FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions are categorized according to the following frequencies: 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); not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma kkategorizzati skont il-frekwenzi li ġejjin: komuni ħafna (1/10); komuni (1/100 sa 1/10); mhux komuni (1/1,000 sa 1/100); rari (1/10,000 sa 1/1,000); rari ħafna (1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: There were no significant pharmacokinetic interactions between bazedoxifene and the following medicinal products: ibuprofen, atorvastatin, azithromycin, or an antacid containing aluminium and magnesium hydroxide.
Maltese: Ma dehrux interazzjonijiet farmakokinetiċi sinifikanti bejn bazedoxifene u l-prodotti mediċinali li ġejjin: ibuprofen, atorvastatin, azithromycin jew antaċidi li fihom l-aluminju u magnesium hydroxide.
English: There was a significant reduction in the incidence of new vertebral fractures after 3 years of treatment with bazedoxifene 20 mg (42%), bazedoxifene 40 mg (37%) and raloxifene 60 mg (42%) compared to placebo.
Maltese: Kien hemm tnaqqis sinifikanti fl-inċidenza ta' ksur vertebrali ġdid wara 3 snin ta' trattament b'bazedoxifene 20 mg (42%), bazedoxifene 40 mg (37%) u raloxifene 60 mg (42%) meta mqabbel mal-plaċebo.
English: The median percent change from baseline of total cholesterol, LDL cholesterol and HDL cholesterol with bazedoxifene 20 mg were -3.75%, -5.36% and 5.10%, respectively, and were similar to that observed with raloxifene 60 mg.
Maltese: Il-bidla perċentwali medjana mil-linja bażi ta' kolesterol totali, kolesterol LDL u kolesterol HDL b'bazedoxifene 20 mg kienet ta' -3.75%, -5.36% u 5.10%, rispettivament, u kienet simili għal dik osservata b'raloxifene 60 mg.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati f' sezzjoni 6.1.
English: EU/1/09/511/001 28 tablets EU/1/09/511/002 30 tablets EU/1/09/511/003 84 tablets EU/1/09/511/004 90 tablets EU/1/09/511/005 7 tablets
Maltese: EU/1/09/511/001 28 Pillola EU/1/09/511/002 30
English: a of subjects with ≥1 new vertebral fracture Kaplan-Meier rate estimates p-value=0.015
Maltese: stimi ta' rati ta' Kaplan-Meier valur p=0.015
English: Race No pharmacokinetic differences based on ethnic group were observed.
Maltese: Razza Ma kienet osservata l-ebda differenza farmakokinetika skont il-grupp etniku.
English: The mean 10-year fracture probability of a major osteoporotic fracture for the entire study population was 11%.
Maltese: Il-medja ta' probabilità ta' ksur f'10 snin ta' ksur osteoporotiku ewlieni għal popolazzjoni kollha li ġiet studjata kien ta' 11%.
English: CONBRIZA 20 mg film-coated tablets Bazedoxifene
Maltese: CONBRIZA 20 mg pilloli miksija b'rita Bazedoxifene
English: The incidence of non-vertebral osteoporosis-related fractures was similar among bazedoxifene 20 mg (5.68%), raloxifene 60 mg (5.87%), and placebo (6.26%) groups.
Maltese: L-inċidenza ta' ksur mhux vertebrali marbut mal-osteoporożi kien simili fost il-gruppi b'bazedoxifene 20 mg (5.68%), raloxifene 60 mg (5.87%), u l-plaċebo (6.26%).
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.
Maltese: Esponiment sistemiku (AUC) għal bazedoxifene f'dawn il-gruppi kien ta' 2.6 u 6.6 drabi dak osservat f'nisa wara l-menopawsa li ngħataw 20 mg/jum għal 14-il jum.
English: There was 1 case (0.1%) of endometrial cancer, 1 case of sarcoma (0.1%), and 1 case (0.1%) of endometrial hyperplasia in the raloxifene 60 mg-treated subjects.
Maltese: Kien hemm każ wieħed (0.1%) ta' kanċer endometrijali, każ wieħed ta' sarkoma (0.1%), u każ wieħed (0.1%) ta' iperplasja endometrijali fl-individwi trattati b'raloxifene 60 mg.
English: CONBRIZA contains the active substance bazedoxifene, and is a medicine that belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs).
Maltese: CONBRIZA fiha s-sustanza attiva bazedoxifene, u hija mediċina li tappartjeni għal grupp ta' mediċini mhux ormonali msejħa Modulaturi Silettivi tar-Riċettaturi tal-Estroġen(SERMs).
English: A total of 3,146 subjects continued into the first 2-year extension (bazedoxifene 20 mg: n=1,047, bazedoxifene 40/20 mg: n=1,041, placebo: n=1,058).
Maltese: Total ta' 3,146 individwu komplew bl-ewwel sentejn ta' estensjoni (bazedoxifene 20 mg: n=1,047, bazedoxifene 40/20 mg: n=1,041, plaċebo: n=1,058).
English: The prevention study (1,583 subjects; mean age, 58 years; mean years since menopause, 11) compared BMD effects of bazedoxifene (10, 20, or 40 mg daily), raloxifene (60 mg daily), and placebo.
Maltese: L-istudju dwar il-prevenzjoni (1,583 individwu; età medja, 58 sena; medja ta' snin mill-menopawsa, 11) qabbel l-effetti tal-BMD fost bazedoxifene (10, 20, jew 40 mg kuljum), raloxifene (60 mg kuljum), u l-plaċebo.
English: 7 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 90 film-coated tablets
Maltese: 7 pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita
English: Following intravenous administration of a 3 mg dose of bazedoxifene, the volume of distribution is 14.7 ± 3.9 l/kg.
Maltese: Wara l-għoti minn ġol-vina ta' doża ta' 3 mg ta' bazedoxifene, il-volum ta' distribuzzjoni huwa ta' 14.7 ± 3.9 l/kg.
English: All subjects were to receive 1,200 mg of elemental calcium and 400 IU of vitamin D daily.
Maltese: L-individwi kollha kellhom jirċievu 1,200 mg ta' kalċju elementali u 400 IU ta' vitamina D kuljum.
English: Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Maltese: Kull pillola miksija b'rita fiha bazedoxifene acetate ekwivalenti għal 20 mg bazedoxifene.
English: After 5 years of treatment, the incidence of new vertebral fractures remained lower in the bazedoxifene 20 mg group (4.49%) compared to placebo (6.82%) with a relative risk reduction of 36% (p=0.014).
Maltese: Wara 5 snin ta' trattament, l-inċidenza ta' ksur vertebrali ġdid baqgħet aktar baxxa fil-grupp ta' bazedoxifene 20 mg (4.49%) meta mqabbla ma' dik tal-plaċebo (6.82%) b'nuqqas relattiv fir- riskju ta' 36% (p=0.014).
English: The disposition of a single 20 mg dose of bazedoxifene was compared in patients with hepatic impairment [Child-Pugh Class A (n=6), B (n=6), and C (n=6)] and subjects with normal hepatic function (n=18).
Maltese: Id-dispożizzjoni ta' doża waħda ta' 20 mg bazedoxifene kienet mqabbla fost pazjenti b'indeboliment tal-fwied [Klassi Child-Pugh A (n=6), B (n=6), u Ċ (n=6)] u individwi b'funzjoni tal-fwied normali (n=18).
English: In the osteoporosis treatment study, transvaginal ultrasonography (TVU) showed minimal changes in endometrial thickness in placebo (-0.08 mm, n=131), bazedoxifene 20 mg (-0.07 mm, n=129), and raloxifene 60 mg (0.16 mm, n=110) treated groups after 2 years.
Maltese: Fl-istudju dwar it-trattament tal-osteoporożi, ultrasonografija transvaġinali (TVU) wriet bidla minima fil-ħxuna endometrijali fil-gruppi ta' trattament bil-plaċebo (-0.08 mm, n=131), b'bazedoxifene 20 mg (-0.07 mm, n=129), u b'raloxifene 60 mg (0.16 mm, n=110), wara sentejn.
English: They are packed in PVC/Aclar blisters and are available in packs of 7, 28, 30, 84 or 90 tablets.
Maltese: Hija tiġi ppakjata f'folji tal-PVC/Aclar u tiġi f'pakketti ta' 7, 28, 30, 84 jew 90 pillola.
English: Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Maltese: Każijiet tromboembolitiċi venużi attivi jew tal-passat, li jinkludu trombożi profonda fil-vina (tas-saqajn), emboliżmu pulmonari u trombożi fil-vina retinali.
English: Effects on lipid metabolism and cardiovascular system In the osteoporosis treatment study after 3 years of treatment, bazedoxifene 20 mg and raloxifene 60 mg exhibited significant reductions in serum total cholesterol, low-density lipoprotein (LDL) cholesterol and a significant increase in high-density lipoprotein (HDL) cholesterol compared to placebo.
Maltese: Effetti fuq il-metaboliżmu tal-lipidi u fuq is-sistema kardijaka Fl-istudju dwar it-trattament għall-osteoporożi wara 3 snin, bazedoxifene 20 mg u raloxifene 60 mg urew tnaqqis sinifikanti fil-kolesterol totali fis-serum, kolesterol tal-lipoproteini ta' densità baxxa (LDL) u żieda sinifikanti fil-kolesterol tal-lipoproteini ta' densità għolja (HDL) meta mqabbel malplaċebo.
English: The safety of CONBRIZA has been evaluated in two multicentre, double-blind, randomised, placeboand active-control, Phase 3 trials: 7,492 evaluable postmenopausal women in a three-year osteoporosis treatment trial (1,886 women received bazedoxifene 20 mg; 1,872 women received bazedoxifene 40 mg; 1,849 women received raloxifene; 1,885 women received placebo) and 1,583 evaluable postmenopausal women in a 2-year osteoporosis prevention trial (321 women received bazedoxifene 10 mg; 322 women received bazedoxifene 20 mg; 319 women received bazedoxifene 40 mg; 311 women received raloxifene; 310 women received placebo).
Maltese: Is-sigurtà ta' CONBRIZA ġiet evalwata f'żewġ provi multiċentrali, ta' Fażi 3, li kienu double-blind, każwali, bi plaċebo bħala kontroll u b'kontrolli attivi: 7,492 mara li diġà kellhom il-menopawsa li setgħu jiġu evalwati fi prova ta' tliet snin ta' kura għall-osteoporożi (1,886 mara rċeviet bazedoxifene 20 mg; 1,872 mara rċeviet bazedoxifene 40 mg; 1,849 mara rċeviet raloxifene; 1,885 mara rċeviet plaċebo) u 1,583 mara li diġà kellhom il-menopawsa li setgħu jiġu evalwati fi prova ta' sentejn fuq il-prevenzjoni tal-osteoporożi (321 mara rċeviet bazedoxifene 10 mg; 322 mara rċeviet bazedoxifene 20 mg; 319-il mara rċeviet bazedoxifene 40 mg; 311-il mara rċeviet raloxifene;
English: Osteoporosis prevention trial
Maltese: Prova ta' prevenzjoni tal-osteoporożi
English: There were 3 cases (0.2%) of endometrial cancer and 1 case (0.1%) of endometrial hyperplasia in the placebo group.
Maltese: Kien hemm 3 każijiet (0.2%) ta' kanċer endometrijali u każ wieħed (0.1%) ta' iperplasja endometrijali fil-grupp tal-plaċebo.
English: After 7 years of treatment, the incidence of new vertebral fractures remained lower in the bazedoxifene 20 mg group (7.64%) compared to placebo (9.90%) with a relative risk reduction of 30% (p=0.022).
Maltese: Wara 7 snin ta' trattament, l-inċidenza ta' ksur vertebrali ġdid baqgħet aktar baxxa fil-grupp ta; bazedoxifene 20 mg (7.64%) meta mqabbla ma' dik tal-plaċebo (9.90%) b'nuqqas relattiv fir-risku ta' 30% (p=0.022).
English: Subjects with no baseline fracture n=757
Maltese: Individwi mingħajr ksur fil-linja bażi n=757
English: Bazedoxifene is eliminated with a half-life of approximately 30 hours.
Maltese: Bazedoxifene jiġi eliminat b'half-life ta' madwar 30 siegħa.
English: The increase in LS BMD compared with placebo with bazedoxifene 20 mg and raloxifene 60 mg was significant at 6 months (1.02% and 1.29%, respectively) and was maintained through 3 years (1.32% and 2.08%, respectively).
Maltese: Iż-żieda fil-BMD tal-LS meta bazedoxifene 20 mg u raloxifene 60 mg kienu mqabbla ma' plaċebo kienet sinifikanti wara 6 xhur (1.02% u 1.29%, rispettivament) u baqgħet tiġi mantnuta għal 3 snin (1.32% u 2.08%, rispettivament).
English: When single doses of 20 mg bazedoxifene were administered with a high-fat meal, Cmax and AUC increased by 28% and 22%, respectively.
Maltese: Meta ngħataw dożi waħdanin ta' 20 mg bazedoxifene ma' ikla li fiha ħafna xaħam, Cmax u AUC żdiedu bi 28% u 22%, rispettivament.
English: Bazedoxifene 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.
Maltese: Bazedoxifene ma kienx ġenotossku jew mutaġeniku f'għadd kbir ta' testijiet li kienu jinkludu assaġġ in vitro ta' mutazzjoni batterika inversa, assaġġ in vitro dwar il-mutazzjoni 'l quddiem ta' ċelluli mammiferi fil-lok ta' thymidine kinase (TK±) f'L5178Y taċ-ċelluli tal-limfoma fil-ġurdien, assaġġ in vitro ta' aberrazzjoni kromosomali fiċ-ċelluli tal-ovarju tal-ħamster Ċiniż (CHO), u fl-assaġġ in vivo mikronukleari tal-ġurdien.
English: Based on in vitro bazedoxifene plasma protein binding characteristics, drug interactions with warfarin, digoxin and diazepam are unlikely.
Maltese: Skont il-karatteristiċi tar-rabta ta' bazedoxifene mal-proteini fil-plażma li kienu in vitro, interazzjonijiet ma' warfarin, digoxin u diazepam mhumiex probabbli li jseħħu.
English: Use in this patient population is not recommended (see sections 4.2 and 4.4).
Maltese: Lużu f'din il-popolazzjoni ta' pazjenti mhux irrakkomandat (ara sezzjonijiet 4.2 u 4.4).
English: Mean changes in mammographic breast density in the bazedoxifene 20 mg group were significantly reduced from baseline (-1.45 percentage points, p<0.05) while no changes were observed in the placebo group (-0.15 percentage points).
Maltese: Il-bidla mammografika medja fid-densita' tas-sider fil-grupp ta' bazedoxifene 20 mg imnaqqsa b'mod sinjifikanti mill-linja bażi (-1.45 punti perċentwali, p<0.05) filwaqt li ma ġiet osservata l-ebda bidla fil-grupp ta' plaċebo (0.15 punti perċentwali).
English: The pharmacokinetics of a 20 mg single-dose of bazedoxifene were evaluated in a study in 26 healthy postmenopausal women.
Maltese: Il-farmakokinetiċi ta' doża waħda ta' 20 mg bazedoxifene kienu evalwati fi studju fuq 26 mara b'saħħitha wara l-menopawsa.
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 2.3-fold increase in AUC.
Maltese: Fuq medja, meta mqabbel ma' nisa ta' etajiet bejn 51 u 64 sena (n=8), u nisa ta' l-etajiet bejn 65 u 74 sena (n=8) kien hemm żieda ta' 1.5 drabi fl-AUC, u nisa 75 sena (n=8) wrew żieda ta' 2.3 drabi fl-AUC.
English: The effect on triglycerides in the bazedoxifene 20 mg and raloxifene 60 mg groups was similar to placebo.
Maltese: L-effett fuq it-trigliċeridi fil-gruppi ta' bazedoxifene 20 mg u raloxifene 60 mg kienu simili għal plaċebo.
English: CONBRIZA 20 mg film-coated tablets
Maltese: CONBRIZA 20 mg pilloli miksija b'rita
English: Assessment of bone histomorphometry and bone turnover In the osteoporosis treatment study in 7,492 postmenopausal women (mean age = 66 years), 121 bone biopsies were obtained from iliac crest after the administration of fluorochrome label from the subjects in bazedoxifene, raloxifene and placebo groups (bazedoxifene 20 mg = 28; bazedoxifene 40 mg = 29, raloxifene 60 mg = 32, placebo = 32) after approximately 2 or 3 years of treatment.
Maltese: Analiżi tal-istomorfometrija tal-għadam u l-bidla tal-għadam Fl-istudju dwar it-trattament tal-osteoporożi f'7,492 mara li diġà għaddew mill-menopawsa (età medja = 66 sena), 121 bijopsija tal-għadam kienu miksuba mill-kresta ilijaka wara l-għoti ta' fluorochrome ttikkettat mill-individwi fil-gruppi ta' bazedoxifene, raloxifene u l-plaċebo (bazedoxifene 20 mg = 28; bazedoxifene 40 mg = 29, raloxifene 60 mg = 32, plaċebo = 32) wara madwar sentejn jew 3 snin ta' trattament.
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.
Maltese: Esponiment sistemiku (AUC) għal bazedoxifene f'dawn il-gruppi kien ta' 35 u 69 darba dak f'nisa wara l-menopawsa li ngħataw 20 mg/jum għal 14-il jum.
English: The apparent oral clearance of bazedoxifene is approximately 4 to 5 l/h/kg.
Maltese: It-tneħħija orali apparenti ta' bazedoxifene hi ta' madwar 4 sa 5 l/h/kg.
English: Paediatric population There is no relevant use of bazedoxifene in the paediatric population.
Maltese: M'hemm ebda użu relevanti ta' bazedoxifene fil-popolazzjoni pedjatrika.
English: In a 30-day study, bazedoxifene increased hormone-binding globulin concentrations, including corticosteroid-binding globulin (CBG), sex hormone-binding globulin (SHBG) and thyroxine-binding globulin (TBG).
Maltese: Fi studju ta' 30 jum, bazedoxifene żied il-konċentrazzjonijiet ta' globulini li jintrabtu ma' ormoni, li jinkludu globulini li jintrabtu ma' kortikosterojdi (CBG), globuluni li jintrabtu ma' ormoni tas-sess (SHBG) u globulini li jintrabtu ma' thyroxine (TBG).
English: The effects of bazedoxifene treatment on bone, uterus, and mammary gland were assessed in ovariectomized rats (0.15 to 1.5 mg/kg/day) and non-human primates [Cynomolgus macaques] (0.2 to 25.0 mg/kg/day).
Maltese: L-effetti ta' trattament b'bazedoxifene fuq l-għadam, l-utru u l-glandola mammarja kienu analizzati f'firien bl-ovarji mneħħija (minn 0.15 sa 1.5 mg/kg/jum) u primati mhux umani [Cynomolgus macaques] (0.2 sa 25.
English: In the osteoporosis treatment trial in 7,492 subjects (mean age = 66 years), the bazedoxifene-treated women had an increased risk of VTE (deep vein thrombosis, pulmonary embolism and retinal vein thrombosis) (see section 4.8).
Maltese: Fil-prova tat-trattament ta' osteoporożi f' 7,492 individwu (eta' medja = 66 sena), in-nisa trattati b' bazedoxifene kellhom żieda fir-riskju ta' VTE (trombożi profonda tal-vina, emboliżmu pulmonari u trombożi fil-vina retinali) (ara sezzjoni 4.8).
English: The increase in LS BMD with bazedoxifene 20 mg and raloxifene 60 mg, compared with placebo, was significant at 6 months (1.14% and 1.26%, respectively) and was maintained through 2 years (1.41% and 1.49%, respectively).
Maltese: Iż-żieda fil-BMD tal-LS b'bazedoxifene 20 mg u raloxifene 60 mg, meta mqabbel mal-plaċebo kienet sinifikanti wara 6 xhur (1.14% u 1.26%, rispettivament) u baqgħet tinżamm għal sentejn (1.41% u 1.49%, rispettivament).
English: The metabolic disposition of bazedoxifene in postmenopausal women has been determined following oral administration of 20 mg of radio-labelled bazedoxifene.
Maltese: Id-dispożizzjoni metabolika ta' bazedoxifene f'nisa wara l-menopawsa ġiet iddeterminata wara l-għoti orali ta' 20 mg bazedoxifene radjutikkettat.
English: The mean pharmacokinetic parameters of bazedoxifene after multiple doses in healthy postmenopausal ambulatory women who were naturally postmenopausal or who had undergone bilateral oophorectomy are summarized in Table 2.
Maltese: Il-parametri farmakokinetiċi medji ta' bazedoxifene wara dożi multipli f'nisa wara l-menopawsa, b'saħħithom li jistgħu jiċċaqilqu u li waslu għall-menopawsa b'mod naturali jew kellhom oforektomija bilaterali huma miġbura fil-qasir f'Tabella 2.
English: These reports include visual acuity reduced, blurred vision, photopsia, visual field defect, visual impairment, dry eye, eyelid oedema, blepharospasm, eye pain and eye swelling.
Maltese: Dawn ir-rapporti jinkludu tnaqqis fl-akutezza tal-vista, vista mċajpra, fototopsja, difett fil-kamp viżwali, indeboliment tal-vista, għajn xotta, edima fil-kappell tal-għajn, blefarospażmu, uġigħ fl-għajnejn u nefħa fl-għajnejn.
English: The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce UGTs, such as rifampicin, phenobarbital, carbamazepine, and phenytoin, potentially leading to decreased systemic concentrations of bazedoxifene.
Maltese: Il-metaboliżmu ta' bazedoxifene jista' jiżdied bl-użu fl-istess ħin ta' sustanzi magħrufin li jinduċu l-UGTs, bħal rifampicin, phenobarbital, carbamazepine, u phenytoin, li potenzjalment iwasslu għal konċentrazzjonijiet sistemiċi mnaqqsa ta' bazedoxifene.
English: After 5 years of treatment, there were 9 cases of breast cancer in the bazedoxifene 20 mg group (1.40 per 1,000 women-years) and 10 cases in the placebo group (1.56 per 1,000 women-years).
Maltese: Wara 5 snin ta' trattament kien hemm 9 każijiet ta' kanċer fis-sider fil-grupp ta' bazedoxifene 20 mg (1.40 għal kull 1,000 sena tan-nisa) u 10 każijiet fil-grupp ta' plaċebo (1.56 għal kull 1,000 sena tan-nisa).
English: In the osteoporosis prevention study, TVU showed minimal changes from baseline in endometrial thickness in placebo (-0.24 mm, n=154), bazedoxifene 20 mg (-0.06 mm, n=158) and raloxifene 60 mg (0.01 mm, n=154) treated groups after 2 years.
Maltese: Fl-istudju dwar il-prevenzjoni tal-osteoporożi, TVU wriet bidliet żgħar mil-linja bażi fil-ħxuna endometrijali fil-gruppi ta' trattament trattati bi plaċebo (-0.24 mm, n=154), b'bazedoxifene 20 mg (0.06 mm, n=158) u b'raloxifene 60 mg (0.01 mm, n=154) wara sentejn.
English: Table 1: Effect of bazedoxifene on risk of vertebral fractures after 3 years of treatment Number of subjects
Maltese: Tabella 1: Effett ta' bazedoxifene fuq ir-riskju marbut ma' ksur vertebrali wara 3 snin ta' trattament
English: The rate per 1,000 women years for transient ischaemic attacks (TIA) was similar between the 20 mg bazedoxifene (1.1) and placebo (0.88) groups and higher in the 40 mg bazedoxifene (1.59) group.
Maltese: Ir-rata ta' attakki iskemiċi li jgħaddu (TIA) għal kull 1,000 sena tan-nisa kienet simili bejn il-gruppi ta' 20 mg bazedoxifene (1.1) u tal-plaċebo (0.88) u kienet aktar għolja filgrupp ta' 40 mg bazedoxifene (1.59).
English: Bazedoxifene belongs to a class of compounds known as selective estrogen receptor modulators (SERMs).
Maltese: Bazedoxifene jappartjeni għal kategorija ta' komposti li jissejħu modulaturi silettivi tar-riċetturi tal-estroġen (SERMs).
English: Bazedoxifene is extensively metabolised in women.
Maltese: Bazedoxifene jiġi metabolizzat b'mod estensiv finnisa.
English: Allergic reaction (including hypersensitivity and urticaria) Rash, itching
Maltese: Reazzjoni allerġika (li jinkludi sensittivita' eċċessiva u urtikarja)
English: *In the osteoporosis treatment trial in 7,492 evaluable subjects (mean age=66 years), the bazedoxifene-treated women had an increased risk of venous thromboembolism (deep vein thrombosis, pulmonary embolism and retinal vein thrombosis).
Maltese: *Fil-prova ta' trattament għall-osteoporożi f'7,492 individwu li setgħu jiġu evalwati (età medja=66 sena), in-nisa trattati b'bazedoxifene kellhom riskju ogħla ta' tromboemboliżmu fil-vina (trombożi profonda tal-vina, emboliżmu pulmonari u trombożi fil-vina retinali).
English: Effects on thyroid and ovarian malignancies
Maltese: Effetti fuq it-tumuri malinni tat-tirojde u tal-ovarji
English: In subjects with 10-year fracture probabilities at or above 16%, bazedoxifene was associated with a significant decrease in the risk of all clinical fractures.
Maltese: F'individwi bi probabiltajiet ta' ksur fuq 10 snin ta' madwar 16% jew aktar, bazedoxifene kien assoċjat ma tnaqqis sinifikanti fir-riskju tal-ksur kliniku kollu.
English: BMD was preserved in bazedoxifene 20 mg and raloxifene 60 mg-treated subjects, while significant loss in BMD was observed in patients receiving placebo.
Maltese: Il-BMD kien priżervat f'individwi trattati b'20 mg bazedoxifene u 60 mg raloxifene, waqt li telf sinifikanti fil-BMD kien osservat f'pazjenti li kienu qed jieħdu l-plaċebo.
English: How to take CONBRIZA
Maltese: Tiħux CONBRIZA
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari marbutin mal-intolleranza għal galactose, id-defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: In the osteoporosis prevention study, the incidence of breast-related adverse events (breast tenderness, pain, breast cancer, benign breast neoplasm) in the bazedoxifene 20 mg and raloxifene 60 mg groups was similar to placebo.
Maltese: Fl-istudju dwar il-prevenzjoni tal-osteoporożi, l-inċidenza ta' każijiet avversi relatati mas-sider (tenerezza tas-sider, uġigħ, kanċer tas-sider, neoplażmu beninn tas-sider) fil-gruppi ta' bazedoxifene 20 mg u raloxifene 60 mg kienu simili għal plaċebo.