natgillin/translations-raw huggingface dataset:
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.hr/ml.
One dose contains 500 mg benzyl alcohol, and up to 1000 mg ethanol anhydrous. 
En odmerek vsebuje 500 mg benzilalkohola in do 1000 mg brezvodnega etanola.
Warnings and precautions Talk to your doctor or pharmacist or nurse before using Fulvestrant Mylan if any of these apply to you: - kidney or liver problems - low numbers of platelets (which help blood clotting) or bleeding disorders - previous problems with blood clots 
Pred začetkom uporabe zdravila Fulvestrant Mylan 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;
Table 4 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints (Investigator Assessment, Intent-To-Treat Population) ─ FALCON study 
Povzetek rezultatov o primarnem opazovanem dogodku učinkovitosti (primary efficacy endpoint - PFS) in ključnih sekundarnih opazovanih dogodkih učinkovitosti (po oceni raziskovalca, populacija z-namenom-zdravljenja) ─ študija FALCON
What Fulvestrant Mylan is and what it is used for 
Kaj je zdravilo Fulvestrant Mylan in za kaj ga uporabljamo
For full instructions on the administration of Fulvestrant Mylan and the use of the safety needle see enclosed, Instructions for administration. 
Za celotna navodila glede uporabe zdravila Fulvestrant Mylan in uporabe varnostne igle glejte priložena navodila za uporabo.
OR 1.253 (0.815 - 1.932) p = 0.3045 
RO 1,253 (0,815 - 1,932) p = 0,3045
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 v premenopavzi 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.
% of patients with OR absolute difference in % 
% bolnic z OR; absolutna razlika v %
Progression-free survival (PFS) was the primary endpoint; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS). 
Glavni opazovani dogodek je bilo preživetje brez napredovanja bolezni (Progression-Free-Survival - PFS), ključni sekundarni opazovani dogodki učinkovitosti so vključevali objektivni delež odziva (Objective Response Rate - ORR), delež klinične dobrobiti (Clinical Benefit Rate - CBR) in celokupno preživetje (Overall Survival - OS).
Secondary end points* OR [% (95% CI)] OR (measurable disease) [% (95% CI)] 
Sekundarni cilji študije* OR [% (95 % IZ)] OR (merljiva bolezen) [% (95 % IZ)]
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 shelf life of Fulvestrant Mylan (see section 6.3). 
Ker je vpliv temperaturnih odklonov na kakovost zdravila kumulativen, se 28-dnevnega obdobja ne sme preseči v celotnem roku uporabnosti zdravila Fulvestrant Mylan (glejte poglavje 6.3).
A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4. 
Klinične študije medsebojnega delovanja z midazolamom (substrat CYP3A4) kažejo, da fulvestrant ne zavira CYP3A4.
When fulvestrant is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib. 
Če se fulvestrant daje v kombinaciji s palbociklibom, je pomembno, da preberete tudi Navodilo za uporabo za palbociklib.
Clinical studies in postmenopausal women with primary breast cancer have shown that fulvestrant significantly down-regulates ER protein in ER positive tumours compared with placebo. 
Klinične študije pri ženskah v pomenopavzi s primarnim rakom dojke so pokazale, da fulvestrant v primerjavi s placebom značilno bolj zmanjšuje količino proteina ER pri ERpozitivnih tumorjih.
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 jetrno okvaro (glejte poglavja 4.3, 4.4 in
Fulvestrant Mylan contains 10% w/v ethanol (alcohol) i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml wine per dose. 
Zdravilo Fulvestrant Mylan vsebuje 10 % m/v etanola (alkohola), to je do 1000 mg na odmerek, kar ustreza 20 ml piva oziroma 8 ml vina na odmerek.
A two-year oncogenicity study in rats (intramuscular administration of fulvestrant) 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. 
Dveletna študija onkogenosti pri podganah (intramuskularna aplikacija fulvestranta) je pokazala povečano pogostost pojavljanja benignih tumorjev granuloznih celic ovarija pri podganjih samicah pri visokih odmerkih 10 mg/podgano/15 dni in povečano pogostost pojavljanja tumorjev Leydigovih celic testisov pri samcih.
-AE subgroup (n=296) -AI subgroup (n=205)a CBRe 
Vse bolnice - podskupina AE (n = 296) - podskupina AI (n = 205)a CBRe
Fulvestrant Mylan 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3. 
Zdravilo Fulvestrant Mylan 500 mg (2 × 250 mg/5 ml raztopine za injiciranje) je treba dati z uporabo dveh napolnjenih injekcijskih brizg, glejte poglavje 3.
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). 
Farmakokinetika fulvestranta je bila vrednotena v klinični študiji z enkratnim odmerkom pri ženskah z blago do zmerno jetrno okvaro (A in B stopnjo po Child-Pughovi klasifikaciji).
Women of childbearing potential Patients of child-bearing potential should be advised to use effective contraception while on treatment. 
Ženske v rodni dobi Bolnice v rodni dobi naj med zdravljenjem uporabljajo ustrezno kontracepcijo.
What you need to know before you use Fulvestrant Mylan 
Kaj morate vedeti, preden boste uporabili zdravilo Fulvestrant Mylan
In patients administered fulvestrant, an increase in exposure of this magnitude is expected to be well tolerated. 
Pri bolnicah, ki so prejemale fulvestrant, je pričakovana dobra sposobnost prenašanja pri povečanju izpostavljenosti v tem obsegu.
Table 3 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints in the CONFIRM study 
Preglednica 3 Povzetek rezultatov glavnega opazovanega dogodka in ključnih sekundarnih opazovanih dogodkov študije CONFIRM
This medicine contains 500 mg benzyl alcohol in each 5 ml. 
To zdravilo vsebuje 500 mg benzilalkohola v 5 ml odmerku.
Caution should be taken if injecting Fulvestrant Mylan at the dorsogluteal site due to the proximity of the underlying sciatic nerve. 
V primeru injiciranja zdravila Fulvestrant Mylan v dorzoglutealni predel je potrebna previdnost zaradi bližine spodaj potekajočega ishiadičnega živca.
These studies compared the safety and efficacy of monthly administration of fulvestrant 250 mg versus the daily administration of 1 mg anastrozole (aromatase inhibitor). 
V študijah so primerjali varnost in učinkovitost uporabe fulvestranta 250 mg enkrat mesečno v primerjavi z enkrat dnevnim odmerkom, 1 mg anastrozola (zaviralec aromataze).
The pre-filled syringe presentation consists of: 
Pakiranje z napolnjeno injekcijsko brizgo vsebuje:
Fulvestrant Mylan should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area). 
Zdravilo Fulvestrant Mylan je treba dati v dveh zaporednih injekcijah po 5 ml; injicirati ju je treba počasi (1-2 min/injekcijo) intramuskularno, eno injekcijo v vsak glutealni predel.
A Phase 3, randomised, double-blind, double-dummy, multicentre study of fulvestrant 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. 
Izvedena je bila randomizirana, dvojno slepa, dvojno s placebom primerjana, multicentrična študija 3. faze, ki je primerjala fulvestrant 500 mg z 1 mg anastrozola, pri ženskah v pomenopavzi z ER-pozitivnim in/ali PgR-pozitivnim lokalno napredovalim ali metastatskim rakom dojke, ki predhodno niso bile zdravljene z nobenim hormonskim zdravljenjem.
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. 
Priporočeni odmerek je 500 mg fulvestranta (dve injekciji 250 mg/5 ml) enkrat na mesec z dodatnim 500-mg odmerkom, uporabljenim 2 tedna po začetnem odmerku.
This should be taken into consideration when prescribing fulvestrant to patients at risk. 
Pri predpisovanju fulvestranta bolnicam s tovrstnim tveganjem je to potrebno upoštevati.
- osteoporosis (loss of bone density) - alcoholism 
- osteoporoza (zmanjšanje mineralne gostote kosti); - alkoholizem.
c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased. 
c Nevtropenija vključuje naslednja PTs: nevtropenija, zmanjšano število nevtrofilcev.
Fulvestrant Mylan is not expected to affect your ability to drive or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Pri zdravilu Fulvestrant Mylan ni pričakovati vpliva na vašo sposobnost za vožnjo ali upravljanje s stroji.
• Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area). 
• Počasi (1-2 minuti/injekcijo) injicirajte intramuskularno v glutealni predel (polovico zadnjice).
NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Fulvestrant Mylan at the dorsogluteal injection site (see section 4.4). 
OPOMBA: Zaradi bližine spodaj potekajočega ishiadičnega živca je v primeru injiciranja zdravila Fulvestrant Mylan v dorzoglutealni predel potrebna previdnost (glejte poglavje 4.4).
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 shelf life of Fulvestrant Mylan. 
Ker je vpliv temperaturnih odklonov na kakovost zdravila kumulativen, se 28-dnevnega obdobja ne sme preseči v celotnem roku uporabnosti zdravila Fulvestrant Mylan.
• 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. 
• kot samostojno zdravljenje lokalno napredovalega ali metastatskega raka dojke s pozitivnimi estrogenskimi receptorji pri ženskah po menopavzi: - ki predhodno niso bile zdravljene z endokrinim zdravljenjem, ali - z recidivom bolezni med ali po adjuvantnem zdravljenju z antiestrogeni ali ob napredovanju bolezni med zdravljenjem z antiestrogeni.
Infections and infestations Very common Infectionsb Blood and lymphatic system disorders Very common Neutropeniac Leukopeniad Anaemiae Thrombocytopeniaf 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 
Infekcijske in parazitske bolezni zelo pogosti okužbeb Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenijac levkopenijad anemijae trombocitopenijaf 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 stomatitisg driska bruhanje Bolezni kože in podkožja zelo pogosti alopecija izpuščajh pogosti suha koža Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost
Name and address of the manufacturer(s) responsible for batch release 
Imena in naslovi izdelovalcev, odgovornih za sproščanje serij
• Expel excess gas from the syringe. 
• Iztisnite odvečni plin iz brizge.
- The other ingredients (excipients) are benzyl benzoate, benzyl alcohol, ethanol, anhydrous, castor oil, refined. 
- Druge sestavine zdravila (pomožne snovi) so benzilbenzoat, benzilalkohol, brezvodni etanol,
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. 
Opravljena je bila klinična študija 3. faze pri 736 ženskah v pomenopavzi z napredovalim rakom dojke, ki se jim je bolezen ponovila med ali po adjuvantnem endokrinološkem zdravljenju ali je napredovala po endokrinološkem zdravljenju napredovale bolezni.
When fulvestrant is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib. 
Če je fulvestrant uporabljen v kombinaciji s palbociklibom, glejte tudi Povzetek glavnih značilnosti za palbociklib.
All Patients -AE subgroup (n=423) -AI subgroup (n=313) a 
Vsi bolniki - podskupina AE (n = 423) - podskupina AI (n = 313)a OSb
e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased. 
e Anemija vključuje naslednje PTs: anemija, znižana vrednost hemoglobina, znižana vrednost hematokrita.
Breast-feeding must be discontinued during treatment with fulvestrant. 
Med zdravljenjem s fulvestrantom je potrebno opustiti dojenje.
Fulvestrant Mylan is used either: 
Zdravilo Fulvestrant Mylan je indicirano:
• Pull shield straight off needle to avoid damaging needle point. 
• Potegnite ščitnik naravnost z igle, da ne poškodujete konice igle.
Marketing Authorisation Holder MYLAN S.A.S. 
Imetnik dovoljenja za promet z zdravilom MYLAN S.A.S.
What Fulvestrant Mylan looks like and contents of the pack Fulvestrant Mylan 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. 
Izgled zdravila Fulvestrant Mylan in vsebina pakiranja Zdravilo Fulvestrant Mylan je bistra, brezbarvna do rumena, viskozna raztopina v napolnjeni injekcijski brizgi z zaporko, ki ščiti pred posegom; brizga vsebuje 5 ml raztopine za injiciranje.
Caution should be taken while administering fulvestrant at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and 4.8). 
Pri injiciranju fulvestranta v dorzoglutealni predel je potrebna previdnost zaradi bližine spodaj potekajočega ishiadičnega živca (glejte poglavji 4.2 in 4.8).
Table 1 Adverse Drug Reactions reported in patients treated with fulvestrant monotherapy 
Preglednica 1 Neželeni učinki zdravila, zabeleženi pri bolnicah, zdravljenih s samostojnim zdravljenjem s fulvestrantom
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). 
V kumulativnem naboru podatkov o samostojnim zdravljenju s fulvestrantom so bili najpogostejši neželeni učinki, o katerih so poročali, reakcije na mestu injiciranja, astenija, navzea in zvišanje jetrnih encimov (ALT, AST, ALP).
Neoadjuvant treatment for up to 16 weeks in breast cancer patients treated with either fulvestrant 500 mg or fulvestrant 250 mg did not result in clinically significant changes in endometrial thickness, indicating a lack of agonist effect. 
Do 16 tednov trajajoče neoadjuvantno zdravljenje s 500 mg ali z 250 mg fulvestranta pri bolnicah z rakom dojke ni klinično pomembno spremenilo debeline endometrija, kar kaže na odsotnost agonističnega učinka.
d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased. 
d Levkopenija vključuje naslednja PTs: levkopenija, zmanjšano število levkocitov.
Your doctor or nurse will give you Fulvestrant Mylan as a slow intramuscular injection, one into each of your buttocks. 
Zdravilo Fulvestrant Mylan vam bo dal zdravnik ali medicinska sestra z dvema počasnima injekcijama v mišico, po eno injekcijo v vsako stran zadnjice.
However, since asthenia has been reported very commonly with fulvestrant, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery. 
Poročali so, da je pojav astenije pri zdravljenju s fulvestrantom zelo pogost, zato morajo biti bolnice, pri katerih se ta neželeni učinek pojavi, previdne pri vožnji in upravljanju strojev.
Neoadjuvant treatment for up to 16 weeks in breast cancer patients with either fulvestrant 500 mg or fulvestrant 250 mg did not result in clinically significant changes in serum bone-turnover markers. 
Do 16 tednov trajajoče neoadjuvantno zdravljenje s 500 mg ali z 250 mg fulvestranta pri bolnicah z rakom dojke ni klinično pomembno spremenilo označevalcev kostne premene v serumu.
Benzyl benzoate Benzyl alcohol Ethanol, anhydrous Castor oil, refined 
benzilbenzoat benzilalkohol brezvodni etanol prečiščeno ricinusovo olje
Intramuscular use. 
za intramuskularno uporabo
Fulvestrant Mylan contains benzyl alcohol 
Zdravilo Fulvestrant Mylan vsebuje benzilalkohol.
Interference with estradiol antibody assays 
Vpliv na teste za določanje estradiola s protitelesi
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. 
Zaključeni sta bili dve klinični študiji 3. faze na skupno 851 ženskah v pomenopavzi z napredovalim rakom dojke, pri katerih se je bolezen ponovila med ali po adjuvantnem endokrinem zdravljenju ali pa je prišlo do poslabšanja bolezni po endokrinem zdravljenju napredovale bolezni.
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 250 mg fulvestranta v 5 ml raztopine.
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat Population) ─ FALCON Study 
Kaplan-Meierjev prikaz preživetja brez napredovanja bolezni (po oceni raziskovalca, populacija z-namenom-zdravljenja) ─ študija FALCON
United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 
United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.
Fulvestrant plus palbociclib (N=141) 
fulvestrant in palbociklib (N = 141)
How to use Fulvestrant Mylan 
Kako uporabljati zdravilo Fulvestrant Mylan
Comparison between groups (Fulvestrant 500 mg/ Fulvestrant 250 mg) Hazard ratio 
Primerjava med skupinami (fulvestrant 500 mg/fulvestrant 250 mg) razmerje ogroženosti
You must not breast-feed while on treatment with Fulvestrant Mylan. 
Med zdravljenjem z zdravilom Fulvestrant Mylan ne smete dojiti.
Comparison between groups (Fulvestrant 500 mg/Fulvestrant 250 mg) 
Primerjava med skupinami (fulvestrant 500 mg/fulvestrant 250 mg) absolutna razlika v %
OR 1.074 (0.716 - 1.614) p = 0.7290 
RO 1,074 (0,716 - 1,614) p = 0,7290
Castor oil, refined 
prečiščeno ricinusovo olje.
Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and pvalue 
Preživetje brez napredovanja bolezni Število dogodkov PFS (%) Razmerje ogroženosti za PFS (95 % IZ) in vrednost p
Two clear type 1 glass pre-filled syringes with polypropylene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Fulvestrant Mylan solution for injection. 
Dve napolnjeni injekcijski brizgi iz prozornega stekla tipa 1 s polipropilenskim potisnim batom z zaporko, ki ščiti pred posegom, od katerih vsaka vsebuje 5 ml Fulvestrant Mylan raztopine za injekcije.
• Check that the needle is locked to the Luer connector before moving out of the vertical plane. 
• Pred premikom iz navpične ravnine preverite, ali je igla pričvrščena na nastavku Luer.
Figure 2 Kaplan-Meier plot of progression-free survival (investigator assessment, intentto-treat population) - PALOMA3 study 
Kaplan-Meierjev prikaz preživetja brez napredovanja bolezni (po oceni raziskovalca, vključeni bolniki) - študija PALOMA3
No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min). 
Pri bolnicah z blago do zmerno ledvično okvaro (kreatininski očistek ≥ 30 ml/min) ni priporočil za prilagoditev odmerka.
Other medicines and Fulvestrant Mylan 
Shranjevanje zdravila Fulvestrant Mylan
What Fulvestrant Mylan contains - The active substance is fulvestrant. 
Kaj vsebuje zdravilo Fulvestrant Mylan - Zdravilna učinkovina je fulvestrant.
The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral. 
b Izraz reakcije na mestu injiciranja ne vključuje izrazov krvavitev na mestu injiciranja, hematom na mestu injiciranja, išias, nevralgija in periferna nevropatija.
A total of 335 patients in the fulvestrant plus palbociclib arm and 166 patients in the fulvestrant plus placebo arm completed the questionnaire at baseline and at least 1 post-baseline visit. 
Vprašalnik je ob izhodišču in vsaj 1 obisku po izhodišču izpolnilo skupno 335 bolnic iz skupine s fulvestrantom in palbociklibom ter 166 bolnic iz skupine s fulvestrantom in placebom.
e 
ali
For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 4). 
Zaradi praktičnosti pri uporabi je prirezani del igle na strani ročice (glejte sliko 4).
Fulvestrant solution for injection and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies. 
V študijah s ponavljajočimi odmerki so raztopino fulvestranta za injiciranje in druge oblike s fulvestrantom dobro prenašale vse živalske vrste.
4.4 Special warnings and precautions for use Fulvestrant should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2). 
Fulvestrant uporabljajte previdno pri bolnicah z blago do zmerno jetrno okvaro (glejte poglavja 4.2, 4.3 in 5.2).
Fulvestrant plus palbociclib (N=206) 
Nevisceralna bolezen fulvestrant in palbociklib (N = 206)
Blood and lymphatic system disorders 
Bolezni krvi in limfatičnega sistema pogosti zmanjšanje števila trombocitove
Fulvestrant plus placebo (N=105) 
fulvestrant in placebo (N = 105)
• 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 
• Zdravilo Fulvestrant Mylan se uporablja ali:samo, za zdravljenje žensk po menopavzi s posebno vrsto raka dojke (t.i. rakom dojke s pozitivnimi estrogenskimi receptorji), ki je lokalno napredoval ali se je razširil v druge dele telesa (je metastatski), ali
Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant 
Fulvestrant Mylan 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi fulvestrant
Mylan EPD d.o.o. 
Mylan Hrvatska d.o.o.
Fulvestrant 250 mg 
250 mg).
Fulvestrant plus placebo (N=69) 
fulvestrant in placebo (N = 69)
One clear type 1 glass pre-filled syringe with polypropylene plunger rod, fitted with a tamper-evident closure, containing 5 ml Fulvestrant Mylan solution for injection. 
Eno napolnjeno injekcijsko brizgo iz prozornega stekla tipa 1 s polipropilenskim potisnim batom z zaporko, ki ščiti pred posegom, vsebuje 5 ml Fulvestrant Mylan raztopine za injekcije.
Fulvestrant plus placebo (N=174) 
fulvestrant in placebo (N = 174)