natgillin/translations-raw huggingface dataset:
Ospemifene has been administered to subjects in single doses for up to 800 mg day and repeat doses up to 240 mg/day for 7 days and up to 200 mg/day for 12 weeks.
Ospemifen je primjenjivan na ispitanicama u pojedinačnim dozama do 800 mg na dan i ponavljanim dozama do 240 mg/dan tijekom 7 dana i do 200 mg/dan tijekom 12 tjedana.
Talk to your doctor before taking Senshio with:
Obratite se svom liječniku prije nego uzmete Senshio s:
Symptoms of an allergic reaction may include rash, itchy skin, raised patches on your skin (urticaria), swelling of the tongue and throat that may cause difficulty in breathing or swallowing.
Simptomi alergijske reakcije mogu uključivati osip, svrbež kože, uzdignute mrlje na koži (urtikarija), oticanje jezika i grla koje može uzrokovati otežano disanje i gutanje.
Senshio works in a similar way to some of the helpful effects of oestrogen, helping to improve these symptoms and the underlying causes of vulvar and vaginal atrophy.
Senshio djeluje slično nekim korisnim učincima estrogena, tako da pomaže ublažiti ove simptome i s njima povezane uzroke vulvarne i vaginalne atrofije.
- If any vaginal bleeding occurs while taking Senshio or soon after you have stopped taking it, you should speak to your doctor.
- Ako nastupi krvarenje iz rodnice dok uzimate lijek Senshio ili ubrzo nakon što ste ga prestali uzimati, morate se obratiti svom liječniku.
Fertility studies were not conducted.
Ispitivanja utjecaja na plodnost nisu provedena.
Ospemifene and 4-hydroxyospemifene are highly (both >99%) bound to serum proteins.
Ospemifen i 4-hidroksiospemifen u velikoj se mjeri (oba >99%) vežu na proteine seruma.
Overall, tumour development in these studies is believed to be the result of rodent specific hormonal mechanisms when treated during their reproductive lives; these findings are unlikely to have any clinical relevance in postmenopausal women.
Sveukupno, vjeruje se da je razvoj tumora u ovim ispitivanjima rezultat specifičnih hormonskih mehanizama u glodavaca kada su liječeni tijekom reproduktivne faze života; ovi nalazi vjerojatno nemaju kliničkog značaja za žene u postmenopauzi.
Patients with suspected breast cancer or patients undergoing active treatment (including adjuvant therapy) for breast cancer (see section 4.4).
Bolesnice kod kojih postoji sumnja na postojanje raka dojke ili bolesnice koje se aktivno liječe (uključujući i adjuvantnu terapiju) zbog raka dojke (vidjeti dio 4.4).
Therefore, caution is recommended when ospemifene is combined with orlistat.
Stoga, preporučuje se oprez kada se ospemifen primjenjuje u kombinaciji s orlistatom.
Each film-coated tablet contains 1.82 mg lactose as monohydrate.
Jedna filmom obložena tableta sadrži 1,82 mg laktoze u obliku hidrata.
In patients with moderate hepatic impairment the exposure of ospemifene and 4-hydroxyospemifene was approximately 30% and 70% higher.
U bolesnica s umjerenim oštećenjem jetre izloženost ospemifenu i 4-hidroksiospemifenu bila je približno 30% i 70% viša.
Plasma/blood cell partitioning of [14C]-Ospemifene (< 3%) and [14C]-4-hydroxyospemifene (< 2%) is low.
Razdioba [14C]-ospemifena (<3%) i [14C]-4-hidroksiospemifena (<2%) između plazme/krvnih stanica je niska.
In contrast, abnormal, not clinically significant, findings on mammography increased in the placebo population from 6.5% to 8.3%.
Nasuprot tomu, abnormalni, klinički ne i značajni nalazi na mamografiji bili su u porastu u populaciji koja je primala placebo od 6,5% do 8,3%.
For the treatment of vulvar and vaginal atrophy, ospemifene should only be initiated for symptoms that adversely affect quality of life e.g. dyspareunia and vaginal dryness.
Za liječenje vulvarne i vaginalne atrofije, liječenje ospemifenom potrebno je započeti samo za one simptome koji negativno utječu na kvalitetu života, poput dispareunije i vaginalne suhoće.
They are packed in blisters and are available in pack sizes of 7, 28 or 84 film-coated tablets.
Pakirane su u blisterima i dostupne su u veličinama pakiranja od 7, 28 ili 84 filmom obloženih tableta.
The biological activity profile in humans is predominantly due to the parent compound.
Za profil biološke aktivnosti u ljudi odgovoran je prvenstveno ishodni spoj.
Substantial improvement 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
Značajno poboljšanje 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
One tablet should be swallowed whole once daily with food and should be taken at the same time each day.
Jednu tabletu treba progutati cijelu jedanput dnevno s hranom i mora se uzimati svakoga dana u isto vrijeme.
Treatment with Senshio can be restarted as soon as you regain your mobility and in consultation with your doctor.
Liječenje lijekom Senshio može se ponovo nastaviti čim ponovno postanete pokretni i prema savjetu Vašeg liječnika.
Renal clearance of unchanged active substance is a minor pathway of elimination, less than 0.2% of the ospemifene dose is excreted unchanged in urine.
Bubrežni klirens nepromijenjene djelatne tvari manje je značajan put eliminacije, manje od 0,2% doze ospemifena izlučuje se nepromijenjeno urinom.
This is because there are no data on the use of Senshio in pregnant or pre-menopausal women or those who are breast-feeding.
To je zato što nema podataka o primjeni lijeka Senshio u trudnica ili žena u premenopauzi ili dojilja.
In repeat dose toxicity studies in mouse, rat, dog and the cynomolgus monkey main target organs of toxicity were the ovary, uterus and the liver.
U ispitivanjima toksičnosti ponovljenih doza na miševima, štakorima, psima i makaki majmunima, glavni ciljni organi toksičnosti bili su jajnik, maternica i jetra.
When ospemifene is administered with a high fat meal, the Cmax and AUC are 2.5-fold and 1.9-fold higher, respectively, with lower variability relative to the fasting state.
Kada se ospemifen uzima s obrokom s visokim udjelom masnoće, Cmax i AUC su 2,5 odnosno 1,9 puta viši, uz nižu varijabilnost u odnosu kada se uzima natašte.
The recommended dose is one 60 mg tablet once daily with food taken at the same time each day.
Preporučena doza je jedna tableta od 60 mg jedanput dnevno s hranom, uzeta svakog dana u isto vrijeme.
Table 2 shows the percentage of subjects who reported a change in their MBS at week 12.
Tablica 2 prikazuje postotak ispitanica koje su prijavile promjene simptoma koji ih najviše smeta u 12. tjednu.
Suspected or active sex-hormone dependent malignancy (e.g. endometrial cancer).
Postojanje sumnje na ili aktivna maligna bolest ovisnu o spolnim hormonima (npr. rak endometrija).
- If you experience signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, difficulty in breathing or a stroke while taking Senshio, stop taking Senshio and see a doctor immediately.
- Ako primijetite znakove nastanka krvnog ugruška, poput bolnog oticanja i crvenila nogu, iznenadne boli u prsištu, otežanog disanja ili moždanog udara dok uzimate Senshio, prestanite uzimati Senshio i odmah se obratite svom liječniku.
No dose adjustment is necessary in patients above the age of 65 years (see section 5.2).
U bolesnica starijih od 65 godina prilagodba doze nije potrebna (vidjeti dio 5.2).
Pharmacokinetic differences due to race have been studied in 1,091 postmenopausal women, including 93.1% White, 3.9% Black, 1.8% Asian and 1.1% other in VVA trials.
Razlike u farmakokinetici ovisne o rasi ispitane su u ispitivanjima VVA na 1091 ženi u postmenopauzi, uključujući 93,1% žena bjelačke, 3,9% crnačke, 1,8% azijatske i 1,1% ostalih rasa.
- If you are unable to walk for a long time or are sitting for a long time in the same position because of major surgery, injury or illness, it may prevent good blood circulation and may temporarily increase your risk of blood clots.
Dok uzimate lijek Senshio: - Ako dugotrajno niste sposobni kretati se ili morate dugo vremena sjediti u istom položaju zbog velikog kirurškog zahvata, ozljede ili bolesti, to može sprečavati dobru cirkulaciju krvi i privremeno povećati rizik za nastanak krvnih ugrušaka.
Taken together, the liver changes observed in experimental animals in repeat dose toxicity studies are regarded as adaptive changes due to enzyme induction and given the lack of any clinical signs are unlikely to represent a safety concern for humans.
U cjelini, promjene na jetri primijećene u eksperimentalnim životinjama u ispitivanjima toksičnosti ponovljenih doza, smatraju se adaptivnim promjenama uslijed indukcije enzima, a zbog pomanjkanja kliničkih znakova nije vjerojatno da predstavljaju sigurnosni problem u ljudi.
It is unknown if ospemifene is a substrate for BCRP in the intestine.
Nije poznato je li ospemifen supstrat za BCRP u crijevu.
There was a single subject (0.3%) who developed endometrial hyperplasia in the ospemifene group (simple hyperplasia without atypia) 88 days after the last dose of study drug.
U jedne ispitanice (0,3%) u skupini ospemifena zabilježen je razvoj hiperplazije endometrija (jednostavna hiperplazija bez atipije) 88 dana nakon posljednje doze ispitivanog lijeka.
The principal radioactive component in both plasma and faeces was ospemifene and the main metabolite 4hydroxyospemifene.
Glavna radioaktivna komponenta u plazmi i u fecesu bio je ospemifen, a glavni metabolit 4-hidroksiospemifen.
The glycogen content of vaginal epithelial cells also decreases, resulting in reduced colonisation by lactobacilli and increased vaginal pH.
Sadržaj glikogena u stanicama vaginalnog epitela također opada, posljedica čega je smanjena kolonizacija laktobacila i povišeni vaginalni pH.
In patients with severe renal impairment the ospemifene exposure was increased by approximately 20%, when compared to healthy matched subjects.
U bolesnica s teškim oštećenjem bubrega izloženost ospemifenu bila je povećana za približno 20% u usporedbi sa zdravim podudarnim ispitanicama.
EU/1/14/978/001 EU/1/14/978/002 EU/1/14/978/003
EU/1/14/978/002
Co-administration with fluconazole
Istodobna primjena s flukonazolom
Ospemifene belongs to a group of medicines that do not contain hormones called Selective Estrogen Receptor Modulators (SERMs).
Ospemifen pripada skupini lijekova koji ne sadrže hormone i nazivaju se selektivni modulatori estrogenskih receptora (engl. selective oestrogen receptor modulator, SERM).
On the basis of the scientific conclusions for ospemifene the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ospemifene is unchanged subject to the proposed changes to the product information
Na temelju znanstvenih zaključaka za ospemifen, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) ospemifen nepromijenjen, uz predložene izmjene informacija o lijeku.
Therefore ospemifene should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Stoga je ospemifen za liječenje VVA potrebno koristiti samo nakon što je liječenje raka dojke, uključujući i adjuvantnu terapiju, dovršeno.
In addition, these changes can result in chronic symptoms associated with VVA, the most common of which are vaginal dryness and dyspareunia.
Nadalje, ove promjene mogu imati za posljedicu pojavu kroničnih simptoma povezanih s VVA, od kojih su najčešći suhoća vagine i dispareunija.
If you take more Senshio than you should
Ako uzmete više lijeka Senshio nego što ste trebali
This effect was likely due to the anti-oestrogenic effect of ospemifene in this target tissue, which was attenuating the physiological thymic involution (atrophy) process induced by oestrogens starting during puberty.
Taj učinak je vjerojatno posljedica antiestrogenog učinka ospemifena na ovo ciljno tkivo, koji je oslabljivao proces fiziološke involucije (atrofije) timusa koji je induciran djelovanjem estrogena u pubertetu.
In a two-generation reproductive study on pre-and postnatal development ospemifene induced an increased post-implantation loss, an increased number of dead pups at birth as well as an increased incidence of postnatal loss of pups in the F1 generation.
U reproduktivnom ispitivanju prenatalnog i postnatalnog razvoja u dvije generacije, ospemifen je inducirao porast postimplantacijskih gubitaka, porast broja mrtvookoćene mladunčadi, kao i porast incidencije postnatalnog gubitka mladunčadi u F1 generaciji.
In the liver hepatocyte hypertrophy or increased glycogen storage, increase in alanine aminotransferase (ALT) and alkaline phosphatase (ALP) were observed.
U jetri su primijećeni hipertrofija hepatocita ili pojačana pohrana glikogena, porast alanin aminotransferaze (ALT) i alkalne fosfataze (ALP).
These results suggest that co-administration of ospemifene with any medicinal product that inhibits both CYP3A4 and CYP2C9 activity (e.g. fluconazole) would be expected to increase the exposure of ospemifene in a similar way.
Ovi rezultati sugeriraju da se istodobnom primjenom ospemifena s bilo kojim lijekom koji inhibira aktivnost i CYP3A4 i CYP2C9 (npr. flukonazol) može očekivati povećana izloženost ospemifenu na sličan način.
Across all placebo-controlled clinical trials of ospemifene, deep vein thrombosis occurred at a frequency of approximately 3.65 cases per 1,000 patient years on 60 mg ospemifene (95% confidence interval of 0.44 to 13.19) versus 3.66 cases per 1,000 patient years for placebo (95% confidence interval of 0.09 to 20.41; relative risk is 1.0).
U svim placebom kontroliranim kliničkim ispitivanjima ospemifena, duboka venska tromboza javljala se s učestalošću od oko 3,65 slučajeva na 1000 bolesnik godina na 60 mg ospemifena (95% interval pouzdanosti od 0,44 do 13,19) naspram 3,66 slučajeva na 1000 bolesnik godina za placebo (95% interval pouzdanosti od 0,09 do 20,41; relativni rizik je 1,0).
It is recommended that ospemifene should be taken with food at the same time each day.
Preporučuje se ospemifen uzimati s hranom svakog dana u isto vrijeme.
The risk of cerebrovascular events associated with ospemifene cannot be excluded.
Rizik od cerebrovaskularnih događaja povezanih s ospemifenom ne može se isključiti.
In the two 12 weeks studies (trials 1 and 2), 739 patients received ospemifene and 724 patients received placebo.
U dva ispitivanja u trajanju od 12 tjedana (ispitivanje 1 i 2), 739 bolesnica primalo je ospemifen a 724 je primalo placebo.
Based on a review of data from clinical trials and post-marketing reporting, the PRAC considers that a causal relationship between ospemifene and the adverse reaction vaginal bleeding cannot be ruled out and therefore recommends an updated to section 4.8 of the SmPC.
Na temelju pregledanih podataka iz kliničkih ispitivanja i izvješća nakon stavljanja lijeka u promet, PRAC smatra da se uzročno-posljedična povezanost između ospemifena i nuspojave vaginalnog krvarenja ne može isključiti i stoga preporučuje ažuriranje dijela 4.8 sažetka opisa svojstava lijeka.
If you take more tablets than you should, tell your doctor or pharmacist.
Ako ste uzeli više tableta nego što ste trebali, obratite se svom liječniku ili ljekarniku.
A clinical monitoring of a decrease in the efficacy of ospemifene should be made.
U tom slučaju potreban je klinički nadzor smanjenja djelotvornosti ospemifena.
Mean ospemifene Cmax and AUC0-24hr were 785 ng/mL and 5,448 ng•hr/mL, respectively, after repeat doses of 60 mg ospemifene once daily in the fed state.
Srednji Cmax i AUC0-24hr za ospemifen bili su 785 ng/mL odnosno 5448 ng•h/mL, nakon ponovljenih doza od 60 mg ospemifena jedanput na dan nakon jela.
These non-clinical findings are consistent with findings from clinical trials, in which ospemifene demonstrated benefits on vaginal physiology without apparent oestrogen-like effects on breast tissue (see subheading Clinical safety).
Ovi neklinički nalazi u skladu su s nalazima iz kliničkih ispitivanja u kojima je ospemifen pokazao pozitivno djelovanje na vaginalnu fiziologiju bez očitih učinaka nalik estrogenu na tkivo dojke (vidjeti podnaslov Klinička sigurnost).
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
Senshio je indiciran za liječenje umjerene do teške simptomatske vulvarne i vaginalne atrofije (VVA) u žena u postmenopauzi koje nisu kandidati za lokalnu vaginalnu estrogensku terapiju.
This should be considered when prescribing ospemifene for postmenopausal women with a history of stroke or other significant stroke risk factors.
Ovo je potrebno uzeti u obzir pri propisivanju ospemifena ženama u postmenopauzi kod kojih u anamnezi postoji podatak o moždanom udaru ili drugi značajni čimbenici rizika za moždani udar.
Endometrial findings
Nalazi na endometriju
This difference is not considered clinically relevant and no dose adjustment is necessary in patients with renal impairment.
Ta razlika se ne smatra klinički relevantnom i nije potrebna prilagodba doze u bolesnica s oštećenjem bubrega.
28 Feb 2021
28. veljače
There is no relevant use of ospemifene in the paediatric population for the indication of the treatment of moderate to severe symptomatic VVA in post-menopausal women.
Nema relevantne primjene ospemifena u pedijatrijskoj populaciji za indikaciju liječenja umjerene do teške simptomatske VVA u žena u postmenopauzi.
The mean age of participants was 61.7 years in the ospemifene 60 mg group and 62.9 years in the placebo group.
Srednja dob ispitanica bila je 61,7 godina u skupini koja je primala 60 mg ospemifena i 62,9 godina u skupini koje je primala placebo.
Interaction studies were performed with probe substrates for CYP2C9 (warfarin), CYP3A4 (midazolam), CYP2C19, and CYP3A4 (omeprazole) and CYP2B6 (bupropion).
Provedena su ispitivanja interakcija s probnim supstratima za CYP2C9 (varfarin), CYP3A4 (midazolam), CYP2C19, CYP3A4 (omeprazol) i CYP2B6 (bupropion).
Across all placebo controlled clinical trials, there was no significant difference in breast related adverse events between ospemifene and placebo.
U svim placebom kontroliranim kliničkim ispitivanjima nije bilo značajne razlike u pojavnosti štetnih događaja koji se odnose na dojke između skupine koja je primala ospemifen i skupine koja je primala placebo.
In clinical studies, a mean increase of 0.8 mm in endometrial thickness after 12 months (as assessed by protocol-specified ultrasonography) was observed and there was no increase in vaginal bleeding or spotting in the ospemifene-treated group compared to the placebo-treated group.
U kliničkim je ispitivanjima opažena srednja vrijednost porasta debljine endometrija za 0,8 mm nakon 12 mjeseci (utvrđeno protokolom specificiranom ultrasonografijom), bez pojačanog vaginalnog krvarenja ili točkastog krvarenja, u bolesnica liječenih ospemifenom u usporedbi sa skupinom koja je primala placebo.
In post-menopausal women who received ospemifene treatment up to 1 year, benign endometrial polyps were reported in 0.4% compared to 0.2% in women who received placebo treatment.
U 0,4% žena u postmenopauzi koje su liječene ospemifenom u trajanju do 1 godine prijavljena je pojava benignih polipa endometrija, u usporedbi s 0,2% žena koje su primale placebo.
Ospemifene was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests.
Ospemifen nije pokazao mutagena ili klastogena svojstva tijekom ispitivanja u standardnoj seriji in vitro i in vivo testova.
Therefore care should be taken if ospemifene is administered with a BCRP inhibitor.
Stoga je potreban oprez kada se ospemifen primjenjuje s inhibitorima BCRP-a.
Ospemifene-related changes included ovarian follicular cysts, endometrial stromal atrophy and endometrial hypertrophy/hyperplasia which are consistent with the pharmacologic activity of ospemifene in the intact, normally cycling animal.
Promjene povezane s ospemifenom uključivale su folikularne ciste na jajnicima, atrofiju strome endometrija, i hipertrofiju/hiperplaziju endometrija što odgovara farmakološkom djelovanju ospemifena na intaktne životinje s normalnim ciklusima.
All patients received non-hormonal vaginal lubricant for use as needed; therefore, the effects on efficacy endpoints in the ospemifene treatment group were in addition to those achieved with lubricant use alone.
Sve bolesnice dobile su nehormonski vaginalni lubrikant za primjenu po potrebi, stoga su učinci na mjere ishoda djelotvornosti u skupini koja se liječila ospemifenom pridruženi onima postignutima u skupini koja je koristila samo lubrikant.
Pack sizes of 7, 28 or 84 film-coated tablets.
Veličina pakiranja sa 7, 28 ili 84 filmom obloženih tableta.
Non-interventional post-authorisation safety study (PASS): An observational retrospective cohort study of ospemifene to assess the incidence of venous thromboembolism and other safety concerns as agreed in the risk management plan, in VVA patients treated with ospemifene compared to 1) patients newly prescribed SERMs for oestrogen-deficiency conditions or breast cancer prevention, and 2) the incidence in untreated VVA patients.
Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): Opservacijsko retrospektivno ispitivanje kohorti koje primaju ospemifen radi ocjene incidencije venske tromboembolije i drugih sigurnosnih pitanja kako je to dogovoreno planom upravljanja rizikom, u bolesnica s VVA liječenih ospemifenom u usporedbi s 1) bolesnicama kojima su nedavno propisani selektivni modulatori estrogenskih receptora zbog stanja deficita estrogena ili radi prevencije raka dojke, i 2) incidencijom u neliječenih bolesnica s VVA.
This medicine is only intended for use in postmenopausal women.
Ovaj je lijek namijenjen za primjenu samo u žena u postmenopauzi.
This increase is not considered to be clinically significant given the inherent pharmacokinetic variability of ospemifene.
Ovo povećanje ne smatra se klinički značajnim zbog inherentne farmakokinetičke varijabilnosti ospemifena.
Ospemifene did not cause a clinically meaningful change in the exposure to the substrates, indicating that ospemifene does not affect those enzyme activities in vivo to a clinically significant extent.
Ospemifen nije uzrokovao klinički značajne promjene u izloženosti supstratima, pokazujući time da ospemifen ne utječe na aktivnost tih enzima in vivo u klinički značajnoj mjeri.
The absolute bioavailability of ospemifene has not been established.
Apsolutna bioraspoloživost ospemifena nije ustanovljena.
Excipient with known effect
Pomoćna tvar s poznatim učinkom:
Paediatric population Pharmacokinetic studies have not been performed with ospemifene in the paediatric population.
Nisu provedena ispitivanja farmakokinetike ospemifena u pedijatrijskoj populaciji.
Caution is recommended when co-administering ospemifene with fluconazole (see section 4.5).
Preporučuje se oprez pri istodobnoj primjeni ospemifena i flukonazola (vidjeti dio 4.5).
In a 2-year carcinogenicity study in rats, a clear increase in mostly benign thymic tumours was recorded at all ospemifene dose levels.
U dvogodišnjem ispitivanju kancerogenosti na štakorima zabilježen je jasni porast uglavnom benignih tumora timusa pri svim razinama doze ospemifena.
There are no data on the use of ospemifene in pregnant women.
Nema podataka o primjeni ospemifena u trudnica.
Any other medicine belonging to the group called SERMs, such as tamoxifen, toremifene, bazedoxifene and raloxifene.
• bilo kojim drugim lijekom iz skupine SERM, poput tamoksifena, toremifena, bazedoksifena i raloksifena.
Of the 426 subjects enrolled in the study, 363 (85.2%) subjects were randomised to once-daily oral doses of ospemifene 60 mg and 63 (14.8%) subjects were randomised to placebo.
Od 426 ispitanica uključenih u ispitivanje 363 (85,2%) ispitanica randomizirano je na peroralnu dozu ospemifena od 60 mg jedanput dnevno, a 63 (14,8%) ispitanica randomizirano je na placebo.
No clinically meaningful differences in ospemifene pharmacokinetics have been observed over the age range studied (40-80) years of age.
Nisu primijećene bitne razlike u farmakokinetici ospemifena u ispitivanom dobnom rasponu (4080 godina).
Ospemifene and 4-hydroxyospemifene accounted for approximately 20% and 14% of the total radioactivity in serum, respectively.
Na ospemifen i 4-hidroksiospemifen otpadalo je oko 20% odnosno 14% ukupne radioaktivnosti u serumu.