FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: BZA ni bil genotoksičen ali mutagen v nizu testov, vključno z bakterijskim testom reverzne mutacije in vitro, testu naprednih mutacij v celicah sesalcev na lokusu timidin-kinaze (TK/-) pri celicah mišjega limfoma L5178Y in vitro, testu kromosomskih aberacij pri celicah jajčnika kitajskega hrčka (CHO - Chinese hamster ovary) in vitro in testu mikronukleusa pri miših in vivo.
English: This change in BMD was similar to that shown with bazedoxifene 20 mg alone (+1.35%) and less than that seen with CE 0.45 mg/ medroxyprogesterone 1.5 mg (+2.58%) in the same study.
Slovenian: Ta sprememba MGK je bila podobna spremembi, ki so jo ugotovili pri samostojnem bazedoksifenu v odmerku 20 mg (+ 1,35 %), in manjša od spremembe, ki so jo v isti študiji opazili pri kombinaciji 0,45 mg CE/1,5 mg medroksiprogesterona (+ 2,58 %).
English: • Abrupt onset of abdominal pain and passage of bright red blood in the stool, with or without diarrhoea due to sudden blockage of an artery supplying the intestines (ischaemic colitis)
Slovenian: • nenaden pojav bolečine v trebuhu in izločanje svetlo rdeče krvi v blatu, z drisko ali brez nje, zaradi nenadne zamašitve arterije, ki dovaja kri v črevesje (ishemični kolitis);
English: In case of doubt, talk to your doctor before you take this medicine.
Slovenian: V primeru dvomov se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use oestrogen therapy will increase with age (see section 4.4).
Slovenian: To relativno tveganje ni odvisno od starosti ali trajanja uporabe, vendar pa je izhodiščno tveganje močno odvisno od starosti, zato se skupno tveganje možganske kapi pri ženskah, ki uporabljajo zdravljenje samo z estrogenom, zveča s starostjo (glejte poglavje 4.4).
English: • increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer)
Slovenian: • zvečano tveganje za razvoj od estrogenov občutljivega raka (npr. mati, sestra ali babica,
English: • Depression
Slovenian: • depresija;
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.
Slovenian: Simptomi prevelikega odmerjanja zdravil, ki vsebujejo estrogen, pri odraslih in otrocih lahko vključujejo navzeo, bruhanje, občutljivost dojk, omotico, bolečino v trebuhu ter dremavost/utrujenost; pri ženskah se lahko pojavijo odtegnitvene krvavitve.
English: Very common: may affect more than 1 in 10 people • Abdominal pain (stomach ache)
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnic • bolečina v trebuhu.
English: Endometrial hyperplasia and carcinoma
Slovenian: Hiperplazija endometrija in karcinom
English: The observation of benign, ovarian granulosa-cell tumours in female mice and rats administered bazedoxifene is a class effect of SERMs related to its pharmacology in rodents when treated during their reproductive lives, when their ovaries are functional and responsive to hormonal stimulation.
Slovenian: Opaženi benigni granulozocelularni tumorji na jajčnikih pri samicah miši in podgan, ki so prejemale bazedoksifen, so učinek skupine zdravil SERM, ki je povezan z njihovo farmakologijo pri samicah glodavcev, če jih prejemajo v rodni dobi, ko so njihovi jajčniki funkcionalni in se odzivajo na hormonsko stimulacijo.
English: Studies in rats with bazedoxifene have shown adverse effects on fertility (see section 5.3).
Slovenian: Študije z bazedoksifenom na podganah so pokazale škodljive vplive na plodnost (glejte poglavje 5.3).
English: If you stop taking DUAVIVE
Slovenian: Če ste prenehali jemati zdravilo DUAVIVE
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.
Slovenian: Zvečano tveganje postane očitno po nekaj letih uporabe, vendar se vrne na izhodiščno vrednost v nekaj (največ petih) letih po prekinitvi zdravljenja.
English: Do not store above 25ºC.
Slovenian: Shranjujte pri temperaturi do 25 °C.
English: *no differentiation was made between ischaemic and haemorrhagic stroke.
Slovenian: * Niso razlikovali med ishemično in hemoragično možgansko kapjo.
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.
Slovenian: Dodajanje bazedoksifena, ki deluje kot antagonist estrogenskih receptorjev v maternici, znatno zmanjša z estrogeni povezano tveganje hiperplazije endometrija pri nehisterektomiranih ženskah.
English: DUAVIVE is used in postmenopausal women who still have their uterus (womb) and have not had a natural period in the last 12 months.
Slovenian: Zdravilo DUAVIVE se uporablja pri ženskah po menopavzi, ki imajo še vedno maternico in v zadnjih 12 mesecih niso imele naravnega mesečnega perila.
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.
Slovenian: - Kombinacije CE/BZA pri bolnicah z okvarjenim delovanjem jeter (glejte poglavji 4.2 in 5.2) ali holestatskim ikterusom v anamnezi niso raziskovali.
English: - Undiagnosed genital bleeding.
Slovenian: - Nediagnosticirana krvavitev iz spolovil.
English: • A worsening of chorea (an existing neurological disorder characterised by involuntary spasmodic movements of the body)
Slovenian: • poslabšanje horeje (obstoječe nevrološke bolezni, za katero so značilni nenadzorovani spastični gibi telesa);
English: Women taking CE/BZA should not be taking progestins, additional oestrogens or selective oestrogen receptor modulators (SERMs).
Slovenian: Ženske, ki jemljejo CE/BZA, ne smejo jemati progestinov, dodatnih estrogenov ali selektivnih modulatorjev estrogenskih receptorjev (SERM - selective oestrogen receptor modulators).
English: CE/BZA pairs CE with the selective oestrogen receptor modulator (SERM), BZA, which is defined as a tissue selective oestrogen complex (TSEC).
Slovenian: Kombinacija CE/BZA vsebuje CE in selektivni modulator estrogenskih receptorjev (SERM - selective oestrogen receptor modulator) BZA, kar je opredeljeno kot tkivno selektivni estrogenski kompleks (TSEC - tissue selective oestrogen complex).
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
Slovenian: Ena tableta s prirejenim sproščanjem vsebuje 96,9 mg saharoze (vključuje 0,7 mg saharoze v obliki saharoze monopalmitata), 62,9 mg laktoze (v obliki monohidrata), 0,2 mg tekočega maltitola, 0,0176 mg glukoze in 0,0088 mg sorbitola.
English: Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
Slovenian: Čeprav sta ritonavir in nelfinavir znana kot močna zaviralca, pri sočasni uporabi s steroidnimi hormoni kažeta induktivne lastnosti.
English: This medicinal product contains lactose, sucrose, glucose (in polydextrose and maltitol liquid) and sorbitol (in polydextrose).
Slovenian: To zdravilo vsebuje laktozo, saharozo, glukozo (v obliki polidekstroze in tekočega maltitola) in sorbitol (v obliki polidekstroze).
English: Dementia; depression; mood altered; changes in libido
Slovenian: Psihiatrične motnje demenca, depresija, spremenjeno razpoloženje, spremembe libida razdražljivost
English: • fluid retention due to cardiac or kidney problems
Slovenian: • zastajanje tekočine v telesu zaradi težav s srcem ali ledvicami.
English: Conjugated oestrogens is a medicine that belongs to a group of medicines called hormone replacement therapy (HRT).
Slovenian: Konjugirani estrogeni spadajo v skupino zdravil, imenovanih hormonsko nadomestno zdravljenje (HNZ).
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
Slovenian: • huda alergijska reakcija; simptomi lahko vključujejo nenadno piskajoče dihanje in bolečino ali stiskanje v prsnem košu, otekanje vek, obraza, ustnic, ust, jezika ali grla, težko dihanje in kolaps;
English: Age range (years)
Slovenian: Razpon starosti (leta)
English: CE are soluble in water and are well-absorbed from the gastrointestinal tract after release from the medicinal product formulation.
Slovenian: CE so topni v vodi in se po sproščanju iz formulacije zdravila dobro absorbirajo iz prebavil.
English: • a disease affecting the eardrum and hearing (otosclerosis)
Slovenian: • bolezen, ki prizadene bobnič in sluh (otoskleroza);
English: CE/BZA is only for use in postmenopausal women, and is contraindicated in women who are or may become pregnant (see section 4.3).
Slovenian: Kombinacija CE/BZA je namenjena le za uporabo pri ženskah v postmenopavzi in je kontraindicirana pri nosečnicah ali ženskah v rodni dobi (glejte poglavje 4.3).
English: The modified-release tablets are provided in UPVC/Monochlorotrifluorethylene blister packs containing 28 tablets.
Slovenian: Tablete s prirejenim sproščanjem so na voljo v pretisnih omotih iz UPVC/monoklorotrifluoretilena, ki vsebujejo 28 tablet.
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.
Slovenian: V preskušanju zdravljenja osteoporoze z bazedoksifenom (povprečna starost = 66,5 let) je bil delež primerov VTE na 1.000 žensk-let v 3-letnem obdobju izvajanja študije 2,86 v skupini, ki je prejemala bazedoksifen (20 mg), in 1,76 v skupini, ki je prejemala placebo, v 5-letnem obdobju izvajanja študije pa 2,34 v skupini, ki je prejemala 20 mg bazedoksifena, in 1,56 v skupini, ki je prejemala placebo.
English: CE/BZA has not been studied in women over 75 years of age.
Slovenian: Kombinacije CE/BZA niso raziskovali pri ženskah, starejših od 75 let.
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).
Slovenian: V opazovalnih študijah so večinoma poročali o majhnem zvečanju tveganja za raka dojke, ki je bistveno manjše kot pri ženskah, ki so uporabljale kombinacije estrogena in progestogena (glejte poglavje 4.8).
English: Female rats were administered daily dosages of 0.3 to 30 mg/kg (0.15 to 14.6 times the human dose based on body surface area, mg /m2 [20 mg/kg dosage in humans is 12.3 mg/m2]) prior to and during mating with untreated males.
Slovenian: Samicam podgan so dajali dnevne odmerke od 0,3 do 30 mg/kg (0,15- do 14,6-kratni odmerek pri človeku glede na telesno površino, mg /m2 [odmerek 20 mg/kg pri človeku je 12,3 mg/m2]) pred parjenjem s samci, ki niso prejemali zdravila, in v času parjenja.
English: • A worsening of epilepsy (seizures)
Slovenian: • poslabšanje epilepsije (epileptični napadi);
English: Circulating oestrogens exist in a dynamic equilibrium of metabolic interconversions.
Slovenian: Estrogeni v obtoku obstajajo v dinamičnem ravnovesju presnovnih oblik, ki se spreminjajo ena v drugo.
English: Endometrial hyperplasia may be a precursor to endometrial cancer.
Slovenian: Hiperplazija endometrija je lahko prekurzor za raka endometrija.
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.
Slovenian: Vendar je v klinični študiji medsebojnega delovanja večkratno odmerjanje 200 mg itrakonazola, ki je močan zaviralec CYP3A4, minimalno vplivalo na farmakokinetiko CE (merjeno z estronom in ekvilinom) in bazedoksifena, kadar se je uporabljal v enkratnem odmerku 0,45 mg CE/20 mg BZA.
English: • yellowing of your skin or the whites of your eyes (jaundice).
Slovenian: • porumenelost kože ali očesnih beločnic (zlatenica).
English: However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use hormone therapy will increase with age (see section 4.8).
Slovenian: Ker pa je osnovno tveganje za možgansko kap močno odvisno od starosti, se skupno tveganje za možgansko kap pri ženskah, ki uporabljajo hormonsko zdravljenje, zvečuje s starostjo (glejte poglavje 4.8).
English: • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir);
Slovenian: • zdravila za zdravljenje okužbe z virusom HIV (kot so nevirapin, efavirenz, ritonavir in nelfinavir);
English: • Signs of a blood clot in the eye (retinal vein), such as one sided visual disturbance including loss of vision, pain and swelling of the eye especially if sudden.
Slovenian: • znaki krvnega strdka v očesu (mrežnični veni), kot je enostranska motnja vida, vključno z izgubo vida, bolečino v očeh in otekanjem oči, zlasti če se pojavijo nenadno;
English: Endometrial cancer risk
Slovenian: Tveganje za raka endometrija
English: DUAVIVE and cancer
Slovenian: Zdravilo DUAVIVE in rak
English: Ovarian cancer is much rarer than breast cancer.
Slovenian: Rak jajčnikov je bistveno redkejši od raka dojke.
English: If a tablet is forgotten, it should be taken as soon as the patient remembers.
Slovenian: Če bolnica pozabi vzeti tableto, jo mora vzeti takoj, ko se spomni.
English: Steady-state concentrations are achieved by the second week of once-daily administration.
Slovenian: Koncentracije v stanju dinamičnega ravnovesja so dosežene do drugega tedna uporabe enkrat na dan.
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).
Slovenian: Pri ženskah, ki imajo maternico, uporaba HNZ samo z estrogenom ni priporočljiva, ker zveča tveganje za raka endometrija (glejte poglavje 4.4).
English: Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Slovenian: Pretirana zadebelitev maternične sluznice (hiperplazija endometrija) in rak maternične sluznice (rak endometrija)
English: • Swelling of the eyes, nose, lips, mouth, tongue or throat, difficulty in breathing, severe dizziness or fainting, skin rash (symptoms of angioedema)
Slovenian: • otekanje oči, nosu, ustnic, ust, jezika ali grla, težko dihanje, huda omotica ali omedlevica, izpuščaj na koži (simptomi angioedema);
English: Additional cases per 1,000 ET users over 5 years (95% CI)
Slovenian: Dodatni primeri na 1.000 uporabnic ET v obdobju 5 let (95 % IZ)
English: • migraine or severe headaches a rare disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
Slovenian: • redka bolezen imunskega sistema, ki prizadene številne organe v telesu (sistemski eritematozni lupus, SLE);
English: The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Slovenian: Uporaba samo estrogenskega HNZ je bila povezana z rahlo zvečanim tveganjem za raka jajčnikov.
English: Do not take this medicine if you are breast-feeding.
Slovenian: Ne jemljite tega zdravila, če dojite.
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2,000 users.
Slovenian: Pri ženskah, starih od 50 do 54 let, ki uporabljajo HNZ 5 let, to pomeni približno en dodaten primer na 2.000 uporabnic.
English: A reduction in bazedoxifene exposure may be associated with an increased risk of endometrial hyperplasia (see section 4.4).
Slovenian: Zmanjšanje izpostavljenosti bazedoksifenu je lahko povezano z zvečanim tveganjem za hiperplazijo endometrija (glejte poglavje 4.4).
English: Conjugated oestrogens
Slovenian: Konjugirani estrogeni
English: • asthma
Slovenian: • astma;
English: Systemic exposure (AUC) of bazedoxifene in these groups was 2.6 and 6.6 times that observed in postmenopausal women administered 20 mg/day for 14 days.
Slovenian: Sistemska izpostavljenost (AUC) bazedoksifenu pri teh skupinah je bila 2,6- oz. 6,6-krat večja kot pri ženskah v postmenopavzi, ki so 14 dni prejemale odmerek 20 mg/dan.
English: • Growth of benign meningioma, a non-cancerous tumour of the membranes around the brain or spinal cord
Slovenian: • rast benignega meningioma, nerakastega tumorja na možganskih ali hrbtenjačnih ovojnicah.
English: Hormone therapy is associated with a 1.3-3 fold risk of developing VTE.
Slovenian: Hormonsko zdravljenje je povezano z od 1,3- do 3-kratnim zvečanjem tveganja za pojav VTE.
English: • Visible swelling of the face, hands, legs, feet or ankles (peripheral oedema)
Slovenian: • vidno otekanje obraza, dlani, nog, stopal ali gležnjev (periferni edem).
English: When you take DUAVIVE do not take additional oestrogens as this may increase the risk of endometrial hyperplasia.
Slovenian: Ko jemljete zdravilo DUAVIVE, ne smete jemati dodatnih estrogenov, saj lahko to zveča tveganje za hiperplazijo endometrija.
English: What DUAVIVE looks like and contents of the pack
Slovenian: Izgled zdravila DUAVIVE in vsebina pakiranja
English: Pink, oval-shaped, modified-release tablet of 12 mm printed on one side with “0.45/20”.
Slovenian: Rožnata, ovalna tableta s prirejenim sproščanjem, velika 12 mm, z napisom »0.45/20« na eni strani.
English: Should a stroke occur or be suspected, CE/BZA should be discontinued immediately (see section 4.3).
Slovenian: Če se pojavi možganska kap ali sum nanjo, je treba zdravljenje s CE/BZA nemudoma prekiniti (glejte poglavje 4.3).
English: There is some evidence of increased risk of probable dementia in women who start using continuous oestrogen-only therapy after the age of 65.
Slovenian: Obstaja nekaj dokazov o zvečanem tveganju za verjetno demenco pri ženskah, ki začnejo uporabljati samo estrogensko zdravljenje po 65. letu starosti.
English: Kidney stones may develop and cause severe pain in the mid-back region (renal colic).
Slovenian: Lahko nastanejo ledvični kamni in povzročijo hude bolečine v srednjem delu hrbta (ledvična kolika);
English: Systemic exposure (AUC) to bazedoxifene in these groups was 35 and 69 times that in postmenopausal women administered 20 mg/day for 14 days.
Slovenian: Sistemska izpostavljenost (AUC) bazedoksifenu pri teh skupinah je bila 35- oz. 69-krat večja kot pri ženskah v postmenopavzi, ki so 14 dni prejemale odmerek 20 mg/dan.
English: - Known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency, see section 4.4).
Slovenian: - Znane trombofilične motnje (npr. pomanjkanje proteina C, proteina S ali pomanjkanje antitrombina; glejte poglavje 4.4).
English: SERMs (including bazedoxifene) and oestrogens individually increase the risk of VTE (see section 4.8).
Slovenian: Selektivni modulatorji estrogenskih receptorjev (SERM) (vključno z bazedoksifenom) in estrogeni posamično zvečajo tveganje za VTE (glejte poglavje 4.8).
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.
Slovenian: 7 letih je bil delež VTE na 1.000 žensk-let 2,06 v skupini, ki je prejemala 20 mg bazedoksifena, in 1,36 v skupini, ki je prejemala placebo.
English: Blood clots in a vein (thrombosis) DUAVIVE may increase the risk of blood clots.
Slovenian: Krvni strdki v veni (tromboza) Zdravilo DUAVIVE lahko zveča tveganje za krvne strdke.
English: • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine);
Slovenian: • zdravila za zdravljenje epilepsije (kot so fenobarbital, fenitoin in karbamazepin);
English: The recommended dose is one tablet once daily.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan. Tableto pogoltnite celo, s kozarcem vode.
English: Oestrogens are known to increase the risk of VTE (see section 4.4).
Slovenian: Znano je, da estrogeni zvečajo tveganje za VTE (glejte poglavje 4.4).
English: • Changes in breast tissue
Slovenian: • spremembe v tkivu dojk;
English: After a single dose of CE/BZA, baseline-adjusted total estrone (representing CE) is eliminated with a half-life of approximately 17 hours.
Slovenian: Po enkratnem odmerku CE/BZA je razpolovna doba izločanja skupnega estrona, prilagojenega glede na izhodiščno vrednost (ki predstavlja CE), približno 17 ur.
English: Blood triglycerides increased, alanine aminotransferase increased; aspartate aminotransferase increased
Slovenian: Preiskave zvečanje vrednosti trigliceridov v krvi, zvečanje vrednosti alaninaminotransferaze, zvečanje vrednosti aspartataminotransferaze
English: Hypersensitivity Angioedema; anaphylactic/ana phylactoid reactions; urticaria
Slovenian: Bolezni imunskega sistema preobčutljivost angioedem, anafilaktične/ anafilaktoidne reakcije, urtikarija
English: • a large increase in your blood pressure (symptoms may be headache, tiredness, dizziness)
Slovenian: • močno zvišanje krvnega tlaka (simptomi so lahko glavobol, utrujenost, omotica);
English: In a 12-week study, CE 0.45 mg/BZA 20 mg significantly reduced the number and severity of hot flushes compared to placebo at weeks 4 and 12.
Slovenian: V 12-tedenski študiji je kombinacija 0,45 mg CE/20 mg BZA od 4. do 12. tedna pomembno zmanjšala število in resnost vročinskih oblivov v primerjavi s placebom.
English: Uncommon: may affect 1 in 100 people • Gall bladder disease (e.g. gallstones, inflammation of the gall bladder (cholecystitis))
Slovenian: Občasni: pojavijo se lahko pri 1 od 100 bolnic • bolezen žolčnika (npr. žolčni kamni, vnetje žolčnika (holecistitis)).
English: In patients receiving bazedoxifene monotherapy there have been post-marketing reports of visual symptoms such as visual acuity disturbance or blurred vision.
Slovenian: Pri bolnicah, ki so prejemale monoterapijo z bazedoksifenom, so v obdobju trženja zdravila poročali o motnjah vida, kot sta zmanjšana ostrina vida ali zamegljen vid.
English: Changes in weight (increase or decrease)
Slovenian: Preiskave spremembe telesne mase (zvečanje ali zmanjšanje)
English: For women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period.
Slovenian: Pri ženskah v 50-ih, ki ne uporabljajo HNZ, je pričakovati, da bo v povprečju 8 žensk od 1.000 doživelo možgansko kap v obdobju 5 let.
English: • a liver disorder, such as a benign liver tumour
Slovenian: • bolezen jeter, kot je benigni tumor na jetrih;
English: CE/BZA contains bazedoxifene, which reduces the risk of endometrial hyperplasia that can occur with oestrogen-only use (see section 4.4).
Slovenian: Kombinacija CE/BZA vsebuje bazedoksifen, ki zmanjša tveganje za hiperplazijo endometrija, ki se lahko pojavi pri uporabi samostojnega estrogena (glejte poglavje 4.4).
English: There is no relevant use of CE/BZA in the paediatric population.
Slovenian: Kombinacija CE/BZA ni namenjena za uporabo pri pediatrični populaciji.
English: WHI Studies combined - Additional risk of ischaemic stroke* over 5 years use Age range (years) Incidence per 1,000 women in placebo arm over 5 years
Slovenian: Združene študije WHI - dodatno tveganje za ishemično možgansko kap* med 5-letno uporabo Razpon starosti (leta) Incidenca na 1.000 žensk v obdobju 5 let v skupini, ki je prejemala placebo
English: Medical history and regular check-ups
Slovenian: Zdravstvena anamneza (pretekle bolezni in zdravstveno stanje) in redni pregledi
English: You may also have ulcers in the mouth, eyes or genitals and have a fever
Slovenian: Lahko se pojavijo tudi razjede v ustih, na očeh ali na spolovilih ali pa imate zvišano telesno temperaturo.