FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Predklinični varnostni profil dasatiniba je bil ovrednoten z vrsto in vitro ter in vivo študij na miših, podganah, opicah in kuncih.
English: 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%.
Slovenian: V študiji pri zdravih osebah je enkratni odmerek famotidina, dan 10 ur pred enkratnim odmerkom zdravila SPRYCEL, zmanjšal izpostavljenost dasatinibu za 61%.
English: Benzoic acid/Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Slovenian: Benzojska kislina/sol benzoata lahko poveča tveganje za zlatenico (rumeno obarvanje kože in očesnih beločnic) pri novorojenčkih (do 4 tedna starosti).
English: The median duration of treatment for all patients still on therapy with a minimum of 5 years of follow-up (n=205) was 59 months (range 28-66 months).
Slovenian: Srednja vrednost trajanja zdravljenja vseh bolnikov, ki so se zdravili z najmanj 5-letnim obdobjem spremljanja (n=205), je bila 59 mesecev (razpon 28-66 mesecev).
English: If you or your child could be allergic, ask your doctor for advice.
Slovenian: Če mislite, da bi lahko bili vi ali vaš otrok alergični, se posvetujte z zdravnikom.
English: Follow up should be performed according to standard practice guidelines.
Slovenian: Diagnostiko PAH je treba izvesti v skladu z običajnimi smernicami.
English: Other medicines and SPRYCEL Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: A total of 46 dasatinib-treated patients had recurrent pleural effusions.
Slovenian: Skupno je 46 bolnikov, ki so se zdravili z dasatinibom, imelo ponavljajoče se plevralne izlive.
English: These include patients with hypokalaemia or hypomagnesaemia, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicinal products or other medicinal products which lead to QT prolongation, and cumulative high dose anthracycline therapy.
Slovenian: Sem so vključeni bolniki s hipokaliemijo ali hipomagneziemijo, bolniki s kongenitalnim sindromom podaljšanega intervala QT, bolniki, ki se zdravijo z antiaritmiki ali drugimi zdravili, ki lahko povzročijo podaljšanje intervala QT in bolniki, ki se zdravijo z visokimi kumulativnimi odmerki antraciklina.
English: What you need to know before you take SPRYCEL 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo SPRYCEL 3.
English: Body Weight (kg)a
Slovenian: Telesna masa (kg)a
English: Do not take medicines that neutralise stomach acids (antacids such as aluminium hydroxide or magnesium hydroxide) in the 2 hours before or 2 hours after taking SPRYCEL.
Slovenian: Zdravil, ki nevtralizirajo želodčno kislino (antacidi, kot sta aluminijev hidroksid ali magnezijev hidroksid), ne smete jemati 2 uri pred ali 2 uri po jemanju zdravila SPRYCEL.
English: Durability of response and estimated survival rates provide additional evidence of dasatinib clinical benefit.
Slovenian: Trajanje odziva in ocene deležev preživetja bolnikov dodatno potrjujejo klinično korist dasatiniba.
English: For third episode, further reduce dose to 50 mg once daily (for newly diagnosed patients) or discontinue (for patients resistant or intolerant to prior therapy including imatinib).
Slovenian: Pri tretji ponovitvi nadalje zmanjšajte odmerek do 50 mg enkrat na dan (pri bolnikih z na novo diagnosticirano boleznijo) ali zdravljenje prekinite (pri bolnikih, ki se na predhodna zdravljenja, vključno z imatinibom, niso odzvali ali jih niso prenašali).
English: Patients achieving early molecular response had a lower risk of transformation, higher rate of progression-free survival (PFS) and higher rate of overall survival (OS), as shown in Table 10.
Slovenian: Bolniki, ki so dosegli zgodnji molekularni odziv, so imeli manjše tveganje za transformacijo, višji delež preživetja brez napredovanja bolezni in višji delež celokupnega preživetja, kot je prikazano v preglednici 10.
English: If you are pregnant or think you may be pregnant, tell your doctor immediately.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči, to nemudoma povejte zdravniku.
English: Grade 3 or 4 pleural effusion may require thoracocentesis and oxygen therapy.
Slovenian: V primeru plevralnega izliva stopnje 3 ali 4 bo morda treba izvesti torakocentezo in uvesti zdravljenje s kisikom.
English: The efficacy of SPRYCEL in combination with chemotherapy was evaluated in a pivotal study in paediatric patients over one year of age with newly diagnosed Ph+ ALL.
Slovenian: Učinkovitost zdravila SPRYCEL v kombinaciji s kemoterapijo so vrednotili v ključni študiji pri pediatričnih bolnikih, starejših od enega leta, z na novo diagnosticirano Ph+ ALL.
English: Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the adverse reaction.
Slovenian: Nato se lahko z zdravljenjem nadaljuje, in sicer s primerno zmanjšanim odmerkom, odvisno od resnosti prvega pojava neželenega učinka.
English: These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signalling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.
Slovenian: Te predklinične študije kažejo, da lahko dasatinib premaga odpornost na imatinib, kar je posledica čezmerne ekspresije BCR-ABL, mutacij domene BCR-ABL kinaze, aktivacije alternativnih signalnih poti z vključitvijo kinaz iz družine SRC (LYN, HCK) in čezmerno ekspresijo gena za multiplo odpornost (“multidrug resistance gene”).
English: In addition, there were two studies in a total of 161 paediatric patients with Ph+ ALL in which SPRYCEL was administered in combination with chemotherapy.
Slovenian: Poleg tega pa sta bili izvedeni še dve študiji pri skupno 161 pediatričnih bolnikih s Ph+ ALL, v katerih so bolniki zdravilo SPRYCEL prejemali v kombinaciji s kemoterapijo.
English: In a two-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day.
Slovenian: V študiji kancerogenosti, ki je trajala dve leti, so podgane prejemale dnevne peroralne odmerke 0,3 mg/kg, 1 mg/kg in 3 mg/kg.
English: (95% CI) MCyRc
Slovenian: (95% IZ) MCyRc
English: a Results reported in recommended starting dose of 140 mg once daily (see section 4.2).
Slovenian: a Rezultati pri uporabi priporočenega začetnega odmerka 140 mg enkrat na dan (glejte poglavje 4.2).
English: Dose increase or reduction is recommended based on individual patient response and tolerability.
Slovenian: Priporoča se povečanje ali zmanjšanje odmerka na osnovi odziva in prenašanja zdravila pri vsakem posameznem bolniku.
English: The rates of MCyR at 2 years were similar whether patients had any baseline BCR-ABL mutation, P-loop mutation, or no mutation (63%, 61% and 62%, respectively).
Slovenian: Po 2 letih so bili deleži dobrega citološkega odziva podobni ne glede na to, če je bila v izhodišču prisotna katera koli mutacija BCR-ABL, P-loop mutacija ali pa mutacija ni bila prisotna (63%, 61% oziroma 62%).
English: The overall mean terminal half-life of dasatinib is approximately 5-6 hours in patients.
Slovenian: Celotna srednja končna razpolovna doba dasatiniba je pri bolnikih približno 5 do 6 ur.
English: Dasatinib was studied in a randomised clinical study of 519 patients with newly diagnosed CML in chronic phase which included patients with prior cardiac disease.
Slovenian: Uporabo dasatiniba so raziskovali v randomizirani klinični študiji pri 519 bolnikih z na novo diagnosticirano KML v kroničnem obdobju, vključno z bolniki, ki so že predhodno imeli znano bolezen srca.
English: MCyR (0%-35%) combines both complete and partial responses.
Slovenian: MCyR (0%-35%) je kombinacija obeh, popolnega in delnega odziva.
English: Dasatinib PK showed dose proportionality with a dose-related increase in exposure observed in paediatric patients.
Slovenian: Farmakokinetika dasatiniba je pokazala sorazmernost z od odmerka odvisnim povečanjem izpostavljenosti pri pediatričnih bolnikih.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke in škatli poleg oznake “EXP”.
English: Dosing is on the basis of body weight (see Table 1).
Slovenian: Odmerjanje temelji na telesni masi (glejte preglednico 1).
English: In addition to imatinib, 35% of patients had received prior cytotoxic chemotherapy, 65% had received prior interferon, and 10% had received a prior stem cell transplant.
Slovenian: Razen z imatinibom se je 35% bolnikov predhodno zdravilo tudi s citotoksično kemoterapijo, 65% bolnikov z interferonom, pri 10% bolnikov pa je bila predhodno opravljena presaditev krvotvornih matičnih celic.
English: i Gravitational oedema, localised oedema, oedema peripheral.
Slovenian: i Gravitacijski edem, lokalizirani edem in periferni edem.
English: if you experience bruising, bleeding, fever, fatigue and confusion when taking SPRYCEL, contact your doctor.
Slovenian: če se pojavijo modrice, krvavitve, zvišana telesna temperatura, omotica in zmedenost v času zdravljenja z zdravilom SPRYCEL se posvetujte z zdravnikom.
English: Following oral administration, the increase in the mean exposure (AUCτ) is approximately proportional to the dose increment across doses ranging from 25 mg to 120 mg twice daily.
Slovenian: Po peroralnem dajanju se srednja izpostavljenost (AUCτ) povečuje približno sorazmerno s povečevanjem odmerka v razponu odmerkov od 25 mg do 120 mg dvakrat na dan.
English: The pharmacokinetics of dasatinib have been evaluated in 104 paediatric patients with leukaemia or solid tumours (72 who received the tablet formulation and 32 who received the powder for oral suspension).
Slovenian: Farmakokinetiko dasatiniba so ovrednotili pri 104 pediatričnih bolnikih z levkemijo ali s solidnimi tumorji (72 jih je prejemalo zdravilo v obliki tablet, 32 pa v obliki praška za peroralno suspenzijo).
English: Prior imatinib (N = 46)b
Slovenian: Predhodno imatinib (N = 46)b
English: The geometric means of dosenormalized dasatinib Cmax, AUC (0-T), and AUC (INF) appeared to be similar between children and adolescents at different dose levels.
Slovenian: Kaže, da so geometrijske srednje, na odmerek normalizirane vrednosti Cmax, AUC (0-T) in AUC (INF) pri otrocih in mladostnikih pri različnih velikostih odmerka podobne.
English: The median duration of dasatinib-related pleural effusion (all grades) was 283 days (~40 weeks).
Slovenian: Srednja vrednost časa trajanja z dasatinibom povezanega plevralnega izliva (vse stopnje) je bila 283 dni (~40 tednov).
English: Complete haematologic response or MCyR was achieved in patients harbouring a variety of BCR-ABL mutations associated with imatinib resistance except T315I.
Slovenian: Popoln hematološki odziv ali dober citogenetski odziv je bil dosežen pri bolnikih, pri katerih so bile prisotne različne mutacije BCR-ABL, povezane z odpornostjo na imatinib, razen mutacije T315I.
English: Among dasatinib-treated CML-CP paediatric patients previously exposed to imatinib, the mutations detected at the end of treatment were: T315A, E255K and F317L.
Slovenian: Pri pediatričnih bolnikih s KML-KO, ki so se zdravili z dasatinibom, in so bili predhodno izpostavljeni imatinibu, so ob koncu zdravljenja odkrili naslednje mutacije: T315A, E255K in F317L.
English: SPRYCEL is not to be used during pregnancy unless clearly necessary.
Slovenian: Zdravila SPRYCEL se med nosečnostjo ne sme uporabljati, če to ni nujno potrebno.
English: During the consolidation blocks of chemotherapy, CBCs should be performed every 2 days until recovery (see sections 4.2 and 4.8).
Slovenian: Med bloki konsolidacijske kemoterapije je treba preiskavo celotne krvne slike izvajati vsaka 2 dni do izboljšanja (glejte poglavji 4.2 in 4.8).
English: Paediatric population (Ph+ CML-CP and Ph+ ALL)
Slovenian: Pediatrična populacija (Ph+ KML-KO in Ph+ ALL)
English: MR4.5 rates over time are displayed graphically in Figure 3.
Slovenian: Deleži MR4.5 glede na čas so grafično prikazani na sliki 3.
English: If you take more SPRYCEL than you should
Slovenian: Če citopenija traja več kot
English: Once constituted, the bottle contains 99 mL of oral suspension, of which 90 mL is intended for dosing and administration.
Slovenian: Po rekonstituciji plastenka vsebuje 99 ml peroralne suspenzije od katerih je 90 ml namenjenih odmerjanju in aplikaciji.
English: The minimal residual disease (MRD) negativity rate assessed by Ig/TCR rearrangement was 71.7% by the end of consolidation in all treated patients.
Slovenian: Negativni delež minimalne rezidualne bolezni (MRD - minimal residual disease), ocenjen s preureditvijo Ig/TCR do konca konsolidacije pri vseh zdravljenih bolnikih je znašal 71,7%.
English: Common depression, insomnia
Slovenian: Pogosti depresija, nespečnost
English: Refer to the package leaflet for more detailed instructions for use.
Slovenian: Za podrobnejša navodila za uporabo glejte navodilo za uporabo.
English: Rare leukocytoclastic vasculitis, skin fibrosis
Slovenian: Redki levkocitoklastični vaskulitis, kožna fibroza
English: Durability of cCCyR
Slovenian: Trajanje cCCyR
English: (95% CI) NELb
Slovenian: (95% IZ) NELb
English: In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy.
Slovenian: V kliničnih študijah so mielosupresijo nadzirali s prekinitvijo zdravljenja, z zmanjšanjem odmerka ali izključitvijo iz študijskega zdravljenja.
English: Responses were durable across all phases of CML and Ph+ ALL.
Slovenian: Odzivi so se ohranili v vseh obdobjih KML in Ph+ ALL.
English: The starting dose of SPRYCEL for children is calculated by body weight as shown below:
Slovenian: Začetni odmerek zdravila SPRYCEL za otroka se izračuna na osnovi telesne mase, kot je prikazano v nadaljevanju:
English: The cumulative rate of dasatinib-related pleural effusion (all grades) over time was 10% at 12 months, 14% at 24 months, 19% at 36 months, 24% at 48 months and 28% at 60 months.
Slovenian: Kumulativni delež plevralnega izliva (vseh stopenj), povezanega z uporabo dasatiniba, je po 12 mesecih znašal 10%, po 24 mesecih 14%, po 36 mesecih 19%, po 48 mesecih 24 % in po 60 mesecih 28%.
English: In mice, dasatinib induced immunosuppression, which was dose-related and effectively managed by dose reduction and/or changes in dosing schedule.
Slovenian: Pri miših je dasatinib povzročil imunosupresijo, ki je bila odvisna od odmerka in se je lahko učinkovito nadzirala z zmanjšanjem odmerka in/ali spremembo odmerne sheme.
English: GROUP
Slovenian: SKUPINA
English: 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%.
Slovenian: Pri zdravih osebah se je pri sočasni uporabi aluminijevega hidroksida/magnezijevega hidroksida in zdravila SPRYCEL AUC enkratnega odmerka zdravila SPRYCEL zmanjšala za 55%, Cmax pa za 58%.
English: These instructions show you how to give a dose of SPRYCEL oral suspension to the patient.
Slovenian: Ta navodila pojasnjujejo dajanje odmerka zdravila SPRYCEL peroralna suspenzija bolniku.
English: SPRYCEL with food and drink Do not take SPRYCEL with grapefruit or grapefruit juice.
Slovenian: Zdravilo SPRYCEL skupaj s hrano in pijačo Zdravila SPRYCEL ne smete jemati skupaj z grenivko ali s sokom grenivke.
English: Median duration of treatment for all patients at 7 years of follow-up was 29.8 months (range < 1-92.9 months).
Slovenian: Srednja vrednost trajanja zdravljenja vseh bolnikov pri 7-letnem obdobju spremljanja je bila 29,8 meseca (razpon < 1-92,9 meseca).
English: The rate of major molecular response at 24 months was 45% (35% for imatinib-resistant patients and 74% for imatinib-intolerant patients).
Slovenian: Delež dobrega molekularnega odziva po 24 mesecih je bil 45% (35% pri bolnikih, odpornih na imatinib, in 74% pri bolnikih, ki imatiniba niso prenašali).
English: The highest dose resulted in a plasma exposure (AUC) level generally equivalent to the human exposure at the recommended range of starting doses from 100 mg to 140 mg daily.
Slovenian: Pri uporabi največjega odmerka je bil nivo plazemske izpostavljenosti (AUC) ekvivalenten izpostavljenosti pri človeku pri uporabi priporočenih začetnih odmerkov od 100 mg do 140 mg na dan.
English: CCyR (95% CI) 54% (48-59) 33% (26-41) 27% (19-36) 46% (31-61) 54% (39-69)
Slovenian: CCyR (95% IZ) 54% (48-59) 33% (26-41) 27% (19-36) 46% (31-61) 54% (39-69)
English: Efficacy results are presented in Tables 12 and 13.
Slovenian: Rezultati učinkovitosti so predstavljeni v preglednici 12 in preglednici 13.
English: In a paediatric pharmacokinetics study, dose-normalized dasatinib exposure (Cavg, Cmin and Cmax) appears similar between 21 patients with CP-CML and 16 patients with Ph+ ALL.
Slovenian: V pediatrični farmakokinetični študiji je bila izpostavljenost dasatinibu (Cavg, Cmin in Cmax), normalizirana glede na odmerek, pri 21 bolnikih s KO-KML videti podobna kot pri 16 bolnikih s Ph+ ALL.
English: Pleural effusion was usually reversible and managed by interrupting SPRYCEL treatment and using diuretics or other appropriate supportive care measures (see sections 4.2 and 4.4).
Slovenian: Plevralni izliv je bil običajno reverzibilen, zdravili pa so ga s prekinitvijo zdravljenja z zdravilom SPRYCEL in uporabo diuretikov ali drugih ustreznih podpornih ukrepov (glejte poglavji 4.2 in 4.4).
English: There is limited experience with the use of SPRYCEL in this age group.
Slovenian: Izkušenj z uporabo zdravila SPRYCEL v tej starostni skupini je malo.
English: Table 5: Tabulated summary of adverse reactions
Slovenian: Preglednica 5: Tabelarični pregled neželenih učinkov
English: Imatinib-resistant patients n=124
Slovenian: Bolniki, odporni na imatinib n=124
English: There were 33 newly diagnosed paediatric patients with CML-CP who received SPRYCEL powder for oral suspension at a dose of 72 mg/m2.
Slovenian: Vključenih je bilo 33 pediatričnih bolnikov z na novo diagnosticirano KML-KO, ki so prejemali zdravilo SPRYCEL prašek za peroralno suspenzijo v odmerku 72 mg/m2.
English: Constitution in this way produces 90 mL (deliverable volume) of 10 mg/mL SPRYCEL oral suspension.
Slovenian: Na ta način pri rekonstituciji nastane 90 ml (uporabni volumen) 10 mg/ml SPRYCEL peroralne suspenzije.
English: Accelerated phase CML
Slovenian: KML v obdobju pospešenega poteka
English: 3 If recurrence of cytopaenia, repeat step 1 and resume treatment at a reduced dose of 100 mg once daily (second episode) or 80 mg once daily (third episode).
Slovenian: 3 Če se citopenija ponovi, ponovite postopek, opisan pod zaporedno številko 1, in nato ponovno uvedite zdravljenje, in sicer z zmanjšanim odmerkom 100 mg enkrat na dan (druga ponovitev) ali 80 mg enkrat na dan (tretja ponovitev).
English: Similar rates of mutation were observed in both the treatment arms.
Slovenian: V obeh skupinah zdravljenja so poročali o podobnih deležih mutacij.
English: Gastrointestinal toxicity was dose-limiting in rats and monkeys, as the intestine was a consistent target organ.
Slovenian: Pri podganah in opicah je bila gastrointestinalna toksičnost omejena z odmerkom; črevo je bilo konsistentno ciljni organ.
English: How to split a dose that is greater than 11 mL Total prescribed dose (mL)
Slovenian: Kako razdeliti odmerek, ki je večji od 11 ml
English: 70 mg at least 45 kg
Slovenian: 70 mg najmanj 45 kg
English: In the pivotal study, 106 paediatric patients received SPRYCEL in combination with chemotherapy on a continuous dosing regimen.
Slovenian: V ključni študiji je 106 pediatričnih bolnikov prejemalo zdravilo SPRYCEL v kombinaciji s kemoterapijo po režimu neprekinjenega odmerjanja.
English: In patients who report disease progression or discontinue dasatinib or imatinib therapy, BCR-ABL sequencing was performed on blood samples from patients where these are available.
Slovenian: Pri bolnikih, pri katerih je bolezen pri zdravljenju z dasatinibom ali imatinibom napredovala ali pa je bilo zdravljenje z dasatinibom ali imatinibom prekinjeno, so na krvnih vzorcih bolnikov, ki so bili na voljo, izvedli sekvenciranje BCR-ABL.
English: SPRYCEL powder for oral suspension contains approximately 0.29 g/mL of sucrose upon constitution with water.
Slovenian: Zdravilo SPRYCEL prašek za peroralno suspenzijo vsebuje približno 0,29 g/ml saharoze po rekonstituciji z vodo.
English: No specific dose recommendation is necessary in elderly.
Slovenian: Posebna priporočila za odmerjanje pri starostnikih niso potrebna.
English: Guidelines for dose reduction for paediatric patients in whom SPRYCEL powder for oral suspension must be administered with a strong CYP3A4 inhibitor are shown in Table 4.
Slovenian: Smernice za zmanjšanje odmerka pri pediatričnih bolnikih, pri katerih se mora zdravilo SPRYCEL prašek za peroralno suspenzijo uporabljati skupaj z močnim zaviralcem CYP3A4 so prikazane v preglednici 4.
English: Based on the findings from a single-dose pharmacokinetic study, patients with mild, moderate or severe hepatic impairment may receive the recommended starting dose (see section 5.2).
Slovenian: Glede na ugotovitve farmakokinetične študije z enkratnim odmerkom se pri bolnikih z blago, zmerno ali s hudo okvaro jeter zdravljenje lahko uvede s priporočenim začetnim odmerkom (glejte poglavje 5.2).
English: Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and pericardial effusion with or without superficial oedema may be collectively described as “fluid retention”.
Slovenian: Raznovrstni neželeni učinki, kot so plevralni izliv, ascites, pljučni edem in perikardialni izliv s površinskimi edemi ali brez, se lahko enotno opredelijo kot “zastajanje tekočin”.
English: After a minimum of 60 months follow-up the cumulative rate of permanent discontinuation due to grade 3 or 4 myelosuppression was 2.3%.
Slovenian: Po najmanj 60-mesečnem obdobju spremljanja je kumulativni delež trajne prekinitve zdravljenja zaradi pojava mielosupresije stopnje 3 ali 4 znašal 2,3%.
English: at least 45 kg
Slovenian: najmanj 45 kg
English: The tablets may come in packs with calendar blisters.
Slovenian: Tablete se lahko nahajajo v pakiranjih, ki vsebujejo koledarsko označene pretisne omote.
English: h Frequency reported as common in paediatric studies.
Slovenian: h Pogostnost v pediatričnih študijah navedena kot pogosti.
English: Patients developing grade 3 or 4 hypocalcaemia often had recovery with oral calcium supplementation.
Slovenian: Bolniki, pri katerih se je pojavila hipokalciemija stopnje 3 ali 4, so pogosto okrevali po peroralnem nadomeščanju kalcija.
English: Remove the closure from the bottle.
Slovenian: Odstranite zaporko s plastenke.
English: Following resolution of a severe (grade 3 or 4) episode, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the adverse reaction.
Slovenian: Ko bolnik okreva po hudi epizodi (stopnja 3 ali 4), se zdravljenje lahko nadaljuje z ustrezno zmanjšanim odmerkom, odvisno od začetne jakosti neželenega učinka.
English: The effect of hepatic impairment on the single-dose pharmacokinetics of dasatinib was assessed in 8 moderately hepatic-impaired subjects who received a 50 mg dose and 5 severely hepatic-impaired subjects who received a 20 mg dose compared to matched healthy subjects who received a 70 mg dose of dasatinib.
Slovenian: Vpliv okvare jeter na farmakokinetiko enkratnega odmerka dasatiniba so ovrednotili pri osmih osebah z zmerno okvaro jeter, ki so prejele 50 mg odmerek, in petih osebah s hudo okvaro jeter, ki so prejele 20 mg odmerek, in jo primerjali s primerljivimi zdravimi osebami, ki so prejele 70 mg odmerek dasatiniba.
English: Response rates are presented in Table 14.
Slovenian: Deleži odziva so predstavljeni v preglednici 14.