FrancophonIA/ELRC3.0 huggingface dataset:
English: ● If it is more than 6 hours until your next dose, take the missed dose as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo Alecensa ● Če je do naslednjega odmerka zdravila več kot 6 ur, vzemite pozabljeni odmerek takoj, ko se spomnite.
English: In vitro metabolism studies showed that CYP3A4 is the main CYP isozyme mediating alectinib and its major metabolite M4 metabolism, and is estimated to contribute 40-50% of alectinib metabolism.
Slovenian: Študije presnove in vitro so pokazale, da je CYP3A4 glavni izoencim CYP, ki sodeluje v presnovi alektiniba in njegovega glavnega presnovka M4; ocenjeni prispevek CYP3A4 k presnovi alektiniba je od 40 do 50 %.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
English: Therefore, no dose adjustments are required when Alecensa is co-administered with proton pump inhibitors or other medicinal products which raise gastric pH (e.g. H2 receptor antagonists or antacids).
Slovenian: Glede na to med sočasno uporabo zdravila Alecensa in zaviralcev protonske črpalke ali drugih zdravil, ki zvišujejo pH v želodcu (npr. antagonistov receptorjev H2 ali antacidov), odmerka ni treba prilagoditi.
English: Alecensa treatment
Slovenian: Zdravljenje z zdravilom Alecensa
English: A total of 138 patients were included in the phase II part of the study and received Alecensa orally, at the recommended dose of 600 mg twice daily.
Slovenian: V delu študije, ki je bil faze II, je bilo skupaj vključenih 138 bolnikov, ki so prejemali zdravilo Alecensa peroralno v priporočenem odmerku 600 mg dvakrat na dan.
English: In the phase II clinical trials (NP28761, NP28673; N=253), the median duration of exposure to Alecensa was 11 months.
Slovenian: Varnost zdravila Alecensa so ocenili V preskušanjih faze II (NP28761, NP28673; n = 253) je bilo mediano trajanje izpostavljenosti zdravilu Alecensa 11 mesecev.
English: Table 2 Dose modification advice for specified Adverse Drug Reactions (see sections 4.4 and 4.8) CTCAE grade
Slovenian: Smernice za prilagoditev odmerka pri specifičnih neželenih učinkih (glejte poglavji 4.4 in 4.8)
English: Increased blood creatine phosphokinase
Slovenian: Huda mialgija in zvišanja kreatin-fosfokinaze (CPK)
English: The following side effects may happen with this medicine.
Slovenian: Med uporabo tega zdravila se lahko pojavijo spodaj navedeni neželeni učinki.
English: Study NP28673 was a Phase I/II single arm, multicentre study conducted in patients with ALK-positive advanced NSCLC who have previously progressed on crizotinib treatment.
Slovenian: Študija NP28673 je bila multicentrična študija faze I/II z eno samo skupino, opravljena pri bolnikih z ALK-pozitivnim napredovalim nedrobnoceličnim rakom pljuč, ki jim je bolezen pred tem napredovala med zdravljenjem s krizotinibom.
English: ● abnormal results of blood tests to check kidney function (high level of creatinine)
Slovenian: ● nenormalni izvidi preiskav krvi, ki odražajo delovanje ledvic (velika koncentracija kreatinina);
English: ORR results for studies NP28673 and NP28761 were consistent across subgroups of baseline patient characteristics such as age, gender, race, ECOG performance status, Central Nervous System (CNS) metastasis and prior chemotherapy use, especially when considering the small number of patients in some subgroups.
Slovenian: Rezultati ORR v študijah NP28673 in NP28761 so se skladali med podskupinami z različnimi izhodiščnimi značilnostmi bolnikov, npr. glede na starost, spol, raso, stanje zmogljivosti po ECOG,
English: Most of these events were of mild or moderate severity; Grade 3 events were reported for diarrhea (0.7%), nausea (0.5%), and vomiting (0.2%).
Slovenian: Med učinki stopnje 3 so bili driska (0,7 %), navzea (0,5 %) in bruhanje (0,2 %).
English: In the phase III clinical trial BO28984, one patient (0.2%) experienced a Grade 4 event of nausea in the Alecensa arm and the incidence of Grade 3 and 4 events for nausea, vomiting, and diarrhoea was 3.3%, 3.3%, and 2.0%, respectively, in the crizotinib arm.
Slovenian: V kliničnem preskušanju faze III BO28984 je imel en bolnik (0,2 %) v skupini, zdravljeni z zdravilom Alecensa, navzeo stopnje 4, v skupini, zdravljeni s krizotinibom, pa je bila incidenca neželenih učinkov stopnje 3 in 4 naslednja: 3,3 % za slabost, 3,3 %
English: Co-administration of multiple oral doses of 400 mg posaconazole twice daily, a strong CYP3A inhibitor, with a single oral dose of 300 mg alectinib increased alectinib exposure Cmax and AUCinf by 1.18 and 1.75-fold respectively, and reduced M4 Cmax and AUCinf by 71% and 25% respectively.The effect on the combined exposure of alectinib and M4 was minor, reducing Cmax by 7% and increasing AUCinf 1.36-fold.
Slovenian: Sočasna uporaba večkratnih peroralnih odmerkov 400 mg posakonazola (ki je močan zaviralec CYP3A) dvakrat na dan z enkratnim peroralnim odmerkom 300 mg alektiniba je zvečala Cmax alektiniba 1,18-krat in AUCinf alektiniba 1,75-krat ter zmanjšala Cmax M4 za 71 % in AUCinf M4 za
English: If a contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume at reduced dose (see Table 1) upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm, with frequent monitoring as clinically indicated.
Slovenian: Če ne najdete sočasnega zdravila, ki je k temu pripomoglo ali če takega zdravila ne ukinete oz. ne prilagodite njegovega odmerka, znova začnite z manjšim odmerkom (glejte preglednico 1), ko se stanje izboljša na stopnjo ≤ 1 (asimptomatska bradikardija) oz. ko je srčna frekvenca ≥ 60 utripov/minuto.
English: The primary endpoint of the trial was to demonstrate superiority of Alecensa versus crizotinib based on Progression Free survival (PFS) as per investigator assessment using RECIST 1.1.
Slovenian: Alecensa v primerjavi s krizotinibom glede na preživetje brez napredovanja bolezni (PFS - progression free survival) po oceni raziskovalca z uporabo meril RECIST 1.1.
English: Women of childbearing potential must be advised to avoid pregnancy while on Alecensa.
Slovenian: Ženskam v rodni dobi je treba povedati, da med zdravljenjem z zdravilom Alecensa ne smejo zanositi.
English: Among the patients included in the study, 26% of the patients had previously progressed on crizotinib treatment only, and 74% had previously progressed on crizotinib and at least one chemotherapy treatment.
Slovenian: vključenimi v študijo, je bilo 26 % takšnih, ki jim je bolezen pred tem napredovala med zdravljenjem s samim krizotinibom, pri 74 % pa je pred tem napredovala med zdravljenjem s krizotinibom in vsaj še eno kemoterapijo.
English: Alectinib did not inhibit OATP1B1/OATP1B3, OAT1, OAT3 or OCT2 at clinically relevant concentrations in vitro.
Slovenian: Alektinib pri klinično pomembnih koncentracijah in vitro ne zavira OATP1B1/OATP1B3,
English: Look out for these while you are taking Alecensa.
Slovenian: Med jemanjem zdravila Alecensa bodite pozorni na te znake.
English: Temporarily withhold until recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
Slovenian: Začasno prekinite uporabo zdravila, dokler se ne izboljša na stopnjo ≤ 1 (asimptomatska bradikardija) oz. dokler ni srčna frekvenca ≥ 60 utripov/minuto.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Slovenian: Bolnikom z blago do zmerno okvaro ledvic odmerka ni treba prilagoditi.
English: Alectinib caused embryo-foetal toxicity in pregnant rats and rabbits.
Slovenian: Pri brejih podganah in kunkah je alektinib povzročil embrio-fetalno toksičnost.
English: NAME OF THE MEDICINAL PRODUCT Alecensa 150 mg hard capsules alectinib
Slovenian: IME ZDRAVILA Alecensa 150 mg trde kapsule alektinib
English: If no contributing concomitant medicinal product is identified, or if contributing concomitant medicinal products are not discontinued or dose
Slovenian: Če ne najdete sočasnega zdravila, ki je k temu pripomoglo, ukinite zdravljenje z zdravilom
English: SPECIAL STORAGE CONDITIONS Store in the original package and keep the bottle tightly closed in order to protect from moisture
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini, plastenka naj bo tesno zaprta za zagotovitev zaščite pred vlago
English: There were 66 of 365 patients (18%) treated with Alecensa who had post-dose heart rate values below 50 beats per minutes (bpm).
Slovenian: 66 od 365 bolnikov (18 %), zdravljenih z zdravilom Alecensa,
English: These events did not lead to withdrawal from Alecensa treatment.
Slovenian: Ti učinki niso povzročili ukinitve zdravljenja z zdravilom Alecensa.
English: Cases of ILD/pneumonitis have been reported in clinical trials with Alecensa (see section 4.8).
Slovenian: V kliničnih preskušanjih z zdravilom Alecensa so poročali o primerih IBP/pnevmonitisa (glejte poglavje 4.8).
English: No starting dose adjustment is required in patients with underlying mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Slovenian: Bolnikom z obstoječo blago (razreda A po Child-Pughovi lestvici) ali zmerno okvaro jeter (razreda B
English: Proliferative zone extension in GI mucosa in both species was observed at exposures equal to or greater than 20-120% of the human AUC exposure at the recommended dose.
Slovenian: Pri izpostavljenosti, ki je bila (glede na AUC) enaka ali večja od 20 do 120 % izpostavljenosti pri človeku ob uporabi priporočenih odmerkov, so pri obeh živalskih vrstah opažali razširitev proliferacijske cone v sluznici prebavil.
English: CNS-ORR in patients with measurable CNS metastases at baseline
Slovenian: Osrednje živčevje - ORR pri bolnikih z merljivimi metastazami v osrednjem živčevju v izhodišču
English: Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450 mg taken twice daily (total dose of 900 mg) (see section 5.2).
Slovenian: Bolniki z obstoječo hudo okvaro jeter (razreda C po Child-Pughovi lestvici) naj prejmejo začetni odmerek 450 mg dvakrat na dan
English: Two of these cases led to withdrawal from Alecensa treatment.
Slovenian: V dveh od teh dveh primerov je bilo zdravilo Alecensa ukinjeno.
English: ● constipation
Slovenian: ● izpuščaj;
English: ● Fainting, dizziness and low blood pressure (potential signs of slow heart beat)
Slovenian: ● omedlevica, omotica in nizek krvni tlak (morebitni znaki počasnega srčnega utripa); ● novi bolezenski znaki ali poslabšanje bolezenskih znakov, kot so težko dihanje, kratka sapa, kašelj
English: Table 5 Efficacy results from studies NP28673 and NP28761
Slovenian: Rezultati učinkovitosti v študijah NP28673 in NP28761
English: ● sirolimus, a medicine used to prevent the body's immune system from rejecting a transplanted kidney, heart or liver
Slovenian: ● sirolimus, zdravilo za preprečevanje zavrnitve presajene ledvice, srca ali jeter zaradi imunskega odgovora telesa, ● topotekan, zdravilo za zdravljenje nekaterih vrst raka,
English: Take special care when driving and using machines as you may develop problems with vision or slowing of the heartbeat or low blood pressure that can lead to fainting or dizziness while you are taking Alecensa.
Slovenian: Alecensa pojavijo težave z vidom, upočasnjen srčni utrip ali nizek krvni tlak, ki lahko povzroči omedlevico ali omotico.
English: M4 Cmax and AUCinf was 39% and 34% lower respectively, resulting in a combined exposure of alectinib and M4 (AUCinf) 1.8-fold higher in patients with severe hepatic impairment compared with matched healthy subjects.
Slovenian: Skupna izpostavljenost alektinibu in M4 (AUCinf) je bila tako pri bolnikih s hudo okvaro jeter 1,8-krat večja kot pri zdravih preskušancih.
English: ● lapatinib, a medicine used to treat certain types of breast cancer
Slovenian: ● lapatinib, zdravilo za zdravljenje nekaterih vrst raka dojk,
English: What Alecensa is used for
Slovenian: Za kaj uporabljamo zdravilo Alecensa
English: Table 4 Summary of efficacy results from study BO28984 (ALEX)
Slovenian: Povzetek rezultatov učinkovitosti iz študije BO28984 (ALEX) krizotinib n = 151
English: * Key secondary endpoints part of the hierarchical testing ** Competing risk analysis of CNS progression, systemic progression and death as competing events *** 2 patients in the crizotinib arm and 6 patients in the alectinib arm had CR CI = confidence interval; CNS = central nervous system; CR = complete response; DOR = duration of response; HR = hazard ratio; IRC = Independent Review Committee; INV = investigator; NE = not estimable; ORR = objective response rate; PFS = progression free survival
Slovenian: ** Kompetitivna analiza tveganja za napredovanje v osrednjem živčevju, sistemsko napredovanje in smrt kot kompetitivnih dogodkov *** Popolni odziv sta imela 2 bolnika v skupini, zdravljeni s krizotinibom, in 6 bolnikov v skupini, zdravljeni z alektinibom
English: Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Slovenian: Ena trda kapsula vsebuje alektinibijev klorid, kolikor ga ustreza 150 mg alektiniba.
English: In the phase III clinical trial BO28984 15% of patients treated with Alecensa had post-dose heart rate values below 50 bpm versus 20% of patients treated with crizotinib.
Slovenian: BO28984 je imelo 15 % bolnikov, zdravljenih z zdravilom Alecensa, srčno frekvenco po odmerku manj kot 50 utripov na minuto v primerjavi z 20 % bolnikov, zdravljenih s krizotinibom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR BLISTER
Slovenian: PODATKI NA ZUNANJI OVOJNINI VMESNA ŠKATLA ZA PRETISNE OMOTE
English: Bottles: Store in the original package and keep the bottle tightly closed in order to protect from moisture.
Slovenian: Plastenke: Shranjujte v originalni ovojnini, plastenka naj bo tesno zaprta za zagotovitev zaščite pred vlago.
English: Adverse reactions of bilirubin elevations were reported in 18% of the patients treated with Alecensa across clinical trials (NP28761, NP28673, BO28984).
Slovenian: Neželen učinek zvišanega bilirubina so zabeležili pri 18 % bolnikov, zdravljenih z zdravilom Alecensa vkliničnih preskušanjih (NP28761, NP28673, BO28984).
English: Pharmacotherapeutic group: anti-neoplastic agents, protein kinase inhibitor; ATC code: L01XE36.
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinskih kinaz.
English: Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inducers.
Slovenian: Glede na učinke na skupno izpostavljenost alektinibu in M4 med sočasno uporabo zdravila Alecensa in induktorjev CYP3A odmerka ni treba prilagoditi.
English: These include:
Slovenian: Med takšnimi neželenimi učinki so:
English: This medicine contains 48 mg sodium (main component of cooking/table salt) per recommended daily dose (1200 mg).
Slovenian: Zdravilo Alecensa vsebuje natrij To zdravilo vsebuje 48 mg natrija (glavne sestavine kuhinjske soli) v priporočenem dnevnem odmerku
English: Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa.
Slovenian: Med zdravljenjem z zdravilom Alecensa bo zdravnik opravljal preiskave krvi vsaj na 2 tedna v prvem mesecu zdravljenja in pozneje po potrebi.
English: The primary endpoint was to evaluate the efficacy of Alecensa by Objective Response Rate (ORR) as per central Independent Review Committee (IRC) assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the overall population (with and without prior exposure of cytotoxic chemotherapy treatments).
Slovenian: (IRC - Independent Review Committee) na podlagi meril RECIST (Response Evaluation Criteria in Solid Tumors, različica 1.1) v celotni populaciji (tako pri bolnikih, ki so bili, in tistih, ki niso bili predhodno izpostavljeni citotoksični kemoterapiji).
English: The PFS benefit was consistent for patients with CNS metastases at baseline (HR = 0.40, 95% CI: 0.25-0.64, median PFS for Alecensa = NE, 95% CI: 9.2-NE, median PFS for crizotinib = 7.4 months, 95%CI: 6.6-9.6) and without CNS metastases at baseline (HR = 0.51, 95% CI: 0.33-0.80, median PFS for Alecensa = NE, 95% CI: NE, NE, median PFS for crizotinib = 14.8 months, 95% CI:10.8-20.3), indicating benefit of Alecensa over crizotinib in both subgroups.
Slovenian: IZ: 9,2-NO, mediano PFS za krizotinib = 7,4 mececev, 95-% IZ: 6,6-9,6) in bolniki brez metastaz v osrednjem živčevju v izhodišču (HR = 0,51; 95-% IZ: 0,33-0,80; mediano PFS za zdravilo
English: Co-administration of multiple oral doses of 600 mg rifampicin once daily, a strong CYP3A inducer, with a single oral dose of 600 mg alectinib reduced alectinib Cmax, and AUCinf by 51% and 73% respectively and increased M4 Cmax and AUCinf 2.20 and 1.79-fold respectively.
Slovenian: enkrat na dan z enkratnim peroralnim odmerkom 600 mg alektiniba je zmanjšala Cmax alektiniba za 51 % in AUCinf alektiniba za 73 % ter zvečala Cmax M4 2,20-krat in AUCinf M4 1,79-krat.
English: ULN) with total bilirubin elevation > 2 times ULN in the absence of cholestasis or haemolysis
Slovenian: > 2-kratno ZMN, brez holestaze ali hemolize
English: Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
Slovenian: Zdravilo Alecensa je v monoterapiji indicirano za zdravljenje odraslih bolnikov z ALK-pozitivnim,
English: Following administration of a single oral dose of 300 mg alectinib in subjects with severe (Child-Pugh C) hepatic impairment, alectinib Cmax was the same and AUCinf was 2.2-fold higher compared with the same parameters in matched healthy subjects.
Slovenian: Po uporabi enkratnega peroralnega odmerka 300 mg alektiniba je bila Cmax alektiniba pri preskušancih s hudo okvaro jeter (razreda C po Child-Pughovi lestvici) enaka kot pri zdravih preskušancih, AUCinf alektiniba pa 2,2-krat večja; Cmax M4 je bila manjša za 39 %, AUCinf M4 pa za 34 %.
English: CNS responders n (%) [95% CI]
Slovenian: Odzivni bolniki n (%) [95-% IZ]
English: Constipation (35%), nausea (19%), diarrhoea (16%) and vomiting (11%) were the most commonly reported gastrointestinal (GI) reactions.
Slovenian: (19 %), driski (16 %) in bruhanju (11 %).
English: ALT or AST elevation of Grade ≥ 2 (> 3 times
Slovenian: Zvišanje ALT ali AST ≥ stopnje 2 (> 3-kratna ZMN) in zvišanje celokupnega bilirubina na
English: Severe myalgia has not been reported in the clinical trial BO28984.
Slovenian: BO28984 o hudi mialgiji niso poročali.
English: What you need to know before you take Alecensa
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Alecensa Ne jemljite zdravila Alecensa:
English: upon recovery to ≤ Grade 1 (asymptomatic) bradycardia or to a heart rate of ≥ 60 bpm.
Slovenian: ko se stanje izboljša na stopnjo ≤ 1 (asimptomatska bradikardija) oz. ko je srčna frekvenca ≥ 60 utripov/minuto.
English: Duration of response (INV) Median (months) [95 % CI]
Slovenian: Trajanje odziva (raziskovalec) Mediana (meseci) [95-% IZ]
English: Alectinib absorbs UV light between 200 and 400 nm and demonstrated a phototoxic potential in an in vitro photosafety test in cultured murine fibroblasts after UVA irradiation.
Slovenian: Pokazal je fototoksičen potencial v preizkusu svetlobne varnosti in vitro na kulturi mišjih fibroblastov po obsevanju z UVA.
English: There are no or limited amount of data from the use of Alecensa in pregnant women.
Slovenian: O uporabi zdravila Alecensa pri nosečnicah je malo podatkov ali jih ni. Glede na mehanizem delovanja bi zdravilo Alecensa lahko škodovalo plodu, če je uporabljeno pri nosečnici.
English: ● abnormal results of blood tests to check for liver problems (high levels of alanine aminotransferase, aspartate aminotransferase and bilirubin)
Slovenian: ● nenormalni izvidi preiskav krvi, ki odražajo delovanje jeter (velike koncentracije alanin aminotransferaze, aspartat-aminotransferaze in bilirubina); ● nenormalni izvidi preiskav krvi, ki odražajo poškodbo mišic (velika koncentracija kreatin fosfokinaze);
English: ● Yellowing of your skin or the whites of your eyes, pain on the right side of your stomach area, dark urine, itchy skin, feeling less hungry than usual, nausea or vomiting, feeling tired, bleeding or bruising more easily than normal (potential signs of liver problems)
Slovenian: srbenje kože, občutek manjše lakote kot običajno, slabost ali bruhanje, občutek utrujenosti, večja nagnjenost h krvavitvam ali modricam kot običajno (morebitni znaki težav z jetri);
English: Severe ILD/pneumonitis occurred in patients treated with Alecensa.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Alecensa, so se pojavili hudi primeri IBP/pnevmonitisa.
English: Concurrent elevations in ALT or AST greater than or equal to three times the ULN and total bilirubin greater than or equal to two times the ULN, with normal alkaline phosphatase, occurred in one patient (0.2%) treated in Alecensa clinical trials.
Slovenian: V kliničnih preskušanjih z zdravilom Alecensa so pri enem bolniku (0,2 %) zabeležili sočasno zvišanje ALT ali AST na več ali enako kot 3-kratno ZMN ali celokupnega bilirubina na več ali enako kot 2-kratno ZMN, vrednosti alkalne fosfataze so bile normalne.
English: ● methotrexate, a medicine used to treat certain types of cancer or to treat autoimmune diseases (e.g.
Slovenian: ● metotreksat, zdravilo za zdravljenje nekaterih vrst raka ali za zdravljenje avtoimunskih bolezni
English: Abnormal erythrocyte morphology was observed at exposures equal or greater than 10-60% the human exposure by AUC at the recommended dose.
Slovenian: Pri izpostavljenosti, ki je bila (glede na AUC) enaka ali večja 10 do 60 % izpostavljenosti pri človeku ob uporabi priporočenih odmerkov, so opažali nenormalno morfologijo eritrocitov.
English: Based on the effects on the combined exposure of alectinib and M4, no dose adjustments are required when Alecensa is co-administered with CYP3A inhibitors.
Slovenian: Glede na učinke na skupno izpostavljenost alektinibu in M4 med sočasno uporabo zdravila Alecensa in zaviralcev CYP3A odmerka ni treba prilagoditi.
English: Table 3 lists the ADRs occurring in patients who received Alecensa across two phase II clinical trials (NP28761, NP28673) and one phase III clinical trial (BO28984; ALEX), and during post-marketing.
Slovenian: Preglednica 3 navaja neželene učinke, ki so se v dveh kliničnih preskušanjih faze II (NP28761 in NP28673) in enem kliničnem preskušanju faze III (BO28984; ALEX) in med obdobjem trženja pojavili pri bolnikih, zdravljenih z zdravilom Alecensa.
English: CI = confidence interval; DOR = duration of response; IRC = independent review committee; NE = not estimable; ORR = objective response rate; PFS= progression free survival; RE = response evaluable a
Slovenian: Committee); NO = ni ocenljivo; ORR = delež objektivnega odziva (objective response rate); PFS = preživetje brez napredovanja bolezni (progression free survival).
English: Severe myalgia and creatine phosphokinase (CPK) elevation Myalgia or musculoskeletal pain was reported in patients in pivotal trials with Alecensa, including Grade 3 events (see section 4.8).
Slovenian: Pri bolnikih v ključnih preskušanjih z zdravilom Alecensa so poročali o mialgiji ali mišično-skeletnih bolečinah, vključno z dogodki stopnje 3 (glejte poglavje 4.8).
English: Crizotinib pre-treated patients
Slovenian: Bolniki, predhodno zdravljeni s krizotinibom
English: ● St. John's Wort, a herbal medicine used to treat depression
Slovenian: ● šentjanževka, zdravilo rastlinskega izvora za zdravljenje depresije,
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines:
Slovenian: Še zlasti morate zdravniku ali farmacevtu povedati, če jemljete katero od naslednjih zdravil: ● digoksin, zdravilo za zdravljenje težav s srcem,
English: The hepatic impairment study also included a group with moderate (Child-Pugh B) hepatic impairment, and a modestly higher alectinib exposure was observed in this group compared with matched healthy subjects.
Slovenian: V tej skupini so v primerjavi z zdravimi preskušanci opazili zmerno povečanje izpostavljenosti alektinibu.
English: Primary efficacy parameters ORR (IRC) in RE population Responders N (%) [95% CI]
Slovenian: Primarni parametri učinkovitosti ORR (IRC) v populaciji z ocenljivim odzivom