natgillin/translations-raw huggingface dataset:
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.
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.
N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; DOR=duration of response
N = število bolnikov, IZ = interval zaupanja, NO = ni ocenljivo, OR = objektivni odziv, CBR = odziv klinične koristi, DOR = trajanje odziva
The steady-state trough concentrations of fulvestrant in children in this study were consistent with that in adults (see section 5.2).
Najnižje koncentracije fulvestranta v stanju dinamičnega ravnovesja pri otrocih v tej študiji so bile podobne koncentracijam pri odraslih (glejte poglavje 5.2).
*(31% maturity)-not final OS analysis **for patients with measurable disease
*(31-odstotna zrelost) - ni končna analiza celokupnega preživetja **Za bolnice z merljivo boleznijo DoR: trajanje odziva (Duration of response)
Studies using human liver preparations and recombinant human enzymes indicate that CYP3A4 is the only P450 isoenzyme involved in the oxidation of fulvestrant; however, non-P450 routes appear to be more predominant in vivo.
V študijah so z uporabo preparatov jeter človeka in rekombinantnih humanih encimov pokazali, da je CYP3A4 edini izoencim P-450, ki sodeluje pri oksidaciji fulvestranta, čeprav se zdi, da in vivo prevladujejo poti, ki ne vključujejo P-450.
Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Klinične študije medsebojnega delovanja z rifampicinom (induktor CYP3A4) in ketokonazolom (zaviralec CYP3A4) niso pokazale klinično pomembnih sprememb v očistku fulvestranta.
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.
V 2-tedenski študiji na zdravih prostovoljkah v pomenopavzi, ki so prejemale 20 µg etinilestradiola dnevno, so ugotovili, da je predhodno zdravljenje s fulvestrantom 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.
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.
Zdravilo vsebuje etanol (alkohol), to je do 1000 mg na odmerek, kar ustreza 20 ml piva oziroma 8 ml vina na odmerek.
Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Izpostavljenost temperaturam pod 2 °C zdravilu ne bo škodovala, pod pogojem, da ni shranjeno pri temperaturi pod −20 °C.
The primary efficacy endpoint of the study was investigator assessed progression-free survival (PFS) evaluated according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumours).
Primarni opazovani dogodek učinkovitosti v študiji je bilo preživetje brez napredovanja bolezni (progression-free survival - PFS) po oceni raziskovalca na podlagi meril RECIST 1.1 (Response Evaluation Criteria in Solid Tumours).
Fulvestrant Mylan contains 10% w/v ethanol (alcohol)
Zdravilo Fulvestrant Mylan vsebuje 10 % m/v etanola (alkohola).
Fulvestrant Mylan contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Zdravilo Fulvestrant Mylan vsebuje zdravilno učinkovino fulvestrant, ki spada v skupino zaviralcev estrogena.
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).
Dodatek palbocikliba fulvestrantu je povzročilo izboljšanje simptomov z značilnim podaljšanjem časa do poslabšanja simptomov bolečine v primerjavi s kombinacijo fulvestranta in placeba (mediano 8,0 mesecev v primerjavi z 2,8 meseca; HR 0,64 [95 % IZ: 0,49; 0,85], p < 0,001).
Local reactions, including myositis and granulomata at the injection site were attributed to the vehicle but the severity of myositis in rabbits increased with fulvestrant, compared to the saline control.
Lokalne reakcije na mestu injiciranja, vključno z miozitisom in granulomi, so pripisali vehiklu, vendar pa je resnost miozitisa pri kuncih večja pri fulvestrantu v primerjavi s kontrolno raztopino natrijevega klorida.
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).
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).
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.
Pred začetkom zdravljenja s kombinacijo fulvestranta 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.
Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Ker sta si fulvestrant in estradiol po strukturi podobna, lahko fulvestrant moti teste za določanje estradiola, ki temeljijo na uporabi protiteles, in lahko povzroči lažno zvišane rezultate koncentracije estradiola.
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