natgillin/translations-raw huggingface dataset:
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
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.
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.