FrancophonIA/ELRC3.0 huggingface dataset:
English: Bazedoxifene was not genotoxic or mutagenic in a battery of tests, including in vitro bacterial reverse mutation assay, in vitro mammalian cell forward mutation assay at the thymidine kinase (TK±) locus in L5178Y mouse lymphoma cells, in vitro chromosome aberration assay in Chinese hamster ovary (CHO) cells, and in vivo mouse micronucleus assay.
Slovenian: Bazedoksifen ni bil genotoksičen ali mutagen v seriji testov, med drugim pri in vitro bakterijskem testu reverznih mutacij, in vitro testu naprednih mutacij v sesalskih celicah na lokusu timidinske kinaze (TK±) v celicah mišjega limfoma L5178Y, in vitro testu kromosomskih aberacij v ovarijskih celicah kitajskega hrčka (CHO) in in vivo mikronukleusnem testu pri miših.
English: In clinical trials, the highest rate of VTE was observed during the first year of treatment, with a relative risk of 2.69 compared to placebo.
Slovenian: V kliničnih preskušanjih so največji delež VTE opažali v prvem letu zdravljenja, pri čemer je relativno tveganje v primerjavi s placebom znašalo 2,69.
English: This study included mostly Caucasian (87.3%) subjects who were either osteoporotic without baseline vertebral fracture (BMD T-score at lumbar spine [LS] or femoral neck [FN] between -2.5 and -4.0) or osteoporotic, with at least 1 mild baseline vertebral fracture.
Slovenian: V to študijo so bile vključene večinoma belke (87,3 %), ki so bodisi imele osteoporozo brez izhodiščnega zloma vretenc (ocena T na lestvici MKG na ledveni hrbtenici [LS] ali stegneničnem vratu [FN] med -2,5 in -4,0), bodisi so imele osteoporozo z vsaj enim blagim izhodiščnim zlomom vretenc.
English: The effect of bazedoxifene on BMD at other skeletal sites was similar.
Slovenian: Učinek bazedoksifena na MKG na drugih mestih v skeletu je bil podoben.
English: Very common(may affect more than 1 in 10 people):
Slovenian: Zelo pogosti(pojavijo se lahko pri več kot 1 od 10 bolnic):
English: In subjects with a fracture probability of 20% or greater (n = 618), the risk of non-vertebral fractures in bazedoxifene-treated subjects was decreased by 55% (95% CI: 18-76) compared to placebo-treated subjects.
Slovenian: Pri osebah z verjetnostjo zloma 20 % ali več (n = 618) se je nevarnost nevretenčnih zlomov pri osebah, zdravljenih z bazedoksifenom, v primerjavi z osebami, ki so prejemale placebo, zmanjšala za 55 % (95 % IZ: 18-76).
English: CONBRIZA is associated with an increased risk of venous thromboembolism (VTE).
Slovenian: Zdravilo CONBRIZA je povezano s povečanim tveganjem za pojav venske trombembolije (VTE).
English: Bazedoxifene acts as both an oestrogen-receptor agonist and/or antagonist, depending upon the cell and tissue type and target genes.
Slovenian: Bazedoksifen deluje kot oboje, agonist ali antagonist estrogenskih receptorjev, odvisno od vrste celic in tkiva in pa tarčnih genov.
English: Repeated-dose studies in normally cycling rodents and cynomolgus monkeys revealed a marked stimulation of ovarian follicle growth without ovulation, leading to partly haemorrhagic-ovarian cysts and markedly elevated estradiol levels.
Slovenian: Študije ponavljajočih se odmerkov pri glodalcih in opicah cinomolgus z normalnim ciklom so pokazale izrazito spodbujanje rasti ovarijskih foliklov brez ovulacije, kar povzroči nastanek delno hemoragičnih ovarijskih cist in izrazito zvišano koncentracijo estradiola.
English: No data are available on the concomitant use with agents used in the treatment of early or advanced breast cancer.
Slovenian: O sočasni uporabi z zdravili, ki se uporabljajo za zdravljenje zgodnjega ali napredovalega raka dojk, podatkov ni na voljo.
English: Safety and efficacy of bazedoxifene have not been evaluated in patients with hepatic impairment; use in this population is not recommended (see sections 4.4 and 5.2).
Slovenian: Pri bolnicah z okvaro jeter varnosti in učinkovitosti bazedoksifena niso ovrednotili; uporaba zdravila pri tej skupini bolnic ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: The observation of benign, ovarian granulosa-cell tumours in female mice and rats administered bazedoxifene is a class effect of SERMs, related to its pharmacology in rodents when treated during their reproductive lives, when their ovaries are functional and responsive to hormonal stimulation.
Slovenian: Opaženi benigni ovarijski granulozocelularni tumorji pri mišjih in podganjih samicah, ki so prejemale bazedoksifen, je učinek skupine SERM, ki je povezan z njihovo farmakologijo pri samicah glodalcev, ki jih prejemajo v reproduktivni dobi, ko so njihovi jajčniki funkcionalni in se odzivajo na hormonsko stimulacijo.
English: Effects on the breast
Slovenian: Učinki na maternico
English: Negligible amounts of bazedoxifene were eliminated in urine.
Slovenian: Z urinom se je izločila zanemarljiva količina bazedoksifena.
English: if you have any vaginal bleeding while you take CONBRIZA, you should speak with your doctor.
Slovenian: če med jemanjem zdravila CONBRIZA začnete krvaveti iz nožnice, se morate pogovoriti z zdravnikom.
English: White to off-white, capsule-shaped, film-coated tablet debossed on one side with “WY20”.
Slovenian: Bela do sivobela, po obliki kapsuli podobna filmsko obložena tableta z napisom “WY20”, vtisnjenim na eni strani.
English: Bazedoxifene functions primarily as an oestrogen-receptor antagonist in uterine and breast tissues.
Slovenian: Bazedoksifen deluje primarno kot antagonist estrogenskih receptorjev v tkivih maternice in dojk.
English: In vitro data suggest that bazedoxifene is unlikely to interact with co-administered medicinal products via CYP-mediated metabolism.
Slovenian: Podatki in vitro kažejo, da je malo verjetno, da bazedoksifen medsebojno deluje s sočasno danimi zdravili preko presnove, ki jo uravnava CYP.
English: CONBRIZA has only been studied in women who have reached menopause, and therefore is not recommended.
Slovenian: Zdravilo CONBRIZA so raziskovali le pri ženskah, ki so dosegle menopavzo, zato ga pri ženskah pred menopavzo ne priporočamo.
English: Additionally, uterine wet weights were reduced compared with untreated animals and histologic evaluation demonstrated little to no difference from the untreated controls.
Slovenian: Poleg tega je bila vlažna teža maternice v primerjavi z živalmi, ki niso prejemale bazedoksifena, zmanjšana, histološki pregled pa je pokazal malo ali nič razlik med njimi in kontrolno skupino.
English: The disposition of a single 20 mg dose of bazedoxifene was compared in patients with hepatic impairment [Child-Pugh Class A (n=6), B (n=6), and C (n=6)] and subjects with normal hepatic function (n=18).
Slovenian: Primerjali so presnovo enkratnega 20 mg odmerka bazedoksifena pri bolnicah z okvaro jeter [razredi A (n = 6), B (n = 6) in C (n = 6) po Child-Pughovi lestvici] in bolnicah z normalnim delovanjem jeter (n = 18).
English: If you stop taking CONBRIZA
Slovenian: Če ste prenehali uporabljati zdravilo CONBRIZA
English: What CONBRIZA looks like and contents of the pack
Slovenian: Izgled zdravila CONBRIZA in vsebina pakiranja
English: Patients with hepatic impairment showed a 4.3-fold increase in area under the curve (AUC) [on average] compared with controls.
Slovenian: Bolnice z okvarami jeter so v primerjavi s kontrolno skupino pokazale 4,3-kratno zvečanje površine pod krivuljo (AUC) [povprečno].
English: CONBRIZA is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.
Slovenian: Zdravilo CONBRIZA je indicirano za zdravljenje postmenopavzalne osteoporoze pri ženskah z zvečanim tveganjem zlomov.
English: In the breast-density study, an ancillary study of the osteoporosis treatment study, 444 postmenopausal women (mean age = 59 years) with osteoporosis from all 4 treatment groups, were evaluated for mammographic breast density changes at 24 months.
Slovenian: V študiji preverjanja gostote dojk, stranski študiji ob študiji zdravljenja osteoporoze, je bilo ocenjenih 444 žensk v obdobju po menopavzi (povprečna starost = 59 let) z osteoporozo iz vseh 4 skupin zdravljenja, glede na spremembe v mamografski gostoti dojk po 24 mesecih.
English: Subjects with no baseline fracture n=757
Slovenian: Osebe brez izhodiščnih zlomov n = 757
English: On average, patients with hepatic impairment showed a 4.3-fold increase in AUC compared with controls.
Slovenian: Bolnice z okvaro jeter so v primerjavi s kontrolno skupino pokazale v povprečju 4,3-kratno zvečanje AUC.
English: Blood triglycerides increased, alanine aminotransferase increased, aspartate aminotransferase increased.
Slovenian: Preiskave zvišani trigliceridi v krvi, zvišana alaninaminotransferaza, zvišana aspartataminotransferaza
English: On average, compared to women 51 to 64 years of age (n=8), women 65 to 74 years of age (n=8) showed a 1.5-fold increase in AUC, and women 75 years of age (n=8) showed a 2.3-fold increase in AUC.
Slovenian: V primerjavi z ženskami, starimi 51 do 64 let (n = 8), so imele ženske, stare 65 do 74 let (n = 8), 1,5-krat večjo AUC, ženske, stare  75 let (n = 8), pa 2,3-krat večjo AUC.
English: If you take more CONBRIZA than you should
Slovenian: Če ste vzeli večji odmerek zdravila CONBRIZA, kot bi smeli
English: The effect on triglycerides in the bazedoxifene 20 mg and raloxifene 60 mg groups was similar to placebo.
Slovenian: Učinek na trigliceride v skupinah z bazedoksifenom v odmerku 20 mg in raloksifenom v odmerku 60 mg je bil podoben učinku placeba.
English: After 7 years of treatment with bazedoxifene the increases in BMD relative to placebo remained statistically significant at the femoral neck, femoral trochanter, and total hip.
Slovenian: Po sedmih letih zdravljenja z bazedoksifenom so povečanja MKG v primerjavi s placebom ostala statistično pomembna za stegnenični vrat, stegnenični trohanter in celoten kolk.
English: Subjects with 1 baseline fracture n=967
Slovenian: Osebe z ≥ 1 izhodiščnim zlomom n = 967
English: Like the rodent results, bazedoxifene treatment in non-human primates resulted in uterine and mammary gland atrophy without other histological differentiation from untreated animals.
Slovenian: Podobno kot pri glodalcih je dajanje bazedoksifena nehumanim primatom povzročilo atrofijo maternice in mlečnih žlez brez drugih histoloških razlik v primerjavi z živalmi, ki niso prejemale bazedoksifena.
English: Paediatric population There is no relevant use of bazedoxifene in the paediatric population.
Slovenian: Pediatrična populacija Bazedoksifen ni primeren za uporabo pri pediatrični populaciji.
English: It may increase serum triglyceride levels; therefore, caution should be exercised in patients with known hypertriglyceridaemia (see section 5.1).
Slovenian: Ker bazedoksifen lahko zviša koncentracijo trigliceridov v serumu, je pri bolnicah z znano hipertrigliceridemijo potrebna previdnost (glejte poglavje 5.1).
English: Systemic exposure (AUC) of bazedoxifene in these groups was 2.6 and 6.6 times that observed in postmenopausal women administered 20 mg/day for 14 days.
Slovenian: Sistemska izpostavljenost (AUC) bazedoksifenu v teh skupinah je bila 2,6-krat oziroma 6,6-krat večja kot pri ženskah v postmenopavzi, ki so 14 dni prejemale po 20 mg/kg/dan.
English: The underlying nature of these events is uncertain.
Slovenian: Vzrok teh učinkov ni natančno znan.
English: Treatment of rats at maternally toxic doses 1 mg/kg/day (0.3 times the human exposure) resulted in reduced numbers of live foetuses and/or reductions in foetal body weights.
Slovenian: Odmerki  1 mg/kg/dan ( 0,3-kratna izpostavljenost pri človeku) so pri podganah povzročili zmanjšano število živih plodov in/ali zmanjšanje njihove telesne mase.
English: The increases in BMD relative to placebo remained statistically significant at all skeletal sites throughout the 5 years of treatment with bazedoxifene.
Slovenian: Povečanja MKG v primerjavi s placebom so v petih letih zdravljenja z bazedoksifenom ostala statistično pomembna na vseh mestih v skeletu.
English: Paediatric population The pharmacokinetics of bazedoxifene have not been studied in the paediatric population.
Slovenian: Pediatrična populacija Pri pediatrični populaciji farmakokinetike bazedoksifena niso proučevali.
English: Systemic exposure (AUC) to bazedoxifene in these groups was 35 and 69 times that in postmenopausal women administered 20 mg/day for 14 days.
Slovenian: Sistemska izpostavljenost (AUC) bazedoksifenu pri teh skupinah je bila 35-krat oziroma 69-krat večja kot pri ženskah v postmenopavzi, ki so 14 dni dobivale po 20 mg/dan.
English: These reports include visual acuity reduced, blurred vision, photopsia, visual field defect, visual impairment, dry eye, eyelid oedema, blepharospasm, eye pain and eye swelling.
Slovenian: Ta poročila vključujejo zmanjšanje ostrine vida, zamegljen vid, fotopsijo, izpad vidnega polja, okvaro vida, suhe oči, edem očesne veke, blefarospazem, bolečine v očesu in otekanje očesa.
English: If ocular symptoms occur, patients should be advised to seek medical attention.
Slovenian: Če se očesni neželeni učinki pojavijo, naj bolnica poišče medicinsko pomoč.
English: Median reductions from baseline over 25% for C-telopeptide and osteocalcin were observed with bazedoxifene therapy.
Slovenian: Pri zdravljenju z bazedoksifenom so ugotovili mediano znižanje C-telopeptida in osteokalcina od izhodišča za več kot 25 %.
English: Female rats were administered daily doses of 0.3 to 30 mg/kg (0.03 to 8 times the human exposure) prior to and during mating with untreated males.
Slovenian: Podganje samice so prejemale dnevne odmerke od 0,3 do 30 mg/kg na dan (0,03- do 8-kratnik izpostavljenosti pri človeku) pred parjenjem s samci, ki niso prejeli zdravila, in po njem.
English: Such discontinuation was statistically significant more frequently in the placebo group (4.0%) than in the bazedoxifene 20 mg (2.8%) or raloxifene 60 mg (2.1%) groups.
Slovenian: Taka izključitev je bila pogosteje statistično pomembna v skupini s placebom (4,0 %) kot v skupini z bazedoksifenom v odmerku 20 mg (2,8 %) ali raloksifenom v odmerku 60 mg (2,1 %).
English: Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Slovenian: Sedanja ali pretekla anamneza venskih trombemboličnih dogodkov, vključno z globoko vensko trombozo, pljučno embolijo in trombozo ven mrežnice.
English: The incidence of non-vertebral osteoporosis-related fractures was similar among bazedoxifene 20 mg (5.68%), raloxifene 60 mg (5.87%), and placebo (6.26%) groups.
Slovenian: Pojavnost nevretenčnih zlomov, povezanih z osteoporozo, je bila v skupinah, ki so prejemale bazedoksifen v odmerku 20 mg (5,68 %), raloksifen v odmerku 60 mg (5,87 %) in placebo (6,26 %), podobna.
English: Unexplained uterine bleeding.
Slovenian: Nepojasnjena maternična krvavitev.
English: Bazedoxifene belongs to a class of compounds known as selective estrogen receptor modulators (SERMs).
Slovenian: Bazedoksifen spada v skupino selektivnih modulatorjev estrogenskih receptorjev (SERM).
English: Deep vein thrombosis*, thrombophlebitis superficial
Slovenian: Žilne bolezni vročinski oblivi globoka venska tromboza*, površinski tromboflebitis
English: Bazedoxifene has not been studied in women with triglyceride levels 300 mg/dl (3.4 mmol/litre).
Slovenian: Pri ženskah s koncentracijo trigliceridov  300 mg/dl ( 3,4 mmol/liter) bazedoksifena niso proučevali.
English: CONBRIZA is supplied as a white to off-white, capsule-shaped, film-coated tablet marked with “WY20”.
Slovenian: Zdravilo CONBRIZA je na voljo v obliki belih do sivobelih, po obliki kapsuli podobnih filmsko obloženih tablet z napisom “WY20”.
English: The reduction in the incidence of vertebral fracture was similar among bazedoxifene and raloxifene treatment groups.
Slovenian: Zmanjšanje incidence zlomov vretenc je bilo v skupinah, zdravljenih z bazedoksifenom in raloksifenom, podobno.
English: Bazedoxifene is rapidly absorbed with a tmax of approximately 2 hours and exhibits a linear increase in plasma concentrations for single doses from 0.5 mg up to 120 mg and multiple daily doses from 1 mg to 80 mg.
Slovenian: Bazedoksifen se hitro absorbira s tmax približno 2 uri in kaže linearno zvišanje plazemskih koncentracij pri enkratnih odmerkih od 0,5 mg do 120 mg in večkratnih dnevnih odmerkih od 1 mg do 80 mg. Absolutna biološka uporabnost bazedoksifena je približno 6 %.
English: The safety of CONBRIZA has been evaluated in two multicentre, double-blind, randomised, placeboand active-control, Phase 3 trials: 7,492 evaluable postmenopausal women in a three-year osteoporosis treatment trial (1,886 women received bazedoxifene 20 mg; 1,872 women received bazedoxifene 40 mg; 1,849 women received raloxifene; 1,885 women received placebo) and 1,583 evaluable postmenopausal women in a 2-year osteoporosis prevention trial (321 women received bazedoxifene 10 mg; 322 women received bazedoxifene 20 mg; 319 women received bazedoxifene 40 mg; 311 women received raloxifene; 310 women received placebo).
Slovenian: Varnost zdravila CONBRIZA so ovrednotili v dveh multicentričnih, dvojno slepih, randomiziranih, s placebom in zdravilno učinkovino nadzorovanih preskušanjih 3. faze: 7.492 žensk v postmenopavzi, ki jih je bilo mogoče ovrednotiti, v triletnem preskušanju zdravljenja osteoporoze (1.886 žensk je prejemalo bazedoksifen v odmerku 20 mg; 1.872 žensk je prejemalo bazedoksifen v odmerku 40 mg; 1.849 žensk je prejemalo raloksifen; 1.885 žensk je prejemalo placebo) in 1.583 žensk v postmenopavzi, ki jih je bilo mogoče ovrednotiti, v 2-letnem preskušanju preprečevanja osteoporoze (321 žensk je prejemalo bazedoksifen v odmerku 10 mg; 322 žensk je prejemalo bazedoksifen v odmerku 20 mg; 319 žensk je prejemalo bazedoksifen v odmerku 40 mg; 311 žensk je prejemalo raloksifen; 310 žensk je prejemalo placebo).
English: CONBRIZA 20 mg film-coated tablets Bazedoxifene
Slovenian: CONBRIZA 20 mg filmsko obložene tablete bazedoksifen
English: Some patients have experienced the following side effects while taking CONBRIZA:
Slovenian: Nekatere bolnice so med jemanjem zdravila CONBRIZA opazilenaslednje neželene učinke:
English: A total of 1,732 subjects continued into the second 2-year extension (bazedoxifene 20 mg: n=560, bazedoxifene 40/20 mg: n=582, and placebo: n=590).
Slovenian: Skupno 1.732 oseb je nadaljevalo v drugo 2-letno podaljšanje (bazedoksifen 20 mg: n = 560, bazedoksifen 40/20 mg: n = 582, placebo n = 590).
English: Mean changes in mammographic breast density in the bazedoxifene 20 mg group were significantly reduced from baseline (-1.45 percentage points, p<0.05) while no changes were observed in the placebo group (-0.15 percentage points).
Slovenian: Povprečne vrednosti sprememb mamografske gostote dojk v skupini, ki je prejemala bazedoksifen v odmerku 20 mg, so bile pomembno zmanjšane glede na izhodiščno vrednost (-1,45 odstotnih točk, p < 0,05), medtem ko v skupini, ki je prejemala placebo, niso opažali nobenih sprememb (-0,15 odstotnih točk).
English: The safety of CONBRIZA in patients with breast cancer has not been studied.
Slovenian: Varnosti zdravila CONBRIZA pri bolnicah z rakom dojk niso proučevali.
English: In monkeys, treatment with bazedoxifene for 18 months resulted in the partial preservation of cortical and cancellous bone mass as determined by BMD measurements.
Slovenian: Pri opicah je 18-mesečno dajanje bazedoksifena povzročilo delno ohranitev kortikalne in retikularne kostne mase, kar je bilo ugotovljeno z meritvami MKG.
English: Patients may experience visual symptoms such as visual acuity disturbance or blurred vision.
Slovenian: Bolnice lahko doživijo motnje vida, kot so motena ostrina vida ali zamegljen vid.
English: Bazedoxifene caused corticomedullar nephrocalcinosis and enhanced spontaneous chronic progressive nephropathy (CPN) in male rats.
Slovenian: Pri podganjih samcih je bazedoksifen povzročil kortikomedularno nefrokalcinozo in zvečal spontano kronično progresivno nefropatijo (CPN).
English: In 6-month carcinogenicity studies in transgenic mice, there was an increased incidence of benign, ovarian granulosa-cell tumours in female mice given 150 or 500 mg/kg/day.
Slovenian: V 6-mesečnih študijah kancerogenosti na transgenskih miših se je zvečala pojavnost benignih ovarijskih granulozocelularnih tumorjev pri mišjih samicah, ki so prejemale po 150 ali 500 mg/kg/dan.
English: The prevention study (1,583 subjects; mean age, 58 years; mean years since menopause, 11) compared BMD effects of bazedoxifene (10, 20, or 40 mg daily), raloxifene (60 mg daily), and placebo.
Slovenian: V študiji preprečevanja (1.583 oseb; povprečna starost 58 let; povprečno število let od menopavze 11) so primerjali učinke bazedoksifena (10, 20 ali 40 mg na dan), raloksifena (60 mg na dan) in placeba na MKG.
English: In a 2-year carcinogenicity study in rats, an increased incidence of benign, ovarian granulosa-cell tumours was observed in female rats at dietary concentrations of 0.03 and 0.1%.
Slovenian: V dveletni študiji kancerogenosti na podganah so ugotovili zvečano pojavnost benignih ovarijskih granulozocelularnih tumorjev pri podganjih samicah pri koncentracijah v hrani 0,03 in 0,1 %.
English: How to take CONBRIZA
Slovenian: Kako jemati zdravilo CONBRIZA
English: Bazedoxifene decreases bone resorption and reduces biochemical markers of bone turnover to the premenopausal range.
Slovenian: Bazedoksifen zmanjšuje resorpcijo kosti in biokemijske markerje premene kostnine na razpon vrednosti, običajen pred menopavzo.
English: Limited clinical data (n=5) are available in subjects with moderate renal impairment (CrCl  50 ml/min).
Slovenian: Pri bolnicah z zmerno okvaro ledvic (CrCl  50 ml/min) je na voljo malo kliničnih podatkov (n = 5).
English: If you have any further questions on the use or stopping the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: In the osteoporosis treatment study, the incidence of breast-related adverse events in the bazedoxifene group was similar to placebo at 3 years.
Slovenian: V študiji zdravljenja osteoporoze je bila po 3 letih pojavnost z dojkami povezanih neželenih dogodkov v skupini z bazedoksifenom podobna kot v skupini s placebom.
English: You may notice problems with your eyesight such as blurred vision while taking this medicine.
Slovenian: Med jemanjem tega zdravila lahko opazite težave z vidom, kot je zamegljen vid.
English: The median percent change from baseline of total cholesterol, LDL cholesterol and HDL cholesterol with bazedoxifene 20 mg were -3.75%, -5.36% and 5.10%, respectively, and were similar to that observed with raloxifene 60 mg.
Slovenian: Mediane odstotne spremembe od izhodišča pri bazedoksifenu v odmerku 20 mg so bile -3,75 % za celotni holesterol, -5,36 % za LDL holesterol in 5,10 % za HDL holesterol in so bile podobne tistim, ki so jih opazili pri raloksifenu v odmerku 60 mg.
English: CONBRIZA contains lactose
Slovenian: Zdravilo CONBRIZA vsebuje laktozo
English: The increase in LS BMD with bazedoxifene 20 mg and raloxifene 60 mg, compared with placebo, was significant at 6 months (1.14% and 1.26%, respectively) and was maintained through 2 years (1.41% and 1.49%, respectively).
Slovenian: Zvečanje MKG ledvene hrbtenice pri bazedoksifenu v odmerku 20 mg in raloksifenu v odmerku 60 mg je bilo v primerjavi s placebom značilno po 6 mesecih (1,14 % oziroma 1,26 %) in je trajalo 2 leti (1,41 % oziroma 1,49 %).
English: This study included subjects who had a LS or FN neck BMD T-score no less than -2.5.
Slovenian: V to študijo so bile vključene osebe, ki so imele oceno T MKG ledvene hrbtenice ali stegneničnega vratu vsaj -2.5.
English: In the 2-year carcinogenicity study, bazedoxifene, administered orally in the diet to rats at dosages of 0, 0.003%, 0.01%, 0.03%, or 0.1%, resulted in exposures, based on surface area (mg/m2) of approximately 0.6 to 23 times and 0.9 to 31 times in males and females, respectively, the clinical dose of 20 mg.
Slovenian: V dveletni študiji kancerogenosti je bazedoksifen, ki so ga dajali podganam peroralno v hrani v odmerkih 0, 0,003 %, 0,01 %, 0,03 % ali 0,1 %, povzročil izpostavljenosti, izražene na telesno površino (mg/m2), ki so se pri samcih oziroma samicah za 0,6- do 23-krat oziroma 0,9- do 31-krat razlikovale od tiste pri kliničnem odmerku 20 mg.