FrancophonIA/ELRC3.0 huggingface dataset:
English: In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Croatian: U predmenopauzalnih ili perimenopauzalnih žena liječenje u kombinaciji s palbociklibom treba primjenjivati zajedno s agonistom hormona koji otpušta luteinizirajući hormon (engl. luteinizing hormone releasing hormone, LHRH).
English: Hands must remain behind the needle at all times during use and disposal.
Croatian: Ruke se moraju nalaziti ispod vrha igle za vrijeme rukovanja iglom i odlaganja igle.
English: Anastrozole 1 mg (N=232)
Croatian: Anastrozol 1 mg (N=232)
English: A high dose of a shorter duration intramuscular injection formulation was used.
Croatian: Primijenjena je visoka doza lijeka intramuskularnom injekcijom kraćeg trajanja.
English: Updated Analysis (23 October 2015 cut-off) Faslodex plus palbociclib (N=347)
Croatian: Ažurirana analiza (Datum prestanka prikupljanja podataka: 23. listopada 2015.) Faslodex plus palbociklib (N=347)
English: These studies compared the safety and efficacy of monthly administration of Faslodex 250 mg versus the daily administration of 1 mg anastrozole (aromatase inhibitor).
Croatian: U tim su ispitivanjima uspoređene sigurnost primjene i djelotvornost mjesečne primjene lijeka Faslodex u dozi od 250 mg s dnevnom primjenom 1 mg anastrozola (inhibitora aromataze).
English: 2 pre-filled syringes (5 ml each) 2 safety needles
Croatian: 2 napunjene štrcaljke (svaka po 5 ml) 2 sigurnosne igle
English: Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Croatian: Faslodex 500 mg (2 x 250 mg/5 ml otopine za injekciju) treba primijeniti pomoću dvije napunjene štrcaljke, vidjeti dio 3.
English: Combined analysis of both studies showed the hazard ratio of Faslodex 250 mg to anastrozole for progression-free survival was 0.95 (95% CI 0.82 to 1.10).
Croatian: Kombinirana analiza obaju ispitivanja pokazala je da je omjer hazarda lijeka Faslodex 250 mg u odnosu na anastrozol za preživljenje bez progresije bolesti bio 0,95 (95% CI 0,82 do 1,10).
English: In patients receiving fulvestrant in combination with palbociclib in the PALOMA3 study, neutropenia of any grade was reported in 287 (83.2%) patients, with Grade 3 neutropenia being reported in 191 (55.4%) patients, and Grade 4 neutropenia being reported in 37 (10.7%) patients.
Croatian: Među bolesnicama koje su primale fulvestrant u kombinaciji s palbociklibom u ispitivanju PALOMA3, neutropenija bilo kojeg stupnja prijavljena je u 287 (83,2%) bolesnica, pri čemu je neutropenija 3. stupnja prijavljena u 191 (55,4%) bolesnice, a neutropenija 4. stupnja u 37 (10,7%) bolesnica.
English: Animal studies suggest that no effects other than those related directly or indirectly to antiestrogenic activity were evident with higher doses of fulvestrant (see section 5.3).
Croatian: Studije na životinjama ukazuju da kod primjene visokih doza fulvestranta nisu opaženi drugi učinci osim onih izravno ili neizravno povezanih s antiestrogenim djelovanjem (vidjeti dio 5.3).
English: Faslodex should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Croatian: Faslodex treba primjenjivati uz oprez u bolesnica s teškim oštećenjem bubrežne funkcije (klirens kreatinina manji od 30 ml/min).
English: The recommended dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month, with an additional 500 mg dose given 2 weeks after the initial dose.
Croatian: Preporučena doza je 500 mg fulvestranta (dvije injekcije po 250 mg/5 ml) jednom mjesečno, uz jednu dodatnu dozu od 500 mg primijenjenu 2 tjedna nakon početne doze.
English: Due to the intramuscular route of administration, Faslodex should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
Croatian: S obzirom na intramuskularni put primjene, Faslodex treba primjenjivati uz oprez u bolesnica s hemoragičnom dijatezom, trombocitopenijom ili onih koje uzimaju antikoagulacijsku terapiju.
English: A total of 335 patients in the Faslodex plus palbociclib arm and 166 patients in the Faslodex plus placebo arm completed the questionnaire at baseline and at least 1 post-baseline visit.
Croatian: Broj bolesnica pod rizikom palbociklibom i 166 bolesnica iz skupine koja je primala Faslodex i placebo ispunilo upitnik na početku ispitivanja i još najmanje pri 1 posjetu nakon toga.
English: In vitro data suggest that fulvestrant does not inhibit CYP450 isoenzymes.
Croatian: Podaci in vitro ukazuju da fulvestrant ne inhibira izoenzime CYP450.
English: The hazard ratio of Faslodex 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Croatian: Omjer hazarda lijeka Faslodex 250 mg u odnosu na anastrozol za vrijeme do smrti bio je 1,01 (95% CI 0,86 do 1,19).
English: The primary efficacy endpoint of the study was investigator assessed progression-free survival (PFS) evaluated according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumours).
Croatian: Primarna mjera ishoda za djelotvornost bilo je preživljenje bez progresije bolesti (PFS) prema ocjeni ispitivača na temelju verzije 1.1 Kriterija za ocjenu odgovora kod solidnih tumora (engl.
English: Patients were well matched for baseline demographics and prognostic characteristics between the Faslodex plus palbociclib arm and the Faslodex plus placebo arm.
Croatian: Početne demografske i prognostičke značajke bile su dobro ujednačene između skupine liječene lijekom Faslodex plus palbociklibom i one koja je primala Faslodex plus placebo.
English: Table 6 Efficacy results in visceral and non-visceral disease from PALOMA3 study (intentto-treat population)
Croatian: Tablica 6 Rezultati za djelotvornost kod visceralne i nevisceralne bolesti u ispitivanju PALOMA3 (populacija predviđena za liječenje)
English: The pharmacokinetics of fulvestrant has been evaluated in a single-dose clinical study conducted in women with mild to moderate hepatic impairment (Child-Pugh class A and B).
Croatian: Farmakokinetika fulvestranta ispitana je u kliničkom ispitivanju primjene jednokratne doze provedenom u žena s blagim do umjerenim oštećenjem jetre (Child-Pugh stadij A i B).
English: Severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Teško oštećenje jetre (vidjeti dijelove 4.4 i 5.2).
English: Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Croatian: Interferencija s testovima za određivanje estradiola pomoću antitijela Zbog strukturne sličnosti fulvestranta i estradiola, fulvestrant može interferirati s testovima za određivanje estradiola pomoću antitijela i može rezultirati lažno povećanim razinama estradiola.
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.
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.
English: It is not known whether fulvestrant is excreted in human milk.
Croatian: Nije poznato izlučuje li se fulvestrant u majčino mlijeko.
English: In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
Croatian: Prema objedinjenim podacima iz ispitivanja fulvestranta u monoterapiji, najčešće zabilježene nuspojave bile su reakcije na mjestu primjene injekcije, astenija, mučnina i povišene razine jetrenih enzima (ALT, AST, ALP).
English: Fertility The effects of Faslodex on fertility in humans has not been studied.
Croatian: Plodnost Nisu ispitivani učinci lijeka Faslodex na plodnost ljudi.
English: In the fulvestrant + placebo arm (n=172), neutropenia of any grade was reported in 7 (4.1%) patients, with Grade 3 neutropenia reported in 1 (0.6%) patient.
Croatian: U skupini koja je primala fulvestrant + placebo (N=172) neutropenija bilo kojeg stupnja prijavljena je u 7 (4,1%) bolesnica, pri čemu je neutropenija 3. stupnja prijavljena u 1 (0,6%) bolesnice.
English: This study compared the efficacy and safety of Faslodex 500 mg (n=362) with Faslodex 250 mg (n=374).
Croatian: U ovom se ispitivanju uspoređivala djelotvornost i sigurnost primjene lijeka Faslodex u dozi od 500 mg (n=362) i lijeka Faslodex u dozi od 250 mg (n=374).
English: The geometric mean (standard deviation) steady state trough concentration (Cmin,ss) and AUCss was 4.2 (0.9) ng/mL and 3680 (1020) ng*hr/mL, respectively.
Croatian: Geometrijska srednja vrijednost (standardna devijacija) najniže koncentracije lijeka u stanju dinamičke ravnoteže (Cmin, ss) iznosila je 4,2 (0,9) ng/ml, a AUC u stanju dinamičke ravnoteže bio je 3680 (1020) ng*hr/ml.
English: Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Croatian: Pojam „infekcije“ obuhvaća sve preporučene pojmove koji pripadaju klasifikaciji organskog sustava „Infekcije i infestacije“.
English: In dog studies following oral and intravenous administration, effects on the cardiovascular system (slight elevations of the S-T segment of the ECG [oral], and sinus arrest in one dog [intravenous]) were seen.
Croatian: U istraživanjima na psima nakon peroralne i intravenske primjene zabilježeni su učinci na srčano-žilni sustav (blaga povišenja S-T spojnice na EKG-u [peroralna primjena] te sinusni zastoj u jednog psa [intravenska primjena]).
English: No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance 30 ml/min).
Croatian: Ne preporučuje se prilagodba doze za bolesnice s blagim do umjerenim oštećenjem bubrežne funkcije (klirens kreatinina 30 ml/min).
English: No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
Croatian: Ne preporučuje se prilagodba doze za bolesnice s blagim do umjerenim oštećenjem jetrene funkcije.
English: Time-to-Deterioration was pre-specified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores.
Croatian: Vrijeme do pogoršanja unaprijed je specificirano kao razdoblje između početka ispitivanja i prvog povećanja početnih rezultata za bol za ≥ 10 bodova.
English: Table 4 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints (Investigator Assessment, Intent-To-Treat Population) ─ FALCON study
Croatian: Tablica 4 Sažetak rezultata za primarnu mjeru ishoda za djelotvornost (PFS) i ključne sekundarne mjere ishoda za djelotvornost (ocjena ispitivača, populacija predviđena za liječenje) ─ ispitivanje FALCON
English: Table 5 Efficacy results - PALOMA3 study (Investigator assessment, intent-to-treat population)
Croatian: Tablica 5 Rezultati za djelotvornost - ispitivanje PALOMA3 (ocjena ispitivača, populacija predviđena za liječenje)
English: Caution should be taken if injecting Faslodex at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
Croatian: Potreban je oprez ako se Faslodex injicira u dorzoglutealno područje zbog blizine ishijadičnog živca.
English: • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: - not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
Croatian: • kao monoterapija za liječenje lokalno uznapredovalog ili metastatskog raka dojke pozitivnog na estrogenske receptore u postmenopauzalnih žena: - koje prethodno nisu bile liječene endokrinom terapijom, ili - koje su doživjele relaps bolesti tijekom ili nakon adjuvantnog antiestrogenskog liječenja ili progresiju bolesti tijekom antiestrogenskog liječenja.
English: Non-visceral Disease
Croatian: Nevisceralna bolest
English: Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Croatian: Faslodex treba primjenjivati uz oprez u bolesnica s blagim do umjerenim oštećenjem jetrene funkcije (vidjeti dijelove 4.2, 4.3 i 5.2).
English: Combination therapy with palbociclib
Croatian: Kombinirana terapija s palbociklibom
English: Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Croatian: Pokazalo se da fulvestrant u štakora i kunića prolazi placentalnu barijeru nakon jednokratne intramuskularne doze.
English: • Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area).
Croatian: • Primijenite sporom intramuskularnom injekcijom (1-2 minute po injekciji) u mišić stražnjice (područje gluteusa).
English: • Lower back pain irradiating to leg on one side (sciatica)
Croatian: • bol u donjem dijelu leđa koja se širi niz jednu nogu (išijas)
English: The most common (≥2%) Grade ≥3 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.
Croatian: Najčešće (≥ 2%) nuspojave ≥ 3. stupnja bile su neutropenija, leukopenija, anemija, infekcije, povišene vrijednosti AST-a, trombocitopenija i umor.
English: NOTE: Activate away from self and others.
Croatian: Aktivirajte mehanizam s iglom okrenutom od sebe i drugih.
English: This includes avoiding storage at temperatures exceeding 30°C, and not exceeding a 28 day period where the average storage temperature for the product is below 25°C (but above 2°C - 8°C).
Croatian: To znači da treba izbjegavati čuvanje lijeka na temperaturama iznad 30°C te da se lijek ne smije čuvati na prosječnoj temperaturi ispod 25°C (ali iznad 2°C - 8°C) dulje od 28 dana.
English: N=number of patients; CI=confidence interval; OR=objective response; CBR=clinical benefit response
Croatian: N=broj bolesnica; CI=interval pouzdanosti; NP=ne može se procijeniti; OR=objektivni odgovor; CBR=stopa kliničke dobrobiti
English: Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint.
Croatian: Sekundarne mjere ishoda uključivale su OR, CBR, OS, sigurnost i vrijeme do pogoršanja boli.
English: This was evident for pre/perimenopausal women (HR of 0.46 [95% CI: 0.28, 0.75]) and postmenopausal women (HR of 0.52 [95% CI: 0.40, 0.66]) and patients with visceral site of metastatic disease (HR of 0.50 [95% CI: 0.38, 0.65]) and non-visceral site of metastatic disease (HR of 0.48 [95% CI: 0.33, 0.71]).
Croatian: To je bilo primjetno u žena u predmenopauzi/perimenopauzi (HR: 0,46 [95% CI: 0,28; 0,75]) i onih u postmenopauzi (HR: 0,52 [95% CI: 0,40; 0,66]) te bolesnica s visceralnim sijelom metastatske bolesti (HR: 0,50 [95% CI: 0,38; 0,65]) i onih s nevisceralnim sijelom metastatske bolesti (HR: 0,48 [95% CI: 0,33; 0,71]).
English: • Hold the syringe upright on the ribbed part (C).
Croatian: • Primite štrcaljku za rebrasti dio (C) uspravno prema gore.
English: Benefit was also observed regardless of lines of prior therapy in the metastatic setting, whether 0 (HR of 0.59 [95% CI: 0.37, 0.93]), 1 (HR of 0.46 [95% CI: 0.32, 0.64]), 2 (HR of 0.48 [95% CI: 0.30, 0.76]), or ≥3 lines (HR of 0.59 [95% CI: 0.28, 1.22]).
Croatian: Korist je opažena i neovisno o broju prethodnih terapijskih linija za metastatsku bolest, bilo da se radilo o 0 (HR: 0,59 [95% CI: 0,37; 0,93]), 1 (HR: 0,46 [95% CI: 0,32; 0,64]), 2 (HR: 0,48 [95% CI: 0,30; 0,76]) ili ≥ 3 linije (HR: 0,59 [95% CI: 0,28; 1,22]).
English: A 2-week study in healthy postmenopausal volunteers treated with 20 μg per day ethinylestradiol showed that pretreatment with Faslodex 250 mg resulted in significantly reduced stimulation of the postmenopausal endometrium, compared to pre-treatment with placebo, as judged by ultrasound measurement of endometrium thickness.
Croatian: Dvotjedno ispitivanje u zdravih žena u postmenopauzi liječenih etinilestradiolom u dozi od 20 μg na dan pokazalo je da je prethodno liječenje lijekom Faslodex u dozi od 250 mg dovelo do značajno smanjene stimulacije postmenopauzalnog endometrija u odnosu na prethodno liječenje placebom, što je procijenjeno ultrazvučnim mjerenjem debljine endometrija.
English: There were no reports of Grade 4 neutropenia in the fulvestrant + placebo arm.
Croatian: Neutropenija 4. stupnja nije prijavljena ni u jedne bolesnice u skupini koja je primala fulvestrant + placebo.
English: Within each frequency grouping adverse reactions are reported in order of decreasing seriousness.
Croatian: Unutar iste kategorije učestalosti nuspojave su poredane u padajućem nizu prema ozbiljnosti.
English: This 12-month study investigated a range of MAS endpoints and showed a reduction in the frequency of vaginal bleeding and a reduction in the rate of bone age advancement.
Croatian: Ovo 12-mjesečno ispitivanje istraživalo je niz mjera ishoda McCune Albrightovog sindroma i pokazalo smanjenje učestalosti vaginalnog krvarenja i smanjenje stope uznapredovalosti koštane dobi.
English: A safety needle (BD SafetyGlide) for connection to the barrel is also provided.
Croatian: U pakiranju se nalazi i sigurnosna igla (BD SafetyGlide) za spajanje na trup štrcaljke.
English: • Urinary tract infections
Croatian: • infekcije mokraćnih puteva
English: How to use Faslodex
Croatian: Kako primjenjivati Faslodex
English: Patient-reported symptoms were assessed using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and its Breast Cancer Module (EORTC QLQ-BR23).
Croatian: European Organization for Research and Treatment of Cancer, EORTC) i njegova Modula za rak dojke (EORTC QLQ-BR23).
English: The paediatric patients received 4 mg/kg monthly intramuscular dose of fulvestrant.
Croatian: Pedijatrijske bolesnice dobivale su mjesečnu intramuskularnu dozu fulvestranta od 4 mg/kg.
English: A two-year oncogenicity study in rats (intramuscular administration of Faslodex) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/rat/15 days and an increased incidence of testicular Leydig cell tumours in males.
Croatian: Dvogodišnje istraživanje onkogenosti u štakora (uz intramuskularnu primjenu lijeka Faslodex) pokazalo je povećanu incidenciju benignih tumora granuloza stanica jajnika u ženki štakora pri visokoj dozi od 10 mg po štakoru tijekom 15 dana, a u mužjaka povećanu incidenciju tumora Leydigovih stanica testisa.
English: Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Croatian: Jedna napunjena štrcaljka (5 ml) sadržava 250 mg fulvestranta.
English: Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-ToTreat Population) ─ FALCON Study
Croatian: Slika 1 Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje) ─ ispitivanje FALCON
English: • alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
Croatian: • samostalno, u žena nakon menopauze, za liječenje jedne vrste raka dojke koji se zove rak dojke pozitivan na estrogenski receptor, a koji je lokalno uznapredovao ili se proširio na druge dijelove tijela (metastatski rak), ili
English: To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
Croatian: Sadržaj alkohola treba uzeti u obzir kod primjene u bolesnika s visokim rizikom, kao što su bolesnici s oštećenjem jetre ili epilepsijom.
English: When Faslodex is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Croatian: Kada se Faslodex daje u kombinaciji s palbociklibom, važno je da također pročitate i uputu o lijeku za palbociklib.
English: Efficacy results for the CONFIRM study are summarized in Table 3.
Croatian: Rezultati djelotvornosti za ispitivanje CONFIRM sažeto su prikazani u Tablici 3.
English: How to store Faslodex
Croatian: Kako čuvati Faslodex
English: The most common (≥20%) adverse reactions of any grade reported in patients receiving fulvestrant in combination with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anaemia, stomatitis, diarrhoea, and thrombocytopenia.
Croatian: Najčešće nuspojave (≥ 20%) bilo kojeg stupnja prijavljene u bolesnica koje su primale fulvestrant u kombinaciji s palbociklibom bile su neutropenija, leukopenija, infekcije, umor, mučnina, anemija, stomatitis, proljev i trombocitopenija.
English: Listen for click and visually confirm needle tip is fully covered.
Croatian: Morate čuti klik te zatim pregledati je li vrh igle potpuno pokriven.
English: Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Croatian: Pojam „stomatitis“ obuhvaća sljedeće preporučene pojmove: aftozni stomatitis, heilitis, glositis, glosodiniju, ulceracije u ustima, upalu sluznice, bol u usnoj šupljini, nelagodu u usnoj šupljini i ždrijelu, bol u usnoj šupljini i ždrijelu, stomatitis.
English: Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its antiestrogenic activity, at doses similar to the clinical dose.
Croatian: Fulvestrant je pri dozama sličnima kliničkoj dozi pokazao učinke na reprodukciju i razvoj embrija i fetusa sukladan svom antiestrogenskom djelovanju.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva vrlo često osip
English: • Vaginal bleeding
Croatian: • vaginalno krvarenje
English: A Phase 3 clinical study was completed in 736 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Croatian: Kliničko ispitivanje faze 3 provedeno je na 736 žena u postmenopauzi s uznapredovalim rakom dojke u kojih se bolest ponovno pojavila tijekom ili nakon adjuvantnog endokrinog liječenja, ili je došlo do progresije bolesti nakon endokrinog liječenja uznapredovale bolesti.
English: Arteritis involving a range of different tissues was seen in some dogs after chronic (12 months) dosing.
Croatian: U nekih je pasa nakon kronične primjene (12 mjeseci) opažen arteritis u većem broju različitih tkiva.
English: For user convenience, the needle bevel-up position is oriented to the lever arm (see Figure 4).
Croatian: Radi lakše primjene kosi otvor vrha igle okrenut je prema ručici poluge (vidjeti Sliku 4).
English: Neoadjuvant treatment for up to 16 weeks in breast cancer patients with either Faslodex 500 mg or Faslodex 250 mg did not result in clinically significant changes in serum bone-turnover markers.
Croatian: Neoadjuvantno liječenje tijekom najdulje 16 tjedana u bolesnica s rakom dojke liječenih lijekom Faslodex u dozi od 500 mg ili u dozi od 250 mg nije dovelo do klinički značajnih promjena serumskih biljega koštane pregradnje.
English: Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
Croatian: Pojam „neutropenija“ obuhvaća sljedeće preporučene pojmove: neutropeniju, snižen broj neutrofila.
English: Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.
Croatian: Jedna injekcija lijeka Faslodex sadrži 750 mg benzilbenzoata, što odgovara količini od 150 mg/ml.
English: A Phase 3, randomised, double-blind, double-dummy, multicentre study of Faslodex 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Croatian: Provedeno je randomizirano, dvostruko slijepo, multicentrično ispitivanje faze 3 s dvostrukim placebom u kojem se Faslodex u dozi od 500 mg uspoređivao s anastrozolom u dozi od 1 mg u postmenopauzalnih žena s ER-pozitivnim i/ili PgR-pozitivnim lokalno uznapredovalim ili metastatskim rakom dojke koje prethodno nisu primile nikakvu hormonsku terapiju.