natgillin/translations-raw huggingface dataset:
In healthy subjects, co-administration of abemaciclib and the P-glycoprotein (P-gp) substrate loperamide resulted in an increase in loperamide plasma exposure of 9% based on AUC0-∞ and 35% based on Cmax. 
Pri zdravih preskušancih je sočasna uporaba abemacikliba in substrata za P-glikoprotein (P-gp) loperamida povzročila povečanje izpostavljenosti loperamidu v plazmi za 9 % na podlagi AUC0-∞ oziroma za 35 % na podlagi Cmax.
In an exposure-response analysis in healthy subjects at exposures comparable to a 200 mg twice-daily dose, abemaciclib did not prolong the QTcF interval to any clinically relevant extent. 
Pri analizi izpostavljenosti in odziva pri zdravih preskušancih pri izpostavljenostih, primerljivih z odmerkom 200 mg dvakrat na dan, abemaciklib ni klinično pomembno podaljšal intervala QTcF.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni „brez natrija“.
When given together with an aromatase inhibitor or fulvestrant to treat your breast cancer, the recommended dose of Verzenios is 150 mg taken by mouth twice daily. 
Kadar se pri zdravljenju raka dojk daje skupaj z zaviralcem aromataze ali s fulvestrantom, je priporočeni odmerek zdravila Verzenios 150 mg peroralno dvakrat na dan.
• medicines that may reduce the effectiveness of Verzenios: o Carbamazepine (anti-epileptic used to treat seizures or fits) o Rifampicin, used to treat tuberculosis (TB) o Phenytoin (used to treat seizures) o St. John's wort (a herbal product used to treat mild depression and anxiety) 
• zdravila, ki lahko zmanjšajo učinkovitost zdravila Verzenios: o karbamazepin (protiepileptično zdravilo, ki se uporablja za zdravljenje epileptičnih napadov), o rifampicin, ki se uporablja se za zdravljenje tuberkuloze (TB), o fenitoin (uporablja se za zdravljenje epileptičnih napadov) o šentjanževka (rastlinski preparat, ki se uporablja za zdravljenje blage depresije in anksioznosti)
Diarrhoea returned to baseline or lesser grade with supportive treatment such as loperamide and/or dose adjustment (see section 4.2). 
Driska se je s podpornim zdravljenjem, kot sta loperamid in/ali prilagoditev odmerka, vrnila do izhodiščne ali nižje stopnje (glejte poglavje 4.2).
In vivo interactions of abemaciclib with clinically relevant substrates of these transporters, such as dofetilide or creatinine, may occur (see section 4.8). 
MATE2-K. In vivo lahko pride do medsebojnega delovanja abemacikliba in klinično pomembnih substratov teh prenašalcev, kot je dofelitid ali kreatinin (glejte poglavje 4.8).
Tel: +385 1 2350 999 
Tel. št.: +385 1 2350 999
Renal clearance of abemaciclib and its metabolites is minor. 
Ledvični očistek abemacikliba in njegovih presnovkov je majhen.
Effects of abemaciclib on the pharmacokinetics of other medicinal products 
Učinki abemacikliba na farmakokinetiko drugih zdravil
Women of childbearing potential/Contraception in females Women of childbearing potential should use highly effective contraception methods (e.g. double-barrier contraception) during treatment and for at least 3 weeks after completing therapy (see section 4.5). 
Ženske v rodni dobi morajo med zdravljenjem in še vsaj tri tedne po koncu zdravljenja uporabljati zanesljivo kontracepcijsko metodo (dvojno mehansko kontracepcijo) (glejte poglavje 4.5).
Grade 1 (>ULN-3.0 x ULN) Grade 2 (>3.0-5.0 x ULN) 
Stopnja 1 (> ZMN - 3,0 x ZMN) Stopnja 2 (> 3,0-5,0 x ZMN)
Abemaciclib was teratogenic and caused decreased foetal weight at maternal exposures similar to the recommended human dose. 
Abemaciklib je deloval teratogeno in je pri izpostavljenosti matere, ki je bila podobna kot pri priporočenem odmerku za človeka, povzročil zmanjšano telesno maso plodu.
Do not chew, crush or split the tablets before swallowing. 
Tablet pred zaužitjem ne žvečite, drobite ali delite.
Concomitant use of CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib (see section 4.5). 
Sočasna uporaba induktorjev CYP3A4 Sočasni uporabi induktorjev CYP3A4 se je treba izogibati zaradi tveganja za zmanjšano učinkovitost abemacikliba (glejte poglavje 4.5).
It is unknown whether abemaciclib is excreted in human milk. 
Ni znano, ali se abemaciklib izloča v materino mleko.
Please refer to the Summary of Product Characteristics of the endocrine therapy combination partner for the recommended posology. 
Glejte povzetek glavnih značilnosti zdravila za endokrino zdravljenje, ki se uporablja v kombinaciji z abemaciklibom, za priporočeni odmerek.
If strong CYP3A4 inhibitors need to be co-administered, the dose of abemaciclib should be reduced (see section 4.2), followed by careful monitoring of toxicity. 
Če je močne zaviralce CYP3A4 treba dajati sočasno, je treba odmerek abemacikliba znižati (glejte poglavje 4.2), nato pa bolnico skrbno spremljati glede toksičnosti.
Verzenios is available in calendar blister packs of 14, 28, 42, 56, 70 and 168 film-coated tablets and perforated unit dose blisters of 28 x 1 film-coated tablets. 
Zdravilo Verzenios je na voljo v koledarskih pretisnih omotih po 14, 28, 42, 56, 70 in 168 filmsko obloženih tablet in v perforiranih enoodmernih pretisnih omotih po 28 x 1 filmsko obložena tableta.
Increased aminotransferases 
Povišane vrednosti aminotransferaze
Film coating 
Filmska obloga
Persistent or Recurrent Grade 2, or Grade 3 (>5.0-20.0 x ULN) 
Trdovratna ali ponavljajoča se stopnja 2, ali stopnja 3 (> 5,020,0 x ZMN)
However, based on the in vitro inhibition of P-gp and breast cancer resistance protein (BCRP) observed with abemaciclib, in vivo interactions of abemaciclib with narrow therapeutic index substrates of these transporters, such as digoxin or dabigatran etexilate, may occur. 
P-gp in proteina odpornosti pri raku dojke (BCRP - Breast Cancer Resistance Protein) in vitro, ki so ga opazili z abemaciklibom, lahko in vivo pride do medsebojnega delovanja med abemaciklibom in substrati z ozkim terapevtskim indeksom za te prenašalce, kot sta digoksin ali dabigatran eteksilat.
Tel: + 43-(0) 1 711 780 
Tel. št.: + 43-(0) 1 711 780
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands. 
Imetnik dovoljenja za promet z zdravilom Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, Nizozemska.
Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 
Eli Lilly and Company (Ireland) Limited Tel. št.: + 353-(0) 1 661 4377
The primary endpoint was investigator-assessed progression-free survival (PFS) evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS). 
Primarni opazovani dogodek je bilo preživetje brez napredovanja (PFS), ki ga je raziskovalec ocenjeval po merilih RECIST 1.1; ključni sekundarni opazovani dogodki učinkovitosti so vključevali objektivno stopnjo odziva (ORR), stopnjo klinične koristi (CBR) in celokupno preživetje (OS).
Pregnancy You should not use Verzenios if you are pregnant. 
Nosečnost Če ste noseči, zdravila Verzenios ne smete uporabljati.
59% of patients had most recent endocrine therapy in the (neo)adjuvant setting, and 38% in metastatic setting. 
59 % bolnic je prejemalo predhodno endokrino zdravljenje v okviru (neo)adjuvantnega zdravljenja, 38 % pa v okviru zdravljenja metastatske bolezni.
Tablet core croscarmellose sodium lactose monohydrate microcrystalline cellulose colloidal hydrated silica sodium stearyl fumarate 
Premreženi natrijev karmelozat laktoza monohidrat mikrokristalna celuloza koloidni hidratirani silicijev dioksid natrijev stearilfumarat
100 mg twice daily 
100 mg dvakrat na dan
[%] (95% CI) a Measurable disease defined per RECIST version 1.1 b Complete response + partial response c Complete response + partial response + stable disease for ≥ 6 months N=number of patients; CI=confidence interval; NR=not reached. 
b Popolni odziv + delni odziv c Popolni odziv + delni odziv+ stabilna bolezen v trajanju≥ 6 mesecev N = število bolnic; IZ = interval zaupanja; NR = ni doseženo.
Lung infection was reported in patients receiving abemaciclib without concurrent neutropenia. 
O okužbi pljuč so poročali pri bolnicah, ki so prejemale abemaciklib, brez sočasne nevtropenije.
The HR was 1.057 (95% CI: 0.683, 1.633), p=0.8017. 
HR je znašal 1,057 (95 % IZ: 0,683, 1,633), p = 0,8017.
Medicinal products that are substrates of transporters Abemaciclib and its major active metabolites inhibit the renal transporters organic cation transporter 2 (OCT2), multidrug and extrusion toxin protein (MATE1), and MATE2-K. 
Abemaciklib in njegovi glavni aktivni presnovki zavirajo prenašalce v ledvicah, in sicer kationski organski prenašalec 2 (OCT2) ter prenašalca MATE1 (Multidrug and Extrusion Toxin Protein) in
Second dose adjustment 
Drugo prilagajanje odmerka
Verzenios is used to treat women with certain types of breast cancer (hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)) which have spread beyond the original tumour and/or to other organs. 
Zdravilo Verzenios se uporablja za zdravljenje žensk z določenimi vrstami raka dojk (pozitivnega na hormonske receptorje (HR+), negativnega na receptorje humanega epidermalnega rastnega faktorja 2 (HER2-)), ki se je lokalno razširil in/ali se razširil na druge organe.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Patients should start treatment with antidiarrhoeal agents such as loperamide at the first sign of loose stools, increase oral fluids and notify their healthcare provider. 
Bolnice je treba ob prvem znaku tekočega blata začeti zdraviti z antidiaroiki, kot je loperamid, povečati vnos peroralnih tekočin in obvestiti zdravnika.
In patients with advanced and/or metastatic cancer, co-administration of the CYP3A4 inhibitor clarithromycin resulted in a 3.4-fold increase in the plasma exposure of abemaciclib and a 2.5-fold increase in the combined unbound potency adjusted plasma exposure of abemaciclib and its active metabolites. 
Pri bolnicah z napredovalim in/ali metastatskim rakom je sočasna uporaba zaviralca CYP3A4 klaritromicina pripeljala do 3,4-kratnega povečanja abemacikliba v plazmi in 2,5-kratnega povečanja kombinirane nevezane in glede jakosti prilagojene izpostavljenosti abemacikliba in njegovih aktivnih presnovkov v plazmi.
In cancer patients, abemaciclib inhibits CDK4 and CDK6 as indicated by inhibition of phosphorylation of Rb and topoisomerase II alpha, which results in cell cycle inhibition upstream of the G1 restriction point. 
Pri bolnicah z rakom abemaciklib zavira CDK4 in CDK6, s tem je zavrtafosforilacija Rb in topoizomeraze II alfa, kar pripelje do zavrtja celičnega cikla na nivoju faze G1 celičnega cikla.
Across clinical studies, median time to onset of the first diarrhoea event was approximately 6 to 8 days, and median duration of diarrhoea was 9 to 12 days (Grade 2) and 6 to 8 days (Grade 3). 
V kliničnih študijah je bil mediani čas do pojava prve driske približno od 6 do 8 dni, mediano trajanje driske pa od 9 do 12 dni (stopnja 2) oziroma od 6 do 8 dni (stopnja 3).
In patients who have had their dose reduced to 50 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose may be continued with close monitoring of signs of toxicity. 
Pri bolnicah, pri katerih je bil odmerek znižan na 50 mg abemacikliba dvakrat na dan in pri katerih se sočasnemu dajanju močnega zaviralca CYP3A4 ni mogoče izogniti, je mogoče z odmerkom abemacikliba nadaljevati ob natančnem spremljanju znakov toksičnosti.
Complete blood counts should be monitored prior to the start of Verzenios therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated. 
Ob uvedbi zdravljenja z zdravilom Verzenios je potrebno spremljati celotno krvno sliko, in sicer prva dva meseca vsaka dva tedna, enkrat mesečno naslednja dva meseca in v nadaljevanju kot je klinično indicirano.
• Tablet core: colloidal hydrated silica, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate. 
• Jedro tablete: koloidni hidratirani silicijev dioksid, premreženi natrijev karmelozat, laktoza monohidrat, mikrokristalna celuloza, natrijev stearilfumarat
The European Medicines Agency has waived the obligation to submit the results of studies with Verzenios in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use). 
Verzenios za vse podskupine pediatrične populacije za raka dojk (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Infections were reported in patients receiving abemaciclib plus endocrine therapy at a higher rate than in patients treated with placebo plus endocrine therapy. 
Pri bolnicah, ki so prejemale abemaciklib in endokrino zdravljenje, so poročali o večji pogostnosti okužb kot pri bolnicah, zdravljenih s placebom in endokrinim zdravljenjem.
First dose adjustment 
Prvo prilagajanje odmerka
The recommended dose of abemaciclib is 150 mg twice daily when used in combination with endocrine therapy. 
Zdravilo Verzenios v kombinaciji z endokrinim zdravljenjem Priporočeni odmerek abemacikliba je 150 mg dvakrat na dan, kadar se uporablja v kombinaciji z endokrinim zdravljenjem.
After a single oral dose of [14C] -abemaciclib, approximately 81% of the dose was excreted in faeces and 3.4% excreted in urine. 
Po enkratnem peroralnem odmerku [14C] abemacikliba se je približno 81 % odmerka izločilo v blatu,
Before treatment initiation, absolute neutrophil counts (ANC) ≥1500/mm3, platelets ≥100,000/mm3, and haemoglobin ≥8 g/dL are recommended. 
- Absolute Neutrophil Count) ≥ 1.500/mm3, trombocitov ≥ 100.000/mm3 in hemoglobina ≥ 8 g/dl.
You should not breast-feed while taking Verzenios. 
Med jemanjem zdravila Verzenios ne smete dojiti.
• Watering eyes 
• solzne oči
Contents of the pack and other information 
Shranjevanje zdravila Verzenios Vsebina pakiranja in dodatne informacije
Patients were randomised in a 2:1 ratio to receive Verzenios 150 mg twice daily plus a non-steroidal aromatase inhibitor given daily at the recommended dose versus placebo plus a non-steroidal aromatase inhibitor according to the same schedule. 
Bolnice so bile randomizirane v razmerju 2:1 in so prejemale zdravilo Verzenios 150 mg dvakrat na dan in nesteroidni zaviralec aromataze enkrat na dan v priporočenem odmerku v primerjavi s placebom in nesteroidnim zaviralcem aromataze po enakem urniku.
Verzenios is for oral use. 
Zdravilo Verzenios je namenjeno za peroralno uporabo.
Abemaciclib was not mutagenic in a bacterial reverse mutation (Ames) assay, was not clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes, and was not clastogenic in an in vivo rat bone marrow micronucleus assay. 
Abemaciklib pri testu (Amesov test) reverzibilnih mutacij pri bakterijah ni deloval mutageno ter pri testu kromosomskih aberacij in vitro na limfocitih iz človeške periferne krvi in pri testu mikronukleusov v kostnem mozgu podgan in vivo ni deloval klastogeno.
Verzenios has minor influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Verzenios ima manjši vpliv na sposobnost vožnje in upravljanja strojev.
150 mg twice daily 
150 mg dvakrat na dan
Tel: +386 (0)1 580 00 10 
Tel. št.: +386 (0)1 580 00 10
Grade 4 Toxicity 
Toksičnost stopnje 4
In subjects with severe hepatic impairment (Child Pugh C), the AUC0-∞ of abemaciclib and potency adjusted unbound abemaciclib plus its active metabolites increased 2.1-fold and 2.4-fold, respectively. 
Pri preskušancih s hudo (Child Pugh C) jetrno okvaro se je AUC0-∞abemacikliba in za jakost prilagojena izpostavljenost nevezanemu abemaciklibu in njegovim aktivnim presnovkom povečala za 2,1-krat oziroma 2,4-krat.
Objective response rateb [%] (95% CI) Complete response, (%) Partial response, (%) 
Objektivna stopnja odzivab [%] (95 % IZ) Popolni odziv, (%)
50 mg twice daily 
50 mg dvakrat na dan
Concomitant use of strong CYP3A4 inhibitors should be avoided. 
Sočasni uporabi močnih zaviralcev CYP3A4 se je treba izogibati.
Co-administration of abemaciclib with the strong CYP3A4 inducer rifampicin decreased the plasma concentration of abemaciclib by 95% and unbound potency adjusted plasma concentration of abemaciclib plus its active metabolites by 77% based on AUC0-∞. 
Sočasna uporaba abemacikliba in močnega induktorja CYP3A4 rifampicina je zmanjšala plazemsko koncentracijo abemacikliba za 95 %, nevezano in glede jakosti prilagojeno koncentracijo abemacikliba in njegovih aktivnih presnovkov v plazmi pa za 77 % na podlagi AUC0-∞.
The efficacy and safety of Verzenios in combination with an aromatase inhibitor (anastrozole or letrozole) was evaluated in MONARCH 3, a randomised, double-blind, placebo-controlled phase 3 study in women with HR positive, HER2 negative locally advanced or metastatic breast cancer who had not received prior systemic therapy in this disease setting. 
Učinkovitost in varnost zdravila Verzenios v kombinaciji z zaviralcem aromataz (anastrozolom ali letrozolom) so vrednotili v študiji MONARCH 3, randomizirani, dvojno slepi s placebom nadzorovani študiji III. faze pri ženskah s HR-pozitivnim, HER2-negativnim lokalno napredovalim ali metastatskim rakom dojk, ki zaradi te bolezni še niso prejemale sistemskega zdravljenja.
Independent radiographic review, number of events (%) Median [months] (95% CI) 
Neodvisni radiografski pregled, število dogodkov (%) Mediana [meseci] (95 % IZ)
Placebo plus aromatase inhibitor 
Placebo in zaviralec aromataze
Fri. 
Izpuščaj
The median time to onset of Grade 3 or 4 AST elevation was 71 to 185 days, and median time to resolution was 13 to 15 days. 
Mediani čas do pojava povišane vrednosti AST stopnje 3 ali 4 je bil od 71 do 185 dni, mediani čas do izboljšanja pa od 13 do 15 dni.
Common Muscular weakness 
Mišična šibkost
The median time to onset of Grade 3 or 4 ALT elevation was 57 to 61 days, and median time to resolution was 14 days. 
Mediani čas do pojava povišane vrednosti ALT stopnje 3 ali 4 je bil od 57 do 61 dni, mediani čas do izboljšanja pa 14 dni.
17% of patients were pre/perimenopausal on ovarian suppression with a GnRH agonist. 
bolnic je bilo v pred-/perimenopavzi zaradi supresije jajčnikov z agonistom GnRH.
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided. 
Uporabi močnih zaviralcev CYP3A4 sočasno z abemaciklibom se je treba izogibati.
Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000 
United Kingdom Eli Lilly and Company Limited Tel. št.: + 44-(0) 1256 315000
and a Grade 3 or 4 decrease in neutrophil counts (based on laboratory findings) was reported in 28.2% of patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant. 
O nevtropeniji so poročali pogosto (45,1 %), o zmanjšanju števila nevtrofilcev stopnje 3 ali 4 (na podlagi laboratorijskih preiskav) pa pri 28,2 % bolnic, ki so prejemale abemaciklib v kombinaciji z zaviralci aromataze ali s fulvestrantom.
In patients who have had their dose reduced to 100 mg abemaciclib twice daily and in whom co-administration of a strong CYP3A4 inhibitor cannot be avoided, the abemaciclib dose should be further reduced to 50 mg twice daily. 
Pri bolnicah, pri katerih je bil odmerek znižan na 100 mg abemacikliba dvakrat na dan in pri katerih se sočasnemu dajanju močnega zaviralca CYP3A4 ni mogoče izogniti, je treba odmerek abemacikliba dodatno znižati na 50 mg dvakrat na dan.
Lilly S.A. Tel: + 34-91 663 50 00 
Tel. št.: + 34-91 663 50 00
Abemaciclib is metabolised in the liver. 
Abemaciklib se presnavlja v jetrih.
Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. 
Zdravilo Verzenios je indicirano za zdravljenje žensk z lokalno napredovalim ali metastatskim, na hormonske receptorje (HR - Hormone Receptor) pozitivnim in na receptorje humanega epidermalnega rastnega faktorja 2 (HER2 - Human Epidermal Growth Factor Receptor 2) negativnim rakom dojk v kombinaciji z zaviralcem aromataze ali s fulvestrantom kot začetnim endokrinim zdravljenjem ali pri ženskah, ki so prejele predhodno endokrino zdravljenje.
Grade 1 
Stopnja 1
Suspend dose until toxicity resolves to baseline or Grade 1. 
Prekinite odmerjanje do izboljšanja toksičnosti na izhodiščno vrednost ali stopnjo 1.
Abemaciclib should be administered with caution in patients with severe renal impairment, with close monitoring for signs of toxicity. 
Pri dajanju abemacikliba bolnicam s hudo ledvično okvaro sta potrebna previdnost in skrbno spremljanje glede znakov toksičnosti.
• Muscular weakness 
• mišična šibkost
Tel: + 421 220 663 111 
Tel. št.: + 421 220 663 111
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]). 
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]).
Co-administration of abemaciclib with CYP3A4 inhibitors can increase plasma concentrations of abemaciclib. 
Sočasna uporaba abemacikliba in zaviralcev CYP3A4 lahko poveča plazemsko koncentracijo abemacikliba.
Tel: + 420 234 664 111 
Tel. št.: + 420 234 664 111
Grade 3 
Stopnja 3
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. 
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,
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). 
Podatkov o uporabi abemacikliba pri bolnicah s hudo ledvično okvaro, končno ledvično odpovedjo ali pri bolnicah na dializi ni (glejte poglavje 5.2).
Examples of strong CYP3A4 inhibitors include, but not limited to: clarithromycin, itraconazole, ketoconazole, lopinavir/ritonavir, posaconazole or voriconazole. 
vendar niso omejeni na: klaritromicin, itrakonazol, ketokonazol, lopinavir/ritonavir, posakonazol ali vorikonazol.
The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 8 and Figure 2. 
Rezultati primarne učinkovitosti so predstavljeni v preglednici 8 in na sliki 2.
At the first sign of diarrhoea, start treatment with antidiarrhoeal agents, such as loperamide. 
Ob prvem znaku driske začnite zdravljenje s sredstvi proti driski, kot je npr.
Toxicity a 
Toksičnost a
MONARCH 3: Summary of efficacy data (Investigator assessment, intent-to-treat population) 
MONARCH 3: Povzetek podatkov o učinkovitosti (ocena raziskovalca,
Grade 3 Toxicity 
Toksičnost stopnje 3
This leaflet was last revised in Other sources of information 
Navodilo je bilo nazadnje revidirano dne
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 
EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021