FrancophonIA/ELRC3.0 huggingface dataset:
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 so opazili zvečano incidenco benignih granulozocelularnih tumorjev na jajčnikih samic, ki so prejemale 150 ali 500 mg/kg/dan.
English: The addition of bazedoxifene in CE/BZAreduces the risk of endometrial hyperplasia,which may be a precursor of endometrial carcinoma.
Slovenian: Dodatek bazedoksifena v kombinaciji CE/BZA zmanjša tveganje za hiperplazijo endometrija, ki je lahko prekurzor karcinoma endometrija.
English: The table below lists the adverse reactions observed with CE/BZA (n = 3,168) in placebo-controlled clinical trials.
Slovenian: V spodnji preglednici so navedeni neželeni učinki, ki so jih opazili v s placebom nadzorovanih preskušanjih s kombinacijo CE/BZA (n = 3.168).
English: As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer.
Slovenian: Ker estrogeni spodbujajo rast endometrija, dodajanje estrogena brez progestogena zveča tveganje za hiperplazijo in raka endometrija.
English: Use of CE/BZA in this population is contraindicated (see sections 4.2, 4.3 and 4.4).
Slovenian: Pri tej populaciji je uporaba kombinacije CE/BZA kontraindicirana (glejte poglavja 4.2, 4.3 in 4.4).
English: Ovarian cancer is rare-much rarer than breast cancer.
Slovenian: Rak jajčnikov je redek - bistveno redkejši od raka dojke.
English: The pharmacokinetics of CE/BZA have not been evaluated in women over 75 years of age.
Slovenian: Farmakokinetike kombinacije CE/BZA pri ženskah, starejših od 75 let, niso ocenjevali.
English: There is some evidence of a higher risk of memory loss in women who start using oestrogen therapy after the age of 65.
Slovenian: Obstajajo nekateri dokazi, ki kažejo na zvečano tveganje za izgubo spomina pri ženskah, ki z zdravljenjem z estrogenom začnejo po 65. letu starosti.
English: If any of these conditions apply to you, talk to your doctor before you take this medicine.
Slovenian: Če karkoli od navedenega velja za vas, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: In a 1 year study, CE 0.45 mg/BZA 20 mg showed a significant difference from baseline in lumbar spine BMD (+1.52%) at month 12 compared to placebo.
Slovenian: V 1-letni študiji so v 12. mesecu pri kombinaciji 0,45 mg CE/20 mg BZA pokazali pomembno razliko od izhodišča v MGK ledvene hrbtenice (+ 1,52 %) v primerjavi s placebom.
English: DUAVIVE has a minor effect on the ability to drive or use machines.
Slovenian: Zdravilo DUAVIVE ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: • Changes in weight (increase or decrease)
Slovenian: • spremembe telesne mase (zvečanje ali zmanjšanje);
English: For women who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.
Slovenian: Pri ženskah, ki HNZ, ki vsebuje samo estrogen, uporabljajo 5 let, so opazili le majhno zvečanje tveganja za raka dojke ali pa zvečanja tveganja niso opazili.
English: - Active or past history of arterial thromboembolic disease (e.g., myocardial infarction,
Slovenian: - Aktivna arterijska trombembolična bolezen ali arterijska trombembolična bolezen v anamnezi (npr. miokardni infarkt, možganska kap).
English: Following administration of BZA alone, 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 was observed.
Slovenian: Po uporabi samega BZA so opazili linearno zvečanje koncentracij v plazmi po enkratnem odmerku od 0,5 mg do 120 mg in večkratnih dnevnih odmerkih od 1 mg do 80 mg. Absolutna biološka uporabnost BZA je približno 6 %.
English: Breast cancer risk
Slovenian: Tveganje za raka dojke
English: WHI studies oestrogen only arm - additional risk of VTE over 5 years' use Age range (years) Incidence per 1,000 women in placebo arm over 5 years
Slovenian: Študije WHI (skupina, ki je prejemala samo estrogen) - dodatno tveganje za VTE med 5-letno uporabo Razpon starosti (leta) Incidenca na 1.000 žensk v obdobju 5 let v skupini, ki je prejemala placebo
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.
Slovenian: Po enkratnem odmerku CE/BZA je bila vrednost tmax za absorpcijo bazedoksifena približno 2 uri, za skupni estron, prilagojen glede na izhodiščno vrednost, pa 8,5 ur.
English: Venous thromboembolic events (including, pulmonary embolism, retinal vein thrombosis, deep vein thrombosis and thrombophlebitis)
Slovenian: Žilne bolezni venski trombembolični dogodki (vključno s pljučno embolijo, trombozo mrežnične vene, globoko vensko trombozo in tromboflebitisom)
English: DUAVIVE and your heart or circulation
Slovenian: Zdravilo DUAVIVE in srce ali krvni obtok
English: Carcinogenicity, mutagenicity, and impairment of fertility studies with CE/BZA have not been conducted.
Slovenian: Študij kancerogenosti, mutagenosti in okvar plodnosti s kombinacijo CE/BZA niso izvedli.
English: No studies were performed on animals to evaluate the effects on reproduction with the CE/BZA combination.
Slovenian: Študij na živalih, pri katerih bi ugotavljali učinke kombinacije CE/BZA na razmnoževanje, niso izvedli.
English: DUAVIVE contains lactose, sucrose, maltitol liquid, glucose and sorbitol
Slovenian: Zdravilo DUAVIVE vsebuje laktozo, saharozo, tekoči maltitol, glukozo in sorbitol
English: Limited clinical data (n=5) for bazedoxifene monotherapy are available in subjects with moderate renal impairment (creatinine clearance 50 ml/min).
Slovenian: Pri preiskovankah z zmerno okvaro ledvic (kreatininski očistek  50 ml/min) so za monoterapijo z bazedoksifenom na voljo omejeni klinični podatki (n = 5).
English: • Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids)
Slovenian: • suhe oči, bolečine v očesu, zmanjšanje ostrine vida, okvara vida, blefarospazem (neobičajno, nehoteno mežikanje ali spazem očesnih vek).
English: As in all postoperative patients, prophylactic measures need be considered to prevent VTE following surgery.
Slovenian: Konsenza o morebitnem vplivu krčnih žil na VTE ni. Kot pri vseh bolnicah po kirurškem posegu je treba pretehtati možnost uporabe preventivnih ukrepov, da se prepreči VTE po posegu.
English: US WHI Oestrogen only (ET) arm - additional risk of breast cancer after 5 years use
Slovenian: Študija WHI v ZDA (skupina, ki je prejemala samo estrogensko zdravljenje (EZ) - dodatno tveganje za raka dojke po 5 letih uporabe
English: Incidence per 1,000 women in placebo arm over 5 years
Slovenian: Incidenca na 1.000 žensk v obdobju 5 let v skupini, ki je prejemala placebo
English: If you are not sure about any of the points above, talk to your doctor before taking this medicine.
Slovenian: Če niste prepričani, ali karkoli od zgoraj navedenega velja za vas, se posvetujte z zdravnikom, preden začnete jemati to zdravilo.
English: The recommended dose is 0.45 mg conjugated oestrogens (CE) and 20 mg bazedoxifene (BZA) taken as a single oral tablet, once daily.
Slovenian: Priporočeni odmerek je 0,45 mg konjugiranih estrogenov (CE - conjugated oestrogens) in 20 mg bazedoksifena (BZA) v obliki ene peroralne tablete enkrat na dan.
English: The clearance of BZA is 0.4 ±0.1 L/h/kg based on intravenous administration.
Slovenian: Očistek BZA po intravenski uporabi je 0,4 ± 0,1 l/h/kg.
English: Also contains: lactose, sucrose, polydextrose and maltitol liquid.
Slovenian: Vsebuje tudi laktozo, saharozo, polidekstrozo in tekoči maltitol.
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Slovenian: Njihova pogostnost in vrsta naj bosta prilagojeni posamezni ženski.
English: Impaired renal function showed little or no influence on bazedoxifene pharmacokinetics.
Slovenian: Okvarjeno delovanje ledvic je imelo majhen vpliv na farmakokinetiko bazedoksifena ali pa ga sploh ni imelo.
English: CE/BZA is contraindicated in these patients (see section 4.3).
Slovenian: Kombinacija CE/BZA je zato pri teh bolnicah kontraindicirana (glejte poglavje 4.3).
English: Hypromellose 2910 (6 mPa•s) (E464) Titanium dioxide (E171) Macrogol (400)
Slovenian: Barvna obloga hipromeloza 2910 (6 mPa•s) (E464) titanov dioksid (E171) makrogol (400) rdeči železov oksid (E172)
English: What DUAVIVE contains
Slovenian: Kaj vsebuje zdravilo DUAVIVE
English: UPVC/ Monochlorotrifluorethylene blister packs containing 28 modified-release tablets.
Slovenian: Pretisni omoti iz UPVC/monoklorotrifluoretilena, ki vsebujejo 28 tablet s prirejenim sproščanjem.
English: - A 2 to 4-fold increase in the risk of gallbladder disease requiring surgery in postmenopausal women receiving oestrogens has been reported (see section 4.8).
Slovenian: - Pri ženskah v postmenopavzi, ki so prejemale estrogene, so poročali o 2- do 4-kratnem zvečanju tveganja za bolezen žolčnika, pri kateri je potreben kirurški poseg (glejte poglavje 4.8).
English: • Increases in your triglyceride levels (fatty substances in the blood)
Slovenian: • zvišanje ravni trigliceridov (maščob v krvi).
English: CE/BZA is contraindicated during breast-feeding (see section 4.3).
Slovenian: Kombinacija CE/BZA je med dojenjem kontraindicirana (glejte poglavje 4.3).
English: Frequency of occurrence of adverse reactions
Slovenian: Pogostnost neželenih učinkov
English: • Herbal remedies containing St John's Wort (Hypericum perforatum)
Slovenian: • zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum).
English: The active substances are conjugated oestrogens and bazedoxifene.
Slovenian: Učinkovine so konjugirani estrogeni in bazedoksifen.
English: • Feeling irritable
Slovenian: • občutek razdražljivosti;
English: Use in this population is contraindicated (see sections 4.3, 4.4 and 5.2).
Slovenian: Uporaba pri tej populaciji je kontraindicirana (glejte poglavja 4.3, 4.4 in 5.2).
English: Other conditions
Slovenian: Druge bolezni
English: Deep vein thrombosis, thrombophlebitis superficial
Slovenian: Žilne bolezni vročinski obliv globoka venska tromboza, površinski tromboflebitis
English: The metabolic disposition of bazedoxifene in postmenopausal women has been determined following oral administration of 20 mg of radiolabeled BZA.
Slovenian: Presnovo bazedoksifena so ugotavljali pri ženskah v postmenopavzi po peroralni uporabi 20miligramskega odmerka radioaktivno označenega BZA.
English: Detectable amounts of oestrogens have been identified in the milk of mothers receiving CE. Oestrogen administration to breast-feeding mothers has been shown to decrease the quantity and quality of the milk.
Slovenian: Opazili so, da uporaba estrogena pri doječih materah zmanjša količino in kakovost mleka.
English: The safety and efficacy of CE/BZA have not been evaluated in patients with hepatic impairment.
Slovenian: Varnosti in učinkovitosti CE/BZA pri bolnicah z okvaro jeter niso raziskovali.
English: DUAVIVE 0.45 mg/20 mg modified-release tablets
Slovenian: DUAVIVE 0,45 mg/20 mg tablete s prirejenim sproščanjem
English: • Feeling nervous
Slovenian: • nervoznost;
English: You should continue taking this medicine for as long as your doctor tells you.
Slovenian: To zdravilo morate jemati, dokler vam zdravnik ne naroči, da zdravljenje prekinete.
English: The DUAVIVE 0.45 mg/20 mg modified-release tablet is a pink, oval-shaped, tablet marked on one side with “0.45/20”.
Slovenian: Tableta s prirejenim sproščanjem zdravila DUAVIVE 0,45 mg/20 mg je rožnata, ovalna tableta z napisom »0.45/20« na eni strani.
English: Visual acuity reduced, blurred vision, photopsia, visual field defect, visual impairment, dry eye, eyelid oedema, blepharospasm, eye pain and eye swelling
Slovenian: Očesne bolezni tromboza mrežnične vene zmanjšana ostrina vida, zamegljen vid, fotopsija, okvara vidnega polja, poslabšanje vida, suhe oči, edem veke, blefarospazem, bolečine v očeh in otekanje oči
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Slovenian: globulina, ki veže kortikoide (CBG - corticoid binding globulin) in globulina, ki veže spolne hormone (SHBG - sexhormone-binding globulin), se lahko v serumu zvečata, kar zviša raven kortikosteroidov in spolnih steroidov v krvnem obtoku.
English: The distribution of CE and bazedoxifene after administration of CE/BZA has not been studied.
Slovenian: Porazdelitve CE in bazedoksifena po uporabi kombinacije CE/BZA niso raziskovali.
English: DUAVIVE 0.45 mg/20 mg modified-release tablets conjugated oestrogens/bazedoxifene
Slovenian: DUAVIVE 0,45 mg/20 mg tablete s prirejenim sproščanjem konjugirani estrogeni/bazedoksifen
English: For women who have been taking HRT for 5 years, there will be about 3 cases per 2,000 users (i.e. about 1 extra case).
Slovenian: Pri ženskah, ki uporabljajo HNZ 5 let, bodo raka jajčnikov odkrili pri približno 3 izmed 2.000 uporabnic (tj. približno 1 primer več).
English: • fibroids inside your womb growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia)
Slovenian: • razraščanje maternične sluznice zunaj maternice (endometrioza) ali če je pri vas kdaj prišlo do pretirane rasti maternične sluznice (hiperplazija endometrija);
English: Microcrystalline cellulose Hydroxypropylcellulose Hypromellose 2910 (6 mPa•s) (E464) Hypromellose 2910 (15 mPa•s) (E464) Macrogol (400)
Slovenian: Obloga notranjega polnila saharoza mikrokristalna celuloza hidroksipropilceluloza hipromeloza 2910 (6 mPa•s) (E464) hipromeloza 2910 (15 mPa•s) (E464) makrogol (400)
English: For women in their 50s who are taking HRT, there will be 11 cases in 1,000 users, over 5 years (i.e., 3 extra cases).
Slovenian: Pri ženskah v 50-ih, ki uporabljajo HNZ, je pričakovati, da bo v obdobju 5 let možgansko kap doživelo 11 žensk izmed 1.000 uporabnic (tj. do 3 primeri več).
English: • Other ocular reactions (seeing sparks or flashes of light, narrowing of visual field, and swelling of eye or eye lid)
Slovenian: • drugi neželeni učinki, ki vplivajo na oči in/ali vid (videnje isker ali bliskov svetlobe, zoženje vidnega polja in otekanje očesa ali očesne veke).
English: Break-through bleeding and spotting may occur during treatment.If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Slovenian: Če se vmesne krvavitve ali krvavkast izcedek pojavijo po določenem času zdravljenja ali se po prenehanju zdravljenja nadaljujejo, je treba raziskati vzrok zanje.
English: Irregular bleeding and/or spotting was reported in the CE 0.45 mg/BZA 20 mg group by 7% of women during the first 3 months of treatment and by 3% of women during months 10 to 12.
Slovenian: V skupini s kombinacijo 0,45 mg CE/20 mg BZA je o neredni krvavitvi in/ali krvavkastem izcedku poročalo 7 % žensk v prvih 3 mesecih zdravljenja in 3 % žensk med 10. in 12. mesecem.
English: • dimpling of the skin
Slovenian: • izcedek iz nožnice;
English: Adverse reactions that have been observed with bazedoxifene monotherapy
Slovenian: Neželeni učinki, ki so jih opazili pri monoterapiji z bazedoksifenom
English: Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of oestrogens.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), lahko inducirajo presnovo estrogenov.
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: • Enlargement of hepatic haemangiomas, a benign (non-cancerous) tumour of the liver
Slovenian: • povečanje jetrnih hemangiomov, benignega (nerakastega) tumorja jeter;
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).
Slovenian: Pri sočasni uporabi snovi, ki inducirajo delovanje encimov za presnovo zdravil, kot so antikonvulzivi (npr. fenobarbital, fenitoin, karbamazepin) in zdravila proti okužbam (npr. rifampicin, rifabutin, nevirapin, efavirenz), se presnova estrogenov lahko zveča.
English: Risk of venous thromboembolism
Slovenian: Tveganje za vensko trombembolijo
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.
Slovenian: V kliničnih preskušanjih, ki so trajala do 2 leti, je bilo zdravljenje s CE/BZA povezano z zvečanjem koncentracije trigliceridov v serumu za okrog 16 % po 12 mesecih in 20 % po 24 mesecih glede na izhodiščno vrednost, zato je treba razmisliti o letnem spremljanju ravni trigliceridov v serumu.
English: Use in this population is therefore not recommended (see sections 4.4 and 5.2).
Slovenian: Uporaba pri tej populaciji zato ni priporočljiva (glejte poglavji 4.4 in 5.2).
English: Renal cell carcinomas were observed in an 18-month bone efficacy study in aged ovariectomised cynomolgus monkeys at exposure ratios of 0.05 to 16.3 times, and dose ratios, based on surface area (mg/m2), of approximately 0.2 to 24 times the clinical dose of 20 mg.
Slovenian: V 18-mesečni študiji učinka na kosti pri ostarelih opicah cinomolgus z ovariektomijo so pri 0,05- do 16,3-kratnemu razmerju izpostavljenosti in približno 0,2- do 24-kratnemu razmerju odmerkov glede na površino (mg/m2) v primerjavi s kliničnim odmerkom 20 mg opazili pojav karcinomov ledvičnih celic.
English: CE Oestrogen only
Slovenian: Samo estrogen CE
English: The Women's Health Initiative (WHI) trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only therapy.
Slovenian: V preskušanju Women's Health Initiative (WHI) niso ugotovili zvečanja tveganja za raka dojke pri ženskah, ki so jim opravili histerektomijo in so uporabljale samo estrogensko zdravljenje.
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.
Slovenian: Presnovo bazedoksifena lahko zveča sočasna uporaba snovi, ki so znani induktorji uridin difosfatglukuronoziltransferaz (UGT), kot so rifampicin, fenobarbital, karbamazepin in fenitoin.
English: Women taking CE/BZAshould not take additionaloestrogens as this may increase the risk of endometrial hyperplasiaand endometrial carcinoma.
Slovenian: Ženske, ki jemljejo CE/BZA, ne smejo jemati dodatnih estrogenov, saj to lahko zveča tveganje za hiperplazijo endometrija in karcinom endometrija.
English: Irregular bleeding and/or spotting was reported in the CE 0.45 mg/BZA 20 mg group by 8% of women during the first 3 months and by 4% of women during months 10 to 12.
Slovenian: V skupini s kombinacijo 0,45 mg CE/20 mg BZA je o neredni krvavitvi in/ali krvavkastem izcedku poročalo 8 % žensk v prvih 3 mesecih in 4 % žensk med 10. in 12. mesecem.
English: Any increased risk to users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations.
Slovenian: Zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko zdravljenje, je bistveno manjše kot pri ženskah, ki uporabljajo kombinacije estrogena in progestogena.
English: The overall evidence suggests a possible increased risk of breast cancer in women taking oestrogen-only therapy that is dependent on the duration of therapy.
Slovenian: Zbrani dokazi kažejo na zvečano tveganje za raka dojke pri ženskah, ki uporabljajo samo estrogensko zdravljenje; to tveganje je odvisno od trajanja zdravljenja.
English: Exacerbation of porphyria; hypocalcaemia (in patients with disease that can predispose to severe hypocalcaemia)
Slovenian: Presnovne in prehranske motnje intoleranca za glukozo poslabšanje porfirije, hipokalciemija (pri bolnicah z boleznijo, ki povzroča dovzetnost za hudo hipokalciemijo)
English: Growth potentiation of benign meningioma; fibrocystic breast disease
Slovenian: zvečanje rasti benignih meningiomov, fibrocistična bolezen dojk povečanje hepatičnih hemangiomov
English: • Palpitations (awareness of your heart beat)
Slovenian: • palpitacije (razbijanje srca);
English: Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1,000 women with a uterus not using HRT.
Slovenian: Tveganje za raka endometrija pri ženskah, ki imajo maternico in ki ne uporabljajo HNZ, je približno 5 na 1.000 žensk.
English: • Blood clot in the leg veins
Slovenian: • krvni strdki v venah nog;
English: Black Iron oxide (E172) Propylene glycol (E1520) Hypromellose 2910 (6 mPa•s)
Slovenian: propilenglikol (E1520) hipromeloza 2910 (6 mPa•s)
English: The use of oestrogen-only therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Slovenian: Zdravljenje samo z estrogenom je povezano z do 1,5-kratnim zvečanjem relativnega tveganja za ishemično možgansko kap.
English: Use of oestrogen-only HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see section 4.4).
Slovenian: Uporaba samo estrogenskega HNZ je povezana z zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
English: - Known, suspected, or past history of breast cancer.
Slovenian: - Znan rak dojke, sum nanj ali rak dojke v anamnezi.
English: CLINICAL PARTICULARS
Slovenian: Klinični podatki
English: Oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Slovenian: Zdravljenje samo z estrogenom je povezano z do 1,5-kratnim zvečanjem tveganja za ishemično možgansko kap.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišični krči
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 2-letni študiji kancerogenosti na podganah so pri samicah, ki so s hrano prejemale koncentracije 0,03 % in 0,1 %, opazili zvečanje incidence benignih granulozocelularnih tumorjev na jajčnikih.
English: Body mass index (BMI)
Slovenian: Indeks telesne mase (ITM)
English: In women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period.
Slovenian: Pri ženskah, starih od 50 do 54 let, ki ne uporabljajo HNZ, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2.000.
English: • Alopecia (hair loss)
Slovenian: • alopecija (izpadanje las oziroma dlak);
English: • if you become pregnant
Slovenian: • če zanosite;
English: Bazedoxifene Baseline-adjusted total estrone
Slovenian: bazedoksifen skupni estron, prilagojen glede na izhodiščno vrednost
English: • Blood clot in the lungs
Slovenian: • krvni strdki v pljučih;
English: Blood triglycerides increased
Slovenian: Preiskave zvečane vrednosti trigliceridov v krvi
English: • Symptoms of pancreatitis which may include severe upper abdominal pain which may spread to your back, accompanied by abdominal swelling, fever, nausea and vomiting
Slovenian: • simptomi vnetja trebušne slinavke, ki lahko vključujejo hude bolečine v zgornjem delu trebuha, ki se lahko širijo proti hrbtu, spremljajo pa jih otekanje trebuha, zvišana telesna temperatura, občutek slabosti s siljenjem na bruhanje in bruhanje;
English: Ovarian cancer
Slovenian: Rak jajčnikov
English: Adverse reactions reported with CE and/or bazedoxifene monotherapy
Slovenian: Neželeni učinki, o katerih so poročali pri monoterapiji s CE in/ali bazedoksifenom