FrancophonIA/ELRC3.0 huggingface dataset:
English: • fluid retention due to cardiac or kidney problems
Croatian: • zadržavanje tekućine u tijelu zbog problema sa srcem ili bubrezima
English: Limited clinical data (n=5) for bazedoxifene monotherapy are available in subjects with moderate renal impairment (creatinine clearance 50 ml/min).
Croatian: Ograničeni klinički podaci (n=5) za monoterapiju bazedoksifenom dostupni su u bolesnica s umjerenim oštećenjem funkcije bubrega (klirens kreatinina 50 ml/min).
English: However, in a clinical drug-drug interaction study, repeat administration of 200 mg itraconazole, a strong CYP3A4 inhibitor, had minimal impact on the pharmacokinetics of CE (as measured by estrone and equilin) and bazedoxifene when administered with a single dose of CE 0.45 mg/BZA 20 mg.
Croatian: Međutim, u kliničkim ispitivanjima interakcija lijek-lijek, ponovljena primjena 200 mg itrakonazola, snažnog inhibitora CYP3A4, imala je minimalni utjecaj na farmakokinetiku KE (izmjereno estronom i ekvilinom) i bazedoksifena kada se primjenjivao s jednom dozom od 0,45 mg KE/20 mg BZA.
English: Endometrial cancer risk
Croatian: Rizik od raka endometrija
English: For women who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.
Croatian: Kod žena koje uzimaju HNL terapiju koja sadrži samo estrogen tijekom 5 godina primijećeno je malo ili nikakvo povećanje rizika od raka dojke.
English: Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Croatian: Prekomjerno zadebljanje sluznice maternice (hiperplazija endometrija) i rak sluznice maternice (rak endometrija)
English: Hormone therapy is associated with a 1.3-3 fold risk of developing VTE.
Croatian: Hormonska terapija je povezana s 1,3 do 3 puta većim rizikom od razvoja VTE.
English: • A severe allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
Croatian: • Teške alergijske reakcije - simptomi mogu obuhvatiti iznenadno piskanje i bolovi ili stezanje u prsnom košu, oticanje očnih kapaka, lica, usana, usta, jezika ili grla, otežano disanje, kolaps
English: • seizures (epilepsy)
Croatian: • napadaji (epilepsija)
English: A reduction in bazedoxifene exposure may be associated with an increased risk of endometrial hyperplasia (see section 4.4).
Croatian: Smanjeno izlaganje bazedoksifenu može biti povezano s povećanim rizikom od hiperplazije endometrija (vidjeti dio 4.4).
English: The following data are based on the findings in studies with BZA.
Croatian: Niže navedeni podaci temelje se na opažanjima iz ispitivanja s BZA.
English: Bazedoxifene
Croatian: Bazedoksifen
English: Dry mouth
Croatian: Suhoća usta
English: Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Croatian: Opće poznati čimbenici rizika za VTE uključuju uzimanje estrogena, stariju životnu dob, veću operaciju, dugotrajnu nepokretnost, pretilost (ITM > 30 kg/m2), trudnoću/poslijeporođajno razdoblje, sistemski eritemski lupus (SEL) i rak.
English: • migraine or severe headaches a rare disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
Croatian: • rijetka bolest imunološkog sustava koja može zahvatiti mnoge tjelesne organe (sistemski eritemski lupus, SEL)
English: In patients receiving bazedoxifene monotherapy there have been post-marketing reports of visual symptoms such as visual acuity disturbance or blurred vision.
Croatian: U bolesnica koje su primale monoterapiju bazedoksifenom postmarketinški su prijavljene vizualne smetnje kao što su poremećaj oštrine vida ili zamućen vid.
English: Adverse reactions were categorised as very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100) or rare ( 1/10,000 to < 1/1,000).
Croatian: Nuspojave su kategorizirane kao vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100) ili rijetko (≥1/10 000 i <1/1000).
English: Oestrogens are known to increase the risk of VTE (see section 4.4).
Croatian: Poznato je da estrogeni povećavaju rizik od VTE (vidjeti dio 4.4).
English: • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir);
Croatian: • lijekove za infekciju HIV-om (kao što su nevirapin, efavirenz, ritonavir i nelfinavir);
English: Each modified-release tablet contains 96.9 mg sucrose (includes 0.7 mg sucrose as sucrose monopalmitate), 62.9 mg lactose (as monohydrate), 0.2 mg maltitol liquid, 0.0176 mg glucose, and 0.0088 mg sorbitol
Croatian: Jedna tableta s prilagođenim oslobađanjem sadrži 96,9 mg saharoze (uključujući 0,7 mg saharoze u obliku saharozamonopalmitata), 62,9 mg laktoze (u obliku hidrata), 0,2 mg tekućeg maltitola, 0,0176 mg glukoze i 0,0088 mg sorbitola
English: In the bazedoxifene osteoporosis treatment trial (mean age = 66.5 years), the VTE 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.
Croatian: U ispitivanju liječenja osteoporoze bazedoksifenom (prosječna dob = 66,5 godina), stopa razvoja VTE na 1000 žena-godina tijekom 3-godišnjeg razdoblja ispitivanja bila je 2,86 u skupini koja je primala bazedoksifen (20 mg) i 1,76 u placebo skupini, a tijekom 5-godišnjeg razdoblja ispitivanja bila je 2,34 u skupini koja je primila 20 mg bazedoksifena i 1,56 u placebo skupini.
English: - Known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency, see section 4.4).
Croatian: - Dijagnosticirani trombofilijski poremećaji (primjerice, deficijencija proteina C, proteina S ili antitrombina, vidjeti dio 4.4).
English: The following data are based on the findings in studies with bazedoxifene.
Croatian: Niže navedeni podaci temelje se na opažanjima iz ispitivanja s bazedoksifenom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS AND STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
English: • A worsening of asthma
Croatian: • Pogoršanje astme
English: - Porphyria.
Croatian: Porfirija.
English: • Other ocular reactions (seeing sparks or flashes of light, narrowing of visual field, and swelling of eye or eye lid)
Croatian: • Druge očne nuspojave (vidite iskre ili bljeskove svjetla, sužavanje vidnog polja, oticanje očiju ili vjeđa)
English: The addition of bazedoxifene, acting as an oestrogen receptor antagonist in the uterus, greatly reduces the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women.
Croatian: Dodatak bazedoksifena, koji djeluje kao antagonist estrogenskog receptora u maternici, znatno smanjuje rizik od hiperplazije endometrija koji izaziva estrogen u žena koje nisu bile podvrgnute histerektomiji.
English: In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.The reported increase in endometrial cancer risk among oestrogen-onlyusers varies from 2-to 12-fold greater compared with non-users, depending on duration of treatment and oestrogendose.After stopping treatment,risk may remain elevated for at least 10 years.
Croatian: U žena s očuvanom maternicom, dugotrajno liječenje samim estrogenima povećava rizik od hiperplazije i rakaendometrija.Prijavljeno povećanje rizika od rakaendometrija u žena koje uzimaju same estrogene je od 2 do 12 puta veće negou žena koje ne uzimaju te lijekove, ovisno o trajanju liječenja i dozi estrogena.Nakon prekida liječenja rizik može ostati povećan najmanje 10 godina.
English: EXP After opening the blister pouch, use within 60 days.
Croatian: Rok valjanosti: Nakon otvaranja vrećice s blisterom, upotrijebiti unutar 60 dana.
English: After 7 years, the VTE rate per 1,000 women-years was 2.06 in the bazedoxifene 20 mg group and 1.36 in the placebo group.
Croatian: Nakon 7 godina stopa VTE na 1000 žena je bila 2,06 u skupini koja je primala 20 mg bazedoksifena i 1,36 u placebo skupini.
English: Patients treated with CE/BZA should be monitored carefully for signs of development of gallbladder disease.
Croatian: Bolesnice liječene KE/BZA-om potrebno je pažljivo nadzirati kako bi se uočili eventualni znakovi razvoja bolesti žučnog mjehura.
English: Modified-release tablet.
Croatian: Tableta s prilagođenim oslobađanjem.
English: Additional cases per 1,000 ET users over 5 years (95% CI)
Croatian: Dodatni slučajevi na 1000 korisnica ET tijekom 5 godina (95%-tni CI)
English: • Visible swelling of the face, hands, legs, feet or ankles (peripheral oedema)
Croatian: • Vidljivo oticanje lica, šaka, nogu, stopala ili gležnjeva (periferni edem)
English: After a single dose of CE/BZA, baseline-adjusted total estrone (representing CE) is eliminated with a half-life of approximately 17 hours.
Croatian: Nakon jednokratne doze KE/BZA, ukupan estron prilagođen za početnu vrijednost (predstavlja KE) eliminira se s poluvijekom od otprilike 17 sati.
English: Treatment of rats with BZA at maternally toxic dosages  1 mg/kg/day ( 0.4 times the human dose based on body surface area) 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 ( 0,4 puta izloženost nego u ljudi temeljem tjelesne površine) rezultirala je manjim brojem živih fetusa i/ili smanjenjem tjelesne težine fetusa.
English: As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer.
Croatian: Budući da estrogeni potiču rast endometrija, neoponirani estrogen povećava rizik od hiperplazije i raka endometrija.
English: Endometrial hyperplasia may be a precursor to endometrial cancer.
Croatian: Hiperplazija endometrija može biti prekursor raka endometrija.
English: Conjugated oestrogens is a medicine that belongs to a group of medicines called hormone replacement therapy (HRT).
Croatian: Konjugirani estrogeni spadaju u skupinu lijekova koji se nazivaju hormonsko nadomjesno liječenje (HNL).
English: For more information, see ‘Blood clots in a vein
Croatian: Za više informacija, vidjeti „Krvni ugrušci u venama (tromboza)”
English: Exacerbation of chorea
Croatian: Pogoršanje koreje
English: • dimpling of the skin
Croatian: • jamice na koži
English: Venous thromboembolism (VTE)
Croatian: Venska tromboembolija (VTE)
English: The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce uridine diphosphate glucuronosyltransferases (UGTs), such as rifampicin, phenobarbital, carbamazepine, and phenytoin, potentially leading to decreased systemic concentrations of bazedoxifene.
Croatian: Metabolizam bazedoksifena može se povećati istodobnom primjenom tvari za koje se zna da induciraju enzime uridin difosfat glukuronoziltransferaze (UGT), kao što su rifampicin, fenobarbital, karbamazepin i fenitoin, što potencijalno vodi smanjenju sistemske koncentracije bazedoksifena.
English: Oestrogens circulate in the blood largely bound to SHBG and albumin.
Croatian: Estrogeni cirkuliraju u krvi većinom vezani za globulin koji veže spolne hormone i albumin.
English: Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of oestrogens.
Croatian: Biljni pripravci koji sadrže gospinu travu (Hypericum perforatum) mogu inducirati metabolizam estrogena.
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 granuloza stanica jajnika u ženki miševa i štakora kojima je primijenjen bazedoksifen predstavlja učinak farmakoterapijske skupine selektivnih modulatora estrogenskih receptora, povezan s njihovom famakologijom u ženki glodavaca kojima se primjenjuju u reproduktivnoj dobi, kada su im jajnici funkcionalni i odgovaraju na hormonsku stimulaciju.
English: • Herbal remedies containing St John's Wort (Hypericum perforatum)
Croatian: • biljne pripravke koji sadrže gospinu travu (Hypericum perforatum)
English: The metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, such as anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz).
Croatian: Metabolizam estrogena može se povećati istodobnom primjenom tvari za koje se zna da induciraju enzime koji metaboliziraju lijekove, kao što su antikonvulzivi (npr. fenobarbital, fenitoin, karbamazepin) i antiinfektivi (npr. rifampicin, rifabutin, nevirapin, efavirenz).
English: 0.6 to 22 times the clinical dose of 20 mg.
Croatian: 22 puta većim nego kod primjene kliničke doze od 20 mg.
English: The metabolic disposition of bazedoxifene in postmenopausal women has been determined following oral administration of 20 mg of radiolabeled BZA.
Croatian: Metabolička dispozicija bazedoksifena u postmenopauzalnih žena utvrđena je nakon peroralne primjene 20 mg radioaktivno obilježene BZA.
English: - CE/BZA has not been studied in patients with impaired liver function (see sections 4.2 and 5.2) or history of cholestatic jaundice.
Croatian: - KE/BZA nije ispitivan u bolesnica s oštećenom funkcijom jetre (vidjeti dijelove 4.2 i 5.2) ili kolestatskom žuticom u anamnezi.
English: In clinical trials of up to 2 years duration, CE/BZA was associated with an increase from baseline in the concentration of serum triglycerides of approximately 16% at month 12 and 20% at month 24.
Croatian: U kliničkim ispitivanjima u trajanju do 2 godine, KE/BZA je bio povezan s povećanjem koncentracije triglicerida u serumu u odnosu na početnu razinu za otprilike 16% nakon 12 mjeseci, a 20% nakon 24 mjeseca.
English: UPVC/ Monochlorotrifluorethylene blister packs containing 28 modified-release tablets.
Croatian: UPVC/monoklorotrifluoroetilen blister pakiranja koja sadrže 28 tableta s prilagođenim oslobađanjem.
English: Symptoms of overdose of oestrogen-containing medicinal products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females.
Croatian: Simptomi predoziranja lijekom koji sadrži estrogen u odraslih i djece mogu uključivati mučninu, povraćanje, osjetljivost dojki, omaglicu, bol u trbuhu, omamljenost/umor; u žena se može pojaviti vaginalno krvarenje.
English: If you are not sure about any of the points above, talk to your doctor before taking this medicine.
Croatian: Ako niste sigurni za bilo koje od gore navedenih stanja, razgovarajte sa svojim liječnikom prije uzimanja ovog lijeka.
English: • Changes in weight (increase or decrease)
Croatian: • Promjene u tjelesnoj težini (povećanje ili smanjenje)
English: The number of extra cases of stroke due to use of HRT will increase with age.
Croatian: Broj dodatnih slučaja moždanog udara zbog uzimanja HNL terapija povećava se s dobi.
English: If pregnancy occurs during treatment with CE/BZA, it should be withdrawn immediately.
Croatian: Ako dođe do trudnoće tijekom terapije KE/BZA-om, treba odmah prekinuti primjenu.
English: Impaired renal function showed little or no influence on bazedoxifene pharmacokinetics.
Croatian: Oštećenje bubrežne funkcije ne utječe ili malo utječe na farmakokinetiku bazedoksifena.
English: Pink, oval-shaped, modified-release tablet of 12 mm printed on one side with “0.45/20”.
Croatian: Ružičasta, ovalna tableta s prilagođenim oslobađanjem od 12 mm s „0,45/20” otisnutim na jednoj strani.
English: Million women study (Estradiol only arm) - estimated additional risk of breast cancer after 5 years use
Croatian: Ispitivanje Milijun žena (skupina koja je primala samo estradiol) - procijenjeni dodatni rizik od raka dojke nakon 5 godina primjene
English: • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine);
Croatian: • lijekove za epilepsiju (kao što su fenobarbital, fenitoin i karbamazepin);
English: - Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radio-immunoassay).
Croatian: - Estrogeni povećavaju globulin koji veže tiroidne hormone (engl. thyroid binding globulin,TBG), što dovodi do povećanih razina ukupnih hormona štitnjače u cirkulaciji izmjerenih kao jod vezan za proteine (engl. by protein-bound iodine, PBI), razina T4 (izmjerenih u koloni ili radioimunološkim testom) ili T3 razina (izmjerenih radioimunološkim testom).
English: BZA 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: BZA se nije pokazala genotoksičnom niti mutagenom 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: Observational studies have mostly reported a small increase in risk of having breast cancer diagnosed that is substantially lower than that found in users of oestrogen-progestagen combinations (see section 4.8).
Croatian: Opservacijska ispitivanja su uglavnom pokazala mali porast rizika od dijagnoze raka dojke koji je znatno niži nego u žena koje koriste kombinaciju estrogen-progestagen (vidjeti dio 4.8).
English: How to take DUAVIVE
Croatian: Kako uzimati DUAVIVE
English: Swallow tablet whole.
Croatian: Tabletu progutati cijelu.
English: There is some evidence of a higher risk of memory loss in women who start using oestrogen therapy after the age of 65.
Croatian: Postoje neki dokazi za veći rizik od gubitka pamćenja u žena koje započnu uzimati estrogensku terapiju nakon dobi od 65 godina.
English: Results from a clinical drug-drug interaction study conducted with CE/BZA and from interaction studies with CE or bazedoxifene monotherapy are summarised below.
Croatian: Rezultati iz kliničkih ispitivanja interakcija lijek-lijek provedenih s KE/BZA-om i iz ispitivanja interakcija s KE ili bazedoksifenom u monoterapiji sažeti su u nastavku.
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only Hormone Replacement Therapy (HRT), which becomes apparent within 5 years of use and diminishes over time after stopping.
Croatian: Epidemiološki dokazi na osnovi velike metaanalize ukazuju na blago povećani rizik u žena koje uzimaju hormonsko nadomjesno liječenje (HNL) koja sadrži samo estrogen, što postaje vidljivo unutar 5 godina primjene, a nakon prestanka primanja terapije smanjuje se s vremenom.
English: There is no experience in treating women with a premature menopause (due to ovarian failure or surgery) with DUAVIVE.
Croatian: Nema iskustva s primjenom lijeka DUAVIVE u žena s preuranjenom menopauzom (zbog zatajenja jajnika ili kirurškog zahvata na jajnicima).
English: Bazedoxifene does not induce or inhibit the activities of major CYP isoenzymes, and is unlikely to interact with co-administered medicinal products via CYP-mediated metabolism.
Croatian: Bazedoksifen ne inducira niti inhibira aktivnosti glavnih izoenzima CYP-a i mala je vjerojatnost interakcije bazedoksifena s istodobno primijenjenim lijekovima metaboliziranim posredovanjem CYP-a.
English: CE/BZA contains bazedoxifene, which reduces the risk of endometrial hyperplasia that can occur with oestrogen-only use (see section 4.4).
Croatian: KE/BZA sadrži bazedoksifen, koji smanjuje rizik od hiperplazije endometrija koja se može pojaviti s primjenom samog estrogena (vidjeti dio 4.4).
English: DUAVIVE has a minor effect on the ability to drive or use machines.
Croatian: DUAVIVE malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment.
Croatian: Povećani rizik postaje vidljiv nakon nekoliko godina primjene ali se vraća na početnu razinu unutar nekoliko (najviše 5) godina nakon prestanka uzimanja lijeka.
English: The modified-release tablets are provided in UPVC/Monochlorotrifluorethylene blister packs containing 28 tablets.
Croatian: Tablete s prilagođenim oslobađanjem su pakirane u UPVC/monoklorotrifluoroetilen blister pakiranjima koja sadrže 28 tableta.
English: After a single dose of CE/BZA, bazedoxifene and baseline-adjusted total estrone were absorbed with a tmax of approximately 2 hours and 8.5 hours, respectively.
Croatian: Nakon jednokratne doze KE/BZA, bazedoksifen i ukupan estron prilagođen za početnu vrijednost bili su apsorbirani s Tmax koje iznosi otprilike 2 sata odnosno 8,5 sati.
English: Blood clots in a vein (thrombosis) DUAVIVE may increase the risk of blood clots.
Croatian: Krvni ugrušci u venama (tromboza) DUAVIVE može povećati rizik od stvaranja krvnih ugrušaka.
English: In women with a uterus, use of oestrogen-only HRT is not recommended because it increases the risk of endometrial cancer (see section 4.4).
Croatian: U žena s intaktnom maternicom ne preporučuje se primjena samo estrogenskog HNL zato što povećava rizik od raka endometrija (vidjeti dio 4.4).
English: • Swelling of the eyes, nose, lips, mouth, tongue or throat, difficulty in breathing, severe dizziness or fainting, skin rash (symptoms of angioedema)
Croatian: • Oticanje očiju, nosa, usana, usta, jezika ili grla, otežano disanje, teška omaglica ili nesvjestica, osip na koži (simptomi angioedema)
English: • A worsening of epilepsy (seizures)
Croatian: • Pogoršanje epilepsije (napadaji)
English: There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received oestrogen-only therapy.
Croatian: Nema dokaza iz randomiziranih kontroliranih ispitivanja o zaštiti od infarkta miokarda u žena koje imaju ili nemaju KAB, a koje su primile terapiju samim estrogenom.
English: Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1,000 women with a uterus not using HRT.
Croatian: Rizik od raka endometrija je oko 5 na svakih 1000 žena s intaktnom maternicom koje ne primaju HNL.
English: Steady-state concentrations are achieved by the second week of once-daily administration.
Croatian: Koncentracija u stanju ravnoteže postiže se do drugog tjedna kod primjene jednom dnevno.
English: Blood triglycerides increased
Croatian: Povišeni trigliceridi u krvi
English: Carcinogenicity, mutagenicity, and impairment of fertility studies with CE/BZA have not been conducted.
Croatian: Ispitivanja kancerogenosti, mutagenosti i oštećenja plodnosti s KE/BZA-om nisu provedena.
English: This may be accompanied by bone pain and abdominal pain.
Croatian: To može biti popraćeno bolovima u kostima i trbuhu.
English: - Active or past history of arterial thromboembolic disease (e.g., myocardial infarction,
Croatian: - Aktivna ili prijašnja arterijska tromboembolijska bolest (primjerice, infarkt miokarda, moždani udar).
English: Bazedoxifene elicited male rat-specific nephropathies (corticomedullar nephrocalcinosis and enhanced spontaneous chronic progressive nephropathy) and associated adenomas and carcinomas at exposure ratios of 0.05 to 4 times, and dose ratios, based on surface area (mg/m2), of approximately
Croatian: Bazedoksifen je potaknuo nefropatije specifične za mužjake štakora (kortikomedularna nefrokalcinoza i pojačana spontana kronična progresivna nefropatija) te povezane adenome i karcinome pri omjerima izloženosti od 0,05 do 4 puta i omjerima doza prema tjelesnoj površini (mg/m2) otprilike 0,6 do