FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets
Danish: Bosulif 100 mg filmovertrukne tabletter Bosulif 400 mg filmovertrukne tabletter Bosulif 500 mg filmovertrukne tabletter
English: 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).
Danish: Mediantiden til første hændelse var 28 dage (interval: 1-2.633 dage), og medianvarigheden pr. hændelse var 15 dage (interval: 1-1.529 dage).
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).
Danish: Diarre og opkastning kan desuden håndteres ved midlertidig afbrydelse af bosutinib, dosisreduktion og/eller seponering af bosutinib (se pkt.
English: - acute inflammation of the pancreas (acute pancreatitis).
Danish: - akut betændelse bugspytkirtlen (akut pankreatitis).
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).
Danish: 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.
English: Proarrhythmic potential
Danish: Proarytmisk potentiale
English: - St. John's Wort (a herbal preparation obtained without a prescription), used to treat depression.
Danish: - perikon (et naturlægemiddel, der fås i håndkøb), der anvendes til behandling af nedtrykthed.
English: 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).
Danish: Diarré: Ved diarré af NCI Common Terminology Criteria for Adverse Events (CTCAE) grad 3-4 skal behandling med bosutinib afbrydes.
English: 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.
Danish: Det anvendes til behandling af voksne patienter, der har en type leukæmi, der kaldes Philadelphiakromosompositiv (Ph-positiv) kronisk myeloid leukæmi (CML).
English: Bosulif 400 mg film-coated tablets Each carton contains 28 or 30 tablets.
Danish: Bosulif 400 mg filmovertrukne tabletter Hver karton indeholder 28 eller 30 tabletter.
English: 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
Danish: Almindelig Hepatotoksicitet (herunder hepatitis, toksisk hepatitis, leversygdom), abnorm leverfunktion (herunder abnorm leverfunktionstest, forhøjet leverfunktionstest, forhøjede transaminaser), forhøjet bilirubin i blodet
English: Leukopenia (including White blood cell count decreased) Uncommon Febrile neutropenia, Granulocytopenia Immune system disorders
Danish: 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
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.
Danish: Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets bosutinib
Danish: Bosulif 100 mg filmovertrukne tabletter Bosulif 400 mg filmovertrukne tabletter Bosulif 500 mg filmovertrukne tabletter bosutinib
English: Hepatic impairment (see sections 5.1 and 5.2).
Danish: 5.1 og 5.3).
English: The maximum toxicity of Grade 3 neutropenia was experienced in 90 (46%) patients and of Grade 4 in 44 (22%) patients.
Danish: 63 patienter (32 %) oplevede maksimalt grad 1 eller 2, 90 patienter (46 %) oplevede maksimalt grad 3-neutropeni, og 44 patienter (22 %) oplevede grad 4.
English: Tell your doctor if you develop abdominal pain or discomfort.
Danish: Fortæl det til lægen, hvis du får mavesmerter eller maveproblemer.
English: Time to MCyR for responders onlyb, weeks (95% CI) Duration of MCyR
Danish: (95 % CI) Varighed af MCyR
English: Bosulif 500 mg film-coated tablets Each carton contains 28 or 30 tablets.
Danish: Bosulif 500 mg filmovertrukne tabletter Hver karton indeholder 28 eller 30 tabletter.
English: Urticaria, Acne, Pruritus
Danish: Nyrer og urinveje
English: The following active substances may reduce the effectiveness of Bosulif: - rifampicin, used to treat tuberculosis.
Danish: Følgende aktive stoffer kan nedsætte virkningen af Bosulif:
English: 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)
Danish: 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
English: If you accidentally take too many Bosulif tablets or a higher dose than you need, contact a doctor for advice right away.
Danish: Kontakt en læge, hvis du ved et uheld har taget flere Bosulif, end der står i denne information, eller flere end lægen har foreskrevet.
English: EU/1/13/818/003 28 film-coated tablets EU/1/13/818/004 30 film-coated tablets
Danish: EU/1/13/818/004 30 filmovertrukne tabletter.
English: Titanium dioxide (E171) Macrogol 3350
Danish: Macrogol 3350
English: 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.
Danish: 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.
English: 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).
Danish: Væskeretention kan desuden behandles ved midlertidig afbrydelse af bosutinib, dosisreduktion og/eller seponering af bosutinib (se pkt.
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).
Danish: 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.
English: 28 film-coated tablets.
Danish: 28 filmovertrukne tabletter 30 filmovertrukne tabletter
English: Dose and method of administration
Danish: Dosis og indtagelsesmåde
English: What Bosulif is and what it is used for What you need to know before you take Bosulif How to take Bosulif
Danish: Det skal du vide, før du begynder at tage Bosulif Sådan skal du tage Bosulif Bivirkninger
English: The maximum toxicity of thrombocytopenia of Grade 3 was experienced in 161 (36%) patients and Grade 4 in 98 (22%) patients.
Danish: 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.
English: 0.0037a
Danish: F317L
English: - acute kidney failure, kidney failure, kidney impairment.
Danish: - akut nyresvigt, nyresvigt, nedsat nyrefunktion.
English: Cardiac disorders
Danish: Hjertesygdomme
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.
Danish: 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.
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).
Danish: 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).
English: 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.
Danish: 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
English: 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.
Danish: Bosutinib udviser dosisproportionelle stigninger i AUC og Cmax i doseringsområdet 200 - 600 mg.
English: Bosulif 400 mg film-coated tablets
Danish: Bosulif 400 mg filmovertrukne tabletter
English: Tumour lysis syndrome
Danish: , toksisk epidermal nekrolyse
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.
Danish: 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.
English: Each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder 400 mg bosutinib (som monohydrat).
English: Renal and urinary disorders Common
Danish: Infektioner og parasitære sygdomme Meget almindelig
English: 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.
Danish: 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.
English: Bosulif 500 mg film-coated tablets
Danish: Bosulif 500 mg filmovertrukne tabletter
English: Each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder 100 mg bosutinib (som monohydrat).
English: Each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Danish: Hver filmovertrukket tablet indeholder 500 mg bosutinib (som monohydrat).
English: 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).
Danish: 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.
English: Bosulif 100 mg film-coated tablets
Danish: Bosulif 100 mg filmovertrukne tabletter
English: 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).
Danish: 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.
English: Bosulif 400 mg film-coated tablets Polyvinyl alcohol
Danish: Bosulif 400 mg filmovertrukne tabletter Polyvinylalkohol
English: - Keep this medicine out of the sight and reach of children.
Danish: Opbevar dette lægemiddel utilgængeligt for børn.
English: Bosulif 400 mg film-coated tablets bosutinib
Danish: Bosulif 400 mg filmovertrukne tabletter bosutinib
English: Bosulif 500 mg: each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Danish: Bosulif 500 mg: Hver filmovertrukket tablet indeholder 500 mg bosutinib (som monohydrat).
English: Bosulif 500 mg film-coated tablets Polyvinyl alcohol
Danish: Bosulif 500 mg filmovertrukne tabletter Polyvinylalkohol
English: In patients with moderate renal impairment (creatinine clearance [CLCr] 30 to 50 mL/min, estimated by the Cockcroft-Gault formula), the recommended dose of bosutinib is 300 mg daily with food (see sections 4.4 and 5.2).
Danish: Den anbefalede dosis hos patienter med moderat nyreinsufficiens (kreatininclerance (CLCr) 3050 ml/min, beregnet ved hjælp af Cockcroft-Gault-formlen) er 300 mg bosutinib dagligt sammen med føde (se pkt.
English: Bosulif 500 mg film-coated tablets bosutinib
Danish: Bosulif 500 mg filmovertrukne tabletter bosutinib
English: Bosulif 400 mg: each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Danish: Bosulif 400 mg: Hver filmovertrukket tablet indeholder 400 mg bosutinib (som monohydrat).
English: If clinically significant moderate or severe non-haematological toxicity develops, bosutinib should be interrupted, and may be resumed at a dose reduced by 100 mg taken once daily after the toxicity has resolved.
Danish: Hvis der udvikles klinisk signifikant moderat eller svær ikke-hæmatologisk toksicitet, skal behandlingen med bosutinib afbrydes.
English: Bosulif 100 mg film-coated tablets Polyvinyl alcohol
Danish: Bosulif 100 mg filmovertrukne tabletter Polyvinylalkohol
English: Cumulative cytogenetic responsea MCyR, % (95% CI) CCyR, % (95% CI)
Danish: MCyR, % (95 % CI)
English: Bosulif 500 mg film-coated tablets Each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Danish: Bosulif 500 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 500 mg bosutinib (som monohydrat).
English: What Bosulif looks like and contents of the pack Bosulif 100 mg film-coated tablets are yellow, oval biconvex, debossed with “Pfizer” on one side and “100” on the other side.
Danish: Bosulif 100 mg filmovertrukne tabletter er gule, ovale, bikonvekse, præget med ”Pfizer” på den ene side og ”100” på den anden side.
English: Acute kidney injury, Renal failure, Renal impairment General disorders and administration site conditions Very common Pyrexia, Asthenia, Oedema (including Face oedema, Localised oedema, Oedema peripheral), Fatigue (including Malaise)
Danish: Pyreksi, Asteni, Ødem (herunder ansigtsødem, lokalt ødem, perifert ødem),
English: Bosulif 400 mg film-coated tablets Each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Danish: Bosulif 400 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 400 mg bosutinib (som monohydrat).
English: Bosulif 100 mg: each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Danish: Bosulif 100 mg: Hver filmovertrukket tablet indeholder 100 mg bosutinib (som monohydrat).
English: Bosulif 100 mg film-coated tablets bosutinib
Danish: Bosulif 100 mg filmovertrukne tabletter bosutinib
English: Bosulif 400 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.
Danish: Bosulif 400 mg fås i blisterkort, der indeholder enten 14 eller 15 filmovertrukne tabletter.
English: Bosulif 500 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.
Danish: Bosulif 500 mg fås i blisterkort, der indeholder enten 14 eller 15 filmovertrukne tabletter.
English: Blood disorders.
Danish: Blod.
English: Among patients with reports of adverse reactions of elevations in either ALT or AST (all grades), the median time of onset observed was 29 days with a range of onset 1 to 2,465 days for ALT and AST.
Danish: Hos de patienter, der rapporterde forhøjet ALAT eller ASAT (alle grader), var mediantid til indtræden 29 dage med et interval på 1 til 2.465 dage for ALAT og ASAT. Medianvarigheden af en hændelse var 18 dage (interval: 1-775 dage) for ALAT og 15 dage (interval:1-803 dage) for ASAT.
English: Bosulif 100 mg film-coated tablets Each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Danish: Bosulif 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg bosutinib (som monohydrat).
English: The dose at which no adverse reproductive effects were observed in males (30 mg/kg/day) and females (3 mg/kg/day) resulted in exposures equal to 0.6-times and 0.3-times, respectively, the human exposure resulting from the clinical dose of 400 mg, and 0.5-times and 0.2-times, respectively, the human exposure resulting from the clinical dose of 500 mg (based on unbound AUC in the respective species).
Danish: resulterede i eksponeringer, der svarede til hhv. 0,6 gange og 0,3 gange den humane eksponering som følge af den kliniske dosis på 400 mg og hhv. 0,5 og 0,2 gange den eksponering, der blev set hos mennesker ved brug af den kliniske dosis på 500 mg (baseret på ubunden AUC i de respektive arter).
English: - itching, urticaria (hives), acne.
Danish: - kløe, nældefeber (urticaria), akne.
English: • CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Danish: Anvendes hos patienter, som tidligere er behandlet med en eller flere tyrosinkinasehæmmere (TKI'ere) og hvor behandling med imatinib, nilotinib eller dasatinib ikke er egnet.
English: 112 film-coated tablets.
Danish: 28 filmovertrukne tabletter 30 filmovertrukne tabletter 112 filmovertrukne tabletter
English: K-M at year 1/2, % (95% CI)c K-M at year 4/5, % (95% CI)c Median, weeks (95% CI)
Danish: K-M ved år 4/5, % (95 % CI)
English: - joint pain, back pain.
Danish: - brystsmerter, smerter.
English: Belgium
Danish: България
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.
Danish: Der er en risiko for at behandling med Bosulif kan medføre nedsat fertilitet.
English: Hypertension (including Blood pressure increased, Blood pressure systolic increased, Essential hypertension, Hypertensive crisis) Respiratory, thoracic and mediastinal disorders Very common Dyspnoea, Cough Common
Danish: Almindelig Hypertension (herunder forhøjet blodtryk, forhøjet systolisk blodtryk,
English: Duration of CHR/OHRe K-M at year 1/2, % (95% CI)c K-M at year 4/5, % (95% CI)
Danish: K-M ved år 1/2, % (95 % CI)
English: How to store Bosulif
Danish: Bosulif indeholder
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).
Danish: ved eksponeringer, der var mellem ca. 6 og 20 gange den humane eksponering som følge af den kliniske dosis på 400 mg og 4 til 15 gange den humane eksponering som følge af den kliniske dosis på 500 mg (baseret på ubundet Cmax i de respektive arter).
English: Hepatobiliary disorders
Danish: Hæmatologiske bivirkninger
English: Bosulif 500 mg
Danish: INFORMATION I BRAILLESKRIFT Bosulif 500 mg
English: Stomach/intestinal disorders.
Danish: - hududslæt, betændelse i hjertesækken.
English: Month 9 (95% CI)
Danish: CCyR (95 % CI)
English: Serum lipase
Danish: Serumlipase
English: Dose adjustments for adverse reactions
Danish: Dosisjustering ved bivirkninger
English: Hepatic impairment
Danish: Hovedpine
English: Bosulif 100 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets or 112 film-coated tablets.
Danish: Bosulif 100 mg fås i blisterkort, der indeholder enten 14 eller 15 filmovertrukne tabletter.
English: Month 6 (95% CI)
Danish: Måned 3 (95 % CI) Måned 6 (95 % CI) Måned 9 (95 % CI)
English: Tablet core
Danish: Tabletkerne
English: Table 1 - Dose adjustments for neutropenia and thrombocytopenia ANCa < 1.0 × 109/L and/or
Danish: Skema 1 - Dosisjustering ved neutropeni og trombocytopeni
English: Ask your doctor for advice before taking Bosulif if you are pregnant or might become pregnant.
Danish: Hvis du er gravid eller planlægger at blive gravid, skal du spørge lægen til råds, før du tager dette lægemiddel.
English: If you take more Bosulif than you should
Danish: Hvis du har taget for mange Bosulif
English: Liver function abnormalities
Danish: Forstyrrelser i leverfunktionen
English: Bosulif 400 mg
Danish: INFORMATION I BRAILLESKRIFT Bosulif 400 mg
English: Investigations
Danish: Administration