FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 If platelets < 25 x 109/L and/or recurrence of ANC < 0.5 x 109/L for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily for second episode.
Slovenian: 3 Če se število trombocitov zmanjša pod 25 x 109/l in/ali absolutno število nevtrofilcev ponovno zmanjša pod 0,5 x 109/l za > 7 dni, ponovite postopek, opisan pod zaporedno številko 1, in nato ponovno uvedite zdravljenje, in sicer z zmanjšanim odmerkom 80 mg enkrat na dan (druga ponovitev).
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
Slovenian: Občasni miokardni infarkt (tudi s smrtnim izidom)*, podaljšanje intervala QT na elektrokardiogramu*, perikarditis, ventrikularna aritmija (vključno z ventrikularno tahikardijo), angina pektoris, kardiomegalija, nenormalni val T na elektrokardiogramu, zvišana vrednost troponina
English: A statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose females and of prostate adenoma in low-dose males was noted.
Slovenian: Opazili so statistično značilno povečanje v skupni pojavnosti ploščatoceličnega karcinoma in papiloma maternice in materničnega vratu pri samicah, ki so prejemale velike odmerke in adenoma prostate pri samcih, ki so prejemali majhne odmerke.
English: Your pharmacist or qualified healthcare professional will constitute (mix to form a liquid) SPRYCEL powder for oral suspension to form SPRYCEL oral suspension before dispensing to you.
Slovenian: Pred izdajo zdravila bo farmacevt ali ustrezno usposobljen zdravstveni delavec SPRYCEL prašek za peroralno suspenzijo najprej pripravil (zmešal tako, da nastane tekočina) in vam zdravilo nato izdal v obliki SPRYCEL peroralne suspenzije.
English: For patients with chronic phase CML who received 100 mg once daily, dose reduction to 80 mg once daily with further reduction from 80 mg once daily to 50 mg once daily, if needed, is recommended.
Slovenian: Pri bolnikih s KML v kroničnem obdobju, ki so prejemali odmerek 100 mg enkrat na dan, se priporoča zmanjšanje odmerka na 80 mg enkrat na dan in nato po potrebi nadaljnje zmanjšanje z odmerka 80 mg enkrat na dan na odmerek 50 mg enkrat na dan.
English: OUTER CARTON AND LABEL FOR BOTTLE PACK
Slovenian: ŠKATLA IN NALEPKA ZA VSEBNIK ŠKATLA ZA PRETISNE OMOTE
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza premreženi natrijev karmelozat hidroksipropilceluloza magnezijev stearat
English: The starting dose of SPRYCEL is calculated by body weight as shown below:
Slovenian: Začetni odmerek zdravila SPRYCEL se izračuna na osnovi telesne mase, kot je prikazano v nadaljevanju:
English: Accelerated phase (n= 157)c
Slovenian: Obdobje pospešenega poteka (n= 157)c
English: In clinical studies, treatment with SPRYCEL in paediatric patients with Ph+ ALL was administered continuously, added to successive blocks of backbone chemotherapy, for a maximum duration of two years.
Slovenian: V kliničnih študijah je zdravljenje z zdravilom SPRYCEL pri pediatričnih bolnikih s Ph+ ALL trajalo neprekinjeno, dodano je bilo k zaporednim blokom osnovne kemoterapije, zdravljenje pa je trajalo največ dve leti.
English: Minimum of 7 years follow up
Slovenian: Najmanj 7-letno spremljanje
English: Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the tables.
Slovenian: Smernice za pediatrične bolnike s Ph+ ALL, ki se zdravijo v kombinaciji s kemoterapijo, so navedene v ločenem odstavku, ki sledi preglednici.
English: Lymphoid blast phase and Ph+ ALL (n= 168)c
Slovenian: Obdobje limfoblastne preobrazbe in Ph+ ALL (n= 168)c
English: The median time from diagnosis to randomisation was 64 months in the dasatinib group and 52 months in the imatinib group.
Slovenian: V skupini, ki je prejemala dasatinib je od diagnoze do randomizacije minilo v povprečju 64 mesecev, v skupini, ki je prejemala imatinib, pa 52 mesecev.
English: Rare hyperthyroidism, thyroiditis Metabolism and nutrition disorders
Slovenian: Redki hipertiroidizem, tiroiditis Presnovne in prehranske motnje
English: How to take SPRYCEL
Slovenian: Kako jemati zdravilo SPRYCEL
English: PFS was analysed on an intent-to-treat principle and patients were followed to events including subsequent therapy.
Slovenian: Preživetje brez napredovanja bolezni je bilo analizirano po principu vseh vključenih bolnikov (“intent-to-treat”), bolnike pa so spremljali do pojava dogodkov, vključno s kasnejšim zdravljenjem.
English: The median time to first occurrence of grade ≥ 3 dasatinib-related pleural effusion was 175 weeks (range: 114 to 274 weeks).
Slovenian: Srednja vrednost časa do prvega pojava z dasatinibom povezanega plevralnega izliva stopnje ≥ 3 je bila 175 tednov (razpon: 114 do 274 tednov).
English: Two randomised, open-label Phase III studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily.
Slovenian: Izvedeni sta bili dve randomizirani odprti študiji III. faze, ki sta vrednotili učinkovitost uporabe dasatiniba enkrat na dan v primerjavi z uporabo dasatiniba dvakrat na dan.
English: Active substances that may decrease dasatinib plasma concentrations When dasatinib was administered following 8 daily evening administrations of 600 mg rifampicin, a potent CYP3A4 inducer, the AUC of dasatinib was decreased by 82%.
Slovenian: Učinkovine, ki lahko zmanjšajo plazemske koncentracije dasatiniba Pri bolnikih, ki so dasatinib prejeli po 8-dnevnem dajanju rifampicina (močan induktor CYP3A4) v odmerku 600 mg zvečer, se je vrednost AUC dasatiniba zmanjšala za 82%.
English: Of note, major haematologic responses (MaHR) were achieved quickly (most within 35 days of first dasatinib administration for patients with lymphoid blast CML, and within 55 days for patients with Ph+ ALL).
Slovenian: Izpostaviti velja, da je bil dober hematološki odziv dosežen hitro (pri bolnikih s KML v obdobju limfoblastne preobrazbe večinoma v 35 dneh po prejemu prvega odmerka dasatiniba, pri bolnikih s Ph+ ALL pa v 55 dneh).
English: In these patients grade 3 or 4 pulmonary oedema and pulmonary hypertension were each reported in 1% of patients.
Slovenian: Pri teh bolnikih so tako o pljučnem edemu kot pljučni hipertenziji stopnje 3 ali 4 poročali pri 1% bolnikov.
English: They are also available in bottles with child-resistant closure containing 30 film-coated tablets.
Slovenian: Na voljo je tudi v plastenkah z za otroke varnimi zaporkami, ki vsebujejo 30 filmsko obloženih tablet.
English: Treatment with SPRYCEL is associated with anaemia, neutropaenia and thrombocytopaenia.
Slovenian: Zdravljenje z dasatinibom je povezano z anemijo, nevtropenijo in trombocitopenijo.
English: Common pneumonia (including bacterial, viral, and fungal), upper respiratory tract infection/inflammation, herpes virus infection (including cytomegalovirus - CMV), enterocolitis infection, sepsis (including uncommon cases with fatal outcomes)
Slovenian: Pogosti pljučnica (vključno z bakterijsko, virusno in mikotično pljučnico), okužba/vnetje zgornjih dihal, okužba z virusi herpesa (vključno s citomegalovirusom - CMV), enterokolitis, sepsa (tudi občasni primeri s smrtnimi izidi)
English: A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the tablet, in section 4.2, is expected to provide similar exposure to a tablet dose of 60 mg/m2.
Slovenian: Simulacija na osnovi modeliranja populacijske farmakokinetike (PPK) kaže, da se s priporočenim odmerjanjem na osnovi telesne mase, opisanim za tableto v poglavju 4.2, lahko pričakuje podobno izpostavljenost kot pri uporabi tablete v odmerku 60 mg/m2.
English: The oral suspension should not be taken with grapefruit or grapefruit juice (see section 4.5).
Slovenian: Peroralne suspenzije se ne sme jemati skupaj z grenivko ali s sokom grenivke (glejte poglavje 4.5).
English: Patients with BCR-ABL > 10% at 3 months
Slovenian: Bolniki z vrednostjo BCR-ABL > 10% v 3. mesecu
English: Each pack also contains a low-density polyethylene press-in-bottle adapter (PIBA) and a 12-mL oral dosing syringe (polypropylene syringe barrel with high-density polyethylene syringe plunger rod) in a sealed plastic bag.
Slovenian: Vsako pakiranje vsebuje tudi nastavek iz polietilena nizke gostote, ki se ga potisne v plastenko in 12 ml brizgo za peroralno dajanje (brizga iz polipropilena in bat iz polietilena visoke gostote) v zapečateni plastični vreči.
English: Among the dasatinib-treated patients with pleural effusion, 96% achieved a cCCyR, 82% achieved a MMR, and 50% achieved a MR4.5 despite dose interruptions or dose adjustment.
Slovenian: Med bolniki s plevralnim izlivom, ki so se zdravili z dasatinibom, je kljub prekinitvam zdravljenja ali prilagoditvi odmerka cCCyR doseglo 96% bolnikov, MMR 82% bolnikov, MR4.5 pa 50% bolnikov.
English: Cumulative rates of selected adverse reactions that were reported in the 100 mg once daily recommended starting dose are shown in Table 6a.
Slovenian: Kumulativni deleži izbranih neželenih učinkov, o katerih so poročali pri uporabi priporočenega začetnega odmerka 100 mg enkrat na dan, so prikazani v preglednici 6a.
English: If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you or your child, ask your doctor.
Slovenian: Če imate o delovanju zdravila SPRYCEL kakršno koli vprašanje, ali če vas zanima, zakaj je bilo to zdravilo predpisano vam ali vašemu otroku, se posvetujte z zdravnikom.
English: In an additional analysis, more dasatinib-treated patients (84%) achieved early molecular response (defined as BCR-ABL levels ≤ 10% at 3 months) compared with imatinib-treated patients (64%).
Slovenian: V dodatni analizi je zgodnji molekularni odziv (opredeljen kot vrednosti BCR-ABL ≤ 10% v 3. mesecu) doseglo več bolnikov, ki so se zdravili z dasatinibom (84%), v primerjavi z bolniki, ki so se zdravili z imatinibom (64%).
English: The overall safety profile of SPRYCEL in the paediatric Ph+ CML-CP population was similar to that of the adult population, regardless of formulation, with the exception of no reported pericardial effusion, pleural effusion, pulmonary oedema, or pulmonary hypertension in the paediatric population.
Slovenian: Pri pediatrični populaciji s Ph+ KML-KO je bil celokupen varnostni profil zdravila SPRYCEL podoben tistemu pri odraslih, ne glede na farmacevtsko obliko, z izjemo perikardialnega izliva, plevralnega izliva, pljučnega edema ali pljučne hipertenzije, o katerih pri pediatrični populaciji niso poročali.
English: Tartaric acid Trisodium citrate anhydrous Sodium benzoate (E211) Silica hydrophobic colloidal Mixed berry flavour [containing benzyl alcohol, sulphur dioxide (E220)]
Slovenian: vinska kislina brezvodni trinatrijev citrat natrijev benzoat (E211) koloidni hidrofobni silicijev dioksid aroma mešanega jagodičevja [vsebuje benzilalkohol, žveplov dioksid (E220)]
English: In a study of 14 healthy subjects, administration of a single 100-mg dose of SPRYCEL 22 hours following a 4-day, 40-mg omeprazole dose at steady state reduced the AUC of dasatinib by 43% and the Cmax of dasatinib by 42%.
Slovenian: V študiji pri 14 zdravih osebah je uporaba enkratnega 100 mg odmerka zdravila SPRYCEL 22 ur po 4-dnevnem odmerjanju omeprazola v odmerku 40 mg v stanju dinamičnega ravnovesja zmanjšala AUC dasatiniba za 43% in Cmax za 42%.
English: Once constituted, the oral suspension should only be administered using the oral dosing syringe supplied with each pack.
Slovenian: Po rekonstituciji se peroralno suspenzijo lahko daje le s pomočjo brizge za peroralno dajanje, ki je priložena vsakemu pakiranju.
English: In these patients, CCyR and MMR were CCyR: 87.9% [95% CI: (71.8-96.6)] and MMR: 45.5% [95% CI: (28.1-63.6)] at 12 months.
Slovenian: Pri teh bolnikih so bile vrednosti CCyR in MMR po 12 mesecih naslednje: CCyR: 87,9% [95% IZ: (71,8-96,6)] in MMR: 45,5% [95% IZ: (28,1-63,6)].
English: A PPK model-based simulation predicted that the body weight tiered dosing recommendation described for the powder for oral suspension, in section 4.2 of the Summary of Product Characteristics for the powder for oral suspension, is expected to provide similar exposure to a tablet dose of 60 mg/m2.
Slovenian: Simulacija na osnovi modeliranja populacijske farmakokinetike (PPK) kaže, da se s priporočenim odmerjanjem na osnovi telesne mase, opisanim za prašek za peroralno suspenzijo v poglavju 4.2 povzetka glavnih značilnosti zdravila za prašek za peroralno suspenzijo, lahko pričakuje podobno izpostavljenost kot pri uporabi tablete v odmerku 60 mg/m2.
English: The rates of cCCyR in the SPRYCEL and imatinib treatment groups, respectively, within 3 months (54% and 30%), 6 months (70% and 56%), 9 months (75% and 63%), 24 months (80% and 74%), 36 months (83% and 77%), 48 months (83% and 79%) and 60 months (83% and 79%) were consistent with the primary endpoint.
Slovenian: Deleži cCCyR v skupini, ki je prejemala zdravilo SPRYCEL in v skupini, ki je prejemala imatinib, so bili v 3 mesecih (54% oziroma 30%), 6 mesecih (70% oziroma 56%), 9 mesecih (75% oziroma 63%), 24 mesecih (80% oziroma 74%), 36 mesecih (83% in 77%), 48 mesecih (83% in 79%) ter 60 mesecih (83% in 79%) konsistentni s primarnim opazovanim dogodkom.
English: The active substance is dasatinib.
Slovenian: Učinkovina je dasatinib.
English: Data from healthy subjects administered a single 100 mg dose of dasatinib 30 minutes following a high-fat meal indicated a 14% increase in the mean AUC of dasatinib.
Slovenian: Podatki pri zdravih osebah, ki so prejele enkraten 100 mg odmerek dasatiniba 30 minut po obroku z visoko vsebnostjo maščob, kažejo, da se je srednja vrednost AUC povečala za 14%.
English: A low-fat meal 30 minutes prior to dasatinib resulted in a 21% increase in the mean AUC of dasatinib.
Slovenian: Zaužitje obroka z nizko vsebnostjo maščob 30 minut pred prejemom dasatiniba je posledično povečalo srednjo vrednost AUC za 21%.
English: With a minimum of 60 months follow-up, 60% of patients randomised to the SPRYCEL group and 63% of patients randomised to the imatinib group were still receiving first-line treatment.
Slovenian: Po najmanj 60-mesečnem obdobju spremljanja je 60% bolnikov, ki so bili randomizirani v skupino z zdravilom SPRYCEL, in 63% bolnikov, ki so bili randomizirani v skupino z imatinibom, še vedno prejemalo zdravilo prve izbire.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle of powder for oral suspension contains 990 mg of dasatinib (as monohydrate).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena plastenka praška za peroralno suspenzijo vsebuje 990 mg dasatiniba (v obliki monohidrata).
English: While the safety profile of SPRYCEL in elderly was similar to that in the younger population, patients aged 65 years and older are more likely to experience the commonly reported adverse reactions such as fatigue, pleural effusion, dyspnoea, cough, lower gastrointestinal haemorrhage, and appetite disturbance and more likely to experience less frequently reported adverse reactions such as abdominal distention, dizziness, pericardial effusion, congestive heart failure, and weight decrease and should be monitored closely (see section 4.4).
Slovenian: Varnostni profil zdravila SPRYCEL je pri starostnikih sicer podoben kot pri mlajših osebah, vendar pa pri bolnikih, starih 65 let in starejših, obstaja večja verjetnost za pojav pogostejših neželenih učinkov, kot so utrujenost, plevralni izliv, dispneja, kašelj, krvavitve v spodnjih prebavilih in motnje apetita, pa tudi manj pogostih neželenih učinkov, kot so distenzija abdomna, omotica, perikardialni izliv, kongestivno srčno popuščanje in zmanjšanje telesne mase, zato je treba te bolnike skrbno nadzirati (glejte poglavje 4.4).
English: Two randomised, open-label studies were conducted to evaluate the efficacy of dasatinib administered once daily compared with dasatinib administered twice daily.
Slovenian: Izvedeni sta bili dve randomizirani, odprti študiji, ki sta vrednotili učinkovitost uporabe dasatiniba enkrat na dan v primerjavi z uporabo dasatiniba dvakrat na dan.
English: Patients aged 65 years and older are more likely than younger patients to experience pleural effusion, dyspnoea, cough, pericardial effusion and congestive heart failure, and should be monitored closely.
Slovenian: Pri bolnikih, starih 65 let in starejših, je pojav plevralnega izliva, dispneje, kašlja, perikardialnega izliva in kongestivnega srčnega popuščanja verjetnejši kot pri mlajših bolnikih, zato je treba te bolnike skrbno nadzirati.
English: Twenty-one patients (1%) experienced a QTcF > 500 msec (see section 4.4).
Slovenian: Pri 21 bolnikih (1%) je bila vrednost QTcF > 500 milisekund (glejte poglavje 4.4).
English: One 120-mL plastic bottle (with child-resistant closure) contains 33 g of powder for oral suspension.
Slovenian: 120 ml plastenka (z za otroke varno zaporko) vsebuje 33 g praška za peroralno suspenzijo.
English: No additional patients were reported to have QTcF > 500 msec after a minimum of 60 months follow-up.
Slovenian: Po najmanj 60-mesečnem obdobju spremljanja o pojavu vrednosti QTcF > 500 milisekund pri dodatnih bolnikih niso poročali.
English: Make sure that you read and understand these instructions before using the oral suspension.
Slovenian: Pred začetkom uporabe peroralne suspenzije natančno preberite ta navodila.
English: Rare diabetes mellitus Psychiatric disorders
Slovenian: Redki sladkorna bolezen Psihiatrične motnje
English: Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate.
Slovenian: Učinkovine, ki lahko zvečajo plazemske koncentracije dasatiniba In vitro študije kažejo, da je dasatinib substrat za CYP3A4.
English: MCyR was achieved in 55% of imatinib-resistant patients and 82% of imatinib-intolerant patients.
Slovenian: Dober citogenetski odziv je bil dosežen pri 55% bolnikov, ki so bili odporni na imatinib, in 82% bolnikov, ki zdravljenja z imatinibom niso prenašali.
English: They are also available in bottles with child-resistant closure containing 60 film-coated tablets.
Slovenian: Na voljo je tudi v plastenkah z za otroke varnimi zaporkami, ki vsebujejo 60 filmsko obloženih tablet.
English: After resolution, a functional assessment should be performed prior to resuming treatment with dasatinib.
Slovenian: Po okrevanju je treba izvesti testiranje delovanja srca, preden se zdravljenje z dasatinibom nadaljuje.
English: The median duration of therapy in the 100 mg once daily group was 37 months (range 1-91 months).
Slovenian: V skupini z odmerkom 100 mg enkrat na dan je srednja vrednost časa trajanja zdravljenja znašala 37 mesecev (razpon 1-91 mesecev).
English: Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in adults
Slovenian: Preglednica 3: Prilagoditve odmerka v primeru pojava nevtropenije ali trombocitopenije pri odraslih
English: In the Phase I paediatric study, after a minimum of 7 years of follow-up among the 17 patients with imatinib-resistant or intolerant CML-CP, the median duration of PFS was 53.6 months and the rate of OS was 82.4%.
Slovenian: V pediatrični študiji I. faze je po najmanj 7 letih spremljanja pri 17 bolnikih s KML-KO, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali, mediana trajanja preživetja brez napredovanja bolezni (PFS) znašala 53,6 meseca, delež celokupnega preživetja (OS) pa 82,4%.
English: It was usually managed with dose reduction or interruption.
Slovenian: Povišanja so običajno nadzirali s prilagoditvijo odmerka ali prekinitvijo zdravljenja.
English: Median duration of treatment was 23 months for dasatinib (with 44% of patients treated for > 24 months to date) and 3 months for imatinib (with 10% of patients treated for > 24 months to date).
Slovenian: Zdravljenje z dasatinibom je v povprečju trajalo 23 mesecev (pri 44% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev), zdravljenje z imatinibom pa 3 mesece (pri 10% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev).
English: Common tinnitus
Slovenian: Pogosti tinitus
English: Hypokalaemia or hypomagnesaemia should be corrected prior to dasatinib administration.
Slovenian: Pred začetkom zdravljenja z dasatinibom je treba popraviti hipokaliemijo ali hipomagneziemijo.
English: Outer Carton: sprycel 10 mg/mL
Slovenian: Škatla: sprycel 10 mg/ml
English: Dasatinib and its metabolites are minimally excreted via the kidney.
Slovenian: Izločanje dasatiniba in njegovih presnovkov preko ledvic je minimalno.
English: Patients with BCR-ABL ≤ 10% at 3 months
Slovenian: Bolniki z vrednostjo BCR-ABL ≤ 10% v 3. mesecu
English: Do not crush, cut or chew them.
Slovenian: Tablet ne smete drobiti, razpolavljati ali žvečiti.
English: Adults with chronic phase CML (starting dose 100 mg once daily)
Slovenian: Odrasli s KML v kroničnem obdobju (začetni odmerek 100 mg enkrat na dan)
English: Digestive problems: loss of vital nutrients such as protein from your digestive tract, bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus), impairment of kidney function, diabetes
Slovenian: Prebavne težave: izguba nujno potrebnih hranil, kot so beljakovine, iz prebavil, zapora črevesa, analna fistula (nenormalna odprtina, ki povezuje anus s kožo okoli anusa), okvara delovanja ledvic in sladkorna bolezen.
English: The proportion of patients achieving BCR-ABL ratio of ≤0.01% (4-log reduction) at any time was higher in the SPRYCEL group compared to the imatinib group (54.1% versus 45%).
Slovenian: Delež bolnikov z doseženim razmerjem BCR-ABL ≤ 0,01% (zmanjšanje za 4-log vrednosti) v katerem koli času je bil večji v skupini, ki je prejemala zdravilo SPRYCEL, kot v skupini, ki je prejemala imatinib (54,1% v primerjavi s 45%).
English: Among the 126 Ph+ ALL paediatric patients treated with SPRYCEL on a continuous dosing regimen, the median duration of therapy was 23.6 months (range 1.4 to 33 months).
Slovenian: Pri 126 pediatričnih bolnikih s Ph+ ALL, ki so se zdravili z zdravilom SPRYCEL po režimu neprekinjenega odmerjanja, je mediana trajanja zdravljenja znašala 23,6 meseca (razpon 1,4 do 33 mesecev).
English: If SPRYCEL must be administered with a strong CYP3A4 inhibitor, consider a dose decrease to:
Slovenian: Če je treba zdravilo SPRYCEL uporabljati skupaj z močnim zaviralcem CYP3A4, je treba presoditi o zmanjšanju odmerka na:
English: • 12-mL oral syringe provided with the bottle.
Slovenian: • 12-ml brizgo za peroralno dajanje, ki je priložena plastenki.
English: Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropaenia, gastrointestinal bleeding, high uric acid levels in the blood
Slovenian: Preiskave lahko pokažejo: tekočino okrog srca, tekočino v pljučih, motnje srčnega ritma, febrilno nevtropenijo, krvavitve v prebavilih in zvišanje vrednosti sečne kisline v krvi.
English: • 40 mg daily for patients taking SPRYCEL 140 mg tablet daily.
Slovenian: • 40 mg na dan pri bolnikih, ki jemljejo zdravilo SPRYCEL 140 mg tableto na dan.
English: Uncommon renal impairment (including renal failure), urinary frequency, proteinuria
Slovenian: Občasni ledvična okvara (vključno z ledvično odpovedjo), pogosto uriniranje, proteinurija
English: Shake bottle repeatedly for 30 seconds.
Slovenian: Stresajte plastenko 30 sekund
English: Outer Carton: 2D barcode carrying the unique identifier included.
Slovenian: Škatla: Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: Long-term suppression of gastric acid secretion by H2 antagonists or proton pump inhibitors (e.g. famotidine and omeprazole) is likely to reduce dasatinib exposure.
Slovenian: Verjetno je, da bo dolgotrajno zavrtje izločanja želodčne kisline z antagonisti histaminskih receptorjev H2 ali zaviralci protonske črpalke (npr. famotidin in omeprazol) zmanjšalo izpostavljenost dasatinibu.
English: 7 years
Slovenian: 7 let