kendetegnet ved en øget levervægt i korrelation med hepatocellulær hypertrofi, der indtrådte under fravær af forhøjede leverenzymer eller mikroskopiske tegn på hepatocullær cytotoksicitet. 
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.
Patienter med ukontrolleret eller signifikant kardiovaskulær sygdom, inklusive forlænget QT-interval, ved baseline blev ikke inkluderet i kliniske studier (se pkt. 
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).
På grund af den mulige forekomst af tumorlysesyndrom (TLS), anbefales det at korrigereklinisk signifikant dehydrering samt at behandle høje urinsyreniveauer inden behandling med bosutinib (se pkt. 
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).
Ph+ CP CML tidligere behandlet med imatinib alene 
Ph+ CP CML with prior imatinib treatment only
Forhøjede leveraminotransferaser: Ved stigning i leveraminotransferaser til > 5 x øvre normalgrænse (ULN) skal behandlingen med bosutinib afbrydes indtil bedring til ≤ 2,5 x ULN, hvorefter behandlingen kan genoptages med 400 mg 1 gang dagligt. 
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.
- clarithromycin, telithromycin, erythromycin og ciprofloxacin, der er antibiotika til behandling af bakterieinfektioner. 
- clarithromycin, telithromycin, erythromycin, and ciprofloxacin, used to treat bacterial infections.
Amning bør afbrydes under behandlingen med bosutinib. 
Breast-feeding should be discontinued during treatment with bosutinib.
I et studie med studiedeltagere med nyreinsufficiens blev en enkelt dosis på 200 mg bosutinib administreret med føde hos 26 deltagere med let, moderat eller svær nyreinsufficiens og hos 8 tilsvarende raske frivillige. 
In a renal impairment study, a single dose of 200 mg bosutinib was administered with food to 26 subjects with mild, moderate, or severe renal impairment and to 8 matching healthy volunteers.
Magnesiumstearat (E470b) 
Povidone (E1201) Magnesium stearate (E470b)