FrancophonIA/ELRC3.0 huggingface dataset:
English: For the 17 newly diagnosed CML patients who achieved MMR, the median time to first MMR was 5.55 months (95% CI: 5.52, 5.75).
Slovenian: Pri 17 bolnikih z novo odkrito KML, ki so dosegli odziv MMR, je bila srednja vrednost časa do prvega odziva MMR 5,55 meseca (95-odstotni IZ: 5,52, 5,75).
English: <1 Common
Slovenian: <1 pogosti
English: Tasigna should be taken twice daily approximately 12 hours apart and must not be taken with food.
Slovenian: Zdravilo Tasigna je treba jemati dvakrat dnevno s približno 12-urnim presledkom.
English: Liver function (bilirubin and hepatic transaminases levels) should be monitored monthly or as clinically indicated.
Slovenian: Delovanje jeter (koncentracije bilirubina in jetrnih aminotransferaz) je treba spremljati enkrat mesečno oziroma v skladu s kliničnimi indikacijami.
English: The hard capsules are light yellow.
Slovenian: Trde kapsule so svetlo rumene.
English: Substances that may increase nilotinib serum concentrations
Slovenian: Snovi, ki lahko zvišajo koncentracije nilotiniba v serumu
English: None of the 21 resistant or intolerant CML patients who were in MMR on treatment had confirmed loss of MMR.
Slovenian: Pri nobenem od 21 bolnikov s KML in rezistenco ali neprenašanjem in doseženim odzivom MMR v času zdravljenja ni prišlo do potrjene izgube odziva MMR.
English: Discontinuation of nilotinib therapy should be initiated by a physician experienced in the treatment of patients with CML (see sections 4.4 and 5.1).
Slovenian: O prekinitvi zdravljenja z nilotinibom lahko odloča le zdravnik, ki ima izkušnje z zdravljenjem bolnikov s KML (glejte poglavji 4.4 in 5.1)
English: In a healthy volunteer study with exposures that were comparable to the exposures observed in patients, the time-averaged mean placebo-subtracted QTcF change from baseline was 7 msec (CI ± 4 msec).
Slovenian: V študiji z zdravimi prostovoljci, pri katerih so bile izpostavljenosti zdravilu podobne kot pri bolnikih, je bila časovno povprečna srednja sprememba trajanja QTcF glede na izhodišče z odšteto spremembo pri placebu 7 milisekund (IZ ± 4 milisekunde).
English: • Unit packs containing 28 hard capsules in a wallet.
Slovenian: • Posamezno pakiranje vsebuje 28 trdih kapsul v zloženki.
English: How Tasigna works
Slovenian: Kako zdravilo Tasigna deluje
English: Therefore, when the concurrent use of a H2 blocker is necessary, it may be administered approximately 10 hours before and approximately 2 hours after the dose of Tasigna.
Slovenian: Če mora torej bolnik sočasno uporabljati antagoniste histaminskih H2 receptorjev, jih lahko vzame približno 10 ur pred odmerjanjem zdravila Tasigna ali približno 2 uri po njem.
English: Patients with a CHR at baseline achieved a MCyR faster (1.9 versus 2.8 months).
Slovenian: Bolniki s popolnim hematološkim odzivom ob izhodišču so hitreje dosegali pomemben citogenetični odziv (1,9 meseca v primerjavi z 2,8 meseca).
English: Nilotinib is primarily metabolised by CYP3A4, with possible minor contribution from CYP2C8.
Slovenian: Nilotinib se presnavlja predvsem s CYP3A4, nekoliko lahko k presnovi prispeva tudi CYP2C8.
English: INTERMEDIATE CARTON
Slovenian: VMESNA ŠKATLA
English: Significant prolongation of the QT interval may occur when nilotinib is inappropriately taken with strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong the QT interval, and/or food (see section 4.5).
Slovenian: Pri neustreznem sočasnem jemanju nilotiniba z močnimi zaviralci CYP3A4 in/ali z zdravili, za katera je znano, da lahko podaljšujejo interval QT, in/ali s hrano, lahko pride do pomembnega podaljšanja intervala QT (glejte poglavje 4.5).
English: Of the 190 patients who entered the TFR phase, 98 patients (51.6% [95% CI: 44.2, 58.9]) were in MMR at 48 weeks.
Slovenian: Izmed 190 bolnikov, ki so vstopili v fazo remisije brez zdravljenja, je bilo po 48 tednih v stanju odziva MMR 98 bolnikov (51,6 % [95-odstotni IZ: 44,2, 58,9]).
English: No food should be consumed for 2 hours before the dose is taken and for at least one hour after.
Slovenian: Hrane se ne sme uživati 2 uri pred zaužitjem odmerka in vsaj eno uro po zaužitju odmerka.
English: Eye pruritus, conjunctivitis, dry eye (including xerophthalmia)
Slovenian: srbenje v očeh, konjunktivitis, suho oko (vključno s kseroftalmijo)
English: Concomitant treatment with strong CYP3A4 inhibitors, including ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin, should therefore be avoided (see section 4.4).
Slovenian: Zato se je treba izogibati sočasnemu zdravljenju z močnimi zaviralci CYP3A4, med drugim s ketokonazolom, z itrakonazolom, z vorikonazolom, z ritonavirjem, s klaritomicinom in s telitromicinom (glejte poglavje 4.4).
English: It is also used in paediatric patients with CML who are no longer benefiting from previous treatment including imatinib or who experienced serious side effects with previous treatment and are not able to continue taking it.
Slovenian: Uporablja se tudi pri pediatričnih bolnikih s kronično mieloično levkemijo, ki jim predhodno zdravljenje, vključno z imatinibom, ne koristi več ali so imeli resne neželene učinke zaradi predhodnih zdravil in teh zdravil ne morejo več uporabljati.
English: Nilotinib was shown to absorb light in the UV-B and UV-A range, is distributed into the skin and showed a phototoxic potential in vitro, but no effects have been observed in vivo.
Slovenian: Pokazalo se je, da nilotinib absorbira svetlobo v UV-B in UV-A delu spektra in se porazdeli v koži.
English: Substances that may decrease nilotinib serum concentrations
Slovenian: Snovi, ki lahko znižajo koncentracije nilotiniba v serumu
English: Adverse reactions that were reported in adult patients in the Tasigna Phase III study at a frequency of less than 5% are shown in Table 4.
Slovenian: Neželeni učinki, o katerih so pri odraslih bolnikih poročali iz študije faze III z zdravilom Tasigna z manj kot 5-odstotno pogostnostjo, so navedeni v preglednici 4.
English: If you are told to discontinue this medicine, your doctor will continue to monitor your CML and may tell you to re-start Tasigna if your condition indicates that this is necessary.
Slovenian: Če vam bo zdravnik svetoval, da prekinete jemanje tega zdravila, bo še naprej spremljal stanje vaše kronične mieloične levkemije in vam bo morda kasneje naročil, da ponovno začnete jemati zdravilo Tasigna, če bo glede na stanje vaše bolezni to potrebno.
English: Your doctor should assess the level of fats (lipids) and sugar in your blood before initiating treatment with Tasigna and during treatment.
Slovenian: Vaš zdravnik mora pred začetkom zdravljenja in med zdravljenjem z zdravilom Tasigna preverjati vrednost maščob (lipidov) in sladkorja v vaši krvi.
English: Only minor liver alterations were seen in mice or rats treated for up to 26 weeks.
Slovenian: Pri miših in podganah, ki so prejemale zdravilo do 26 tednov, so opažali le manjše spremembe v jetrih.
English: Close monitoring of growth in paediatric patients under nilotinib treatment is recommended.
Slovenian: Pri pediatričnih bolnikih, ki prejemajo nilotinib, je priporočeno skrbno spremljanje rasti.
English: In addition, tell your doctor or pharmacist before taking Tasigna if you are taking any antacids, which are medicines against heartburn.
Slovenian: Preden začnete jemati zdravilo Tasigna, morate svojega zdravnika ali farmacevta obvestiti tudi v primeru, da jemljete katerega od antacidov, to je zdravil, ki jih uporabljamo proti zgagi.
English: However, percentages with one decimal precision are used to identify terms with a frequency of at least 5% and to classify terms according to frequency categories.
Slovenian: *Za prikaz v tej preglednici so števila v odstotkih zaokrožena na cela števila, za ugotavljanje, kateri neželeni učinki dosegajo pogostnost najmanj 5 % in za njihovo razvrščanje v kategorije pogostnosti pa so uporabljeni njihovi odstotki pogostnosti, zaokroženi na eno decimalno mesto natančno.
English: Treatment-emergent haematological toxicities include myelosuppression: thrombocytopenia (18%), neutropenia (15%) and anaemia (8%).
Slovenian: Oblike hematološke toksičnosti ob zdravljenju so vključevale zaviranje delovanja kostnega mozga: trombocitopenijo (18 %), nevtropenijo (15 %) in anemijo (8 %).
English: Metabolism and nutrition disorders Very common:
Slovenian: Presnovne in prehranske motnje zelo pogosti:
English: Among the 21 resistant or intolerant CML patients who were in MMR at any time on treatment, the median time to first MMR was 2.76 months (95% CI: 0.03, 5.55).
Slovenian: Pri 21 bolnikih s KML in rezistenco ali neprenašanjem, ki so dosegli odziv MMR kadarkoli v času zdravljenja, je bila srednja vrednost časa do prvega odziva MMR 2,76 meseca (95-odstotni IZ: 0,03, 5,55).
English: Efficacy data in patients with CML-BC are not yet available.
Slovenian: Podatki o učinkovitosti pri bolnikih s KML v blastni krizi niso dostopni.
English: The average nilotinib trough and peak concentrations over 12 months were approximately 15.7% and 14.8% higher following 400 mg twice daily dosing compared to 300 mg twice daily.
Slovenian: Povprečne najnižje in najvišje koncentracije nilotiniba v 12 mesecih so bile približno za 15,7 % oziroma 14,8 % višje pri odmerjanju 400 mg dvakrat dnevno v primerjavi z odmerjanjem 300 mg dvakrat dnevno.
English: Patients with hepatic impairment might therefore have increased exposure to nilotinib and should be treated with caution (see section 4.2).
Slovenian: Iz tega razloga je pri bolnikih z okvaro jeter izpostavljenost nilotinibu lahko večja in je pri zdravljenju teh bolnikov potrebna previdnost (glejte poglavje 4.2).
English: Caution is recommended in patients with previous history of pancreatitis.
Slovenian: Pri bolnikih z anamnezo pankreatitisa je potrebna previdnost.
English: Cardiovascular events were reported in a randomised Phase III study in newly diagnosed CML patients and observed in post-marketing reports.
Slovenian: O srčnožilnih dogodkih so poročali v randomizirani študiji faze III pri bolnikih z novo odkrito KML in v obdobju trženja zdravila.
English: Clinical studies in newly diagnosed CML in chronic phase An open-label, multicentre, randomised Phase III study was conducted to determine the efficacy of nilotinib versus imatinib in 846 adult patients with cytogenetically confirmed newly diagnosed Philadelphia chromosome positive CML in the chronic phase.
Slovenian: Klinične študije pri bolnikih z novo odkrito KML v kronični fazi Izvedli so odprto, multicentrično, randomizirano študijo faze III, da bi določili učinkovitost nilotiniba v primerjavi z učinkovitostjo imatiniba pri 846 odraslih bolnikih s citogenetsko potrjeno novo odkrito KML s prisotnim kromosomom Philadelphia v kronični fazi.
English: However, patients with hepatic impairment should be treated with caution (see section 4.4).
Slovenian: Kljub temu je pri zdravljenju bolnikov z okvaro jeter potrebna previdnost (glejte poglavje 4.4).
English: Sepsis, subcutaneous abscess, anal abscess, furuncle, tinea pedis, hepatitis B reactivation Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Slovenian: sepsa, podkožni absces, analni absces, furunkel, tinea pedis, reaktivacija hepatitisa B Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) pogosti:
English: Figure 4 Kaplan-Meier estimate of treatment-free survival after start of TFR (full analysis set)
Slovenian: Slika 4 Kaplan-Meierjeva ocena preživetja brez zdravljenja po začetku faze remisije brez zdravljenja (podatki skupine bolnikov za celotno analizo - full analysis set)
English: Following administration of nilotinib in paediatric patients at 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg), steady-state exposure and clearance of nilotinib were found to be similar (within 2-fold) to adult patients treated with 400 mg twice daily.
Slovenian: Po dajanju nilotiniba pediatričnim bolnikom v odmerku 230 mg/m dvakrat na dan, zaokroženem na najbližji mnogokratnik 50-miligramskega odmerka (do najvišjega posameznega odmerka 400 mg), so opažali, da sta bila izpostavljenost v stanju dinamičnega ravnovesja in očistek nilotiniba podobna (v okviru dvakratnih vrednosti) kot pri odraslih bolnikih, ki so prejemali 400 mg dvakrat na dan.
English: The estimated 24-month overall survival rate in CML-AP patients was 70%.
Slovenian: Ocenjeno 24-mesečno celokupno preživetje pri bolnikih s pospešeno fazo KML je bilo 70 %.
English: Cardiac disorders (reported in 300 mg twice daily and/or 400 mg twice daily treatment arm of phase III study) Common:
Slovenian: Srčne bolezni (neželeni učinki, o katerih so poročali v skupinah bolnikov, ki so prejemali 300 mg dvakrat na dan in/ali 400 mg dvakrat na dan v študiji faze III) pogosti:
English: This study suggests that a clinically meaningful drug-drug interaction between nilotinib and warfarin is less likely up to a dose of 25 mg of warfarin.
Slovenian: Rezultati te študije kažejo, da do višine 25 mg odmerka varfarina ni veliko možnosti za klinično pomemebno medsebojno delovanje med nilotinibom in varfarinom.
English: Treatment discontinuation in adult Ph+ CML patients in chronic phase who have achieved a sustained deep molecular response
Slovenian: Prekinitev zdravljenja pri odraslih bolnikih, ki imajo Ph+ KML v kronični fazi in so dosegli trajen globok molekularni odgovor
English: Hearing impaired, ear pain, tinnitus
Slovenian: okvara sluha, bolečina v ušesu, tinitus
English: Alopecia, muscle spasms, decreased appetite, arthralgia, abdominal pain, bone pain, peripheral oedema, asthenia, upper abdominal pain, dry skin, erythema and pain in extremity were observed less commonly (<10% and ≥5%) and have been of mild to moderate severity (Grade 1 or 2).
Slovenian: Alopecijo, mišične krče, zmanjšan apetit, artralgijo, bolečine v trebuhu, bolečine v kosteh, periferne edeme, astenijo, bolečine v zgornjem delu trebuha, suho kožo, eritem in bolečine v okončinah so opažali manj pogosto (pri <10 % in ≥5 %), po intenzivnosti pa so bili blagi do zmerni (stopnje 1 ali 2).
English: Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients in Tasigna clinical studies that serve as the basis for the approved indications are shown in Table 3.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali v kliničnih študijah z zdravilom Tasigna V preglednici 3 so prikazani nehematološki neželeni učinki (razen laboratorijskih nepravilnosti), o katerih so poročali pri vsaj 5 % odraslih bolnikov iz kliničnih študij z zdravilom Tasigna, ki predstavljajo osnovo za odobrene indikacije.
English: In a Phase III study in newly diagnosed CML patients, 1.1% of the patients treated with 400 mg nilotinib twice daily showed a Grade 3-4 elevation in total cholesterol; no Grade 3-4 elevations were however observed in the 300 mg twice daily dose group (see section 4.8).
Slovenian: V študiji faze III pri bolnikih z novo odkrito KML je pri 1,1 % bolnikov, ki so prejemali odmerek 400 mg nilotiniba dvakrat dnevno, prišlo do zvišanja vrednosti celokupnega holesterola 3. do 4. stopnje, pri čemer pa v skupini z odmerkom 300 mg dvakrat dnevno zvišanja 3. do 4. stopnje niso opazili (glejte poglavje 4.8).
English: Increased exposure to nilotinib might also be expected with moderate CYP3A4 inhibitors.
Slovenian: Povečano izpostavljenost nilotinibu je mogoče pričakovati tudi pri sočasni uporabi srednje močnih zaviralcev CYP3A4.
English: Plasma protein binding is approximately 98% on the basis of in vitro experiments.
Slovenian: Glede na poskuse in vitro kaže, da se nilotinib veže na proteine v plazmi v približno 98 %.
English: Discontinuation due to adverse drug reactions was observed in 10% of patients.
Slovenian: Do prekinitve zdravljenja zaradi neželenih učinkov je prišlo pri 10 % bolnikov.
English: How to take Tasigna
Slovenian: Kako jemati zdravilo Tasigna
English: Total* (n=137)
Slovenian: skupaj* (n=137)
English: Of CP patients without a baseline CHR, 70% achieved a CHR, median time to CHR was 1 month and median duration of CHR was 32.8 months.
Slovenian: Izmed bolnikov v kronični fazi brez popolnega hematološkega odziva ob izhodišču jih je 70 % doseglo popoln hematološki odziv, pri tem je bila mediana časa do tega odziva 1 mesec, mediana trajanja teh odzivov je bila 32,8 meseca.
English: Tasigna is used in adult and paediatric patients with newly diagnosed CML or in patients with CML who are no longer benefiting from previous treatment including imatinib.
Slovenian: Zdravilo Tasigna se uporablja pri odraslih in pediatričnih bolnikih z novo odkrito KML ali pri bolnikih s kronično mieloično levkemijo, ki jim predhodno zdravljenje, vključno z imatinibom, ne koristi več.
English: Adverse reactions that were reported in adult patients in the Tasigna clinical studies which serve as a basis for the approved indications at a frequency of less than 5% are shown in Table 4.
Slovenian: Neželeni učinki, o katerih so pri odraslih bolnikih iz kliničnih študij z zdravilom Tasigna poročali z manj kot 5-odstotno pogostnostjo in predstavljajo osnovo za odobrene indikacije, so navedeni v preglednici 4.
English: There was no evidence of carcinogenicity upon administration of nilotinib at 5, 15 and 40 mg/kg/day.
Slovenian: Po odmerjanju nilotiniba 5, 15 in 40 mg/kg/dan ni bilo nobenih znakov karcinogenega delovanja.
English: Use in adults - Patients newly diagnosed with CML: The recommended dose is 600 mg per day.
Slovenian: Uporaba pri odraslih - Bolniki z novo odkrito kronično mieloično levkemijo: Priporočeni odmerek je 600 mg na dan.
English: Rare cases of tumour lysis syndrome have been reported in patients treated with Tasigna.
Slovenian: Poročali so o redkih primerih sindroma tumorske lize pri pacientih, zdravljenih z zdravilom Tasigna.
English: Dose adjustment is not considered necessary in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter prilagajanje odmerkov predvidoma ni potrebno.
English: At 12 months At 24 months At 36 months At 48 months At 60 months At 72 months
Slovenian: po 12 mesecih 11,7 po 24 mesecih 24,5 po 36 mesecih 29,4 po 48 mesecih 33,0 po 60 mesecih 47,9 po 72 mesecih 44,3
English: Figure 2 Cumulative incidence of molecular response of ≤0.01% (4-log reduction)
Slovenian: Slika 2 Kumulativna incidenca molekularnega odziva ≤0,01 % (zmanjšanje števila prepisov za 4 log)
English: Night sweats, eczema, urticaria, hyperhidrosis, contusion, acne, dermatitis (including allergic, exfoliative and acneiform)
Slovenian: nočno potenje, ekcem, urtikarija, prekomerno znojenje, obtolčenina, akna, dermatitis (vključno z alergijskim, eksfoliativnim in akneiformnim)
English: Your doctor may consider discontinuing your treatment with Tasigna based on specific criteria.
Slovenian: Zdravnik lahko na osnovi določenih kriterijev pretehta možnost, da bi prekinili zdravljenje z zdravilom Tasigna.
English: 149 to 517 mg/m2/day), and the median relative dose intensity was 94.7% (range: 32 to 112%).
Slovenian: V združeni populaciji bolnikov s KML je bila srednja vrednost dejanske jakosti odmerjanja 435,5 mg/m2/dan (od 149 do 517 mg/m2/dan), srednja vrednost relativne jakosti odmerjanja pa je bila 94,7 % (od 32 do 112 %).
English: Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients treated with 300 mg of nilotinib twice daily in the randomised Phase III study are shown in Table 3.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali v kliničnih študijah z zdravilom Tasigna V preglednici 3 so prikazani nehematološki neželeni učinki (razen laboratorijskih nepravilnosti), o katerih so poročali pri vsaj 5 % odraslih bolnikov, ki so v randomizirani študiji faze III prejemali 300 mg nilotiniba dvakrat dnevno.
English: Juvenile animal studies
Slovenian: Študije na mladičih
English: 28 hard capsules 40 hard capsules
Slovenian: 28 trdih kapsul 40 trdih kapsul
English: A black imprint is stamped on each hard capsule (“NVR/ABL”).
Slovenian: Na vsaki trdi kapsuli je natisnjena črna oznaka (“NVR/ABL”).
English: MMRat 12 months Response (95% CI) MMR at 24 months Response (95% CI) MMR at 36 months Response (95% CI) MMR at 48 months Response (95% CI) MMR at 60 months Response (95% CI) MMR at 72 months Response (95% CI) Cochran-Mantel-Haenszel (CMH) test p-value for response rate (vs. imatinib 400 mg) <0.0001 Only patients who were in MMR at a specific time point are included as responders for that time point.
Slovenian: glavni molekularni odziv po 12 mesecih odziv (95-odstotni IZ) glavni molekularni odziv po 24 mesecih odziv (95-odstotni IZ) glavni molekularni odziv po 36 mesecih odziv (95-odstotni IZ) glavni molekularni odziv po 48 mesecih odziv (95-odstotni IZ) glavni molekularni odziv po 60 mesecih odziv (95-odstotni IZ) glavni molekularni odziv po 72 mesecih odziv (95-odstotni IZ) Cochran-Mantel-Haenszel test, vrednost p za delež bolnikov z odzivom (v primerjavi z imatinibom 400 mg) <0,0001 Kot odzivni bolniki ob določeni časovni točki so šteti samo bolniki, pri katerih je prišlo do glavnega molekularnega odziva ob tej časovni točki.
English: Close monitoring of growth in paediatric patients under nilotinib treatment is recommended (see section 4.4).
Slovenian: Pri pediatričnih bolnikih, ki prejemajo nilotinib, je priporočeno skrbno spremljanje rasti (glejte poglavje 4.4).
English: Nilotinib is mainly metabolised in the liver with CYP3A4 expected to be the main contributor to the oxidative metabolism.
Slovenian: Nilotinib se večinoma presnavlja v jetrih, pri čemer ima pri oksidativnem metabolizmu verjetno največjo vlogo CYP3A4.
English: Electrolyte imbalance (including hypomagnesaemia, hyperkalaemia, hypokalaemia, hyponatraemia, hypocalcaemia, hypercalcaemia, hyperphosphataemia), diabetes mellitus, hyperglycaemia, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia
Slovenian: elektrolitsko neravnovesje (med drugim hipomagneziemija, hiperkaliemija, hipokaliemija, hiponatriemija, hipokalciemija, hiperkalciemija, hiperfosfatemija), sladkorna bolezen, hiperglikemija, hiperholesterolemija, hiperlipidemija, hipertrigliceridemija občasni:
English: A total of 69 paediatric patients (from 2 to <18 years of age) with either newly diagnosed Ph+ CML in chronic phase (n=25) or imatinib/dasatinib resistant or imatinib-intolerant Ph+ CML in chronic phase (n=44) received nilotinib treatment at a dose of 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg).
Slovenian: Skupno je 69 pediatričnih bolnikov (starih od 2 leti do manj kot 18 let), ki so imeli bodisi novo odkrito KML s prisotnim kromosomom Philadelphia v kronični fazi (n=25) ali so imeli KML s prisotnim kromosomom Philadelphia v kronični fazi in rezistenco na imatinib/dasatinib ali neprenašanje imatiniba (n=44), prejemali zdravljenje z nilotinibom v odmerku 230 mg/m dvakrat na dan, zaokroženem na najbližji mnogokratnik 50-miligramskega odmerka (do najvišjega posameznega odmerka 400 mg).
English: Nilotinib absorption following oral administration was approximately 30%.
Slovenian: Po zaužitju se absorbira približno 30 % nilotiniba.
English: Table 8 Proportions of patients who had molecular response of ≤0.01% (4 log reduction) and ≤0.0032% (4.5 log reduction)
Slovenian: Preglednica 8 Deleži bolnikov z molekularnim odzivom ≤0,01 % (zmanjšanje števila prepisov za 4 log) oziroma ≤0,0032 % (zmanjšanje števila prepisov za 4,5 log)
English: Frequency very common: Growth retardation has been documented in paediatric patients treated with nilotinib.
Slovenian: Pogostnost zelo pogosta: pri pediatričnih bolnikih, ki so prejemali nilotinib, so zabeležili zastoj rasti.
English: In 22 CP patients evaluated for efficacy nilotinib induced a 32% MCyR rate and a 50% CHR rate.
Slovenian: Izmed 22 bolnikov v kronični fazi, pri katerih so ocenjevali učinkovitost, je nilotinib povzročil pomemben citogenetični odziv pri 32 % bolnikov, popolni hematološki odziv pa pri 50 % bolnikov.
English: What Tasigna contains - The active substance is nilotinib.
Slovenian: Kaj vsebuje zdravilo Tasigna - Učinkovina je nilotinib.