natgillin/translations-raw huggingface dataset:
There was also a significant decrease in progesterone receptor expression consistent with a lack of intrinsic estrogen agonist effects.
Prišlo je tudi do pomembnega zmanjšanja izraženosti progesteronskih receptorjev, kar je v skladu s pomanjkanjem intrinzičnih učinkov agonistov estrogena.
The terminal half-life (t1/2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
Končen razpolovni čas (t1/2) po intramuskularnem odmerku določa hitrost absorpcije, in je bil ocenjen na 50 dni.
In toxicity studies with multiple intramuscular doses of fulvestrant in rats and dogs, the antiestrogenic activity of fulvestrant was responsible for most of the effects seen, particularly in the female reproductive system, but also in other organs sensitive to hormones in both sexes.
V študijah toksičnosti na podganah in psih s ponavljajočimi intramuskularnimi odmerki fulvestranta je bilo njegovo antiestrogeno delovanje odgovorno za večino opaženih učinkov, posebej na reprodukcijskem sistemu samic, pa tudi na drugih organih, občutljivih na hormone pri obeh spolih.
All Grades n (%)
Vse stopnje n (%)
Pharmacotherapeutic group: Endocrine therapy, Antiestrogens, ATC code: L02BA03
Farmakoterapevtska skupina: Endokrino zdravljenje, antiestrogeni, oznaka ATC: LO2BA03
The median age of patients enrolled in this study was 57 years (range 29, 88).
Mediana starost bolnic, vključenih v to študijo, je bila 57 let (razpon: od 29 do 88).
It is not known whether fulvestrant is excreted in human milk.
Ni znano, ali se fulvestrant izloča v mleko pri človeku.
Faslodex is not indicated for use in children.
Zdravilo Faslodex ni indicirano za uporabo pri otrocih.
For detailed instructions for administration, see section 6.6.
Za natančna navodila za uporabo glejte poglavje 6.6.
Grade ≥ 3 n (%)
≥ 3. stopnje n (%)
At steady state, fulvestrant plasma concentrations are maintained within a relatively narrow range with up to an approximately 3-fold difference between maximum and trough concentrations.
V stanju dinamičnega ravnovesja se plazemske koncentracije fulvestranta ohranjajo v relativno ozkem območju z do približno 3-kratno razliko med najvišjimi in najnižjimi koncentracijami.
Clear, colourless to yellow, viscous solution.
Bistra, brezbarvna do rumena, viskozna raztopina.
Women with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Ženske s hudo okvaro jeter (stopnjo C po Child - Pughovi klasifikaciji) niso bile ovrednotene.
*Response endpoints based on confirmed and unconfirmed responses.
*Cilji študije na podlagi potrjenih in nepotrjenih odzivov.
• Remove glass syringe barrel from tray and check that it is not damaged.
• Vzemite stekleni valj brizge iz ležišča in preverite, da ni poškodovan.
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Crossover between treatment arms was not allowed.
Prehajanje med zdravljenjema skupinama ni bilo dovoljeno.
The majority of patients (87.0%) had metastatic disease at baseline.
Večina bolnic (87,0 %) je imela metastatsko bolezen ob izhodišču.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 5.3).
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi (glejte poglavje 5.3).
Includes: arthralgia, and less frequently musculoskeletal pain, myalgia and pain in extremity.
Vključuje: artralgijo in, manj pogosto, mišično-skeletne bolečine, mialgijo in bolečine v okončini.
• After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
• Takoj po injiciranju z enim prstom sprožite aktivacijsko asistirano ročico, da boste aktivirali mehanizem za zaščito (glejte sliko 5).
The mechanism of action is associated with downregulation of estrogen receptor protein levels.
Mehanizem delovanja je povezan z zmanjšanjem ravni estrogenskega receptorskega (ER) proteina.
Overall, Faslodex at the 250 mg monthly dose was at least as effective as anastrozole in terms of progression-free survival, objective response, and time to death.
V celoti je bilo zdravilo Faslodex v mesečnem odmerku 250 mg vsaj tako učinkovito kot anastrozol v smislu preživetja brez napredovanja bolezni, objektivnega odgovora in časa do nastopa smrti.
Patient-reported symptoms were assessed using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and its Breast Cancer Module (EORTC QLQ-BR23).
Simptome po navedbi bolnic so ocenjevali z vprašalnikom o kakovosti življenja EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer) in njegovim modulom za raka dojke (EORTC QLQ-BR23).
Therefore these findings are not considered to be relevant to the use of fulvestrant in postmenopausal women with advanced breast cancer.
Zato se ta odkritja ne smatrajo kot klinično pomembna pri uporabi fulvestranta pri ženskah po menopavzi z napredovalim rakom dojke.
There are no long-term data on the effect of fulvestrant on bone.
Ni dolgoročnih podatkov o učinku fulvestranta na kosti.
Faslodex is contraindicated in pregnancy (see section 4.3).
Zdravilo Faslodex je kontraindicirano v nosečnosti (glejte poglavje 4.3).
K-M median in months; hazard ratio
K-M mediana v mesecih; razmerje ogroženosti
PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Antiestrogen.
PFS: preživetje brez napredovanja bolezni; ORR: objektivni delež odziva; OR: objektivni odziv (OR - Objective Response); CBR: delež klinične koristi; CB: klinična korist; OS: celotno preživetje; K-M:Kaplan-Meier; IZ: interval zaupanja; AI: zaviralec aromataze; AE: antiestrogen.
To maintain sterility do not touch the syringe tip (B) (see Figure 2).
Za ohranitev sterilnosti se ne dotikajte konice brizge (B) (glejte sliko 2).
More than half (62%) had an ECOG PS of 0, 60% had visceral metastases, and 60% had received more than 1 prior hormonal regimen for their primary diagnosis.
Več kot polovica bolnic (62 %) je imela stanje zmogljivosti po ECOG 0, 60 % bolnic je imelo visceralne metastaze in 60 % bolnic je zaradi primarne diagnoze prejemalo več kot 1 predhodno hormonsko shemo.
Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Bolnice so dodeljeno zdravljenje prejemale do objektivnega napredovanja bolezni, simptomatskega poslabšanja, nesprejemljivih toksičnih učinkov, smrti ali umika privolitve za sodelovanje, kar od tega se je zgodilo prej.
• Hold the syringe upright on the ribbed part (C).
• Brizgo držite pokonci na rebrastem delu (C).
The efficacy and safety of Faslodex (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
Učinkovitost in varnost zdravila Faslodex (kot samostojno zdravljenje ali v kombinaciji s palbociklibom) nista raziskani pri bolnicah s kritično visceralno boleznijo.
Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, use during lactation is contraindicated (see section 4.3).
Ob upoštevanju možnosti pojava resnih neželenih učinkov zaradi fulvestranta pri dojenčkih, ki so dojeni, je uporaba med obdobjem dojenja kontraindicirana (glejte poglavje 4.3).
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 okvaro ledvic (kreatininski očistek ≤ 30 ml/min) nista bili ugotovljeni in zato je pri teh bolnicah potrebna previdnost (glejte poglavje 4.4).
Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in antiestrogen models.
Znani presnovki (vključno s 17-ketoni, sulfoni, 3-sulfati, 3- in 17-glukuronidnimi presnovki) so lahko manj aktivni ali pa v modelih z antiestrogeni izkazujejo podobno aktivnost kot fulvestrant.
Fulvestrant blocks the trophic actions of estrogens without any partial agonist (estrogen-like) activity.
Zavira trofično delovanje estrogenov brez kakršnekoli delno agonistične (estrogenu podobne) aktivnosti.
ORR was assessed in patients who were evaluable for response at baseline (i.e. those with measurable disease at baseline: 240 patients in the Faslodex 500 mg group and 261 patients in the Faslodex 250 mg group).
ORR je bila ocenjena pri bolnikih, katerih odgovor je bil ovrednoten na izhodišču (tj. tisti z merljivo boleznijo na začetku raziskave: 240 bolnikov v skupini Faslodex 500 mg in 261 bolnikov v skupini Faslodex 250 mg).
The European Medicines Agency has waived the obligation to submit the results of studies with Faslodex in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Faslodex za vse skupine pediatrične populacije pri raku dojke (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Fertility The effects of Faslodex on fertility in humans has not been studied.
Plodnost Vpliv zdravila Faslodex na plodnost pri človeku ni raziskan.
Combined analysis of both studies showed that 83% of patients who received Faslodex progressed, compared with 85% of patients who received anastrozole.
Kombinirane analize obeh študij so pokazale, da je do napredovanja bolezni prišlo pri 83 % bolnic, ki so prejemale fulvestrant, v primerjavi s 85 % bolnic, ki so prejemale anastrozol.
Excipients with known effect (per 5 ml) Ethanol (96%, 500 mg) Benzyl alcohol (500 mg) Benzyl benzoate (750 mg)
Pomožne snovi z znanim učinkom (na 5 ml): etanol (96 %, 500 mg) benzilalkohol (500 mg) benzilbenzoat (750 mg)
Key secondary efficacy endpoints included overall survival (OS) and objective response rate (ORR).
Sekundarni opazovani dogodki učinkovitosti so vključevali celokupno preživetje (OS) in objektivni delež odziva (ORR).
Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations in gonadotropin levels caused by antiestrogens in cycling animals.
Indukcija tovrstnih tumorjev je v skladu s farmakološko povezanimi spremembami endokrine povratne zanke pri ravneh gonadotropina, ki jih povzročajo anti-estrogeni pri živalih, ki imajo cikluse.
After administration of Faslodex long-acting intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (Cmax) are reached after about 5 days.
Po aplikaciji dolgodelujoče intramuskularne injekcije zdravila Faslodex se fulvestrant počasi absorbira in doseže največje plazemske koncentracije (Cmax) po okoli 5 dneh.
However, as fulvestrant exposure may be increased, Faslodex should be used with caution in these patients.
Vendar se izpostavljenost fulvestrantu lahko poveča, zato je zdravilo Faslodex pri teh bolnicah potrebno uporabljati s previdnostjo.
Frequency category differs between pooled safety dataset and FALCON.
Kategorija pogostnosti se razlikuje med naborom podatkov za kumulativno analizo varnosti in študijo FALCON.
• Bruising and bleeding at the site of injection
• modrice in krvavenje na mestu injiciranja
In a population pharmacokinetic analysis of data from Phase 3 studies, no difference in fulvestrant's pharmacokinetic profile was detected with regard to age (range 33 to 89 years), weight (40-127 kg) or race.
V populacijskih farmakokinetičnih analizah podatkov iz študij 3. faze niso ugotovili nobenih razlik v farmakokinetičnih profilih fulvestranta glede na starost (območje od 33 do 89 let), maso (40-127 kg) ali raso.
Fulvestrant is excreted in milk in lactating rats.
Fulvestrant se pri podganah v dobi laktacije izloča v mleko.
• Vomiting, diarrhoea, or loss of appetite*
• bruhanje, driska ali izguba apetita*
Mild to moderate impairment of renal function did not influence the pharmacokinetics of fulvestrant to any clinically relevant extent.
Blago do zmerno poslabšanje ledvične funkcije ni vplivalo na farmakokinetiko fulvestranta v klinično pomembnem obsegu.
Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its antiestrogenic activity, at doses similar to the clinical dose.
Fulvestrant je pokazal učinke na reprodukcijo in razvoj zarodka/ploda, ki so v skladu z njegovim antiestrogenim delovanjem v odmerkih, podobnih kliničnim.
• Injection site reactions, such as pain and/or inflammation
• reakcije na mestu injiciranja, npr. bolečine in/ali vnetje
Environmental risk assessment studies have shown that fulvestrant may have potential to cause adverse effects to the aquatic environment (see section 6.6).
Ocena tveganja za okolje (ERA-Environmental Risk Assessment) Študije za oceno tveganja za okolje so pokazale, da lahko fulvestrant povzroči neželene učinke za vodno okolje (glejte poglavje 6.6).
What you need to know before you use Faslodex
Kaj morate vedeti, preden boste uporabili zdravilo Faslodex
In each treatment arm the majority of patients were White, had documented sensitivity to prior hormonal therapy, and were postmenopausal.
V obeh zdravljenih skupinah je bila večina bolnic belk, imele so dokumentirano občutljivost na predhodno hormonsko zdravljenje in so bile po menopavzi.
A total of 462 patients were randomised 1:1 sequentially to receive either fulvestrant 500 mg or anastrozole 1 mg.
Skupno 462 bolnic so v razmerju 1:1 zaporedno randomizirali na prejemanje 500 mg fulvestranta ali 1 mg anastrozola.
A high dose of a shorter duration intramuscular injection formulation was used.
Uporabljen je bil visok odmerek intramuskularne injekcije s krajšim delovanjem.
*(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)
Of the 65 patients in the Faslodex arm, 40% (26/65) of patients reported joint and musculoskeletal pain within the first month of treatment, and 66.2% (43/65) of patients within the first 3 months of treatment.
Od 65 bolnic v skupini z zdravilom Faslodex jih je 40 % (26/65) poročalo o sklepnih in mišično-skeletnih bolečinah v prvem mesecu zdravljenja in 66,2 % (43/65) v prvih 3 mesecih zdravljenja.
• Increase of gamma-GT, a liver enzyme seen in a blood test
• zvišanje gama-GT, jetrnega encima, ki se ga določa s preiskavo krvi
Progression-Free Survival Probability (%)
Verjetnost preživetja brez napredovanja bolezni (%)
Animal studies suggest that no effects other than those related directly or indirectly to antiestrogenic 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).
Patients enrolled in this study had a median age of 63 years (range 36-90).
Bolnice, vključene v to študijo, so bile mediano stare 63 let (razpon: od 36 do 90 let).
If pregnancy occurs while taking Faslodex, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Če med jemanjem zdravila Faslodex bolnica zanosi, jo je treba seznaniti z možno nevarnostjo za plod in možnim tveganjem za prekinitev nosečnosti.
Administer the injection according to the local guidelines for performing large volume intramuscular injections.
Injiciranje je treba opraviti v skladu z lokalnimi smernicami za intramuskularno injiciranje velikih volumnov.
Faslodex has no or negligible influence on the ability to drive or use machines.
Zdravilo Faslodex nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
* Includes side effects for which the exact role of Faslodex cannot be assessed due to the underlying disease.
*Vključuje neželene učinke, pri katerih zaradi osnovne bolezni ni mogoče natančno oceniti vloge zdravila Faslodex.
% of patients with OR; absolute difference in
% bolnikov z OR; absolutna razlika v %
ADR was not observed in FALCON.
Neželeni učinek ni bil opažen v študiji FALCON.
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).
A reduction in the risk of disease progression or death in the Faslodex plus palbociclib arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics.
Zmanjšanje tveganja za napredovanje bolezni ali smrt so v skupini s kombinacijo zdravila Faslodex in palbocikliba opažali v vseh podskupinah bolnic, opredeljenih po stratifikacijskih faktorjih in
In Table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the Faslodex 500 mg treatment group in pooled safety analyses of studies that compared Faslodex 500 mg with Faslodex 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 Faslodex 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented.
V preglednici 1 so naslednje kategorije pogostnosti neželenih učinkov zdravila izračunane na podlagi skupine, zdravljene z zdravilom Faslodex 500 mg v kumulativnih analizah varnosti študij, ki so primerjale zdravilo Faslodex 500 mg z zdravilom Faslodex 250 mg [CONFIRM (študija D6997C00002), FINDER 1 (študija D6997C00004), FINDER 2 (študija D6997C00006) in NEWEST (študija D6997C00003)] ali iz same študije FALCON (študija D699BC00001), ki je primerjala zdravilo Faslodex 500 mg z 1 mg anastrozola.
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
• alergijske (preobčutljivostne) reakcije, vključno z otekanjem obraza, ustnic, jezika in/ali grla, ki je lahko znak anafilaktične reakcije
Consistent results were observed across the majority of pre-specified patient subgroups.
Pri večini vnaprej določenih podskupin bolnic so opažali konsistentne rezultate.
What Faslodex is and what it is used for
Kaj je zdravilo Faslodex in za kaj ga uporabljamo
Pre-filled syringes are for single use only.
Napolnjene injekcijske brizge so samo za enkratno uporabo.
Preclinical data do not suggest a stimulatory effect of fulvestrant on the postmenopausal endometrium (see section 5.3).
Predklinični podatki ne kažejo na stimulatorni učinek fulvestranta na endometrij po menopavzi (glejte poglavje 5.3).
• Peel open the safety needle (SafetyGlide) outer packaging.
• S potegom odprite zunanjo ovojnino varnostne igle (SafetyGlide).
Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint.
Med sekundarnimi cilji študije so bili OR, CBR, OS, varnost in čas do poslabšanja (TTD - Time-to-Deterioration) bolečin.
What Faslodex is and what it is used for What you need to know before you use Faslodex How to use Faslodex
Kaj je zdravilo Faslodex in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Faslodex Kako uporabljati zdravilo Faslodex Možni neželeni učinki
Table 2 Adverse reactions based on PALOMA3 Study (N=517)
Neželeni učinki na podlagi študije PALOMA3 (N = 517)
Other medicines and Faslodex
Druga zdravila in zdravilo Faslodex
In dog studies following oral and intravenous administration, effects on the cardiovascular system (slight elevations of the S-T segment of the ECG [oral], and sinus arrest in one dog [intravenous]) were seen.
V študijah na psih po peroralni in intravenski uporabi so opazili učinke na kardiovaskularni sistem (rahlo povečanje S-T segmenta v EKG [peroralno] in sinusni zastoj pri enem psu [intravensko]).
The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the pre-specified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Študija je ob vmesni analizi (opravljeni po 82 % načrtovanih dogodkov PFS) dosegla svoj primarni cilj podaljšanja PFS po oceni raziskovalca; rezultati so presegli vnaprej določeno Haybittle-Petovo mejo učinkovitosti (α = 0,00135) ter so dokazali statistično značilno podaljšanje PFS in klinično pomemben terapevtski učinek.
Randomisation was stratified by disease setting (locally advanced or metastatic), prior chemotherapy for advanced disease, and measurable disease.
Randomizacija je bila stratificirana po obsegu bolezni (lokalno napredovala ali metastatska), predhodni kemoterapiji za napredovalo bolezen in merljivosti bolezni.
The objective response rate for Faslodex 250 mg was 19.2% compared with 16.5% for anastrozole.
Objektivni delež odgovorov je bil za zdravilo Faslodex 250 mg 19,2 % v primerjavi s 16,5 % pri anastrozolu.
Faslodex is indicated in patients whose disease had recurred or progressed on an antiestrogen therapy.
Zdravilo Faslodex je indicirano pri bolnikih, katerih bolezen se je ponovila ali napredovala med zdravljenjem z antiestrogeni.
Keep the pre-filled syringe in the original package, in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
Faslodex is indicated:
Zdravilo Faslodex je indicirano:
The results in the AI subgroup are inconclusive.
Na podlagi rezultatov pri AI podskupini ni možno narediti zaključkov.
This 12-month study investigated a range of MAS endpoints and showed a reduction in the frequency of vaginal bleeding and a reduction in the rate of bone age advancement.
Ta 12-mesečna študija, pri kateri so proučevali vrsto ciljev študije v povezavi z MAS, je pokazala manjšo pogostnost vaginalnih krvavitev in počasnejše napredovanje staranja kosti.
There was up to about 2.5-fold increase in AUC in women with hepatic impairment compared to healthy subjects.
Pri ženskah z okvaro jeter se je AUC zvišal za približno 2,5-krat v primerjavi z zdravimi ženskami.
Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
Prilagoditev odmerka tako ni potrebna pri bolnicah, ki sočasno uporabljajo fulvestrant in zaviralce ali induktorje CYP 3A4.
• Inflammation of the liver (hepatitis)
• vnetje jeter (hepatitis)
The descriptions included below are based on the safety analysis set of 228 patients who received at least one (1) dose of fulvestrant and 232 patients who received at least one (1) dose of anastrozole, respectively in the Phase 3 FALCON study.
Spodaj navedeni opisi temeljijo na naboru podatkov za analizo varnosti 228 bolnic, ki so v študiji 3. faze FALCON prejele vsaj en (1) odmerek fulvestranta, in 232 bolnic, ki so prejele vsaj en (1) odmerek anastrozola.
Two syringes must be administered to receive the 500 mg recommended monthly dose.
Dve injekcijski brizgi morata biti injicirani za dosego priporočenega mesečnega odmerka 500 mg.
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.
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.