FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: faze pri bolnikih, ki so prejemali zdravilo v obliki tablet, je ocenjeni delež 24mesečnega preživetja brez napredovanja bolezni (PFS) pri 51 bolnikih z na novo diagnosticirano KML-KO znašal 94,0% (82,6; 98,0), pri 29 bolnikih s KML-KO, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali pa 81,7% (61,4; 92,0).
English: With a minimum of 24 months follow-up, 21 of the 240 patients who had achieved a MCyR had progressed and the median duration of MCyR had not been reached.
Slovenian: Pri spremljanju, ki je trajalo najmanj 24 mesecev, je do napredovanja bolezni prišlo pri 21 od 240 bolnikov, pri katerih je bil dosežen dober citogenetski odziv.
English: Rates of MR4.5 over time were consistently higher in dasatinib-treated patients compared with imatinib-treated patients.
Slovenian: Pri bolnikih, ki so se zdravili z dasatinibom, so bili deleži MR4.5 glede na čas konsistentno višji kot pri bolnikih, ki so se zdravili z imatinibom.
English: SPRYCEL 80 mg, SPRYCEL 100 mg and SPRYCEL 140 mg film-coated tablets Alu/Alu blisters (perforated unit dose blisters).
Slovenian: SPRYCEL 80 mg, SPRYCEL 100 mg in SPRYCEL 140 mg filmsko obložene tablete Alu/Alu pretisni omoti (perforirani enoodmerni pretisni omoti).
English: Carton containing one bottle with 30 film-coated tablets.
Slovenian: Škatla z eno plastenko s 30 filmsko obloženimi tabletami.
English: Minimum of 2 years follow up
Slovenian: Najmanj 2-letno spremljanje
English: Each pack also contains a press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe in a sealed plastic bag.
Slovenian: Vsako pakiranje vsebuje tudi nastavek, ki se ga potisne v plastenko in 12 ml brizgo za peroralno dajanje v zapečateni plastični vreči.
English: The concomitant use of dasatinib and a histamine-2 (H2) antagonist (e.g. famotidine), proton pump inhibitor (e.g. omeprazole), or aluminium hydroxide/magnesium hydroxide may reduce the exposure to dasatinib.
Slovenian: Pri sočasni uporabi dasatiniba in antagonistov histaminskih receptorjev H2 (npr. famotidin), zaviralcev protonske črpalke (npr. omeprazol) ali aluminijevega hidroksida/magnezijevega hidroksida se lahko izpostavljenost dasatinibu zmanjša.
English: Holding the syringe tip firmly into the bottle, turn the bottle with the syringe upside down.
Slovenian: Konico brizge trdno držite v plastenki in plastenko obrnite tako, da bo brizga obrnjena navzdol.
English: Accelerated (n= 174)
Slovenian: Obdobje pospešenega poteka (n = 174)
English: In patients with chronic phase CML (n=548), 5 patients (1%) receiving dasatinib had grade 3 or 4 haemorrhage.
Slovenian: Pri bolnikih s KML v kroničnem obdobju (n=548) so se krvavitve stopnje 3 ali 4 pojavile pri 5 bolnikih (1%), ki so prejemali dasatinib.
English: In severely hepatic-impaired subjects, the mean Cmax and AUC adjusted for the 70 mg dose were decreased by 43% and 28%, respectively, compared to subjects with normal hepatic function (see sections 4.2 and 4.4).
Slovenian: Srednji vrednosti Cmax in AUC, prilagojeni na 70 mg odmerek dasatiniba, sta bili v primerjavi z osebami z normalnim delovanjem jeter manjši tudi pri osebah s hudo okvaro jeter, in sicer Cmax za 43%, AUC pa za 28% (glejte poglavji 4.2 in 4.4).
English: Carton containing one bottle with 60 film-coated tablets.
Slovenian: Škatla z eno plastenko s 60 filmsko obloženimi tabletami.
English: In the Phase III newly diagnosed chronic phase CML study, the following grade 3 or 4 laboratory abnormalities were reported after a minimum of 12 months follow-up in patients taking SPRYCEL: neutropaenia (21%), thrombocytopaenia (19%), and anaemia (10%).
Slovenian: V študiji III. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju so po najmanj 12-mesečnem obdobju spremljanja pri bolnikih, ki so se zdravili z zdravilom SPRYCEL, poročali o naslednjih odstopanjih stopnje 3 ali 4 od normalnih vrednosti laboratorijskih preiskav: nevtropenija (21%), trombocitopenija (19%) in anemija (10%).
English: 5 to less than 10 kg
Slovenian: 5 do manj kot 10 kg
English: Therefore, there is a potential for interaction with other concomitantly administered medicinal products that are metabolised primarily by or modulate the activity of CYP3A4 (see section 4.5).
Slovenian: Pri sočasnem zdravljenju z drugimi zdravili, ki se presnavljajo predvsem s CYP3A4 ali spreminjajo njegovo aktivnost, torej obstaja možnost medsebojnega delovanja (glejte poglavje 4.5).
English: Rare cerebrovascular accident, transient ischaemic attack, convulsion, optic neuritis, VIIth nerve paralysis, dementia, ataxia
Slovenian: Redki cerebrovaskularni akcident, tranzitorna ishemična ataka, konvulzije, vnetje vidnega živca, paraliza sedmega možganskega živca, demenca, ataksija
English: 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).
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom SPRYCEL, je treba namesto antagonistov histaminskih receptorjev H2 ali zaviralcev protonske črpalke uporabljati antacide (glejte poglavje 4.4).
English: Other medicinal products that induce CYP3A4 activity (e.g. dexamethasone, phenytoin, carbamazepine, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St. John´s Wort) may also increase metabolism and decrease dasatinib plasma concentrations.
Slovenian: Druga zdravila, ki inducirajo aktivnost CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, fenobarbital ali zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum)) lahko prav tako povečajo presnovo in zmanjšajo plazemske koncentracije dasatiniba.
English: The estimated 60-month survival rates for dasatinib and imatinib-treated patients were 90.9% (CI: 86.6% - 93.8%) and 89.6% (CI: 85.2% - 92.8%), respectively.
Slovenian: Ocenjeni delež 60-mesečnega preživetja je bil v skupini, ki je prejemala dasatinib 90,9% (IZ: 86,6% - 93,8%), v skupini, ki je prejemala imatinib, pa 89,6% (IZ: 85,2% - 92,8%).
English: Two-level dose reduction
Slovenian: Odmerek, zmanjšan za dve stopnji
English: In CML-CP paediatric patients with non-haematologic adverse reactions, the dose reduction recommendations for haematologic adverse reactions that are described above should be followed.
Slovenian: Pri bolnikih s KML-KO z nehematološkimi neželenimi učinki je treba upoštevati priporočila za zmanjšanje odmerka v primeru pojava hematoloških neželenih učinkov, opisanih zgoraj.
English: In paediatric trials of SPRYCEL in combination with chemotherapy in newly diagnosed Ph+ ALL paediatric patients after a maximum of 2 years of treatment, treatment-related adverse events associated with bone growth and development were reported in 1 (0.6%) patient.
Slovenian: V pediatričnih preskušanjih uporabe zdravila SPRYCEL v kombinaciji s kemoterapijo so pri pediatričnih bolnikih z na novo diagnosticirano Ph+ ALL po največ 2 letih zdravljenja pri 1 (0,6%) bolniku poročali o z zdravljenjem povezanem neželenem dogodku na rast in razvoj kosti.
English: What SPRYCEL contains The active substance is dasatinib.
Slovenian: Kaj vsebuje zdravilo SPRYCEL Učinkovina je dasatinib.
English: Daily Dose, mL (mg)
Slovenian: Dnevni odmerek, ml (mg)
English: Table 6b: Selected adverse reactions reported in phase III dose-optimisation study: Advanced phase CML and Ph+ ALLa
Slovenian: Preglednica 6b: Izbrani neželeni učinki, o katerih so poročali v študiji III. faze za določitev optimalnega odmerka: KML v napredovalem obdobju in Ph+ ALLa
English: The rate of major molecular response (assessed in 41 patients with a CCyR) was 46% at 24 months.
Slovenian: Delež dobrega molekularnega odziva (ovrednoten pri 41 bolnikih s popolnim citogenetskim odzivom) je bil po 24 mesecih 46%.
English: SPRYCEL contains 0.017 mg benzyl alcohol in each mL of oral suspension.
Slovenian: Zdravilo SPRYCEL vsebuje 0,017 mg benzilalkohola v enem ml peroralne suspenzije.
English: Dose reduction
Slovenian: Zmanjšani odmerek
English: MCyR (95% CI)
Slovenian: MCyR (95% IZ)
English: A total of 109 patients received dasatinib 70 mg twice daily (99 resistant and 10 intolerant to imatinib).
Slovenian: Dasatinib v odmerku 70 mg dvakrat na dan je skupaj prejemalo 109 bolnikov (99 rezistentnih in 10 intolerantnih na imatinib).
English: Guidelines for dose modifications in adults are summarised in Table 3 and in paediatric patients with Ph+ CML-CP in Table 4.
Slovenian: Smernice za prilagoditev odmerka pri odraslih so povzete v preglednici 3, pri pediatričnih bolnikih s Ph+ KML-KO pa v preglednici 4.
English: The main secondary endpoint was MCyR by total daily dose level in the imatinib-resistant patients.
Slovenian: Glavni sekundarni opazovani dogodek je bil dober citogenetski odziv glede na skupni dnevni odmerek pri bolnikih z odpornostjo na imatinib.
English: 30 to less than 45 kg
Slovenian: 30 do manj kot 45 kg
English: ANC < 0.5 x 109/L and/or platelets < 10 x 109/L
Slovenian: Absolutno število nevtrofilcev < 0,5 x 109/l in/ali trombocitov < 10 x 109/l
English: c Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial (> 0%-35%).
Slovenian: c Kriteriji citogenetskega odziva: popolni (0% Ph+ metafaze) ali delni (> 0%-35%).
English: The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used for these patients.
Slovenian: Pri bolnikih s telesno maso, manjšo od 10 kg, uporaba tablet ni priporočljiva; pri teh bolnikih je treba uporabljati prašek za peroralno suspenzijo.
English: SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets
Slovenian: SPRYCEL 20 mg filmsko obložene tablete SPRYCEL 50 mg filmsko obložene tablete SPRYCEL 70 mg filmsko obložene tablete SPRYCEL 80 mg filmsko obložene tablete SPRYCEL 100 mg filmsko obložene tablete SPRYCEL 140 mg filmsko obložene tablete
English: Efficacy was achieved across all dasatinib treatment groups with the once daily schedule demonstrating comparable efficacy (non-inferiority) to the twice daily schedule on the primary efficacy endpoint (difference in MCyR 1.9%; 95% confidence interval [-6.8% - 10.6%]); however, the 100 mg once daily regimen demonstrated improved safety and tolerability.
Slovenian: Pri režimu odmerjanja enkrat na dan je bila učinkovitost pri primarnem opazovanem dogodku primerljiva (enakovredna) z učinkovitostjo pri režimu odmerjanja dvakrat na dan (razlika pri dobrem citogenetskem odzivu 1,9%; 95% interval zaupanja [-6,8% - 10,6%]), vendar pa je bil režim odmerjanja 100 mg enkrat na dan povezan z boljšo varnostjo in prenašanjem.
English: In people with CML, white cells called granulocytes start growing out of control.
Slovenian: Pri bolnikih s KML se bele krvne celice, imenovane granulociti, nenadzorovano delijo.
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.
Slovenian: V študiji III. faze za določitev optimalnega odmerka pri bolnikih s KML v napredovalem obdobju ali s Ph+ ALL so o povišanju vrednosti transaminaz ali bilirubina stopnje 3 ali 4 poročali pri od 1% do 5% bolnikov v vseh zdravljenih skupinah.
English: ANC < 0.5 x 109/L and/or platelets < 50 x 109/L
Slovenian: Absolutno število nevtrofilcev < 0,5 x 109/l in/ali trombocitov < 50 x 109/l
English: A prior MCyR to imatinib was achieved in 28% and 29% of the patients in the dasatinib and imatinib arms, respectively.
Slovenian: Predhodni dober citogenetski odziv (MCyR) na imatinib je bil dosežen pri 28% bolnikov v skupini, ki je prejemala dasatinib, in 29% bolnikov v skupini, ki je prejemala imatinib.
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.
Slovenian: V skupini 258 bolnikov, ki so prejemali dasatinib in v skupini 258 bolnikov, ki so prejemali imatinib v študiji III. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju, so po najmanj 60 mesečnem obdobju spremljanja o podaljšanju intervala QTc kot neželenem učinku poročali pri 1 bolniku (< 1%) iz vsake skupine.
English: Adults with accelerated and blast phase CML and Ph+ ALL (starting dose 140 mg once daily)
Slovenian: Odrasli s KML v obdobju pospešenega poteka in obdobju blastne preobrazbe ter Ph+ ALL (začetni odmerek 140 mg enkrat na dan)
English: In patients who experienced grade 3 or 4 myelosuppression, recovery generally occurred following brief dose interruptions and/or reductions and permanent discontinuation of treatment occurred in 5% of patients.
Slovenian: Bolniki z mielosupresijo stopnje 3 ali 4 so običajno okrevali po kratki prekinitvi zdravljenja in/ali zmanjšanju odmerka.
English: c Cytogenetic response criteria: complete (0% Ph+ metaphases) or partial (>0%-35%).
Slovenian: c Kriteriji citogenetskega odziva: popolni (0% Ph+ metafaze) ali delni (> 0% - 35%).
English: Phase III clinical studies in patients with CML in chronic, accelerated, or myeloid blast phase, and Ph+ ALL who were resistant or intolerant to imatinib
Slovenian: Klinične študije III. faze pri bolnikih s KML v kroničnem obdobju, obdobju pospešenega poteka ali mieloblastne preobrazbe in pri bolnikih s Ph+ ALL, ki se na predhodno zdravljenje z imatinibom niso odzvali ali ga niso prenašali
English: SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 80 mg film-coated tablets SPRYCEL 100 mg film-coated tablets SPRYCEL 140 mg film-coated tablets dasatinib
Slovenian: SPRYCEL 20 mg filmsko obložene tablete SPRYCEL 50 mg filmsko obložene tablete SPRYCEL 70 mg filmsko obložene tablete SPRYCEL 80 mg filmsko obložene tablete SPRYCEL 100 mg filmsko obložene tablete SPRYCEL 140 mg filmsko obložene tablete dasatinib
English: After constitution, shake bottle well before each use.
Slovenian: peroralna uporaba po rekonstituciji Po rekonstituciji plastenko pred vsako uporabo dobro pretresite.
English: Figure 3: MR4.5 rates over time - all randomised patients in a phase 3 study of newly diagnosed patients with chronic phase CML
Slovenian: Deleži MR4.5 glede na čas - vsi randomizirani bolniki v študiji 3. faze, izvedeni pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju
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.
Slovenian: Pri sočasni uporabi dasatiniba in zdravil ali snovi, ki močno zavirajo CYP3A4 (npr. ketokonazol, itrakonazol, eritromicin, klaritromicin, ritonavir, telitromicin, sok grenivke) se lahko poveča izpostavljenost dasatinibu.
English: Lymphoid blast (n= 33)
Slovenian: Obdobje limfoblastne preobrazbe (n= 33)
English: Your doctor will decide the right dose based on your weight.
Slovenian: Ustrezen odmerek bo določil zdravnik na osnovi telesne mase.
English: Rare protein-losing gastroenteropathy, ileus, anal fistula
Slovenian: Redki eksudativna gastroenteropatija, ileus, analna fistula
English: Uncommon anxiety, confusional state, affect lability, libido decreased Nervous system disorders
Slovenian: Občasni anksioznost, zmedenost, čustvena labilnost, zmanjšan libido
English: if you have a liver or heart problem, or used to have one if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older), or due to changes in the blood vessels supplying the lungs if you have ever had or might now have a hepatitis B infection.
Slovenian: če jemljete zdravila za redčenje krvi ali preprečevanje nastanka krvnih strdkov (glejte “Druga zdravila in zdravilo SPRYCEL”) če imate težave z jetri ali s srcem, ali ste jih imeli v preteklosti če med jemanjem zdravila SPRYCEL začnete težko dihati, začutite bolečino v prsih ali začnete kašljati, je to lahko znak zastajanja tekočine v pljučih ali prsnem košu (kar je lahko pogostejše pri bolnikih, starih 65 let ali starejših) ali posledica sprememb v krvnih žilah, ki s krvjo oskrbujejo pljuča če ste kdaj bili ali ste okuženi z virusom hepatitisa B. Zdravilo SPRYCEL namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
English: Very common side effects (may affect more than 1 in 10 people) Infections (including bacterial, viral and fungal) Heart and lungs: shortness of breath
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) Okužbe (vključno z bakterijskimi, virusnimi in glivičnimi okužbami).
English: An echocardiography should be performed at treatment initiation in every patient presenting symptoms of cardiac disease and considered in patients with risk factors for cardiac or pulmonary disease.
Slovenian: O elektrokardiografiji je treba razmisliti tudi pri bolnikih z dejavniki tveganja za srčno ali pljučno bolezen.
English: (n= 387)
Slovenian: Kronično obdobje (n = 387)
English: Thus, H2 antagonists and proton pump inhibitors are not recommended and aluminium hydroxide/magnesium hydroxide products should be administered up to 2 hours prior to, or 2 hours following the administration of dasatinib (see section 4.5).
Slovenian: Zdravila z aluminijevim hidroksidom/magnezijevim hidroksidom mora bolnik vzeti najmanj 2 uri pred ali 2 uri po jemanju dasatiniba (glejte poglavje 4.5).
English: Lymphoid blast (n= 48)
Slovenian: Obdobje limfoblastne preobrazbe (n = 48)
English: Use the oral syringe included in the package.
Slovenian: Uporabite brizgo za peroralno dajanje, ki je priložena ovojnini.
English: Accelerated (n= 158)
Slovenian: Obdobje pospešenega poteka (n= 158)
English: In the Phase III study in patients with newly diagnosed chronic phase CML, one patient (< 1%) of the SPRYCEL-treated patients had a QTcF > 500 msec after a minimum of 12 months follow-up (see section 4.4).
Slovenian: V študiji III. faze pri bolnikih z na novo diagnosticirano KML v kroničnem obdobju so po najmanj 12-mesečnem obdobju spremljanja pri enem bolniku (< 1%), ki se je zdravil z zdravilom SPRYCEL, poročali o vrednosti QTcF > 500 milisekund (glejte poglavje 4.4).
English: Imatinib-resistant patients
Slovenian: Bolniki, odporni na imatinib
English: At clinically relevant concentrations of dasatinib, binding to plasma proteins was approximately 96% on the basis of in vitro experiments.
Slovenian: Na osnovi in vitro preskušanj je bilo ugotovljeno, da je pri klinično pomembnih koncentracijah dasatiniba vezava na plazemske proteine približno 96%.
English: Response rate (95% CI)
Slovenian: Delež odziva (95% IZ)
English: Your doctor will check for some of these effects during your treatment.
Slovenian: Nekatere od neželenih učinkov bo zdravnik med zdravljenjem redno nadziral.
English: In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
Slovenian: V kliničnih študijah so pri odraslih bolnikih s KML in Ph+ ALL, pri katerih hematološki ali citogenetski odziv z uporabo priporočenega začetnega odmerka ni bil dosežen, odmerek povečali na 140 mg enkrat na dan (KML v kroničnem obdobju) ali 180 mg enkrat na dan (KML v napredovalem obdobju ali Ph+ ALL).
English: Bone growth and development will be closely monitored in children taking SPRYCEL.
Slovenian: Pri otroku, ki jemlje zdravilo SPRYCEL, bo zdravnik skrbno nadziral rast in razvoj kosti.
English: MMR (95% CI) Newly diagnosed (N = 51)a
Slovenian: MMR (95% IZ) Na novo diagnosticirana (N = 51)a
English: c MCyR combines both complete (0% Ph+ metaphases) and partial (> 0%-35%) responses.
Slovenian: c Pomemben citogenetski odziv (MCyR) je kombinacija popolnega (0% Ph+ metafaze) in delnega (> 0%-35%) odziva.
English: Common appetite disturbancesa, hyperuricaemia Uncommon tumour lysis syndrome, dehydration, hypoalbuminemia, hypercholesterolemia
Slovenian: Občasni sindrom tumorske lize, dehidracija, hipoalbuminemija, hiperholesterolemija
English: Inflammation of the lungs
Slovenian: Vnetje pljuč
English: PAH (pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization) has been reported in association with dasatinib treatment (see section 4.8).
Slovenian: V povezavi z uporabo dasatiniba so poročali o pojavu PAH (prekapilarni pljučni arterijski hipertenziji, potrjeni s kateterizacijo desne strani srca) (glejte poglavje 4.8).
English: SPRYCEL contains the active substance dasatinib.
Slovenian: Zdravilo SPRYCEL vsebuje učinkovino dasatinib.
English: Table 14: Efficacy of SPRYCEL in phase III dose-optimisation study: advanced phase CML and Ph+ ALL (2 year results)a
Slovenian: Preglednica 14: Učinkovitost zdravila SPRYCEL v študiji III. faze za določitev optimalnega odmerka: KML v napredovalem obdobju in Ph+ ALL (rezultati po 2 letih)a
English: Non-clinical data demonstrate that the solubility of dasatinib is pH-dependent.
Slovenian: Predklinični podatki kažejo, da je topnost dasatiniba odvisna od vrednosti pH.
English: Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev V primeru pojava neželenih učinkov, kot sta omotica ali zamegljen vid, bodite pri upravljanju vozil in strojev še posebej previdni.
English: Bleeding drug-related adverse reactions, ranging from petechiae and epistaxis to grade 3 or 4 gastrointestinal haemorrhage and CNS bleeding, were reported in patients taking SPRYCEL (see section 4.4).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom SPRYCEL, so poročali o pojavu krvavitev, od petehij in epistakse do krvavitev v prebavilih in osrednjem živčevju stopnje 3 ali 4 (glejte poglavje 4.4).
English: You should stop breast-feeding while you are taking SPRYCEL.
Slovenian: Med jemanjem zdravila SPRYCEL morate z dojenjem prenehati.
English: CCyR (95% CI) Newly diagnosed (N = 51)a
Slovenian: CCyR (95% IZ) Na novo diagnosticirana (N = 51)a
English: The other ingredients are: Tablet core: lactose monohydrate (see section 2 "SPRYCEL contains lactose"); microcrystalline cellulose; croscarmellose sodium; hydroxypropylcellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide (E171); macrogol 400
Slovenian: Druge sestavine zdravila so: Jedro tablete: laktoza monohidrat (glejte poglavje 2 "Zdravilo SPRYCEL vsebuje laktozo”), mikrokristalna celuloza, premreženi natrijev karmelozat, hidroksipropilceluloza in magnezijev stearat.
English: Common visual disorder (including visual disturbance, vision blurred, and visual acuity reduced), dry eye Uncommon visual impairment, conjunctivitis, photophobia, lacrimation increased Ear and labyrinth disorders
Slovenian: Pogosti motnje vida (vključno z okvaro vida, zamegljenim vidom in zmanjšano ostrino vida), suhe oči
English: k Fluid overload, fluid retention, gastrointestinal oedema, generalised oedema, peripheral swelling, oedema, oedema due to cardiac disease, perinephric effusion, post procedural oedema, visceral oedema.
Slovenian: k Preobremenitev s tekočino, retencija tekočin, gastrointestinalni edem, generalizirani edem, periferno otekanje, edem, edem zaradi bolezni srca, perinefritični izliv, edem po posegu in visceralni edem.