FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 3 year core study the rate per 1,000 women-years for ischaemic strokes was similar between the 20 mg bazedoxifene (1.98) and placebo (2.2) groups and higher in the 40 mg bazedoxifene (2.72) group.
Maltese: Fl-istudju prinċipali ta' 3 snin, ir-rata ta' puplesiji iskemiċi għal kull 1,000 sena tan-nisa kienet simili bejn il-gruppi ta' 20 mg bazedoxifene (1.98) u tal-plaċebo (2.2) u kienet aktar għolja fil-grupp ta' 40 mg bazedoxifene (2.72).
English: Female rats were administered daily doses of 0.3 to 30 mg/kg (0.03 to 8 times the human exposure) prior to and during mating with untreated males.
Maltese: Firien nisa ngħataw dożi ta' kuljum ta' 0.3 sa 30 mg/kg (0.03 sa 8 darbiet l-esponiment fil-bniedem) qabel u waqt it-tgħammir b'irġiel mhux trattati.
English: In clinical trials, the highest rate of VTE was observed during the first year of treatment, with a relative risk of 2.69 compared to placebo.
Maltese: Fi provi kliniċi, l-aktar rata għolja ta' VTE ġiet osservata matul l-ewwel sena ta' trattament, b'riskju relattiv ta' 2.69 meta mqabbel mal-plaċebo.
English: After 5 years of treatment the rate per 1,000 women-years for ischaemic strokes was similar between the 20 mg bazedoxifene (1.87) and the placebo (2.02) groups.
Maltese: Wara 5 snin ta' trattament ir-rata ta' puplesiji iskemiċi għal kull 1,000 sena tan-nisa kienet simili bejn il-gruppi ta' 20 mg bazedoxifene (1.87) u l-gruppi tal-plaċebo (2.02).
English: Repeated-dose studies in normally cycling rodents and cynomolgus monkeys revealed a marked stimulation of ovarian follicle growth without ovulation, leading to partly haemorrhagic-ovarian cysts and markedly elevated estradiol levels.
Maltese: Studji dwar dożi ripetuti f'annimali gerriema u xadini cynomolgus b'ċikli normali wrew stimulazzjoni qawwija fl-iżvilupp ta' follikuli ovarjani mingħajr ovulazzjoni, li wassal għal ċisti parzjament emorraġiċi fl-ovarji u livelli ta' estradiol notevolment ogħla.
English: Such discontinuation was statistically significant more frequently in the placebo group (4.0%) than in the bazedoxifene 20 mg (2.8%) or raloxifene 60 mg (2.1%) groups.
Maltese: Dan il-waqfien kien statistikament sinifikanti b'mod aktar frekwenti fil-grupp tal-plaċebo (4.0%) milli fil-grupp ta' bazedoxifene 20 mg (2.8%) jew raloxifene 60 mg (2.1%).
English: Blood triglycerides increased, alanine aminotransferase increased, aspartate aminotransferase increased.
Maltese: Żieda fil-livell ta' trigliċeridi fid-demm, żieda f'alanine aminotransferase ; żieda f' aspartate aminotransferase
English: Similar reductions in the rate of bone turnover have been observed in the osteoporosis prevention study.
Maltese: Tnaqqis simili fir-rata tat-tibdil tal-għadam ġie osservat flistudju ta' prevenzjoni tal-osteoporożi.
English: In an 18-month bone efficacy study in aged ovariectomized cynomolgus monkeys, bazedoxifene, administered orally to monkeys at dosages of 0, 0.2, 0.5, 1, 5, or 25 mg/kg/day, resulted in exposures, based on surface area (mg/m2) of approximately 0.2 to 24 times the clinical dose of 20 mg. Renal cell carcinomas were observed in this study.
Maltese: Fl-istudju ta' 18-il xahar dwar l-effikaċja fl-għadam f'xadini cynomolgus anzjani li tneħħewlhom lovarji, bazedoxifene li ngħata lix-xadini mill-ħalq f'dożi ta' 0, 0.2, 0.5, 1, 5, or 25 mg/kg/jum, wassal għal esponimenti, bbażati fuq erja tas-superfiċje (mg/m2) ta' madwar 0.2 sa 24 darba d-doża klinika ta'
English: Τηλ.
Maltese: Tel.
English: The majority of adverse reactions occurring during the clinical trials were mild to moderate in severity and did not lead to discontinuation of therapy.
Maltese: Il-maġġoranza ta' reazzjonijiet avversi li seħħew waqt il-provi kliniċi kienu minn ħfief sa moderati u ma wasslux sabiex titwaqqaf it-terapija.
English: Endometrial polyps were diagnosed in 10 subjects in the bazedoxifene 20 mg, 17 subjects in the raloxifene 60 mg, and 11 subjects in the placebo treatment groups through month 36.
Maltese: Polipi endometrijali kienu ddijanjosati f'10 individwi fil-grupp ta' bazedoxifene 20 mg, 17-il individwu fil-grupp ta' raloxifene 60 mg, u 11-il individwu fil-grupp tal-plaċebo sat-36 xahar.
English: Swelling of the hands, feet and legs (peripheral oedema)
Maltese: Nefħa fl-idejn, is-saqajn u r-riġlejn (edema periferali)
English: In a post-hoc analysis, the 10-year fracture probability as an index of baseline fracture risk was determined.
Maltese: F'analiżi li saret wara dan, il-probabilità ta' ksur f'10 snin bħala indiċi ta' riskju ta' ksur fil-linja bażi kienet stabilita.
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.
Maltese: Il-preżenza ta' tumuri beninni ta' ċelluli granulosa tal-ovarji fi ġrieden u fil-firien nisa li ngħataw bazedoxifene hu effett tal-klassi tal-mediċini SERMs, marbut mal-farmakoloġija tiegħu f'annimali gerriema meta trattati waqt il-ħajja riproduttiva tagħhom, meta l-ovarji tagħhom ikunu jaħdmu u jirrispondu għal stimulazzjoni ormonali.
English: Bazedoxifene must not be taken by women of child-bearing potential (see sections 4.6 and 5.3).
Maltese: Bazedoxifene m'għandux jittieħed min-nisa li għad jista' jkollhom it-tfal (ara sezzjonijiet 4.6 u 5.3).
English: The major route of excretion of radio-labelled bazedoxifene is the faeces, and less than 1% of the dose is eliminated in urine.
Maltese: Il-passaġġ ewlieni ta' eliminazzjoni ta' bazedoxifene radjutikkettat hu fl-ippurgar, u inqas minn 1% tad-doża tiġi eliminata fl-awrina.
English: In the breast-density study, an ancillary study of the osteoporosis treatment study, 444 postmenopausal women (mean age = 59 years) with osteoporosis from all 4 treatment groups, were evaluated for mammographic breast density changes at 24 months.
Maltese: Fl-istudju ta' densita' tas-sider, studju ieħor tat-trattament ta' osteoporożi, 444 ta' nisa li diġa għaddew mill-menopawża (eta' medja = 59 sena) b'osteoporożi minn kull wieħed mill-4 gruppi tat-trattamenti, ġew evalwati għal bidla mammografika fid-densita' tas-sider wara 24 xahar.
English: Histomorphometric assessment revealed normal mineralisation, as evidenced by the presence of normal osteoid thickness, normal mineralisation lag time, and mineral apposition rate.
Maltese: Analiżi istomorfometrika irrivelat mineralizzazzjoni normali, kif deher bil-preżenza ta' ħxuna normali tal-osteojd, il-ħin ta' dewmien għal mineralizzazzjoni normali, u r-rata ta' appożizzjoni minerali.
English: The highest rate of VTE per 1,000 women-years of follow up was observed during the first year: 4.64 in the bazedoxifene 20 mg group and 1.73 in the placebo group (relative risk 2.69).The rate per 1,000 women-years at 3 years was 2.86 in the bazedoxifene 20 mg group and 1.76 in the placebo group (relative risk 1.63).
Maltese: L-aktar rata għolja ta' VTE għal kull 1,000 sena tan-nisa matul il-perijodu ta' kura ta' wara, ġiet osservata matul l-ewwel sena: 4.64 fil-grupp ta' bazedoxifene 20 mg u 1.73 fil-grupp tal-plaċebo (riskju relattiv ta' 2.69).
English: In the osteoporosis treatment study in 7,492 postmenopausal women (mean age, 66 years), among 1,886 subjects treated with bazedoxifene (20 mg), there were 5 cases of thyroid cancer (0.69 per 1,000) and among 1,885 subjects treated with placebo, there was 1 case of thyroid cancer (0.14 per 1,000) after 7 years of treatment.
Maltese: Fl-istudju dwar it-trattament għall-osteoporożi li sar fuq 7,492 mara li diġa għaddew mill-menopawża (età medja, 66 sena), kien hemm 5 każijiet ta' kanċer fit-tirojde (0.69 għal kull 1,000) fost 1,886 individwu trattati b'bazedoxifene (20 mg), u kien hemm każ wieħed ta' kanċer fit-tirojde (0.14 għal kull 1,000) fost 1,885 individwu trattati bil-plaċebo, wara 7 snin ta' trattament.
English: After 7 years the rate per 1,000 women-years was 2.06 in the bazedoxifene 20 mg group and 1.36 in the placebo group (relative risk 1.51).
Maltese: Wara 7 snin, ir-rata għal kull 1,000 sena tan-nisa kienet ta' 2.06 fil-gruppi ta' bazedoxifene 20 mg u 1.36 tal-paċebo (riskju relattiv ta' 1.51).
English: The efficacy of bazedoxifene was established in two multicentre, double-blind, randomised, placeboand active-control, Phase 3 trials: 3-year osteoporosis treatment trial and a 2-year osteoporosis prevention trial.
Maltese: L-effikaċja ta' bazedoxifene ġiet stabbilita f'żewġ provi multiċentrali, ta' Fażi 3 li kienu double-blind, każwali, bi plaċebo bħala kontroll jew bħala kontrolli attivi: prova ta' kura għall-osteoporożi ta' 3 snin u prova ta' prevenzjoni tal-osteoporożi ta' sentejn.
English: After 5 years of treatment, the endometrial thickness in the bazedoxifene 20 mg group did not change and remained similar to placebo; there were no cases of endometrial cancer in the bazedoxifene 20 mg group compared to 6 cases in the placebo group (p<0.05).
Maltese: Wara 5 snin ta' trattament, il-ħxuna tal-endometriju fil-grupp ta' bazedoxifene 20mg ma nbidilx u baqa' simili għal-dak tal-plaċebo; ma kienx hemm każijiet ta'kanċer tal-endometriju fil-grupp ta' bazedoxifene 20 mg meta mqabbel mas-6 każijiet fil-grupp ta' plaċebo (p<0.05).
English: This study included mostly Caucasian (87.3%) subjects who were either osteoporotic without baseline vertebral fracture (BMD T-score at lumbar spine [LS] or femoral neck [FN] between -2.5 and -4.0) or osteoporotic, with at least 1 mild baseline vertebral fracture.
Maltese: Kawkasi (87.3%) li kienu jew osteoporotiċi mingħajr ksur vertebrali fil-linja bażi (punteġġ-T tal-BMD fis-sinsla lumbari [LS] jew l-għonq femurali [FN] bejn -2.5 u -4.0) jew osteoporotiċi, b'tal-anqas ksur vertebrali wieħed ħafif bħala linja bażi.
English: Bazedoxifene functions primarily as an oestrogen-receptor antagonist in uterine and breast tissues.
Maltese: Bazedoxifene jiffunzjona prinċipalment bħala antagonist għar-riċettatur tal-estroġen fit-tessuti tal-utru u tas-sider.
English: Safety and efficacy of bazedoxifene have not been evaluated in patients with hepatic impairment; use in this population is not recommended (see sections 4.4 and 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' bazedoxifene ma ġewx evalwati f'pazjenti b'indeboliment tal-fwied; l-użu f'din il-popolazzjoni mhux irrakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: Bazedoxifene is rapidly absorbed with a tmax of approximately 2 hours and exhibits 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.
Maltese: Bazedoxifene jiġi assorbit malajr b'tmax ta' madwar sagħtejn u jesebixxi żieda lineari fil-konċentrazzjonijiet tal-plażma għal dożi waħdanin minn 0.5 mg sa 120 mg u għal dożi multipli ta' kuljum minn 1 mg sa 80 mg.
English: This lipid profile was maintained throughout the 7 years of treatment.
Maltese: Dan il-profil ta' lipidi inżamm matul il-7 snin ta' trattament.
English: In the osteoporosis treatment study in 7,492 postmenopausal women (mean age, 66 years), among 1,886 subjects treated with bazedoxifene (20 mg), there were 5 cases of ovarian cancer (0.69 per 1,000) and among 1,885 subjects treated with placebo, there were 0 cases of ovarian cancer after 7 years of treatment.
Maltese: Fl-istudju dwar it-trattament għall-osteoporożi li sar fuq 7,492 mara li diġa għaddew mill-menopawża (età medja, 66 sena), kien hemm 5 każijiet ta' kanċer fl-ovarji (0.69 għal kull 1,000) fost 1,886 individwu trattati b'bazedoxifene (20 mg), u ma kien hemm l-ebda każ ta' kanċer fl-ovarji fost 1,885 individwu trattati bil-plaċebo, wara 7 snin ta' trattament.
English: The bazedoxifene 40 mg dose was decreased to a 20 mg dose after approximately 4 years.
Maltese: Id-doża ta' 40 mg ta' bazedoxifene ġiet imnaqqsa għal doża ta' 20 mg, wara bejn wieħed u ieħor 4 snin.
English: There were 5 cases of breast cancer per 4,591 person-years of follow-up in the bazedoxifene 20 mg group (1.09 per 1,000), 7 cases of breast cancer per 4,526 person-years of follow-up in the raloxifene 60 mg group (1.55 per 1,000), and 8 cases of breast cancer per 4,604 person-years of follow-up in the placebo group (1.74 per 1,000).
Maltese: Kien hemm 5 każijiet ta' kanċer tas-sider għal kull 4,591 sena tan-nies wara l-kura fil-grupp ta' bazedoxifene 20 mg (1.09 kull 1,000), 7 każijiet ta' kanċer tas-sider għal kull 4,526 sena tan-nies wara l-kura fil-grupp ta' raloxifene 60 mg (1.55 kull 1,000), u 8 każijiet ta' kanċer tas-sider għal kull 4,604 snin tan-nies wara l-kura fil-grupp ta' plaċebo (1.74 kull 1,000).
English: The increase from baseline in lumbar spine BMD at 7 years in the bazedoxifene 20 mg group was not statistically greater than in the placebo group.
Maltese: Wara 7 snin, iż-żieda mil-linja bażi fil-BMD talspina lumbari fil-grupp ta' bazedoxifene 20 mg ma kinitx statistikament aktar għolja meta mqabbla mal-plaċebo.
English: In the osteoporosis treatment study, 7,492 postmenopausal women (mean age of 66 years; range 50 to 85 years and a mean time of 19.5 years since menopause) received bazedoxifene (20 or 40 mg daily), raloxifene (60 mg daily), or placebo to evaluate the incidence of new vertebral fractures over 3 years (3-year core study).
Maltese: Fl-istudju dwar it-trattament tal-osteoporożi, 7,492 mara li diġà kellhom il-menopawsa (età medja ta' 66 sena; fuq firxa ta' etajiet bejn il-50 u l-85 sena u bi żmien medju ta' dsatax-il sena u nofs mill-menopawsa) irċevew bazedoxifene (20 jew 40 mg kuljum), raloxifene (60 mg kuljum), jew plaċebo sabiex tiġi evalwata l-inċidenza ta' ksur vertebrali ġdid fuq 3 snin (studju prinċipali ta' 3 snin).
English: In the osteoporosis treatment study, bazedoxifene 20 mg and raloxifene 60 mg therapy resulted in a significant reduction of serum markers of bone resorption (C-telopeptide) and bone formation (osteocalcin), when compared to placebo, indicating a reduction in bone turnover.
Maltese: Fl-istudju dwar it-trattament għall-osteoporożi, terapija b'bazedoxifene 20 mg u raloxifene 60 mg irriżultat fi tnaqqis sinifikanti fil-markers tas-serum għax-xedd tal-għadam (C-telopeptide) u għal formazzjoni tal-għadam (osteocalcin), meta mqabbel ma' plaċebo, li jindika tnaqqis fil-bidla tal-għadam.
English: At 3 years, there were no cases of endometrial cancer and 1 case (0.1%) of endometrial hyperplasia in the bazedoxifene 20 mg-treated subjects.
Maltese: Ma 3 snin, ma kienx hemm każijiet ta' kanċer endometrijali u każ wieħed (0.1%) ta' iperplasja endometrijali fl-individwi trattati b'bazedoxifene 20 mg.
English: Treatment of rats at maternally toxic doses 1 mg/kg/day (0.3 times the human exposure) resulted in reduced numbers of live foetuses and/or reductions in foetal body weights.
Maltese: Trattament fuq firien b'dożi materni tossiċi ta'  1 mg/kg/jum ( 0.3 drabi l-espożizzjoni umana) irriżulta f'numru inqas ta' feti ħajjin u/jew tnaqqis fil-piżijiet korporali tal-feti.
English: Additionally, uterine wet weights were reduced compared with untreated animals and histologic evaluation demonstrated little to no difference from the untreated controls.
Maltese: Addizzjonalment, piżijiet tal-utru mhux imnixxef kienu mnaqqsa meta mqabbla ma' annimali mhux trattati u evalwazzjoni istoloġika wriet ftit jew lebda differenza mill-kontrolli mhux trattati.
English: The safety data in the following table are derived from both clinical trials and spontaneous post-marketing reporting.
Maltese: Id-dejta tas-sigurtà fit-tabella li ġejja hija miksuba kemm minn provi kliniċi kif ukoll minn rapportar spontanju ta' wara t-tqegħid fis-suq.
English: Use of CONBRIZA is not recommended in women at an increased risk for venous thromboembolic events.
Maltese: L-użu ta' CONBRIZA mhux rrakkomandat f'nisa b'riskju ogħla ta' każijiet tromboembolitiċi venużi.
English: In the 2-year carcinogenicity study, bazedoxifene, administered orally in the diet to rats at dosages of 0, 0.003%, 0.01%, 0.03%, or 0.1%, resulted in exposures, based on surface area (mg/m2) of approximately 0.6 to 23 times and 0.9 to 31 times in males and females, respectively, the clinical dose of 20 mg.
Maltese: Fl-istudju dwar irriskju ta' kanċer li dam sejjer sentejn, bazedoxifene, li ngħata mill-ħalq lill-firien fid-dieta f'dożi ta' 0, 0.003%, 0.01%, 0.03%, jew 0.1%, irriżulta f'esponimenti, bbażati fuq erja tas-superfiċje (mg/m2) ta'
English: In the osteoporosis treatment study, the incidence of breast-related adverse events in the bazedoxifene group was similar to placebo at 3 years.
Maltese: Fl-istudju dwar it-trattament għall-osteoporożi, l-inċidenza ta' każijiet avversi relatati mas-sider fil-grupp ta' bazedoxifene kien simili għal plaċebo sa 3 snin.
English: The rate per 1,000 women years for TIA was higher for the bazedoxifene 20 mg group (0.96) compared to placebo (0.55).
Maltese: Ir-rata għal kull 1,000 sena tannisa għal-TIA kienet aktar għolja fil-grupp ta' 20 mg bazedoxifene (0.96) meta mqabbla ma' dik talplaċebo (0.55).
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.
Maltese: Fi studji li damu sejrin 6 xhur dwar ir-riskju ta' kanċer fuq ġrieden transġeniċi, kien hemm inċidenza ogħla ta' tumuri beninni taċ-ċelluli granulosa tal-ovarju fi ġrieden nisa li ngħataw 150 jew 500 mg/kg/jum.
English: After 7 years of treatment, the endometrial thickness in the bazedoxifene 20 mg group did not change and remained similar to placebo; there were no cases of endometrial cancer in the bazedoxifene 20 mg group compared to 7 cases in the placebo group (p<0.008).
Maltese: Wara 7 snin ta' trattament, il-ħxuna tal-endometriju fil-grupp ta' bazdoxifene 20mg ma nbidlitx u baqgħet simili għal dik tal-plaċebo; ma kienx hemm każijiet ta' kanċer tal-endometriju fil-grupp ta' bazedoxifene 20 mg meta mqabbel mas-7 każijiet fil-grupp tal-plaċebo (p<0.
English: Osteoporosis treatment trial
Maltese: IL-PRODOTT MEDIĊINALI
English: The 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.
Maltese: Ir-rata għal kull 1,000 sena tannisa matul il-perijodu ta' 3 snin tal-istudju kienet ta' 2.86 fil-grupp ta' bazedoxifene 20 mg u 1.76 filgrupp tal-plaċebo, u matul il-perijodu ta' 5 snin tal-istudju kienet ta' 2.34 fil-grupp ta' bazedoxifene 20 mg u 1.56 fil-grupp tal-plaċebo.
English: The most frequent drug-related adverse reactions in double-blind, randomised studies were hot flushes and muscle spasms (includes leg cramps).
Maltese: L-aktar reazzjonijiet avversi frekwenti relatati mal-mediċina fi studji każwali u double-blind kienu fwawar u spażmi muskolari (li kienu jinkludu l-bugħawwieġ fir-riġlejn).
English: It may increase serum triglyceride levels; therefore, caution should be exercised in patients with known hypertriglyceridaemia (see section 5.1).
Maltese: Huwa jista' jgħolli l-livelli ta' trigliċeridi fis-serum; għalhekk, kawtela hi meħtieġa f'pazjenti magħrufin li għandhom ipertrigliċeridemija (ara sezzjoni 5.1).
English: The treatment effect on lipids was similar in the osteoporosis prevention study.
Maltese: L-effett tat-trattament fuq il-lipidi kien simili fl-istudju ta' prevenzjoni tal-osteoporożi.
English: After 7 years of treatment, the rate per 1,000 women-years for ischaemic strokes was the same for the 20 mg bazedoxifene (1.78) and the placebo (1.78) groups.
Maltese: Wara 7 snin ta' trattament, ir-rata ta' puplesiji iskemiċi għal kull 1,000 sena tan-nisa kienet l-istess filgruppi ta' 20 mg bazedoxifene (1.78) u fil-gruppi tal-plaċebo (1.78).
English: When determining the choice of CONBRIZA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Maltese: Fl-għażla ta' CONBRIZA jew ta' terapiji oħra, li jinkludu estroġeni, għal nisa individwali wara l-menopawsa, għandha tingħata konsiderazzjoni għas-sintomi tal- menopawsa, l-effetti fuq it-tessuti tal-utru u tas-sider, ir-riskji kardjovaskulari u l-benefiċċji (ara sezzjoni 5.1).
English: The partial preservation of bone mass was achieved by reductions in the ovariectomy-induced increases in bone turnover, evaluated by biochemical markers of bone turnover and histomorphometric indices measured in cancellous and cortical bone.
Maltese: Il-preservazzjoni parzjali ta' massa ta' għadam kienet inkisbet permezz ta' tnaqqis, fiż-żidiet tat-tibdil tal-għadam stimulati mit-tneħħijja tal-ovarji, li ġew evalwati b'markers bijokimiċi li jimmarkaw t-tibdil tal-għadam u indiċi istomorfometriċi mkejla f'għadam kanċelluż u kortiku.
English: After 3 years the relative risk was 1.63 and after a 5 year study period the relative risk was 1.50.
Maltese: Ir-rata ta' VTE kienet l-aktar għolja fl-ewwel sena b'riskju relattiv ta' 2.69. Wara 3 snin ir-riskju relattiv kien ta' 1.63 u wara 5 snin ta' perijodu ta' studju, ir-riskju relattiv kien ta' 1.50.
English: After 7 years of treatment, there were 13 cases of breast cancer in the bazedoxifene 20 mg group (1.78 per 1,000 women-years) and 11 cases in the placebo group (1.50 per 1,000 women-years).
Maltese: Wara 7 snin ta' trattament, kien hemm 13-il każ ta' kanċer fis-sider fil-grupp ta' bazedoxifene 20 mg (1.78 għal kull 1,000 sena tan-nisa) u 11-il każ ta' kanċer fis-sider fil-grupp tal-plaċebo (1.50 għal kull 1,000 sena tan-nisa).
English: Bazedoxifene undergoes little or no cytochrome P450 (CYP)-mediated metabolism.
Maltese: Hemm ftit jew l-ebda attività li tidher li hija medjada minn cytochrome P450.
English: The rate per 1,000 women-years through the 7 year study period was 2.06 in the bazedoxifene 20 mg group and 1.36 in the placebo group.
Maltese: Ir-rata għal kull 1,000 sena tan-nisa matul il-perijodu ta' 7 snin talistudju kienet ta' 2.06 fil-grupp ta' bazedoxifene 20 mg u 1.36 fil-grupp tal-plaċebo.
English: Muscle spasms (includes leg cramps) Hot flushes
Maltese: Spażmi muskolari (li jinkludu bugħawwieġ fir-riġlejn) Fwawar
English: In rabbit studies, 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 foetuses were present at maternally toxic doses of 0.5 mg/kg/day (1.5 times the human exposure).
Maltese: prinċipalment tas-sinsla u tal-kranju) fil-feti kienu preżenti f'dożi materni tossiċi ta'  0.5 mg/kg/jum (1.5 drabi l-espożizzjoni umana).
English: The rate per 1,000 women years for TIA was higher for the 20 mg bazedoxifene group (0.94) compared to placebo (0.62).
Maltese: Ir-rata għal kull 1,000 sena tannisa għal-TIA kienet aktar għolja fil-grupp ta' 20 mg bazedoxifene (0.94) meta mqabbla ma' dik talplaċebo (0.62).
English: All subjects received calcium supplementation daily; most received 600 mg calcium (e.g., Caltrate) daily, while some received up to 1,200 mg daily.
Maltese: L-individwi kollha rċevew supplimenti tal-kalċju kuljum; il-maġġoranza rċevew 600 mg kalċju (eż. Caltrate) kuljum, filwaqt li xi wħud rċevew sa 1,200 mg kuljum.
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 90 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 50 pillola 56 pillola 90 pillola 98 pillola
English: Athens, Greece
Maltese: Ateni, il-Greċja
English: Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Maltese: Tlieta mis-sitt metaboliti identifikati huma attivi (M-II, MIII, u M-IV).
English: Alanine aminotransferase increased 6
Maltese: Ma' insulina żieda f'alanine aminotransferase6
English: The other ingredients are lactose monohydrate, hydroxypropylcellulose, carmellose calcium and magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, hydroxypropylcellulose, carmellose calcium u magnesium stearate.