FrancophonIA/ELRC3.0 huggingface dataset:
English: Two syringes must be administered to receive the 500 mg recommended monthly dose.
Slovenian: Dve injekcijski brizgi morata biti injicirani za dosego priporočenega mesečnega odmerka 500 mg.
English: 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.
Slovenian: 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.
English: There are isolated reports of overdose with Faslodex in humans.
Slovenian: Obstajajo posamezni poročani primeri prevelikega odmerjanja zdravila Faslodex pri človeku.
English: • Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat
Slovenian: • alergijske (preobčutljivostne) reakcije, vključno z otekanjem obraza, ustnic, jezika in/ali žrela
English: Updated Analysis (23 October 2015 cut-off) Faslodex plus palbociclib (N=347)
Slovenian: Posodobljena analiza (datum zamejitve 23. oktober 2015) Zdravilo Faslodex in palbociklib (N = 347)
English: N=number of patients; CI=confidence interval; OR=objective response; CBR=clinical benefit response
Slovenian: N = število bolnikov, IZ = interval zaupanja, OR = objektivni odziv, CBR = odziv klinične koristi
English: Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone releasing hormone (LHRH) agonist.
Slovenian: Ženske, ki še niso dosegle menopavze, bodo zdravljene tudi z zdravilom, imenovanim agonist gonadoliberina (LHRH).
English: • Anaphylactic reactions
Slovenian: • anafilaktične reakcije
English: Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Slovenian: Klinične študije medsebojnega delovanja z rifampicinom (induktor CYP 3A4) in ketokonazolom (zaviralec CYP 3A4) niso pokazale klinično pomembnih sprememb v očistku fulvestranta.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Fifty-five percent (55.0%) of patients had visceral metastasis at baseline.
Slovenian: Petinpetdeset odstotkov (55 %) bolnic je imelo visceralne metastaze ob izhodišču.
English: 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.
Slovenian: Če bi lahko zanosili, morate uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Faslodex in še 2 leti po vašem zadnjem odmerku tega zdravila.
English: All patients had received prior systemic therapy and most patients in each treatment arm had received a previous chemotherapy regimen for their primary diagnosis.
Slovenian: Vse bolnice so predhodno prejemale sistemsko zdravljenje in večina bolnic v eni in drugi zdravljeni skupini je zaradi primarne diagnoze prejemala predhodno shemo kemoterapije.
English: 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.
Slovenian: 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.
English: Seventy seven percent (77%) of the study population had estrogen receptor positive breast cancer.
Slovenian: V skupini bolnic, ki so sodelovale v študiji, jih je sedeminsedemdeset odstotkov (77 %) imelo rak dojke s pozitivnimi
English: Clinical studies in postmenopausal women with primary breast cancer have shown that fulvestrant significantly downregulates ER protein in ER positive tumours compared with placebo.
Slovenian: 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.
English: There was an increased incidence of foetal variations in rabbits (backwards displacement of the pelvic girdle and 27 pre-sacral vertebrae).
Slovenian: Pri kuncih se je pojavila povečana pogostnost pojavljanja sprememb ploda (nazaj premaknjena medenični obroč in 27. presakralno vretence).
English: 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).
Slovenian: 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).
English: Although the data collected were limited, the steady-state trough concentrations of fulvestrant in children appear to be consistent with those in adults.
Slovenian: Čeprav so bili zbrani podatki omejeni, so bile najnižje koncentracije fulvestranta v stanju dinamičnega ravnovesja pri otrocih podobne koncentracijam pri odraslih.
English: In vitro data suggest that fulvestrant does not inhibit CYP450 isoenzymes.
Slovenian: In vitro podatki kažejo, da fulvestrant ne zavira CYP450 izoencimov.
English: • Lower back pain irradiating to leg on one side (sciatica)
Slovenian: • bolečina v križu, ki izžareva v nogo na eni strani (išias)
English: 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.
Slovenian: 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.
English: palbociclib+fulvestrant placebo+fulvestrant
Slovenian: palbociklib in fulvestrant placebo in fulvestrant
English: Benzyl alcohol Faslodex contains benzyl alcohol as an excipient which may cause allergic reactions.
Slovenian: Benzilalkohol Zdravilo Faslodex vsebuje pomožno snov benzilalkohol, ki lahko povzroči alergijske reakcije.
English: The safety and efficacy of Faslodex in children from birth to 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Faslodex pri otrocih od rojstva do18.
English: Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Slovenian: Zdravilo Faslodex vsebuje učinkovino fulvestrant, ki spada v skupino zaviralcev estrogena.
English: The steady-state trough concentrations of fulvestrant in children in this study were consistent with that in adults (see section 5.2).
Slovenian: Najnižje koncentracije fulvestranta, v stanju dinamičnega ravnovesja pri otrocih v tej študiji, so bile podobne koncentracijam pri odraslih (glejte poglavje 5.2).
English: Store and transport in a refrigerator (2C - 8C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 C - 8 C).
English: 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).
Slovenian: 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).
English: Faslodex should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Slovenian: Zdravilo Faslodex uporabljajte previdno pri bolnicah s hudo okvaro ledvic (kreatininski očistek manjši od 30 ml/min).
English: Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Slovenian: Neželeni učinki, navedeni spodaj, so našteti glede na pogostnost in organski sistem.
English: 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.
Slovenian: Zaradi intramuskularne poti uporabe zdravilo Faslodex uporabljajte previdno pri zdravljenju bolnic s hemoragično diatezo, trombocitopenijo ali bolnic, ki se zdravijo z antikoagulanti.
English: 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).
Slovenian: 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).
English: All Patients -AE subgroup (n=296) -AI subgroup (n=205) CBR
Slovenian: Vsi bolniki -AE podskupina (n = 296) -AI podskupina (n = 205) CBR
English: Table 2 reports the adverse reactions from PALOMA3.
Slovenian: Preglednica 2 prikazuje neželene učinke v študiji PALOMA3.
English: There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Slovenian: Ni podatkov o zdravilu pri bolnicah s hudo okvaro jeter (glejte poglavja 4.3, 4.4 in 5.2).
English: N=number of patients; CI=confidence interval; OR= objective response; TTR=time to first tumour response.
Slovenian: N = število bolnikov, IZ = interval zaupanja, OR = objektivni odziv, TTR = čas do prvega odziva tumorja (TTR - Time to first Tumor Response).
English: Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with Faslodex (see section 4.8).
Slovenian: 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).
English: 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
Slovenian: 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
English: Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Absolute difference in %
Slovenian: Primerjava med skupinami (Faslodex 500 mg/Faslodex 250 mg) absolutna razlika v %
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The paediatric patients were aged 1 to 8 years and received 4 mg/kg monthly intramuscular dose of fulvestrant.
Slovenian: Pediatrične bolnice so bile stare od 1 do 8 let in so mesečno prejemale fulvestrant v intramuskularnem odmerku 4 mg/kg.
English: 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).
Slovenian: 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).
English: 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
Slovenian: 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);
English: Median duration of exposure to palbociclib in the fulvestrant + palbociclib arm was 10.8 months.
Slovenian: V skupini, ki je prejemala fulvestrant in palbociklib, je mediano trajanje izpostavljenosti palbociklibu bilo 10,8 meseca.
English: This study compared the efficacy and safety of Faslodex 500 mg (n=362) with Faslodex 250 mg (n=374).
Slovenian: Ta študija je primerjala učinkovitost in varnost zdravila Faslodex 500 mg (n = 362) in zdravila Faslodex 250 mg (n = 374).
English: Time-to-Deterioration was pre-specified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores.
Slovenian: 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.
English: In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed.
Slovenian: Pri podganah so opazili reverzibilno zmanjšanje plodnosti samic in preživetje zarodka, distocijo in povečano pogostnost pojavljanja nenormalnosti ploda, vključno s tarzalnim upogibom.
English: 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.
Slovenian: Nobena bolnica ni poročala o učinkih, ki bi bili ≥ 3. stopnje po CTCAE, ali bi zahtevali zmanjšanje odmerka, prekinitev uporabe ali prenehanje zdravljenja.
English: A safety needle (BD SafetyGlide) for connection to the barrel is also provided.
Slovenian: Priložena je tudi varnostna igla (BD SafetyGlide) za povezavo z valjem.
English: The hazard ratio of Faslodex 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Slovenian: 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).
English: Store and transport in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Patients of childbearing potential should use effective contraception during treatment with Faslodex and for 2 years after the last dose.
Slovenian: Bolnice v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z zdravilom Faslodex in še 2 leti po zadnjem odmerku zdravila.
English: All other side effects:
Slovenian: Za vsako od obeh brizg:
English: 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).
Slovenian: 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.
English: 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.
Slovenian: 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.
English: How to use Faslodex
Slovenian: Kako uporabljati zdravilo Faslodex
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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
English: • Increase of bilirubin (bile pigment produced by the liver)
Slovenian: • zvišanje bilirubina (žolčnega barvila, ki nastaja v jetrih)
English: The pharmacokinetics of fulvestrant has been evaluated in a clinical study conducted in 30 girls with Progressive Precocious Puberty associated with McCune Albright Syndrome (see section 5.1).
Slovenian: Farmakokinetika fulvestranta je bila vrednotena v klinični študiji pri 30 deklicah s progresivno prezgodnjo puberteto, povezano z McCune-Albrightovim sindromom (glejte poglavje 5.1).
English: A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4.
Slovenian: Klinične študije medsebojnega delovanja z midazolamom (substrat CYP 3A4) kažejo, da fulvestrant ne zavira CYP 3A4.
English: The overall safety profile of fulvestrant when used in combination with palbociclib is based on data from 517 patients with HR-positive, HER2-negative advanced or metastatic breast cancer in the randomised PALOMA3 study (see section 5.1).
Slovenian: Celoten varnostni profil fulvestranta, uporabljenega v kombinaciji s palbociklibom, temelji na podatkih 517 bolnic s HER2-negativnim napredovalim ali metastatskim rakom dojke s pozitivnimi hormonskimi receptorji v randomizirani študiji PALOMA3 (glejte poglavje 5.1).
English: Table 6 Efficacy results in visceral and non-visceral disease from PALOMA3 study (intentto-treat population)
Slovenian: Rezultati učinkovitosti pri visceralni in nevisceralni bolezni v študiji PALOMA3 (vključeni bolniki)
English: 1 pre-filled syringe (5 ml) 1 safety needle
Slovenian: 1 napolnjena injekcijska brizga (5 ml) 1 varnostna igla
English: Anastrozole 1 mg (N=232)
Slovenian: anastrozol 1 mg (N = 232)
English: Efficacy results for the CONFIRM study are summarized in Table 3.
Slovenian: Rezultati študije CONFIRM so predstavljeni v preglednici 3.
English: Within each frequency grouping adverse reactions are reported in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Table 4 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints (Investigator Assessment, Intent-To-Treat Population) ─ FALCON study
Slovenian: Povzetek rezultatov o primarnem opazovanem dogodku učinkovitosti (PFS) in ključnih sekundarnih opazovanih dogodkih učinkovitosti (po oceni raziskovalca, vključeni bolniki) ─ študija FALCON
English: 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 4-year shelf life of Faslodex (see section 6.3).
Slovenian: Ker je vpliv temperaturnih odklonov na kakovost zdravila kumulativen, se 28-dnevnega obdobja ne sme preseči v celotnem 4-letnem roku uporabnosti zdravila Faslodex (glejte poglavje 6.3).
English: Combination therapy with palbociclib
Slovenian: Kombinirano zdravljenje s palbociklibom
English: For full instructions on the administration of Faslodex and the use of the safety needle see enclosed, Instructions for administration.
Slovenian: Za celotna navodila glede uporabe zdravila Faslodex in uporabe varnostne igle glejte priložena navodila za uporabo.
English: 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).
Slovenian: Farmakokinetika fulvestranta je bila vrednotena v klinični študiji z enkratnim odmerkom pri ženskah z blago do zmerno okvaro jeter (A in B stopnjo po Child - Pughovi klasifikaciji).
English: A two-year oncogenicity study in rats (intramuscular administration of Faslodex) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/rat/15 days and an increased incidence of testicular Leydig cell tumours in males.
Slovenian: Dveletna študija onkogenosti pri podganah (intramuskularna aplikacija zdravila Faslodex) 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.