FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Nema relevantne primjene ospemifena u pedijatrijskoj populaciji za indikaciju liječenja umjerene do teške simptomatske VVA u žena u postmenopauzi.
English: The mean age of participants was 61.7 years in the ospemifene 60 mg group and 62.9 years in the placebo group.
Croatian: 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.
English: Interaction studies were performed with probe substrates for CYP2C9 (warfarin), CYP3A4 (midazolam), CYP2C19, and CYP3A4 (omeprazole) and CYP2B6 (bupropion).
Croatian: Provedena su ispitivanja interakcija s probnim supstratima za CYP2C9 (varfarin), CYP3A4 (midazolam), CYP2C19, CYP3A4 (omeprazol) i CYP2B6 (bupropion).
English: Across all placebo controlled clinical trials, there was no significant difference in breast related adverse events between ospemifene and placebo.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Ospemifene was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests.
Croatian: Ospemifen nije pokazao mutagena ili klastogena svojstva tijekom ispitivanja u standardnoj seriji in vitro i in vivo testova.
English: Therefore care should be taken if ospemifene is administered with a BCRP inhibitor.
Croatian: Stoga je potreban oprez kada se ospemifen primjenjuje s inhibitorima BCRP-a.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Pack sizes of 7, 28 or 84 film-coated tablets.
Croatian: Veličina pakiranja sa 7, 28 ili 84 filmom obloženih tableta.
English: 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.
Croatian: 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.
English: This medicine is only intended for use in postmenopausal women.
Croatian: Ovaj je lijek namijenjen za primjenu samo u žena u postmenopauzi.
English: This increase is not considered to be clinically significant given the inherent pharmacokinetic variability of ospemifene.
Croatian: Ovo povećanje ne smatra se klinički značajnim zbog inherentne farmakokinetičke varijabilnosti ospemifena.
English: 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.
Croatian: 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.
English: The absolute bioavailability of ospemifene has not been established.
Croatian: Apsolutna bioraspoloživost ospemifena nije ustanovljena.
English: Excipient with known effect
Croatian: Pomoćna tvar s poznatim učinkom:
English: Paediatric population Pharmacokinetic studies have not been performed with ospemifene in the paediatric population.
Croatian: Nisu provedena ispitivanja farmakokinetike ospemifena u pedijatrijskoj populaciji.
English: Caution is recommended when co-administering ospemifene with fluconazole (see section 4.5).
Croatian: Preporučuje se oprez pri istodobnoj primjeni ospemifena i flukonazola (vidjeti dio 4.5).
English: In a 2-year carcinogenicity study in rats, a clear increase in mostly benign thymic tumours was recorded at all ospemifene dose levels.
Croatian: U dvogodišnjem ispitivanju kancerogenosti na štakorima zabilježen je jasni porast uglavnom benignih tumora timusa pri svim razinama doze ospemifena.
English: There are no data on the use of ospemifene in pregnant women.
Croatian: Nema podataka o primjeni ospemifena u trudnica.
English: Any other medicine belonging to the group called SERMs, such as tamoxifen, toremifene, bazedoxifene and raloxifene.
Croatian: • bilo kojim drugim lijekom iz skupine SERM, poput tamoksifena, toremifena, bazedoksifena i raloksifena.
English: 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.
Croatian: 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.
English: No clinically meaningful differences in ospemifene pharmacokinetics have been observed over the age range studied (40-80) years of age.
Croatian: Nisu primijećene bitne razlike u farmakokinetici ospemifena u ispitivanom dobnom rasponu (4080 godina).
English: Ospemifene and 4-hydroxyospemifene accounted for approximately 20% and 14% of the total radioactivity in serum, respectively.
Croatian: Na ospemifen i 4-hidroksiospemifen otpadalo je oko 20% odnosno 14% ukupne radioaktivnosti u serumu.
English: Ospemifene exhibits linear pharmacokinetics in the fed state within the dose range of 60 mg to 240 mg.
Croatian: Ospemifen pokazuje linearnu farmakokinetiku kada se uzima na nakon jela u rasponu doze od 60 mg do 240 mg.
English: Other special populations
Croatian: Ostale posebne populacije Spol
English: The incidence of abnormal, but not clinically significant, findings on breast palpation and mammography decreased in the ospemifene 60 mg population during the 1-year study (trial 3) from 1.6% to 0.6% and from 11.8% to 8.1% respectively.
Croatian: Incidencija abnormalnih, ali klinički ne i značajnih nalaza pri palpaciji dojki ili mamografiji smanjila se u populaciji koja je primala 60 mg ospemifena tijekom jednogodišnjeg ispitivanja (ispitivanje 3) od 1,6% do 0,6% odnosno 11,8% do 8,1%.
English: The pharmacokinetics of ospemifene has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class score >9).
Croatian: Farmakokinetika ospemifena nije ispitana u bolesnica s teškim oštećenjem jetre (Child-Pugh rezultat >9).
English: In two separate 12 week pivotal trials (trials 1 and 2), ospemifene was associated with a statistically significant mean decrease from baseline in the percentage of parabasal cells and vaginal pH and a statistically significant mean increase from baseline in the percentage of superficial cells, compared with placebo (P<0.001 for each parameter) at weeks 4 and 12.
Croatian: U dva odvojena ključna ispitivanja u trajanju od 12 tjedana (ispitivanja 1 i 2), ospemifen je povezan sa statistički značajnim srednjim smanjenjem postotka parabazalnih stanica i vaginalnog pH u odnosu na početak ispitivanja, i statistički značajnim srednjim porastom postotka površinskih stanica u odnosu na početak ispitivanja, u usporedbi s placebo skupinom (P<0,001 za svaki parametar) u 4. i 12. tjednu.
English: Furthermore in vitro studies have shown that ospemifene is a weak inducer for CYP2B6 and CYP3A4.
Croatian: Nadalje, u ispitivanjima in vitro pokazano je da ospemifen je slab induktor CYP2B6 i CYP3A4.
English: The clinical efficacy and safety of ospemifene was determined primarily from two multi-centre, placebo-controlled trials of 12 weeks duration (trials 1 and 2) and a third long-term safety trial of 52 weeks duration (trial 3) in post-menopausal patients with VVA.
Croatian: Klinička djelotvornost i sigurnost ospemifena utvrđena je prvenstveno u dva multicentrična, placebom kontrolirana ispitivanja u trajanju od 12 tjedana (ispitivanje 1 i 2) i trećim ispitivanjem sigurnosti dugotrajne primjene u trajanju od 52 tjedna (ispitivanje 3), provedenima na bolesnicama u postmenopauzi s VVA-om.
English: Senshio tablets are oval biconvex, white to off-white, film-coated tablets (approximately 12 mm long by 6.45 mm wide) debossed with “60” on one side.
Croatian: Tablete Senshio su ovalne, bikonveksne, bijele do gotovo bijele, filmom obložene tablete (oko 12 mm duge i 6,45 mm široke) s utisnutom oznakom „60“ na jednoj strani.
English: Therefore, co-administration of ospemifene with strong enzyme inducers like carbamazepine, phenytoin, St John's wort and rifabutin would be expected to decrease the exposure of ospemifene, which may decrease the clinical effect.
Croatian: Stoga bi se pri istodobnoj primjeni ospemifena s jakim induktorima enzima poput karbamazepina, fenitoina, gospine trave i rifabutina očekivalo smanjenje izloženosti ospemifenu, što može smanjiti klinički učinak.
English: The reproductive effects observed are considered to be related to oestrogen receptor activity of ospemifene.
Croatian: Za primijećene reproduktivne učinke smatra se da su povezani s aktivnošću ospemifena na estrogenskim receptorima.
English: Senshio contains lactose.
Croatian: Senshio sadrži laktozu.
English: The long-term study (trial 3) was a 52-week, randomised, double-blind, placebo-controlled safety and efficacy study in 426 postmenopausal women with an intact uterus.
Croatian: Ispitivanje dugotrajne primjene (ispitivanje 3) bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje sigurnosti i djelotvornosti u trajanju od 52 tjedna, a provedeno je na 426 žena u postmenopauzi s intaktnim uterusom.
English: No cases of endometrial hyperplasia were reported at either time point.
Croatian: Nije zabilježen niti jedan slučaj hiperplazije endometrija niti u jednoj vremenskoj točki ispitivanja.
English: There were no abnormal breast palpation findings in the placebo group at baseline or at study end.
Croatian: Nije bilo abnormalnih nalaza palpacije dojki u skupini koja je primala placebo na početku ili na kraju ispitivanja.
English: In in vitro studies, ospemifene and 4-hydroxyospemifene did not inhibit P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporter polypeptide (OATP)1B1, OATP1B3, OCT2, organic anion transporter (OAT)1, OAT3, or bile salt export pump (BSEP) transporters at clinically relevant concentrations.
Croatian: U ispitivanjima in vitro, ospemifen i 4-hidroksiospemifen nisu inhibirali P-glikoprotein (P-gp), protein rezistencije raka dojke (engl. breast cancer resistance protein, BCRP), polipeptidni prijenosnik organskih aniona (engl. organic anion transporter polypeptide, OATP)1B1, OATP1B3, OCT2, prijenosnik organskih aniona (engl. organic anion transporter, OAT)1, OAT3 niti pumpu za izbacivanje žučnih soli (engl. bile salt export pump, BSEP) u klinički relevantnim koncentracijama.
English: Inhibition of UGT1A3, UGT2B7, UGT1A1, or UGT1A8 may potentially affect the glucuronidation of ospemifene and/or 4-hydroxyospemifene.
Croatian: Inhibicija enzima UGT1A3, UGT2B7, UGT1A1 ili UGT1A8 potencijalno može utjecati na glukuronidaciju ospemifena i/ili 4-hidroksiospemifena.
English: A trend was observed in both trials in the improvement of MBS from baseline to week 4 in favour of ospemifene compared to placebo, although the difference was not statistically significant.
Croatian: U oba ispitivanja primijećen je trend poboljšanja simptoma koji najviše smeta od početka ispitivanja do 4. tjedna u korist ospemifena u usporedbi s placebom, iako razlika nije bila statistički značajna.
English: Obligation to conduct post-authorisation measures
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
English: In those trials, a total of 1,102 subjects received 60 mg of ospemifene and 787 subjects received placebo.
Croatian: Tijekom tih ispitivanja ukupno je 1102 ispitanica primalo 60 mg ospemifena a 787 ispitanica je primalo placebo.
English: For subjects completing the trial 1 extension study (ospemifene, n=41; placebo, n= 18) and for subjects in the long-term 52-week safety study (trial 3: ospemifene, n=276; placebo, n=46), endometrial safety was assessed by endometrial biopsy at baseline and at 12 months.
Croatian: U ispitanica koje su dovršile produžetak ispitivanja 1 (ospemifen, n=41; placebo, n=18) i u ispitanica koje su sudjelovale u ispitivanju sigurnosti dugotrajne primjene u trajanju od 52 tjedna (ispitivanje 3: ospemifen, n=276; placebo, n=46), sigurnost za endometrij procijenjena je na temelju biopsije endometrija učinjene na početku ispitivanja i nakon 12 mjeseci.
English: Senshio is not indicated during breast-feeding.
Croatian: Senshio nije indiciran za primjenu tijekom dojenja.
English: 7 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Croatian: OBLIK I SADRŽAJ 7 filmom obloženih tableta 28 filmom obloženih tableta 84 filmom obloženih tableta
English: Rifampicin, a strong CYP3A / CYP2C9 enzyme inducer, decreased the AUC of ospemifene by 58%.
Croatian: Rifampicin, jaki induktor enzima CYP3A / CYP2C9, smanjio je AUC ospemifena za 58%.
English: CYP2C9 poor metabolisers
Croatian: Slabi metabolizatori CYP2C9
English: In in vitro studies ospemifene is a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8 and CYP2D6.
Croatian: U ispitivanjima in vitro ospemifen je slabi inhibitor CYP2B6, CYP2C9, CYP2C19, CYP2C8 i CYP2D6.
English: In healthy subjects, the absorption of ospemifene is not affected by co-administration of oral omeprazole, a medicinal product that increases gastric pH.
Croatian: U zdravih ispitanica na apsorpciju ospemifena ne utječe istodobna primjena oralnog omeprazola, lijeka koji povisuje želučani pH.
English: Ospemifene is primarily metabolised by the liver.
Croatian: Ospemifen se prvenstveno metabolizira u jetri.
English: Decreases in oestrogen levels that occur after the menopause lead to VVA, characterised by decreased maturation of vaginal epithelial cells, a progressive decrease in the vascularity of the vaginal tissues, and decreased lubrication.
Croatian: Pad razine estrogena koji se događa nakon menopauze dovodi do VVA, karakterizirane smanjenim sazrijevanjem stanica vaginalnog epitela, progresivnim smanjenjem vaskularnosti vaginalnih tkiva i smanjenom lubrikacijom.
English: Any of the following medicines, which may lead to a reduced effect of Senshio: Rifampicin and rifabutin commonly used to treat tuberculosis.
Croatian: • bilo kojim od sljedećih lijekova, jer to može smanjiti učinak lijeka Senshio: o rifampicinom i rifabutinom koji se obično koriste za liječenje tuberkuloze o karbamazepinom i fenitoinom koji se koriste zaliječenje konvulzija/napadaja
English: Ospemifene is absorbed rapidly after oral administration, with a Tmax of approximately 3 - 4 hours post-dose in the fed state.
Croatian: Ospemifen se brzo apsorbira nakon peroralne primjene, s Tmax od oko 3 do 4 sata nakon doze uzete nakon jela.
English: Nonclinical findings show that ospemifene and its major metabolite have an oestrogen like effect in the vagina increasing the cellular maturation and mucification of the vaginal epithelium.
Croatian: Neklinički nalazi ukazuju da ospemifen i njegov glavni metabolit imaju na vaginu učinak nalik estrogenu, povećavajući maturaciju i transformaciju stanica vaginalnog epitela u stanice koje luče sluz.
English: Each film-coated tablet contains 60 mg ospemifene.
Croatian: Jedna filmom obložena tableta sadrži 60 mg ospemifena.
English: Ospemifene has not been formally studied in women with a prior history of breast cancer.
Croatian: Ospemifen nije formalno ispitan na ženama koje su imale rak dojke u anamnezi.
English: The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective estrogen receptor modulators (SERMs).
Croatian: Rizik za pojavu VTE (tromboze dubokih vena i plućne embolije) povećan je tijekom primjene drugih selektivnih modulatora estrogenskih receptora (engl. selective oestrogen receptor modulator, SERM).
English: Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Croatian: Aktivni venski tromboembolijski događaji (engl. venous thromboembolic event, VTE) ili takav događaj u anamnezi, uključujući duboku vensku trombozu, plućnu emboliju i trombozu retinalne vene.
English: In total, there were 317 subjects on ospemifene and 64 subjects on placebo who had a baseline as well as a week 52 biopsy.
Croatian: Sveukupno je 317 ispitanica na ospemifenu i 64 ispitanica na placebu bilo podvrgnuto biopsiji na početku ispitivanja i u 52. tjednu.
English: If you forget to take Senshio
Croatian: Ako ste zaboravili uzeti Senshio
English: The safety of using ospemifene concomitantly with oestrogens or other SERMS, such as tamoxifen, toremifene, bazedoxifene and raloxifene, has not been studied and its concurrent use is not recommended.
Croatian: Sigurnost istodobne primjene ospemifena s estrogenima ili drugim selektivnim modulatorima estrogenskih receptora, poput tamoksifena, toremifena, bazedoksifena i raloksifena, nije ispitana te se istodobna primjena ne preporučuje.
English: Oval biconvex, white to off-white, film-coated tablets of dimensions 12 mm x 6.45 mm, debossed with “60” on one side.
Croatian: Ovalne bikonveksne bijele do gotovo bijele filmom obložene tablete dimenzija 12 mm x 6,45 mm, s utisnutom oznakom „60“ na jednoj strani.
English: Relief
Croatian: Olakšanje
English: Senshio is used to treat women with moderate to severe post-menopausal symptoms in and outside the vagina, such as itching, dryness, burning and pain during sex (dyspareunia) if local oestrogen therapy is not suitable.
Croatian: Senshio se koristi za liječenje umjerenih do teških simptoma postmenopauze u i izvan vagine, poput svrbeža, suhoće rodnice, peckanja i boli prilikom snošaja (dispareunija) u žena u kojih lokalna terapija estrogena nije prikladna.
English: Ospemifene's biological actions are mediated through the binding of ospemifene and its major metabolite to oestrogen receptors.
Croatian: Biološka djelovanja ospemifena posredovana su vezivanjem ospemifena i njegovog glavnog metabolita na estrogenske receptore.
English: The recommended dose is one tablet taken orally at the same time each day.
Croatian: Preporučena doza je jedna tableta uzeta kroz usta uvijek u isto doba svaki dan.
English: Senshio contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Croatian: Senshio sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: Systemic exposure (AUC) at the administered doses was 0.3-, 1.0- and 1.2-times the AUC in postmenopausal woman administered 60 mg/day.
Croatian: Sistemska izloženost (AUC) pri primijenjenim dozama bila je 0,3, 1,0 i 1,2 puta veća od AUC-a u žena u postmenopauzi koje su primale 60 mg/dan.
English: Venous thromboembolic events (VTEs)
Croatian: Venski tromboembolijski događaji (VTE)
English: Both CYP2C9 and CYP3A4 are involved in the metabolism of ospemifene.
Croatian: I CYP2C9 i CYP3A4 uključeni su u metabolizam ospemifena.
English: These changes in pharmacokinetics of ospemifene by moderate hepatic impairment are not considered to be clinically significant in consideration of inherent pharmacokinetic variability of ospemifene.
Croatian: Te promjene u farmakokinetici ospemifena uzrokovane umjerenim oštećenjem jetre ne smatraju se klinički značajnim uzimajući u obzir farmakokinetičku varijabilnost ospemifena.
English: These changes result in clinical signs which include vaginal dryness, redness, petechiae, pallor, and friability in the mucosa.
Croatian: Ove promjene imaju za posljedicu pojavu kliničkih znakova koji uključuju suhoću vagine, crvenilo, petehije, bljedilo i fragilnost sluznice.
English: Following a single oral administration of 60 mg ospemifene in the fed state, 17.9%, 10.0% and 1.4% of the administered dose was excreted in faeces as ospemifene, 4hydroxyospemifene and 4'-hydroxyospemifene, respectively.
Croatian: Nakon jednokratne peroralne primjene 60 mg ospemifena nakon jela, 17,9% primijenjene doze izlučuje se fecesom u obliku ospemifena, 10,0% u obliku 4-hidroksiospemifena, odnosno 1,4% u obliku 4'-hidroksiospemifena.
English: The risk of VTE associated with ospemifene cannot be excluded.
Croatian: Rizik za pojavu VTE-a povezanog s ospemifenom ne može se isključiti.
English: In the liver, an increase in hepatocellular tumours were recorded at all ospemifene dose levels.
Croatian: U jetri je zabilježen porast hepatocelularnih tumora pri svim razinama doze ospemifena.
English: Systemic exposure (AUC) at these doses was 2.1-, 4.0- and 4.7-times the AUC in postmenopausal woman administered 60 mg/day.
Croatian: Sistemska izloženost (AUC) pri tim dozama bila je 2,1, 4,0 i 4,7 puta veća od AUC-a u žena u postmenopauzi koje su primale 60 mg/dan.
English: Endometrial safety in women was assessed at baseline and 12 weeks in the two 12-week phase III studies (trials 1 and 2: ospemifene, n=302; placebo, n= 301).
Croatian: Sigurnost za endometrij u žena procjenjivana je na početku i u 12. tjednu u dva ispitivanja faze III u trajanju od 12 tjedana (ispitivanja 1 i 2: ospemifen, n=302; placebo, n=301).
English: Dyspareunia 60 mg OSP Placebo p-value 60 mg OSP Placebo p-value
Croatian: Dispareunija 60 mg OSP Placebo p-vrijednost 60 mg OSP Placebo p-vrijednost
English: In vitro, ospemifene and 4-hydroxyospemifene did not inhibit or induce the activity of CYP450 enzymes at clinically relevant concentrations.
Croatian: In vitro, ospemifen i 4-hidroksiospemifen nisu inhibirali ili inducirali aktivnost enzima CYP450 u klinički relevantnim koncentracijama.
English: In a 2-year carcinogenicity study in female mice, ospemifene caused treatment related increases in neoplastic findings in the adrenal gland and ovary.
Croatian: U dvogodišnjem ispitivanju kancerogenosti na ženkama miša, ospemifen je uzrokovao porast neoplastičkih nalaza u nadbubrežnoj žlijezdi i jajniku povezanih s liječenjem.