FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Povečanje MKG ledvene hrbtenice od izhodišča po sedmih letih zdravljenja za skupino z 20 mg bazedoksifena ni bilo statistično večje od skupine s placebom.
English: There were 3 cases (0.2%) of endometrial cancer and 1 case (0.1%) of endometrial hyperplasia in the placebo group.
Slovenian: V skupini s placebom so bili 3 primeri (0,2 %) raka endometrija in 1 primer (0,1 %) hiperplazije endometrija.
English: The active substance is bazedoxifene.
Slovenian: - Zdravilna učinkovina je bazedoksifen.
English: Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids).
Slovenian: palpitacije (občutek razbijanja srca) suhe oči, bolečine v očesu, zmanjšanje ostrine vida, okvara vida, blefarospazem (neobičajno, nehoteno mežikanje ali spazem očesnih vek)
English: In an 18-month bone efficacy study in aged ovariectomized cynomolgus monkeys, bazedoxifene, administered orally to monkeys at dosages of 0, 0.2, 0.5, 1, 5, or 25 mg/kg/day, resulted in exposures, based on surface area (mg/m2) of approximately 0.2 to 24 times the clinical dose of 20 mg. Renal cell carcinomas were observed in this study.
Slovenian: V 18-mesečni študiji učinkovitosti za kosti pri starih ovariektomiranih opicah cinomolgus je bazedoksifen, ki so ga dajali opicam peroralno v odmerkih 0, 0,2, 0,5, 1, 5 ali 25 mg/kg/dan, povzročil izpostavljenosti, izražene na telesno površino (mg/m2), ki so se za 0,2- do 24-krat razlikovale od tiste pri kliničnem odmerku 20 mg.
English: There were 5 cases of breast cancer per 4,591 person-years of follow-up in the bazedoxifene 20 mg group (1.09 per 1,000), 7 cases of breast cancer per 4,526 person-years of follow-up in the raloxifene 60 mg group (1.55 per 1,000), and 8 cases of breast cancer per 4,604 person-years of follow-up in the placebo group (1.74 per 1,000).
Slovenian: Ugotovili so 5 primerov raka dojk na 4.591 oseb-let spremljanja v skupini z bazedoksifenom v odmerku 20 mg (1,09 na 1.000), 7 primerov raka dojk na 4.526 oseb-let spremljanja v skupini z raloksifenom v odmerku 60 mg (1,55 na 1.000) in 8 primerov raka dojk na 4.604 oseb-let spremljanja v skupini s placebom (1,74 na 1.000).
English: Lactose monohydrate Microcrystalline cellulose Pregelatinised starch (maize) Sodium starch glycolate Sodium lauryl sulfate
Slovenian: laktoza monohidrat mikrokristalna celuloza predgelirani škrob (koruzni) natrijev karboksimetilškrob natrijev lavrilsulfat koloidni brezvodni silicijev dioksid magnezijev stearat askorbinska kislina
English: The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs, such as rifampicin, phenobarbital, carbamazepine, and phenytoin, potentially leading to decreased systemic concentrations of bazedoxifene.
Slovenian: Presnovo bazedoksifena lahko poveča sočasna uporaba snovi, ki so znani induktorji UGT, kot so rifampicin, fenobarbital, karbamazepin in fenitoin.
English: In the osteoporosis prevention study, the incidence of breast-related adverse events (breast tenderness, pain, breast cancer, benign breast neoplasm) in the bazedoxifene 20 mg and raloxifene 60 mg groups was similar to placebo.
Slovenian: V študiji preprečevanja osteoporoze je bila pojavnost z dojkami povezanih neželenih dogodkov (občutljivost dojk, bolečina v dojkah, rak dojk, benigna neoplazma dojk) v skupinah z bazedoksifenom v odmerku 20 mg in raloksifenom v odmerku 60 mg podobna kot pri placebu.
English: Use in this patient population is not recommended (see sections 4.2 and 4.4).
Slovenian: Uporaba zdravila pri tej skupini bolnic ni priporočljiva (glejte poglavji 4.2 in 4.4).
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravilanesmete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: A total of 3,146 subjects continued into the first 2-year extension (bazedoxifene 20 mg: n=1,047, bazedoxifene 40/20 mg: n=1,041, placebo: n=1,058).
Slovenian: Skupno 3.146 oseb je s sodelovanjem v študiji nadaljevalo v prvem 2-letnem podaljšanju (bazedoksifen 20 mg: n = 1.047, bazedoksifen 40/20 mg: n = 1.041, placebo: n = 1.058).
English: After 7 years of treatment, the endometrial thickness in the bazedoxifene 20 mg group did not change and remained similar to placebo; there were no cases of endometrial cancer in the bazedoxifene 20 mg group compared to 7 cases in the placebo group (p<0.008).
Slovenian: Po 7 letih zdravljenja se debelina endometrija v skupini, ki je prejemala bazedoksifen v odmerku 20 mg, ni spremenila in je ostala podobna kot pri placebu; ni bilo nobenih primerov raka endometrija v skupini, ki je prejemala bazedoksifen v odmerku 20 mg, v primerjavi s 7 primeri v skupini, ki je prejemala placebo (p < 0,008).
English: The metabolic disposition of bazedoxifene in postmenopausal women has been determined following oral administration of 20 mg of radio-labelled bazedoxifene.
Slovenian: Presnovo bazedoksifena pri ženskah v postmenopavzi so ugotavljali po peroralnem dajanju 20 mg radioaktivno označenega bazedoksifena.
English: After 5 years of treatment, the endometrial thickness in the bazedoxifene 20 mg group did not change and remained similar to placebo; there were no cases of endometrial cancer in the bazedoxifene 20 mg group compared to 6 cases in the placebo group (p<0.05).
Slovenian: Po 5 letih zdravljenja se debelina endometrija v skupini, ki je prejemala bazedoksifen v odmerku 20 mg, ni spremenila in je ostala podobna kot pri placebu; ni bilo nobenih primerov raka endometrija v skupini, ki je prejemala bazedoksifen v odmerku 20 mg, v primerjavi s 6 primeri v skupini, ki je prejemala placebo (p < 0,05).
English: In the osteoporosis treatment study, bazedoxifene 20 mg and raloxifene 60 mg therapy resulted in a significant reduction of serum markers of bone resorption (C-telopeptide) and bone formation (osteocalcin), when compared to placebo, indicating a reduction in bone turnover.
Slovenian: V študiji zdravljenja osteoporoze je terapija z bazedoksifenom v odmerku 20 mg in raloksifenom v odmerku 60 mg v primerjavi s placebom pomembno znižala serumske označevalce resorpcije kosti (C-telopeptid) in nastajanja kosti (osteokalcin), kar kaže na zmanjšanje premene kostnine.
English: After 5 years of treatment, the incidence of new vertebral fractures remained lower in the bazedoxifene 20 mg group (4.49%) compared to placebo (6.82%) with a relative risk reduction of 36% (p=0.014).
Slovenian: Po 5 letih zdravljenja je pogostnost pojavljanja novih zlomov vretenc ostala manjša v skupini, ki je prejemala bazedoksifen v odmerku 20 mg (4,49 %) v primerjavi s placebom (6,82 %), z relativnim zmanjšanjem tveganja za 36 % (p = 0,014).
English: Uncommon (may affect up to 1 in 100 people):
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnic):
English: In the osteoporosis treatment study, 7,492 postmenopausal women (mean age of 66 years; range 50 to 85 years and a mean time of 19.5 years since menopause) received bazedoxifene (20 or 40 mg daily), raloxifene (60 mg daily), or placebo to evaluate the incidence of new vertebral fractures over 3 years (3-year core study).
Slovenian: V študiji zdravljenja osteoporoze je 7.492 žensk v postmenopavzi (povprečna starost 66 let; razpon 50 do 85 let in povprečni čas od menopavze 19,5 let) prejemalo bazedoksifen (20 ali 40 mg na dan), raloksifen (60 mg na dan) ali placebo za ovrednotenje incidence novih zlomov vretenc v treh letih (3-letna temeljna študija).
English: The treatment effect on lipids was similar in the osteoporosis prevention study.
Slovenian: V študiji preprečevanja osteoporoze je bil učinek zdravljenja na lipide podoben.
English: After 7 years of treatment, the incidence of new vertebral fractures remained lower in the bazedoxifene 20 mg group (7.64%) compared to placebo (9.90%) with a relative risk reduction of 30% (p=0.022).
Slovenian: Po 7 letih zdravljenja je pogostnost pojavljanja novih zlomov vretenc ostala manjša v skupini, ki je prejemala bazedoksifen v odmerku 20 mg (7,64 %) v primerjavi s placebom (9,90 %), z relativnim zmanjšanjem tveganja za 30 % (p = 0,022).
English: Endometrial polyps were diagnosed in 10 subjects in the bazedoxifene 20 mg, 17 subjects in the raloxifene 60 mg, and 11 subjects in the placebo treatment groups through month 36.
Slovenian: Diagnozo polipov endometrija so v vseh 36 mesecih postavili pri 10 bolnicah v skupini z bazedoksifenom v odmerku 20 mg, 17 bolnicah v skupini z raloksifenom v odmerku 60 mg in 11 bolnicah v skupini s placebom.
English: Assessment of bone histomorphometry and bone turnover In the osteoporosis treatment study in 7,492 postmenopausal women (mean age = 66 years), 121 bone biopsies were obtained from iliac crest after the administration of fluorochrome label from the subjects in bazedoxifene, raloxifene and placebo groups (bazedoxifene 20 mg = 28; bazedoxifene 40 mg = 29, raloxifene 60 mg = 32, placebo = 32) after approximately 2 or 3 years of treatment.
Slovenian: Ocenjevanje histomorfometrije kosti in premene kostnine V študiji zdravljenja osteoporoze pri 7.492 ženskah v postmenopavzi (povprečna starost = 66 let) so odvzeli 121 biopsij kosti iz črevničnega grebena po aplikaciji fluorokromnega označevalca osebam v skupinah z bazedoksifenom, raloksifenom in placebom (bazedoksifen 20 mg = 28; bazedoksifen 40 mg = 29, raloksifen 60 mg = 32, placebo = 32) po približno 2 oziroma 3 letih zdravljenja.
English: Common(may affect up to 1 in 10 people):
Slovenian: Pogosti(pojavijo se lahko pri največ 1 od 10 bolnic):
English: The increase in LS BMD compared with placebo with bazedoxifene 20 mg and raloxifene 60 mg was significant at 6 months (1.02% and 1.29%, respectively) and was maintained through 3 years (1.32% and 2.08%, respectively).
Slovenian: Zvečanje MKG ledvene hrbtenice pri bazedoksifenu v odmerku 20 mg in raloksifenu v odmerku 60 mg v primerjavi s placebom je bilo značilno pri 6 mesecih (1,02 % oziroma 1,29 %) in je trajalo vsa 3 leta (1,32 % oziroma 2,08 %).
English: Bazedoxifene-5-glucuronide is the major circulating metabolite.
Slovenian: Poglavitni presnovek v krvi je bazedoksifen-5-glukuronid.
English: The raloxifene group was discontinued during the first 2-year extension.
Slovenian: V prvem 2-letnem podaljšanju je skupina, ki je prejemala raloksifen, z zdravljenjem prenehala.
English: In the osteoporosis treatment study, transvaginal ultrasonography (TVU) showed minimal changes in endometrial thickness in placebo (-0.08 mm, n=131), bazedoxifene 20 mg (-0.07 mm, n=129), and raloxifene 60 mg (0.16 mm, n=110) treated groups after 2 years.
Slovenian: V študiji zdravljenja osteoporoze je transvaginalna ultrasonografija (TVU) pokazala minimalne spremembe debeline endometrija v skupinah, ki so 2 leti prejemale placebo (-0,08 mm, n = 131), bazedoksifen v odmerku 20 mg (-0,07 mm, n = 129) in raloksifen v odmerku 60 mg (0,16 mm, n = 110).
English: *In the osteoporosis treatment trial in 7,492 evaluable subjects (mean age=66 years), the bazedoxifene-treated women had an increased risk of venous thromboembolism (deep vein thrombosis, pulmonary embolism and retinal vein thrombosis).
Slovenian: *V preskušanju zdravljenja osteoporoze pri 7.492 osebah, ki jih je bilo mogoče ovrednotiti (povprečna starost = 66 let), je bilo pri ženskah, zdravljenih z bazedoksifenom, zvečano tveganje venske trombembolije (globoka venska tromboza, pljučna embolija in tromboza ven mrežnice).
English: There was no evidence of osteomalacia, peritrabecular or marrow fibrosis, cellular toxicity or woven bone in any of the bone-biopsy specimens in any of the treatment groups.
Slovenian: V nobenem od vzorcev kostnih biopsij v nobeni od zdravljenih skupin ni bilo znakov osteomalacije, peritrabekularne fibroze ali fibroze kostnega mozga, toksičnosti za celice ali prepletene (retikularne) kostnine.
English: There were no cases on thyroid cancer in the 40 mg treatment group up to 5 years.
Slovenian: V skupini, ki se je zdravila s 40 mg odmerkom do 5 let, niso odkrili nobenega primera raka ščitnice.
English: Effects on lipid metabolism and cardiovascular system In the osteoporosis treatment study after 3 years of treatment, bazedoxifene 20 mg and raloxifene 60 mg exhibited significant reductions in serum total cholesterol, low-density lipoprotein (LDL) cholesterol and a significant increase in high-density lipoprotein (HDL) cholesterol compared to placebo.
Slovenian: V študiji zdravljenja osteoporoze sta po 3 letih zdravljenja bazedoksifen v odmerku 20 mg in raloksifen v odmerku 60 mg povzročila pomembno znižanje celokupnega serumskega holesterola, LDL holesterola (LDL = lipoprotein majhne gostote) in pomembno zvišanje HDL holesterola (HDL = lipoprotein velike gostote) v primerjavi s placebom.
English: After 5 years of treatment, there were 9 cases of breast cancer in the bazedoxifene 20 mg group (1.40 per 1,000 women-years) and 10 cases in the placebo group (1.56 per 1,000 women-years).
Slovenian: Po 5 letih zdravljenja so ugotovili 9 primerov raka dojk v skupini, ki je prejemala bazedoksifen v odmerku 20 mg (1,40 na 1.000 žensk-let) in 10 primerov v skupini, ki je prejemala placebo (1,56 na 1.000 žensk-let).
English: Swelling of the hands, feet and legs (peripheral oedema)
Slovenian: mišični krči (vključno s krči v nogah) vročinski oblivi otekanje dlani, stopal in nog (periferni edem)
English: In the osteoporosis prevention study, TVU showed minimal changes from baseline in endometrial thickness in placebo (-0.24 mm, n=154), bazedoxifene 20 mg (-0.06 mm, n=158) and raloxifene 60 mg (0.01 mm, n=154) treated groups after 2 years.
Slovenian: V študiji preprečevanja osteoporoze je TVU po 2 letih pokazala minimalne spremembe debeline endometrija od izhodišča v skupinah, ki so prejemale placebo (-0,24 mm, n = 154), bazedoksifen 20 mg (-0,06 mm, n = 158) in raloksifen 60 mg (0,01 mm, n = 154).
English: The rate per 1,000 women-years through the 3-year study period was 2.86 in the bazedoxifene 20 mg group and 1.76 in the placebo group, and through the 5-year study period was 2.34 in the bazedoxifene 20 mg group and 1.56 in the placebo group.
Slovenian: Pogostnost na 1.000 žensk-let v 3-letnem obdobju študije je bila 2,86 v skupini z bazedoksifenom v odmerku 20 mg in 1,76 v skupini s placebom, v 5-letnem obdobju študije pa je v skupini, ki je prejemala 20 mg bazedoksifena, znašala 2,34, v skupini, ki je prejemala placebo, pa 1,56.
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.
Slovenian: Po 3 letih zdravljenja z bazedoksifenom v odmerku 20 mg (42 %), bazedoksifenom v odmerku 40 mg (37 %) in raloksifenom v odmerku 60 mg (42 %) se je v primerjavi s placebom incidenca novih zlomov vretenc pomembno zmanjšala.
English: In the 3 year core study the rate per 1,000 women-years for ischaemic strokes was similar between the 20 mg bazedoxifene (1.98) and placebo (2.2) groups and higher in the 40 mg bazedoxifene (2.72) group.
Slovenian: V 3 leta trajajoči temeljni študiji je bilo število ishemičnih kapi na 1.000 žensk-let podobno v skupinah, ki sta prejemali bazedoksifen v odmerku 20 mg (1,98) in placebo (2,2), večje pa v skupini, ki je prejemala bazedoksifen v odmerku 40 mg (2,72).
English: The rate per 1,000 women years for transient ischaemic attacks (TIA) was similar between the 20 mg bazedoxifene (1.1) and placebo (0.88) groups and higher in the 40 mg bazedoxifene (1.59) group.
Slovenian: Število tranzitornih ishemičnih atak (TIA) na 1.000 žensk-let je bilo v skupinah, ki sta prejemali bazedoksifen v odmerku 20 mg (1,1) in placebo (0,88) podobno, večje pa v skupini, ki je prejemala bazedoksifen v odmerku 40 mg (1,59).
English: Bazedoxifene has not been studied in premenopausal women.
Slovenian: Pri ženskah pred menopavzo bazedoksifena niso proučevali.
English: The rate per 1,000 women-years through the 7 year study period was 2.06 in the bazedoxifene 20 mg group and 1.36 in the placebo group.
Slovenian: Pogostnost na 1.000 žensk-let v 7-letnem obdobju študije je bila 2,06 v skupini z bazedoksifenom v odmerku 20 mg in 1,36 v skupini s placebom.
English: a of subjects with ≥1 new vertebral fracture
Slovenian: a oseb z ≥ 1 novim zlomom vretenc
English: If you have signs of a blood clot in the legs or lungs, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing;
Slovenian: če imate znake krvnega strdka v nogah ali pljučih, kot so boleče otekanje in rdečina nog, nenadna bolečina v prsnem košu ali težave z dihanjem če imate znake krvnega strdka v očesu (mrežnični veni), kot so enostranska motnja vida ali poslabšanje vida ali zameglitev ali izguba vida na enem očesu če opazite katerokoli od težav, naštetih pod 'Ne jemljite zdravila CONBRIZA'
English: Effects on thyroid and ovarian malignancies
Slovenian: Učinki na ščitnico in neoplazme jajčnikov
English: After 7 years of treatment, there were 13 cases of breast cancer in the bazedoxifene 20 mg group (1.78 per 1,000 women-years) and 11 cases in the placebo group (1.50 per 1,000 women-years).
Slovenian: Po 7 letih zdravljenja so ugotovili 13 primerov raka dojk v skupini, ki je prejemala bazedoksifen v odmerku 20 mg (1,78 na 1.000 žensk-let) in 11 primerov v skupini, ki je prejemala placebo (1,50 na 1.000 žensk-let).
English: a of subjects with new vertebral fracture
Slovenian: a oseb z novim zlomom vretenc
English: What CONBRIZA contains
Slovenian: Kaj vsebuje zdravilo CONBRIZA
English: There was 1 case (0.1%) of endometrial cancer, 1 case of sarcoma (0.1%), and 1 case (0.1%) of endometrial hyperplasia in the raloxifene 60 mg-treated subjects.
Slovenian: Pri bolnicah, zdravljenih z raloksifenom v odmerku 60 mg, so ugotovili 1 primer (0,1 %) raka endometrija, 1 primer (0,1 %) sarkoma in 1 primer (0,1 %) hiperplazije endometrija.
English: CONBRIZA contains lactose.
Slovenian: Zdravilo CONBRIZA vsebuje laktozo.
English: Talk to your doctor or pharmacist before taking CONBRIZA
Slovenian: Pred začetkom jemanja zdravila CONBRIZA se posvetujte zzdravnikom ali farmacevtom.
English: There was one case of ovarian cancer in the 40 mg treatment group up to 5 years.
Slovenian: V skupini, ki se je zdravila s 40 mg odmerkom do 5 let, so odkrili en primer raka jajčnikov.
English: If you decide to stop taking this medicine before finishing the prescribed course of treatment, you should talk to your doctor first.
Slovenian: Pogovorite se z zdravnikom, preden se odločite, da boste prenehali jemati to zdravilo pred zaključkom predpisanega režima zdravljenja.
English: In the osteoporosis treatment trial in 7,492 subjects (mean age = 66 years), the bazedoxifene-treated women had an increased risk of VTE (deep vein thrombosis, pulmonary embolism and retinal vein thrombosis) (see section 4.8).
Slovenian: V preskušanju, v katerem je šlo za zdravljenje osteoporoze pri 7.492 osebah (povprečna starost = 66 let), je bilo povečano tveganje za pojav VTE (globoka venska tromboza, pljučna embolija in tromboza ven mrežnice) pri ženskah, ki so se zdravile z bazedoksifenom (glejte poglavje 4.8).
English: Increase in blood triglycerides (fat found in your blood) Increase in liver enzymes
Slovenian: alergijska reakcija (vključno s preobčutljivostjo in koprivnico) izpuščaj, srbenje suha usta zvišanje trigliceridov (vrsta maščob v vaši krvi) v krvi zvišanje jetrnih encimov zaspanost
English: BMD was preserved in bazedoxifene 20 mg and raloxifene 60 mg-treated subjects, while significant loss in BMD was observed in patients receiving placebo.
Slovenian: Pri osebah, zdravljenih z bazedoksifenom v odmerku 20 mg in raloksifenom v odmerku 60 mg, je bila MKG ohranjena, pri bolnicah, ki so jemale placebo, pa so ugotovili pomembno izgubo MKG.
English: The rate per 1,000 women years for TIA was higher for the 20 mg bazedoxifene group (0.94) compared to placebo (0.62).
Slovenian: Število TIA na 1.000 žensk-let je bilo večje v skupini, ki je prejemala bazedoksifen v odmerku 20 mg (0,94) v primerjavi s skupino, ki je prejemala placebo (0,62).
English: At 3 years, there were no cases of endometrial cancer and 1 case (0.1%) of endometrial hyperplasia in the bazedoxifene 20 mg-treated subjects.
Slovenian: Po 3 letih ni bilo pri bolnicah, zdravljenih z bazedoksifenom v odmerku 20 mg, nobenega primera raka endometrija in 1 primer (0,1 %) hiperplazije endometrija.
English: The rate per 1,000 women years for TIA was higher for the bazedoxifene 20 mg group (0.96) compared to placebo (0.55).
Slovenian: Število TIA na 1.000 žensk-let je bilo večje v skupini, ki je prejemala bazedoksifen v odmerku 20 mg (0,96) v primerjavi s skupino, ki je prejemala placebo (0,55).
English: Bazedoxifene is extensively metabolised in women.
Slovenian: Bazedoksifen se pri ženskah presnovi v veliki meri.
English: In rabbit studies, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies in the foetuses were present at maternally toxic doses of 0.5 mg/kg/day (1.5 times the human exposure).
Slovenian: V raziskavah na kuncih so se pri odmerkih  0,5 mg/kg/dan (izpostavljenost, 1,5-krat večja od tiste pri človeku), ki so bili toksični za mater, pri plodovih pojavljali splav in zvečana incidenca anomalij srca (defekt prekatnega pretina) in skeleta (zapoznelo zakostenevanje skeleta, deformirane ali napačno razvrščene kosti, predvsem hrbtenice in lobanje).
English: CONBRIZA is only indicated for use in postmenopausal women.
Slovenian: Zdravilo CONBRIZA je indicirano za uporabo samo pri ženskah v postmenopavzi.
English: Glucuronidation is the major metabolic pathway.
Slovenian: Poglavitna presnovna pot je glukuronidacija.
English: The rate per 1,000 women-years at 5 years was 2.34 in the bazedoxifene 20 mg group and 1.56 in the placebo group (relative risk 1.50).
Slovenian: Število na 1.000 žensk-let je po 5 letih znašalo 2,34 v skupini, ki je prejemala bazedoksifen v odmerku 20 mg, in 1,56 v skupini, ki je prejemala placebo (relativno tveganje 1,50).
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pljučna embolija*
English: After 5 years of treatment the rate per 1,000 women-years for ischaemic strokes was similar between the 20 mg bazedoxifene (1.87) and the placebo (2.02) groups.
Slovenian: Po 5 letih zdravljenja je bilo število ishemičnih kapi na 1.000 žensk-let v skupini, ki je prejemala bazedoksifen v odmerku 20 mg (1,87), podobno tistemu v skupini, ki je prejemala placebo (2,02).
English: Patients with renal impairment
Slovenian: Bolnice z okvaro ledvic
English: No cases of hyperplasia or endometrial malignancy were identified in any bazedoxifene- or raloxifene-treated subjects.
Slovenian: Niti pri bolnicah, zdravljenih z bazedoksifenom, niti pri tistih, ki so prejemale raloksifen, niso ugotovili nobenega primera hiperplazije ali neoplazme endometrija.
English: CONBRIZA is only for use in postmenopausal women.
Slovenian: Zdravilo CONBRIZA je namenjeno le za uporabo pri ženskah v postmenopavzi.
English: In the osteoporosis treatment study in 7,492 postmenopausal women (mean age, 66 years), among 1,886 subjects treated with bazedoxifene (20 mg), there were 5 cases of ovarian cancer (0.69 per 1,000) and among 1,885 subjects treated with placebo, there were 0 cases of ovarian cancer after 7 years of treatment.
Slovenian: V študiji zdravljenja osteoporoze pri 7.492 ženskah v postmenopavzi (povprečna starost = 66 let) so po 7 letih zdravljenja med 1.886 osebami, ki so prejemale bazedoksifen (20 mg), ugotovili 5 primerov raka jajčnikov (0,69 na 1.000), med 1.885 osebami, ki so prejemale placebo, pa so ugotovili 0 primerov raka jajčnikov.
English: There have been post-marketing reports of ocular events other than retinal vein thrombosis.
Slovenian: V obdobju trženja so poročali o drugih očesnih neželenih učinkih, razen o trombozi ven mrežnice.