natgillin/translations-raw huggingface dataset:
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions 
• alergijske (preobčutljivostne) reakcije, vključno z otekanjem obraza, ustnic, jezika in/ali grla, ki je lahko znak anafilaktične reakcije
Consistent results were observed across the majority of pre-specified patient subgroups. 
Pri večini vnaprej določenih podskupin bolnic so opažali konsistentne rezultate.
What Faslodex is and what it is used for 
Kaj je zdravilo Faslodex in za kaj ga uporabljamo
Pre-filled syringes are for single use only. 
Napolnjene injekcijske brizge so samo za enkratno uporabo.
Preclinical data do not suggest a stimulatory effect of fulvestrant on the postmenopausal endometrium (see section 5.3). 
Predklinični podatki ne kažejo na stimulatorni učinek fulvestranta na endometrij po menopavzi (glejte poglavje 5.3).
• Peel open the safety needle (SafetyGlide) outer packaging. 
• S potegom odprite zunanjo ovojnino varnostne igle (SafetyGlide).
Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint. 
Med sekundarnimi cilji študije so bili OR, CBR, OS, varnost in čas do poslabšanja (TTD - Time-to-Deterioration) bolečin.
What Faslodex is and what it is used for What you need to know before you use Faslodex How to use Faslodex 
Kaj je zdravilo Faslodex in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Faslodex Kako uporabljati zdravilo Faslodex Možni neželeni učinki
Table 2 Adverse reactions based on PALOMA3 Study (N=517) 
Neželeni učinki na podlagi študije PALOMA3 (N = 517)
Other medicines and Faslodex 
Druga zdravila in zdravilo Faslodex
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. 
V študijah na psih po peroralni in intravenski uporabi so opazili učinke na kardiovaskularni sistem (rahlo povečanje S-T segmenta v EKG [peroralno] in sinusni zastoj pri enem psu [intravensko]).
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. 
Študija je ob vmesni analizi (opravljeni po 82 % načrtovanih dogodkov PFS) dosegla svoj primarni cilj podaljšanja PFS po oceni raziskovalca; rezultati so presegli vnaprej določeno Haybittle-Petovo mejo učinkovitosti (α = 0,00135) ter so dokazali statistično značilno podaljšanje PFS in klinično pomemben terapevtski učinek.
Randomisation was stratified by disease setting (locally advanced or metastatic), prior chemotherapy for advanced disease, and measurable disease. 
Randomizacija je bila stratificirana po obsegu bolezni (lokalno napredovala ali metastatska), predhodni kemoterapiji za napredovalo bolezen in merljivosti bolezni.
The objective response rate for Faslodex 250 mg was 19.2% compared with 16.5% for anastrozole. 
Objektivni delež odgovorov je bil za zdravilo Faslodex 250 mg 19,2 % v primerjavi s 16,5 % pri anastrozolu.
Faslodex is indicated in patients whose disease had recurred or progressed on an antiestrogen therapy. 
Zdravilo Faslodex je indicirano pri bolnikih, katerih bolezen se je ponovila ali napredovala med zdravljenjem z antiestrogeni.
Keep the pre-filled syringe in the original package, in order to protect from light. 
Napolnjeno injekcijsko brizgo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Faslodex is indicated: 
Zdravilo Faslodex je indicirano:
The results in the AI subgroup are inconclusive. 
Na podlagi rezultatov pri AI podskupini ni možno narediti zaključkov.
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. 
Ta 12-mesečna študija, pri kateri so proučevali vrsto ciljev študije v povezavi z MAS, je pokazala manjšo pogostnost vaginalnih krvavitev in počasnejše napredovanje staranja kosti.
There was up to about 2.5-fold increase in AUC in women with hepatic impairment compared to healthy subjects. 
Pri ženskah z okvaro jeter se je AUC zvišal za približno 2,5-krat v primerjavi z zdravimi ženskami.
Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly. 
Prilagoditev odmerka tako ni potrebna pri bolnicah, ki sočasno uporabljajo fulvestrant in zaviralce ali induktorje CYP 3A4.
• Inflammation of the liver (hepatitis) 
• vnetje jeter (hepatitis)
The descriptions included below are based on the safety analysis set of 228 patients who received at least one (1) dose of fulvestrant and 232 patients who received at least one (1) dose of anastrozole, respectively in the Phase 3 FALCON study. 
Spodaj navedeni opisi temeljijo na naboru podatkov za analizo varnosti 228 bolnic, ki so v študiji 3. faze FALCON prejele vsaj en (1) odmerek fulvestranta, in 232 bolnic, ki so prejele vsaj en (1) odmerek anastrozola.
Two syringes must be administered to receive the 500 mg recommended monthly dose. 
Dve injekcijski brizgi morata biti injicirani za dosego priporočenega mesečnega odmerka 500 mg.
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. 
Raven brez opaženega učinka ('the no-effect level') ter ravni sistemske izpostavljenosti (AUC) so bile za te ugotovitve pri podganah približno 1,5-kratnik vrednosti ravni, pričakovanih za človeka tako pri moških kot pri ženskah, ter pri miših približno 0,8-kratnik vrednosti ravni, pričakovanih za človeka, tako pri moških kot pri ženskah.
There are isolated reports of overdose with Faslodex in humans. 
Obstajajo posamezni poročani primeri prevelikega odmerjanja zdravila Faslodex pri človeku.
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat 
• alergijske (preobčutljivostne) reakcije, vključno z otekanjem obraza, ustnic, jezika in/ali žrela
Updated Analysis (23 October 2015 cut-off) Faslodex plus palbociclib (N=347) 
Posodobljena analiza (datum zamejitve 23. oktober 2015) Zdravilo Faslodex in palbociklib (N = 347)
N=number of patients; CI=confidence interval; OR=objective response; CBR=clinical benefit response 
N = število bolnikov, IZ = interval zaupanja, OR = objektivni odziv, CBR = odziv klinične koristi
Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone releasing hormone (LHRH) agonist. 
Ženske, ki še niso dosegle menopavze, bodo zdravljene tudi z zdravilom, imenovanim agonist gonadoliberina (LHRH).
• Anaphylactic reactions 
• anafilaktične reakcije
Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance. 
Klinične študije medsebojnega delovanja z rifampicinom (induktor CYP 3A4) in ketokonazolom (zaviralec CYP 3A4) niso pokazale klinično pomembnih sprememb v očistku fulvestranta.
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). 
V odprti študiji 2. faze so raziskovali varnost, učinkovitost in farmakokinetiko fulvestranta pri 30 deklicah, starih od 1 do 8 let, s progresivno prezgodnjo puberteto, povezano z MacCune-Albrightovim sindromom (MAS).
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. 
V študijah so z uporabo preparatov jeter človeka in rekombinantnih humanih encimov pokazali, da je CYP 3A4 edini izoencim P-450, ki sodeluje pri oksidaciji fulvestranta, čeprav se zdi, da in vivo prevladujejo poti, ki ne vključujejo P-450.
Fifty-five percent (55.0%) of patients had visceral metastasis at baseline. 
Petinpetdeset odstotkov (55 %) bolnic je imelo visceralne metastaze ob izhodišču.
If you can become pregnant, you should use effective contraception while you are being treated with Faslodex and for 2 years after your last dose. 
Če bi lahko zanosili, morate uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Faslodex in še 2 leti po vašem zadnjem odmerku tega zdravila.
All patients had received prior systemic therapy and most patients in each treatment arm had received a previous chemotherapy regimen for their primary diagnosis. 
Vse bolnice so predhodno prejemale sistemsko zdravljenje in večina bolnic v eni in drugi zdravljeni skupini je zaradi primarne diagnoze prejemala predhodno shemo kemoterapije.
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. 
Pri bolnicah, ki so prejemale fulvestrant v kombinaciji s palbociklibom, je bil mediani čas do prvega pojava nevtropenije 15 dni (razpon: od 13 do 317), mediano trajanje nevtropenije ≥ 3. stopnje pa je bilo 7 dni.
Seventy seven percent (77%) of the study population had estrogen receptor positive breast cancer. 
V skupini bolnic, ki so sodelovale v študiji, jih je sedeminsedemdeset odstotkov (77 %) imelo rak dojke s pozitivnimi
Clinical studies in postmenopausal women with primary breast cancer have shown that fulvestrant significantly downregulates ER protein in ER positive tumours compared with placebo. 
Klinične študije pri ženskah po menopavzi s primarnim rakom dojke so pokazale, da fulvestrant v primerjavi s placebom značilno bolj zmanjšuje količino proteina ER pri ER pozitivnih tumorjih.
There was an increased incidence of foetal variations in rabbits (backwards displacement of the pelvic girdle and 27 pre-sacral vertebrae). 
Pri kuncih se je pojavila povečana pogostnost pojavljanja sprememb ploda (nazaj premaknjena medenični obroč in 27. presakralno vretence).
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). 
Uporaba sheme z zdravilom Faslodex 500 mg doseže raven izpostavljenosti, ki je v ali blizu stanja dinamičnega ravnovesja, v prvem mesecu dajanja (povprečje [KV]: AUC 475 [33,4 %] ng.dan/ml, Cmax 25,1 [35,3 %] ng/ml, Cmin 16,3 [25,9 %] ng/ml).
Although the data collected were limited, the steady-state trough concentrations of fulvestrant in children appear to be consistent with those in adults. 
Čeprav so bili zbrani podatki omejeni, so bile najnižje koncentracije fulvestranta v stanju dinamičnega ravnovesja pri otrocih podobne koncentracijam pri odraslih.
In vitro data suggest that fulvestrant does not inhibit CYP450 isoenzymes. 
In vitro podatki kažejo, da fulvestrant ne zavira CYP450 izoencimov.
• Lower back pain irradiating to leg on one side (sciatica) 
• bolečina v križu, ki izžareva v nogo na eni strani (išias)
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. 
Lokalne reakcije na mestu injiciranja, vključno z miozitisom in granulomatomom, so pripisali vehiklu, vendar pa je resnost miozitisa pri kuncih večja pri fulvestrantu v primerjavi s kontrolno raztopino natrijevega klorida.
palbociclib+fulvestrant placebo+fulvestrant 
palbociklib in fulvestrant placebo in fulvestrant
Benzyl alcohol Faslodex contains benzyl alcohol as an excipient which may cause allergic reactions. 
Benzilalkohol Zdravilo Faslodex vsebuje pomožno snov benzilalkohol, ki lahko povzroči alergijske reakcije.
The safety and efficacy of Faslodex in children from birth to 18 years of age have not been established. 
Varnost in učinkovitost zdravila Faslodex pri otrocih od rojstva do18.
Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers. 
Zdravilo Faslodex vsebuje učinkovino fulvestrant, ki spada v skupino zaviralcev estrogena.
The steady-state trough concentrations of fulvestrant in children in this study were consistent with that in adults (see section 5.2). 
Najnižje koncentracije fulvestranta, v stanju dinamičnega ravnovesja pri otrocih v tej študiji, so bile podobne koncentracijam pri odraslih (glejte poglavje 5.2).
Store and transport in a refrigerator (2C - 8C). 
Shranjujte in prevažajte v hladilniku (2 C - 8 C).
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). 
Primarni opazovani dogodek učinkovitosti v študiji je bilo preživetje brez napredovanja bolezni (PFS) po oceni raziskovalca na podlagi meril RECIST 1.1 (Response Evaluation Criteria in Solid Tumours).
Faslodex should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min). 
Zdravilo Faslodex uporabljajte previdno pri bolnicah s hudo okvaro ledvic (kreatininski očistek manjši od 30 ml/min).
Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). 
Neželeni učinki, navedeni spodaj, so našteti glede na pogostnost in organski sistem.
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. 
Zaradi intramuskularne poti uporabe zdravilo Faslodex uporabljajte previdno pri zdravljenju bolnic s hemoragično diatezo, trombocitopenijo ali bolnic, ki se zdravijo z antikoagulanti.
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). 
V študijo je bilo vključenih 423 bolnic pri katerih je do napredovanja ali ponovitve bolezni prišlo med antiestrogenskim zdravljenjem (AE podskupina) in 313 bolnic, pri katerih je prišlo do napredovanja ali ponovitve med zdravljenjem z zaviralcem aromataze (AI podskupina).
All Patients -AE subgroup (n=296) -AI subgroup (n=205) CBR 
Vsi bolniki -AE podskupina (n = 296) -AI podskupina (n = 205) CBR
Table 2 reports the adverse reactions from PALOMA3. 
Preglednica 2 prikazuje neželene učinke v študiji PALOMA3.
There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2). 
Ni podatkov o zdravilu pri bolnicah s hudo okvaro jeter (glejte poglavja 4.3, 4.4 in 5.2).
N=number of patients; CI=confidence interval; OR= objective response; TTR=time to first tumour response. 
N = število bolnikov, IZ = interval zaupanja, OR = objektivni odziv, TTR = čas do prvega odziva tumorja (TTR - Time to first Tumor Response).
Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with Faslodex (see section 4.8). 
Tromboembolične dogodke so pogosto opažali pri ženskah z napredovalim rakom dojke, opazili pa so jih tudi v kliničnih študijah z zdravilom Faslodex (glejte poglavje 4.8).
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 
nevtropenija levkopenija anemija trombocitopenija občasni febrilna nevtropenija Presnovne in prehranske motnje zelo pogosti zmanjšanje apetita Bolezni živčevja pogosti dizgevzija Očesne bolezni pogosti močnejše solzenje zamegljen vid suho oko Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti epistaksa Bolezni prebavil zelo pogosti navzea stomatitis driska bruhanje Bolezni kože in podkožja zelo pogosti alopecija izpuščaj pogosti suha koža Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost zvišana telesna temperatura pogosti astenija Preiskave pogosti zvišana vrednost AST zvišana vrednost ALT
Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Absolute difference in % 
Primerjava med skupinami (Faslodex 500 mg/Faslodex 250 mg) absolutna razlika v %
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. 
Ker sta si fulvestrant in estradiol po strukturi podobna, lahko fulvestrant moti preizkuse za določanje estradiola, ki temeljijo na uporabi protiteles, in lahko povzroči lažno zvišane rezultate koncentracije estradiola.
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. 
V 2-tedenski študiji na zdravih prostovoljkah po menopavzi, ki so prejemale 20 mikrogramov etinilestradiola dnevno, so ugotovili, da je predhodno zdravljenje z zdravilom Faslodex 250 mg vodilo k pomembnemu zmanjšanju stimulacije endometrija po menopavzi, v primerjavi s predhodnim zdravljenjem s placebom, kar je bilo ocenjeno z ultrazvočnim merjenjem debeline endometrija.
The paediatric patients were aged 1 to 8 years and received 4 mg/kg monthly intramuscular dose of fulvestrant. 
Pediatrične bolnice so bile stare od 1 do 8 let in so mesečno prejemale fulvestrant v intramuskularnem odmerku 4 mg/kg.
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). 
Dodatek palbocikliba zdravilu Faslodex je povzročilo izboljšanje simptomov z značilnim podaljšanjem časa do poslabšanja simptomov bolečine v primerjavi s kombinacijo zdravila Faslodex in placeba (mediano 8,0 mesecev v primerjavi z 2,8 meseca; HR 0,64 [95 % IZ: 0,49; 0,85], p < 0,001).
Talk to your doctor or pharmacist or nurse before using Faslodex if any of these apply to you: - kidney or liver problems - low numbers of platelets (which help blood clotting) or bleeding disorders 
Pred začetkom uporabe zdravila Faslodex se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če se karkoli od naštetega nanaša na vas: - če imate težave z ledvicami ali jetri; - če imate nizko število trombocitov (pomagajo pri strjevanju krvi), ali motnje, povezane s krvavitvami; - če ste imeli težave s krvnimi strdki; - osteoporoza (zmanjšanje mineralne gostote kosti);
Median duration of exposure to palbociclib in the fulvestrant + palbociclib arm was 10.8 months. 
V skupini, ki je prejemala fulvestrant in palbociklib, je mediano trajanje izpostavljenosti palbociklibu bilo 10,8 meseca.
This study compared the efficacy and safety of Faslodex 500 mg (n=362) with Faslodex 250 mg (n=374). 
Ta študija je primerjala učinkovitost in varnost zdravila Faslodex 500 mg (n = 362) in zdravila Faslodex 250 mg (n = 374).
Time-to-Deterioration was pre-specified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores. 
Čas do poslabšanja je bil vnaprej določen kot čas od izhodišča do prvega pojava povečanja ocene simptomov bolečine za ≥ 10 točk v primerjavi z izhodiščem.
In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed. 
Pri podganah so opazili reverzibilno zmanjšanje plodnosti samic in preživetje zarodka, distocijo in povečano pogostnost pojavljanja nenormalnosti ploda, vključno s tarzalnim upogibom.
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. 
Nobena bolnica ni poročala o učinkih, ki bi bili ≥ 3. stopnje po CTCAE, ali bi zahtevali zmanjšanje odmerka, prekinitev uporabe ali prenehanje zdravljenja.
A safety needle (BD SafetyGlide) for connection to the barrel is also provided. 
Priložena je tudi varnostna igla (BD SafetyGlide) za povezavo z valjem.
The hazard ratio of Faslodex 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19). 
Razmerje ogroženosti med zdravilom Faslodex 250 mg in anastrozolom glede časa do nastopa smrti je bilo 1,01 (95 % IZ 0,86 do 1,19).
Store and transport in a refrigerator (2°C - 8°C). 
Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3. 
Zdravilo Faslodex 500 mg (2 x 250 mg/5 ml raztopine za injiciranje) je treba dati z uporabo dveh napolnjenih injekcijskih brizg, glejte poglavje 3.
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. 
Pred začetkom zdravljenja s kombinacijo zdravila Faslodex in palbocikliba ter med celotnim trajanjem takšnega zdravljenja morajo ženske pred menopavzo in ženske v perimenopavzi prejemati tudi agoniste LHRH v skladu z lokalno klinično prakso.
Patients of childbearing potential should use effective contraception during treatment with Faslodex and for 2 years after the last dose. 
Bolnice v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Faslodex in še 2 leti po zadnjem odmerku zdravila.
All other side effects: 
Za vsako od obeh brizg:
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 vključuje izogibanje shranjevanju pri temperaturi nad 30 °C, obdobje shranjevanja, med katerim je povprečna temperatura pod 25 °C (vendar nad 2 °C - 8 °C), pa ne sme biti daljše od 28 dni.
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. 
Pri bolnicah, ki so v študiji PALOMA3 prejemale fulvestrant v kombinaciji s palbociklibom, so o nevtropeniji (katere koli stopnje) poročali pri 287 (83,2 %) bolnicah, o nevtropeniji 3. stopnje pri 191 (55,4 %) bolnicah in o nevtropeniji 4. stopnje pri 37 (10,7 %) bolnicah.
How to use Faslodex 
Kako uporabljati zdravilo Faslodex
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. 
V dveh kratkotrajnih študijah (1 in 12 tednov) pri bolnicah pred menopavzo z benignimi ginekološkimi obolenji niso opazili značilne razlike v debelini endometrija (z ultrazvočnim merjenjem) med tistimi, ki so jemale fulvestrant, in tistimi, ki so prejemale placebo.
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. 
Geometrijska srednja vrednost (standardna deviacija) najnižje koncentracije v stanju dinamičnega ravnovesja (Cmin,ss) in AUCss je bila 4,2 (0,9) ng/ml oziroma 3680 (1020) ng
• Increase of bilirubin (bile pigment produced by the liver) 
• zvišanje bilirubina (žolčnega barvila, ki nastaja v jetrih)