FrancophonIA/ELRC3.0 huggingface dataset:
English: Suspend dose until toxicity resolves to baseline or Grade 1.
Slovenian: Prekinite odmerjanje do izboljšanja toksičnosti na izhodiščno vrednost ali stopnjo 1.
English: Abemaciclib should be administered with caution in patients with severe renal impairment, with close monitoring for signs of toxicity.
Slovenian: Pri dajanju abemacikliba bolnicam s hudo ledvično okvaro sta potrebna previdnost in skrbno spremljanje glede znakov toksičnosti.
English: Lilly France Tél: +33-(0) 1 55 49 34 34
Slovenian: Tél: +33-(0) 1 55 49 34 34
English: • Muscular weakness
Slovenian: • mišična šibkost
English: Tel: + 421 220 663 111
Slovenian: Tel. št.: + 421 220 663 111
English: A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.481 [95% CI: 0.369, 0.627]), median PFS 14.7 months versus 6.5 months; in patients with bone-only disease (HR of 0.543 [95% CI: 0.355, 0.833]); patients with measurable disease (HR of 0.523 [95% CI: 0.412, 0.644]).
Slovenian: Zmanjšanje tveganja za napredovanje bolezni ali smrt so opazili pri bolnicah z boleznijo v visceralnih organih (HR 0,481 [95 % IZ: 0,369, 0,627]), mediani PFS 14,7 meseca v primerjavi s 6,5 meseca, pri bolnicah z boleznijo samo v kosteh (HR 0,543, [95 % IZ: 0,355, 0,833]) in pri bolnicah z merljivo boleznijo (HR 0,523, [95 % IZ: 0,412, 0,644]).
English: Co-administration of abemaciclib with CYP3A4 inhibitors can increase plasma concentrations of abemaciclib.
Slovenian: Sočasna uporaba abemacikliba in zaviralcev CYP3A4 lahko poveča plazemsko koncentracijo abemacikliba.
English: Tel: + 420 234 664 111
Slovenian: Tel. št.: + 420 234 664 111
English: Grade 3
Slovenian: Stopnja 3
English: In clinical studies, increases in serum creatinine occurred within the first month of abemaciclib dosing, remained elevated but stable through the treatment period, were reversible upon treatment discontinuation, and were not accompanied by changes in markers of renal function, such as blood urea nitrogen (BUN), cystatin C, or calculated glomerular filtration rate based on cystatin C.
Slovenian: V kliničnih študijah so se vrednosti kreatinina v serumu povišale v prvem mesecu jemanja abemacikliba, ves čas zdravljenja so ostale povišane, vendar stabilne, bile so reverzibilne po prekinitvi zdravljenja in jih niso spremljale spremembe označevalcev delovanja ledvic,
English: There are no data regarding abemaciclib administration in patients with severe renal impairment, end stage renal disease, or in patients on dialysis (see section 5.2).
Slovenian: Podatkov o uporabi abemacikliba pri bolnicah s hudo ledvično okvaro, končno ledvično odpovedjo ali pri bolnicah na dializi ni (glejte poglavje 5.2).
English: Examples of strong CYP3A4 inhibitors include, but not limited to: clarithromycin, itraconazole, ketoconazole, lopinavir/ritonavir, posaconazole or voriconazole.
Slovenian: vendar niso omejeni na: klaritromicin, itrakonazol, ketokonazol, lopinavir/ritonavir, posakonazol ali vorikonazol.
English: The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 8 and Figure 2.
Slovenian: Rezultati primarne učinkovitosti so predstavljeni v preglednici 8 in na sliki 2.
English: At the first sign of diarrhoea, start treatment with antidiarrhoeal agents, such as loperamide.
Slovenian: Ob prvem znaku driske začnite zdravljenje s sredstvi proti driski, kot je npr.
English: Toxicity a
Slovenian: Toksičnost a
English: MONARCH 3: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Slovenian: MONARCH 3: Povzetek podatkov o učinkovitosti (ocena raziskovalca,
English: Grade 3 Toxicity
Slovenian: Toksičnost stopnje 3
English: This leaflet was last revised in Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: EU/1/18/1307/016 EU/1/18/1307/017 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021
Slovenian: EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021
English: Investigator assessment, number of events Median [months] (95% CI)
Slovenian: Ocena raziskovalca, število dogodkov (%) Mediana [meseci] (95 % IZ)
English: Abemaciclib in combination with letrozole, anastrozole, or fulvestrant.
Slovenian: Povečana vrednost aspartat-aminotransferaze a Abemaciklib v kombinaciji z letrozolom, anastrozolom ali s fulvestrantom.
English: Objective response rateb [%] (95% CI) Duration of response [months] (95% CI)
Slovenian: Objektivna stopnja odzivab [%] (95 % IZ) Trajanje odziva [meseci] (95 % IZ)
English: What Verzenios looks like and contents of the pack
Slovenian: Izgled zdravila Verzenios in vsebina pakiranja
English: No dose adjustments are necessary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
Slovenian: Jetrna okvara Pri bolnicah z blago (Child Pugh A) ali zmerno (Child Pugh B) jetrno okvaro prilagajanje odmerka ni potrebno.
English: Verzenios contains lactose
Slovenian: Zdravilo Verzenios vsebuje laktozo
English: o Itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections) o Lopinavir/ritonavir (used to treat HIV/AIDS) o Digoxin (used to treat heart disorders) o Dabigatran etexilate (used to reduce the risk of stroke and blood clots)
Slovenian: o lopinavir/ritonavir (uporabljata se za zdravljenje okužbe z virusom HIV/AIDS-a), o digoksin (uporablja se za zdravljenje težav s srcem), o dabigatran eteksilat (uporablja se za zmanjševanje tveganja kapi in krvnih strdkov)
English: In the following tables, adverse reactions are listed in order of MedDRA body system organ class and frequency.
Slovenian: V naslednjih preglednicah so neželeni učinki navedeni po vrstnem redu organskih sistemov po
English: In the therapeutic dose range of 50-200 mg, the increase in plasma exposure (AUC) and Cmax is approximately dose proportional.
Slovenian: V terapevtskem razponu odmerkov 50-200 mg je povečanje izpostavljenosti v plazmi
English: No dose adjustment required.
Slovenian: Prilagajanje odmerka ni potrebno.
English: The primary endpoint was investigator-assessed PFS evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Slovenian: RECIST 1.1; ključni sekundarni opazovani dogodki učinkovitosti so vključevali objektivno stopnjo odziva (ORR - Objective Response Rate), stopnjo klinične koristi (CBR - Clinical Benefit Rate) in celokupno preživetje (OS - Overall Survival).
English: Median PFS was significantly prolonged in the Verzenios plus fulvestrant arm (HR of 0.553 [95% CI 0.449, 0.681]); median PFS was 16.4 months versus 9.3 months in the placebo plus fulvestrant arm.
Slovenian: Mediani PFS je bil značilno daljši v skupini, ki je prejemala zdravilo Verzenios in fulvestrant (HR 0,553 [95 % IZ 0,449, 0,681]); mediani PFS je bil 16,4 meseca v primerjavi z 9,3 meseca v skupini, ki je prejemala placebom in fulvestrant.
English: Do not take a double dose to make up for the forgotten or vomited dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek oziroma ste ga izbruhali.
English: Eli Lilly Lietuva Tel. +370 (5) 2649600
Slovenian: Tel. +370 (5) 2649600
English: Grade 2
Slovenian: Stopnja 2
English: MONARCH 2: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Slovenian: Slika 2: MONARCH 2: Kaplan-Meierjeva krivulja preživetja brez napredovanja (ocena raziskovalca, populacija, ki so jo nameravali zdraviti)
English: Reporting of suspected adverse reactions
Slovenian: Poročanje o domnevnih neželenih učinkih:
English: Venous thromboembolic events include DVT, pulmonary embolism, cerebral venous sinus thrombosis, subclavian, axillary vein thrombosis,DVT inferior vena cava and pelvic venous thrombosis
Slovenian: c Venska trombembolija je vključevala GVT, pljučno embolijo, možgansko vensko trombozo, trombozo v subklavijski in aksilarni veni, GVT v spodnji veni kavi in trombozo pelvične vene.
English: MONARCH 2: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Slovenian: MONARCH 2: Povzetek podatkov o učinkovitosti (ocena raziskovalca,
English: The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 7 and Figure 1.
Slovenian: Rezultati primarne učinkovitosti so predstavljeni v preglednici 7 in na sliki 1.
English: The primary target organ findings of potential relevance to humans included gastrointestinal and haematolymphopoietic organ effects in rats and dogs in studies up to 13 weeks duration.
Slovenian: V do 13 tednov trajajočih študijah pri podganah in psih so ugotovitve glede primarnih ciljnih organov, ki so potencialno pomembne za ljudi, vključevale učinke na prebavila in hematolimfopoetske organe.
English: Carcinogenicity
Slovenian: Rakotvornost
English: Although not an adverse reaction, abemaciclib has been shown to increase serum creatinine in 98.3% of patients (based on laboratory findings), 1.9% Grade 3 or 4 (based on laboratory findings).
Slovenian: 98,3 % bolnic (na podlagi laboratorijskih preiskav), pri 1,9 % do stopnje 3 ali 4 (na podlagi laboratorijskih preiskav).
English: Dose adjustment recommendations for adverse reactions Verzenios dose combination therapy
Slovenian: Odmerek zdravila Verzenios pri kombiniranem zdravljenju
English: System organ class
Slovenian: Organski sistem Pogostnost
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: A. PROIZVAJALEC ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij
English: • Film-coating: titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), macrogol 3350 (E1521), iron oxide yellow (E172) [50 mg and 150 mg tablets only], iron oxide red (E172) [50 mg tablets only].
Slovenian: • Filmska obloga: titanov dioksid (E171), smukec (E553b), polivinilalkohol (E1203), makrogol 3350 (E1521), rumeni železov oksid (E172) [samo 50 mg in 150 mg tablete],
English: MONARCH 3: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Slovenian: Slika 1: MONARCH 3: Kaplan-Meierjeva krivulja preživetja brez napredovanja (ocena raziskovalca, populacija, ki so jo nameravali zdraviti)
English: Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets
Slovenian: Verzenios 50 mg filmsko obložene tablete Verzenios 100 mg filmsko obložene tablete Verzenios 150 mg filmsko obložene tablete
English: Toxicitya
Slovenian: Toksičnosta
English: CYP3A4 inducers
Slovenian: Induktorji CYP3A4
English: Very common
Slovenian: Pogosti
English: EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010 EU/1/18/1307/011 EU/1/18/1307/012 EU/1/18/1307/013 EU/1/18/1307/014 EU/1/18/1307/015
Slovenian: EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010 EU/1/18/1307/011 EU/1/18/1307/012 EU/1/18/1307/013 EU/1/18/1307/014 EU/1/18/1307/015 EU/1/18/1307/016 EU/1/18/1307/017
English: Hazard ratio (95% CI) and p-value
Slovenian: Razmerje tveganja (95 % IZ) in p-vrednost
English: There are no data in patients with severe renal impairment, end stage renal disease or in patients on dialysis.
Slovenian: Podatkov o uporabi abemacikliba pri bolnicah s hudo ledvično okvaro, končno ledvično odpovedjo ali pri bolnikih na dializi ni.
English: Phadisco Ltd Τηλ: +357 22 715000
Slovenian: Τηλ: +357 22 715000
English: Each film-coated tablet contains 42 mg of lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 42 mg laktoze (v obliki monohidrata).
English: Each film-coated tablet contains 28 mg of lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 28 mg laktoze (v obliki monohidrata).
English: No dose adjustments are necessary in patients with mild or moderate renal impairment.
Slovenian: Pri bolnicah z blago ali zmerno ledvično okvaro prilagajanje odmerka ni potrebno.
English: A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), race, geographic region, disease site, endocrine therapy resistance, presence of measurable disease, progesterone receptor status, and menopausal status.
Slovenian: ≥ 65 let), z rasno pripadnostjo, geografsko regijo, mestom bolezni, odpornostjo proti endokrinemu zdravljenju, prisotnostjo merljive bolezni, statusom progesteronskih receptorjev in z menopavzalnim statusom, pokazale skladne rezultate.
English: The efficacy and safety of Verzenios in combination with fulvestrant was evaluated in MONARCH 2, a randomised, double-blind, placebo-controlled phase 3 study in women with HR positive, HER2 negative locally advanced or metastatic breast cancer.
Slovenian: Randomizirana študija III. faze MONARCH 2: Zdravilo Verzenios v kombinaciji s fulvestrantom Učinkovitost in varnost zdravila Verzenios v kombinaciji s fulvestrantom so vrednotili v študiji MONARCH 2, randomizirani, dvojno slepi s placebom nadzorovani študiji III. faze pri ženskah s HRpozitivnim, HER2-negativnim lokalno napredovalim ali metastatskim rakom dojk.
English: Keep the blister card intact
Slovenian: Pretisni omot hranite nepoškodovan.
English: Increases in ALT and AST were reported in patients receiving abemaciclib.
Slovenian: Pri bolnicah, ki so prejemale abemaciklib, so poročali o povišanih vrednostih ALT in AST.
English: Treatment with antidiarrhoeal agents, such as loperamide, should be started at the first sign of loose stools.
Slovenian: Priporočila za obvladovanje driske Ob prvih znakih tekočega blata je treba začeti zdravljenje z antidiaroiki, kot je loperamid.
English: Eli Lilly Slovakia s.r.o.
Slovenian: Slovenská republika Eli Lilly Slovakia s.r.o.
English: Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00
Slovenian: Tlf: + 47 22 88 18 00
English: Package leaflet: Information for the patient Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets abemaciclib This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Verzenios 50 mg filmsko obložene tablete Verzenios 100 mg filmsko obložene tablete Verzenios 150 mg filmsko obložene tablete abemaciklib Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Each film-coated tablet contains 14 mg of lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 14 mg laktoze (v obliki monohidrata).
English: If the CYP3A4 inhibitor is discontinued, the abemaciclib dose should be increased to the dose used prior to the initiation of the CYP3A4 inhibitor (after 3 to 5 half-lives of the CYP3A4 inhibitor).
Slovenian: kakršen je bil pred uvedbo zaviralca CYP3A4 (po 3-5 razpolovnih časih zaviralca CYP3A4).
English: Neutropenia was reported in patients receiving abemaciclib.
Slovenian: Pri bolnicah, ki so prejemale abemaciklib, so poročali o nevtropeniji.
English: Patients were randomised in a 2:1 ratio to receive Verzenios 150 mg twice daily plus fulvestrant 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose, versus placebo plus fulvestrant according to the same schedule.
Slovenian: 500 mg v enomesečnih razmikih, z dodatnim odmerkom 500 mg dva tedna po prvem odmerku, ali placebo in fulvestrant po enakem urniku.
English: Figure 1.
Slovenian: Preglednica 1.
English: - Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other.
Slovenian: - Verzenios 150 mg filmsko obložene tablete so rumene ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „150“ na drugi.
English: How to store Verzenios
Slovenian: Shranjevanje zdravila Verzenios
English: No large change (that is, >20 ms) in the QTcF interval was detected at the mean observed maximal steady state abemaciclib concentration following a therapeutic dosing schedule.
Slovenian: Pri največjih povprečnih opaženih koncentracijah abemacikliba v stanju dinamičnega ravnovesja po terapevtskem urniku odmerjanja niso opazili večjih sprememb (tj. >20 ms) intervala QTcF.
English: Lilly Hungária Kft. Tel: + 36 1 328 5100
Slovenian: Tel. št.: + 36 1 328 5100
English: - Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other.
Slovenian: - Verzenios 100 mg filmsko obložene tablete so bele ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „100“ na drugi.
English: Grade 3 or 4 ALT or AST elevations (based on laboratory findings) were reported in 6.1% and 4.2% patients.
Slovenian: Pri 6,1 % in 4,2 % bolnic so poročali o povišanju stopnje 3 ali 4 ALT oz. AST (na podlagi laboratorijskih preiskav).
English: Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Slovenian: Tel. št.: + 39- 055 42571
English: CYP3A4 inhibitors
Slovenian: Zaviralci CYP3A4
English: • Alteration in sense of taste
Slovenian: • spremenjeno okušanje
English: - Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other.
Slovenian: - Verzenios 50 mg filmsko obložene tablete so bež ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „50“ na drugi.
English: b
Slovenian: PRILOGA I
English: Oral use
Slovenian: za peroralno uporabo
English: Based on the level of ALT or AST elevation, abemaciclib may require dose modification (see section 4.2).
Slovenian: Glede na povišanje vrednosti ALT ali AST je mogoče potrebna prilagoditev odmerka (glejte poglavje 4.2).
English: Duration of response [months] (95%CI)
Slovenian: Mediana [meseci] (95 % IZ)
English: Very common Diarrhoea Vomiting Nausea
Slovenian: Zelo pogosti Nevtropenija Levkopenija Anemija
English: You must tell your doctor if you become pregnant.
Slovenian: Če zanosite, morate povedati zdravniku.
English: Verzenios plus aromatase inhibitor
Slovenian: Zdravilo Verzenios in zaviralec aromataze
English: Abemaciclib plus endocrine therapya All Grades Toxicity
Slovenian: Abemaciklib in endokrino zdravljenjea
English: No dose adjustment is necessary for patients treated with moderate or weak CYP3A4 inhibitors.
Slovenian: Pri bolnicah, zdravljenih z zmernimi ali šibkimi zaviralci CYP3A4, ni potrebno prilagajanje odmerka, vendar jih je treba skrbno spremljati glede toksičnosti.
English: How to take Verzenios Recommended dose
Slovenian: Kako jemati zdravilo Verzenios
English: Very common Infectionsb
Slovenian: Infekcijske in parazitske bolezni Zelo pogosti Okužbeb
English: Dose adjustments
Slovenian: Prilagajanje odmerkov
English: 0.246, 0.698); in patients who were progesterone receptor negative, the HR was 0.509 (95% CI: 0.325,
Slovenian: Pri bolnicah v pred-/perimenopavzi je bilo razmerje ogroženosti 0,415 (95 % IZ: 0,246, 0,698), pri bolnicah, negativnih za progesteronske receptorje, je HR znašal 0,509 (95 % IZ: 0,325, 0,797).
English: Contents of the pack and other information What Verzenios contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Verzenios - Učinkovina je abemaciklib.
English: Verzenios 100 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b)
Slovenian: Verzenios 100 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b)
English: Sun.
Slovenian: Ned.
English: Verzenios contains sodium
Slovenian: Zdravilo Verzenios vsebuje natrij
English: Abemaciclib is metabolised to several metabolites primarily by cytochrome P450 (CYP) 3A4.
Slovenian: predvsem s citokromom P450 (CYP) 3A4.
English: Verzenios 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Verzenios 100 mg
English: Figure 2.
Slovenian: Preglednica 2.
English: Verzenios 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Verzenios 150 mg
English: Verzenios plus fulvestrant
Slovenian: Zdravilo Verzenios in fulvestrant
English: Progression-free survival (PFS) was significantly prolonged in the Verzenios plus aromatase inhibitor (AI) arm, (Hazard Ratio [HR] of 0.540 [95% CI, 0.418 to 0.698]); median PFS was 28.18 months in the Verzenios plus AI arm and was 14.76 months in the placebo plus AI arm.
Slovenian: Verzenios in zaviralec aromataze (AI), (razmerje ogroženosti [HR] 0,540 [95 % IZ, 0,418-0,698]); mediani PFS je bil 28,18 meseca v skupini, ki je prejemala zdravilo Verzenios in AI, ter 14,76 meseca v skupini, ki je prejemala placebo in AI.
English: A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.567 [95% CI: 0.407, 0.789]), median PFS 21.6 months versus 14.0 months; in patients with bone-only disease (HR 0.565, [95% CI: 0.306, 1.044]); and in patients with measurable disease (HR 0.517, [95% CI: 0.392, 0.681]).
Slovenian: 0,407, 0,789], mediani PFS 21,6 meseca v primerjavi s 14,0 meseci), pri bolnicah z boleznijo samo v kosteh (HR 0,565, [95 % IZ: 0,306, 1,044]) in pri bolnicah z merljivo boleznijo (HR 0,517, [95 % IZ:
English: Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia (see section 4.2).
Slovenian: Pri bolnicah, pri katerih se pojavi nevtropenija stopnje 3 ali 4, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
English: Each film-coated tablet contains 100 mg abemaciclib.
Slovenian: Ena filmsko obložena tableta vsebuje 100 mg abemacikliba.
English: Each film-coated tablet contains 50 mg abemaciclib.
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg abemacikliba.
English: Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST increase (see section 4.2).
Slovenian: Pri bolnicah, pri katerih se pojavi povišanje vrednosti ALT ali AST stopnje 3 ali 4, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
English: Eli Lilly Nederland B.V. Tel: +372 6 817 280
Slovenian: Tel. št.: +372 6 817 280
English: • Dizziness
Slovenian: • izpuščaj
English: Each film-coated tablet contains 150 mg abemaciclib.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg abemacikliba.
English: • Verzenios 150 mg film-coated tablet: each tablet contains 150 mg abemaciclib.
Slovenian: • Verzenios 150 mg filmsko obložena tableta: ena tableta vsebuje 150 mg abemacikliba.
English: Belgique/België/Belgien
Slovenian: Belgique/België/Belgien Eli Lilly Benelux S.A./N.V.
English: Verzenios 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib.
Slovenian: Verzenios 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg abemacikliba.
English: Contact your doctor immediately for any of the following: - Symptoms such as chills or fever.
Slovenian: Nemudoma se posvetujte z zdravnikom, če opazite katerega koli od naslednjih učinkov:
English: A series of prespecified subgroup PFS analyses showed consistent results across patient subgroups including age (<65 or ≥65 years), disease site, disease setting (de novo metastatic vs recurrent metastatic vs locally advanced recurrent), presence of measurable disease, progesterone receptor status, and baseline ECOG performance status.
Slovenian: Vnaprej opredeljene analize PFS so v vseh podskupinah bolnic, vključno s starostjo (< 65 ali ≥ 65 let),
English: Verzenios 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib.
Slovenian: Verzenios 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg abemacikliba.
English: • Verzenios 100 mg film-coated tablet: each tablet contains 100 mg abemaciclib.
Slovenian: • Verzenios 100 mg filmsko obložena tableta: ena tableta vsebuje 100 mg abemacikliba.
English: Verzenios 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib.
Slovenian: Verzenios 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg abemacikliba.
English: Verzenios 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Verzenios 50 mg
English: Verzenios 150 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172)
Slovenian: Verzenios 150 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b) rumeni železov oksid (E172)