FrancophonIA/ELRC3.0 huggingface dataset:
English: The median duration of therapy in 1,618 adult patients with chronic phase CML was 29 months (range 0 to 92.9 months).
Estonian: Ravi kestuse mediaan 1618 kroonilises faasis KML täiskasvanud patsiendil oli 29 kuud (vahemik 0...92,9 kuud).
English: Figure 2: MMR rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML
Estonian: Joonis 2: MMR määrad aja jooksul - kõik kolmanda faasi uuringusse randomiseeritud esmase diagnoosiga kroonilises faasis KML patsiendid.
English: 2 If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥ 1.0 x 109/L and platelets ≥ 20 x 109/L and resume at the original starting dose.
Estonian: 2 Kui tsütopeenia ei ole leukeemiaga seotud, siis katkestada ravi, kuni neutrofiilid ≥ 1,0 x 109/l ja trombotsüüdid ≥ 20 x 109/l ning jätkata seejärel algannusega.
English: Dasatinib had phototoxic potential in an in vitro neutral red uptake phototoxicity assay in mouse fibroblasts.
Estonian: Neutraalpunase omastamise katses fototoksilisuse hindamiseks in vitro hiire fibroblastidel ilmnes dasatiniibil fototoksiline potentsiaal.
English: Each mL of oral suspension contains 10 mg of dasatinib (as monohydrate).
Estonian: Üks ml suukaudset suspensiooni sisaldab 10 mg dasatiniibi (monohüdraadina).
English: Rare deep vein thrombosis, embolism, livedo reticularis
Estonian: Harv süvaveenide tromboos, emboolia, marmornahk
English: Each film-coated tablet contains 189 mg of lactose monohydrate.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 189 mg laktoosmonohüdraati.
English: In the Phase III clinical study in patients with newly diagnosed chronic phase CML, grade 3 or 4 fluid retention was reported in 13 patients (5%) in the dasatinib-treatment group and in 2 patients (1%) in the imatinib-treatment group after a minimum of 60 months follow-up (see section 4.8).
Estonian: Kolmanda faasi kliinilises uuringus esmaselt diagnoositud kroonilises faasis KML patsientidel teatati vähemalt 60 kuud kestnud jälgimisel 3. või 4. astme vedelikupeetusest 13 patsiendil (5%) dasatiniibi harust ja 2 patsiendil (1%) imatiniibi harust (vt lõik 4.8).
English: Among imatinib-resistant patients, the estimated rate of PFS was 88% (95% CI: [84%-92%]) at 1 year and 75% (95% CI: [69%-81%]) at 2 years.
Estonian: Imatiniibile resistentsete patsientide hulgas oli hinnanguline PFS määr esimeseks aastaks 88% (95% CI: [84%-92%]) ja teiseks aastaks 75% (95% CI: [69%-81%]).
English: By 5 years 76%, p<.0022
Estonian: 5 aastat p<0,0022
English: If cytopaenia is unrelated to leukaemia, stop treatment until ANC ≥1.0 × 109/L and platelets ≥75 × 109/L and resume at the original starting dose or at a reduced dose.
Estonian: Kui tsütopeenia ei ole leukeemiaga seotud, siis katkestada ravi, kuni neutrofiilid ≥ 1,0 x 109/l ja trombotsüüdid ≥ 75 x 109/l ning jätkata seejärel algannusega või vähendatud annusega.
English: PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib exposure.
Estonian: Teatatud on PAH (pre-kapillaarne pulmonaalne arteriaalne hüpertensioon, mis on kinnituse saanud südame parema poole kateteriseerimisel) juhtudest dasatiniibi kasutamisel.
English: In the Phase II paediatric study, in patients receiving the tablet formulation, estimated 24-month PFS rate among the 51 patients with newly diagnosed CML-CP was 94.0% (82.6, 98.0), and 81.7% (61.4, 92.0) among the 29 patients with imatinib-resistant/intolerant CML-CP. After 24 months of follow-up, OS in newly diagnosed patients was 100%, and 96.6% in imatinib-resistant or intolerant patients.
Estonian: II faasi lasteuuringus, kus manustati tablette, oli hinnatud 24 kuu progressioonivaba elulemuse määr 51-l KML-CP patsiendil 94,0% (82,6; 98,0) ning 81,7% (61,4; 92,0) 29-l imatiniibile resistentsel/talumatul KML-CP patsiendil.
English: In the Phase III dose-optimisation study in advanced phase CML and Ph+ALL, grade 3 or 4 elevations of transaminases or bilirubin were reported in 1% to 5% of patients across treatment groups.
Estonian: Kolmanda faasi annuse optimeerimise uuringus kaugelearenenud faasi KML ja Ph+ ALL korral oli teateid transaminaaside või bilirubiini 3. või 4. astme suurenemisest ravigruppides 1...5% patsientidest.
English: Common congestive heart failure/cardiac dysfunction*c, pericardial effusion*, arrhythmia (including tachycardia), palpitations
Estonian: Sage südame paispuudulikkus / kardiaalne düsfunktsioon*c, perikardi efusioon*, arütmia (sh tahhükardia), palpitatsioonid
English: 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.
Estonian: Kliinilistes uuringutes jätkati ravi SPRYCEL'iga täiskasvanutel, kellel oli Ph+ KML-CP, aktseleratsiooni, müeloidses või lümfoidses blastses faasis (kaugelearenenud faasis) KML või Ph+ ALL, ning lastel, kellel oli Ph+ KML-CP, kuni haiguse progresseerumise või talumatuse tekkimiseni.
English: Uncommon renal impairment (including renal failure), urinary frequency, proteinuria
Estonian: Aeg-ajalt neerukahjustus (sealhulgas neerupuudulikkus), sage urineerimine, proteinuuria
English: Based on the Kaplan-Meier estimates, the proportion of patients who had progression-free survival (PFS) for 1 year was 91% (95% CI: [85%-97%]) for dasatinib and 73% (95% CI: [54%-91%]) for imatinib.
Estonian: Kaplan-Meier'i hinnangufunktsiooni põhjal oli progressioonivaba elulemusega (PFS) patsientide osakaal 1 aasta jookusul 91% (95% CI: [85%-97%]) dasatiniibi ja 73% (95% CI: [54%-91%]) imatiniibi rühmas.
English: The safety profile of SPRYCEL administered as single-agent therapy in paediatric patients with Ph+ CML-CP was comparable to the safety profile in adults.
Estonian: Monoteraapiana manustatud Sprycel'i ohutusprofiil Ph+ KML-CP lastel oli võrreldav täiskasvanutel täheldatud ohutusprofiiliga.
English: Table 14: Efficacy of SPRYCEL in phase III dose-optimisation study: advanced phase CML and Ph+ ALL (2 year results)a
Estonian: Tabel 14: SPRYCEL'i efektiivsus III faasi annuse optimeerimise uuringus: kaugelearenenud faasis KML ja Ph+ ALL (kahe aasta tulemused)a aktseleratsioon (n= 158)
English: Each film-coated tablet contains 135.0 mg of lactose monohydrate.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 135,0 mg laktoosmonohüdraati.
English: MEDIAN (95% CI)
Estonian: KESKMINE (95% CI)
English: 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.
Estonian: Toimeained, mille kontsentratsiooni plasmas võib dasatiniib mõjutada Dasatiniibi ja CYP3A4 substraadi kooskasutamisel võib suureneda CYP3A4 substraadi toime.
English: Daily Dose (mg)
Estonian: Ööpäevane annus (mg)
English: Dose
Estonian: Kattekile
English: Outer Carton: sprycel 140 mg
Estonian: Väliskarp: sprycel 140 mg
English: Rare anaphylactic shock Endocrine disorders Uncommon hypothyroidism
Estonian: Harv anafülaktiline šokk Endokriinsüsteemi häired
English: Rare cor pulmonale, myocarditis, acute coronary syndrome, cardiac arrest, electrocardiogram PR prolongation, coronary artery disease, pleuropericarditis
Estonian: Harv cor pulmonale, müokardiit, äge koronaarsündroom, südameseiskus, PR intervalli pikenemine kardiogrammis, südame isheemiatõbi, pleuroperikardiit
English: The rate of major molecular response (defined as BCR-ABL/control transcripts ≤ 0.1% by RQ-PCR in peripheral blood samples) prior to crossover was 29% for dasatinib and 12% for imatinib.
Estonian: Olulise molekulaarse ravivastuse määr enne üleminekut oli dasatiniibi rühmas 29% ja imatiniibi rühmas 12% (määratletud kui BCR-ABL/kontroll transkriptsioonid ≤ 0.1% mõõdetuna RQ-PCR meetodil perifeerse vere proovis).
English: Laboratory test abnormalities Haematology
Estonian: Kõrvalekalded laboratoorsetes analüüsides Hematoloogia
English: The OS rate by specific time point is displayed graphically in Figure 4.
Estonian: Üldise elulemuse (OS) määr erinevates ajapunktides on toodud graafiliselt joonisel 4.
English: Concomitant use of dasatinib and medicinal products or substances which potently inhibit CYP3A4 (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, grapefruit juice) may increase exposure to dasatinib.
Estonian: Dasatiniibi samaaegne kasutamine koos ravimite või substantsidega, mis võivad inhibeerida CYP3A4 (nt ketokonasool, itrakonasool, erütromütsiin, klaritromütsiin, ritonaviir, telitromütsiin, greipfruudimahl) võib tugevdada dasatiniibi toimet.
English: Treatment with SPRYCEL is associated with anaemia, neutropaenia and thrombocytopaenia.
Estonian: SPRYCEL'i ravi ajal on esinenud aneemiat, neutropeeniat ja trombotsütopeeniat.
English: SPRYCEL contains benzoic acid and sodium benzoate SPRYCEL contains 0.25 mg benzoic acid in each mL of oral suspension and 0.25 mg sodium benzoate in each mL of oral suspension.
Estonian: SPRYCEL sisaldab bensoehapet ja naatriumbensoaati SPRYCEL sisaldab suukaudse suspensiooni 1 ml kohta 0,25 mg bensoehapet ja 0,25 mg naatriumbensoaati.
English: A total of 48 patients with lymphoid blast CML received dasatinib 70 mg twice daily (42 resistant and 6 intolerant to imatinib).
Estonian: 70 mg dasatiniibi 2 korda ööpäevas said kokku 48 patsienti lümfoblastse KML-ga (42 resistentset ja 6 intolerantset imatiniibi suhtes).
English: Following resolution of the first episode, reintroduction of dasatinib at the same dose level should be considered.
Estonian: Pärast esimese episoodi möödumist võib dasatiniibi taasalustada sama annusega.
English: Outer Carton: sprycel 70 mg
Estonian: Väliskarp: sprycel 70 mg
English: In these patients grade 3 or 4 pulmonary oedema and pulmonary hypertension were each reported in 1% of patients.
Estonian: Nendest patsientidest registreeriti CTC 3. või 4. astme kopsuturset 1%-l patsientidest.
English: SPRYCEL 20 mg tablets dasatinib
Estonian: SPRYCEL 20 mg tabletid Dasatiniib
English: SPRYCEL 70 mg tablets dasatinib
Estonian: SPRYCEL 70 mg tabletid Dasatiniib
English: Each film-coated tablet contains 108 mg of lactose monohydrate.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 108 mg laktoosmonohüdraati.
English: Rates of MR4.5 over time were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Estonian: Dasatiniibi saanud patsientidel olid MR4.5 määrad püsivalt suuremad kui imatiniibi saanud patsientidel.
English: The rate of major molecular response (assessed in 19 patients with a CCyR) was 68% at 24 months.
Estonian: Olulise molekulaarse ravivastuse määr (hinnatud CCyR saavutanud 19 patsiendil) oli 24 kuul 68%.
English: Based on the Kaplan-Meier estimates, the proportion of patients who maintained MCyR for 1 year was 92% (95% CI: [85%-100%]) for dasatinib (CCyR 97%, 95% CI: [92%-100%]) and 74% (95% CI: [49%-100%]) for imatinib (CCyR 100%).
Estonian: Kaplan-Meier'i hinnangufunktsiooni põhjal oli nende patsientide osakaal, kellel MCyR püsis ühe aasta 92% (95% CI: [85%-100%]) dasatiniibi (CCyR 97%, 95% CI: [92%-100%]) ja 74% (95% CI: [49%-100%]) imatiniibi rühmas (CCyR 100%).
English: In patients with Ph+ ALL treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months the median PFS was 4 months, and the median overall survival was 7 months.
Estonian: Ph+ ALL patsientidel, kes said ravi annusega 140 mg üks kord ööpäevas, oli MaHR kestvuse mediaankeskmine 5 kuud; progressioonivaba elulemuse mediaan 4 kuud ja üldise elulemuse mediaan oli 7 kuud.
English: Each film-coated tablet contains 27 mg of lactose monohydrate.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 27 mg laktoosmonohüdraati.
English: In 258 dasatinib-treated patients and 258 imatinib-treated patients with a minimum of 60 months follow-up in the Phase III study in newly diagnosed chronic phase CML, 1 patient (< 1%) in each group had QTc prolongation reported as an adverse reaction.
Estonian: Kolmanda faasi uuringus esmaselt diagnoositud kroonilise KML 258 dasatiniibravi saanud ja 258 imatiniibravi saanud patsiendist esines vähemalt 60 kuud kestnud jälgimisel ühel patsiendil (< 1%) kummagis harus QTc pikenemine, millest teatati kõrvaltoimena.
English: Results are shown in Table 15.
Estonian: Ravi efektiivsuse tulemused on toodud tabelis 15.
English: The rate of major molecular response (all 25 treated patients with a CCyR) was 52% at 24 months.
Estonian: Olulise molekulaarse ravivastuse määr (kõik ravitud CCyR saavutanud 25 patsienti) oli 24 kuul 52%.
English: Not known interstitial lung disease
Estonian: Teadmata interstitsiaalne kopsuhaigus Seedetrakti häired
English: If a pleural effusion is diagnosed, dasatinib should be interrupted until patient is examined, asymptomatic or has returned to baseline.
Estonian: Pleura efusiooni diagnoosimisel tuleb dasatiniibiga ravi katkestada kuni patsienti on uuritud, sümptomite kadumiseni või algtaseme saavutamiseni.
English: Patients with BCR-ABL ≤ 10% at 3 months
Estonian: Patsiendid kellel 3 kuul oli BCR-ABL ≤ 10%
English: Uncommon myocardial infarction (including fatal outcome)*, electrocardiogram QT prolonged*, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly, electrocardiogram T wave abnormal, troponin increased
Estonian: Aeg-ajalt müokardi infarkt (sh letaalse lõppega)*, EKGs pikenenud QT aeg*, perikardiit, ventrikulaarne arütmia (sh ventrikulaarne tahhükardia), rinnaangiin, kardiomegaalia, T-saki muutused kardiogrammis, troponiinisisalduse suurenemine
English: Each film-coated tablet contains 94.5 mg of lactose monohydrate.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 94,5 mg laktoosmonohüdraati.
English: Outer Carton: sprycel 20 mg
Estonian: Väliskarp: sprycel 20 mg
English: In patients with accelerated phase CML treated with the 140 mg once daily regimen, the median duration of MaHR and the median overall survival was not reached and the median PFS was 25 months.
Estonian: Aktseleratsioonifaasis KML patsientidel, kes said ravi annusega 140 mg üks kord ööpäevas, ei saavutatud MaHR kestvuse mediaankeskmist ja üldise elulemuse keskmist ning progressioonivaba elulemuse mediaankeskmine oli 25 kuud.
English: The main secondary endpoint was MCyR by total daily dose level in the imatinib-resistant patients.
Estonian: Teiseks peamiseks tulemusnäitajaks oli MCyR vastavalt imatiniibile resistentsetele patsientidele manustatud ööpäevasele annusele.
English: Uncommon hepatitis, cholecystitis, cholestasis Skin and subcutaneous tissue disorders
Estonian: Aeg-ajalt hepatiit, koletsüstiit, kolestaas Naha ja nahaaluskoe kahjustused
English: Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth nerve paralysis, dementia, ataxia
Estonian: Harv tserebrovaskulaarne atakk, transitoorne isheemiline atakk, krambid, nägemisnärvi neuriit, VII närvi paralüüs, dementsus, ataksia
English: Haematologic response rateb (%) MaHR (95% CI)
Estonian: Hematoloogilise ravivastuse määrb (%) MaHR (95% CI)
English: Holding the syringe tip firmly in the bottle, turn the bottle with the syringe upright again.
Estonian: Hoidke süstlaotsikut kindlalt pudelis ning pöörake pudel tagasi õigetpidi.
English: The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients.
Estonian: Tablette ei soovitata kasutada alla 10 kg kaaluvatel patsientidel, nendel patsientidel tuleb kasutada suukaudse suspensiooni pulbrit.
English: Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm. With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover.
Estonian: Kestvama ravi ning jätkuravi korral (keskmiselt 24 kuud) saavutati MCyR enne üleminekut dasatiniibi rühmas 53% (CCyR 44%) ja imatiniibiga ravitud patsientidel 33% (CCyR 18%).
English: A total of 611 patients were randomised to either the dasatinib 140 mg once daily or 70 mg twice daily group.
Estonian: Uuringus osalenud 611 patsienti randomiseeriti rühmadesse, kus dasatiniibi manustati kas 140 mg üks kord ööpäevas või 70 mg kaks korda ööpäevas.
English: HAZARD RATIO (95% CI)
Estonian: RISKI MÄÄR (95% CI)
English: Common depression, insomnia
Estonian: Sage depressioon, unetus
English: A total of 109 patients received dasatinib 70 mg twice daily (99 resistant and 10 intolerant to imatinib).
Estonian: 70 mg dasatiniibi kaks korda ööpäevas said kokku 109 patsienti (99 resistentset ja 10 intolerantset imatiniibi suhtes).
English: Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received dasatinib in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Estonian: Kliinilistes uuringutes dasatiniibi saanud 2182 varasema imatiniibravi suhtes resistentsel või intolerantsel patsiendil esines kõrvaltoimena teatatud QTc pikenemist 15 patsiendil (1%).
English: The rate of major molecular response (all 22 treated patients with a CCyR) was 50% at 24 months.
Estonian: Olulise molekulaarse ravivastuse määr (kõik ravitud CCyR saavutanud 22 patsienti) oli 24 kuul 50%.
English: Pain: inflammation of vein which can cause redness, tenderness and swelling, inflammation of the tendon
Estonian: Valu: veenipõletik mis võib põhjustada punetuse, tundlikkuse ja turse, kõõlusepõletik Aju: mälukaotus
English: The median time from diagnosis to start of treatment was 28 months.
Estonian: Keskmine intervall haiguse diagnoosimisest ravi alustamiseni oli 28 kuud.
English: SPRYCEL contains sucrose
Estonian: SPRYCEL sisaldab sahharoosi
English: In the 2,712 adult patients with either chronic phase CML, advanced phase CML or Ph+ ALL, the median duration of therapy was 19.2 months (range 0 to 93.2 months).
Estonian: Kroonilises või kaugelearenenud faasis KML või Ph+ ALL 2 712 täiskasvanud patsiendil oli ravi kestuse mediaan 19,2 kuud (vahemik 0...93,2 kuud).
English: 10 to less than 20 kg
Estonian: 10 kuni 20 kg
English: There is no dose recommendation for SPRYCEL with children under 1 year of age.
Estonian: SPRYCEL'i annustamise juhised alla 1 aastastele lastele puuduvad.
English: CCyRb within 24 months cCCyRa CCyRb within 36 months cCCyRa CCyRb within 48 months cCCyRa CCyRb within 60 months cCCyRa CCyRb Major molecular responsec
Estonian: 48 kuu jooksul cCCyRa CCyRb
English: Concomitant use of dasatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John's Wort) may substantially reduce exposure to dasatinib, potentially increasing the risk of therapeutic failure.
Estonian: Dasatiniibi ja CYP3A4 indutseerivate preparaatide (deksametasoon, fenütoiin, karbamasepiin, rifampitsiin, fenobarbitaal või lihtnaistepuna (Hypericum perforatum) sisaldavad taimsed preparaadid) samaaegne kasutamine võib oluliselt vähendada dasatiniibi toimet, mis võib suurendada ravi ebaõnnestumise riski.
English: c MCyR combines both complete (0% Ph+ metaphases) and partial (> 0%-35%) responses.
Estonian: c Oluline tsütogeneetiline ravivastus (MCyR) sisaldab nii täieliku (0% Ph+ metafaase) kui osalise (> 0%-35%) ravivastuse.
English: Patients should be tested for HBV infection before initiating treatment with SPRYCEL.
Estonian: Enne SPRYCEL´iga ravi alustamist tuleb patsienti uurida HBV-infektsiooni suhtes.
English: Fluid retention Superficial oedema Pleural effusion Generalised oedema Congestive heart failure /cardiac dysfunctionb
Estonian: Kõhulahtisus Vedelikupeetus Pindmine turse Pleura efusioon Generaliseerunud turse Südame paispuudulikkus /kardiaalne düsfunktsioonb
English: SPRYCEL 10 mg/mL powder for oral suspension
Estonian: SPRYCEL 10 mg/ml suukaudse suspensiooni pulber
English: 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
Estonian: Joonis 4: Kolmanda faasi uuringu esmase diagnoosiga kroonilise faasi KML patsientide üldise elulemuse diagramm vastavalt BCR-ABL tasemele (≤ 10% või > 10%) kolmandaks kuuks.
English: What SPRYCEL is and what it is used for 2.
Estonian: 1. Mis ravim on SPRYCEL ja milleks seda kasutatakse 2. Mida on vaja teada enne SPRYCEL'i kasutamist 3.
English: Accelerated phase (n= 157)c
Estonian: (n= 165)b Aktseleratsioonifaas (n= 157)c
English: SPRYCEL 50 mg tablets dasatinib
Estonian: SPRYCEL 50 mg tabletid Dasatiniib
English: Rare gait disturbance
Estonian: Harv kõnnaku häired
English: Rare side effects (may affect up to 1 in 1,000 people) Heart and lungs: enlargement of the right ventricle in the heart, inflammation of the heart muscle, collection of conditions resulting from blockage of blood supply to the heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from the heart), coronary (heart) artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
Estonian: Harva esinevad kõrvaltoimed (võib esineda kuni ühel kasutajal tuhandest) Süda ja kopsud: südame parema vatsakese laienemine, südamelihase põletik, südamelihase verevarustuse häirest tekkinud sümptomite kogum (äge koronaarsündroom), südame seiskumine (verevoolu peatumine südamest), koronaararterite (südame) isheemiatõbi, südant ja kopsu katva koe põletik, verehüübed, verehüübed kopsus
English: Common pulmonary oedema*, pulmonary hypertension*, lung infiltration, pneumonitis, cough Uncommon pulmonary arterial hypertension, bronchospasm, asthma
Estonian: Sage kopsuturse*, pulmonaalne hüpertensioon*, kopsu infiltratsioon, pneumoniit, köha
English: Improvements in haemodynamic and clinical parameters have been observed in dasatinib-treated patients with PAH following cessation of dasatinib therapy.
Estonian: Dasatiniibiga ravitud PAH patsientidel on täheldatud dasatiniibravi lõpetamisel hemodünaamika ja kliiniliste näitajate paranemist.
English: Table 6a: Selected adverse reactions reported in a phase 3 dose optimisation study (imatinib intolerant or resistant chronic phase CML)a
Estonian: Tabel 6a: III faasi annuse optimeerimise uuringus teatatud valitud kõrvaltoimed (imatiniibi suhtes intolerantne või resistentne kroonilises faasis KML)a
English: Among imatinib-intolerant patients, the estimated rate of PFS was 98% (95% CI: [95%-100%]) at 1 year and 94% (95% CI: [88%-99%]) at 2 years.
Estonian: Imatiniibi mittetalunud patsientide hinnanguline PFS määr oli esimeseks aastaks 98% (95% CI: [95%-100%]) ja teiseks aastaks 94% (95% CI: [88%-99%]).
English: Efficacy results are reported in Table 11.
Estonian: Ravi efektiivsuse tulemused on toodud tabelis 11.
English: Not known atrial fibrillation/atrial flutter Vascular disorders
Estonian: Teadmata kodade virvendus/kodade laperdus Vaskulaarsed häired
English: Outer Carton: sprycel 50 mg
Estonian: Väliskarp: sprycel 50 mg
English: 20 to less than 30 kg
Estonian: 20 kuni 30 kg
English: b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma, haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural haemorrhage.
Estonian: b Hõlmab: KNS hemorraagia, tserebraalne hematoom, tserebraalne hemorraagia, ekstraduraalne hematoom, intrakraniaalne hemorraagia, hemorraagiline insult, subarahnoidaalne hemorraagia, subduraalne hematoom ja subduraalne hemorraagia.
English: Outer Carton: sprycel 100 mg
Estonian: Väliskarp: sprycel 100 mg
English: The median time from diagnosis to start of treatment was 48 months.
Estonian: Keskmine intervall haiguse diagnoosimisest ravi alustamiseni oli 48 kuud.
English: Following resolution of a subsequent episode, dasatinib at one dose level reduction should be reintroduced.
Estonian: Pärast järgmise episoodi möödumist kaaluge ravi dasatiniibiga taasalustamist üks aste madalamal tasemel.