natgillin/translations-raw huggingface dataset:
Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Faslodex treba primjenjivati uz oprez u bolesnica s blagim do umjerenim oštećenjem jetrene funkcije (vidjeti dijelove 4.2, 4.3 i 5.2).
Combination therapy with palbociclib
Kombinirana terapija s palbociklibom
Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Pokazalo se da fulvestrant u štakora i kunića prolazi placentalnu barijeru nakon jednokratne intramuskularne doze.
• Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area).
• Primijenite sporom intramuskularnom injekcijom (1-2 minute po injekciji) u mišić stražnjice (područje gluteusa).
• Lower back pain irradiating to leg on one side (sciatica)
• bol u donjem dijelu leđa koja se širi niz jednu nogu (išijas)
The most common (≥2%) Grade ≥3 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.
Najčešće (≥ 2%) nuspojave ≥ 3. stupnja bile su neutropenija, leukopenija, anemija, infekcije, povišene vrijednosti AST-a, trombocitopenija i umor.
NOTE: Activate away from self and others.
Aktivirajte mehanizam s iglom okrenutom od sebe i drugih.
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).
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.
N=number of patients; CI=confidence interval; OR=objective response; CBR=clinical benefit response
N=broj bolesnica; CI=interval pouzdanosti; NP=ne može se procijeniti; OR=objektivni odgovor; CBR=stopa kliničke dobrobiti
Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint.
Sekundarne mjere ishoda uključivale su OR, CBR, OS, sigurnost i vrijeme do pogoršanja boli.
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]).
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]).
• Hold the syringe upright on the ribbed part (C).
• Primite štrcaljku za rebrasti dio (C) uspravno prema gore.
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]).
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]).
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.
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.
There were no reports of Grade 4 neutropenia in the fulvestrant + placebo arm.
Neutropenija 4. stupnja nije prijavljena ni u jedne bolesnice u skupini koja je primala fulvestrant + placebo.
Within each frequency grouping adverse reactions are reported in order of decreasing seriousness.
Unutar iste kategorije učestalosti nuspojave su poredane u padajućem nizu prema ozbiljnosti.
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.
Ovo 12-mjesečno ispitivanje istraživalo je niz mjera ishoda McCune Albrightovog sindroma i pokazalo smanjenje učestalosti vaginalnog krvarenja i smanjenje stope uznapredovalosti koštane dobi.
A safety needle (BD SafetyGlide) for connection to the barrel is also provided.
U pakiranju se nalazi i sigurnosna igla (BD SafetyGlide) za spajanje na trup štrcaljke.
• Urinary tract infections
• infekcije mokraćnih puteva
How to use Faslodex
Kako primjenjivati Faslodex
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).
European Organization for Research and Treatment of Cancer, EORTC) i njegova Modula za rak dojke (EORTC QLQ-BR23).
The paediatric patients received 4 mg/kg monthly intramuscular dose of fulvestrant.
Pedijatrijske bolesnice dobivale su mjesečnu intramuskularnu dozu fulvestranta od 4 mg/kg.
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.
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.
Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Jedna napunjena štrcaljka (5 ml) sadržava 250 mg fulvestranta.
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-ToTreat Population) ─ FALCON Study
Slika 1 Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje) ─ ispitivanje FALCON
• 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
• 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
To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
Sadržaj alkohola treba uzeti u obzir kod primjene u bolesnika s visokim rizikom, kao što su bolesnici s oštećenjem jetre ili epilepsijom.
When Faslodex is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Kada se Faslodex daje u kombinaciji s palbociklibom, važno je da također pročitate i uputu o lijeku za palbociklib.
Efficacy results for the CONFIRM study are summarized in Table 3.
Rezultati djelotvornosti za ispitivanje CONFIRM sažeto su prikazani u Tablici 3.
How to store Faslodex
Kako čuvati Faslodex
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.
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.
Listen for click and visually confirm needle tip is fully covered.
Morate čuti klik te zatim pregledati je li vrh igle potpuno pokriven.
Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
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.
Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its antiestrogenic activity, at doses similar to the clinical dose.
Fulvestrant je pri dozama sličnima kliničkoj dozi pokazao učinke na reprodukciju i razvoj embrija i fetusa sukladan svom antiestrogenskom djelovanju.
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva vrlo često osip
• Vaginal bleeding
• vaginalno krvarenje
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.
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.
Arteritis involving a range of different tissues was seen in some dogs after chronic (12 months) dosing.
U nekih je pasa nakon kronične primjene (12 mjeseci) opažen arteritis u većem broju različitih tkiva.
For user convenience, the needle bevel-up position is oriented to the lever arm (see Figure 4).
Radi lakše primjene kosi otvor vrha igle okrenut je prema ručici poluge (vidjeti Sliku 4).
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.
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.
Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
Pojam „neutropenija“ obuhvaća sljedeće preporučene pojmove: neutropeniju, snižen broj neutrofila.
Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.
Jedna injekcija lijeka Faslodex sadrži 750 mg benzilbenzoata, što odgovara količini od 150 mg/ml.
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.
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.
Adverse reactions by system organ class and frequency Infections and infestations
Nuspojave prema klasifikaciji organskih sustava i učestalosti pojavljivanja Infekcije i infestacije često infekcije mokraćnih puteva
• Decreased levels of platelets (thrombocytopenia)
• smanjena razina trombocita (trombocitopenija)
Two Phase 3 clinical studies were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Završena su dva klinička ispitivanja faze 3 s ukupno 851 ženom u postmenopauzi s uznapredovalim rakom dojke u kojih se bolest ponovno javila tijekom ili nakon adjuvantnog endokrinog liječenja ili je došlo do progresije nakon endokrinog liječenja uznapredovale bolesti.
No patients reported events that were CTCAE Grade ≥3 or that required a dose reduction, dose interruption, or discontinued treatment due to these adverse reactions.
Common Terminology Criteria for Adverse Events, CTCAE) niti događaj koji je zahtijevao smanjenje doze, privremeni prekid primjene ili obustavu liječenja zbog tih nuspojava.
Uncommon Febrile neutropenia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Common Dysgeusia Eye disorders Common Lacrimation increased Vision blurred Dry eye Respiratory, thoracic and mediastinal disorders Common Epistaxis Gastrointestinal disorders Very common Nausea Stomatitis Diarrhoea Vomiting Skin and subcutaneous tissue disorders Very common Alopecia Rash Common Dry skin General disorders and administration site conditions Very common Fatigue Pyrexia Common Asthenia Investigations Common AST increased ALT increased
Manje često febrilna neutropenija Poremećaji metabolizma i prehrane Vrlo često smanjen tek Poremećaji živčanog sustava Često disgeuzija Poremećaji oka Često pojačano suzenje zamagljen vid suhoća oka Poremećaji dišnog sustava, prsišta i sredoprsja Često epistaksa
The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral.
Izraz reakcije na mjestu injekcije ne obuhvaća krvarenje na mjestu injekcije niti hematom na mjestu injekcije, išijas, neuralgiju, i perifernu neuropatiju.
Faslodex contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Faslodex sadrži 10% m/V etanola (alkohol), odnosno do 500 mg po injekciji, što odgovara 10 ml piva ili 4 ml vina.
Do not use Faslodex: - if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant or breast-feeding - if you have severe liver problems
Nemojte primjenjivati Faslodex - ako ste alergični na fulvestrant ili neki drugi sastojak ovog lijeka (naveden u dijelu 6. „Što
Mechanism of action and pharmacodynamic effects Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.
Fulvestrant je kompetitivni antagonist estrogenskih receptora (ER), čiji je afinitet usporediv s estradiolom.
One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Jedna napunjena štrcaljka sadržava 250 mg fulvestranta u 5 ml otopine.
• Back pain*
• bol u leđima*
• in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1).
• u kombinaciji s palbociklibom za liječenje lokalno uznapredovalog ili metastatskog raka dojke koji je pozitivan na hormonski receptor (HR) i negativan na receptor humanog epidermalnog faktora rasta 2 (engl. human epidermal growth factor receptor 2, HER2) u žena koje su prethodno primale endokrinu terapiju (vidjeti dio 5.1).
Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA3 study
Slika 2. Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje) - ispitivanje PALOMA3
The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the pre-specified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Rezultati su nadmašili unaprijed specificiranu granicu djelotvornosti prema Haybittleu i Petou (α=0,00135) te pokazali statistički značajno produljenje PFS-a i klinički važan terapijski učinak.
A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to Faslodex plus palbociclib or Faslodex plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Ukupno je 521 žena u predmenopauzi/perimenopauzi i postmenopauzi kojoj je bolest progredirala tijekom ili unutar 12 mjeseci od završetka adjuvantne endokrine terapije odnosno tijekom ili unutar mjesec dana od završetka endokrine terapije za uznapredovalu bolest randomiziranu u omjeru 2:1 za liječenje kombinacijom lijeka Faslodex i palbocikliba ili kombinacijom lijeka Faslodex i placeba.
• in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, that is locally advanced or has spread to other parts of the body (metastatic).
• u kombinaciji s palbociklibom, za liječenje žena s jednom vrstom raka dojke koji se zove rak dojke pozitivan na hormonski receptor i negativan na receptor ljudskog epidermalnog faktora rasta 2, a koji je lokalno uznapredovao ili se proširio na druge dijelove tijela (metastatski rak).
Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and p-value
Preživljenje bez progresije bolesti Broj događaja PFS-a (%) Omjer hazarda (95% CI) i p-vrijednost za PFS
Two clear type 1 glass pre-filled syringes with polystyrene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Faslodex solution for injection.
Dvije napunjene štrcaljke od prozirnog stakla tipa 1 s potisnim klipom od polistirena i sigurnosnim zatvaračem, od kojih svaka sadrži 5 ml Faslodex otopine za injekciju.
- The other ingredients (excipients) are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
- Drugi sastojci (pomoćne tvari) su etanol (96 postotni), benzilni alkohol, benzilbenzoat i rafinirano ricinusovo ulje.
Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Pojam „anemija“ obuhvaća sljedeće preporučene pojmove: anemiju, sniženu vrijednost hemoglobina, sniženu vrijednost hematokrita.
Ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
Etanol (96 postotni), benzilni alkohol, benzilbenzoat i rafinirano ricinusovo ulje.
Faslodex 250 mg solution for injection.
Faslodex 250 mg otopina za injekciju.
It has also been shown that fulvestrant 500 mg downregulates ER and the proliferation marker Ki67, to a greater degree than fulvestrant 250 mg in breast tumours in postmenopausal neoadjuvant setting.
Pokazalo se također da u neoadjuvantnom liječenju tumora dojke u postmenopauzalnih žena fulvestrant u dozi od 500 mg snižava broj estrogenskih receptora i biljega proliferacije Ki67 u većoj mjeri nego fulvestrant u dozi od 250 mg.
Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Pojam „osip“ obuhvaća sljedeće preporučene pojmove: osip, makulopapularni osip, pruritički osip, eritemski osip, papularni osip, dermatitis, akneiformni dermatitis, izbijanje kožnih promjena uzrokovanih toksičnim učinkom lijeka.
You must not breast-feed while on treatment with Faslodex.
Tijekom liječenja lijekom Faslodex ne smijete dojiti.
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with Faslodex injection.
Kod primjene Faslodex injekcije, zabilježeni su događaji povezani s mjestom injiciranja uključujući išijas, neuralgiju, neuropatsku bol, i perifernu neuropatiju.
In patients administered Faslodex, an increase in exposure of this magnitude is expected to be well tolerated.
Očekuje se da će bolesnice koje su primile Faslodex dobro podnijeti ovu razinu izloženosti.
Faslodex + Palbociclib (N=345)
Faslodex + palbociklib (N=345)
was the primary endpoint; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Preživljenje bez progresije bolesti (PFS) bila je primarna mjera ishoda studije; ključne sekundarne mjere ishoda studije obuhvaćale su stopu objektivnog odgovora (ORR), stopu kliničke dobrobiti (CBR) i ukupno preživljenje (OS).
Caution should be taken while administering Faslodex at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and
Potreban je oprez pri primjeni lijeka Faslodex u dorzoglutealno mjesto injekcije zbog blizine ishijadičnog živca (vidjeti dijelove 4.2 i 4.8)
Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Navedene nuspojave klasificirane su prema učestalosti i klasifikaciji organskih sustava.
Neoadjuvant treatment for up to 16 weeks in breast cancer patients treated with either Faslodex 500 mg or Faslodex 250 mg did not result in clinically significant changes in endometrial thickness, indicating a lack of agonist effect.
Neoadjuvantno liječenje tijekom najdulje 16 tjedana nije u bolesnica s rakom dojke liječenima lijekom Faslodex u dozi od 500 mg ili lijekom Faslodex u dozi od 250 mg dovelo do klinički značajnih promjena u debljini endometrija, što ukazuje da lijek nema agonistički učinak.
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
• alergijske reakcije (reakcije preosjetljivosti), uključujući oticanje lica, usana, jezika i/ili grla,
One clear type 1 glass pre-filled syringe with polystyrene plunger rod, fitted with a tamper-evident closure, containing 5 ml Faslodex solution for injection.
Jedne napunjene štrcaljke od prozirnog stakla tipa 1 s potisnim klipom od polistirena i sigurnosnim zatvaračem, koja sadrži 5 ml Faslodex otopine za injekciju.
What Faslodex looks like and contents of the pack Faslodex is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection.
Faslodex je bistra, bezbojna do žuta, viskozna otopina u napunjenoj štrcaljki sa sigurnosnim zatvaračem, koja sadržava 5 ml otopine za injekciju.
Faslodex plus palbociclib (N=206)
Faslodex plus palbociklib (N=206)
Faslodex plus palbociclib (N=141)
Faslodex plus palbociklib (N=141)
• Pull shield straight off needle to avoid damaging needle point.
• Povucite zaštitni zatvarač s igle ravno, kako ne biste oštetili vrh igle.
Faslodex 250 mg solution for injection fulvestrant
Faslodex 250 mg otopina za injekciju fulvestrant
In the FALCON study, the number of patients who reported an adverse reaction of joint and musculoskeletal pain was 65 (31.2%) and 48 (24.1%) for fulvestrant and anastrozole arms, respectively.
Bol u zglobovima, mišićima i kostima je kao nuspojavu u ispitivanju FALCON prijavilo 65 (31,2%) bolesnica u skupini koja je primala fulvestrant i 48 (24,1%) onih u skupini koja je primala anastrozol.
All Patients -AE subgroup (n=423) -AI subgroup (n=313)
Svi bolesnici -AE podskupina (n=423) -AI podskupina (n=313)
A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of Faslodex 500 mg plus palbociclib 125 mg versus Faslodex 500 mg plus placebo was conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo) adjuvant or metastatic setting.
od 125 mg uspoređivala s kombinacijom lijeka Faslodex u dozi od 500 mg i placeba u žena - neovisno o njihovu menopauzalnom statusu - s lokalno uznapredovalim HR-pozitivnim i HER2-negativnim rakom dojke koji se nije mogao kurativno liječiti resekcijom ni radioterapijom ili metastatskim rakom dojke, kojima je bolest uznapredovala nakon prethodne endokrine terapije u (neo)adjuvantnim ili metastatskim uvjetima.