FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Na prvi znak mekane stolice bolesnice trebaju započeti liječenje antidijaroicima, kao što je loperamid, povećati peroralni unos tekućine i obavijestiti svog liječnika.
English: The recommended dose of abemaciclib is 150 mg twice daily when used in combination with endocrine therapy.
Croatian: Verzenios u kombinaciji s endokrinom terapijom Preporučena doza abemacikliba je 150 mg dvaput na dan kada se primjenjuje u kombinaciji s endokrinom terapijom.
English: In vitro, Rb-negative and Rb-depleted cancer cell lines are generally less sensitive to abemaciclib.
Croatian: Stanične linije raka negativne na Rb i one sa smanjenom razinom Rb-a u načelu su manje osjetljive na abemaciklib in vitro.
English: 50 mg twice daily
Croatian: 50 mg dvaput na dan
English: Grade 3
Croatian: 3. stupnja
English: Lilly France Tél: +33-(0) 1 55 49 34 34
Croatian: Tél: +33-(0) 1 55 49 34 34
English: 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.
Croatian: Neutropenija je prijavljena često (45,1%), dok je smanjenje broja neutrofila 3. ili 4. stupnja (na temelju laboratorijskih nalaza) prijavljeno u 28,2% bolesnica koje su primale abemaciklib u kombinaciji s inhibitorima aromataze ili fulvestrantom.
English: 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.
Croatian: 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.
English: 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.
Croatian: Medijan vremena do nastupa neutropenije 3. ili 4. stupnja iznosio je 29 - 33 dana, a medijan vremena do njezina povlačenja 11 - 15 dana.
English: At the first sign of diarrhoea, start treatment with antidiarrhoeal agents, such as loperamide.
Croatian: Na prvi znak mekane stolice potrebno je započeti liječenje antidijaroicima, kao što je loperamid.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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).
English: Infections were reported in patients receiving abemaciclib plus endocrine therapy at a higher rate than in patients treated with placebo plus endocrine therapy.
Croatian: 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.
English: The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 8 and Figure 2.
Croatian: Primarni rezultati za djelotvornost sažeto su prikazani u Tablici 8 i na Slici 2.
English: There are no data in patients with severe renal impairment, end stage renal disease or in patients on dialysis.
Croatian: Nema podataka o primjeni u bolesnica s teškim oštećenjem bubrežne funkcije, bolesnica u terminalnoj fazi bubrežne bolesti ni u bolesnica na dijalizi.
English: 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.
Croatian: 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.
English: Venous thromboembolic events include DVT, pulmonary embolism, cerebral venous sinus thrombosis, subclavian, axillary vein thrombosis,DVT inferior vena cava and pelvic venous thrombosis
Croatian: 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.
English: In the event of an abemaciclib overdose, fatigue and diarrhoea may occur.
Croatian: U slučaju predoziranja abemaciklibom mogu se javiti umor i proljev.
English: A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.567 [95% CI: 0.407, 0.789]), median PFS 21.6 months versus 14.0 months; in patients with bone-only disease (HR 0.565, [95% CI: 0.306, 1.044]); and in patients with measurable disease (HR 0.517, [95% CI: 0.392, 0.681]).
Croatian: 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]).
English: Median PFS was significantly prolonged in the Verzenios plus fulvestrant arm (HR of 0.553 [95% CI 0.449, 0.681]); median PFS was 16.4 months versus 9.3 months in the placebo plus fulvestrant arm.
Croatian: 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.
English: • Film-coating: titanium dioxide (E171), talc (E553b), polyvinyl alcohol (E1203), macrogol 3350 (E1521), iron oxide yellow (E172) [50 mg and 150 mg tablets only], iron oxide red (E172) [50 mg tablets only].
Croatian: • 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].
English: 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.
Croatian: 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.
English: If you take too many tablets, or if someone else takes your medicine, contact a doctor or hospital for advice.
Croatian: Ako uzmete previše tableta, ili ako netko drugi uzme
English: • Abnormalities in liver blood tests
Croatian: • odstupanja u nalazima krvnih pretraga kojima se provjerava rad jetre
English: MONARCH 2: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Croatian: Slika 2. MONARCH 2: Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje)
English: Yellow, oval tablet of 7.5 x 13.7 mm, debossed with “Lilly” on one side and “150” on the other.
Croatian: Žuta ovalna tableta, dimenzija 7,5 x 13,7 mm, s utisnutom oznakom „Lilly“ na jednoj strani i „150“ na drugoj strani.
English: 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).
Croatian: 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)
English: Use of strong CYP3A4 inhibitors together with abemaciclib should be avoided.
Croatian: Treba izbjegavati primjenu snažnih inhibitora CYP3A4 s abemaciklibom.
English: The study met its primary endpoint of improving PFS. Primary efficacy results are summarised in Table 7 and Figure 1.
Croatian: Primarni rezultati za djelotvornost sažeto su prikazani u Tablici 7 i na Slici 1.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: White, oval tablet of 6.6 x 12.0 mm, debossed with “Lilly” on one side and “100” on the other.
Croatian: Bijela ovalna tableta, dimenzija 6,6 x 12,0 mm, s utisnutom oznakom „Lilly“ na jednoj strani i „100“ na drugoj strani.
English: How to store Verzenios
Croatian: Kako uzimati Verzenios
English: Progression-free survival
Croatian: Preživljenje bez progresije bolesti
English: Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea (see section 4.2).
Croatian: Preporučuje se prilagodba doze za bolesnice u kojih se razvije proljev ≥ 2. stupnja (vidjeti dio 4.2).
English: The primary endpoint was investigator-assessed PFS evaluated according to RECIST 1.1; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Croatian: 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
English: Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia (see section 4.2).
Croatian: Preporučuje se prilagodba doze za bolesnice u kojih se razvije neutropenija 3. ili 4. stupnja (vidjeti dio 4.2).
English: No dose adjustments are necessary in patients with mild or moderate renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnica s blagim ili umjerenim oštećenjem bubrežne funkcije.
English: Examples of strong CYP3A4 inhibitors include, but not limited to: clarithromycin, itraconazole, ketoconazole, lopinavir/ritonavir, posaconazole or voriconazole.
Croatian: između ostalih: klaritromicin, itrakonazol, ketokonazol, lopinavir/ritonavir, posakonazol i vorikonazol.
English: • 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)
Croatian: 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)
English: MONARCH 3: Kaplan-Meier plot of progression-free survival (Investigator assessment, intent-to-treat population)
Croatian: Slika 1. MONARCH 3: Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje)
English: MONARCH 3: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Croatian: Tablica 7. MONARCH 3: Sažetak podataka o djelotvornosti (ocjena ispitivača, populacija predviđena za liječenje)
English: Diarrhoea returned to baseline or lesser grade with supportive treatment such as loperamide and/or dose adjustment (see section 4.2).
Croatian: Nakon potpornog liječenja, primjerice loperamidom, i/ili prilagodbe doze, proljev se vratio na početnu razinu ili niži stupanj (vidjeti dio 4.2).
English: CYP3A4 inhibitors
Croatian: Inhibitori CYP3A4
English: It is unknown whether abemaciclib is excreted in human milk.
Croatian: Nije poznato izlučuje li se abemaciklib u majčino mlijeko.
English: In patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant, ALT and AST elevations were reported frequently (15.1% and 14.2%, respectively).
Croatian: 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.
English: 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.
Croatian: i MATE2) primjenjivao istodobno s abemaciklibom u dozi od 400 mg opaženo je malo povećanje plazmatske izloženosti metforminu (37%) koje nije bilo klinički značajno.
English: In a sub-population with locally advanced or metastatic disease that had not received prior endocrine therapy, the PFS was also consistent.
Croatian: PFS je bio dosljedan i u podskupini bolesnica s lokalno uznapredovalom ili metastatskom bolešću koje prethodno nisu primale endokrinu terapiju.
English: Phadisco Ltd Τηλ: +357 22 715000
Croatian: Τηλ: +357 22 715000
English: Dose modification is recommended for patients who develop Grade 3 or 4 ALT or AST increase (see section 4.2).
Croatian: 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).
English: Renal clearance of abemaciclib and its metabolites is minor.
Croatian: Oštećenje funkcije bubrega Bubrežni je klirens abemacikliba i njegovih metabolita malen.
English: Very common Neutropenia Leukopenia Anaemia Thrombocytopenia Common Lymphopenia Uncommon Febrile neutropenia
Croatian: Poremećaji krvi i limfnog sustava vrlo često neutropenija leukopenija anemija trombocitopenija često limfopenija manje često febrilna neutropenija
English: Lung infection was reported in patients receiving abemaciclib without concurrent neutropenia.
Croatian: U bolesnica koje su primale abemaciklib prijavljene su plućne infekcije koje nisu bile praćene neutropenijom.
English: Concomitant use of inducers of CYP3A4
Croatian: Istodobna primjena induktora CYP3A4
English: Abemaciclib should be administered with caution in patients with severe renal impairment, with close monitoring for signs of toxicity.
Croatian: U bolesnica s teškim oštećenjem bubrežne funkcije abemaciklib treba primjenjivati uz oprez i pažljivo praćenje zbog mogućih znakova toksičnosti.
English: Duration of response [months] (95%CI)
Croatian: Medijan [mjeseci] (95% CI)
English: Clinical benefit ratec (measurable disease)
Croatian: Djelomičan odgovor, (%) Stopa kliničke koristic (mjerljiva bolest)
English: Suspend dose until toxicity resolves to Grade 2 or less.
Croatian: Odgoditi primjenu doze dok se toksičnost ne ublaži do 2. ili nižeg stupnja.
English: Each film-coated tablet contains 28 mg of lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 28 mg laktoze (u obliku hidrata).
English: Figure 2.
Croatian: PRILOG II.
English: Each film-coated tablet contains 42 mg of lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 42 mg laktoze (u obliku hidrata).
English: Beige, oval tablet of 5.2 x 9.5 mm, debossed with “Lilly” on one side and “50” on the other.
Croatian: Bež ovalna tableta, dimenzija 5,2 x 9,5 mm, s utisnutom oznakom „Lilly“ na jednoj strani i „50“ na drugoj strani.
English: Very common side effects (may affect more than 1 in 10 people)
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • infekcije
English: Lilly S.A. Tel: + 34-91 663 50 00
Croatian: Tel: + 34 -91 663 50 00
English: Dose adjustment recommendations for adverse reactions Verzenios dose combination therapy
Croatian: Doza lijeka Verzenios u kombiniranoj terapiji
English: You should not breast-feed while taking Verzenios.
Croatian: Tijekom liječenja lijekom Verzenios ne smijete dojiti.
English: Tablet core croscarmellose sodium lactose monohydrate microcrystalline cellulose colloidal hydrated silica sodium stearyl fumarate
Croatian: Jezgra tablete karmelozanatrij, umrežena laktoza hidrat celuloza, mikrokristalična silicijev dioksid, koloidni, hidratizirani natrijev stearilfumarat
English: Concomitant use of strong CYP3A4 inhibitors should be avoided.
Croatian: Inhibitori CYP3A4 Istodobnu primjenu snažnih inhibitora CYP3A4 treba izbjegavati.
English: Suspend dose until toxicity resolves to Grade 1 or less.
Croatian: Odgoditi primjenu doze dok se toksičnost ne ublaži do 1. ili nižeg stupnja.
English: 17% of patients were pre/perimenopausal on ovarian suppression with a GnRH agonist.
Croatian: 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.
English: CYP3A4 inducers
Croatian: Induktori CYP3A4
English: Serious infections such as lung infections can be life-threatening; - cause blood clots in the veins; - affect the way your liver works; - cause diarrhoea.
Croatian: - uzrokovati stvaranje krvnih ugrušaka u venama - utjecati na rad jetre
English: MONARCH 2: Summary of efficacy data (Investigator assessment, intent-to-treat population)
Croatian: Tablica 8. MONARCH 2: Sažetak podataka o djelotvornosti (ocjena ispitivača, populacija predviđena za liječenje)
English: Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets
Croatian: Verzenios 50 mg filmom obložene tablete Verzenios 100 mg filmom obložene tablete Verzenios 150 mg filmom obložene tablete
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane vrlo često smanjen tek
English: • Tiredness
Croatian: • omaglica
English: Each film-coated tablet contains 14 mg of lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 14 mg laktoze (u obliku hidrata).
English: - Verzenios 150 mg film-coated tablets are yellow, oval tablets debossed with “Lilly” on one side and “150” on the other.
Croatian: - Verzenios 150 mg filmom obložene tablete su žute, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “150” na drugoj strani.
English: Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00
Croatian: Tlf: + 47 22 88 18 00
English: 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).
Croatian: U populacijskoj farmakokinetičkoj analizi bolesnika s rakom (135 muškaraca i 859 žena; raspon dobi:
English: o Itraconazole, ketoconazole, posaconazole, voriconazole (used to treat fungal infections) o Lopinavir/ritonavir (used to treat HIV/AIDS) o Digoxin (used to treat heart disorders) o Dabigatran etexilate (used to reduce the risk of stroke and blood clots)
Croatian: o itrakonazol, ketokonazol, posakonazol, vorikonazol (koriste se za liječenje gljivičnih infekcija)
English: Very common Infectionsb
Croatian: Infekcije i infestacije vrlo često infekcijeb
English: Verzenios 100 mg film-coated tablets polyvinyl alcohol (E1203) titanium dioxide (E171) macrogol (E1521) talc (E553b)
Croatian: Verzenios 100 mg filmom obložene tablete poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b)
English: EU/1/18/1307/001 EU/1/18/1307/002 EU/1/18/1307/003 EU/1/18/1307/004 EU/1/18/1307/005 EU/1/18/1307/006 EU/1/18/1307/007 EU/1/18/1307/008 EU/1/18/1307/009 EU/1/18/1307/010 EU/1/18/1307/011 EU/1/18/1307/012 EU/1/18/1307/013 EU/1/18/1307/014 EU/1/18/1307/015
Croatian: 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
English: 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.
Croatian: 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.
English: EU/1/18/1307/016 EU/1/18/1307/017 EU/1/18/1307/018 EU/1/18/1307/019 EU/1/18/1307/020 EU/1/18/1307/021
Croatian: 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
English: Contact your doctor immediately for any of the following: - Symptoms such as chills or fever.
Croatian: Odmah se obratite svom liječniku ako primijetite bilo koju od sljedećih nuspojava:
English: A reduction in the risk of disease progression or death was observed in patients with visceral disease, (HR of 0.481 [95% CI: 0.369, 0.627]), median PFS 14.7 months versus 6.5 months; in patients with bone-only disease (HR of 0.543 [95% CI: 0.355, 0.833]); patients with measurable disease (HR of 0.523 [95% CI: 0.412, 0.644]).
Croatian: 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:
English: - Verzenios 50 mg film-coated tablets are beige, oval tablets debossed with “Lilly” on one side and “50” on the other.
Croatian: - Verzenios 50 mg filmom obložene tablete su bež, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “50” na drugoj strani.
English: You must tell your doctor if you become pregnant.
Croatian: Ako zatrudnite, morate o tome obavijestiti svog liječnika.
English: - Verzenios 100 mg film-coated tablets are white, oval tablets debossed with “Lilly” on one side and “100” on the other.
Croatian: - Verzenios 100 mg filmom obložene tablete su bijele, ovalne tablete s utisnutom oznakom “Lilly” na jednoj strani i “100” na drugoj strani.
English: Belgique/België/Belgien
Croatian: Belgique/België/Belgien Eli Lilly Benelux S.A./N.V.