FrancophonIA/ELRC3.0 huggingface dataset:
English: IMBRUVICA 140 mg film-coated tablets IMBRUVICA 280 mg film-coated tablets IMBRUVICA 420 mg film-coated tablets IMBRUVICA 560 mg film-coated tablets ibrutinib
Slovenian: IMBRUVICA 140 mg filmsko obložene tablete IMBRUVICA 280 mg filmsko obložene tablete IMBRUVICA 420 mg filmsko obložene tablete IMBRUVICA 560 mg filmsko obložene tablete ibrutinib
English: The median age was 68 years (range, 34; 88 years), 74% were male and 87% were Caucasian.
Slovenian: Mediana starost bolnikov je bila 68 let (razpon, 34; 88 let), 74% jih je bilo moškega spola in 87% je bilo belcev.
English: Administer supportive care including hydration and/or cytoreduction as indicated.
Slovenian: Bolnike je treba skrbno spremljati in po potrebi uvesti podporne ukrepe vključno s hidracijo in/ali citoredukcijo.
English: Ninety patients randomised to placebo+BR crossed over to receive IMBRUVICA following IRC confirmed progression.
Slovenian: Ko je IRC potrdila napredovanje bolezni, je 90 bolnikov, ki so bili randomizirani na placebo + BR prešlo na zdravljenje z zdravilom IMBRUVICA.
English: Yellow to orange oblong tablets (19 mm in length and 8.1 mm in width), debossed with “ibr” on one side and “560” on the other side.
Slovenian: Rumene do oranžne, podolgovate tablete (19 mm dolge in 8,1 mm široke) z vtisnjeno oznako “ibr” na eni in "560" na drugi strani.
English: Lymphocytosis was not observed in patients with WM treated with IMBRUVICA.
Slovenian: Pri bolnikih z WM, zdravljenih z zdravilom IMBRUVICA, limfocitoze niso opazili.
English: Ibrutinib was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse at oral doses up to 2000 mg/kg/day with an exposure margin of approximately 23 (males) to 37 (females) times the human AUC of ibrutinib at a dose of 560 mg daily.
Slovenian: V 6-tedenski študiji pri transgenih miših (Tg.rasH2), ki so peroralno prejemale ibrutinib v odmerku do 2000 mg/kg/dan in meji izpostavljenosti, ki je bila 23-kratnik (samci) do 27-kratnik (samice) vrednosti AUC ibrutiniba pri ljudeh, ki so prejemali dnevni odmerek 560 mg, ibrutinib ni bil karcinogen.
English: If the toxicity reoccurs, the once daily dose should be reduced by 140 mg. A second reduction of dose by 140 mg may be considered as needed.
Slovenian: Če se znaki toksičnega učinkovanja ponovijo, je treba dnevni odmerek zmanjšati za 140 mg.
English: The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo+BR (Study CLL3001).
Slovenian: Varnost in učinkovitost zdravila IMBRUVICA pri bolnikih, predhodno zdravljenih za KLL so ocenjevali tudi v randomizirani, multicentrični, dvojno slepi študiji faze 3, kjer so primerjali zdravilo IMBRUVICA v kombinaciji z BR in kombinacijo placebo + BR (študija CLL3001).
English: In vitro platelet aggregation
Slovenian: Agregacija trombocitov in vitro
English: HDPE bottles with a child-resistant polypropylene closure.
Slovenian: Plastenka iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko.
English: Ninety-three percent of patients had a baseline ECOG performance status of 0 or 1, and 7% of patients had a baseline ECOG performance status of 2.
Slovenian: Triindevetdeset odstotkov bolnikov je imelo izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 ali 1, 7% bolnikov pa je imelo izhodiščno oceno po lestvici ECOG 2.
English: The median age was 68 years (range: 40 to 84 years), 77% were male and 92% were Caucasian.
Slovenian: Njihova mediana starost je bila 68 let (od 40 do 84 let), 77% jih je bilo moškega spola in 92% je bilo belcev.
English: Number of events (%) Median (95% CI), months
Slovenian: PFS število dogodkov (%) mediana (95% IZ), meseci ni dosežena
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily.
Slovenian: Pri bolnikih z blago okvaro jeter (razreda A po Child-Pughu) je priporočeni odmerek 280 mg na dan.
English: For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (two capsules).
Slovenian: Pri bolnikih z blago okvaro jeter (razreda A po Child-Pughu) je priporočeni odmerek 280 mg (dve kapsuli) na dan.
English: Table 11: Efficacy results in Study PCYC-1127-CA Endpoint
Slovenian: Preglednica 11: Rezultati učinkovitosti v študiji PCYC-1127-CA
English: At baseline, the median serum IgM value was 3.2 g/dL (range, 0.6 to 8.3 g/dL), 63% of patients were anaemic (haemoglobin ≤11 g/dL or 6.8 mmol/L) and MYD88 L265P mutations were present in 77% of patients, absent in 13% of patients, and 9% of patients were not evaluable for mutation status.
Slovenian: (hemoglobin ≤11 g/dl ali 6,8 mmol/l), mutacije MYD88 L265P pa so bile prisotne pri 77% bolnikov in odsotne pri 13% bolnikov, medtem ko pri 9% bolnikih mutacijskega statusa ni bila mogoče oceniti.
English: IMBRUVICA contains sodium
Slovenian: Zdravilo IMBRUVICA vsebuje natrij
English: CI=confidence interval; CR=complete response; DOR=duration of response; ORR=overall response rate; PR=partial response; NR=not reached
Slovenian: IZ = interval zaupanja, CR (complete response) = popolni odgovor, DOR (duration of response) = trajanje odgovora, ND = ni dosežen
English: Not reached HR=0.203 [95% CI: 0.150, 0.276]
Slovenian: PFS mediana (95% IZ), meseci ni dosežena HR = 0,203 [95% IZ: 0,150; 0,276]
English: If the benefit outweighs the risk and a strong CYP3A4 inhibitor must be used, reduce the IMBRUVICA dose to 140 mg for the duration of the inhibitor use or withhold IMBRUVICA temporarily (for 7 days or less).
Slovenian: Če mora bolnik jemati katerega od močnih zaviralcev CYP3A4, in koristi sočasne uporabe presegajo tveganja, je treba odmerek zdravila IMBRUVICA med sočasno uporabo zaviralcev zmanjšati na 140 mg ali pa začasno (za 7 dni ali manj) prekiniti zdravljenje z zdravilom IMBRUVICA.
English: • Do not breast-feed while you are taking this medicine.
Slovenian: - V času jemanja tega zdravila ne smete dojiti.
English: Figure 1: Kaplan-Meier curve of PFS (ITT Population) in Study MCL3001
Slovenian: Slika 1: Kaplan-Meierjeva krivulja PFS (populacija z namenom zdravljenja; (ITT-Intention To Treat Population) v študiji MCL3001
English: IMBRUVICA 140 mg film-coated tablets: Each tablet contains 140 mg of ibrutinib.
Slovenian: IMBRUVICA 140 mg filmsko obložene tablete: Ena tableta vsebuje 140 mg ibrutiniba.
English: • If you miss a dose, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.
Slovenian: Če ste pozabili vzeti zdravilo IMBRUVICA - Če ste pozabili vzeti odmerek, ga lahko vzamete čimprej istega dne, naslednjega dne pa spet začnete z odmerjanjem po običajnem razporedu.
English: Patients (n=150) were randomized 1:1 to receive either IMBRUVICA 420 mg daily or placebo in combination with rituximab until disease progression or unacceptable toxicity.
Slovenian: Bolniki (n=150) so bili v razmerju 1:1 randomizirani na prejemanje bodisi zdravila IMBRUVICA 420 mg na dan ali placeba v kombinaciji z rituksimabom do napredovanja bolezni ali do nesprejemljivega toksičnega delovanja zdravil.
English: VGPR (%)
Slovenian: PFS (%)
English: • Tell your doctor immediately if you become pregnant.
Slovenian: - Če zanosite, takoj obvestite zdravnika.
English: The response rate per IRC observed in the monotherapy arm was 71% (0% CR, 29% VGPR, 42% PR).
Slovenian: Po oceni komisije IRC je bil delež odgovora v skupini z monoterapijo 71% (0% s popolnim odgovorom, 29% z zelo dobrim delnim odgovorom in 42% z delnim odgovorom).
English: The median age was 64 years (range, 31 to 86 years), 66% were male, and 91% were Caucasian.
Slovenian: Mediana starost bolnikov je bila 64 let (od 31 do 86 let), 66% jih je bilo moškega spola in 91% je bilo belcev.
English: The median time since diagnosis was 6 years and the median number of prior treatments was 2 (range, 1 to 11 treatments).
Slovenian: Mediana časa od postavitve diagnoze je bila 6 let, mediano število predhodnih terapij je bilo 2 (od 1 do 11 terapij).
English: Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies.
Slovenian: Pri bolnikih z okvaro ledvic niso izvajali posebnih študij, so pa bolnike z blago oziroma zmerno okvaro ledvic zdravili v okviru kliničnih študij zdravila IMBRUVICA.
English: • Take the tablets orally (by mouth) with a glass of water.
Slovenian: Jemanje tega zdravila - Tablete zaužijte peroralno s kozarcem vode.
English: HOW TO TAKE IMBRUVICA
Slovenian: Kako jemati zdravilo IMBRUVICA
English: How to take IMBRUVICA
Slovenian: KAKO JEMATI ZDRAVILO IMBRUVICA
English: All subjects
Slovenian: vsi preiskovanci
English: Do not open, break or chew them.
Slovenian: Kapsul se ne sme odpirati, drobiti ali žvečiti.
English: The safety and efficacy of IMBRUVICA in patients with treatment naïve CLL/SLL were further evaluated in a randomized, multi-center, open-label, Phase 3 study (PCYC-1130-CA) of IMBRUVICA in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab.
Slovenian: Varnost in učinkovitost zdravila IMBRUVICA pri bolnikih s KLL/SLL brez predhodnega zdravljenja so ocenjevali tudi v randomizirani, multicentrični, odprti študiji faze 3 (študiji PCYC-1130-CA) z zdravilom IMBRUVICA v kombinaciji z obinutuzumabom v primerjavi s klorambucilom v kombinaciji z obinutuzumabom.
English: IMBRUVICA 560 mg film-coated tablets Each film-coated tablet contains 560 mg of ibrutinib.
Slovenian: IMBRUVICA 560 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 560 mg ibrutiniba.
English: Ibrutinib did not show meaningful inhibition of platelet aggregation using other agonists of platelet aggregation.
Slovenian: Pri sočasni uporabi ibrutiniba z drugimi agonisti agregacije trombocitov ibrutinib ni pomembno zaviral agregacije trombocitov.
English: Eighty-one percent of patients had a baseline ECOG performance status of 0 or 1, and 19% had a baseline ECOG performance status of 2.
Slovenian: Enainosemdeset odstotkov bolnikov je imelo izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 ali 1, 19% bolnikov pa je imelo izhodiščno oceno po lestvici ECOG 2.
English: Your doctor will check your blood counts before or during the treatment and in rare cases they may need to give you another medicine.
Slovenian: Zdravnik bo pregledoval vašo krvno sliko pred zdravljenjem ali med njim.
English: Strong CYP3A4 inhibitors
Slovenian: Močni zaviralci CYP3A4
English: Each 560 mg film-coated tablet contains 112 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom Ena 560 mg filmsko obložena tableta vsebuje 112 mg laktoze (v obliki monohidrata)
English: INFORMATION IN BRAILLE Imbruvica 140 mg
Slovenian: Imbruvica 140 mg
English: Each 420 mg film-coated tablet contains 84 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom Ena 420 mg filmsko obložena tableta vsebuje 84 mg laktoze (v obliki monohidrata)
English: Moderate CYP3A4 inhibitors
Slovenian: Zmerni zaviralci CYP3A4
English: IMBRUVICA 420 mg film-coated tablets
Slovenian: IMBRUVICA 420 mg filmsko obložene tablete
English: CI=confidence interval; HR=hazard ratio; CR=complete response; PR=partial response.
Slovenian: IZ = interval zaupanja, HR (hazard ratio) = razmerje ogroženosti, CR (complete response) = popolni odgovor, ORR
English: Ninety one percent of patients had a baseline ECOG performance status of 0 or 1 and 9% had an ECOG performance status of 2.
Slovenian: Enaindevetdeset odstotkov bolnikov je imelo izhodiščno oceno splošne zmogljivosti po lestvici ECOG 0 ali 1, 9% pa ECOG 2.
English: What IMBRUVICA is
Slovenian: Kaj je zdravilo IMBRUVICA
English: NE=not estimable; HR=hazard ratio; CI=confidence interval; ORR=overall response rate; PFS=progression-free survival IRC evaluated.
Slovenian: NE (not estimable) = ocena ni mogoča, HR (hazard ratio) = razmerje ogroženosti, IZ = interval zaupanja, ORR (Overall Response Rate) = celokupni delež odgovora, PFS (Progression Free Survival) = preživetje brez napredovanja bolezni ocenjeno s strani IRC
English: The recommended dose for the treatment of MCL is 560 mg (four capsules) once daily.
Slovenian: MCL Priporočeni odmerek za zdravljenje MCL je 560 mg (štiri kapsule) enkrat na dan.
English: Consider prophylaxis according to standard of care in patients who are at increased risk for opportunistic infections.
Slovenian: Pri bolnikih s povečanim tveganjem za oportunistične okužbe razmislite o standardnih ukrepih za njihovo preprečevanje.
English: Cases of progressive multifocal leukoencephalopathy (PML) including fatal ones have been reported following the use of ibrutinib within the context of a prior or concomitant immunosuppressive therapy.
Slovenian: Pri uporabi ibrutiniba ob predhodni ali sočasni uporabi imunosupresivnega zdravljenja so poročali o progresivni multifokalni levkoencefalopatiji (PML), vključno s smrtnimi primeri.
English: The safety and efficacy of IMBRUVICA in WM were further evaluated in patients with treatment-naïve or previously treated WM in a randomized, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with rituximab versus placebo in combination with rituximab (PCYC-1127-CA).
Slovenian: Varnost in učinkovitost zdravila IMBRUVICA pri WM so ocenjevali tudi pri bolnikih, ki predhodno še niso bili oziroma so že bili predhodno zdravljeni za WM, in sicer v randomizirani, multicentrični, dvojno slepi študiji faze 3 z zdravilom IMBRUVICA v kombinaciji z rituksimabom v primerjavi z uporabo placeba v kombinaciji z rituksimabom (študija PCYC-1127-CA).
English: IMBRUVICA 560 mg film-coated tablets
Slovenian: IMBRUVICA 560 mg filmsko obložene tablete
English: Janssen-Cilag B.V. Tel: +31 76 711 1111 janssen@jacnl.jnj.com
Slovenian: Tel: +31 76 711 1111 janssen@jacnl.jnj.com
English: Therefore, no precautions are necessary in patients with different CYP2D6 genotypes.
Slovenian: Kaže, da je encim CYP2D6 v zelo majhni meri vpleten v presnovo ibrutiniba, zato pri bolnikih z različnimi genotipi encima CYP2D6 ni potrebna posebna previdnost pri odmerjanju zdravila.
English: Hazard Ratio
Slovenian: Stadij Rai
English: IMBRUVICA 140 mg hard capsules ibrutinib
Slovenian: IMBRUVICA 140 mg kapsule ibrutinib
English: The median age was 67 years (range: 30 to 88 years), 68% were male, and 90% were Caucasian.
Slovenian: Mediana starost bolnikov je bila 67 let (od 30 do 88 let), 68% jih je bilo moškega spola, 90% je bilo belcev.
English: No specific studies have been conducted to date in subjects with impaired renal function.
Slovenian: Pri bolnikih z zmanjšanim delovanjem ledvic do zdaj niso izvajali nobenih specifičnih študij.
English: The median age was 63 years (range: 44 to 86 years), 76% were male, and 95% were Caucasian.
Slovenian: Njihova mediana starost je bila 63 let (od 44 do 86 let), 76% jih je bilo moškega spola in 95% je bilo belcev.
English: A hepatic impairment trial was performed in non-cancer subjects administered a single dose of 140 mg of medicinal product under fasting conditions.
Slovenian: V študiji uporabe zdravila pri neonkoloških bolnikih z okvaro jeter, so bolniki na tešče prejeli enkratni, 140 mg odmerek zdravila.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Slovenian: 28 filmsko obloženih tablet 30 filmsko obloženih tablet
English: Table 4: Efficacy results in Study PCYC-1115-CA Endpoint
Slovenian: Preglednica 4: Rezultati učinkovitosti v študiji PCYC-1115-CA Cilji opazovanja
English: The investigator-assessed ORR in the IMBRUVICA arm was 87.7% versus 22.4% in the ofatumumab arm. At the time of final analysis, 133 (67.9%) of the 196 subjects originally randomized to the ofatumumab treatment arm had crossed over to ibrutinib treatment.
Slovenian: V času pregleda končne analize je skupno 133 preiskovancev (67,9%) od 196 tistih, ki so bili sprva randomizirani v skupino z ofatumumabom, kasneje prejemalo ibrutinib v okviru navzkrižnega zdravljenja.
English: IMBRUVICA 560 mg film-coated tablets: Each tablet contains 560 mg of ibrutinib.
Slovenian: IMBRUVICA 560 mg filmsko obložene tablete: Ena tableta vsebuje 560 mg ibrutiniba
English: Very common Arthralgia Muscle spasms Musculoskeletal pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti artralgija mišični krči mišičnoskeletne bolečine*
English: IMBRUVICA 280 mg film-coated tablets
Slovenian: IMBRUVICA 280 mg filmsko obložene tablete
English: Transient ischaemic attack Ischaemic stroke a, #
Slovenian: prehodni ishemični napad ishemična možganska kap a, #
English: Cases of leukostasis have been reported in patients treated with IMBRUVICA.
Slovenian: Pri bolnikih, ki so jemali zdravilo IMBRUVICA, so poročali o primerih levkostaze.
English: CI=confidence interval; CR=complete response; HR=hazard ratio; MR=minor response; NE=not estimable; PR=partial response; R=Rituximab; TTnT=time to next treatment; VGPR=very good partial response IRC evaluated.
Slovenian: IZ = interval zaupanja; CR (complete response) = popolni odgovor; HR (hazard ratio) = razmerje ogroženosti; MR (minor response) = minimalni odgovor; NE (not estimable) = ocena ni mogoča; PR (partial response) = delni odgovor; R =rituksimab; TTnT (time to next treatment) = čas do naslednjega zdravljenja; VGPR (very good partial response) = zelo dober delni odgovor ocenjeno s strani IRC vrednost p v povezavi z deležem odgovora je bila <0,0001 opredeljeno kot zvišanje za ≥2 g/dl nad izhodiščno koncentracijo ne glede na vrednost izhodiščne koncentracije ali kot zvišanje na >11 g/dl z izboljšanjem za ≥0,5 g/dl, če je bila izhodiščna koncentracija ≤11 g/dl.
English: IMBRUVICA 280 mg film-coated tablets Each film-coated tablet contains 280 mg of ibrutinib.
Slovenian: IMBRUVICA 280 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 280 mg ibrutiniba.
English: IMBRUVICA 140 mg film-coated tablets
Slovenian: IMBRUVICA 140 mg filmsko obložene tablete
English: IMBRUVICA 420 mg film-coated tablets Each film-coated tablet contains 420 mg of ibrutinib.
Slovenian: IMBRUVICA 420 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 420 mg ibrutiniba.
English: Periodically monitor all patients clinically for cardiac arrhythmia.
Slovenian: Zaradi možnosti pojava srčnih aritmij je treba vse bolnike občasno klinično pregledati.
English: Figure 7: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1112-CA at Final Analysis with 65 Months Follow-up
Slovenian: Slika 7: Kaplan-Meierjeva krivulja PFS (ITT populacija) v študiji PCYC-1112-CA ob končni analizi po 65-mesečnem spremljanju
English: The median age was 69 years (range, 36 to 89 years), 66% were male, and 79% were Caucasian.
Slovenian: Mediana starost bolnikov je bila 69 let (od 36 do 89 let), 66% jih je bilo moškega spola in 79% je bilo belcev.
English: Ventricular tachyarrhythmia
Slovenian: podplutba* hipertenzija*
English: Figure 5: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1130-CA
Slovenian: Slika 5: Kaplan-Meierjeva krivulja PFS (ITT populacija) v študiji PCYC-1130-CA
English: Progression free survival (PFS) as assessed by an IRC according to IWCLL criteria indicated a 78% statistically significant reduction in the risk of death or progression for patients in the IMBRUVICA arm.
Slovenian: Podatki o preživetju brez napredovanja bolezni (PFS), ki jih je ocenila komisija IRC po kriterijih IWCLL, so pokazali 77-odstotno statistično značilno zmanjšanje tveganja za smrt ali napredovanje bolezni v skupini, ki je prejemala zdravilo IMBRUVICA.
English: Treatment-emergent grade 3 or 4 cytopenias (neutropenia, thrombocytopenia and anaemia) were reported in patients treated with IMBRUVICA.
Slovenian: Pri bolnikih, ki so jemali zdravilo IMBRUVICA, so poročali o z zdravljenjem povzročenih citopenijah (nevtropeniji, trombocitopeniji ali anemiji) stopnje 3 ali 4.
English: Tumour lysis syndrome has been reported with IMBRUVICA therapy.
Slovenian: Pri zdravljenju z zdravilom IMBRUVICA so poročali o sindromu razpada tumorja.
English: IMBRUVICA 280 mg film-coated tablets: Each tablet contains 280 mg of ibrutinib.
Slovenian: IMBRUVICA 280 mg filmsko obložene tablete: Ena tableta vsebuje 280 mg ibrutiniba.
English: IMBRUVICA 420 mg film-coated tablets: Each tablet contains 420 mg of ibrutinib.
Slovenian: IMBRUVICA 420 mg filmsko obložene tablete: Ena tableta vsebuje 420 mg ibrutiniba.
English: Each 140 mg film-coated tablet contains 28 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom Ena 140 mg filmsko obložena tableta vsebuje 28 mg laktoze (v obliki monohidrata)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (28 days)
Slovenian: ZGIBANKA 560 MG TABLETE (28 dni)
English: Figure 8: Kaplan-Meier Curve of PFS (ITT Population) in Study PCYC-1127-CA
Slovenian: Slika 8: Kaplan-Meierjeva krivulja PFS (populacija ITT) v študiji PCYC-1127-CA
English: Each 280 mg film-coated tablet contains 56 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom Ena 280 mg filmsko obložena tableta vsebuje 56 mg laktoze (v obliki monohidrata)
English: Stomatitis
Slovenian: IMBRUVICA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 560 MG TABLET (30 days)
Slovenian: ZGIBANKA 560 MG TABLETE (30 dni)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (30 days)
Slovenian: ZGIBANKA 420 MG TABLETE (30 dni)
English: HR=0.628 [95% CI: 0.385, 1.024]
Slovenian: HR = 0,628 [95% IZ: 0,385; 1,024]
English: What IMBRUVICA contains
Slovenian: Kaj vsebuje zdravilo IMBRUVICA
English: Number of prior lines
Slovenian: Število predhodnih terapij
English: • Tablet film-coat: polyvinyl alcohol, macrogol, talc, titanium dioxide (E171); IMBRUVICA 140 mg and IMBRUVICA 420 mg film-coated tablets also contain black iron oxide (E172) and yellow iron oxide (E172); IMBRUVICA 280 mg film-coated tablets also contain black iron oxide (E172) and red iron oxide (E172); IMBRUVICA 560 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).
Slovenian: Jedro tablete: brezvodni koloidni silicijev dioksid, premrežen natrijev karmelozat, laktoza monohidrat (glejte poglavje 2 “Zdravilo IMBRUVICA vsebuje laktozo), magnezijev stearat, mikrokristalna celuloza, povidon, natrijev lavrilsulfat (E487) Filmska obloga tablet: polivinilalkohol, makrogol, smukec, titanov dioksid (E171) IMBRUVICA 140 mg in IMBRUVICA 420 mg filmsko obložene tablete vsebujejo črni železov oksid (E172) in rumeni železov oksid (E172).
English: BTK's pivotal role in signalling through the B-cell surface receptors results in activation of pathways necessary for B-cell trafficking, chemotaxis and adhesion.
Slovenian: Signaliziranje preko površinskih receptorjev celic B je ključna naloga Brutonove tirozinske kinaze in povzroča aktivacijo biokemične poti, ki je potrebna za potovanje, kemotakso in adhezijo celic B. Rezultati predkliničnih študij kažejo, da ibrutinib učinkovito zavira proliferacijo malignih celic B in njihovo preživetje in vivo ter migracijo celic in adhezijo substratov in vitro.
English: Table 8: Subgroup analysis of PFS (Study PCYC-1112-CA)
Slovenian: Preglednica 8: Analiza podskupin PFS (študija PCYC-1112-CA) Razmerje ogroženosti
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 420 MG TABLET (28 days)
Slovenian: ZGIBANKA 420 MG TABLETE (28 dni)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (28 days)
Slovenian: ZGIBANKA 280 MG TABLETE (28 dni)
English: Very common Diarrhoea Vomiting
Slovenian: Bolezni prebavil zelo pogosti diareja bruhanje stomatitis* navzea obstipacija
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING WALLET 280 MG TABLET (30 days)
Slovenian: ZGIBANKA 280 MG TABLETE (30 dni)
English: The largest upper bound of the 2-sided 90% CI for the baseline adjusted mean differences between ibrutinib and placebo was below 10 ms.
Slovenian: Ibrutinib ni klinično pomembno podaljšal intervala QTc pri supraterapevtskem odmerku 1.680 mg. Največja zgornja meja dvostranskega 90% intervala zaupanja povprečne razlike med ibrutinibom in placebom, prilagojena izhodiščni vrednosti je bila manj kot 10 ms.
English: The dose of ibrutinib should be reduced to 280 mg once daily when used concomitantly with moderate CYP3A4 inhibitors.
Slovenian: Pri sočasni uporabi z zmernimi zaviralci CYP3A4 je treba odmerek ibrutiniba zmanjšati na 280 mg na dan.