FrancophonIA/ELRC3.0 huggingface dataset:
English: There are isolated reports of overdose with Faslodex in humans.
Croatian: Prijavljeni su izolirani slučajevi predoziranja lijekom Faslodex u ljudi.
English: • Remove the cap (A) in a straight upward direction.
Croatian: • Skinite zatvarač (A) ravno prema gore.
English: In each treatment arm the majority of patients were White, had documented sensitivity to prior hormonal therapy, and were postmenopausal.
Croatian: Većina bolesnica u svakoj skupini bila je bijele rase, imala je dokumentiranu osjetljivost na prethodnu hormonsku terapiju te je bila u postmenopauzi.
English: Faslodex has no or negligible influence on the ability to drive or use machines.
Croatian: Faslodex ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed.
Croatian: U štakora su opaženi reverzibilno smanjenje plodnosti ženki i preživljenja embrija, distocija i povećana učestalost fetalnih anomalija, uključujući tarzalnu fleksiju.
English: The study included 423 patients whose disease had recurred or progressed during antiestrogen therapy (AE subgroup) and 313 patients whose disease had recurred or progressed during aromatase inhibitor therapy (AI subgroup).
Croatian: U ispitivanje su bile uključene 423 bolesnice u kojih se bolest ponovno pojavila ili je uznapredovala tijekom liječenja antiestrogenom (AE podskupina) i 313 bolesnica u kojih se bolest ponovno pojavila ili je uznapredovala tijekom liječenja inhibitorom aromataze (AI podskupina).
English: This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports.
Croatian: Podaci navedeni u ovom dijelu temelje se na svim nuspojavama iz kliničkih ispitivanja, ispitivanja nakon stavljanja lijeka u promet i spontanih prijava.
English: • Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
Croatian: • Nataknite sigurnosnu iglu na Luer-Lok i zakrećite dok igla ne bude čvrsto pričvršćena (vidjeti Sliku 3).
English: • Numbness, tingling and pain
Croatian: • utrnulost, trnci i bol
English: However, as fulvestrant exposure may be increased, Faslodex should be used with caution in these patients.
Croatian: Međutim, budući da može biti povećana izloženost fulvestrantu, u tih bolesnica Faslodex treba primjenjivati uz oprez.
English: Prior to the start of treatment with the combination of Faslodex plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Croatian: Prije početka liječenja kombinacijom lijeka Faslodex i palbocikliba te tijekom njegova cjelokupnog trajanja žene u predmenopauzi/perimenopauzi treba liječiti agonistima LHRH-a u skladu s lokalnom kliničkom praksom.
English: Pre/perimenopausal women received the LHRH agonist goserelin.
Croatian: Žene u predmenopauzi/perimenopauzi primale su agonist LHRH-a goserelin.
English: The frequencies in Table 1 were based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Croatian: Učestalost u Tablici 1 temelji se na svim prijavljenim nuspojavama, bez obzira na to kako je ispitivač ocijenio povezanost s primjenom lijeka.
English: Studies using human liver preparations and recombinant human enzymes indicate that CYP3A4 is the only P450 isoenzyme involved in the oxidation of fulvestrant; however, non-P450 routes appear to be more predominant in vivo.
Croatian: Ispitivanja na preparatima ljudske jetre uz primjenu rekombinantnih ljudskih enzima ukazuju da je CYP3A4 jedini izoenzim citokroma P450 uključen u oksidaciju fulvestranta; međutim, čini se da in vivo prevladavaju putovi koji ne uključuju P450.
English: Benzyl alcohol Faslodex contains benzyl alcohol as an excipient which may cause allergic reactions.
Croatian: Benzilni alkohol Kao pomoćnu tvar, Faslodex sadrži benzilni alkohol koji može uzrokovati alergijske reakcije.
English: Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance <30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Croatian: Nisu ispitane sigurnost primjene i djelotvornost u bolesnica s teškim oštećenjem bubrežne funkcije (klirens kreatinina <30 ml/min) te se, stoga, u tih bolesnica preporučuje oprez (vidjeti dio 4.4).
English: Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone releasing hormone (LHRH) agonist.
Croatian: Žene koje još nisu ušle u menopauzu liječit će se još jednim lijekom, koji se zove agonist hormona koji otpušta luteinizirajući hormon (engl. luteinizing hormone releasing hormone, LHRH).
English: The paediatric patients were aged 1 to 8 years and received 4 mg/kg monthly intramuscular dose of fulvestrant.
Croatian: Pedijatrijske bolesnice bile su u dobi od 1 do 8 godina i dobivale su mjesečnu intramuskularnu dozu fulvestranta od 4 mg/kg.
English: Store and transport in a refrigerator (2°C - 8°C).
Croatian: Čuvati i prevoziti na hladnom (2°C - 8°C).
English: Faslodex is used either:
Croatian: Faslodex se koristi:
English: Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
Croatian: Stoga nije potrebno prilagođavati dozu u bolesnica koje istovremeno primaju fulvestrant i inhibitore ili induktore CYP3A4.
English: * Includes side effects for which the exact role of Faslodex cannot be assessed due to the underlying disease.
Croatian: * Uključuje nuspojave kod kojih se ne može procijeniti točna uloga lijeka Faslodex zbog postojeće bolesti.
English: 1 pre-filled syringe (5 ml) 1 safety needle
Croatian: 1 napunjena štrcaljka (5 ml) 1 sigurnosna igla
English: Pre-filled syringes are for single use only.
Croatian: Napunjene štrcaljke namijenjene su isključivo za jednokratnu primjenu.
English: Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
Croatian: Faslodex je dostupan u 2 pakiranja: kutija koja sadrži 1 staklenu napunjenu štrcaljku ili kutija koja sadrži 2 staklene napunjene štrcaljke.
English: In Table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the Faslodex 500 mg treatment group in pooled safety analyses of studies that compared Faslodex 500 mg with Faslodex 250 mg [CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006), and NEWEST (Study D6997C00003) studies], or from FALCON (Study D699BC00001) alone that compared Faslodex 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented.
Croatian: Kategorije učestalosti nuspojava navedenih u Tablici 1 izračunate su na temelju skupine koja je primala Faslodex 500 mg u zbirnim analizama podataka o sigurnosti primjene iz ispitivanja u kojima se uspoređivao Faslodex u dozi od 500 mg s lijekom Faslodex u dozi od 250 mg [CONFIRM (ispitivanje D6997C00002), FINDER 1 (ispitivanje D6997C00004), FINDER 2 (ispitivanje D6997C00006) i NEWEST (ispitivanje D6997C00003)] ili samo na temelju ispitivanja FALCON (ispitivanje D699BC00001), u kojem se uspoređivao Faslodex u dozi od 500 mg s anastrozolom u dozi od 1 mg.
English: ORR was assessed in patients who were evaluable for response at baseline (i.e. those with measurable disease at baseline: 240 patients in the Faslodex 500 mg group and 261 patients in the Faslodex 250 mg group).
Croatian: ORR je ocijenjena u bolesnica čiji se odgovor mogao procijeniti na početku ispitivanja (tj. onih s mjerljivom bolešću na početku ispitivanja: 240 bolesnica u skupini koja je primala Faslodex 500 mg te 261 bolesnica u skupini koja je primala Faslodex 250 mg).
English: The steady-state trough concentrations of fulvestrant in children in this study were consistent with that in adults (see section 5.2).
Croatian: Najniže koncentracije fulvestranta u stanju dinamičke ravnoteže u djece u ovom ispitivanju odgovarale su onima zabilježenima u odraslih (vidjeti dio 5.2).
English: An open-label Phase 2 study investigated the safety, efficacy and pharmacokinetics of fulvestrant in 30 girls aged 1 to 8 years with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).
Croatian: U otvorenom ispitivanju faze 2 ispitivane su sigurnost primjene, djelotvornost i farmakokinetika fulvestranta u 30 djevojčica u dobi od 1 do 8 godina s progresivnim preuranjenim pubertetom povezanim s McCune Albrightovim sindromom (MAS).
English: Randomisation was stratified by disease setting (locally advanced or metastatic), prior chemotherapy for advanced disease, and measurable disease.
Croatian: Randomizacija je bila stratificirana prema tipu bolesti (lokalno uznapredovala ili metastatska), prethodnoj kemoterapiji za uznapredovalu bolest i mjerljivoj bolesti.
English: Clinical studies in postmenopausal women with primary breast cancer have shown that fulvestrant significantly downregulates ER protein in ER positive tumours compared with placebo.
Croatian: Klinička ispitivanja kod žena u postmenopauzi s primarnim rakom dojke pokazala su da fulvestrant, u usporedbi s placebom, značajno smanjuje količinu proteina ER u ER pozitivnim tumorima.
English: • Vomiting, diarrhoea, or loss of appetite*
Croatian: • povraćanje, proljev ili gubitak teka*
English: Table 1 Adverse Drug Reactions reported in patients treated with Faslodex monotherapy
Croatian: Tablica 1 Nuspojave lijeka prijavljene u bolesnica liječenih lijekom Faslodex u monoterapiji
English: Faslodex should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).
Croatian: Faslodex treba primijeniti kao dvije uzastopne injekcije od 5 ml, sporom intramuskularnom injekcijom (1-2 minute po injekciji), po jednu u svaki mišić stražnjice (područje gluteusa).
English: Patients of childbearing potential should use effective contraception during treatment with Faslodex and for 2 years after the last dose.
Croatian: Bolesnice reproduktivne dobi trebaju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Faslodex i tijekom 2 godine nakon posljednje doze.
English: Combined analysis of both studies showed that 83% of patients who received Faslodex progressed, compared with 85% of patients who received anastrozole.
Croatian: Kombinirana analiza obaju ispitivanja pokazala je da je bolest napredovala u 83% bolesnica koje su primale Faslodex, u odnosu na 85% bolesnica koje su primale anastrozol.
English: This should be taken into consideration when prescribing Faslodex to patients at risk.
Croatian: Ovo treba uzeti u obzir kad se Faslodex propisuje bolesnicama s tom vrstom rizika.
English: A total of 462 patients were randomised 1:1 sequentially to receive either fulvestrant 500 mg or anastrozole 1 mg.
Croatian: Ukupno su 462 bolesnice bile sekvencijski randomizirane u omjeru 1:1 za primanje fulvestranta u dozi od 500 mg ili anastrozola u dozi od 1 mg.
English: Mild to moderate impairment of renal function did not influence the pharmacokinetics of fulvestrant to any clinically relevant extent.
Croatian: Blago do umjereno oštećenje bubrega nije utjecalo na farmakokinetiku fulvestranta u klinički značajnoj mjeri.
English: All Patients -AE subgroup (n=296) -AI subgroup (n=205) CBR
Croatian: Svi bolesnici -AE podskupina (n=296) -AI podskupina (n=205) CBR
English: Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Croatian: Klinička ispitivanja interakcije s rifampicinom (induktorom CYP3A4) i ketokonazolom (inhibitorom CYP3A4) nisu ukazala na klinički značajne promjene u klirensu fulvestranta.
English: In two short-term studies (1 and 12 weeks) in premenopausal patients with benign gynaecologic disease, no significant differences in endometrial thickness were observed by ultrasound measurement between fulvestrant and placebo groups.
Croatian: U dvije kratkotrajne studije (1 i 12 tjedana) u bolesnica u premenopauzi s benignom ginekološkom bolešću, ultrazvučnim mjerenjem nisu opažene značajne razlike u debljini endometrija između skupine liječene fulvestrantom i skupine koja je primala placebo.
English: Faslodex is indicated in patients whose disease had recurred or progressed on an antiestrogen therapy.
Croatian: Faslodex je indiciran u bolesnica u kojih se bolest ponovno javila ili je uznapredovala tijekom liječenja antiestrogenom.
English: Frequency category differs between pooled safety dataset and FALCON.
Croatian: Kategorija učestalosti u zbirnoj analizi podataka o sigurnosti razlikuje se od one u ispitivanju FALCON.
English: An updated RMP should be submitted • At the request of the European Medicines Agency;
Croatian: • na zahtjev Europske agencije za lijekove;
English: Table 3 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints in the CONFIRM study
Croatian: Tablica 3 Sažetak rezultata primarnih mjera ishoda djelotvornosti (PFS) i ključnih sekundarnih mjera ishoda djelotvornosti u studiji CONFIRM
English: Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, use during lactation is contraindicated (see section 4.3).
Croatian: S obzirom na moguće ozbiljne nuspojave u dojenčadi zbog primjene fulvestranta, primjena tijekom dojenja je kontraindicirana (vidjeti dio 4.3).
English: ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients Preferred Terms (PTs) are listed according to MedDRA 17.1.
Croatian: ALT=alanin aminotransferaza; AST=aspartat aminotransferaza; N/n=broj bolesnica
English: Infections and infestations Very common Infections Blood and lymphatic system disorders Very common Neutropenia Leukopenia Anaemia Thrombocytopenia
Croatian: Infekcije i infestacije Vrlo često infekcije Poremećaji krvi i limfnog sustava Vrlo često neutropenija leukopenija anemija trombocitopenija
English: At the no-effect level for these findings, systemic exposure levels (AUC) were, in rats, approximately 1.5-fold the expected human exposure levels in females and 0.8-fold in males, and in mice, approximately 0.8-fold the expected human exposure levels in both males and females.
Croatian: Razina bez učinka za ove nalaze bila je pri razinama sistemske izloženosti (AUC) koje su u ženki štakora bile približno 1,5 puta veće, a u mužjaka štakora 0,8 puta veće od očekivane razine izloženosti u ljudi, dok je ta vrijednost i u mužjaka i u ženki miševa bila približno 0,8 puta veća od očekivane razine izloženosti u ljudi.
English: There is no evidence of adverse endometrial effects in the breast cancer patients studied.
Croatian: Nema znakova štetnih učinaka na endometrij u ispitanih bolesnica s karcinomom dojke.
English: Table 2 reports the adverse reactions from PALOMA3.
Croatian: Tablici 2 navode se nuspojave iz ispitivanja PALOMA3.
English: Do not use this medicine after the expiry date which is stated on the carton or syringe labels after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici štrcaljke iza oznake „Rok valjanosti“ ili kratice EXP.
English: The overall safety profile of fulvestrant when used in combination with palbociclib is based on data from 517 patients with HR-positive, HER2-negative advanced or metastatic breast cancer in the randomised PALOMA3 study (see section 5.1).
Croatian: Sveukupan sigurnosni profil fulvestranta kada se primjenjuje u kombinaciji s palbociklibom temelji se na podacima prikupljenima u 517 bolesnica s HR-pozitivnim, HER2-negativnim uznapredovalim ili metastatskim rakom dojke iz randomiziranog ispitivanja PALOMA3 (vidjeti dio 5.1).
English: Breast-feeding must be discontinued during treatment with Faslodex.
Croatian: Dojenje treba prekinuti za vrijeme liječenja lijekom Faslodex.
English: Environmental risk assessment studies have shown that fulvestrant may have potential to cause adverse effects to the aquatic environment (see section 6.6).
Croatian: Ispitivanja provedena radi procjene rizika za okoliš pokazala su da bi fulvestrant mogao uzrokovati štetne učinke na vodeni okoliš (vidjeti dio 6.6).
English: Preclinical data do not suggest a stimulatory effect of fulvestrant on the postmenopausal endometrium (see section 5.3).
Croatian: Pretklinički podaci ne ukazuju na to da fulvestrant ima stimulativni učinak na endometrij nakon menopauze (vidjeti dio 5.3).
English: Treatment --- Fulvestrant 500 mg (N=230) - - - - - - Anastrozole 1 mg (N=232)
Croatian: Liječenje --- Fulvestrant 500 mg (N=230) - - - - - - Anastrozol 1 mg (N=232)
English: The role of sex hormone-binding globulin (SHBG) has not been determined.
Croatian: Nije ustanovljeno koja je uloga globulina koji veže spolne hormone (SHBG).
English: There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Croatian: Nema podataka kod bolesnica s teškim oštećenjem jetrene funkcije (vidjeti dijelove 4.3, 4.4 i 5.2).
English: The primary endpoint of the study was investigator-assessed PFS evaluated according to RECIST 1.1.
Croatian: Primarna mjera ishoda u ispitivanju bio je PFS prema ocjeni ispitivača na temelju verzije 1.1 RECIST kriterija.
English: A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4.
Croatian: Kliničko ispitivanje interakcije s midazolamom (supstratom CYP3A4) pokazalo je da fulvestrant ne inhibira CYP3A4.
English: • Anaphylactic reactions
Croatian: • anafilaktičke reakcije
English: The pharmacokinetics of fulvestrant has been evaluated in a clinical study conducted in 30 girls with Progressive Precocious Puberty associated with McCune Albright Syndrome (see section 5.1).
Croatian: Farmakokinetika fulvestranta ocijenjena je u kliničkom ispitivanju provedenom na 30 djevojčica s progresivnim preuranjenim pubertetom povezanim s McCune Albrightovim sindromom (vidjeti dio 5.1).
English: Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Croatian: Izlaganje temperaturama ispod 2°C neće naškoditi lijeku, pod uvjetom da se ne čuva na temperaturi ispod -20°C.
English: Addition of palbociclib to Faslodex resulted in a symptom benefit by significantly delaying Time-to-Deterioration in pain symptom compared with Faslodex plus placebo (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Croatian: Dodavanje palbocikliba lijeku Faslodex ostvarilo je koristan učinak na taj simptom jer je značajno odgodilo vrijeme do pogoršanja boli u odnosu na Faslodex plus placebo (medijan: 8,0 mjeseci naspram 2,8 mjeseci; HR: 0,64 [95% CI: 0,49; 0,85]; p < 0,001).
English: Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Absolute difference in %
Croatian: Usporedba između skupina (Faslodex 500 mg/Faslodex 250 mg) Apsolutna razlika u %
English: • Peel open the safety needle (SafetyGlide) outer packaging.
Croatian: • Izvadite sigurnosnu iglu (SafetyGlide) iz vanjskog pakiranja.
English: Administration of Faslodex 500 mg regimen achieves exposure levels at, or close to, steady state within the first month of dosing (mean [CV]: AUC 475 [33.4%] ng.days/ml, Cmax 25.1 [35.3%] ng/ml, Cmin 16.3 [25.9%] ng/ml, respectively).
Croatian: Primjenom režima doziranja lijeka Faslodex 500 mg, razine izloženosti koje su u ili približne stanju dinamičke ravnoteže postižu se tijekom prvog mjeseca doziranja (srednje vrijednosti [CV]: AUC = 475 [33,4%] ng.dan/ml, Cmax = 25,1 [ 35,3%] ng/ml, Cmin = 16,3 [25,9%] ng/ml).
English: Increases in placental weight and post-implantation loss of foetuses were seen.
Croatian: Opažena je povećana masa placente i gubitak fetusa nakon implantacije.
English: Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed due to the underlying disease.
Croatian: Uključujući nuspojave kod kojih se ne može procijeniti točan doprinos lijeka Faslodex zbog osnovne bolesti.
English: Local reactions, including myositis and granulomata at the injection site were attributed to the vehicle but the severity of myositis in rabbits increased with fulvestrant, compared to the saline control.
Croatian: Lokalne reakcije, uključujući miozitis i granulomatozne nakupine na mjestu injekcije pripisane su pomoćnim tvarima, no miozitis je u kunića bio ozbiljniji kod primjene fulvestranta u usporedbi s fiziološkom otopinom kao kontrolom.
English: Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
Croatian: Pojam „leukopenija“ obuhvaća sljedeće preporučene pojmove: leukopeniju, snižen broj bijelih krvnih stanica.
English: In patients receiving fulvestrant in combination with palbociclib, the median time to first episode of any grade neutropenia was 15 days (range: 13-317) and the median duration of Grade ≥3 neutropenia was 7 days.
Croatian: Među bolesnicama koje su primale fulvestrant u kombinaciji s palbociklibom, medijan vremena do prve epizode neutropenije bilo kojeg stupnja iznosio je 15 dana (raspon: 13 - 317), dok je medijan trajanja neutropenije ≥ 3. stupnja iznosio 7 dana.
English: Consistent results were observed across the majority of pre-specified patient subgroups.
Croatian: U većini unaprijed specificiranih podskupina bolesnica opaženi su dosljedni rezultati.
English: Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the 4-year shelf life of Faslodex (see section 6.3).
Croatian: Temperaturna odstupanja imaju kumulativan učinak na kvalitetu lijeka, pa se ne smije prekoračiti spomenuto razdoblje od 28 dana tijekom četverogodišnjeg roka valjanosti lijeka Faslodex (vidjeti dio 6.3).
English: Women with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Croatian: Nisu ocijenjene žene s teškim oštećenjem jetre (Child-Pugh stadij C).
English: Safety needles (BD SafetyGlide) for connection to each barrel are also provided.
Croatian: U pakiranju se nalaze i sigurnosne igle (BD SafetyGlide) za spajanje na svaki trup štrcaljke.
English: There was up to about 2.5-fold increase in AUC in women with hepatic impairment compared to healthy subjects.
Croatian: U žena s oštećenjem jetre došlo je do povećanja AUC od približno 2,5 puta u odnosu na zdrave ispitanike.
English: Very low density lipoprotein (VLDL), low density lipoprotein (LDL), and high density lipoprotein (HDL) fractions are the major binding components.
Croatian: Glavne vezivne komponente su frakcije lipoproteina vrlo niske gustoće (VLDL), lipoproteina niske gustoće (LDL) i lipoproteina visoke gustoće (HDL).
English: Median duration of exposure to fulvestrant was 11.2 months in the fulvestrant + palbociclib arm and 4.9 months in the fulvestrant + placebo arm.
Croatian: Medijan trajanja izloženosti fulvestrantu iznosio je 11,2 mjeseca u skupini koja je primala fulvestrant + palbociklib te 4,9 mjeseci u skupini koja je primala fulvestrant + placebo.
English: However, since asthenia has been reported very commonly with Faslodex, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Croatian: Međutim, budući da je uz primjenu lijeka Faslodex vrlo često prijavljivana astenija, bolesnice koje dobiju tu nuspojavu moraju biti oprezne ako voze ili rade na stroju.
English: AstraZeneca Tél: +33 1 41 29 40 00
Croatian: Tél: +33 41 29 40 00
English: In a two-year mouse oncogenicity study (daily oral administration) there was an increased incidence of ovarian sex cord stromal tumours (both benign and malignant) at doses of 150 and 500 mg/kg/day.
Croatian: U dvogodišnjem istraživanju onkogenosti u miševa (svakodnevna peroralna primjena) primijećena je povećana incidencija tumora specijalizirane strome jajnika (i dobroćudnih i zloćudnih) pri dozama od 150 i 500 mg/kg na dan.