FrancophonIA/ELRC3.0 huggingface dataset:
English: In a post-hoc analysis, the relative risk of non-vertebral fractures in bazedoxifene-treated subjects decreased with increased fracture probability.
Croatian: U post-hoc analizi se relativan rizik za nevertebralne prijelome u ispitanica liječenih bazedoksifenom smanjivao kako se vjerojatnost prijeloma povećavala.
English: The major route of excretion of radio-labelled bazedoxifene is the faeces, and less than 1% of the dose is eliminated in urine.
Croatian: Radioaktivno označen bazedoksifen izlučuje se prvenstveno fecesom, a manje od 1% doze eliminira se mokraćom.
English: In a post-hoc analysis, the 10-year fracture probability as an index of baseline fracture risk was determined.
Croatian: U post-hoc analizi utvrđena je 10-godišnja vjerojatnost prijeloma, izražena kao indeks početnog rizika prijeloma.
English: Additionally, uterine wet weights were reduced compared with untreated animals and histologic evaluation demonstrated little to no difference from the untreated controls.
Croatian: Osim toga, u usporedbi s neliječenim životinjama smanjena je mokra masa maternice, a histološka procjena pokazala je male ili nikakve razlike u odnosu na neliječene kontrolne životinje.
English: Very common(may affect more than 1 in 10 people):
Croatian: Vrlo često(mogu se javiti u više od 1 na 10osoba):
English: The active substance is bazedoxifene.
Croatian: Djelatna tvar je bazedoksifen.
English: White to off-white, capsule-shaped, film-coated tablet debossed on one side with “WY20”.
Croatian: Bijela do gotovo bijela filmom obložena tableta u obliku kapsule, s utisnutom oznakom "WY20" na jednoj strani.
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.
Croatian: U usporedbi sa ženama u dobi od 51 do 64 godine (n=8), u žena u dobi između 65 i 74 godine (n=8) zabilježen je prosječan porast AUC-a za 1,5 puta, a u žena u dobi od > 75 godina (n=8) prosječan porast AUC-a za 2,3 puta.
English: Use in this population is not recommended (see sections 4.2 and 5.2).
Croatian: Ne preporučuje se primjena u ovoj populaciji (vidjeti dijelove 4.2 i 5.2).
English: CONBRIZA contains the active substance bazedoxifene, and is a medicine that belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs).
Croatian: CONBRIZA sadrži djelatnu tvar bazedoksifen i pripada skupini nehormonskih lijekova koji se nazivaju selektivnim modulatorima estrogenskih receptora.
English: The most frequent drug-related adverse reactions in double-blind, randomised studies were hot flushes and muscle spasms (includes leg cramps).
Croatian: Najčešće nuspojave povezane s primjenom lijeka u dvostruko slijepim, randomiziranim ispitivanjima bili su valunzi i grčevi mišića (uključujući grčeve u nogama).
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.
Croatian: U kliničkim je ispitivanjima najviša stopa VTE-a zabilježena u prvoj godini liječenja, uz relativan rizik od 2,69 u usporedbi s placebom.
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.
Croatian: Ženkama štakora primijenjene su dnevne doze od 0,3 do 30 mg/kg (izloženost 0,03 do 8 puta veća od one u ljudi) prije i tijekom parenja s mužjacima koji nisu primali lijek.
English: Bazedoxifene must not be taken by women of child-bearing potential (see sections 4.6 and 5.3).
Croatian: Bazedoksifen ne smiju uzimati žene reproduktivne dobi (vidjeti dijelove 4.6 i 5.3).
English: The pharmacokinetics of a 20 mg single-dose of bazedoxifene were evaluated in a study in 26 healthy postmenopausal women.
Croatian: Farmakokinetika jedne doze bazedoksifena od 20 mg ocijenjena je u ispitivanju sa 26 zdravih žena u postmenopauzi.
English: CONBRIZA has minor influence on the ability to drive and use machines.
Croatian: CONBRIZA zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: CONBRIZA 20 mg film-coated tablets
Croatian: CONBRIZA 20 mg filmom obložene tablete
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).
Croatian: Sigurnost i djelotvornost bazedoksifena nisu ispitivane u bolesnica s oštećenjem jetre; ne preporučuje se primjena u ovoj populaciji (vidjeti dijelove 4.4 i 5.2).
English: CONBRIZA is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.
Croatian: CONBRIZA je indicirana za liječenje postmenopauzalne osteoporoze u žena s povećanim rizikom od prijeloma.
English: Bazedoxifene functions primarily as an oestrogen-receptor antagonist in uterine and breast tissues.
Croatian: Bazedoksifen primarno djeluje kao antagonist estrogenskih receptora u tkivima maternice i dojki.
English: Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Croatian: Sadašnji ili raniji venski tromboembolijski događaji, uključujući duboku vensku trombozu, plućnu emboliju i trombozu mrežnične vene.
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.
Croatian: Primjena u štakora u dozama toksičnima za majku od  1 mg/kg na dan (0,3 puta veća izloženost nego u ljudi) rezultirala je manjim brojem živih fetusa i/ili smanjenjem tjelesne težine fetusa.
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.
Croatian: Bazedoksifen se brzo apsorbira, uz tmax od približno 2 sata, a koncentracije u plazmi rastu linearno nakon primjene jedne doze u rasponu od 0,5 mg do 120 mg i višestrukih dnevnih doza od 1 mg do 80 mg.
English: Paediatric population There is no relevant use of bazedoxifene in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene bazedoksifena u pedijatrijskoj populaciji
English: In subjects treated with bazedoxifene, the incidence of fractures was related to the baseline fracture risk: the higher the fracture risk, the greater the benefit with bazedoxifene treatment.
Croatian: U ispitanica liječenih bazedoksifenom incidencija prijeloma bila je povezana s početnim rizikom od prijeloma: što je taj rizik bio veći, to je bila veća korist liječenja bazedoksifenom.
English: Safety and efficacy have not been evaluated further in patients with hepatic insufficiency.
Croatian: Sigurnost primjene i djelotvornost nisu dodatno ispitivane u bolesnica s oštećenjem jetre.
English: Patients with hepatic impairment showed a 4.3-fold increase in area under the curve (AUC) [on average] compared with controls.
Croatian: U bolesnica s oštećenjem jetre zabilježeno je povećanje područja ispod krivulje (AUC) za [prosječno] 4,3 puta u odnosu na kontrolne ispitanice.
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).
Croatian: Uspoređena je raspoloživost jedne doze bazedoksifena od 20 mg u bolesnica s oštećenjem jetre [Child-Pugh stadij A (n=6), B (n=6) i C (n=6)] i ispitanica s normalnom jetrenom funkcijom (n=18).
English: CONBRIZA is supplied as a white to off-white, capsule-shaped, film-coated tablet marked with “WY20”.
Croatian: CONBRIZA je dostupna u obliku bijele do gotovo bijele filmom obložene tablete u obliku kapsule, s oznakom "WY20".
English: It may increase serum triglyceride levels; therefore, caution should be exercised in patients with known hypertriglyceridaemia (see section 5.1).
Croatian: Ovaj lijek može povisiti razine triglicerida u serumu te je potreban oprez u bolesnica s hipertrigliceridemijom (vidjeti dio 5.1).
English: Elderly patients No dose adjustment is necessary based on age (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu s obzirom na dob (vidjeti dio 5.2).
English: Bazedoxifene decreases bone resorption and reduces biochemical markers of bone turnover to the premenopausal range.
Croatian: Bazedoksifen smanjuje resorpciju kosti te snižava biokemijske pokazatelje koštane pregradnje na predmenopauzalne razine.
English: The other ingredients are lactose monohydrate (see section 2 “CONBRIZA contains lactose”), microcrystalline cellulose, pre-gelatinised starch (maize), sodium starch glycolate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171) and macrogol 400.
Croatian: Drugi sastojci su laktoza hidrat (vidjeti dio 2 "CONBRIZA sadrži laktozu"), mikrokristalična celuloza, prethodno geliran škrob (kukuruzni), natrijev škroboglikolat, natrijev laurilsulfat, bezvodni, koloidni silicijev dioksid, magnezijev stearat, askorbatna kiselina, hipromeloza, titanijev dioksid (E171) i makrogol 400.
English: When single doses of 20 mg bazedoxifene were administered with a high-fat meal, Cmax and AUC increased by 28% and 22%, respectively.
Croatian: Kad su pojedinačne doze od 20 mg bazedoksifena primijenjene uz punomasan obrok, Cmax je porastao za 28%, a AUC za 22%.
English: CONBRIZA has only been studied in women who have reached menopause, and therefore is not recommended.
Croatian: CONBRIZA je ispitivana samo u žena koje su ušle u menopauzu te se stoga ne preporučuje u žena prije menopauze.
English: The partial preservation of bone mass was achieved by reductions in the ovariectomy-induced increases in bone turnover, evaluated by biochemical markers of bone turnover and histomorphometric indices measured in cancellous and cortical bone.
Croatian: Djelomično očuvanje koštane mase postignuto je smanjenjem ovarijektomijom uzrokovanog povećanja koštane pregradnje, što je procijenjeno vrijednostima biokemijskih pokazatelja koštane pregradnje i histomorfometrijskim indeksima izmjerenima u spongioznoj i kortikalnoj kosti.
English: CONBRIZA contains lactose
Croatian: CONBRIZA sadrži laktozu
English: Paediatric population The pharmacokinetics of bazedoxifene have not been studied in the paediatric population.
Croatian: Pedijatrijska populacija Farmakokinetika bazedoksifena nije ispitivana u pedijatrijskoj populaciji.
English: Negligible amounts of bazedoxifene were eliminated in urine.
Croatian: Mokraćom je eliminirana neznatna količina bazedoksifena.
English: Total number of subjects n=1,724 n=1,741
Croatian: Ukupan broj ispitanica n=1724
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.
Croatian: Bazedoksifen se nije pokazao genotoksičnim niti mutagenim u nizu testova, uključujući in vitro bakterijski test reverzne mutacije, in vitro test genskih mutacija stanica sisavaca na lokusu timidin kinaze (TK±) u stanicama mišjeg limfoma L5178Y, in vitro test kromosomske aberacije na stanicama jajnika kineskog hrčka te mikronukleusni test na miševima in vivo.
English: In vitro data suggest that bazedoxifene is unlikely to interact with co-administered medicinal products via CYP-mediated metabolism.
Croatian: Podaci dobiveni in vitro upućuju na to da bazedoksifen vjerojatno neće ulaziti u interakcije s istodobno primijenjenim lijekovima preko CYP-posredovanog metabolizma.
English: This must be investigated by your doctor.
Croatian: Vaš liječnik mora ispitati uzrok tog krvarenja.
English: as it may increase your risk of getting blood clots.
Croatian: jer ovaj lijek može povećati rizik od nastajanja krvnih ugrušaka.
English: The metabolic disposition of bazedoxifene in postmenopausal women has been determined following oral administration of 20 mg of radio-labelled bazedoxifene.
Croatian: Metabolička dispozicija bazedoksifena u postmenopauzalnih žena određena je nakon peroralne primjene doze od 20 mg radioaktivno označenog bazedoksifena.
English: Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids).
Croatian: suho oko, bol u oku, smanjena oštrina vida, oštećenje vida, blefarospazam (abnormalno, nevoljno žmirkanje ili grč očnih kapaka).
English: In a 30-day study, bazedoxifene increased hormone-binding globulin concentrations, including corticosteroid-binding globulin (CBG), sex hormone-binding globulin (SHBG) and thyroxine-binding globulin (TBG).
Croatian: U 30-dnevnom ispitivanju bazedoksifen je povisio koncentracije globulina koji veže hormone, uključujući globulin koji veže kortikosteroide, globulin koji veže spolne hormone i globulin koji veže tiroksin.
English: The apparent oral clearance of bazedoxifene is approximately 4 to 5 l/h/kg.
Croatian: Prividan klirens bazedoksifena nakon peroralne primjene je približno 4 do 5 l/h/kg.
English: An additional study evaluating the effects of a standardized medium-fat meal on the pharmacokinetics of bazedoxifene at steady-state showed a 42% and 35% increase in Cmax and AUC, respectively, when 20 mg bazedoxifene was administered with food.
Croatian: Dodatno ispitivanje u kojemu su ispitivani učinci standardiziranog umjereno masnog obroka na farmakokinetiku bazedoksifena u stanju dinamičke ravnoteže pokazalo je povećanje Cmax za 42%, a AUC-a za 35% kada se doza bazedoksifena od 20 mg primjenjivala s hranom.
English: Bazedoxifene has not been sufficiently evaluated in patients with severe renal impairment; caution should be used in this population.
Croatian: Bazedoksifen nije dovoljno ispitan u bolesnica s teškim oštećenjem bubrega te je potreban oprez kod primjene u ovoj populaciji.
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.
Croatian: Slično rezultatima u glodavaca, primjena bazedoksifena u nečovjekolikih primata dovela je do atrofije maternice i mliječnih žlijezda, bez drugih histoloških razlika u odnosu na životinje koje nisu primale bazedoksifen.
English: If you have signs of a blood clot in the eye (retinal vein), such as one sided visual disturbance or visual impairment or blurring or loss of vision in one eye.
Croatian: Ako se pojave znakovi krvnog ugruška u oku (mrežnična vena) poput smetnje vida na jednom oku ili oštećenje vida ili zamagljen vid ili gubitak vida na jednom oku.
English: CONBRIZA contains lactose.
Croatian: CONBRIZA sadrži laktozu.
English: No dose adjustment is required for mild or moderate renally impaired patients.
Croatian: Nije potrebno prilagođavati dozu u bolesnica s blagim ili umjerenim oštećenjem bubrega.
English: This medicine should be taken with an adequate amount of calcium and vitamin D. Consult your doctor to see if your dietary calcium and vitamin D intake is adequate and whether you need calcium and vitamin D supplementation.
Croatian: Porazgovarajte sa svojim liječnikom o tome unosite li prehranom dovoljno kalcija i vitaminaD ili trebate uzimati nadomjeske kalcija i vitaminaD.
English: Steady-state concentrations are achieved by the second week of once-daily administration.
Croatian: Koncentracije u stanju dinamičke ravnoteže postižu se do drugog tjedna primjene jedanput na dan.
English: See leaflet for further information.
Croatian: Vidjeti Uputu o lijeku za dodatne informacije
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.
Croatian: Incidencija nevertebralnih osteoporotičnih prijeloma bila je podjednaka u skupinama koje su primale bazedoksifen u dozi od 20 mg (5,68%), raloksifen u dozi od 60 mg (5,87%) i placebo (6,26%).
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.
Croatian: Sistemska izloženost bazedoksifenu (AUC) u tim je skupinama bila 2,6 odnosno 6,6 puta veća od izloženosti u postmenopauzalnih žena koje su primale dozu od 20 mg dnevno tijekom 14 dana.
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.
Croatian: Nalaz benignih tumora granuloznih stanica jajnika u ženki miševa i štakora kojima je primijenjen bazedoksifen predstavlja učinak razreda selektivnih modulatora estrogenskih receptora, povezan s njihovom farmakologijom u ženki glodavaca kojima se primjenjuju u reproduktivnoj dobi, kada su im jajnici funkcionalni i odgovaraju na hormonsku stimulaciju.
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.
Croatian: Nakon sedam godina liječenja bazedoksifenom porast BMD-a u odnosu na placebo zadržao je statističku značajnost na vratu bedrene kosti, trohanteru bedrene kosti i cijelom kuku.
English: Effects on the breast
Croatian: Učinci na maternicu
English: After 3 years the relative risk was 1.63 and after a 5 year study period the relative risk was 1.50; after 7 years the relative risk was 1.51 (see sections 4.8 and 5.1).
Croatian: Relativan rizik nakon 3 godine bio je 1,63, nakon 5 godina 1,50, a nakon 7 godina ispitivanja 1,51 (vidjeti dijelove 4.8 i 5.1).
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.
Croatian: U ovo su ispitivanje većinom bile uključene ispitanice bijele rase (87,3%), koje su ili imale osteoporozu bez prijeloma kralješka na početku ispitivanja (T-vrijednosti BMD-a na lumbalnom dijelu kralježnice ili vratu bedrene kosti između -2,5 i -4,0) ili osteoporozu uz najmanje jedan blagi prijelom kralješka na početku ispitivanja.
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.
Croatian: 6-mjesečnim ispitivanjima kancerogenosti na transgeničnim miševima zabilježena je povećana incidencija benignih tumora granuloznih stanica jajnika u ženki miševa kojima je primijenjena doza od 150 ili 500 mg/kg na dan.
English: The increase from baseline in lumbar spine BMD at 7 years in the bazedoxifene 20 mg group was not statistically greater than in the placebo group.
Croatian: Porast od početnih vrijednosti BMD-a u lumbalnom dijelu kralježnice nakon 7 godina u skupini liječenoj bazedoksifenom u dozi od 20 mg nije bio statistički veći nego u skupini koja je primala placebo.
English: On average, patients with hepatic impairment showed a 4.3-fold increase in AUC compared with controls.
Croatian: U bolesnica s oštećenjem jetre zabilježeno je povećanje AUC-a za prosječno 4,3 puta u odnosu na kontrolne ispitanice.
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.
Croatian: Među ispitanicama čija je vjerojatnost prijeloma bila jednaka ili veća od 20% (n=618) rizik za nevertebralne prijelome smanjen je za 55% (95% CI: 18-76) u ispitanica liječenih bazedoksifenom u odnosu na ispitanice koje su primale placebo.
English: Bazedoxifene is extensively metabolised in women.
Croatian: Bazedoksifen se u žena opsežno metabolizira.
English: There was a significant reduction in the incidence of new vertebral fractures after 3 years of treatment with bazedoxifene 20 mg (42%), bazedoxifene 40 mg (37%) and raloxifene 60 mg (42%) compared to placebo.
Croatian: Zabilježeno je značajno smanjenje incidencije novih prijeloma kralježaka nakon 3 godine liječenja bazedoksifenom u dozi od 20 mg (42%), bazedoksifenom u dozi od 40 mg (37%) i raloksifenom u dozi od 60 mg (42%) u usporedbi s placebom.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava somnolencija
English: CONBRIZA 20 mg film-coated tablets Bazedoxifene
Croatian: CONBRIZA 20 mg filmom obložene tablete bazedoksifen
English: Use in this patient population is not recommended (see sections 4.2 and 4.4).
Croatian: Ne preporučuje se primjena u ovoj populaciji bolesnica (vidjeti dijelove 4.2 i 4.4).
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.
Croatian: Sistemska izloženost bazedoksifenu (AUC) u tim je skupinama bila 35 odnosno 69 puta veća od izloženosti u postmenopauzalnih žena koje su primale dozu od 20 mg dnevno tijekom 14 dana.
English: There have been post-marketing reports of ocular events other than retinal vein thrombosis.
Croatian: Nakon stavljanja u promet prijavljene su druge očne nuspojave osim tromboze mrežnične vene.
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).
Croatian: Prosječne promjene mamografske gustoće dojki u skupini liječenoj bazedoksifenom 20 mg bile su značajno smanjene u odnosu na početne vrijednosti (-1,45 postotnih bodova, p<0,05), dok u skupini koja je primala placebo nisu opažene promjene (-0,15 postotnih bodova).
English: Bazedoxifene undergoes little or no cytochrome P450 (CYP)-mediated metabolism.
Croatian: Bazedoksifen se metabolizira neznatno ili nimalo posredstvom izoenzima citokroma P450 (CYP).
English: Common(may affect up to 1 in 10 people):
Croatian: Često(mogu se javiti u do 1 na 10osoba):
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%.
Croatian: U dvogodišnjem ispitivanju kancerogenosti na štakorima opažena je povećana incidencija benignih tumora granuloznih stanica jajnika u ženki štakora pri koncentracijama u hrani od 0,03 i 0,1%.
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.
Croatian: One uključuju smanjenje oštrine vida, zamagljen vid, fotopsiju, poremećaj vidnog polja, smetnje vida, suhoću oka, edem kapka, blefarospazam, bol u oku i oticanje oka.
English: Deep vein thrombosis*, thrombophlebitis superficial
Croatian: Krvožilni poremećaji valunzi duboka venska tromboza*, površinskitrombof lebitis