natgillin/translations-raw huggingface dataset:
If you are taking Fareston and other medicines that affect your heart there is an increased risk for altering your heartbeat.
Pri jemanju zdravila Fareston bodite pazljivi pri: v kolikor uživate zdravilo Fareston in druga zdravila z vplivom na srce, obstaja povečano tveganje za spremembe v srčnem utripu.
Therefore, do not take Fareston together with the following medicines:
Zato zdravila Fareston ne jemljite skupaj z naslednjimi zdravili:
- antiarrhythmics like quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide,
- antiaritmiki, kot so kinidin, hidrokinidin, disopiramid, amiodaron, sotalol, dofetilid, ibutilid,
- neuroleptics like phenothiazines, pimozide, sertindole, haloperidol, sultopride
- nevroleptiki, kot so fenotiazini, pimozid, sertindol, haloperidol, sultoprid,
- certain antimicrobials agents (moxifloxacin, erythromycin IV, pentamidine, antimalarials particularly
- določene antimikrobne snovi (moksifloksacin, intravenski eritromicin, pentamidin, antimalariki,
halofantrine),
predvsem halofantrin),
- certain antihistaminics (terfenadine, astemizole, mizolastine),
- določeni antihistaminiki (terfenadin, astemizol, mizolastin),
- others (cisapride, intravenous vincamine, bepridil, diphemanil.
- druga zdravila (cisaprid, intravenski vinkamin, bepridil, difemanil).
If you are admitted to the hospital or if you are prescribed a new medicine, please tell your doctor that you are taking Fareston.
Če ste sprejeti v bolnišnico ali če vam predpišejo novo zdravilo, povejte svojemu zdravniku, da jemljete zdravilo Fareston.
Pregnancy and breast-feeding Fareston is recommended for women who have had their menopause.
Nosečnost in dojenje Zdravilo Fareston priporočamo ženskam po menopavzi.
It should not be used during pregnancy or breast-feeding.
Ne smete ga uporabljati v času nosečnosti ali dojenja.
Driving and using machines Toremifene has no influence on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Toremifen nima vpliva na vožnjo ali upravljanje s stroji.
Important information about some of the ingredients of Fareston Fareston contains lactose (30 mg per tablet).
Pomembne informacije o nekaterih sestavinah zdravila Fareston Fareston vsebuje laktozo (30 mg na tableto).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, pokličite svojega zdravnika, preden začnete jemati to zdravilo.
HOW TO TAKE FARESTON
KAKO JEMATI ZDRAVILO FARESTON
Always take Fareston exactly as your doctor has told you.
Pri jemanju zdravila Fareston natančno upoštevajte zdravnikova navodila.
The usual dose is 60 mg tablet taken orally, once daily.
Priporočeni odmerek je ena 60 mg tableta, zaužita peroralno enkrat na dan.
If you take more Fareston than you should Contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Fareston, kot bi smeli Takoj obvestite svojega zdravnika.
Symptoms of overdose may be dizziness and headache.
Med simptomi prevelikega odmerjanja so lahko omotica in glavobol.
If you forget to take Fareston If you miss one dose take the next tablet as usual and continue treatment as recommended.
Če ste pozabili vzeti zdravilo Fareston Če pozabite en odmerek, vzemite naslednjo tableto kot običajno in nadaljujte z zdravljenjem v skladu z navodili.
If you have missed several doses, please inform your doctor and follow his instructions.
Če pozabite več odmerkov, obvestite svojega zdravnika in sledite njegovim navodilom.
If you stop taking Fareston The treatment with Fareston should only be stopped when advised by your doctor.
Zdravljenje z zdravilom Fareston smete prekiniti le po nasvetu zdravnika.
Like all medicines, Fareston can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Fareston neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Side effects may occur with certain frequencies, which are defined as follows:
21 Lahko se pojavijo neželeni učinki, ki so opredeljeni z naslednjimi stopnjami pogostnosti: – zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov, – pogosti: pojavijo se pri 1 do 10 bolnikih na 100 bolnikov, – občasni: pojavijo se pri 1 do 10 bolnikih na 1. 000 bolnikov, – redki: pojavijo se pri 1 do 10 bolnikih na 10. 000 bolnikov, – zelo redki: pojavijo se pri manj kot 1 bolniku na 10. 000 bolnikov, – neznana pogostnost: na podlagi razpoložljivih podatkov ni mogoče oceniti pogostnosti.
Very common side effects Hot flushes, sweating.
Zelo pogosti neželeni učinki Navali vročine, znojenje.
Common side effects Fatigue, oedema (swelling), nausea (feeling sick), vomiting, rash, itching, dizziness, depression, uterine bleeding, white discharge.
Pogosti neželeni učinki Utrujenost, edem (zatekanje) slabost (siljenje na bruhanje), bruhanje, izpuščaj, srbenje, omotica, depresija, krvavitve iz maternice, beli tok.
Uncommon side effects Headache, weight increase, sleep disorders, shortness of breath, constipation, loss of appetite, endometrial hypertrophy, thromboembolic events.
Občasni neželeni učinki Glavobol, povečanje telesne mase, motnje spanja, težko dihanje, zaprtje, izguba teka, endometrijska hipertrofija, tromboembolija.
Rare side effects Vertigo, endometrial polyps, increase of liver transaminases.
Redki neželeni učinki Vrtoglavica, polipi endometrija, zvišanje jetrnih transaminaz.
Very rare side effects Changes in the lining of the uterus (endometrium), endometrial cancer, alopecia, transient corneal opacity, jaundice.
Zelo redki neželeni učinki Spremembe maternične sluznice (endometrija), rak endometrija, alopecija, prehodna motnost roženice, zlatenica.
You should immediately contact your doctor if you notice any of the following symptoms: swelling or tenderness in your calf, unexplained shortness of breath or sudden chest pain, vaginal bleeding or changes in vaginal discharge.
Če opazite katerega od naslednjih simptomov, o tem nemudoma obvestite svojega zdravnika: otekanje meč ali občutljivost meč, nerazložljive težave z dihanjem ali nenadne bolečine v prsih, krvavitve iz vagine ali spremembe vaginalnega toka.
Fareston increases the QTc interval in a dose-related manner.
Zdravilo Fareston glede na odmerek podaljšuje interval QT.
Thus electrocardiogram changes (QTc interval prolongation, arrhythmias) are possible side effects.
Možni neželeni učinki so spremembe v elektrokardiogramu (podaljšanje intervala QTc, aritmije).
HOW TO STORE FARESTON
SHRANJEVANJE ZDRAVILA FARESTON
Do not use Fareston after the expiry date which is stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
The expiry date refers to the last day of that month. Fareston does not require any special storage conditions.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Medicines should not be disposed of via wastewater or household waste.
Za shranjevanje ni posebnih navodil.
Ask your pharmacist how to dispose of medicines no longer required.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
These measures will help to protect the environment.
O načinu shranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
What Fareston contains
Kaj vsebuje zdravilo Fareston
- The active substance is toremifene; each tablet contains 60 mg (as citrate).
- Zdravilna učinkovina je toremifen; ena tableta vsebuje 60 mg (v obliki citrata).
- The other ingredients are maize starch, lactose, povidone, sodium starch glycolate, microcrystalline
- Pomožne snovi so: koruzni škrob, laktoza, povidon, natrijev karboksimetilškrob, mikrokristalna
cellulose, colloidal anhydrous silica and magnesium stearate.
celuloza, brezvoden koloidni silicijev dioksid in magnezijev stearat.
What Fareston looks like and contents of the pack White, round, flat, bevelled edge tablet with TO 60 on one side.
22 Izgled zdravila in vsebina pakiranja Bele, okrogle, ravne tablete z zaobljenim robom in napisom TO 60 na eni strani.
21 Orionintie 1 FIN-02200 Espoo Finland
Imeznik dovoljenja za promet z zdravilom Orion Corporation Orionintie 1 FIN- 02200 Espoo Finska
Manufacturer Orion Corporation, Orion Pharma Tengströminkatu 8 FIN-20360 Turku Finland
Izdelovalec Orion Corporation, Orion Pharma Tengströminkatu 8 FIN- 20360 Tuku Finska
22 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
23 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
It is available in prefilled syringes (250 mg).
Na voljo je v napolnjenih brizgah (250 mg).
Faslodex is used for the treatment of locally advanced or metastatic breast cancer in postmenopausal women (women who have been through the menopause).
Zdravilo Faslodex se uporablja za zdravljenje lokalno napredovalega ali metastatskega raka dojke pri ženskah po menopavzi.
It is used when the cancer is ‘ oestrogen receptor positive ’ (where the cancer cells have receptors for the hormone oestrogen on their surface). ‘ Metastatic’ means that the cancer has spread to other parts of the body.
„ Metastatski “ pomeni, da se je rak razširil na druge dele telesa.
Faslodex is used when the disease has returned during or after treatment with an ‘ anti-oestrogen’ (a type of medicine used to treat breast cancer), or when the disease has got worse during treatment with an anti-oestrogen.
Zdravilo Faslodex se uporablja, kadar se je bolezen ponovila med zdravljenjem z antiestrogeni (vrsto zdravila, ki se uporablja pri zdravljenju raka dojke) ali po njem, oz. kadar se je bolezen med zdravljenjem z antiestrogeni poslabšala.
The recommended dose of Faslodex is 250 mg once a month, given by slow injection into the buttock muscle.
Priporočeni odmerek zdravila Faslodex je 250 mg enkrat mesečno, ki se daje s počasno injekcijo v mišico zadnjice.
Faslodex should be used with caution in patients who have problems with their liver or severe problems with their kidneys.
Zdravilo Faslodex je treba pri bolnicah, ki imajo težave z jetri ali hude težave z ledvicami, uporabljati previdno.
It should not be used in patients who have severe liver problems.
Pri bolnicah s hudimi težavami z jetri se zdravila Faslodex ne sme uporabljati.
Most types of breast cancer grow in response to the hormone oestrogen.
Večina vrst raka dojke se razvije kot odziv na hormon estrogen.
The active substance in Faslodex, fulvestrant, is an anti-oestrogen.
Zdravilna učinkovina zdravila Faslodex, fulvestrant, je antiestrogen.
It attaches to the receptors for oestrogen on the surface of cells, where it blocks the effects of the hormone and causes the number of oestrogen receptors to fall.
Ta se veže na estrogenske receptorje na površini celic, kjer blokira učinke hormona in povzroča zmanjšanje števila estrogenskih receptorjev.
Faslodex is absorbed slowly into the body, with the effects of each injection lasting over a month.
Zdravilo Faslodex telo absorbira počasi, učinki posamezne injekcije pa trajajo več kot en mesec.
The levels of the medicine in the body increase with subsequent injections, reaching a steady level after around six injections.
Koncentracija zdravila v telesu se povečuje z nadaljnjimi injekcijami, stanje dinamičnega ravnovesja pa je doseženo po približno šestih injekcijah.
The effects of Faslodex were first tested in experimental models before being studied in humans.
Učinki zdravila Faslodex so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Reproduction is authorised provided the source is acknowledged. studies compared the effects of two doses of Faslodex (either 125 mg or 250 mg every month) with those of anastrozole (another anticancer medicine) taken at a dose of 1 mg every day.
V obeh študijah so primerjali učinke dveh odmerkov zdravila Faslodex (125 mg ali 250 mg vsak mesec) z učinki anastrozola (drugega zdravila proti raku), dajanega v odmerku 1 mg vsak dan.
In the first study, the patients knew which medicine they were taking, but not in the second study.
V prvi študiji so bolnice vedele, katero zdravilo prejemajo, v drugi študiji pa ne.
In both studies, the main measure of effectiveness was the time until the disease got worse.
V obeh študijah je bilo glavno merilo učinkovitosti čas do poslabšanja bolezni.
Faslodex was at least as effective as anastrozole.
Zdravilo Faslodex je bilo vsaj tako učinkovito kot anastrozol.
Looking at the results of the two studies taken together, it took an average of 166 days for the disease to get worse in the patients receiving 250 mg Faslodex once a month, compared with 126 days in those taking anastrozole.
Če pogledamo rezultate obeh študij skupaj, ugotovimo, da se je pri bolnicah, ki so prejemale zdravilo Faslodex 250 mg enkrat mesečno, bolezen poslabšala po 166 dneh, v primerjavi s 126 dnevi pri bolnicah, ki so jemale anastrozol.
The 250-mg dose of Faslodex was more effective than the 125-mg dose.
Odmerek 250 mg zdravila Faslodex se je izkazal za učinkovitejšega od odmerka 125 mg.
The most common side effect with Faslodex (seen in more than 1 patient in 10) is hot flushes.
Najpogostejši neželeni učinek pri jemanju zdravila Faslodex (opažen pri več kot 1 bolnici izmed 10) so navali vročine.
Faslodex should not be used in people who may be hypersensitive (allergic) to fulvestrant or any of the other ingredients.
Zdravila Faslodex ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) fulvestrant ali katerokoli drugo sestavino zdravila.
Faslodex must not be used in patients who are pregnant or breast-feeding, or in patients who have severe liver disease.
Zdravila Faslodex ne smejo uporabljati bolnice, ki so noseče ali dojijo, ali bolnice s hudo boleznijo jeter.
The Committee for Medicinal products for Human Use (CHMP) decided that Faslodex’ s benefits are greater than its risks for the treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Faslodex pri zdravljenju žensk po menopavzi s pozitivnimi estrogenskimi receptorji pri lokalno napredovalem ali metastatskem raku dojke v primeru ponovitve bolezni med ali po adjuvantnem zdravljenju z antiestrogeni ali v primeru napredovanja bolezni med zdravljenjem z antiestrogeni večje od z njim povezanih tveganj.
The Committee recommended that Faslodex be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Faslodex odobri dovoljenje za promet.
The marketing authorisation was renewed on 10 March 2009.
Dovoljenje za promet je bilo obnovljeno dne 10. marca 2009.
EU number
vsebina Izmišljeno ime Številka EU
Packaging
(koncentracija)
250 mg/ 5 ml
250 mg /
Solution for injection
Raztopina za Intramuskularna
Intramuscular use
1 napolnjena
Pre-filled syringe (glass)
injekcijska brizga (steklo)
1 pre-filled syringe + 1 safety needle
injekcijska brizga + 1 varnostna igla
Faslodex 250 mg solution for injection
Faslodex 250 mg raztopina za injiciranje
Faslodex is indicated for the treatment of postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-estrogen therapy or disease progression on therapy with an anti-estrogen.
Zdravilo Faslodex je indicirano za zdravljenje žensk po menopavzi s pozitivnimi estrogenskimi receptorji pri lokalno napredovalem ali metastatskem raku dojke ob ponovitvi bolezni med ali po adjuvantnem zdravljenju z antiestrogeni ali ob napredovanju bolezni med zdravljenjem z antiestrogeni.
Posology Adult females (including the elderly) The recommended dose is 250 mg at intervals of 1 month.
Odmerjanje Odrasle ženske (vključno s starejšimi):
Paediatric patients Faslodex is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group.
Zdravila Faslodex ni priporočljivo uporabljati pri otrocih ali mladostnikih, ker pri tej starostni skupini varnost in učinkovitost zdravila nista dokazani.
Renal impairment 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) niso priporočljive prilagoditve odmerka.
Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/ min), and, therefore, caution is recommended in these patients (see section 4.4).
Varnost in učinkovitost zdravila pri bolnicah s hudo ledvično okvaro (kreatininski očistek ≤ 30 ml/ min) nista bili ugotovljeni in zato je pri teh bolnicah potrebna previdnost (glejte poglavje 4. 4).
Hepatic impairment No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
Pri bolnicah z blago do zmerno jetrno okvaro niso priporočljive prilagoditve odmerka.
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 5. 2).
Method of administration Faslodex should be administered by slow intramuscular injection into the buttock.
Zdravilo Faslodex aplicirajte s počasno intramuskularno injekcijo v zadnjico.
For detailed instructions for administration, see section 6.6.
Za natančna navodila za uporabo glejte poglavje 6. 6.
4.3 Contraindications
2
Hypersensitivity to the active substance, or to any of the other excipients.
- Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov;
Pregnancy and lactation (see section 4.6) Severe hepatic impairment (see sections 4.4 and 5.2).
Nosečnost in dojenje (glejte poglavje 4. 6); Huda jetrna okvara (glejte poglavji 4. 4 in 5. 2).
2 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Zdravilo Faslodex uporabljajte previdno pri bolnicah z blago do zmerno jetrno okvaro (glejte poglavja 4. 2, 4. 3 in 5. 2).
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 ledvično okvaro (kreatininski očistek manjši od 30 ml/ min)
Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical trials with Faslodex (see section 4.8).
Tromboembolične dogodke so pogosto opažali pri ženskah z napredovalim rakom dojke, opazili pa so jih tudi v kliničnih preskušanjih z zdravilom Faslodex (glejte poglavje 4. 8).
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 CYP 3A4.
Faslodex is contraindicated in pregnancy (see section 4.3).
Zdravilo Faslodex je kontraindicirano v nosečnosti (glejte poglavje 4. 3).
Studies in animals have shown reproductive toxicity including an increased incidence of foetal abnormalities and deaths (see section 5.3).
Študije na živalih so pokazale toksične vplive na sposobnost razmnoževanja, vključno s povečano pogostnostjo pojavljanja abnormalnosti in smrti ploda (glejte poglavje 5. 3).
Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, lactation is contraindicated (see section 4.3).
Ob upoštevanju možnosti pojava resnih neželenih učinkov zaradi fulvestranta pri dojenčkih, ki so dojeni, je dojenje kontraindicirano (glejte poglavje 4. 3).
Faslodex has no or negligible influence on the ability to drive or use machines.
Faslodex nima ali ima zanemarljiv vpliv na sposobnost vožnje ali upravljanja s stroji.
However, since asthenia has been reported commonly with Faslodex, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Pri vožnji in upravljanju s stroji morajo biti zato bolnice, pri katerih se ta neželeni učinek pojavi, previdne.
This section provides information based on all adverse reactions from clinical trials, post-marketing studies or spontaneous reports.
To poglavje navaja informacije, ki temeljijo na vseh neželenih učinkih iz kliničnih preskušanj, postmarekinških študij in spontanih poročil. V programu kliničnih preskušanj so se pri približno
Approximately 47% of patients experienced adverse reactions in the clinical trial programme.
3 47% bolnic pojavili neželeni učinki.
However, only 0.9% of patients stopped therapy because of an adverse reaction.
Vendar je zaradi neželenih učinkov prekinilo zdravljenje le 0, 9% bolnic.
Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Najpogostejši neželeni učinki, o katerih so poročali, so navali vročine, navzea in reakcije na mestu injiciranja.
Frequency groupings are defined according to the following convention:
Neželeni učinki, navedeni spodaj, so našteti glede na pogostnost in organski sistem.
Within each frequency grouping adverse reactions are reported in order of decreasing seriousness.
Pogostnosti so opredeljene glede na sledeči dogovor: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1000, < 1/ 100). V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
3 Table 1 Adverse Drug Reactions
Preglednica 1 Neželeni učinki
SOC
Organski sistem
Headache Vomiting, nausea and diarrhoea
glavobol bruhanje, navzea in driska
Renal and urinary disorders
Bolezni sečil Bolezni kože in podkožja
Urinary tract infections
okužbe sečil izpuščaj
Back pain
bolečine v križu
Hot flushes
navali vročine
General disorders and administration site conditions
venska trombembolija astenija reakcije na mestu injiciranja, vključno z bolečino in vnetjem1
Hypersensitivity reactions, including angioedema and urticaria
preobčutljivostne reakcije, vključno z angioedemom in urtikarijo
Increased Hepatic Enzymes2
zvišanje jetrnih encimov2
Reproductive system and breast disorders 1
1
Vaginal moniliasis Leukorrhea Vaginal haemorrhage
nožnična kandidiaza levkoreja krvavitev iz nožnice
2 the vast majority < 2xULN
reakcije na mestu injiciranja, vključno s prehodno bolečino pri 7% bolnic (1% injiciranj), ki so prejele posamezno 5 ml injekcijo 2 večini primerov < 2- kratne ULN
Animal studies suggest that no effects other than those related directly or indirectly to anti-estrogenic activity were evident with higher doses of fulvestrant (see section 5.3).
Študije na živalih kažejo, da drugih učinkov kot tistih, ki so neposredno ali posredno povezani z antiestrogenim delovanjem, pri višjih odmerkih fulvestranta niso opazili (glejte poglavje 5. 3).
Anti-estrogens, ATC code:
Antiestrogeni, oznaka ATC:
Mechanism of action Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.
Mehanizem delovanja Fulvestrant je kompetitivni antagonist estrogenskih receptorjev z afiniteto, primerljivo z afiniteto estradiola.
4 Clinical trials in postmenopausal women with primary breast cancer have shown that fulvestrant significantly down-regulates ER protein in ER positive tumours compared with placebo.
Klinična preskušanja pri ženskah po menopavzi s primarnim rakom dojke so pokazala, da fulvestrant v primerjavi s placebom značilno bolj zmanjšuje količino proteina ER pri ER pozitivnih tumorjih.