FrancophonIA/ELRC3.0 huggingface dataset:
English: The following data are based on the findings in studies with bazedoxifene.
Slovenian: Podatki v nadaljevanju temeljijo na ugotovitvah študij z bazedoksifenom.
English: Other medicines and DUAVIVE
Slovenian: Druga zdravila in zdravilo DUAVIVE
English: These substitute for the loss of oestrogen production in menopausal women, and alleviate menopausal symptoms.
Slovenian: Ti nadomeščajo nezmožnost tvorbe estrogena pri ženskah v menopavzi in lajšajo menopavzalne simptome.
English: Adverse reactions were categorised as very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from available data).
Slovenian: Neželeni učinki so bili razvrščeni kot zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Medical examination/follow-up
Slovenian: Zdravstveni pregled/kontrolni pregled
English: Venous thromboembolism (VTE)
Slovenian: Venska trombembolija (VTE)
English: What you need to know before you take DUAVIVE
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo DUAVIVE
English: The distribution of exogenous oestrogens is similar to that of endogenous oestrogens.
Slovenian: Porazdelitev eksogenih estrogenov je podobna porazdelitvi endogenih estrogenov.
English: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
Slovenian: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija.
English: - Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal.
Slovenian: - Akutna bolezen jeter ali bolezen jeter v anamnezi, dokler se vrednosti testov funkcije jeter ne vrnejo na normalne.
English: • regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel.
Slovenian: • si redno pregledujete dojke in ste pozorni na vse spremembe, kot so nastanek jamic na koži, spremembe na bradavicah ali kakršnekoli zatrdline, ki jih lahko vidite ali otipate.
English: The following data are based on the findings in studies with BZA.
Slovenian: Podatki v nadaljevanju temeljijo na ugotovitvah študij z BZA.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: There are no data from the use of CE/BZA in pregnant women.
Slovenian: Podatkov o uporabi CE/BZA pri nosečnicah ni.
English: The risk of ovarian cancer varies with age.
Slovenian: Tveganje za raka jajčnikov se spreminja s starostjo.
English: Swallow tablet whole.
Slovenian: Tableto pogoltnite celo.
English: CE components, 17β-estradiol, estrone, and estriol are excreted in the urine, along with glucuronide and sulfate conjugates.
Slovenian: Komponente CE, 17β-estradiol, estron in estriol, se izločijo z urinom, skupaj z glukuronidom in sulfatnimi konjugati.
English: There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin and azithromycin or an antacid containing aluminium and magnesium hydroxide.
Slovenian: Med bazedoksifenom in naslednjimi zdravili ni bilo pomembnih farmakokinetičnih interakcij: ibuprofen, atorvastatin, azitromicin ali antacid, ki vsebuje aluminijev in magnezijev hidroksid.
English: Patients treated with CE/BZA should be monitored carefully for signs of development of gallbladder disease.
Slovenian: Bolnice, ki se zdravijo s CE/BZA, je treba skrbno spremljati glede znakov pojava bolezni žolčnika.
English: Red Iron oxide (E172)
Slovenian: Črnilo črni železov oksid (E172)
English: Among these, 1,585 women were treated with CE 0.45 mg/BZA 20 mg and 1,241 received placebo.
Slovenian: Med njimi je 1.585 žensk prejemalo 0,45 mg CE /20 mg BZA, 1.241 žensk pa je prejemalo placebo.
English: BZA is eliminated with a half-life of approximately 30 hours.
Slovenian: Razpolovna doba izločanja BZA je približno 30 ur.
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin).
Slovenian: Koncentracije drugih beljakovin v plazmi se lahko zvečajo (angiotenzinogen/substrat renina, alfa-1-antitripsin, ceruloplazmin).
English: Heart disease (heart attack)
Slovenian: Bolezen srca (srčna kap)
English: Conditions which need supervision
Slovenian: Bolezenska stanja, pri katerih je potreben nadzor
English: If prolonged immobilisation is to follow elective surgery temporarily stopping CE/BZA 4 to 6 weeks earlier is recommended.
Slovenian: Če elektivnemu kirurškemu posegu sledi daljša imobilizacija, je priporočljivo zdravljenje s CE/BZA začasno prekiniti 4 do 6 tednov pred posegom.
English: The bazedoxifene component of this medicine has been reported to cause problems with eyesight such as blurred vision.
Slovenian: Poročali so, da bazedoksifenska komponenta tega zdravila povzroča težave z vidom, npr. zamegljen vid.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake Uporabno do.
English: DUAVIVE is indicated for the treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.
Slovenian: Zdravilo DUAVIVE je indicirano za zdravljenje simptomov pomanjkanja estrogena pri ženskah v postmenopavzi z maternico (vsaj 12 mesecev od zadnje menstruacije), pri katerih zdravljenje s progestini ni primerno.
English: On average, compared to women 51 to 64 years of age (n=8), women 65 to 74 years of age (n=8) showed a 1.5-fold increase in AUC, and women 75 years of age (n=8) showed a 2.6-fold increase in AUC.
Slovenian: V primerjavi z ženskami, starimi od 51 do 64 let (n = 8), so pri ženskah, starih od 65 do 74 let (n = 8), opazili povprečno 1,5-kratno zvečanje vrednosti AUC, pri ženskah, starih 75 let (n = 8), pa 2,6-kratno zvečanje vrednosti AUC.
English: Estradiol only
Slovenian: Samo estradiol
English: For women with a history of cholestatic jaundice associated with past oestrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, CE/BZA should be discontinued.
Slovenian: Pri ženskah s holestatskim ikterusom, povezanim s preteklo uporabo estrogenov ali z nosečnostjo, je potrebna previdnost, pri ponovitvi bolezni pa je treba zdravljenje s CE/BZA prekiniti.
English: *WHI study in women with no uterus, which did not show an increase in risk of breast cancer
Slovenian: * Študija WHI pri ženskah brez maternice, pri katerih niso ugotovili zvečanega tveganja za raka dojke.
English: These may be signs of a liver disease
Slovenian: To sta lahko znaka bolezni jeter;
English: • Changes in mood
Slovenian: • spremembe razpoloženja;
English: • Cervical erosion found on medical examination
Slovenian: • erozija materničnega vratu, ugotovljena pri zdravniškem pregledu;
English: If you forget to take DUAVIVE
Slovenian: Če ste pozabili vzeti zdravilo DUAVIVE
English: • high blood pressure
Slovenian: • visok krvni tlak;
English: DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and bazedoxifene.
Slovenian: DUAVIVE je zdravilo, ki vsebuje dve učinkovini, imenovani konjugirani estrogeni in bazedoksifen.
English: Of the total number of women in phase 3 clinical trials who received CE/BZA 20 mg, 2.4% (n=77) were aged ≥65 years.
Slovenian: Od skupnega števila žensk v kliničnih preskušanjih 3. faze, ki so prejemale CE/BZA, jih je bilo 2,4 % (n = 77) starih ≥ 65 let.
English: If you have any unexpected vaginal bleeding, you must contact your doctor as soon as possible.
Slovenian: Če se vam pojavijo nepričakovane krvavitve iz nožnice, morate čimprej obvestiti zdravnika.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Slovenian: Bolnice z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze, intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharaze-izomaltaze ne smejo jemati tega zdravila.
English: This medicine contains conjugated oestrogens and bazedoxifene and is used to treat women with a uterus (womb).
Slovenian: To zdravilo vsebuje konjugirane estrogene in bazedoksifen, uporablja pa se za zdravljenje žensk, ki imajo maternico.
English: If you take more DUAVIVE than you should
Slovenian: Če ste vzeli večji odmerek zdravila DUAVIVE, kot bi smeli
English: Relief of oestrogen-deficiency symptoms and bleeding patterns
Slovenian: Lajšanje simptomov pomanjkanja estrogena in vzorci krvavitve
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).
Slovenian: Neželeni učinki so bili razvrščeni kot zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100) ali redki ( 1/10.000 do
English: If such symptoms occur, patients should avoid driving or use of machines that requires accurate visual perception until symptoms have resolved, or until they have received medical advice that it is safe to do so.
Slovenian: Če se pojavijo taki simptomi, se morajo bolnice izogibati vožnji ali upravljanju strojev, ki zahtevajo natančno vidno zaznavo, dokler simptomi ne izzvenijo ali dokler jim zdravnik ne svetuje, da so te dejavnosti varne.
English: It may harm them,
Slovenian: ki je imela raka dojke);
English: CE/BZA has a minor influence on the ability to drive and use machines.
Slovenian: Kombinacija CE/BZA ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: - Jaundice or deterioration in liver function - Significant increase in blood pressure -New onset of migraine-type headache
Slovenian: - zlatenica ali poslabšanje delovanja jeter; - pomembno zvišanje krvnega tlaka; - nov napad migrenskega glavobola.
English: In clinical trials with bazedoxifene monotherapy, somnolence was reported as an adverse reaction, and patients should be advised on the potential effect on driving and using machines.
Slovenian: V kliničnih preskušanjih z monoterapijo z bazedoksifenom so poročali o zaspanosti kot neželenem učinku, zato je treba bolnice opozoriti na možne učinke na sposobnost vožnje in upravljanja strojev.
English: Risk ratio & 95% CI
Slovenian: Razmerje tveganja in 95 % IZ
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.
Slovenian: Epidemiološki podatki iz obširne metaanalize kažejo rahlo zvečano tveganje pri ženskah, ki uporabljajo samo estrogensko hormonsko nadomestno zdravljenje (HNZ), kar postane očitno po 5 letih uporabe in se po prenehanju sčasoma počasi zmanjšuje.
English: The following side effects have been observed when either conjugated oestrogens and/or bazedoxifene (the active ingredients in this medicine) has been used alone and may occur also with this medicine:
Slovenian: Naslednje neželene učinke so opazili pri jemanju konjugiranih estrogenov in/ali bazedoksifena (učinkovin v tem zdravilu) kot samostojnih zdravil, lahko pa se pojavijo tudi pri tem zdravilu:
English: The additional risk of ischaemic stroke over five years of use was assessed in the largest randomised trial in women without a uterus (WHI) from 50-59 years of age.
Slovenian: Dodatno tveganje za ishemično možgansko kap v petih letih uporabe so ocenili v največjem randomiziranem preskušanju pri ženskah brez maternice (WHI), starih od 50 do 59 let.
English: Do not store above 25C.
Slovenian: Shranjujte pri temperaturi do 25 C.
English: Uncommon: may affect 1 in 100 people • If you begin to get migraine-like headaches, or severe headaches
Slovenian: Občasni: pojavijo se lahko pri 1 od 100 bolnic • če se pojavijo glavoboli, podobni migreni, ali hudi glavoboli.
English: • increased risk of developing blood clots [see “Blood clots in a vein (thrombosis)”]
Slovenian: • zvečano tveganje za razvoj krvnih strdkov (glejte »Krvni strdki v veni (tromboza)«);
English: • if any of your close relatives has ever had a blood clot in the leg, lung or another organ
Slovenian: • če je kdorkoli v ožji družini imel krvni strdek v nogi, pljučih ali drugem organu;
English: Risk ratio
Slovenian: Razmerje tveganja
English: • A worsening of asthma
Slovenian: • poslabšanje astme;
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.
Slovenian: Splošno znani dejavniki tveganja za VTE vključujejo uporabo estrogenov, starost, večji kirurški poseg, dolgotrajno imobilizacijo, debelost (ITM > 30 kg/m2), nosečnost/poporodno obdobje, sistemski eritematozni lupus (SLE) in raka.
English: If so, you should see your doctor more often for check-ups:
Slovenian: Če to za vas drži, morate zdravnika obiskovati pogosteje:
English: Therapy should be discontinued in case a contraindication is discovered (e.g., venous thromboembolism, stroke, and pregnancy) and in the following situations:
Slovenian: Zdravljenje je treba prekiniti, če se odkrije kontraindikacija (npr. venska trombembolija, možganska kap in nosečnost) in v naslednjih primerih:
English: - Untreated endometrial hyperplasia.
Slovenian: - Nezdravljena hiperplazija endometrija.
English: - Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully monitored when being treated with CE/BZA.
Slovenian: - Estrogeni lahko povzročijo zastajanje tekočine v telesu, zato je treba bolnice z motenim delovanjem srca ali ledvic med zdravljenjem s CE/BZA skrbno spremljati.
English: Relief of symptoms occurring after menopause
Slovenian: Lajšanje simptomov, ki se pojavijo po menopavzi
English: • Blood clot in a vein at the back of the eye (retinal vein) which may lead to loss of vision
Slovenian: • krvni strdek v veni na zadnjem delu očesa (mrežnična vena), ki lahko povzroči izgubo vida;
English: • Erythema multiforme: symptoms may include skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.
Slovenian: • multiformni eritem: simptomi lahko vključujejo izpuščaj na koži z rožnato-rdečimi madeži, zlasti na dlaneh ali podplatih, kjer se lahko pojavijo tudi mehurji.
English: • Changes in your interest in sex (increased or decreased libido)
Slovenian: • spremembe v zanimanju za spolnost (zvečan ali zmanjšan libido);
English: The disposition of a single 20 mg dose of bazedoxifene was compared in women with hepatic impairment (Child-Pugh Class A [n=6], B [n=6], and C [n=6]) and subjects with normal hepatic function (n=18).
Slovenian: Farmakokinetiko enkratnega 20 mg odmerka bazedoksifena so primerjali pri ženskah z okvaro jeter (razred A [n = 6], B [n = 6] in C [n = 6] po Child-Pughovi lestvici) in preiskovankah z normalnim delovanjem jeter (n = 18).
English: - Women with pre-existing hypertriglyceridaemia should be followed closely during treatment with oestrogens, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Slovenian: - Ženske z obstoječo hipertrigliceridemijo je treba med zdravljenjem z estrogeni skrbno opazovati, ker so v redkih primerih pri zdravljenju bolnic v takem stanju z estrogenom poročali o velikem zvečanju trigliceridov v plazmi, ki je vodilo v pankreatitis.
English: * Taken from baseline incidence rates in developed countries Overall risk ratio.
Slovenian: * Na podlagi izhodiščne incidence v razvitih državah.
English: Bazedoxifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs).
Slovenian: Bazedoksifen spada v skupino nehormonskih zdravil, imenovano selektivni modulatorji estrogenskega receptorja (SERM).
English: In clinical trials of up to 2 years duration in postmenopausal women with CE/BZA, cases of VTE have been reported (see section 4.8).
Slovenian: V kliničnih preskušanjih pri ženskah v postmenopavzi s CE/BZA, ki so trajala do 2 leti, so poročali o primerih VTE (glejte poglavje 4.8).
English: Million women study (Estradiol only arm) - estimated additional risk of breast cancer after 5 years use
Slovenian: Študija Million Women Study (skupina, ki je prejemala samo estradiol) - ocenjeno dodatno tveganje za raka dojke po 5 letih uporabe
English: • Medicines for tuberculosis (such as rifampicin, rifabutin);
Slovenian: • zdravila za zdravljenje tuberkuloze (kot sta rifampicin, rifabutin);
English: Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, collapse or even death.
Slovenian: Krvni strdki so lahko resni, ob prehodu v pljuča pa lahko povzročijo bolečine v prsnem košu, zasoplost, kolaps ali celo smrt.
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.
Slovenian: Rezultati klinične študije medsebojnega delovanja, ki so jo izvedli s CE/BZA, in študij medsebojnega delovanja, ki so jih izvedli s CE ali monoterapijo z bazedoksifenom, so povzeti spodaj.
English: Physical (including pelvic and breast) examination should be guided by this and by the contraindications and precautions for use.
Slovenian: Telesni pregled (vključno z medeničnim predelom in dojkami) je treba opraviti glede na anamnezo, kontraindikacije in previdnostne ukrepe za uporabo.
English: On average, women with hepatic impairment showed a 4.3-fold increase in AUC compared with controls.
Slovenian: Pri ženskah z okvaro jeter je bila vrednost AUC povprečno 4,3-krat večja kot pri ženskah v kontrolni skupini.
English: The other ingredients are: lactose monohydrate, sucrose, sucrose monopalmitate, polydextrose (E1200, containing glucose and sorbitol) and maltitol liquid (see section 2), microcrystalline cellulose, powdered cellulose, hydroxypropylcellulose, hydroxyethylcellulose, magnesium stearate, ascorbic acid, hypromellose (E464), povidone (E1201), poloxamer 188, calcium phosphate, titanium dioxide (E171), macrogol (400), red iron oxide (E172), black iron oxide (E172) and propylene glycol (E1520).
Slovenian: Druge sestavine zdravila so: laktoza monohidrat, saharoza, saharoza monopalmitat, polidekstroza (E1200, vsebuje glukozo in sorbitol) in tekoči maltitol (glejte poglavje 2), mikrokristalna celuloza, celuloza v prahu, hidroksipropilceluloza, hidroksietilceluloza, magnezijev stearat, askorbinska kislina, hipromeloza (E464), povidon (E1201), poloksamer 188, kalcijev fosfat, titanov dioksid (E171), makrogol (400), rdeči železov oksid (E172), črni železov oksid (E172) in propilenglikol (E1520).
English: The active ingredients of CE are primarily the sulphate esters of estrone, equilin sulphates and 17α/β- estradiol.
Slovenian: Učinkovine CE so predvsem sulfatni estri estrona, ekvilinski sulfati in 17α/β-estradiol.
English: DUAVIVE alleviates these symptoms after menopause.
Slovenian: Zdravilo DUAVIVE lajša te simptome po menopavzi.
English: The risk of having a stroke is about 1.5 times higher in HRT users than in non-users.
Slovenian: Tveganje za možgansko kap je približno 1,5-krat večje pri uporabnicah HNZ kot pa pri ženskah, ki ne uporabljajo HNZ.
English: These tumours are known to occur in aged nonhuman primates and were considered spontaneous in the aged monkeys and irrelevant to humans.
Slovenian: Za te tumorje je znano, da se pojavljajo pri ostarelih živalskih primatih, in pri ostarelih opicah veljajo za spontane, torej te ugotovitve niso pomembne za ljudi.
English: Bazedoxifene
Slovenian: Bazedoksifen
English: Mean ± SD Steady-State Pharmacokinetic Parameters (n=24) Cmax (ng/mL)
Slovenian: Povprečje farmakokinetičnih parametrov ± SD v stanju dinamičnega ravnovesja (n = 24) Cmax (ng/ml)
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.
Slovenian: Bazedoksifen niti ne inducira niti ne zavira aktivnosti poglavitnih izoencimov CYP in je malo verjetno, da medsebojno deluje s sočasno uporabljenimi zdravili preko presnove, ki jo uravnava CYP.
English: If you take too many tablets you may have nausea (feel sick) or vomit.
Slovenian: Če vzamete preveč tablet, vam bo morda slabo ali boste bruhali.
English: Lactose, sucrose and glucose
Slovenian: Laktoza, saharoza in glukoza
English: • smoking
Slovenian: • kajenje;
English: You may need to stop taking DUAVIVE about 4 to 6 weeks before the operation, to reduce the risk of a blood clot (see Blood clots in a vein).
Slovenian: Za zmanjšanje tveganja za nastanek krvnega strdka boste morda morali prenehati z jemanjem zdravila DUAVIVE približno 4 do 6 tednov pred operacijo (glejte Krvni strdki v veni).
English: Effects on bone mineral density (BMD)
Slovenian: Učinki na mineralno gostoto kosti (MGK)
English: For the treatment of postmenopausal symptoms, CE/BZA should only be initiated for symptoms that adversely affect quality of life.
Slovenian: Kombinacija CE/BZA se lahko uporablja samo za zdravljenje postmenopavzalnih simptomov, ki negativno vplivajo na kakovost življenja.
English: When single doses of CE 0.625 mg/BZA 20 mg were administered with a high-fat meal, bazedoxifene Cmax was unaffected, but Area Under Curve (AUC) increased by approximately 25%.
Slovenian: Kadar so posamezne odmerke 0,625 mg CE/20 mg BZA dajali skupaj z obrokom z veliko vsebnostjo maščob, je bila vrednost Cmax za bazedoksifen nespremenjena, vendar se je vrednost površine pod krivuljo (AUC - area under the curve) zvečala za približno 25 %.
English: Patients with known thrombophilic states have an increased risk of VTE and hormone therapy may add to this risk.
Slovenian: Pri bolnicah z znanimi trombofiličnimi stanji je tveganje za VTE zvečano, hormonsko zdravljenje pa lahko to tveganje še zveča.
English: 28 modified-release tablets
Slovenian: 28 tablet s prirejenim sproščanjem
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: There is no experience in treating women with a premature menopause (due to ovarian failure or surgery) with DUAVIVE.
Slovenian: Izkušenj z zdravljenjem žensk z zgodnjo menopavzo (zaradi odpovedi jajčnikov ali kirurškega posega) z zdravilom DUAVIVE ni.
English: Oestrogen-only and bazedoxifene monotherapy increase the risk of blood clots in the veins (also called deep vein thrombosis, or DVT), especially during the first year of taking these medicines.
Slovenian: Samostojno zdravljenje samo z estrogenom ali z bazedoksifenom zveča tveganje za nastanek krvnih strdkov v venah (imenovanih tudi globoka venska tromboza ali GVT), zlasti v prvem letu jemanja zdravila.
English: Clinically, an increased metabolism of oestrogens may lead to decreased effect and changes in the uterine bleeding profile.
Slovenian: S kliničnega vidika lahko zvečana presnova estrogenov povzroči zmanjšan učinek in spremembe pri krvavitvah iz maternice.