natgillin/translations-raw huggingface dataset:
Eksponeringen ved den højeste afprøvede dosis hos kaniner (10 mg/kg/dag), som ikke resulterede i uønskede føtale effekter, var henholdsvis 0,9 gange og 0,7 gange den humane eksponering som følge af den kliniske dosis på 400 mg eller 500 mg (baseret på ubunden AUC hos de respektive arter). 
The exposure at the highest dose tested in rabbits (10 mg/kg/day) that did not result in adverse foetal effects was 0.9-times and 0.7-times the human exposure resulting from the clinical dose of 400 mg or 500 mg, respectively (based on unbound AUC in the respective species).
I et studie med studiedeltagere med nyreinsufficiens sås øget bosutinib-eksponering hos patienter med moderat og svær nyreinsufficiens. 
In a renal impairment study, bosutinib exposures were increased in subjects with moderately and severely impaired renal function.
Bosulif 400 mg filmovertrukne tabletter EU/1/13/818/006 
Bosulif 400 mg film-coated tablets EU/1/13/818/006
Ikke almindelig Anafylaktisk shock, overfølsomhed Metabolisme og ernæring 
Uncommon Anaphylactic shock, Hypersensitivity Metabolism and nutrition disorders Very common Decreased appetite Common
- hoste. 
- cough.
Orange, oval (bredde 8,8 mm, længde 16,9 mm), bikonveks, filmovertrukket tablet præget med ”Pfizer” på den ene side og ”400” på den anden side. 
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.
Kontakt lægen, apotekspersonalet eller sundhedspersonalet før du tager Bosulif: - hvis du har eller tidligere har haft leverproblemer. 
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Bosulif:
Ved samtidig administration anbefales det, om muligt, at vælge et andet lægemiddel uden eller med minimalt potentiale for CYP3A-enzymhæmning. 
Selection of an alternate concomitant medicinal product with no or minimal CYP3A enzyme inhibition potential, if possible, is recommended.
Samtidig brug af bosutinib og potente eller moderate CYP3A-induktorer skal undgås, da det vil medføre lavere bosutinib-plasmakoncentrationen (se pkt. 
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).
Bosulif 500 mg filmovertrukne tabletter EU/1/13/818/003 
Bosulif 500 mg film-coated tablets EU/1/13/818/003
Gul, oval (bredde 5,6 mm, længde 10,7 mm), bikonveks, filmovertrukket tablet præget med ”Pfizer” på den ene side og ”100” på den anden side. 
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.
- vejrtrækningsstop. 
- respiratory failure.
Bemærk: MMR blev defineret som ≤ 0,1 % BCR-ABL/ABL-forhold efter international skala (svarende til ≥ 3 log-reduktion fra standardiseret baseline) med minimum 3.000 ABL-transskriper i henhold til centrallaboratoriets vurdering. 
Note: MMR was defined as ≤ 0.1% BCR-ABL/ABL ratio by international scale (corresponding to ≥ 3 log reduction from standardised baseline) with a minimum of 3,000 ABL transcripts assessed by the central laboratory.
I et studie med 24 raske frivillige studiedeltagere, der fik 400 mg ketoconazol (en stærk CYP3Ahæmmer) 5 gange dagligt sammen med en enkelt dosis af 100 mg bosutinib under faste, øgede ketoconazol bosutinib-Cmax 5,2 gange og bosutinib-AUC 8,6 gange i forhold til niveauerne ved administration af bosutinib alene. 
In a study of 24 healthy subjects in whom 5 daily doses of 400 mg ketoconazole (a strong CYP3A inhibitor) were co-administered with a single dose of 100 mg bosutinib under fasting conditions, ketoconazole increased bosutinib Cmax by 5.2-fold, and bosutinib AUC in plasma by 8.6-fold, as compared with administration of bosutinib alone.
- svimmelhed, ændring af smagssansen. 
- feeling of instability (dizziness), alteration of the sense of taste (dysgeusia).
Efter samtidig administration af en enkelt dosis bosutinib og 6 daglige doser af 600 mg rifampicin til 24 raske frivillige studiedeltagere efter fødeindtagelse faldt bosutinibeksponeringen (Cmax og AUC) til hhv. 14 % og 6 % af de værdier, der blev set, når bosutinib 500 mg blev administreret alene. 
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.
Fortæl det til lægen, hvis du får symptomer som: smertefuldt rødt eller lilla udslæt, der breder sig og bliver til vabler og/eller andre læsioner begynder at vise sig på slimhinden (f.eks. mund og læber). 
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).
Baseret på populationsfarmakokinetiske analyser blev der i studierne set øget eksponering (AUC) hos patienter, 
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
Patienter med CML i accelereret fase og blastfase Effektresultaterne fra patienter med Ph+ CML i accelereret fase (opfølgning på mindst 48 måneder, median behandlingsvarighed på 10 måneder og 17,7% stadig i behandling efter 48 måneder) og i blastfase (opfølgning på mindst 48 måneder, median behandlingsvarighed på 2,8 måneder og 3,1% stadig i behandling efter 48 måneder) er vist i skema 5. 
The efficacy results for AP (minimum follow-up 48 months, median treatment duration of 10 months and 17.7% still on-treatment at 48 months) and BP (minimum follow-up 48 months, median treatment duration of 2.8 months and 3.1% still on-treatment at 48 months) Ph+ CML patients are present in Table 5.
- unormalt højt blodtryk i lungearteriene. 
- abnormally high blood pressure in the arteries of the lungs (pulmonary hypertension).
Bosulif 400 mg filmovertrukne tabletter er orange, ovale, bikonvekse, præget med ”Pfizer” på den ene side og ”400” på den anden side. 
Bosulif 400 mg film-coated tablets are orange, oval biconvex, debossed with “Pfizer” on one side and “400” on the other side.
Almindelig Svimmelhed, smagsforstyrrelser Øre og labyrint 
Dizziness, Dysgeusia Ear and labyrinth disorders Common
Bosulif 100 mg filmovertrukne tabletter EU/1/13/818/001 
Bosulif 100 mg film-coated tablets EU/1/13/818/001
Den dosis, der ikke medførte uønskede virkninger på udviklingen (10 mg/kg/dag), resulterede i eksponeringer, der svarede til hhv. 1,3 gange og 1,0 gange den humane eksponering som følge af den kliniske dosis på hhv. 400 mg og 500 mg (baseret på ubunden AUC i de respektive arter). 
The dose at which no adverse development effects were observed (10 mg/kg/day) resulted in exposures equal to 1.3-times and 1.0-times human exposure resulting from the clinical dose of 400 mg and 500 mg, respectively (based on unbound AUC in the respective species).
Bosulif 100 mg filmovertrukne tabletter Hver karton indeholder 28, 30 eller 112 tabletter. 
Bosulif 100 mg film-coated tablets Each carton contains 28, 30 or 112 tablets.
Før initiering af behandlingen hos patienter med positiv hepatitis B-serologi (herunder patienter med aktiv sygdom) og hos patienter, der testes HBV-positive under behandlingen, bør der konsulteres eksperter i leversygdomme og i behandling af hepatitis B. Bærere af HBV, der har behov for behandling med bosutinib, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion i hele behandlingsperioden og i flere måneder efter ophør af behandlingen (se pkt. 
Experts in liver disease and in the treatment of HBV should be consulted before treatment is initiated in patients with positive HBV serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Myelosuppression skal/kan behandles ved midlertidig afbrydelse af bosutinib, dosisreduktion og/eller seponering af bosutinib (se pkt. 
Myelosuppression should/can be managed by withholding bosutinib temporarily, dose reduction, and/or discontinuation of bosutinib (see sections 4.2 and 4.8).
- åndenød. 
- shortness of breath.
Bosulif 500 mg filmovertrukne tabletter er røde, ovale, bikonvekse, præget med ”Pfizer” på den ene side og ”500” på den anden side. 
Bosulif 500 mg film-coated tablets are red, oval biconvex, debossed with “Pfizer” on one side and “500” on the other side.
Det var enten patienter med nydiagnosticeret CML i kronisk fase eller patienter med CML i kronisk fase, accelereret fase eller blastfase, der var resistente eller intolerante over for tidligere behandlinger eller patienter med Ph+ akut lymfoblastær leukæmi (ALL). 
These patients were either newly diagnosed, with CP CML or were resistant or intolerant to prior therapy with chronic, accelerated, or blast phase CML or Ph+ acute lymphoblastic leukaemia (ALL).
MMR blev defineret som ≤ 0,1% BCR-ABL/ABL-forhold efter international skala (svarende til ≥ 3 log-reduktion i forhold til standardiseret baseline) med minimum 3.000 ABL-transskripter i henhold til centrallaboratoriets vurdering. 
MMR was defined as ≤ 0.1% BCR-ABL/ABL ratio by international scale (corresponding to ≥ 3 log reduction from standardised baseline) with a minimum of 3,000 ABL transcripts as assessed by the central laboratory.
MMR blev defineret som ≤ 0,1% BCR ABL/ABL-forhold på international skala (svarende til ≥ 3 log-reduktion fra standardiseret baseline) med minimum 3.000 ABL-transskripter i henhold til centrallaboratoriets vurdering. 
MMR was defined as ≤ 0.1% BCR-ABL/ABL ratio on international scale (corresponding to ≥ 3 log reduction from standardised baseline) with a minimum of 3,000 ABL transcripts assessed by the central laboratory.
Rød, oval (bredde 9,5 mm, længde 18,3 mm), bikonveks, filmovertrukket tablet præget med ”Pfizer” på den ene side og ”500” på den anden side. 
Red oval (width: 9.5 mm; length: 18.3 mm) biconvex, film-coated tablet debossed with “Pfizer” on one side and “500”on the other side.
Forkortelser: BCR ABL=breakpoint cluster region Abelson; CI=konfidensinterval; CMH=Cochran Mantel Haenszel; CML=kronisk myeloid leukæmi; mITT=modificeret intent to treat; MMR=major molekylært respons; Ph+=Philadelphiakromosompositiv. 
Abbreviations: BCR-ABL=breakpoint cluster region-Abelson; CI=confidence interval; CMH=Cochran-Mantel-Haenszel; CCyR=complete cytogenetic response; mITT=modified intent-to-treat; MMR=major molecular response; N/n=number of patients; Ph+=Philadelphia chromosome-positive.
I et studie med 20 raske frivillige studiedeltagere, der fik en enkelt dosis på 125 mg aprepitant (en moderat CYP3A-hæmmer) sammen med en enkelt dosis på 500 mg bosutinib uden faste, øgede aprepitant bosutinib-Cmax 1,5 gange og bosutinib-AUC 2,0 gange i forhold til niveauerne ved administration af bosutinib alene. 
In a study of 20 healthy subjects, in whom a single dose of 125 mg aprepitant (a moderate CYP3A inhibitor) was co-administered with a single dose of 500 mg bosutinib under fed conditions, aprepitant increased bosutinib Cmax by 1.5-fold, and bosutinib AUC in plasma by 2.0-fold, as compared with administration of bosutinib alone.
Bosulif 100 mg filmovertrukne tabletter Bosulif 400 mg filmovertrukne tabletter Bosulif 500 mg filmovertrukne tabletter 
Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets
Mediantiden til første hændelse var 28 dage (interval: 1-2.633 dage), og medianvarigheden pr. hændelse var 15 dage (interval: 1-1.529 dage). 
Among these patients, the median time to first event was 28 days (range: 1 to 2,633 days) and the median duration per event was 15 days (range: 1 to 1,529 days).
Diarre og opkastning kan desuden håndteres ved midlertidig afbrydelse af bosutinib, dosisreduktion og/eller seponering af bosutinib (se pkt. 
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).
- akut betændelse bugspytkirtlen (akut pankreatitis). 
- acute inflammation of the pancreas (acute pancreatitis).
I det kliniske fase 3-studie med patienter med nydiagnosticeret CML i kronisk fase, som blev behandlet med bosutinib 400 mg, var der ingen patienter i bosutinib-behandlingsgruppen med en stigning på > 60 msek. 
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).
Proarytmisk potentiale 
Proarrhythmic potential
- perikon (et naturlægemiddel, der fås i håndkøb), der anvendes til behandling af nedtrykthed. 
- St. John's Wort (a herbal preparation obtained without a prescription), used to treat depression.
Diarré: Ved diarré af NCI Common Terminology Criteria for Adverse Events (CTCAE) grad 3-4 skal behandling med bosutinib afbrydes. 
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).
Det anvendes til behandling af voksne patienter, der har en type leukæmi, der kaldes Philadelphiakromosompositiv (Ph-positiv) kronisk myeloid leukæmi (CML). 
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.
Bosulif 400 mg filmovertrukne tabletter Hver karton indeholder 28 eller 30 tabletter. 
Bosulif 400 mg film-coated tablets Each carton contains 28 or 30 tablets.
Almindelig Hepatotoksicitet (herunder hepatitis, toksisk hepatitis, leversygdom), abnorm leverfunktion (herunder abnorm leverfunktionstest, forhøjet leverfunktionstest, forhøjede transaminaser), forhøjet bilirubin i blodet 
Hepatotoxicity (including Hepatitis, Hepatitis toxic, Liver disorder), Hepatic function abnormal (including Liver function test abnormal, Liver function test increased, Transaminases increased), Blood bilirubin increased (including Hyperbilirubinaemia), Gamma-glutamyltransferase increased Uncommon Liver injury (including Drug-induced liver injury) Skin and subcutaneous tissue disorders
Trombocytopeni (herunder nedsat trombocyttal), neutropeni (herunder nedsat neutrofiltal), anæmi (herunder nedsat hæmoglobin) Almindelig Leukopeni (herunder nedsat antal hvide blodlegemer) Ikke almindelig Febril neutropeni, granulocytopeni Immunsystemet 
Leukopenia (including White blood cell count decreased) Uncommon Febrile neutropenia, Granulocytopenia Immune system disorders
Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig. 
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.
Bosulif 100 mg filmovertrukne tabletter Bosulif 400 mg filmovertrukne tabletter Bosulif 500 mg filmovertrukne tabletter bosutinib 
Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets bosutinib
5.1 og 5.3). 
Hepatic impairment (see sections 5.1 and 5.2).
63 patienter (32 %) oplevede maksimalt grad 1 eller 2, 90 patienter (46 %) oplevede maksimalt grad 3-neutropeni, og 44 patienter (22 %) oplevede grad 4. 
The maximum toxicity of Grade 3 neutropenia was experienced in 90 (46%) patients and of Grade 4 in 44 (22%) patients.
Fortæl det til lægen, hvis du får mavesmerter eller maveproblemer. 
Tell your doctor if you develop abdominal pain or discomfort.
(95 % CI) Varighed af MCyR 
Time to MCyR for responders onlyb, weeks (95% CI) Duration of MCyR
Bosulif 500 mg filmovertrukne tabletter Hver karton indeholder 28 eller 30 tabletter. 
Bosulif 500 mg film-coated tablets Each carton contains 28 or 30 tablets.
Nyrer og urinveje 
Urticaria, Acne, Pruritus
Følgende aktive stoffer kan nedsætte virkningen af Bosulif: 
The following active substances may reduce the effectiveness of Bosulif: - rifampicin, used to treat tuberculosis.
Diarré, opkastning, kvalme, abdominalsmerter (herunder abdominalt ubehag, nedre abdominalsmerter, øvre abdominalsmerter, abdominal ømhed, gastrointestinale smerter) Almindelig Gastritis, gastrointestinal blødning (herunder anal blødning, gastrisk blødning, tarmblødning, nedre gastrointestinal blødning, rektal blødning) Ikke almindelig Pankreatitis (herunder akut pankreatitis) Lever og galdeveje Meget almindelig 
Pleural effusion Uncommon Pulmonary hypertension, Respiratory failure, Acute pulmonary oedema Gastrointestinal disorders Very common Diarrhoea, Vomiting, Nausea, Abdominal pain (including Abdominal discomfort, Abdominal pain lower, Abdominal pain upper, Abdominal tenderness, Gastrointestinal pain)
Kontakt en læge, hvis du ved et uheld har taget flere Bosulif, end der står i denne information, eller flere end lægen har foreskrevet. 
If you accidentally take too many Bosulif tablets or a higher dose than you need, contact a doctor for advice right away.
EU/1/13/818/004 30 filmovertrukne tabletter. 
EU/1/13/818/003 28 film-coated tablets EU/1/13/818/004 30 film-coated tablets
Macrogol 3350 
Titanium dioxide (E171) Macrogol 3350
Hos de patienter med AP og BP CML, der tidligere var blevet behandlet med mindst 1 TKI (imatinib), var effektmålene det kumulative totale hæmatologiske respons (OHR) og tid til og varighed af OHR. 
For patients previously treated with both imatinib and at least 1 additional TKI, the endpoints include the cumulative MCyR rate, time to and duration of MCyR, and time to and duration of CHR. For patients with AP and BP CML previously treated with at least 1 prior TKI (imatinib), the endpoints were cumulative overall haematological response (OHR) and time to and duration of OHR.
Væskeretention kan desuden behandles ved midlertidig afbrydelse af bosutinib, dosisreduktion og/eller seponering af bosutinib (se pkt. 
In addition, fluid retention can also be managed by withholding bosutinib temporarily, dose reduction, and/or discontinuation of bosutinib (see sections 4.2 and 4.8).
Der blev udført et åbent enkeltarms, fase 1/2 multicenterstudiefor at vurdere effekten og sikkerheden af bosutinib 500 mg 1 gang dagligt hos patienter med imatinib-resistent eller -intolerant CML med separate kohorter for sygdom i kronisk fase, accelereret fase og blastfasen. 
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).
28 filmovertrukne tabletter 30 filmovertrukne tabletter 
28 film-coated tablets.
Dosis og indtagelsesmåde 
Dose and method of administration
Det skal du vide, før du begynder at tage Bosulif Sådan skal du tage Bosulif Bivirkninger 
What Bosulif is and what it is used for What you need to know before you take Bosulif How to take Bosulif
186 patienter (42%) oplevede maksimalt grad 1 eller 2, 161 patienter (36 %) oplevede trombocytopeni af maksimalt grad 3, og 98 patienter (22 %) oplevede grad 4. 
The maximum toxicity of thrombocytopenia of Grade 3 was experienced in 161 (36%) patients and Grade 4 in 98 (22%) patients.
F317L 
0.0037a
- akut nyresvigt, nyresvigt, nedsat nyrefunktion. 
- acute kidney failure, kidney failure, kidney impairment.
Hjertesygdomme 
Cardiac disorders
I det kliniske fase I/II-studie med patienter med Ph+ leukæmi, der tidligere var blevet behandlet, blev der set forlænget QTcF-interval > 60 msek. 
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.
nedsat gang indtraf ved eksponeringer, der var ca. 11 gange den humane eksponering som følge af den kliniske dosis på 400 mg og 8 gange den humane eksponering som følge af den kliniske dosis på 500 mg (baseret på ubundet Cmax i de respektive arter). 
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).
Patienter med tidligere behandlet CML og CML i fremskreden fase, der fik 500 mg, havde en median eGRF nedsættelse på 5,3 ml/min/1,73 m efter 3 måneder, 7,6 ml/min/1,73 m 2 efter 
Pretreated and advanced stage CML patients on 500 mg showed a median eGFR decline of 5.3 ml/min/1.73 m2 at 3 months, of 7.6 ml/min/1.73 m2 at 12 months and of up to 10.9 ml/min/1.73 m2 in up to 4 years on treatment.
Bosutinib udviser dosisproportionelle stigninger i AUC og Cmax i doseringsområdet 200 - 600 mg. 
Bosutinib exhibits dose proportional increases in AUC and Cmax, over the dose range of 200 to 600 mg. Food increased bosutinib Cmax 1.8-fold and bosutinib AUC 1.7-fold compared to the fasting state.
Bosulif 400 mg filmovertrukne tabletter 
Bosulif 400 mg film-coated tablets
, toksisk epidermal nekrolyse 
Tumour lysis syndrome
I det kliniske fase 3-studie med patienter med nydiagnosticeret Ph+ CP CML, som blev behandlet med bosutinib 500 mg, blev der set forlænget QTcF-interval > 60 msek. 
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.
Hver filmovertrukket tablet indeholder 400 mg bosutinib (som monohydrat). 
Each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Infektioner og parasitære sygdomme Meget almindelig 
Renal and urinary disorders Common
9,2 ml/min/1,73 m2 efter 12 måneder og op til 16,3 ml/min/1,73 m2 indtil 5 års opfølgning for patienter i behandling. 
Treatment-naïve CML patients treated with 500 mg showed a median eGFR decline of 5.1 ml/min/1.73 m2 at 3 months, of 9.2 ml/min/1.73 m2 at 12 months and of up to 16.3 ml/min/1.73 m2 until 5 years follow-up for patients on treatment.
Bosulif 500 mg filmovertrukne tabletter 
Bosulif 500 mg film-coated tablets
Hver filmovertrukket tablet indeholder 100 mg bosutinib (som monohydrat). 
Each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Hver filmovertrukket tablet indeholder 500 mg bosutinib (som monohydrat). 
Each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Den anbefalede dosis hos patienter med svær nyreinsufficiens (CLCr <30 ml/min, beregnet ved hjælp af Cockcroft-Gault-formlen) er 300 mg bosutinib dagligt (se pkt. 
In patients with severe renal impairment (CLCr < 30 mL/min, calculated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 300 mg daily (see sections 4.4 and 5.2).
Bosulif 100 mg filmovertrukne tabletter 
Bosulif 100 mg film-coated tablets
Den anbefalede dosis hos patienter med svær nyreinsufficiens (CLCr < 30 ml/min, beregnet ved hjælp af Cockcroft-Gault-formlen) er 200 mg bosutinib dagligt sammen med føde (se pkt. 
In patients with severe renal impairment (CLCr < 30 mL/min, estimated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 200 mg daily with food (see sections 4.4 and 5.2).
Bosulif 400 mg filmovertrukne tabletter Polyvinylalkohol 
Bosulif 400 mg film-coated tablets Polyvinyl alcohol
Opbevar dette lægemiddel utilgængeligt for børn. 
- Keep this medicine out of the sight and reach of children.
Bosulif 400 mg filmovertrukne tabletter bosutinib 
Bosulif 400 mg film-coated tablets bosutinib
Bosulif 500 mg: Hver filmovertrukket tablet indeholder 500 mg bosutinib (som monohydrat). 
Bosulif 500 mg: each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Bosulif 500 mg filmovertrukne tabletter Polyvinylalkohol 
Bosulif 500 mg film-coated tablets Polyvinyl alcohol