natgillin/translations-raw huggingface dataset:
Blandt imatinib- intolerante patienter var den estimerede hyppighed af PFS 98% (95% KI:
Among imatinib-intolerant patients, the estimated rate of PFS was 98% (95% CI:
[95% - 100%]) efter et år og 94% (95% KI:
[95%-100%]) at 1 year and 94% (95% CI:
[88% - 99%]) efter to år.
[88%-99%]) at 2 years.
Hyppigheden af større molekylært respons ved 24 måneder var 45% (35% for imatinib- resistente patienter og 74% for imatinib- intolerante patienter).
The rate of major molecular response at 24 months was 45% (35% for imatinib-resistant patients and 74% for imatinib-intolerant patients).
CML i accelereret fase:
Accelerated Phase CML:
Der er gennemført et åbent, enkeltsarms -, multicenter- forsøg med patienter med intolerans eller resistens over for imatinib.
An open-label, single-arm, multicenter study was conducted in patients intolerant or resistant to imatinib.
Ialt 174 patienter fik dasatinib 70 mg 2 gange daglig (161 resistente og 13 intolerante over for imatinib).
A total of 174 patients received dasatinib 70 mg twice daily (161 resistant and 13 intolerant to imatinib).
Den gennemsnitlige tid fra diagnose til start af behandling var 82 måneder.
The median time from diagnosis to start of treatment was 82 months.
Den gennemsnitlige varighed af behandling med dasatinib var 14 måneder og 31% af patienterne er til dato behandlet i > 24 måneder.
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
Yderligere effektresultater fremgår af Tabel 5.
Further efficacy results are reported in Table 5.
CML i myeloid blastfase:
Myeloid Blast Phase CML:
Der er gennemført et åbent, enkeltarms -, multicenter- forsøg med patienter med intolerans eller resistens over for imatinib.
An open-label, single-arm, multicenter study was conducted in patients intolerant or resistant to imatinib.
Ialt 109 patienter fik dasatinib 70 mg 2 gange daglig (99 resistente og 10 intolerante over for imatinib).
A total of 109 patients received dasatinib 70 mg twice daily (99 resistant and 10 intolerant to imatinib).
Gennemsnitlig tid fra diagnose til start af behandling var 48 måneder.
The median time from diagnosis to start of treatment was 48 months.
Den gennemsnitlige varighed af behandling med dasatinib var 3, 5 måneder med 12% af patienterne behandlet i > 24 måneder til dato.
Median duration of treatment on dasatinib was 3.5 months with 12% of patients treated for > 24 months to date.
15 Kliniske forsøg med CML i lymfoid blastfase og Ph+ ALL:
Clinical trials in Lymphoid Blast Phase CML and Ph+ ALL:
Der er gennemført et åbent, enkeltarms -, multicenter- forsøg med patienter med CML i lymfoid blastfase eller Ph+ ALL, som var resistente eller intolerante over for tidligere imatinibbehandling.
An open-label, single-arm, multicenter study was conducted in patients with lymphoid blast phase CML or Ph+ ALL who were resistant or intolerant to prior imatinib therapy.
Ialt 48 patienter med CML i lymfoid blastfase fik dasatinib 70 2 gange daglig (42 resistente og 6 intolerante over for imatinib).
A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib).
Gennemsnitlig tid fra diagnose til start af behandling var 28 måneder.
The median time from diagnosis to start of treatment was 28 months.
Gennemsnitlig varighed af behandling med dasatinib var 3 måneder med 2% behandlet i > 24 måneder til dato.
Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date.
Derudover fik 46 patienter med Ph+ ALL dasatinib 70 mg 2 gange daglig (44 resistente og 2 intolerante over for imatinib).
In addition, 46 patients with Ph+ ALL received dasatinib 70 mg twice daily (44 resistant and 2 intolerant to imatinib).
Gennemsnitlig tid fra diagnose til behandlingsstart var 18 måneder.
Median duration of
Gennemsnitlig varighed af behandling med dasatinib var 3 måneder med 7% af patienterne behandlet i > 24 måneder til dato.
15 treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
Hyppigheden af større molekylært respons (alle 25 behandlede patienter med CCyR) ved 24 måneder var 52%.
The rate of major molecular response (all 25 treated patients with a CCyR) was 52% at 24 months.
Det bør bemærkes, at der hurtigt opnåedes større hæmatologiske respons (MaHR) (de fleste inden for 35 dage efter første administration af dasatinib til patienter med CML i lymfoid blastfase, og inden for 55 dage for patienter med Ph+ ALL).
Of note, major haematologic responses (MaHR) were achieved quickly (most within 35 days of first dasatinib administration for patients with lymphoid blast CML, and within 55 days for patients with Ph+ ALL).
Effekt i enkeltarmede fase II- forsøg med SPRYCEL a
Efficacy in Phase II SPRYCEL Single-Arm
Lymfoid
(n= 387)
Hæmatologisk responsrateb (%)
(n= 174)
Kronisk Accelereret Myeloid blast (n= 387) (n= 174) (n= 109)
(n= 109)
blast (n= 48)
(n= 48)
MaHR (95% KI)
Haematologic Response Rateb (%) MaHR (95% CI)
64% (57– 72)
64% (57– 72)
33% (24– 43)
33% (24– 43)
35% (22– 51)
35% (22– 51)
41% (27– 57)
41% (27– 57)
CHR (95% KI) NEL (95% KI)
CHR (95% CI) NEL (95% CI)
Varighed af MaHR (%; Kaplan- Meier- estimater)
Duration of MaHR (%; Kaplan-Meier Estimates)
1 år 2 år
1 Year 2 Year
(95% KI) CCyR (95% KI)
Cytogenetic Response (%) MCyR (95% CI) CCyR (95% CI)
62% (57– 67) 54% (48– 59)
62% (57– 67) 54% (48 – 59)
Overlevelse (%; Kaplan- Meier- estimater) Progressionsfri
Survival (%; Kaplan-Meier Estimates) Progression-Free
Overordnet a
Overall a
år 2 år
1 Year 2 Year
Tal angivet i fed er resultater af de primære endpoint. b Hæmatologiske responskriterier (alle respons bekræftet efter 4 uger):
Numbers in bold font are the results of primary endpoints. b Haematologic response criteria (all responses confirmed after 4 weeks):
Større hæmatologisk respons:
Major haematologic response:
(MaHR) = fuldstændigt hæmatologisk respons (CHR) + ingen tegn på leukæmi (NEL).
(MaHR) = complete haematologic response (CHR) + no evidence of leukemia (NEL).
CHR (kronisk CML):
CHR (chronic CML):
WBC ≤ institutionens ULN, trombocytter < 450. 000/ mm3, ingen blaster eller promyelocytter i perifert blod, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering.
WBC ≤ institutional ULN, platelets < 450,000/ mm3, no blasts or promyelocytes in peripheral blood, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
CHR (fremskreden CML/ Ph+ ALL):
CHR (advanced CML/ Ph+ ALL):
WBC ≤ institutionens ULN, ANC ≥ 1. 000/ mm3, trombocytter ≥ 100. 000/ mm3, ingen blaster eller promyelocytter i perifert blod, knoglemarvsblaster ≤ 5%, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering.
WBC ≤ institutional ULN, ANC ≥ 1000/ mm3, platelets ≥ 100,000/ mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
3 NEL: samme kriterier som for CHR, men ANC ≥ 500/ mm3 og < 1. 000/ mm eller trombocytter ≥ 20. 000/ mm3 og 3 ≤ 100. 000/ mm. c Cytogene responskriterier: fuldstændigt (0% Ph+ metafaser) eller delvist (> 0% – 35%).
NEL: same criteria as for CHR but ANC ≥ 500/ mm3 and< 1000/mm3, or platelets ≥ 20,000/mm3 and ≤ 1 00,000/mm3. c Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial (> 0%– 35%).
MCyR (0% – 35%) kombinerer både fuldstændigt og delvist respons. n/ a = ikke relevant KI = konfidensinterval ULN = øvre normalgrænsee.
MCyR (0% – 35%) combines both complete and partial responses. n/ a = not applicable CI = confidence interval ULN = upper limit normal range.
16 Fase- III kliniske forsøg Der er gennemført 2 randomiserede, åbne forsøg for at evaluere effekten af dasatinib, administreret 1 gang dagligt sammenlignet med dasatinib, administreret 2 gange dagligt:
Phase III Clinical Trials Two randomised, open-label studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily:
1 - I forsøget med CML i kronisk fase, var det primære endpoint MCyR hos imatinib- resistente patienter.
1- In the study of chronic phase CML, the primary endpoint was MCyR in imatinib-resistant patients.
Det vigtigste sekundære endpoint var MCyR i forhold til total daglig dosis hos imatinib - resistente patienter.
The main secondary endpoint was MCyR by total daily dose level in the imatinib-resistant patients.
Andre sekundære endpoint omfattede varighed af MCyR, progressionsfri overlevelse samt overordnet overlevelse.
Other secondary endpoints included duration of MCyR, progression-free survival, and overall survival.
Ialt 670 patienter, af hvem 498 var imatinib- resistente, blev randomiseret til dasatinib 100 mg 1 gang dagligt, 140 mg 1 gang dagligt, 50 mg 2 gange dagligt eller 70 mg 2 gange dagligt.
A total of 670 patients, of whom 498 were imatinib-resistant, were randomised to the dasatinib 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily group.
8 måneder (1- 15 måneder).
Median duration of treatment was approximately 8 months (range < 1– 15 months).
Responsrater præsenteres i Tabel 6.
16 Response rates are presented in Table 6.
Det opnåedes effekt på tværs af alle dasatinib- behandlingsgrupper med dosering 1 gang dagligt med sammenlignelig effekt (non- inferior) i forhold til dosering 2 gange dagligt for det primære effektendpoint (forskel i MCyR 2, 8%; 95% konfidensinterval [- 6% - 11, 6%]).
Efficacy was achieved across all dasatinib treatment groups with the once daily schedule demonstrating comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MCyR 2.8%; 95% confidence interval [-6% - 11.6%]).
Det første sekundære endpoint i forsøget viste også sammenlignelig effekt (non- inferioritet) mellem 100 mg dagligt og 140 mg dagligt (forskel i MCyR - 0, 8%; 95% konfidensinterval [- 9, 6% - 8, 0%]).
The main secondary endpoint of the study also showed comparable efficacy (non-inferiority) between the 100 mg total daily dose and the 140 mg total daily dose (difference in MCyR -0.8%; 95% confidence interval [-9.6% - 8.0%]).
Varighed af MCyR, progressionsfri overlevelse og overordnet overlevelse var ensartet på tværs af de 4 behandlingsgrupper.
Durations of MCyR, progression-free survival, and overall survival were similar across the four treatment groups.
Middelværdi for overordnet overlevelse blev ikke opnået for nogen af de 4 behandlingsgrupper.
The median overall survival had not been reached for any of the four treatment groups.
Effekt af SPRYCEL i Fase- III forsøg vedrørende dosisoptimering: CML i kronisk fase 100 mg 1 gang 50 mg 2 gange 140 mg 1 gang 70 mg 2 gange dagligt dagligt dagligt dagligt n = 167 n = 168 n = 167 n = 168
Efficacy of SPRYCEL in Phase III Dose-Optimisation Study: Chronic 100 mg once daily 50 mg twice daily 140 mg once daily n = 167 n = 168 n = 167
Procentdel (%) af patienter a
Phase CML 70 mg twice daily n = 168
Hæmatologisk responsrate (%) CHR
Percent (%) of Patients a Haematologic Response Rate (%) CHR
Cytogent respons (%) MCyR Alle patienter
Cytogenetic Response (%) MCyR All Patients (95% CI) Imatinib-
resistente patienter (n/ N)
resistant patients (n/ N) CCyR
Alle patienter Imatinib -
All Patients Imatinib-
resistente patienter (n/ N)
resistant patients (n/ N) a
Hæmatologiske responskriterier (alle respons konfirmeret efter 4 uger):
Haematologic response criteria (all responses confirmed after 4 weeks):
WBC ≤ institutionel ULN, trombocytter < 450. 000/ mm3, ingen blaster eller promyelocytter i perifert blod, < 5% myelocytter plus metamyelocytter i perifert blod, basofilocytter i perifert blod < 20% og ingen ekstramedullær involvering. b Cytogene responskriterier: komplet (0% Ph+ metafaser) eller delvis (> 0% – 35%).
WBC ≤ institutional ULN, platelets < 450,000/ mm3, no blasts or promyelocytes in peripheral blood, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood< 20%, and no extramedullary involvement. b Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial (> 0%–35%).
MCyR (0% – 35%) kombinerer komplette og delvise respons.
MCyR (0% – 35%) combines both complete and partial responses.
2 - I forsøget med CML i fremskreden fase og Ph+ALL, var det primære endpoint MaHR.
2- In the study of advanced phase CML and Ph+ALL, the primary endpoint was MaHR.
Ialt 611 patienter blev randomiseret til dasatinib 140 mg 1 gang dagligt eller 70 mg 2 gange dagligt.
A total of 611 patients were randomised to either the dasatinib 140 mg once daily or 70 mg twice daily group.
6 måneder (1- 16 måneder).
Median duration of treatment was approximately 6 months (range < 1-16 months).
Dosering 1 gang dagligt viste sammenlignelig effekt (non- inferioritet) med dosering 2 gange dagligt med hensyn til det primære effekt- endpoint (forskel i MaHR 0, 2%; 95% konfidensinterval [- 7, 8% - 8, 1%]).
The once daily schedule demonstrated comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MaHR 0.2%; 95% confidence interval [-7.8% - 8.1%]).
Efter en opfølgning på 6 måneder synes varigheden af respons dog at være bedre med dosering 2 gange dagligt på tværs af de forskellige faser af fremskreden sygdom, særligt faser med
However, with a follow-up of 6 months, the duration of response seems to favor the twice daily schedule across the different phases of advanced disease, particularly phases with lymphoid transformation.
Derfor er 70 mg 2 gange dagligt fortsat den anbefalede dosis til imatinib - resistente eller - intolerante patienter med CML i fremskreden fase eller Ph+ALL.
Therefore 70 mg twice daily remains the recommended dose schedule in imatinib-resistant or intolerant patients with advanced phase CML and Ph+ALL.
Dasatinib absorberes hurtigt hos patienter efter oral administration, med maksimal koncentration efter  0, 5 til 3 timer.
Dasatinib is rapidly absorbed in patients following oral administration, with peak concentrations between 0.5-3 hours.
Efter oral administration er stigningen i gennemsnitlig eksponering (AUCτ) ca. proportional med dosisstigningen over et dosisspænd på 25- 120 mg 2 gange dagligt.
17 approximately proportional to the dose increment across doses ranging from 25 mg to 120 mg twice daily.
5- 6 timer.
The overall mean terminal half-life of dasatinib is approximately 5-6 hours in patients.
Dasatinib har hos patienter et stort tilsyneladende fordelingsvolumen (2. 505 l), hvilket tyder på, at produktet i omfattende grad fordeles i det ekstravaskulære rum.
In patients, dasatinib has a large apparent volume of distribution (2,505 l) suggesting that the medicinal product is extensively distributed in the extravascular space.
96%, på basis af in vitro - eksperimenter.
At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments.
Dasatinib metaboliseres i omfattende grad hos mennesker, og mange enzymer er involverede i metabolitdannelsen.
Dasatinib is extensively metabolized in humans with multiple enzymes involved in the generation of the metabolites.
Hos raske frivillige, der fik 100 mg [14C] - mærket dasatinib, udgjorde uomdannet dasatinib 29% af den cirkulerende radioaktivitet i plasma.
In healthy subjects administered 100 mg of [14C]-labelled dasatinib, unchanged dasatinib represented 29% of circulating radioactivity in plasma.
89% af dosis udskilt inden for 10 dage, og henholdsvis 4% og 85% af radioaktiviteten kunne genfindes i urin og fæces.
Following a single oral dose of [14C]-labelled dasatinib, approximately 89% of the dose was eliminated within 10 days, with 4% and 85% of the radioactivity recovered in the urine and faeces, respectively.
Uomdannet dasatinib stod for henholdsvis 0, 1% og 19% af dosis i urin og fæces, mens resten af dosis var metabolitter.
Unchanged dasatinib accounted for 0.1% and 19% of the dose in urine and faeces, respectively, with the remainder of the dose as metabolites.
4. 4).
Exposure to dasatinib may be expected to increase if liver function is impaired (see section 4.4).
Dastainibs ikke- kliniske sikkerhedsprofil er vurderet i mange in vitro og in vivo- forsøg med mus, rotter, aber og kaniner.
The non-clinical safety profile of dasatinib was assessed in a battery of in vitro and in vivo studies in mice, rats, monkeys, and rabbits.
Nyreforandringer hos aber behandlet i op til 9 måneder var begrænset til en stigning i baggrundsnyremineralisering.
Renal changes in monkeys treated for up to 9 months were limited to an increase in background kidney mineralization.
Hos rotter hæmmede dasatinib
Cutaneous haemorrhage was observed in an acute, single-dose oral study in monkeys but was not observed in repeat-dose studies in either monkeys or rats.
18 trombocytaggregationen in vitro og forlængede overhudsblødning in vivo, men forårsagede ikke spontan blødning.
In rats, dasatinib inhibited platelet aggregation in vitro and prolonged cuticle bleeding time in vivo, but did not invoke spontaneous haemorrhage.
Dasatinib- aktivitet in vitro i hERG - og Purkinje- fiberassay tydede på et potentiale for forlængelse af kardiel ventrikelrepolarisering (QT- interval).
Dasatinib activity in vitro in hERG and Purkinje fiber assays suggested a potential for prolongation of cardiac ventricular repolarization (QT interval).
I et in vivo enkeldosisforsøg med monitorerede aber, der var ved bevidsthed, er der dog ikke set ændringer i QT- interval eller formen af EKG- takker.
However, in an in vivo single-dose study in conscious telemetered monkeys, there were no changes in QT interval or ECG wave form.
Dasatinib var ikke mutagent i in vitro bakterielle celle- assay (Ames test) og var ikke genotoksisk i et in vivo mikronukleus- forsøg med rotter.
18 Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
Dasatinib var clastogent in vitro med deling af CHO- celler (Chinese Hamster Ovary celler).
Dasatinib was clastogenic in vitro to dividing Chinese Hamster Ovary (CHO) cells.
I et konventionelt rottefertilitetsforsøg og i forsøg vedrørende tidlig embryoudvikling påvirkede dasatinib ikke fertiliteten hos han - eller hunrotter, men inducerede embryoletalitet ved dosisniveauer omtrent svarende til human klinisk optagelse.
Dasatinib did not affect male or female fertility in a conventional rat fertility and early embryonic development study, but induced embryolethality at dose levels approximating human clinical exposures.
Disse virkninger forekom ved doser, der ikke gav maternel toksicitet hvilket tyder på, at dasatinib er selektivt reproduktionstoksisk fra implantering til og med organgenesen er afsluttet.
These effects occurred at doses that did not produce maternal toxicity, indicating that dasatinib is a selective reproductive toxicant from implantation through the completion of organogenesis.
Dasatinib inducerede immunosuppression hos mus, som var dosisrelateret og effektivt kunne behandles med dosisreduktion og/ eller ændringer dosisskemaet.
In mice, dasatinib induced immunosuppression, which was dose-related and effectively managed by dose reduction and/ or changes in dosing schedule.
Dasatinib havde fototoksisk potentiale i et in vitro neutral red uptake fototoksicitets- assay i musefibroblaster.
Dasatinib had phototoxic potential in an in vitro neutral red uptake phototoxicity assay in mouse fibroblasts.
Dasatinib anses for at være ikke- fototoksisk in vivo efter en enkelt oral administration til hårløse hunmus ved doser op til 3 gange større end de humane doser efter administration af den anbefalede terapeutiske dosis (baseret på AUC).
Dasatinib was considered to be non-phototoxic in vivo after a single oral administration to female hairless mice at exposures up to 3-fold the human exposure following administration of the recommended therapeutic dose (based on AUC).
Der er ikke udført carcinogeneseforsøg med dasatinib.
No carcinogenesis studies were conducted with dasatinib.
Lactosemonohydrat Cellulose, mikrokrystallinsk Croscarmellosenatrium Hydroxypropylcellulose Magnesiumstearat
Lactose monohydrate Cellulose, microcrystalline Croscarmellose sodium Hydroxypropyl cellulose Magnesium stearate
Hypromellose Titandioxid Macrogol 400
Hypromellose Titanium dioxide Macrogol 400
19 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container
Alu/ Alu blistere (kalender- blistere og éngangsdosisblistere) og high- density polyethene (HDPE) flaske med børnesikret polypropylen låg.
Alu/ Alu blisters (calendar blisters and unit dose blisters) and high-density polyethylene (HDPE) bottle with child resistant closure of polypropylene.
Æske der indeholder 56 filmovertrukne tabletter i 4 blisterkort, som hver indeholder 14 filmovertrukne tabletter.
Cartons containing 56 film-coated tablets in 4 blisters of 14 film-coated tablets each.
Æske der indeholder 60 filmovertrukne tabletter i perforerede engangsdosis- blistere.
Cartons containing 60 film-coated tablets in perforated unit dose blisters.
Æske der indeholder en flaske med 60 filmovertrukne tabletter.
19 Cartons containing one bottle with 60 film-coated tablets.
Tabletterne består af en kernetablet, omgivet af filmovertræk for at undgå, at sundhedspersonalet udsættes for det aktive stof.
The tablets consist of a core tablet, surrounded by a film coating to prevent exposure of health care professionals to the active substance.
Hvis tabletter imidlertid utilsigtet knuses eller knækkes, bør sundhedspersonalet bære éngangshandsker egnet til brug ved kemoterapi for hensigtsmæssig bortskaffelse, med henblik på at minimere risiko for optagelse gennem huden.
However, if the tablets are unintentionally crushed or broken, health care professionals should wear disposable chemotherapy gloves for appropriate disposal in order to minimize the risk of dermal exposure.
EU/ 1/ 06/ 363/ 004 - 56 filmovertrukne tabletter (blistere) EU/ 1/ 06/ 363/ 007 - 60 x 1 filmovertrukne tabletter (engangsdosis- blistere) EU/ 1/ 06/ 363/ 001 - 60 filmovertrukne tabletter (flaske)
EU/ 1/ 06/ 363/ 004 - 56 film-coated tablets (blisters) EU/ 1/ 06/ 363/ 007 - 60 x 1 film-coated tablets (unit-dose blisters) EU/ 1/ 06/ 363/ 001 - 60 film-coated tablets (bottle)
Hjælpestof: hver tablet indeholder 67, 5 mg lactosemonohydrat.
Excipients: each tablet contains 67.5 mg of lactose monohydrate.
Hvide til gråligt hvide, bikonvekse, oval tabletter med "BMS" printet på den ene side og "528" på den anden.
White to off-white, biconvex, oval tablet with "BMS" debossed on one side and "528" on the other side.
21 Dosistitrering:
21 Dose escalation:
22 Brug til børn:
Paediatric patients:
Leverinsufficiens: der er ikke gennemført kliniske forsøg med SPRYCEL med patienter med moderat til svært nedsat leverfunktion (patienter med ALAT og/ eller ASAT > 2, 5 gange den øvre normalgrænse og/ eller total- bilirubin > 2 gange den øvre normalgrænse blev ekskluderet i forsøgene).
22 Hepatic impairment: no clinical trials were conducted with SPRYCEL in patients with moderate to severe hepatic impairment (trials excluded patients with ALT and/ or AST > 2.5 times the upper limit of the normal range and/ or total bilirubin > 2 times the upper limit of the normal range).
23 Vigtige uønskede reaktioner Myelosuppression:
Important adverse reactions Myelosuppression: treatment with dasatinib is associated with anaemia, neutropenia and thrombocytopenia.
Myelosuppression var almindeligvis reversibel og kunne oftest håndteres ved midlertidigt at afbryde dasatinib eller ved dosisreduktion (se pkt.
23 reversible and usually managed by withholding dasatinib temporarily or by dose reduction (see sections 4.2 and 4.8).
24 4. 5 Interaktion med andre lægemidler og andre former for interaktion
24 4.5 Interaction with other medicinal products and other forms of interaction
25 Amning Der er utilstrækkelig/ begrænset information vedrørende udskillelse af dasatinib i human modermælk og brystmælk hos dyr.
25 Lactation There is insufficient/ limited information on the excretion of dasatinib in human or animal breast milk.