natgillin/translations-raw huggingface dataset:
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.
U bolesnica kojima je doza abemacikliba već smanjena na 100 mg dvaput na dan i u kojih se ne može izbjeći istodobna primjena snažnog inhibitora CYP3A4, dozu abemacikliba potrebno je dodatno smanjiti na 50 mg dvaput na dan.
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.
Medijan vremena do nastupa neutropenije 3. ili 4. stupnja iznosio je 29 - 33 dana, a medijan vremena do njezina povlačenja 11 - 15 dana.
At the first sign of diarrhoea, start treatment with antidiarrhoeal agents, such as loperamide.
Na prvi znak mekane stolice potrebno je započeti liječenje antidijaroicima, kao što je loperamid.
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.
Verzenios je indiciran za liječenje žena s lokalno uznapredovalim ili metastatskim rakom dojke pozitivnim na hormonski receptor (engl. hormone receptor, HR) i negativnim na receptor humanog epidermalnog faktora rasta 2 (engl. human epidermal growth factor receptor 2, HER2) u kombinaciji s inhibitorom aromataze ili fulvestrantom kao početna endokrina terapija ili u žena koje su prethodno primale endokrinu terapiju.
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.
Djelotvornost i sigurnost lijeka Verzenios u kombinaciji s inhibitorom aromataze (anastrozolom ili letrozolom) ocjenjivala se u ispitivanju MONARCH 3, koje je bilo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 3 provedeno u žena s HR pozitivnim, HER2 negativnim lokalno uznapredovalim ili metastatskim rakom dojke koje prethodno nisu primale sistemsku terapiju za liječenje uznapredovale ili metastatske bolesti.
The median time to onset of the first diarrhoea event was approximately 6 to 8 days across studies, and the median duration of diarrhoea was 9 to 12 days (Grade 2) and 6 to 8 days (Grade 3) across studies.
U svim je ispitivanjima medijan vremena do prvog nastupa proljeva iznosio približno 6 - 8 dana, dok je medijan trajanja proljeva bio 9 - 12 dana (2. stupanj) odnosno 6 - 8 dana (3. stupanj).
Infections were reported in patients receiving abemaciclib plus endocrine therapy at a higher rate than in patients treated with placebo plus endocrine therapy.
U bolesnica koje su primale abemaciklib plus endokrinu terapiju stopa prijavljenih infekcija bila je viša nego u bolesnica koje su primale placebo plus endokrinu terapiju.
The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 8 and Figure 2.
Primarni rezultati za djelotvornost sažeto su prikazani u Tablici 8 i na Slici 2.
There are no data in patients with severe renal impairment, end stage renal disease or in patients on dialysis.
Nema podataka o primjeni u bolesnica s teškim oštećenjem bubrežne funkcije, bolesnica u terminalnoj fazi bubrežne bolesti ni u bolesnica na dijalizi.
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.
Medijan vremena do nastupa povišenja vrijednosti ALT-a 3. ili 4. stupnja iznosio je 57 - 61 dan, a medijan vremena do njegova povlačenja 14 dana.
Venous thromboembolic events include DVT, pulmonary embolism, cerebral venous sinus thrombosis, subclavian, axillary vein thrombosis,DVT inferior vena cava and pelvic venous thrombosis
Venski tromboembolijski događaji uključuju duboku vensku trombozu, plućnu emboliju, trombozu venskih sinusa mozga, trombozu subklavijalne/aksilarne vene, duboku vensku trombozu donje šuplje vene i trombozu zdjeličnih vena.
In the event of an abemaciclib overdose, fatigue and diarrhoea may occur.
U slučaju predoziranja abemaciklibom mogu se javiti umor i proljev.
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]).
Opaženo je smanjenje rizika od progresije bolesti ili smrti u bolesnica s visceralnom bolešću (HR: 0,567 [95% CI: 0,407; 0,789]; medijan PFS-a: 21,6 mjeseci naspram 14,0 mjeseci), u bolesnica samo s koštanom bolešću (HR: 0,565 [95% CI: 0,306; 1,044]) i bolesnica s mjerljivom bolešću (HR: 0,517 [95% CI: 0,392; 0,681]).
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.
Medijan PFS-a bio je značajno produljen u skupini koja je primala Verzenios u kombinaciji s fulvestrantom (HR: 0,553 [95% CI: 0,449; 0,681]) te je iznosio 16,4 mjeseca u odnosu na 9,3 mjeseca u skupini koja je primala placebo plus fulvestrant.
• 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].
• Film ovojnica: titanijev dioksid (E171), talk (E553b), poli(vinilni alkohol) (E1203), makrogol 3350 (E1521), žuti željezov oksid (E172) [samo tablete od 50 mg i 150 mg], crveni željezov oksid (E172) [samo tablete od 50 mg].
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.
Medijan vremena do nastupa povišenja vrijednosti AST-a 3. ili 4. stupnja iznosio je 71 - 185 dana, a medijan vremena do njegova povlačenja 13 - 15 dana.
If you take too many tablets, or if someone else takes your medicine, contact a doctor or hospital for advice.
Ako uzmete previše tableta, ili ako netko drugi uzme
• Abnormalities in liver blood tests
• odstupanja u nalazima krvnih pretraga kojima se provjerava rad jetre
MONARCH 2: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Slika 2. MONARCH 2: Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje)
Yellow, oval tablet of 7.5 x 13.7 mm, debossed with “Lilly” on one side and “150” on the other.
Žuta ovalna tableta, dimenzija 7,5 x 13,7 mm, s utisnutom oznakom „Lilly“ na jednoj strani i „150“ na drugoj strani.
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).
U kliničkim je ispitivanjima medijan vremena do prvog nastupa proljeva iznosio približno 6 - 8 dana, dok je medijan trajanja proljeva iznosio 9 - 12 dana (2. stupanj)
Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided.
Treba izbjegavati primjenu snažnih inhibitora CYP3A4 s abemaciklibom.
The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 7 and Figure 1.
Primarni rezultati za djelotvornost sažeto su prikazani u Tablici 7 i na Slici 1.
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.
U ispitanika s teškim oštećenjem jetrene funkcije (Child Pugh stadij C), AUC0-∞ abemacikliba povećao se 2,1 puta, dok se AUC0-∞ prilagođen za potentnost nevezanog abemacikliba i njegovih aktivnih metabolita povećao 2,4 puta.
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.
Bolesnice su bile randomizirane u omjeru 2:1 za liječenje lijekom Verzenios u dozi od 150 mg dvaput na dan u kombinaciji s nesteroidnim inhibitorom aromataze koji se primjenjivao svakodnevno u preporučenoj dozi, odnosno za primanje placeba u kombinaciji s nesteroidnim inhibitorom aromataze koji se primjenjivao prema istom rasporedu.
White, oval tablet of 6.6 x 12.0 mm, debossed with “Lilly” on one side and “100” on the other.
Bijela ovalna tableta, dimenzija 6,6 x 12,0 mm, s utisnutom oznakom „Lilly“ na jednoj strani i „100“ na drugoj strani.
How to store Verzenios
Kako uzimati Verzenios
Progression-free survival
Preživljenje bez progresije bolesti
Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea (see section 4.2).
Preporučuje se prilagodba doze za bolesnice u kojih se razvije proljev ≥ 2. stupnja (vidjeti dio 4.2).
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).
Primarna mjera ishoda bio je PFS prema ocjeni ispitivača na temelju verzije 1.1 RECIST kriterija; najvažnije sekundarne mjere ishoda za djelotvornost uključivale su stopu objektivnog odgovora (ORR), stopu kliničke koristi
Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia (see section 4.2).
Preporučuje se prilagodba doze za bolesnice u kojih se razvije neutropenija 3. ili 4. stupnja (vidjeti dio 4.2).
No dose adjustments are necessary in patients with mild or moderate renal impairment.
Nije potrebno prilagođavati dozu u bolesnica s blagim ili umjerenim oštećenjem bubrežne funkcije.
Examples of strong CYP3A4 inhibitors include, but not limited to: clarithromycin, itraconazole, ketoconazole, lopinavir/ritonavir, posaconazole or voriconazole.
između ostalih: klaritromicin, itrakonazol, ketokonazol, lopinavir/ritonavir, posakonazol i vorikonazol.
• 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)
o karbamazepin (antiepileptik koji se koristi za liječenje napadaja) o rifampicin, koristi se za liječenje tuberkuloze (TBC) o fenitoin (koristi se za liječenje napadaja) o gospina trava (biljni pripravak koji se koristi za liječenje blage depresije i tjeskobe)
MONARCH 3: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Slika 1. MONARCH 3: Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje)
MONARCH 3: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Tablica 7. MONARCH 3: Sažetak podataka o djelotvornosti (ocjena ispitivača, populacija predviđena za liječenje)
Diarrhoea returned to baseline or lesser grade with supportive treatment such as loperamide and/or dose adjustment (see section 4.2).
Nakon potpornog liječenja, primjerice loperamidom, i/ili prilagodbe doze, proljev se vratio na početnu razinu ili niži stupanj (vidjeti dio 4.2).
CYP3A4 inhibitors
Inhibitori CYP3A4
It is unknown whether abemaciclib is excreted in human milk.
Nije poznato izlučuje li se abemaciklib u majčino mlijeko.
In patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant, ALT and AST elevations were reported frequently (15.1% and 14.2%, respectively).
U bolesnica koje su primale abemaciklib u kombinaciji s inhibitorima aromataze ili fulvestrantom, povišenja vrijednosti ALT-a i AST-a prijavljena su često (15,1% odnosno 14,2%), a povišenja vrijednosti ALT-a ili AST-a 3. ili 4. stupnja (na temelju laboratorijskih nalaza) prijavljena su u 6,1% odnosno 4,2% bolesnica.
In a clinical drug interaction study with metformin (substrate of OCT2, MATE1 and 2) co-administered with 400 mg abemaciclib, a small but not clinically relevant increase (37%) in metformin plasma exposure was observed.
i MATE2) primjenjivao istodobno s abemaciklibom u dozi od 400 mg opaženo je malo povećanje plazmatske izloženosti metforminu (37%) koje nije bilo klinički značajno.
In a sub-population with locally advanced or metastatic disease that had not received prior endocrine therapy, the PFS was also consistent.
PFS je bio dosljedan i u podskupini bolesnica s lokalno uznapredovalom ili metastatskom bolešću koje prethodno nisu primale endokrinu terapiju.
Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST increase (see section 4.2).
Preporučuje se prilagodba doze za bolesnice u kojih dođe do povišenja vrijednosti ALT-a ili AST-a 3. ili 4. stupnja (vidjeti dio 4.2).
Renal clearance of abemaciclib and its metabolites is minor.
Oštećenje funkcije bubrega Bubrežni je klirens abemacikliba i njegovih metabolita malen.
Very common Neutropenia Leukopenia Anaemia Thrombocytopenia Common Lymphopenia Uncommon Febrile neutropenia
Poremećaji krvi i limfnog sustava vrlo često neutropenija leukopenija anemija trombocitopenija često limfopenija manje često febrilna neutropenija
Lung infection was reported in patients receiving abemaciclib without concurrent neutropenia.
U bolesnica koje su primale abemaciklib prijavljene su plućne infekcije koje nisu bile praćene neutropenijom.
Concomitant use of inducers of CYP3A4
Istodobna primjena induktora CYP3A4
Abemaciclib should be administered with caution in patients with severe renal impairment, with close monitoring for signs of toxicity.
U bolesnica s teškim oštećenjem bubrežne funkcije abemaciklib treba primjenjivati uz oprez i pažljivo praćenje zbog mogućih znakova toksičnosti.
Duration of response [months] (95%CI)
Medijan [mjeseci] (95% CI)
Clinical benefit ratec (measurable disease)
Djelomičan odgovor, (%) Stopa kliničke koristic (mjerljiva bolest)
Suspend dose until toxicity resolves to Grade 2 or less.
Odgoditi primjenu doze dok se toksičnost ne ublaži do 2. ili nižeg stupnja.
Each film-coated tablet contains 28 mg of lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 28 mg laktoze (u obliku hidrata).
Figure 2.
PRILOG II.
Each film-coated tablet contains 42 mg of lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 42 mg laktoze (u obliku hidrata).
Beige, oval tablet of 5.2 x 9.5 mm, debossed with “Lilly” on one side and “50” on the other.
Bež ovalna tableta, dimenzija 5,2 x 9,5 mm, s utisnutom oznakom „Lilly“ na jednoj strani i „50“ na drugoj strani.
Very common side effects (may affect more than 1 in 10 people)
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • infekcije
Lilly S.A. Tel: + 34-91 663 50 00
Tel: + 34 -91 663 50 00
Dose adjustment recommendations for adverse reactions Verzenios dose combination therapy
Doza lijeka Verzenios u kombiniranoj terapiji
You should not breast-feed while taking Verzenios.
Tijekom liječenja lijekom Verzenios ne smijete dojiti.
Tablet core croscarmellose sodium lactose monohydrate microcrystalline cellulose colloidal hydrated silica sodium stearyl fumarate
Jezgra tablete karmelozanatrij, umrežena laktoza hidrat celuloza, mikrokristalična silicijev dioksid, koloidni, hidratizirani natrijev stearilfumarat
Concomitant use of strong CYP3A4 inhibitors should be avoided.
Inhibitori CYP3A4 Istodobnu primjenu snažnih inhibitora CYP3A4 treba izbjegavati.
Suspend dose until toxicity resolves to Grade 1 or less.
Odgoditi primjenu doze dok se toksičnost ne ublaži do 1. ili nižeg stupnja.
17% of patients were pre/perimenopausal on ovarian suppression with a GnRH agonist.
17% bolesnica bile su žene u predmenopauzi/perimenopauzi koje su primale agonist hormona koji oslobađa gonadotropin (engl. gonadotropine-releasing hormone, GnRH) radi supresije funkcije jajnika.
CYP3A4 inducers
Induktori CYP3A4
Serious infections such as lung infections can be life-threatening; - cause blood clots in the veins; - affect the way your liver works; - cause diarrhoea.
- uzrokovati stvaranje krvnih ugrušaka u venama - utjecati na rad jetre
MONARCH 2: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Tablica 8. MONARCH 2: Sažetak podataka o djelotvornosti (ocjena ispitivača, populacija predviđena za liječenje)
Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets
Verzenios 50 mg filmom obložene tablete Verzenios 100 mg filmom obložene tablete Verzenios 150 mg filmom obložene tablete
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane vrlo često smanjen tek
• Tiredness
• omaglica
Each film-coated tablet contains 14 mg of lactose (as monohydrate).
Jedna filmom obložena tableta sadrži 14 mg laktoze (u obliku hidrata).
- Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other.
- Verzenios 150 mg filmom obložene tablete su žute, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “150” na drugoj strani.
Age, gender, and body weight had no effect on the exposure of abemaciclib in a population pharmacokinetic analysis in patients with cancer (135 males and 859 females; age range 24-91 years; and body weight range 36-175 kg).
U populacijskoj farmakokinetičkoj analizi bolesnika s rakom (135 muškaraca i 859 žena; raspon dobi:
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 itrakonazol, ketokonazol, posakonazol, vorikonazol (koriste se za liječenje gljivičnih infekcija)
Very common Infectionsb
Infekcije i infestacije vrlo često infekcijeb
Verzenios 100 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b)
Verzenios 100 mg filmom obložene tablete poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b)
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
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.
CYP3A4 klaritromicina povećala je plazmatsku izloženost abemaciklibu 3,4 puta, dok je kombiniranu plazmatsku izloženost abemaciklibu i njegovim aktivnim metabolitima prilagođenu za potentnost nevezane frakcije povećala 2,5 puta.
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/1/18/1307/010 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 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021
Contact your doctor immediately for any of the following: - Symptoms such as chills or fever.
Odmah se obratite svom liječniku ako primijetite bilo koju od sljedećih nuspojava:
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]).
Opaženo je smanjenje rizika od progresije bolesti ili smrti u bolesnica s visceralnom bolešću (HR: 0,481 [95% CI: 0,369; 0,627], medijan PFS-a od 14,7 mjeseci naspram 6,5 mjeseci), u bolesnica samo s koštanom bolešću (HR: 0,543 [95% CI:
- Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other.
- Verzenios 50 mg filmom obložene tablete su bež, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “50” na drugoj strani.
You must tell your doctor if you become pregnant.
Ako zatrudnite, morate o tome obavijestiti svog liječnika.
- Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other.
- Verzenios 100 mg filmom obložene tablete su bijele, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “100” na drugoj strani.
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 sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
- If you get any side effects, talk to your doctor, pharmacist or nurse.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
Each film-coated tablet contains 100 mg abemaciclib.
Jedna filmom obložena tableta sadrži 100 mg abemacikliba.
Nervous system disorders
Poremećaji živčanog sustava vrlo često disgeuzija omaglica
Suspend dose until toxicity resolves to baseline or Grade 1.
Odgoditi primjenu doze dok se toksičnost ne ublaži do 1. stupnja ili početne razine.
Eli Lilly Polska Sp. z o.o.
Eli Lilly Italia S.p.A.
Each film-coated tablet contains 50 mg abemaciclib.
Jedna filmom obložena tableta sadrži 50 mg abemacikliba.
Excipients: lactose.
- uzrokovati proljev.
• Verzenios 100 mg film-coated tablet: each tablet contains 100 mg abemaciclib.
• Verzenios 100 mg filmom obložena tableta: jedna tableta sadrži 100 mg abemacikliba.
Each film-coated tablet contains 150 mg abemaciclib.
Jedna filmom obložena tableta sadrži 150 mg abemacikliba.
• Verzenios 150 mg film-coated tablet: each tablet contains 150 mg abemaciclib.
• Verzenios 150 mg filmom obložena tableta: jedna tableta sadrži 150 mg abemacikliba.
You should avoid becoming pregnant while taking Verzenios.
Tijekom liječenja lijekom Verzenios morate izbjegavati trudnoću.
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.
U kliničkim su se ispitivanjima povišenja serumskih vrijednosti kreatinina javljala unutar prvog mjeseca primjene abemacikliba te su se tijekom cijelog razdoblja liječenja održavale na povišenoj, ali stabilnoj razini, da bi se nakon prekida liječenja vratile u normalu.
Verzenios 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib.
Verzenios 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg abemacikliba.
• Verzenios 50 mg film-coated tablet: each tablet contains 50 mg abemaciclib.
• Verzenios 50 mg filmom obložena tableta: jedna tableta sadrži 50 mg abemacikliba.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 150 MG FILM-COATED TABLETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FILMOM OBLOŽENE TABLETE OD 150 MG
Verzenios 150 mg film-coated tablets
Verzenios 150 mg filmom obložene tablete
Mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had no effect on the exposure of abemaciclib.
Blago (Child Pugh stadij A) i umjereno (Child Pugh stadij B)
Neutropenia was reported in patients receiving abemaciclib.
U bolesnica koje su primale abemaciklib prijavljeni su slučajevi neutropenije.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 100 MG FILM-COATED TABLETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA FILMOM OBLOŽENE TABLETE OD 100 MG