FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiac adverse reactions were more frequent in patients with risk factors or a history of cardiac disease.
Slovenian: Neželeni učinki za srce so bili pogostejši pri bolnikih, ki so imeli dejavnike tveganja za bolezni srca ali pa so že kdaj imeli bolezen srca.
English: Renal changes in monkeys treated for up to 9 months were limited to an increase in background kidney mineralisation.
Slovenian: Pri opicah, ki so zdravilo prejemale do 9 mesecev, so bile spremembe v ledvicah omejene na mineralizacijo.
English: Caution should be exercised if patients are required to take medicinal products that inhibit platelet function or anticoagulants.
Slovenian: Pri bolnikih, ki potrebujejo zdravljenje z zdravili, ki zavirajo funkcijo trombocitov ali z antikoagulanti, je potrebna previdnost.
English: Your doctor will decide the right dose based on age and weight.
Slovenian: Ustrezen odmerek bo določil zdravnik na osnovi starosti in telesne mase.
English: Each mL of oral suspension contains approximately 291 mg of sucrose, 2.1 mg of sodium, 0.25 mg of sodium benzoate, 0.25 mg of benzoic acid, 0.017 mg of benzyl alcohol and <10 ppm of sulphur dioxide (E220).
Slovenian: En ml peroralne suspenzije vsebuje približno 291 mg saharoze, 2,1 mg natrija, 0,25 mg natrijevega benzoata, 0,25 mg benzojske kisline, 0,017 mg benzilalkohola in < 10 ppm žveplovega dioksida (E220).
English: If cytopaenia persists for more than 3 weeks, check if cytopaenia is related to leukaemia (marrow aspirate or biopsy).
Slovenian: Če citopenija traja več kot 3 tedne, preverite, če je citopenija povezana z levkemijo (aspiracija ali biopsija kostnega mozga).
English: Due to the limitations of this clinical study, caution is recommended when administering dasatinib to patients with hepatic impairment.
Slovenian: Zaradi omejitev pri tej klinični študiji, je pri zdravljenju bolnikov z okvaro jeter z dasatinibom priporočena previdnost.
English: n/a Duration of MaHR (%; Kaplan-Meier estimates) 1 year n/a
Slovenian: n/a Trajanje MaHR (%; Kaplan-Meierjeva ocena) 1 leto n/a
English: (95% CI) CHRb
Slovenian: (95% IZ) CHRb
English: SPRYCEL tablets can be taken with or without a meal.
Slovenian: SPRYCEL tablete lahko jemljete skupaj s hrano ali brez nje.
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
Slovenian: Grafični prikaz (“Landmark plot”) celokupnega preživetja pri uporabi dasatiniba pri vrednosti BCR-ABL (≤ 10% ali > 10%) v 3. mesecu v študiji 3. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju
English: 1 bottle of 33 g powder 1 bottle adapter 1 oral syringe
Slovenian: 1 plastenka s 33 g praška 1 nastavek za plastenko 1 brizga za peroralno dajanje
English: ALLOW TO AIR DRY AFTER EACH USE
Slovenian: PO VSAKI UPORABI NAJ SE BRIZGA POSUŠI NA ZRAKU
English: If laboratory or clinical findings associated with TMA occur in a patient receiving SPRYCEL, treatment with SPRYCEL should be discontinued and thorough evaluation for TMA, including ADAMTS13 activity and antiADAMTS13-antibody determination, should be completed.
Slovenian: V primeru s TMA povezanih rezultatov laboratorijskih ali kliničnih preiskav v času zdravljenja z zdravilom SPRYCEL, je treba zdravljenje prekiniti in opraviti temeljito oceno za potrditev TMA, vključno z določanjem aktivnosti ADAMTS13 in prisotnosti protiteles antiADAMTS13.
English: These reduced doses of SPRYCEL are predicted to adjust the area under the curve (AUC) to the range observed without CYP3A4 inhibitors; however, clinical data are not available with these dose adjustments in patients receiving strong CYP3A4 inhibitors.
Slovenian: Predvidevamo, da se bo s temi zmanjšanji odmerka zdravila SPRYCEL območje pod krivuljo (AUC) prilagodilo na obseg, opažen v odsotnosti zaviralcev CYP3A4, vendar pa pri bolnikih, ki prejemajo močne zaviralce CYP3A4, klinični podatki s temi prilagoditvami odmerka niso na voljo.
English: Table 15: Efficacy of SPRYCEL in paediatric patients with CML-CP Cumulative response over time by minimum follow-up period 3 months
Slovenian: Preglednica 15: Učinkovitost zdravila SPRYCEL pri pediatričnih bolnikih s KML-KO Kumulativni odziv glede na čas po najmanjšem obdobju spremljanja 3 mesece
English: Do not use this medicine after the expiry date which is stated on the bottle label, blister or carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke, pretisnem omotu ali škatli poleg oznake “EXP”.
English: The primary toxicities occurred in the gastrointestinal, haematopoietic, and lymphoid systems.
Slovenian: Do primarne toksičnosti je prišlo v gastrointestinalnem, hematopoetskem in limfoidnem sistemu.
English: 56 film-coated tablets 60 x 1 film-coated tablets 60 film-coated tablets
Slovenian: 56 filmsko obloženih tablet 60 x 1 filmsko obložena tableta 60 filmsko obloženih tablet
English: Before you prepare a dose of SPRYCEL oral suspension for administration to the patient, get the following supplies ready:
Slovenian: Pred pripravo odmerka zdravila SPRYCEL peroralna suspenzija za dajanje bolniku si pripravite naslednje pripomočke:
English: Rare gait disturbance
Slovenian: Redki motnje pri hoji
English: Preferred term
Slovenian: Priporočeni izraz
English: Pleural effusion
Slovenian: Plevralni izliv
English: Not known nephrotic syndrome Pregnancy, puerperium and perinatal conditions
Slovenian: Neznana pogostnost nefrotski sindrom Motnje v času nosečnosti, puerperija in perinatalnem obdobju
English: Patients who are able to swallow tablets and who desire to switch from SPRYCEL powder for oral suspension to SPRYCEL tablets or patients who are not able to swallow tablets and who desire to switch from tablets to oral suspension, may do so, provided that the correct dosing recommendations for the dosage form are followed.
Slovenian: Pri bolnikih, ki lahko pogoltnejo tablete, in želijo preiti z zdravljenja z zdravilom SPRYCEL prašek za peroralno suspenzijo na zdravljenje z zdravilom SPRYCEL v obliki tablet ali pri bolnikih, ki ne morejo pogoltniti tablet, in želijo preiti z zdravljenja s tabletami na zdravljenje s peroralno suspenzijo se zdravljenje lahko zamenja, vendar pa je pri tem treba upoštevati ustrezna priporočila za odmerjanje posamezne farmacevtske oblike.
English: These data should be considered if patients are to switch from powder for oral suspension to tablets or vice versa.
Slovenian: Te podatke je treba upoštevati, če bolniki preidejo z zdravljenja s praškom za peroralno suspenzijo na zdravljenje s tabletami ali obratno.
English: Women of childbearing potential/contraception in males and females Both sexually active men and women of childbearing potential should use effective methods of contraception during treatment.
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah Med zdravljenjem morajo spolno aktivni moški in ženske v rodni dobi uporabljati učinkovito kontracepcijo.
English: This medicinal product contains 2.1 mg sodium (main component of cooking/table salt) per mL of SPRYCEL oral suspension.
Slovenian: To zdravilo vsebuje 2,1 mg natrija (glavne sestavine kuhinjske soli) na ml SPRYCEL peroralne suspenzije.
English: In vivo, in separate experiments using murine models of CML, dasatinib prevented the progression of chronic CML to blast phase and prolonged the survival of mice bearing patient-derived CML cell lines grown at various sites, including the central nervous system.
Slovenian: Pri ločenem in vivo preizkusu na mišjem modelu KML je dasatinib preprečil napredovanje KML iz kroničnega obdobja v obdobje blastne preobrazbe in podaljšal dobo preživetja miši z vnesenimi humanimi celičnimi linijami KML, ki so rasle na različnih mestih, tudi v centralnem živčevju.
English: In the paediatric ALL studies, the rates of laboratory abnormalities were consistent with the known profile for laboratory parameters in adults, within the context of an acute leukaemia patient receiving a background chemotherapy regimen.
Slovenian: V pediatričnih študijah ALL so bili deleži laboratorijskih odstopanj skladni z znanim profilom za laboratorijske parametre pri odraslih, v kontekstu bolnikov z akutno levkemijo, ki prejemajo režim osnovne kemoterapije.
English: You or your child will also have blood tests regularly while taking SPRYCEL.
Slovenian: Med jemanjem zdravila SPRYCEL bodo vam ali vašemu otroku redno opravljali krvne preiskave.
English: At 60 months, transformation to accelerated or blast phase occurred in fewer dasatinib-treated patients (n=8; 3%) compared with imatinib-treated patients (n=15; 5.8%).
Slovenian: Po 60 mesecih je bila transformacija do faze pospešenega poteka ali blastne preobrazbe zabeležena pri manjšem številu bolnikov, ki so se zdravili z dasatinibom (n = 8; 3%), v primerjavi s številom bolnikov, ki so se zdravili z imatinibom (n = 15; 5,8%).
English: SPRYCEL is mainly handled by the liver.
Slovenian: Zdravilo SPRYCEL se v glavnem presnavlja v jetrih.
English: Important adverse reactions
Slovenian: Pomembni neželeni učinki
English: Musculoskeletal and connective tissue: delayed fusion of the rounded ends that form joints (epiphyses); slower or delayed growth
Slovenian: Mišično-skeletni sistem in vezivno tkivo: zapoznelo zaprtje zaobljenih delov kosti, ki tvorijo sklepe (epifize), počasnejša ali zaostala rast
English: Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
Slovenian: Zdravljenje sme uvesti le zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolnikov z levkemijo.
English: Carefully prepare the SPRYCEL oral suspension for administration, measure the dose, and fill the syringe, like this:
Slovenian: Previdno pripravite zdravilo SPRYCEL peroralna suspenzija za dajanje, odmerite odmerek in napolnite brizgo kot je prikazano v nadaljevanju:
English: Other relevant efficacy results included CCyR and complete molecular response (CMR) rates.
Slovenian: Drugi relevantni rezultati učinkovitosti so vključevali CCyR in deleže popolnega molekularnega odziva (CMR; “complete molecular response”).
English: Uncommon hypersensitivity (including erythema nodosum)
Slovenian: Občasni preobčutljivost (vključno z nodoznim eritemom)
English: Following resolution of the first episode, reintroduction of dasatinib at the same dose level should be considered.
Slovenian: Ko bolnik okreva po prvi epizodi, je treba razmisliti o ponovni uvedbi zdravljenja z dasatinibom v istem odmerku.
English: Instructions for constitution of powder for oral suspension
Slovenian: Navodila za rekonstitucijo praška za peroralno suspenzijo
English: A change in dose may occur when switching between formulations (i.e., tablets and powder for oral suspension), so you should not switch from one to the other.
Slovenian: Pri zamenjavi farmacevtske oblike (npr. tablet in praška za peroralno suspenzijo) se lahko spremeni odmerek, zato sami ne smete preiti z ene na drugo obliko.
English: Patients with risk factors (e.g. hypertension, hyperlipidaemia, diabetes) or a history of cardiac disease (e.g. prior percutaneous coronary intervention, documented coronary artery disease) should be monitored carefully for clinical signs or symptoms consistent with cardiac dysfunction such as chest pain, shortness of breath, and diaphoresis.
Slovenian: Bolnike z dejavniki tveganja (npr. hipertenzija, hiperlipidemija, sladkorna bolezen) in bolnike s predhodno boleznijo srca (npr. predhodna perkutana koronarna intervencija, dokumentirana bolezen koronarnih arterij) je treba skrbno nadzirati glede znakov in simptomov srčne disfunkcije, kot so bolečina v prsnem košu, kratka sapa in čezmerno znojenje.
English: If these clinical signs or symptoms develop, physicians are advised to interrupt dasatinib administration and consider the need for alternative CML-specific treatment.
Slovenian: V primeru pojava teh kliničnih znakov ali simptomov je priporočljivo, da zdravnik zdravljenje z dasatinibom prekine in presodi o potrebi po alternativnem specifičnem zdravljenju KML.
English: Secondary endpoints included time in cCCyR (measure of durability of response), time to cCCyR, major molecular response (MMR) rate, time to MMR, progression free survival (PFS) and overall survival (OS).
Slovenian: Sekundarni opazovani dogodki so vključevali čas trajanja cCCyR (merilo trajanja odziva), čas do dosega cCCyR, delež dobrega molekularnega odziva (MMR; “major molecular response”), čas do dosega MMR, preživetje brez napredovanja bolezni (PFS; “progression free survival”) in celokupno preživetje (OS; “overall survival”).
English: MCyR All patients Imatinib-resistant patients CCyR All patients Imatinib-resistant patients Major molecular response in patients achieving CCyRd (%) (95% CI)
Slovenian: MCyR Vsi bolniki Bolniki, odporni na imatinib CCyR Vsi bolniki Bolniki, odporni na imatinib Dober molekularni odziv pri bolnikih, ki so dosegli CCyRd (%) (95% IZ)
English: The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic or molecular response [including complete cytogenetic response (CCyR), major molecular response (MMR) and MR4.5] has not been investigated.
Slovenian: Učinek prekinitve zdravljenja po dosegu citogenetskega ali molekularnega odziva [vključno s popolnim citogenetskim odzivom (CCyR), dobrim molekularnim odzivom (MMR) in MR4.5] na dolgoročni izid bolezni ni bil raziskan.
English: Rare deep vein thrombosis, embolism, livedo reticularis
Slovenian: Redki globoka venska tromboza, embolija, livedo reticularis
English: The efficacy of dasatinib is based on haematological and cytogenetic response rates.
Slovenian: Učinkovitost dasatiniba temelji na odstotkih hematološkega in citogenetskega odziva.
English: Myelosuppression was also reported less frequently in the 100 mg once daily treatment group (see Laboratory test abnormalities below).
Slovenian: Pri uporabi odmerka 100 mg enkrat na dan so manj pogosto poročali tudi o pojavu mielosupresije (glejte Odstopanja od normalnih vrednosti laboratorijskih preiskav v nadaljevanju).
English: Since dasatinib is associated with grade 3 or 4 myelosuppression (see section 4.4), patients who ingest more than the recommended dose should be closely monitored for myelosuppression and given appropriate supportive treatment.
Slovenian: Ker je uporaba dasatiniba povezana s pojavom mielosupresije stopnje 3 ali 4 (glejte poglavje 4.4), je treba bolnike v primeru prevelikega odmerka skrbno nadzirati glede pojava mielosupresije in uvesti ustrezno podporno zdravljenje.
English: 30 to less than 45
Slovenian: 30 do manj kot 45
English: The safety profile of SPRYCEL administered in combination with chemotherapy in paediatric patients with Ph+ ALL was consistent with the known safety profile of SPRYCEL in adults and the expected effects of chemotherapy, with the exception of a lower pleural effusion rate in paediatric patients as compared to adults.
Slovenian: Varnostni profil zdravila SPRYCEL v kombinaciji s kemoterapijo je bil pri pediatričnih bolnikih s Ph+ ALL skladen z znanim varnostnim profilom zdravila SPRYCEL pri odraslih in pričakovanimi učinki kemoterapije, z izjemo manjšega deleža plevralnega izliva pri pediatričnih bolnikih v primerjavi z odraslimi.
English: Pack size: 1 bottle
Slovenian: Velikost pakiranja: 1 plastenka
English: Original dose
Slovenian: Običajni odmerek
English: Breast-feeding should be stopped during treatment with SPRYCEL.
Slovenian: Med zdravljenjem z zdravilom SPRYCEL je treba prenehati z dojenjem.
English: If SPRYCEL is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Slovenian: V primeru uporabe zdravila SPRYCEL med nosečnostjo morate bolnici pojasniti možno tveganje za plod.
English: For the recommended paediatric dosage, SPRYCEL oral suspension contains 1.17 grams sucrose per 40 mg dasatinib and 4.37 grams sucrose per 150 mg dasatinib.
Slovenian: Pri priporočenem pediatričnem odmerku zdravilo SPRYCEL peroralna suspenzija vsebuje 1,17 grama saharoze na 40 mg dasatiniba in 4,37 gramov saharoze na 150 mg dasatiniba.
English: CHR (95% CI) 91% (88-94) 50% (42-58) 26% (18-35) 29% (17-44) 35% (21-50) NEL (95% CI)
Slovenian: CHR (95% IZ) 91% (88-94) 50% (42-58) 26% (18-35) 29% (17-44) 35% (21-50) NEL (95% IZ)
English: Myelosuppression is generally reversible and usually managed by withholding dasatinib temporarily or by dose reduction.
Slovenian: Mielosupresija je v splošnem reverzibilna in običajno nadzirana z začasno prekinitvijo zdravljenja z dasatinibom ali z zmanjšanjem odmerka.
English: • 1 SPRYCEL oral suspension bottle containing a white to yellow opaque suspension.
Slovenian: SPRYCEL peroralna suspenzija, ki vsebuje belo do rumeno neprozorno suspenzijo.
English: Patients with PAH reported during dasatinib treatment were often taking concomitant medicinal products or had co-morbidities in addition to the underlying malignancy.
Slovenian: Bolniki, pri katerih so med zdravljenjem z dasatinibom poročali o pojavu PAH, so se pogosto sočasno zdravili z drugimi zdravili ali pa so poleg osnovne maligne bolezni sočasno imeli še druge bolezni.
English: Therefore, concomitant use of potent CYP3A4 inducers with dasatinib is not recommended.
Slovenian: Sočasna uporaba močnih induktorjev CYP3A4 in dasatiniba torej ni priporočljiva.
English: There were 45 different BCR-ABL mutations in 38% of patients enrolled in this study.
Slovenian: Pri 38% bolnikov, vključenih v to študijo, je bilo ugotovljenih 45 različnih mutacij BCR-ABL.
English: Number of patients (%) Transformation at 60 months, n/N (%) Rate of PFS at 60 months (95% CI) Rate of OS at 60 months (95% CI)
Slovenian: Število bolnikov (%) Transformacija v 60. mesecu, n/N (%) Delež preživetja brez napredovanja bolezni v 60. mesecu (95% IZ) Delež celokupnega preživetja v 60. mesecu (95% IZ)
English: newly diagnosed Ph+ ALL in combination with chemotherapy.
Slovenian: z na novo diagnosticirano Ph+ ALL v kombinaciji s kemoterapijo.
English: Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg, 50 mg, 70 mg, 80 mg, 100 mg ali 140 mg dasatiniba (v obliki monohidrata).
English: Dasatinib exposure variability is higher under fasted conditions (47% CV) compared to light-fat meal (39% CV) and high-fat meal (32% CV) conditions.
Slovenian: Variabilnost izpostavljenosti dasatinibu je večja pri uporabi zdravila na tešče (KV 47 %) v primerjavi z uporabo zdravila skupaj z obrokom z nizko vsebnostjo maščob (KV 39 %) in obrokom z visoko vsebnostjo maščob (KV 32 %).
English: 85% of the radioactivity recovered in the urine and faeces, respectively.
Slovenian: radioaktivnosti so zasledili v urinu, 85% pa v blatu.
English: The powder for oral suspension consists of powder blend with the active substance plus excipients, contained within a bottle for constitution.
Slovenian: Prašek za peroralno suspenzijo je sestavljen iz praškaste mešanice z učinkovino in pomožnimi snovmi, ki so na voljo v plastenki za rekonstitucijo.
English: There were no mutations detected in newly diagnosed CML-CP patients at the end of treatment.
Slovenian: Pri bolnikih z na novo diagnosticirano KML-KO ob koncu zdravljenja mutacij niso odkrili.
English: Among 188 patients in paediatric studies, the median duration of therapy was 26.3 months (range 0 to 99.6 months).
Slovenian: Pri 188 bolnikih v pediatričnih študijah je mediana trajanja zdravljenja znašala 26,3 meseca (razpon 0 do 99,6 meseca).
English: Approximately 5% of the SPRYCEL-treated patients who had normal baseline levels experienced grade 3 or 4 transient hypocalcaemia at some time during the course of the study.
Slovenian: Pri približno 5% z zdravilom SPRYCEL zdravljenih bolnikov z normalnimi izhodiščnimi vrednostmi se je v določenem času med potekom študije pojavila prehodna hipokalciemija stopnje 3 ali 4.
English: The rate of MMR at any time in each risk group determined by Hasford score was higher in the SPRYCEL group compared with the imatinib group (low risk: 90% and 69%; intermediate risk: 71% and 65%; high risk: 67% and 54%, respectively).
Slovenian: Delež MMR v katerem koli času v vsaki skupini tveganja, opredeljeni z oceno po Hasfordu, je bil večji v skupini, ki je prejemala zdravilo SPRYCEL, kot v skupini, ki je prejemala imatinib (nizko tveganje: 90% oziroma 69%; srednje tveganje: 71% oziroma 65%; visoko tveganje: 67% oziroma
English: Thus, antacids may be administered up to 2 hours prior to or 2 hours following SPRYCEL (see section 4.4).
Slovenian: Bolnik lahko antacid vzame do 2 uri pred ali 2 uri po jemanju zdravila SPRYCEL (glejte poglavje 4.4).
English: Patients who develop symptoms suggestive of pleural effusion such as dyspnoea or dry cough should be evaluated by chest X-ray.
Slovenian: Pri bolnikih, pri katerih se pojavijo simptomi, ki kažejo na plevralni izliv, npr. dispneja ali suh kašelj, je treba opraviti rentgensko slikanje prsnega koša.
English: No clinically relevant age-related pharmacokinetic differences have been observed in these patients.
Slovenian: Pri teh bolnikih niso zasledili klinično pomembnih razlik v farmakokinetičnih lastnostih, povezanih s starostjo.
English: 1 Check if cytopaenia is related to leukaemia (marrow aspirate or biopsy).
Slovenian: 1 Preverite, če je citopenija povezana z levkemijo (aspiracija ali biopsija kostnega mozga).
English: The concomitant use of strong CYP3A4 inhibitors and grapefruit juice with SPRYCEL should be avoided (see section 4.5).
Slovenian: Sočasni uporabi močnih zaviralcev CYP3A4 in soka grenivke skupaj z zdravilom SPRYCEL se je treba izogibati (glejte poglavje 4.5).
English: At 3 months, a MCyR occurred more often in the dasatinib arm (36%) than in the imatinib arm (29%).
Slovenian: Po 3 mesecih je bil dober citogenetski odziv pogostejši v skupini, ki je prejemala dasatinib (36%) kot pa v skupini, ki je prejemala imatinib (29%).
English: These data should be considered if patients are to switch from tablets to powder for oral suspension or vice versa.
Slovenian: Te podatke je treba upoštevati, če bolniki preidejo z zdravljenja s tabletami na zdravljenje s peroralno suspenzijo ali obratno.
English: Table 4: Dose reduction for concomitant use of strong CYP3A4 inhibitors in paediatric patients
Slovenian: Preglednica 4: Zmanjšanje odmerka pri sočasni uporabi močnih zaviralcev CYP3A4 pri pediatričnih bolnikih
English: If you could be allergic, ask your doctor for advice.
Slovenian: Če mislite, da bi lahko bili alergični, se posvetujte z zdravnikom.
English: Selected adverse reactions that were reported in the recommended starting dose of 140 mg once daily are shown in Table 6b.
Slovenian: Izbrani neželeni učinki, o katerih so poročali pri uporabi priporočenega začetnega odmerka 140 mg enkrat na dan, so prikazani v preglednici 6b.
English: These reactions are presented by system organ class and by frequency.
Slovenian: Neželeni učinki so navedeni glede na organski sistem in pogostnost.
English: In adult and paediatric patients with chronic phase CML, complete blood counts should be performed every 2 weeks for 12 weeks, then every 3 months thereafter or as clinically indicated.
Slovenian: Pri odraslih in pediatričnih bolnikih s KML v kroničnem obdobju je treba preiskavo celotne krvne slike prvih 12 tednov zdravljenja izvajati na vsaka 2 tedna, nato pa na vsake 3 mesece, oziroma kot je to klinično indicirano.
English: There is no dose recommendation for SPRYCEL with children under 1 year of age.
Slovenian: Priporočila za odmerjanje zdravila SPRYCEL pri otrocih, mlajših od 1 leta, niso na voljo.
English: The median time to first dasatinib-related grade 1 or 2 pleural effusion was 114 weeks (range: 4 to 299 weeks).
Slovenian: Srednja vrednost časa do prvega z dasatinibom povezanega plevralnega izliva stopnje 1 ali 2 je bila 114 tednov (razpon: 4 do 299 tednov).
English: Minimum of 5 years follow up
Slovenian: Najmanj 5-letno spremljanje
English: Plasma concentration and measured in vitro activity indicate that metabolites of dasatinib are unlikely to play a major role in the observed pharmacology of the product.
Slovenian: Plazemska koncentracija in izmerjena aktivnost in vitro kažeta na majhno verjetnost, da bi lahko presnovki dasatiniba imeli pomembnejšo vlogo pri opazovanih farmakoloških učinkih zdravila.