natgillin/translations-raw huggingface dataset:
Patienterne skal informeres om, at de kan opleve bivirkninger som fx svimmelhed og sløret syn under behandling med dasatinib.
Patients should be advised that they may experience adverse reactions such as dizziness or blurred vision during treatment with dasatinib.
NEL: samme kriterier som for CHR, men absolut neutrofiltal ≥ 500/mm3 og < 1.000/mm3 eller trombocytter ≥ 20.000/mm3 og ≤ 100.000/mm3.
NEL: same criteria as for CHR but ANC ≥ 500/mm3 and < 1,000/mm3, or platelets ≥ 20,000/mm3 and ≤ 100,000/mm3.
Det bør overvejes, at bruge antacida i stedet for H2-antagonister eller protonpumpe-hæmmere, til patienter, der er i behandling med SPRYCEL (se pkt.
The use of antacids should be considered in place of H2 antagonists or proton pump inhibitors in patients receiving SPRYCEL therapy (see section 4.4).
I kliniske studier er behandling med SPRYCEL hos voksne med Ph+ CML-CP, accelereret, myeloid eller lymfoid blastfase (fremskreden fase) CML eller Ph+ ALL og pædiatriske patienter med Ph+ CML-CP fortsat indtil sygdomsprogression, eller indtil patienten ikke længere tålte behandlingen.
In clinical studies, treatment with SPRYCEL in adults with Ph+ CML-CP, accelerated, myeloid or lymphoid blast phase (advanced phase) CML, or Ph+ ALL and paediatric patients with Ph+ CML-CP was continued until disease progression or until no longer tolerated by the patient.
Almindelig pneumoni (inklusive bakteriel, viral og mykotisk), øvre luftvejsinfektion/inflammation, herpes virus infektion (herunder cytomegalovirus (CMV)), enterocolitis, sepsis (inklusive ikke almindelige tilfælde med dødelig udgang)
Common pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus - CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes)
Samtidig brug af potente CYP3A4-hæmmere og grapefrugtjuice sammen med SPRYCEL skal undgås (se pkt.
The concomitant use of strong CYP3A4 inhibitors and grapefruit juice with SPRYCEL should be avoided (see section 4.5).
4.4 for yderligere oplysninger om patienter med CML i kronisk fase og CML i fremskreden fase eller Ph+ ALL.
See section 4.4 for further information on patients with chronic phase CML and advanced phase CML or Ph+ ALL.
Lørdag
Saturday Sunday
120-ml flaske i højdensitetspolypropylen med børnesikret lukning af polypropylen indeholdende 33 g pulver til oral suspension.
120-mL high-density polyethylene bottle with polypropylene child-resistant closure containing 33 g of powder for oral suspension.
Følgende medicin må ikke anvendes sammen med SPRYCEL: ketoconazol, itraconazol - som er svampemidler erythromycin, clarithromycin, telithromycin - som er antibiotika ritonavir - som er et virusdræbende (antiviralt) lægemiddel phenytoin, carbamazepin, phenobarbital - som er medicin mod epilepsi rifampicin - som er medicin mod tuberkulose famotidin, omeprazol - som er mavesyrehæmmere perikon - et naturlægemiddel der kan købes uden recept og som bruges mod depression og andre lidelser (også kendt som Hypericum perforatum)
These medicines are not to be used with SPRYCEL: ketoconazole, itraconazole - these are antifungal medicines erythromycin, clarithromycin, telithromycin - these are antibiotics ritonavir - this is an antiviral medicine phenytoin, carbamazepine, phenobarbital - these are treaments for epilepsy rifampicin - this is a treatment for tuberculosis famotidine, omeprazole - these are medicines that block stomach acids St. John's wort - a herbal preparation obtained without a prescription, used to treat depression and other conditions (also known as Hypericum perforatum)
Retningslinjer for dosisændringer hos voksne er opsummeret i Tabel 3 og hos pædiatriske patienter med Ph+ CML-CP i Tabel 4.
Guidelines for dose modifications in adults are summarised in Table 3 and in paediatric patients with Ph+ CML-CP in Table 4.
Mediantiden til første dasatinib relateret pleuraeffusion grad 1 eller 2 var 114 uger (4-299 uger).
The median time to first dasatinib-related grade 1 or 2 pleural effusion was 114 weeks (range: 4 to 299 weeks).
7 år
7 years
Sørg for en udvaskningsperiode på cirka 1 uge efter hæmmeren er seponeret, før genoptagelse af SPRYCEL.
Allow a washout period of approximately 1 week after the inhibitor is stopped before reinitiating SPRYCEL.
Dasatinib administreres oralt en gang dagligt i form af enten SPRYCEL pulver til oral suspension eller filmovertrukne tabletter (se Produktresumé for SPRYCEL filmovertrukne tabletter).
Dasatinib is administered orally once daily in the form of either SPRYCEL powder for oral suspension or film-coated tablets (see Summary of Product Characteristics for SPRYCEL film-coated tablets).
Dasatinib hæmmer aktivitet af BCR-ABL kinasen og kinaser i SRC-kinasefamilien samt en række andre udvalgte onkogene kinaser, inklusive c-KIT, efrinreceptor-kinaser og PDGFβ-receptorer.
Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGFβ receptor.
Ikke almindelig høretab, vertigo Hjerte
Uncommon hearing loss, vertigo Cardiac disorders
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) Infektioner: lungebetændelse, herpes virusinfektion (herunder cytomegalovirus (CMV)), infektion i øvre luftveje, alvorlig infektion i blod eller væv (herunder ikke almindelige tilfælde med dødelig udgang)
Common side effects (may affect up to 1 in 10 people) Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infection, serious infection of the blood or tissues (including uncommon cases with fatal outcomes)
56 filmovertrukne tabletter 60 × 1 filmovertrukne tablettter 60 filmovertrukne tabletter
56 film-coated tablets 60 x 1 film-coated tablets 60 film-coated tablets
Blandt de 126 pædiatriske patienter med Ph+ ALL behandlet med SPRYCEL i et kontinuerligt dosisregime var medianvarigheden af behandlingen 23,6 måneder (interval 1,4 til 33 måneder).
Among the 126 Ph+ ALL paediatric patients treated with SPRYCEL on a continuous dosing regimen, the median duration of therapy was 23.6 months (range 1.4 to 33 months).
Dosisreduktion for samtidig brug af potente CYP3A4-hæmmere
Dose reduction for concomitant use of strong CYP3A4 inhibitors
kronisk, accelereret eller blastfase CML, som er resistente eller intolerante over for tidligere behandling, inklusive imatinib.
chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib.
Efter mindst 60 måneders opfølgning fik 60% af de patienter, der var randomiseret til SPRYCEL gruppen, og 63% af de patienter, der var randomiseret til imatinib gruppen, stadig førstelinjebehandling.
With a minimum of 60 months follow-up, 60% of patients randomised to the SPRYCEL group and 63% of patients randomised to the imatinib group were still receiving first-line treatment.
Efter oral enkeltdosis af [14C]-mærket dasatinib, var ca. 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
Én 120-ml plastikflaske med børnesikret lukning indeholder 33 g pulver til oral suspension.
One 120-mL plastic bottle (with child-resistant closure) contains 33 g of powder for oral suspension.
Der er blevet udført et internationalt, åbent, multicenter, randomiseret, komparativt fase III-studie med voksne patienter med nyligt diagnosticeret CML i kronisk fase.
An international open-label, multicentre, randomised, comparative Phase III study was conducted in adult patients with newly diagnosed chronic phase CML.
Figur 4: Landmark plot for samlet overlevelse for dasatinib ved BCR-ABL-niveau (≤ 10% eller > 10% ved måned 3 i et fase 3-studie med patienter med nyligt diagnosticeret CML i kronisk fase
Figure 4: Landmark plot for overall survival for dasatinib by BCR-ABL level (≤ 10% or > 10%) at 3 months in a phase 3 study of newly diagnosed patients with chronic phase CML
Hvis cytopeni kommer igen, gentag knoglemarvsaspirat/-biopsi og genoptag behandling ved en lavere dosis.
If cytopaenia recurs, repeat marrow aspirate/biopsy and resume treatment at a reduced dose.
Tabel 3: Dosisjusteringer ved neutropeni og trombocytopeni hos voksne
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in adults
Blandt 188 patienter i pædiatriske studier var medianbehandlingstiden 26,3 måneder (interval 0 til 99,6 måneder).
Among 188 patients in paediatric studies, the median duration of therapy was 26.3 months (range 0 to 99.6 months).
I et enkeltdosisstudie med raske frivillige reduceredes ekponeringen af dasatinib med 61% efter administration af famotidin 10 timer inden indtagelse af enkeltdosis SPRYCEL.
In a single-dose study in healthy subjects, the administration of famotidine 10 hours prior to a single dose of SPRYCEL reduced dasatinib exposure by 61%.
Dasatinib har tilsvarende induceret embryoletalitet forbundet med nedsat kuldstørrelse i embryoføtale udviklingsstudier i rotter samt føtale skeletforandringer hos såvel rotter og kaniner.
In embryofoetal development studies, dasatinib likewise induced embryolethality with associated decreases in litter size in rats, as well as foetal skeletal alterations in both rats and rabbits.
I kliniske studier med patienter med CML eller Ph+ ALL i fremskreden fase, der fik SPRYCEL ved de anbefalede doser (n=304), sås væskeretention grad 3 eller 4 hos 8% af patienterne, inklusive pleura- og perikardieeffusion grad 3 eller 4, som blev indberettet hos henholdsvis 7% og 1% af patienterne.
In clinical studies in patients with advanced phase CML or Ph+ ALL receiving SPRYCEL at the recommended dose (n=304), grade 3 or 4 fluid retention was reported in 8% of patients, including grade 3 or 4 pleural and pericardial effusion reported in 7% and 1% of patients, respectively.
Særlig vejledning for, hvordan SPRYCEL skal håndteres Andre personer end patienten bør bruge handsker når SPRYCEL håndteres.
Persons other than the patient should use gloves when handling SPRYCEL.
Et åbent, randomiseret, non-komparativt multicenter-studie med patienter med behandlingssvigt ved initial behandling med 400 eller 600 mg imatinib.
An open-label, randomised, non-comparative multicentre study was conducted in patients who failed initial treatment with 400 or 600 mg imatinib.
Forhøjet kreatininniveau grad 3 eller 4 blev rapporteret hos < 1% af patienterne med CML i kronisk fase og blev rapporteret med en øget hyppighed på 1-4% hos patienterne med CML i fremskreden fase.
Grade 3 or 4 elevations in creatinine were reported in < 1% of patients with chronic phase CML and were reported with an increased frequency of 1 to 4% of patients with advanced phase CML.
a Resultater rapporteret med anbefalet startdosis på 140 mg én gang dagligt (se pkt.
a Results reported in recommended starting dose of 140 mg once daily (see section 4.2).
CCyRb inden for 48 måneder cCCyRa CCyRb inden for 60 måneder cCCyRa
CCyRb within 24 months cCCyRa CCyRb within 36 months cCCyRa CCyRb within 48 months cCCyRa CCyRb within 60 months cCCyRa CCyRb Major molecular responsec
ANC < 0,5 × 109/l og/eller trombocytter < 10 × 109/l
ANC < 0.5 x 109/L and/or platelets < 10 x 109/L
Der sås hovedsagligt toksicitet i det gastrointestinale, hæmatopoietiske og lymfoide system.
The primary toxicities occurred in the gastrointestinal, haematopoietic, and lymphoid systems.
Lymfoid toksicitet hos rotter bestod af lymfoidtab i lymfeknuder, milt og thymus samt reduceret vægt af lymfoide organer.
Lymphoid toxicity in rats consisted of lymphoid depletion of the lymph nodes, spleen, and thymus, and decreased lymphoid organ weights.
Retningslinjer for pædiatriske patienter med Ph+ ALL behandlet i kombination med kemoterapi kan ses i et særskilt afsnit efter tabellerne.
Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the tables.
Hos voksne patienter med CML eller Ph+ ALL i fremskreden fase, behandlet med dasatinib som monoterapi, bør der tages fuldstændigt blodbillede (CBC) ugentligt i de første 2 måneder og herefter hver måned, eller som klinisk indiceret.
In adult patients with advanced phase CML or Ph+ ALL treated with dasatinib as monotherapy, complete blood counts (CBCs) should be performed weekly for the first 2 months, and then monthly thereafter, or as clinically indicated.
Patienter, som udvikler symptomer svarende til pleuraeffusion, fx dyspnø eller tør hoste, skal evalueres ved thorax-røntgen.
Patients who develop symptoms suggestive of pleural effusion such as dyspnoea or dry cough should be evaluated by chest X-ray.
Ved samtidig brug af aluminiumhydroxid-/magnesiumhydroxidantacida og SPRYCEL hos raske frivillige reduceres AUC efter indtagelse af enkeltdosis SPRYCEL med 55% og Cmax med 58%.
In healthy subjects, the concomitant use of aluminium hydroxide/magnesium hydroxide antacids with SPRYCEL reduced the AUC of a single dose of SPRYCEL by 55% and the Cmax by 58%.
# PATIENTER, DER RESPONDERER / # RANDOMISERET HAZARD RATIO (95% CI)
# RESPONDERS / # RANDOMIZED HAZARD RATIO (95% CI)
Aktive stoffer, hvis plasmakoncentration kan ændres af dasatinib Samtidig brug af dasatinib og et CYP3A4-substrat kan øge eksponeringen af CYP3A4-substratet.
Active substances that may have their plasma concentrations altered by dasatinib Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate.
Af 126 pædiatriske patienter med Ph+ ALL i et kontinuerligt dosisregime oplevede 2 (1,6%), bivirkninger, der medførte behandlingsophør.
Of the 126 Ph+ ALL paediatric patients on a continuous dosing regimen, 2 (1.6%) experienced adverse reactions leading to treatment discontinuation.
Almindelig lungeødem*, pulmonal hypertension*, lungeinfiltration, pneumonitis, hoste Ikke almindelig pulmonal arteriel hypertension, bronkospasme, astma
Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma
Mindst 5 års opfølgning
Minimum of 5 years follow up
SPRYCEL er indiceret til behandling af voksne patienter med: nyligt diagnosticeret Philadelphia-kromosompositiv (Ph+) kronisk myeloid leukæmi (CML) i den kroniske fase.
SPRYCEL is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
Anden dosis (ml)
Second dose (mL)
Imatinib intolerante patienter
Imatinib-intolerant patients
I alt 670 patienter, af hvem 497 var imatinib resistente, blev randomiseret til dasatinib 100 mg én gang dagligt, 140 mg én gang dagligt, 50 mg 2 gange dagligt eller 70 mg 2 gange dagligt.
A total of 670 patients, of whom 497 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.
Blandt 130 patienter med CML i kronisk fase (CML-CP) behandlet i to pædiatriske studier et fase I, åbent, non-randomiseret dosisintervalforsøg og et fase II, åbent, non-randomiseret forsøg, var 84 patienter (udelukkende fra fase II-forsøget) nydiagnosticerede med CML-CP og 46 patienter (17 fra fase I-forsøget og 29 fra fase II-forsøget) resistente eller intolerante overfor tidligere behandling med imatinib.
Among 130 patients with chronic phase CML (CML-CP) treated in two paediatric studies, a Phase I, open-label, nonrandomized dose-ranging trial and a Phase II, open-label, nonrandomized trial, 84 patients (exclusively from the Phase II trial) were newly diagnosed with CML-CP and 46 patients (17 from the Phase I trial and 29 from the Phase II trial) were resistant or intolerant to previous treatment with imatinib.
5 "Opbevaring") for instruktioner om bortskaffelse af ubrugt lægemiddel samt sprøjten og flasken.
Refer to the package leaflet (see section 5 ‘How to store SPRYCEL') for instructions on discarding any unused medicine, syringe and bottle.
I et akut, oralt enkeltdosisstudie med aber sås kutan blødning, men dette sås ikke i studier med gentagne doser, hverken hos aber eller rotter.
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.
CHR Cytogenetisk responsc (%) (95% CI)
CHR Cytogenetic responsec (%) (95% CI)
For patienter med CML i fremskreden fase eller Ph+ ALL, som fik 140 mg dagligt, anbefales dosisreduktion til 100 mg én gang dagligt med yderligere reduktion fra 100 mg én gang dagligt til 50 mg én gang dagligt, hvis det findes nødvendigt.
For patients with advanced phase CML or Ph+ ALL who received 140 mg once daily, dose reduction to 100 mg once daily with further reduction from 100 mg once daily to 50 mg once daily, if needed, is recommended.
Æske der indeholder en flaske med 30 filmovertrukne tabletter.
Carton containing one bottle with 30 film-coated tablets.
Fertiliteten af han- og hunrotter blev ikke påvirket af behandling med dasatinib i dyrestudier (se pkt.
In animal studies, the fertility of male and female rats was not affected by treatment with dasatinib (see section 5.3).
Aktivt stof: dasatinib.
The active substance is dasatinib.
Væskeretentionsbivirkninger håndteredes sædvanligvis ved understøttende tiltag, der omfatter diuretika og kortvarig behandling med steroider (se pkt.
Fluid retention adverse reactions were typically managed by supportive care measures that include diuretics and short courses of steroids (see sections 4.2 and 4.8).
Sådan deles en dosis større end 11 ml
How to split a dose that is greater than 11 mL Total prescribed dose (mL)
Samtidig brug af potente CYP3A4-induktorer og dasatinib anbefales derfor ikke.
Therefore, concomitant use of potent CYP3A4 inducers with dasatinib is not recommended.
I dasatinib armen opnåede 93% af patienterne CHR inden crossover og i imatinib armen opnåede 82% af patienterne CHR inden crossover.
Ninety-three percent of patients in the dasatinib arm and 82% of patients in the imatinib arm achieved a CHR prior to crossover.
I studiet vedrørende nyligt diagnosticeret CML i kronisk fase omfattede dasatinib relaterede væskeretentionsbivirkninger efter mindst 60 måneders opfølgning pleuraeffusion (28%), superficielt ødem (14%), pulmonal hypertension (5%), generaliseret ødem (4%) og perikardie-effusion (4%).
In the newly diagnosed chronic phase CML study after a minimum of 60 months follow-up, dasatinib-related fluid retention adverse reactions included pleural effusion (28%), superficial oedema (14%), pulmonary hypertension (5%), generalised oedema (4%), and pericardial effusion (4%).
Voksne med accelereret og blastfase CML og Ph+ ALL (startdosis 140 mg én gang dagligt)
Adults with accelerated and blast phase CML and Ph+ ALL (starting dose 140 mg once daily)
I fase III-dosisoptimeringsstudiet med patienter med CML i fremskreden fase og Ph+ ALL var medianbehandlingsvarigheden 14 måneder for CML i accelereret fase, 3 måneder for CML i myeloid blastfase, 4 måneder for CML i lymfoid blastfase og 3 måneder for Ph+ ALL.
In the Phase III dose-optimisation study in patients with advanced phase CML and Ph+ ALL, the median duration of treatment was 14 months for accelerated phase CML, 3 months for myeloid blast CML, 4 months for lymphoid blast CML and 3 months for Ph+ ALL.
Patienter med BCR-ABL ≤ 10% efter 3 måneder
Patients with BCR-ABL ≤ 10% at 3 months
6.6 Regler for bortskaffelse og anden håndtering SPRYCEL pulver til oral suspension skal rekonstitueres af apotekspersonalet eller en kvalificeret sundhedsperson, før det udleveres til patienten.
SPRYCEL powder for oral suspension must be constituted by a pharmacist or qualified healthcare professional prior to being dispensed to the patient.
Raten for MMR på specifikke tidspunkter er vist grafisk i Figur 2.
MMR rates by specific time point are displayed graphically in Figure 2.
I et konventionelt rottefertilitetsstudie og i et studie vedrørende tidlig embryoudvikling påvirkede dasatinib ikke fertiliteten hos han- eller hunrotter, men inducerede embryoletalitet ved dosisniveauer omtrent svarende til human klinisk eksponeringer.
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.
I kliniske studier er behandling med SPRYCEL hos pædiatriske patienter med Ph+ ALL administreret kontinuerligt som supplement til successive serier af standardkemoterapi i højst to år.
In clinical studies, treatment with SPRYCEL in paediatric patients with Ph+ ALL was administered continuously, added to successive blocks of backbone chemotherapy, for a maximum duration of two years.
Første dosis (ml)
First dose (mL)
Der bør derfor udvises forsigtighed, når dasatinib administreres samtidigt med CYP3A4-substrater med snævert terapeutisk indeks, som fx astemizol, terfenadin, cisaprid, pimozid, quinidin, bepridil eller sekalealkaloider (ergotamin, dihydroergotamin) (se pkt.
Therefore, caution is warranted when dasatinib is coadministered with CYP3A4 substrates of narrow therapeutic index, such as astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine) (see section 4.5).
Samlet overlevelsesrate på specifikke tidspunkter er vist grafisk i Figur 4.
The OS rate by specific time point is displayed graphically in Figure 4.
Kumulative grad 3 eller 4 cytopenier hos patienter, der fik 100 mg én gang dagligt, var ens ved år 2 og år 5 og omfattede: neutropeni (35% versus 36%), trombocytopeni (23% versus 24%) og anæmi (13%
Cumulative grade 3 or 4 cytopaenias among patients treated with 100 mg once daily were similar at 2 and 5 years including: neutropaenia (35% vs. 36%), thrombocytopaenia (23% vs. 24%) and anaemia (13% vs. 13%).
Derudover hæmmer dasatinib kinaser i SRC-kinasefamilien ved subnanomolære koncentrationer.
Additionally, dasatinib inhibits SRC family kinases at subnanomolar concentrations.
Voksne med CML i kronisk fase (startdosis 100 mg én gang dagligt)
Adults with chronic phase CML (starting dose 100 mg once daily)
Mens flasken holdes lodret indsættes sprøjtens spids fast i flaskens adapter.
With the bottle in an upright position, insert the tip of the syringe firmly into the bottle adapter.
Det anbefales at anvende latex- eller nitrilhandsker til hensigtsmæssig bortskaffelse af tabletter, der utilsigtet knuses eller knækkes for at minimere risikoen for optagelse gennem huden.
The use of latex or nitrile gloves for appropriate disposal when handling tablets that are inadvertently crushed or broken is recommended, to minimise the risk of dermal exposure.
10 til under 20
10 to less than 20
ANC < 0,5 × 109/l og/eller trombocytter < 50 × 109/l
ANC < 0.5 x 109/L and/or platelets < 50 x 109/L
Hvis der udvikles alvorlige, grad 3 eller 4, ikke-hæmatologiske bivirkninger med dasatinib, afbrydes behandlingen, indtil bivirkningen er forsvundet.
If a severe grade 3 or 4, non-haematologic adverse reaction develops with dasatinib, treatment must be withheld until the adverse reaction has resolved.
Æske der indeholder en flaske med 60 filmovertrukne tabletter.
Carton containing one bottle with 60 film-coated tablets.
Hos disse patienter var CCyR og MMR hhv. 87,9% [95%CI: (71,8-96,6)] og 45,5% [95% CI: (28,1-63,6)] ved 12 måneder.
In these patients, CCyR and MMR were CCyR: 87.9% [95% CI: (71.8-96.6)] and MMR: 45.5% [95% CI: (28.1-63.6)] at 12 months.
Derudover er der udført et åbent, randomiseret komparativt fase III-studie med voksne patienter med nyligt diagnosticeret CML i kronisk fase.
In addition, one open-label, randomised, comparative Phase III study was conducted in adult patients with newly diagnosed chronic phase CML.
PAH (præ-kapillær pulmonal arteriel hypertension diagnosticeret med højresidig hjertekateterisation) er blevet rapporteret i forbindelse med dasatinib behandling.
PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib exposure.
Pulver: Opbevares ved temperaturer under 25 °C.
Powder: Store below 25°C.