FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Men i et interaktionsstudie med gentagen administration af 200 mg itraconazol, en potent CYP3A4-hæmmer, sammen med en enkeltdosis konjugerede østrogener 0,45 mg/bazedoxifen 20 mg havde itraconazol minimal indflydelse på farmakokinetikken af konjugerede østrogener (målt som estron og equilin) og bazedoxifen.
English: Visual acuity reduced, blurred vision, photopsia, visual field defect, visual impairment, dry eye, eyelid oedema, blepharospasm, eye pain and eye swelling
Danish: Nedsat synsskarphed, sløret syn, fotopsi, synsfeltdefekt, nedsat syn, tørre øjne, øjenlågsødem, blefarospasme, øjensmerter og hævelse af øjet.
English: • Breast pain, breast tenderness, swollen breasts
Danish: • Brystsmerter, brystømhed, hævede bryster
English: There is no relevant use of CE/BZA in the paediatric population.
Danish: Anvendelse af konjugerede østrogener/bazedoxifen er ikke relevant hos den pædiatriske population.
English: Exacerbation of asthma
Danish: Forværring af astma
English: Adverse reactions that have been observed with bazedoxifene monotherapy
Danish: Bivirkninger, der er observeret med bazedoxifen som monoterapi
English: - Active or past history of arterial thromboembolic disease (e.g., myocardial infarction,
Danish: - Aktiv eller tidligere arteriel tromboembolisk lidelse (f. eks. myokardieinfarkt, apopleksi).
English: • Blood clot in the leg veins
Danish: • Blodprop i venerne i benet
English: If you have or have had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it.
Danish: - Hvis du har eller nogensinde har haft brystkræft, eller hvis der er mistanke om, at du har det. - Hvis du har eller har haft kræft, der er følsom over for østrogener, såsom kræft i livmoderslimhinden (endometrium), eller hvis der er mistanke om, at du har det. - Hvis du for nylig har haft uforklarlig blødning fra skeden.
English: Endometrial hyperplasia may be a precursor to endometrial cancer.
Danish: Endometriehyperplasi kan være et forstadie til endometriecancer.
English: In order for this medicine to work, it should be taken daily as prescribed.
Danish: Du bør fortsætte med at tage dette lægemiddel, så længe din læge råder dig til det. For at dette lægemiddel skal virke, skal det tages dagligt som foreskrevet.
English: When you take DUAVIVE do not take additional oestrogens as this may increase the risk of endometrial hyperplasia.
Danish: Når du tager DUAVIVE, må du ikke tage yderligere østrogener, da dette kan øge risikoen for fortykkelse af livmoderslimhinden (endometriehyperplasi).
English: Risk of ischaemic stroke
Danish: Risiko for iskæmisk apopleksi
English: Risk ratio & 95%CI Additional cases per 1,000 ET users
Danish: Risikoratio & 95 % CI Yderligere tilfælde pr. 1.000 ET-brugere
English: CE 0.45 mg/BZA 20 mg demonstrated similar changes in mammographic breast density compared to placebo over 1 year of treatment.
Danish: Konjugerede østrogener 0,45 mg/bazedoxifen 20 mg viste samme ændringer i mammografisk brystdensitet som placebo ved behandling i mere end 1 år.
English: Risk ratio & 95%CI Additional cases per 1,000 HRT users over 5 years
Danish: Risikoratio & 95 % CI Yderligere tilfælde pr. 1.000 HRTbrugere over 5 år
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.
Danish: • Tegn på en blodprop i øjet (i blodåre i nethinden), såsom synsforstyrrelser på det ene øje, herunder synstab, smerter og hævelse i øjet, især hvisdet opstår pludseligt
English: Also contains: lactose, sucrose, polydextrose and maltitol liquid.
Danish: Indeholder også: Lactose, saccharose, polyglucose og flydende maltitol.
English: • Muscle spasms (including leg cramps)
Danish: • Muskelspasmer (også benkramper)
English: • Other ocular reactions (seeing sparks or flashes of light, narrowing of visual field, and swelling of eye or eye lid)
Danish: • Andre bivirkninger, som påvirker øjne og/eller syn (hvis du ser gnister eller lysglimt, indsnævring af synsfeltet og hævede øjne eller øjnelåg)
English: DUAVIVE 0.45 mg/20 mg modified-release tablets
Danish: Duavive 0,45 mg/20 mg tabletter med modificeret udløsning
English: • Alopecia (hair loss)
Danish: • Hårtab (alopeci)
English: The active substances are conjugated oestrogens and bazedoxifene.
Danish: Aktive stoffer: konjugerede østrogener og bazedoxifen.
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.
Danish: Der blev observeret nyrecellekarcinomer i et 18-måneders studie af virkningen på knoglerne hos ældre cynomolgusaber uden æggestokke ved eksponeringsratioer og doser baseret på overfladeareal (mg/m2), der var hhv. 0,05-16,3 gange og cirka 0,2-24 gange den kliniske dosis på 20 mg.
English: • Changes in weight (increase or decrease)
Danish: • Vægtændringer (stigning eller tab)
English: - Known, past or suspected oestrogen-dependent malignant tumours (e.g., endometrial cancer).
Danish: - Kendte eller formodede østrogenafhængige maligne tumorer eller disse i anamnesen (f.
English: Arthralgia; leg cramps
Danish: Arthralgi, benkramper
English: Urticaria, rash, pruritus
Danish: Urticaria, udslæt, pruritus
English: • Cervical erosion found on medical examination
Danish: • Forskydning af det indvendige væv af livmoderhalsen (ektropion) fundet ved helbredsundersøgelse
English: • Growth of benign meningioma, a non-cancerous tumour of the membranes around the brain or spinal cord
Danish: • Vækst af en godartet svulst i membranerne omkring hjernen eller rygmarven (godartet meningiom)
English: If any of these conditions apply to you, talk to your doctor before you take this medicine.
Danish: Hvis et eller flere af ovenstående forhold gælder for dig, skal du tale med lægen, inden du tager dette lægemiddel.
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).
Danish: Da risikoen for apopleksi ved baseline er stærkt aldersafhængig, stiger den samlede risiko for apopleksi hos kvinder, der bruger hormonbehandling, imidlertid med alderen (se pkt.
English: If VTE develops after initiating therapy, or is suspected, CE/BZA should be discontinued immediately.
Danish: Hvis VTE udvikles efter påbegyndt behandling, eller der er formodning om VTE, skal konjugerede østrogener/bazedoxifen straks seponeres.
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.
Danish: Der blev rapporteret uregelmæssig blødning og/eller pletblødning hos 7 % af kvinderne i behandlingsgruppen med konjugerede østrogener 0,45 mg/bazedoxifen 20 mg i løbet af de 3 første måneder af behandlingen, og hos 3 % af kvinderne i 10.-12. måned af behandlingen.
English: • Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids)
Danish: • Tørre øjne, øjensmerter, nedsat synsskarphed, synsforringelse, unormalt, ufrivillig blinken eller muskelsammentrækninger i øjenlågene (blefarospasme).
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.
Danish: Der blev rapporteret uregelmæssig blødning og/eller pletblødning hos 8 % af kvinderne i gruppen med konjugerede østrogener 0,45 mg/bazedoxifen 20 mg i løbet af de første 3 måneder og hos 4 % af kvinderne i 10.-12. måned.
English: The pharmacokinetics of CE/BZA have not been evaluated in women over 75 years of age.
Danish: De farmakokinetiske egenskaber ved konjugerede østrogener /bazedoxifen er ikke blevet vurderet hos kvinder over 75 år.
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
Danish: Bazedoxifen fremkaldte hanrotte-specifikke nefropatier (kortikomedullær nefrokalcinose og forstærket spontan kronisk progressiv nefropati) og forbundne adenomer og karcinomer ved eksponeringsratioer og doser baseret på overfladeareal (mg/m2), der var henholdsvis cirka 0,05-4 gange og 0,6-22 gange den kliniske dosis på 20 mg.
English: • Blood clot in the lungs
Danish: • Blodprop i lungerne
English: Clear coating
Danish: Klart overtræk
English: You can take the tablet at any time of the day, with or without food; however, it is advisable to take your tablet at the same time each day as this will help to remind you to take your medicine.
Danish: Det anbefales dog at tage tabletten på samme tidspunkt hver dag, da du så bedre kan huske at tage din medicin.
English: Endometrial cancer risk
Danish: Risiko for endometriecancer
English: • gallstones
Danish: • galdesten
English: • you notice signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing.
Danish: • du bemærker tegn på en blodprop, som f. eks. smertende hævelse af og rødme på benene, pludselige brystsmerter eller åndenød.
English: Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Danish: Fortykkelse af livmoderslimhinden (endometriehyperplasi) og kræft i livmoderslimhinden (endometriecancer)
English: The use of oestrogen-only therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Danish: Behandling med østrogen alene er associeret med en øget relativ risiko for iskæmisk apopleksi på op til 1,5 gang.
English: Use of oestrogen-only HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see section 4.4).
Danish: HRT-behandling med østrogen alene er blevet associeret med en let øget risiko for at få ovariecancer (se pkt.4.4).
English: Evidence suggests that taking oestrogen-only HRT possibly increases the risk of breast cancer.
Danish: Behandling med HRT, der kun indeholder østrogen, kan muligvis øge risikoen for brystkræft.
English: CE/BZA pairs CE with the selective oestrogen receptor modulator (SERM), BZA, which is defined as a tissue selective oestrogen complex (TSEC).
Danish: Konjugerede østrogener/bazedoxifen kombinerer konjugerede østrogener med den selektive østrogenreceptormodulator bazedoxifen, der er defineret som et vævsselektivt østrogenkompleks (TSEC).
English: The effect of DUAVIVE on the risk of stroke is unknown.
Danish: Duavives virkning på risikoen for slagtilfælde er ukendt.
English: Use in this population is therefore not recommended (see sections 4.4 and 5.2).
Danish: Anvendelse til denne population anbefales derfor ikke (se pkt.
English: The distribution of CE and bazedoxifene after administration of CE/BZA has not been studied.
Danish: Fordelingen af konjugerede østrogener og bazedoxifen efter administration af konjugerede østrogener/bazedoxifen er ikke blevet undersøgt.
English: Retinal vein thrombosis
Danish: Retinal venetrombose
English: How to take DUAVIVE
Danish: Sådan skal du tage Duavive
English: Conjugated oestrogens tablet core
Danish: Tabletkerne af konjugerede østrogener
English: SERMs (including bazedoxifene) and oestrogens individually increase the risk of VTE (see section 4.8).
Danish: Selektive østrogen receptor modulatorer (herunder bazedoxifen) og østrogener øger hver især risikoen for VTE (se pkt.
English: Physical (including pelvic and breast) examination should be guided by this and by the contraindications and precautions for use.
Danish: bækken og bryst) bør baseres på anamnesen, kontraindikationerne samt forsigtighedsregler vedrørende brug.
English: The effect of DUAVIVE on the risk of breast cancer is unknown.
Danish: Duavives virkning på risikoen for brystkræft er ukendt.
English: In another study, amenorrhea was reported in 96% of the women who received CE 0.45 mg/BZA 20 mg during months 10 to 12.
Danish: I et andet studie, blev der rapporteret amenoré hos 96 % af de kvinder, der fik konjugerede østrogener 0,45 mg/ bazedoxifen 20 mg i 10.-12. måned.
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.
Danish: Epidemiologisk evidens fra en omfattende meta-analyse tyder på, at risikoen er let forhøjet hos kvinder, der tager hormonsubstitutionsbehandling (HRT) med østrogen alene.
English: Pancreatitis; ischaemic colitis; vomiting
Danish: Pankreatitis, iskæmisk colitis, opkastning
English: Adverse reactions reported with CE and/or bazedoxifene monotherapy
Danish: Bivirkninger rapporteret med konjugerede østrogener og/eller bazedoxifen som monoterapi
English: CE/BZA contains bazedoxifene, which reduces the risk of endometrial hyperplasia that can occur with oestrogen-only use (see section 4.4).
Danish: Konjugerede østrogener/bazedoxifen indeholder bazedoxifen, som reducerer risikoen for endometriehyperplasi, der kan forekomme ved brug af østrogen alene (se pkt.
English: - Known thrombophilic disorders (e.g., protein C, protein S, or antithrombin deficiency, see section 4.4).
Danish: - Kendte trombofilisygdomme (f. eks. protein C-, protein S- eller antitrombinmangel, se pkt.
English: • a liver disorder, such as a benign liver tumour
Danish: • en leversygdom, f. eks. en godartet leversvulst
English: The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Danish: HRT-behandling med østrogen alene er blevet forbundet med let øget risiko for kræft i æggestokkene.
English: DUAVIVE 0.45 mg/20 mg modified-release tablets conjugated oestrogens/bazedoxifene
Danish: Duavive 0,45 mg/20 mg tabletter med modificeret udløsning konjugerede østrogener/bazedoxifen
English: Modified-release tablet.
Danish: Tablet med modificeret udløsning
English: - Known, suspected, or past history of breast cancer.
Danish: - Kendt eller formodet brystcancer eller dette i anamnesen.
English: Randomised controlled data found no increased risk of coronary artery disease in hysterectomised women using oestrogen-only therapy.
Danish: Randomiserede kontrollede data viste ikke enøget t risiko for koronar arteriesygdom hos hysterektomerede kvinder, der behandles med østrogen alene.
English: For more information, see ‘Blood clots in a vein
Danish: Du kan se flere oplysninger under "Blodpropper i en vene (trombose)".
English: Oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Danish: Behandling med østrogen alene er associeret med en øget risiko for iskæmisk apopleksi på op til 1,5 gange.
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.
Danish: Den rapporterede stigning i risikoen for endometriecancer er mellem 2-12 gange større risiko hos østrogen-behandlede sammenlignet med ikke-behandlede, afhængig af behandlingsvarighed og østrogendosis.
English: • migraine or severe headaches a rare disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
Danish: • en sjælden sygdom i immunsystemet, som påvirker mange af kroppens organer
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)
Danish: • vækst af livmoderslimhinde uden for livmoderen (endometriose) eller fortilfælde af fortykkelse af livmoderslimhinden (endometriehyperplasi)
English: For example, 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.
Danish: Eksempel: Blandt kvinder i alderen 5054 år, som ikke tager HRT, diagnosticeres kræft i æggestokkene hos ca. 2 ud af 2.000 kvinder i løbet af en periode på 5 år.
English: Carcinogenicity, mutagenicity, and impairment of fertility studies with CE/BZA have not been conducted.
Danish: Der er ikke udført studier af karcinogenicitet, mutagenicitet og nedsat fertilitet med konjugerede østrogener/bazedoxifen.
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.
Danish: Blandt kvinder i alderen 50-54 år, der ikke tager HRT, diagnosticeres ovariecancer hos ca. 2 ud af 2.000 kvinder i løbet af en periode på 5 år.
English: In one study, amenorrhea was reported in 97% of the women who received CE 0.45 mg/BZA 20 mg during months 10 to 12.
Danish: I et studie er der rapporteret amenoré hos 97 % af de kvinder, der fik konjugerede østrogener 0,45 mg/ bazedoxifen 20 mg i 10.-12. måned.
English: CE/BZA has not been studied in women over 75 years of age.
Danish: Konjugerede østrogener/bazedoxifen er ikke undersøgt hos kvinder over 75 år.
English: In rabbit studies with BZA, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies in the fetuses were present at maternally toxic dosages of  0.5 mg/kg/day (1.5 times the human exposure).
Danish: I kaninforsøg med bazedoxifen forekom der ved maternelle toksiske doser på  0,5 mg/kg/dag (1,5 gange den humane eksponering) abort og højere incidens af anomalier i hjerte (ventrikelseptumdefekt) og skeletsystem (forsinkelse i ossifikation, misdannelse eller skævhed i knogler primært i rygsøjle og kranium) hos fostrene.
English: The safety and efficacy of CE/BZA have not been evaluated in patients with hepatic impairment.
Danish: Sikkerheden og virkningen af konjugerede østrogener/bazedoxifen er ikke blevet vurderet hos patienter med nedsat leverfunktion.
English: CE/BZA has a minor influence on the ability to drive and use machines.
Danish: Konjugerede østrogener/bazedoxifen påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: • Increases in your triglyceride levels (fatty substances in the blood)
Danish: • Stigninger i fedtindholdet i blodet (triglycerider)
English: • Herbal remedies containing St John's Wort (Hypericum perforatum)
Danish: • Naturlægemidler, der indeholder perikon (Hypericum perforatrum).
English: If you are pregnant or could still become pregnant or you are breast-feeding.
Danish: - Hvis du er gravid eller stadig kan blive gravid, eller hvis du ammer.
English: • Signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain or difficulty in breathing.
Danish: • Tegn på en blodprop, såsom smertefuld hævelse af og rødme på benene, pludselige brystsmerter eller åndenød
English: The addition of bazedoxifene in CE/BZAreduces the risk of endometrial hyperplasia,which may be a precursor of endometrial carcinoma.
Danish: Tilsætningen af bazedoxifen til konjugerede østrogener/bazedoxifen reducerer risikoen for endometriehyperplasi, der kan være et forstadie til endometriekarcinom.
English: Women taking CE/BZAshould not take additionaloestrogens as this may increase the risk of endometrial hyperplasiaand endometrial carcinoma.
Danish: Kvinder, der tager konjugerede østrogener/bazedoxifen, bør ikke tage yderligere østrogener, da dette kan øge risikoen for endometriehyperplasi og endometriekarcinom.
English: • Migraine
Danish: • Hovedpine
English: Abdominal pain Constipation; diarrhoea; nausea
Danish: Opstipation, diarré, kvalme
English: • A heart attack - symptoms will usually include pain, including chest pain spreading to the jaw, neck and upper arm. You may feel sweaty, breathless, fatigued, nauseous and faint in addition to the pain
Danish: • Et hjerteanfald - symptomerne vil som regel være smerter, herunder brystsmerter, der breder sig til kæben, halsen og overarmen.
English: • Discharge from the nipples
Danish: • Udflåd fra brystvorterne
English: After opening the blister pouch, use within 60 days.
Danish: Anvendes inden 60 dage efter åbning af blisterpose.
English: • an irregular heartbeat
Danish: • et uregelmæssigt hjerteslag
English: If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Danish: Patienten skal overvåges nøje, hvis et eller flere af følgende tilstande forekommer, tidligere er forekommet og/eller er blevet forværret under graviditet eller tidligere hormonbehandling, Der skal tages højde for, at -nedenstående tilstande kan komme igen eller blive forværret under behandling med konjugerede østrogener/bazedoxifen:
English: Ischaemic stroke
Danish: Iskæmisk apopleksi
English: Hepatic impairment The pharmacokinetics of CE/BZA have not been evaluated in women with hepatic impairment.
Danish: De farmakokinetiske egenskaber ved konjugerede østrogener /bazedoxifen er ikke blevet vurderet hos kvinder med nedsat leverfunktion.
English: Following multiple doses of CE 0.45 mg/BZA 20 mg, the mean steady state pharmacokinetic parameters for CE and bazedoxifene (baseline adjusted for total estrone) are summarised below.
Danish: De gennemsnitlige steady-state farmakokinetiske parametre for konjugerede østrogener og bazedoxifen (korrigeret ved baseline for total estron) efter flere doser konjugerede østrogener 0,45 mg/bazedoxifen 20 mg er opsummeret nedenfor.
English: What you need to know before you take DUAVIVE 3.
Danish: Det skal du vide, før du begynder at tage Duavive Sådan skal du tage Duavive Bivirkninger
English: You may experience breast tenderness, dizziness, abdominal pain, drowsiness/fatigue or experience a short period of vaginal bleeding.
Danish: Hvis du har taget for mange tabletter, kan du få kvalme (føle dig dårlig) eller kaste op. Du kan opleve brystømhed, svimmelhed, mavesmerter, døsighed/træthed eller opleve en kort periode med blødning fra skeden.
English: Use in this population is contraindicated (see sections 4.3, 4.4 and 5.2).
Danish: 4.3, 4.4 og 5.2).
English: Risk of venous thromboembolism
Danish: Risiko for venøs tromboemboli
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.
Danish: Hvis der forekommer gennembruds- eller pletblødning efter længere tids behandling, eller hvis det fortsætter, efter at behandlingen er seponeret, skal årsagen undersøges.
English: Swallow tablet whole.
Danish: Tabletten skal synkes hel.
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).
Danish: Anvendelse af HRT produkter udelukkende indeholdende østrogen frarådes til kvinder med bevaret livmoder, da det øger risikoen for endometriecancer (se pkt.
English: Muscle spasms (includes leg cramps)
Danish: Muskelspasmer ( inkl.kramper i benene)
English: Each tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Danish: Hver tablet indeholder 0,45 mg konjugerede østrogener og bazedoxifenacetat svarende til 20 mg bazedoxifen.