natgillin/translations-raw huggingface dataset:
Investigator assessment, number of events Median [months] (95% CI) 
Ocena raziskovalca, število dogodkov (%) Mediana [meseci] (95 % IZ)
Abemaciclib in combination with letrozole, anastrozole, or fulvestrant. 
Povečana vrednost aspartat-aminotransferaze a Abemaciklib v kombinaciji z letrozolom, anastrozolom ali s fulvestrantom.
Objective response rateb [%] (95% CI) Duration of response [months] (95% CI) 
Objektivna stopnja odzivab [%] (95 % IZ) Trajanje odziva [meseci] (95 % IZ)
What Verzenios looks like and contents of the pack 
Izgled zdravila Verzenios in vsebina pakiranja
No dose adjustments are necessary in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. 
Jetrna okvara Pri bolnicah z blago (Child Pugh A) ali zmerno (Child Pugh B) jetrno okvaro prilagajanje odmerka ni potrebno.
Verzenios contains lactose 
Zdravilo Verzenios vsebuje laktozo
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) 
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)
In the following tables, adverse reactions are listed in order of MedDRA body system organ class and frequency. 
V naslednjih preglednicah so neželeni učinki navedeni po vrstnem redu organskih sistemov po
In the therapeutic dose range of 50-200 mg, the increase in plasma exposure (AUC) and Cmax is approximately dose proportional. 
V terapevtskem razponu odmerkov 50-200 mg je povečanje izpostavljenosti v plazmi
No dose adjustment required. 
Prilagajanje odmerka ni potrebno.
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). 
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).
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. 
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.
Do not take a double dose to make up for the forgotten or vomited dose. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek oziroma ste ga izbruhali.
Grade 2 
Stopnja 2
MONARCH 2: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population) 
Slika 2: MONARCH 2: Kaplan-Meierjeva krivulja preživetja brez napredovanja (ocena raziskovalca, populacija, ki so jo nameravali zdraviti)
Reporting of suspected adverse reactions 
Poročanje o domnevnih neželenih učinkih:
Venous thromboembolic events include DVT, pulmonary embolism, cerebral venous sinus thrombosis, subclavian, axillary vein thrombosis,DVT inferior vena cava and pelvic venous thrombosis 
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.
MONARCH 2: Summary of efficacy data (Investigator assessment, intent-to-treat population) 
MONARCH 2: Povzetek podatkov o učinkovitosti (ocena raziskovalca,
The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 7 and Figure 1. 
Rezultati primarne učinkovitosti so predstavljeni v preglednici 7 in na sliki 1.
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. 
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.
Carcinogenicity 
Rakotvornost
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). 
98,3 % bolnic (na podlagi laboratorijskih preiskav), pri 1,9 % do stopnje 3 ali 4 (na podlagi laboratorijskih preiskav).
Dose adjustment recommendations for adverse reactions Verzenios dose combination therapy 
Odmerek zdravila Verzenios pri kombiniranem zdravljenju
System organ class 
Organski sistem Pogostnost
Name and address of the manufacturer(s) responsible for batch release 
A. PROIZVAJALEC ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij
• 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]. 
• Filmska obloga: titanov dioksid (E171), smukec (E553b), polivinilalkohol (E1203), makrogol 3350 (E1521), rumeni železov oksid (E172) [samo 50 mg in 150 mg tablete],
MONARCH 3: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population) 
Slika 1: MONARCH 3: Kaplan-Meierjeva krivulja preživetja brez napredovanja (ocena raziskovalca, populacija, ki so jo nameravali zdraviti)
Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets 
Verzenios 50 mg filmsko obložene tablete Verzenios 100 mg filmsko obložene tablete Verzenios 150 mg filmsko obložene tablete
Toxicitya 
Toksičnosta
CYP3A4 inducers 
Induktorji CYP3A4
Very common 
Pogosti
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/1/18/1307/001 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
Hazard ratio (95% CI) and p-value 
Razmerje tveganja (95 % IZ) in p-vrednost
There are no data in patients with severe renal impairment, end stage renal disease or in patients on dialysis. 
Podatkov o uporabi abemacikliba pri bolnicah s hudo ledvično okvaro, končno ledvično odpovedjo ali pri bolnikih na dializi ni.
Each film-coated tablet contains 42 mg of lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 42 mg laktoze (v obliki monohidrata).
Each film-coated tablet contains 28 mg of lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 28 mg laktoze (v obliki monohidrata).
No dose adjustments are necessary in patients with mild or moderate renal impairment. 
Pri bolnicah z blago ali zmerno ledvično okvaro prilagajanje odmerka ni potrebno.
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. 
≥ 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.
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. 
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.
Keep the blister card intact 
Pretisni omot hranite nepoškodovan.
Increases in ALT and AST were reported in patients receiving abemaciclib. 
Pri bolnicah, ki so prejemale abemaciklib, so poročali o povišanih vrednostih ALT in AST.
Treatment with antidiarrhoeal agents, such as loperamide, should be started at the first sign of loose stools. 
Priporočila za obvladovanje driske Ob prvih znakih tekočega blata je treba začeti zdravljenje z antidiaroiki, kot je loperamid.
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. 
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.
Each film-coated tablet contains 14 mg of lactose (as monohydrate). 
Ena filmsko obložena tableta vsebuje 14 mg laktoze (v obliki monohidrata).
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). 
kakršen je bil pred uvedbo zaviralca CYP3A4 (po 3-5 razpolovnih časih zaviralca CYP3A4).
Neutropenia was reported in patients receiving abemaciclib. 
Pri bolnicah, ki so prejemale abemaciklib, so poročali o nevtropeniji.
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. 
500 mg v enomesečnih razmikih, z dodatnim odmerkom 500 mg dva tedna po prvem odmerku, ali placebo in fulvestrant po enakem urniku.
Figure 1. 
Preglednica 1.
- Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other. 
- Verzenios 150 mg filmsko obložene tablete so rumene ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „150“ na drugi.
How to store Verzenios 
Shranjevanje zdravila Verzenios
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. 
Pri največjih povprečnih opaženih koncentracijah abemacikliba v stanju dinamičnega ravnovesja po terapevtskem urniku odmerjanja niso opazili večjih sprememb (tj. >20 ms) intervala QTcF.
Lilly Hungária Kft. Tel: + 36 1 328 5100 
Tel. št.: + 36 1 328 5100
- Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other. 
- Verzenios 100 mg filmsko obložene tablete so bele ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „100“ na drugi.
Grade 3 or 4 ALT or AST elevations (based on laboratory findings) were reported in 6.1% and 4.2% patients. 
Pri 6,1 % in 4,2 % bolnic so poročali o povišanju stopnje 3 ali 4 ALT oz. AST (na podlagi laboratorijskih preiskav).
Eli Lilly Italia S.p.A. Tel: + 39- 055 42571 
Tel. št.: + 39- 055 42571
CYP3A4 inhibitors 
Zaviralci CYP3A4
• Alteration in sense of taste 
• spremenjeno okušanje
- Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other. 
- Verzenios 50 mg filmsko obložene tablete so bež ovalne tablete z vtisnjeno oznako „Lilly“ na eni strani in „50“ na drugi.
b 
PRILOGA I
Oral use 
za peroralno uporabo
Based on the level of ALT or AST elevation, abemaciclib may require dose modification (see section 4.2). 
Glede na povišanje vrednosti ALT ali AST je mogoče potrebna prilagoditev odmerka (glejte poglavje 4.2).
Duration of response [months] (95%CI) 
Mediana [meseci] (95 % IZ)
Very common Diarrhoea Vomiting Nausea 
Zelo pogosti Nevtropenija Levkopenija Anemija
You must tell your doctor if you become pregnant. 
Če zanosite, morate povedati zdravniku.
Verzenios plus aromatase inhibitor 
Zdravilo Verzenios in zaviralec aromataze
Abemaciclib plus endocrine therapya All Grades Toxicity 
Abemaciklib in endokrino zdravljenjea
No dose adjustment is necessary for patients treated with moderate or weak CYP3A4 inhibitors. 
Pri bolnicah, zdravljenih z zmernimi ali šibkimi zaviralci CYP3A4, ni potrebno prilagajanje odmerka, vendar jih je treba skrbno spremljati glede toksičnosti.
How to take Verzenios Recommended dose 
Kako jemati zdravilo Verzenios
Very common Infectionsb 
Infekcijske in parazitske bolezni Zelo pogosti Okužbeb
Dose adjustments 
Prilagajanje odmerkov
0.246, 0.698); in patients who were progesterone receptor negative, the HR was 0.509 (95% CI: 0.325, 
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).
Contents of the pack and other information What Verzenios contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Verzenios - Učinkovina je abemaciklib.
Verzenios 100 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) 
Verzenios 100 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b)
Verzenios contains sodium 
Zdravilo Verzenios vsebuje natrij
Abemaciclib is metabolised to several metabolites primarily by cytochrome P450 (CYP) 3A4. 
predvsem s citokromom P450 (CYP) 3A4.
Verzenios 100 mg 
PODATKI V BRAILLOVI PISAVI Verzenios 100 mg
Figure 2. 
Preglednica 2.
Verzenios 150 mg 
PODATKI V BRAILLOVI PISAVI Verzenios 150 mg
Verzenios plus fulvestrant 
Zdravilo Verzenios in fulvestrant
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. 
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.
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]). 
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:
Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia (see section 4.2). 
Pri bolnicah, pri katerih se pojavi nevtropenija stopnje 3 ali 4, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
Each film-coated tablet contains 100 mg abemaciclib. 
Ena filmsko obložena tableta vsebuje 100 mg abemacikliba.
Each film-coated tablet contains 50 mg abemaciclib. 
Ena filmsko obložena tableta vsebuje 50 mg abemacikliba.
Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST increase (see section 4.2). 
Pri bolnicah, pri katerih se pojavi povišanje vrednosti ALT ali AST stopnje 3 ali 4, je priporočljivo prilagoditi odmerek (glejte poglavje 4.2).
Eli Lilly Nederland B.V. Tel: +372 6 817 280 
Tel. št.: +372 6 817 280
• Dizziness 
• izpuščaj
Each film-coated tablet contains 150 mg abemaciclib. 
Ena filmsko obložena tableta vsebuje 150 mg abemacikliba.
• Verzenios 150 mg film-coated tablet: each tablet contains 150 mg abemaciclib. 
• Verzenios 150 mg filmsko obložena tableta: ena tableta vsebuje 150 mg abemacikliba.
Verzenios 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib. 
Verzenios 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg abemacikliba.
Contact your doctor immediately for any of the following: - Symptoms such as chills or fever. 
Nemudoma se posvetujte z zdravnikom, če opazite katerega koli od naslednjih učinkov:
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. 
Vnaprej opredeljene analize PFS so v vseh podskupinah bolnic, vključno s starostjo (< 65 ali ≥ 65 let),
Verzenios 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib. 
Verzenios 150 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg abemacikliba.
• Verzenios 100 mg film-coated tablet: each tablet contains 100 mg abemaciclib. 
• Verzenios 100 mg filmsko obložena tableta: ena tableta vsebuje 100 mg abemacikliba.
Verzenios 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib. 
Verzenios 50 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 50 mg abemacikliba.
Verzenios 50 mg 
PODATKI V BRAILLOVI PISAVI Verzenios 50 mg
Verzenios 150 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) 
Verzenios 150 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b) rumeni železov oksid (E172)
Verzenios 50 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b) iron oxide yellow (E172) iron oxide red (E172) 
Verzenios 50 mg filmsko obložene tablete polivinilalkohol (E1203) titanov dioksid (E171) makrogol (E1521) smukec (E553b) rumeni železov oksid (E172)
• Verzenios 50 mg film-coated tablet: each tablet contains 50 mg abemaciclib. 
• Verzenios 50 mg filmsko obložena tableta: ena tableta vsebuje 50 mg abemacikliba.
Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800 
Tel. št.: + 31-(0) 30 60 25 800
EU/1/18/1307/007 (14 film-coated tablets) EU/1/18/1307/008 (168 film-coated tablets) EU/1/18/1307/009 (28 x 1 film-coated tablets) EU/1/18/1307/014 (28 film-coated tablets) EU/1/18/1307/015 (56 film-coated tablets) EU/1/18/1307/020 (42 film-coated tablets) EU/1/18/1307/021 (70 film-coated tablets) 
EU/1/18/1307/007 (14 filmsko obloženih tablet) EU/1/18/1307/008 (168 filmsko obloženih tablet) EU/1/18/1307/009 (28 x1 filmsko obložena tableta) EU/1/18/1307/014 (28 filmsko obloženih tablet) EU/1/18/1307/015 (56 filmsko obloženih tablet) EU/1/18/1307/020 (42 filmsko obloženih tablet) EU/1/18/1307/021 (70 filmsko obloženih tablet)
The median time to onset of Grade 3 or 4 neutropenia was 29 to 33 days, and median time to resolution was 11 to 15 days. 
Mediani čas do pojava nevtropenije stopnje 3 ali 4 je bil od 29
• Tiredness 
• omotica
EU/1/18/1307/001 (14 film-coated tablets) EU/1/18/1307/002 (168 film-coated tablets) EU/1/18/1307/003 (28 x 1 film-coated tablets) EU/1/18/1307/010 (28 film-coated tablets) EU/1/18/1307/011 (56 film-coated tablets) EU/1/18/1307/016 (42 film-coated tablets) EU/1/18/1307/017 (70 film-coated tablets) 
EU/1/18/1307/001 (14 filmsko obloženih tablet) EU/1/18/1307/002 (168 filmsko obloženih tablet) EU/1/18/1307/003 (28 x1 filmsko obložena tableta) EU/1/18/1307/010 (28 filmsko obloženih tablet) EU/1/18/1307/011 (56 filmsko obloženih tablet) EU/1/18/1307/016 (42 filmsko obloženih tablet) EU/1/18/1307/017 (70 filmsko obloženih tablet)
EU/1/18/1307/004 (14 film-coated tablets) EU/1/18/1307/005 (168 film-coated tablets) EU/1/18/1307/006 (28 x 1 film-coated tablets) EU/1/18/1307/012 (28 film-coated tablets) EU/1/18/1307/013 (56 film-coated tablets) EU/1/18/1307/018 (42 film-coated tablets) EU/1/18/1307/019 (70 film-coated tablets) 
EU/1/18/1307/004 (14 filmsko obloženih tablet) EU/1/18/1307/005 (168 filmsko obloženih tablet) EU/1/18/1307/006 (28 x1 filmsko obložena tableta) EU/1/18/1307/012 (28 filmsko obloženih tablet) EU/1/18/1307/013 (56 filmsko obloženih tablet) EU/1/18/1307/018 (42 filmsko obloženih tablet) EU/1/18/1307/019 (70 filmsko obloženih tablet)
Suspend dose until toxicity resolves to Grade 2 or less. 
Prekinite odmerjanje do izboljšanja na stopnjo 2 ali nižjo.
Verzenios 150 mg film-coated tablets abemaciclib 
Verzenios 150 mg filmsko obložene tablete abemaciklib
Verzenios 50 mg tablets abemaciclib 
IME ZDRAVILA Verzenios 50 mg tablete abemaciklib
Discuss contraception with your doctor if there is any possibility that you may become pregnant. 
Če obstaja možnost, da lahko zanosite, se posvetujte z zdravnikom glede kontracepcije.
Verzenios 50 mg film-coated tablets abemaciclib 
Verzenios 50 mg filmsko obložene tablete abemaciklib
Always take this medicine exactly as your doctor or pharmacist has told you. 
Priporočeni odmerek Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta.
Verzenios 100 mg film-coated tablets abemaciclib 
Verzenios 100 mg filmsko obložene tablete abemaciklib
Verzenios 150 mg tablets abemaciclib 
IME ZDRAVILA Verzenios 150 mg tablete abemaciklib
Tabulated list of adverse reactions 
Preglednice z neželenimi učinki
de la Industria 30, 28108 Alcobendas, Madrid, Spain For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
o Clarithromycin (antibiotic used to treat bacterial infections) 
o klaritromicin (antibiotik, ki se uporablja za zdravljenje bakterijskih okužb), o itrakonazol, ketokonazol, posakonazol, vorikonazol (uporabljajo se za zdravljenje glivičnih okužb),
Verzenios 150 mg abemaciclib 
IME ZDRAVILA Verzenios 150 mg abemaciklib
Verzenios 100 mg tablets abemaciclib 
IME ZDRAVILA Verzenios 100 mg tablete abemaciklib
Suspend dose until toxicity resolves to Grade 1 or less. 
Prekinite odmerjanje do izboljšanja na stopnjo 1 ali manj.
Verzenios 100 mg abemaciclib 
IME ZDRAVILA Verzenios 100 mg abemaciklib
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 150 MG FILM-COATED TABLETS 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 150 MG FILMSKO OBLOŽENE TABLETE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 100 MG FILM-COATED TABLETS 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 100 MG FILMSKO OBLOŽENE TABLETE
Breast-feeding 
Limfopenija
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 100 MG FILMCOATED TABLETS 
PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 100 MG FILMSKO OBLOŽENE TABLETE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 50 MG FILM-COATED TABLETS 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 50 MG FILMSKO OBLOŽENE TABLETE
Alanine aminotransferase increased Aspartate aminotransferase increased a 
Povečana vrednost aminotransferaz
Very common Decreased appetite 
Zelo pogosti Sprememba okusa Omotica
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 50 MG FILMCOATED TABLETS 
PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 50 MG FILMSKO OBLOŽENE TABLETE
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER TO BE USED INSIDE THE CALENDAR BLISTER CARD FOR 150 MG FILMCOATED TABLETS 
PRETISNI OMOT, KI BO UPORABLJEN V NOTRANJOSTI KOLEDARSKEGA PRETISNEGA OMOTA ZA 150 MG FILMSKO OBLOŽENE TABLETE
Verzenios 50 mg abemaciclib 
IME ZDRAVILA Verzenios 50 mg abemaciklib
Frequency Preferred term 
Priporočeni izraz
You should avoid becoming pregnant while taking Verzenios. 
Med jemanjem zdravila Verzenios se izogibajte zanositvi.
Verzenios 150 mg film-coated tablets 
KOLEDARSKI PRETISNI OMOT ZA 150 MG FILMSKO OBLOŽENE TABLETE