natgillin/translations-raw huggingface dataset:
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
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.
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).
Bosulif 500 mg filmovertrukne tabletter bosutinib
Bosulif 500 mg film-coated tablets bosutinib
Bosulif 400 mg: Hver filmovertrukket tablet indeholder 400 mg bosutinib (som monohydrat).
Bosulif 400 mg: each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Hvis der udvikles klinisk signifikant moderat eller svær ikke-hæmatologisk toksicitet, skal behandlingen med bosutinib afbrydes.
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.
Bosulif 100 mg filmovertrukne tabletter Polyvinylalkohol
Bosulif 100 mg film-coated tablets Polyvinyl alcohol
MCyR, % (95 % CI)
Cumulative cytogenetic responsea MCyR, % (95% CI) CCyR, % (95% CI)
Bosulif 500 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 500 mg bosutinib (som monohydrat).
Bosulif 500 mg film-coated tablets Each film-coated tablet contains 500 mg bosutinib (as monohydrate).
Bosulif 100 mg filmovertrukne tabletter er gule, ovale, bikonvekse, præget med ”Pfizer” på den ene side og ”100” på den anden side.
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.
Pyreksi, Asteni, Ødem (herunder ansigtsødem, lokalt ødem, perifert ødem),
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)
Bosulif 400 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 400 mg bosutinib (som monohydrat).
Bosulif 400 mg film-coated tablets Each film-coated tablet contains 400 mg bosutinib (as monohydrate).
Bosulif 100 mg: Hver filmovertrukket tablet indeholder 100 mg bosutinib (som monohydrat).
Bosulif 100 mg: each film-coated tablet contains 100 mg bosutinib (as monohydrate).
Bosulif 100 mg filmovertrukne tabletter bosutinib
Bosulif 100 mg film-coated tablets bosutinib
Bosulif 400 mg fås i blisterkort, der indeholder enten 14 eller 15 filmovertrukne tabletter.
Bosulif 400 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.
Bosulif 500 mg fås i blisterkort, der indeholder enten 14 eller 15 filmovertrukne tabletter.
Bosulif 500 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.
Blod.
Blood disorders.
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.
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.
Bosulif 100 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg bosutinib (som monohydrat).
Bosulif 100 mg film-coated tablets Each film-coated tablet contains 100 mg bosutinib (as monohydrate).
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).
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).
- kløe, nældefeber (urticaria), akne.
- itching, urticaria (hives), acne.
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.
• 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.
28 filmovertrukne tabletter 30 filmovertrukne tabletter 112 filmovertrukne tabletter
112 film-coated tablets.
K-M ved år 4/5, % (95 % CI)
K-M at year 1/2, % (95% CI)c K-M at year 4/5, % (95% CI)c Median, weeks (95% CI)
- brystsmerter, smerter.
- joint pain, back pain.
Der er en risiko for at behandling med Bosulif kan medføre nedsat fertilitet.
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.
Almindelig Hypertension (herunder forhøjet blodtryk, forhøjet systolisk blodtryk,
Hypertension (including Blood pressure increased, Blood pressure systolic increased, Essential hypertension, Hypertensive crisis) Respiratory, thoracic and mediastinal disorders Very common Dyspnoea, Cough Common
K-M ved år 1/2, % (95 % CI)
Duration of CHR/OHRe K-M at year 1/2, % (95% CI)c K-M at year 4/5, % (95% CI)
Bosulif indeholder
How to store Bosulif
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).
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).
Hæmatologiske bivirkninger
Hepatobiliary disorders
INFORMATION I BRAILLESKRIFT Bosulif 500 mg
Bosulif 500 mg
- hududslæt, betændelse i hjertesækken.
Stomach/intestinal disorders.
CCyR (95 % CI)
Month 9 (95% CI)
Serumlipase
Serum lipase
Dosisjustering ved bivirkninger
Dose adjustments for adverse reactions
Hovedpine
Hepatic impairment
Bosulif 100 mg fås i blisterkort, der indeholder enten 14 eller 15 filmovertrukne tabletter.
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.
Måned 3 (95 % CI) Måned 6 (95 % CI) Måned 9 (95 % CI)
Month 6 (95% CI)
Tabletkerne
Tablet core
Skema 1 - Dosisjustering ved neutropeni og trombocytopeni
Table 1 - Dose adjustments for neutropenia and thrombocytopenia ANCa < 1.0 × 109/L and/or
Hvis du er gravid eller planlægger at blive gravid, skal du spørge lægen til råds, før du tager dette lægemiddel.
Ask your doctor for advice before taking Bosulif if you are pregnant or might become pregnant.
Hvis du har taget for mange Bosulif
If you take more Bosulif than you should
Forstyrrelser i leverfunktionen
Liver function abnormalities
INFORMATION I BRAILLESKRIFT Bosulif 400 mg
Bosulif 400 mg
Administration
Investigations
Annex relateret til artikel 127a
Annex related to the Art. 127a
Detaljerne i dette PPP, herunder implementeringen af nationale foranstaltninger for at vurdere effektiviteten og overholdelsen af PPP, skal aftales med den relevante nationale myndighed i hvert enkelt medlemsland og være på plads, inden præparatet markedsføres.
Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Medlemslandet skal sikre, at indehaveren af markedsføringstilladelsen implementerer et program til svangerskabsforebyggelse (PPP, Pregnancy Prevention Programme) inden for landets område.
The Member State shall ensure that the MAH shall implement a pregnancy prevention programme (PPP) within their territory.