natgillin/translations-raw huggingface dataset:
Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with fulvestrant (see section 4.8).
Tromboembolijski događaji često su primijećeni u žena s uznapredovalim rakom dojke i bili su zabilježeni u kliničkim ispitivanjima s fulvestrantom (vidjeti dio 4.8).
Fulvestrant has no or negligible influence on the ability to drive or use machines.
Fulvestrant ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Prior to the start of treatment with the combination of fulvestrant plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Prije početka liječenja kombinacijom lijeka fulvestrant i palbocikliba te tijekom njegova cjelokupnog trajanja žene u predmenopauzi/perimenopauzi treba liječiti agonistima LHRH-a u skladu s lokalnom kliničkom praksom.
This medicinal product contains ethanol (alcohol), i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml of wine per dose.
Ovaj lijek sadrži etanol (alkohol), tj. do 1000 mg po dozi, što odgovara 20 ml piva ili 8 ml vina po dozi.
The study included 423 patients whose disease had recurred or progressed during anti-estrogen therapy (AE subgroup) and 313 patients whose disease had recurred or progressed during aromatase inhibitor therapy (AI subgroup).
U ispitivanje su bile uključene 423 bolesnice u kojih se bolest ponovno pojavila ili je uznapredovala tijekom liječenja antiestrogenom (AE podskupina) i 313 bolesnica u kojih se bolest ponovno pojavila ili je uznapredovala tijekom liječenja inhibitorom aromataze (AI podskupina).
- osteoporosis (loss of bone density) - alcoholism
- ranije tegobe s krvnim ugrušcima - osteoporoza (gubitak gustoće kostiju) - alkoholizam
Fulvestrant solution for injection and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
Otopinu fulvestranta za injekcije i druge oblike fulvestranta dobro su podnosile životinjske vrste korištene u istraživanjima višekratnih doza.
* Includes side effects for which the exact role of Fulvestrant Mylan cannot be assessed due to the underlying disease.
* Uključuje nuspojave kod kojih se ne može procijeniti točna uloga lijeka Fulvestrant Mylan zbog postojeće bolesti.
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1253/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1253/001
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.
Zbog strukturne sličnosti fulvestranta i estradiola, fulvestrant može interferirati sa testovima za određivanje estradiola pomoću antitijela i može rezultirati lažno povećanim razinama estradiola.
However, as fulvestrant exposure may be increased, fulvestrant should be used with caution in these patients.
Međutim, budući da može biti povećana izloženost fulvestrantu, u tih bolesnica fulvestrant treba primjenjivati uz oprez.
Combined analysis of both studies showed that 83% of patients who received fulvestrant progressed, compared with 85% of patients who received anastrozole.
Kombinirana analiza obaju ispitivanja pokazala je da je bolest napredovala u 83% bolesnica koje su primale fulvestrant, u odnosu na 85% bolesnica koje su primale anastrozol.
It may harm them,
Fulvestrant je indiciran:
Your doctor or nurse will give you Fulvestrant Mylan as a slow intramuscular injection, one into each of your buttocks.
Vaš liječnik ili medicinska sestra dat će vam Fulvestrant Mylan sporom injekcijom u mišić, po jednu injekciju u svaki mišić stražnjice.
Fulvestrant Mylan has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
Fulvestrant Mylan je dostupan u 2 pakiranja: kutija koja sadrži 1 staklenu napunjenu štrcaljku ili kutija koja sadrži 2 staklene napunjene štrcaljke.
Excipients with known effect
Pomoćne tvari s poznatim učinkom:
In table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the fulvestrant 500 mg treatment group in pooled safety analyses of studies that compared fulvestrant 500 mg with fulvestrant 250 mg [CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006), and NEWEST (Study D6997C00003) studies], or from FALCON (Study D699BC00001) alone that compared fulvestrant 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented.
Kategorije učestalosti nuspojava navedenih u Tablici 1 izračunate su na temelju skupine koja je primala fulvestrant 500 mg u zbirnim analizama podataka o sigurnosti primjene iz ispitivanja u kojima se uspoređivao fulvestrant u dozi od 500 mg s fulvestrantom u dozi od 250 mg [CONFIRM (ispitivanje D6997C00002), FINDER 1 (ispitivanje D6997C00004), FINDER 2 (ispitivanje D6997C00006) i NEWEST (ispitivanje D6997C00003)] ili samo na temelju ispitivanja FALCON (ispitivanje D699BC00001), u kojem se uspoređivao fulvestrant u dozi od 500 mg s anastrozolom u dozi od 1 mg.
% of patients with OR absolute difference in %
% bolesnika s OR; apsolutna razlika u %
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).
Fulvestrant Mylan treba primijeniti kao dvije uzastopne injekcije od 5 ml, sporom intramuskularnom injekcijom (1 - 2 minute po injekciji), po jednu u svaki mišić stražnjice (područje gluteusa).
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).
U otvorenom ispitivanju faze 2 ispitivane su sigurnost primjene, djelotvornost i farmakokinetika fulvestranta u 30 djevojčica u dobi od 1 do 8 godina s progresivnim preuranjenim pubertetom povezanim s McCune Albrightovim sindromom (MAS).
Administration of fulvestrant 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).
Primjenom režima doziranja fulvestranta od 500 mg, razine izloženosti koje su u ili približne stanju dinamičke ravnoteže postižu se tijekom prvog mjeseca doziranja (srednje vrijednosti [CV]: AUC 475 [33,4 %] ng.dan/ml, Cmax 25,1 [35,3 %] ng/ml, Cmin odnosno 16,3 [25,9 %] ng/ml).
The terminal half-life (t1/2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
Terminalni poluvijek (t½) nakon intramuskularne primjene ovisi o brzini apsorpcije i procjenjuje se na oko 50 dana.
Temperature excursions outside 2°C - 8°C should be limited 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).
Treba ograničiti temperaturna odstupanja od raspona 2°C - 8°C, te se lijek ne smije čuvati na prosječnoj temperaturi ispod 25°C (ali iznad 2°C - 8°C) dulje od 28 dana.
The frequencies in Table 1 were based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Učestalost Tablici 1 temelji se na svim prijavljenim nuspojavama, bez obzira na to kako je ispitivač ocijenio povezanost s primjenom lijeka.
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.
Fulvestrant Mylan sadrži 10% m/V etanola (alkohol), tj. do 1000 mg po dozi što odgovara 20 ml piva ili 8 ml vina po dozi.
One dose contains 500 mg benzyl alcohol, and up to 1000 mg ethanol anhydrous.
Jedna doza sadrži 500 mg benzilnog alkohola i do 1000 mg bezvodnog etanola.
d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
d Pojam 'leukopenija' obuhvaća sljedeće preporučene pojmove: leukopeniju, snižen broj bijelih krvnih stanica.
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 0.8fold the expected human exposure levels in both males and females.
Razina bez učinka za ove nalaze bila je pri razinama sistemske izloženosti (AUC) koje su u ženki štakora bile približno 1,5 puta veće, a u mužjaka štakora 0,8 puta veće od očekivane razine izloženosti u ljudi, dok je ta vrijednost i u mužjaka i u ženki miševa bila približno 0,8 puta veća od očekivane razine izloženosti u ljudi.
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.
Međutim, budući da je uz primjenu fulvestranta vrlo često prijavljivana astenija, bolesnice koje dobiju tu nuspojavu moraju biti oprezne ako voze ili rade na stroju.
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.
Klinička ispitivanja kod žena u postmenopauzi s primarnim rakom dojke pokazala su da fulvestrant, u usporedbi s placebom, značajno smanjuje količinu proteina ER u ER pozitivnim tumorima.
ORR was assessed in patients who were evaluable for response at baseline (i.e. those with measurable disease at baseline: 240 patients in the fulvestrant 500 mg group and 261 patients in the fulvestrant 250 mg group).
d ORR je ocijenjena u bolesnica čiji se odgovor mogao procijeniti na početku ispitivanja (tj. onih s mjerljivom bolešću na početku ispitivanja: 240 bolesnica u skupini koja je primala fulvestrant 500 mg te 261 bolesnica u skupini koja je primala fulvestrant 250 mg).
Includes adverse drug reactions for which the exact contribution of fulvestrant cannot be assessed due to the underlying disease.
Uključujući nuspojave kod kojih se ne može procijeniti točan doprinos fulvestranta zbog osnovne bolesti.
With the other hand, take hold of the cap (A) and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist (see Figure 1).
Drugom rukom primite zatvarač (A) i pažljivo nakrenite naprijed i nazad dok se zatvarač ne odvoji i može se skinuti, ne zakrećite zatvarač (vidjeti Sliku 1).
Updated Analysis (23 October 2015 cut-off) Fulvestrant plus palbociclib (N=347)
Ažurirana analiza (Datum prestanka prikupljanja podataka: 23. listopada 2015.) Faslodex plus palbociklib (N=347)
Caution should be taken if injecting Fulvestrant Mylan at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
Potreban je oprez ako se Fulvestrant Mylan injicira u dorzoglutealno područje zbog blizine ishijadičnog živca.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
O tome treba voditi računa u trudnica ili dojilja, djece te visokorizičnih skupina ljudi, poput bolesnika s bolešću jetre ili epilepsijom.
-AE subgroup (n=423)
- AE podskupina (n=423)
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).
Temperaturna odstupanja imaju kumulativan učinak na kvalitetu lijeka pa se ne smije prekoračiti spomenuto razdoblje od 28 dana tijekom roka valjanosti lijeka Fulvestrant Mylan (vidjeti dio 6.3).
The hazard ratio of fulvestrant 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Omjer hazarda lijeka fulvestrant 250 mg u odnosu na anastrozol za vrijeme do smrti bio je 1,01 (95% CI 0,86 do 1,19).
What you need to know before you use Fulvestrant Mylan
Što morate znati prije nego počnete primjenjivati Fulvestrant Mylan
This study compared the efficacy and safety of fulvestrant 500 mg (n=362) with fulvestrant 250 mg (n=374).
U ovom se ispitivanju uspoređivala djelotvornost i sigurnost primjene fulvestranta u dozi od 500 mg (n=362) i fulvestranta u dozi od 250 mg (n=374).
Interference with estradiol antibody assays
Interferencija sa testovima za određivanje estradiola pomoću antitijela
g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration,
g Pojam 'stomatitis' obuhvaća sljedeće preporučene pojmove: aftozni stomatitis, heilitis, glositis, glosodiniju,
Addition of palbociclib to fulvestrant resulted in a symptom benefit by significantly delaying Time-to-Deterioration in pain symptom compared with fulvestrant plus placebo (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Dodavanje palbocikliba lijeku Faslodex ostvarilo je koristan učinak na taj simptom jer je značajno odgodilo vrijeme do pogoršanja boli u odnosu na Faslodex plus placebo (medijan: 8,0 mjeseci naspram 2,8 mjeseci; HR: 0,64 [95% CI: 0,49; 0,85]; p < 0,001).
Fulvestrant is indicated in patients whose disease had recurred or progressed on an anti-estrogen therapy.
a Fulvestrant je indiciran u bolesnica u kojih se bolest ponovno javila ili je uznapredovala tijekom liječenja antiestrogenom.
Due to the intramuscular route of administration, fulvestrant should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
S obzirom na intramuskularni put primjene, fulvestrant treba primjenjivati uz oprez u bolesnica s hemoragičnom dijatezom, trombocitopenijom ili onih koje uzimaju antikoagulacijsku terapiju.
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.
Temperaturna odstupanja imaju kumulativan učinak na kvalitetu lijeka pa se ne smije prekoračiti spomenuto razdoblje od 28 dana tijekom roka valjanosti lijeka Fulvestrant Mylan.
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).
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).
Fulvestrant Mylan 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Fulvestrant Mylan 500 mg (2 × 250 mg/5 ml otopine za injekciju) treba primijeniti pomoću dvije napunjene štrcaljke, vidjeti dio 3.
Marketing Authorisation Holder MYLAN S.A.S.
Nositelj odobrenja za stavljanje lijeka u promet MYLAN S.A.S.
These studies compared the safety and efficacy of monthly administration of fulvestrant 250 mg versus the daily administration of 1 mg anastrozole (aromatase inhibitor).
U tim su ispitivanjima uspoređene sigurnost primjene i djelotvornost mjesečne primjene fulvestranta u dozi od 250 mg s dnevnom primjenom 1 mg anastrozola (inhibitora aromataze).
This medicine contains 500 mg benzyl alcohol in each 5 ml.
Ovaj lijek sadrži 500 mg benzilnog alkohola u 5 ml otopine.
-AE subgroup (n=296) -AI subgroup (n=205)a CBRe
Svi bolesnici - AE podskupina (n=296) - AI podskupina (n=205)a CBRe
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
ALT=alanin aminotransferaza; AST=aspartat aminotransferaza; N/n=broj bolesnica a Preporučeni pojmovi navode se prema verziji 17.1 rječnika MedDRA.
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).
Studije na životinjama ukazuju da kod primjene visokih doza fulvestranta nisu opaženi drugi učinci osim onih izravno ili neizravno povezanih s antiestrogenim djelovanjem (vidjeti dio 5.3).
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.
Kako Fulvestrant Mylan izgleda i sadržaj pakiranja Fulvestrant Mylan je bistra, bezbojna do žuta, viskozna otopina u napunjenoj štrcaljki sa sigurnosnim zatvaračem, koja sadrži 5 ml otopine za injekciju.
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.
Broj bolesnica pod rizikom palbociklibom i 166 bolesnica iz skupine koja je primala Faslodex i placebo ispunilo upitnik na početku ispitivanja i još najmanje pri 1 posjetu nakon toga.
No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min).
Ne preporučuje se prilagodba doze za bolesnice s blagim do umjerenim oštećenjem bubrežne funkcije (klirens kreatinina ≥30 ml/min).
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
Poremećaji krvi i limfnog sustava Vrlo često neutropenijac leukopenijad anemijae trombocitopenijaf 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
Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Fulvestrant treba primjenjivati uz oprez u bolesnica s teškim oštećenjem bubrežne funkcije (klirens kreatinina manji od 30 ml/min).
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 vrijednost (standardna devijacija) najniže koncentracije lijeka u stanju dinamičke ravnoteže (Cmin,ss) iznosila je 4,2 (0,9) ng/ml, a AUC u stanju dinamičke ravnotežes bio je 3680 (1020) ng*hr/ml.
This should be taken into consideration when prescribing fulvestrant to patients at risk.
Ovo treba uzeti u obzir kada se fulvestrant propisuje bolesnicama s tom vrstom rizika.
N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; DOR=duration of response
N=broj bolesnica; CI=interval pouzdanosti; NP=ne može se procijeniti; OR=objektivni odgovor; CBR=stopa kliničke dobrobiti
• 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.
• kao monoterapija za liječenje lokalno uznapredovalog ili metastatskog raka dojke pozitivnog na estrogenske receptore u postmenopauzalnih žena: - koje prethodno nisu bile liječene endokrinom terapijom, ili - koje su doživjele relaps bolesti tijekom ili nakon adjuvantnog antiestrogenskog liječenja ili progresiju bolesti tijekom antiestrogenskog liječenja.
A 2-week study in healthy postmenopausal volunteers treated with 20 μg per day ethinylestradiol showed that pre-treatment with fulvestrant 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 fulvestrantom 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.
treatment comparison
Način primjene
-AI subgroup (n=313)a
- AI podskupina (n=313)a
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).
Potreban je oprez pri primjeni lijeka fulvestrant u dorzoglutealno mjesto injekcije zbog blizine ishijadičnog živca (vidjeti dijelove 4.2 i 4.8).
Benzyl benzoate Benzyl alcohol Ethanol, anhydrous Castor oil, refined
benzilbenzoat benzilni alkohol etanol, bezvodni ricinusovo ulje, rafinirano
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat Population) ─ FALCON Study
Slika 1 Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje) ─ ispitivanje FALCON
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).
Zbog blizine ishijadičnog živca, potreban je oprez ako se Fulvestrant Mylan primjenjuje na dorzoglutealnom mjestu injiciranja (vidjeti dio 4.4).
Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Izlaganje temperaturama ispod 2°C neće naškoditi lijeku, pod uvjetom da se ne čuva na temperaturi ispod −20°C.
Comparison between groups (Fulvestrant 500 mg/Fulvestrant 250 mg)
Usporedba između skupina (Fulvestrant 500 mg/ Fulvestrant 250 mg)
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.
Dvogodišnje istraživanje onkogenosti u štakora (uz intramuskularnu primjenu fulvestranta) 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.
c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
c Pojam 'neutropenija' obuhvaća sljedeće preporučene pojmove: neutropeniju, snižen broj neutrofila.
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.
Neoadjuvantno liječenje tijekom najdulje 16 tjedana u bolesnica s rakom dojke liječenih fulvestrantom u dozi od 500 mg ili u dozi od 250 mg nije dovelo do klinički značajnih promjena serumskih biljega koštane pregradnje.
When fulvestrant is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Kada se fulvestrant daje u kombinaciji s palbociklibom, važno je da također pročitate i uputu o lijeku za palbociklib.
Secondary end points* OR [% (95% CI)] OR (measurable disease) [% (95% CI)]
Sekundarne mjere ishoda* OR [% (95% CI)] OR (mjerljiva bolest) [% (95% CI)]
- The other ingredients (excipients) are benzyl benzoate, benzyl alcohol, ethanol, anhydrous, castor oil, refined.
- Drugi sastojci (pomoćne tvari) su benzilbenzoat, benzilni alkohol, bezvodni etanol i rafinirano ricinusovo ulje.
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva vrlo često osipe
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadržava 250 mg fulvestranta u 5 ml otopine.
Fertility The effects of fulvestrant on fertility in humans has not been studied.
Plodnost Nisu ispitivani učinci fulvestranta na plodnost ljudi.
Variable Type of estimate
Varijabla Vrsta procjene, usporedba liječenja