FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional cases per 1,000 ET users over 5 years (95%CI)
Maltese: Każijiet addizzjonali kull 1 000 utent tal-ET fuq 5 snin (95 % CI)
English: Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of oestrogens.
Maltese: Preparazzjonijiet erbali li fihom is-St John's wort (Hypericum perforatum) jistgħu jinduċu l-metaboliżmu tal-estroġeni.
English: Also contains: lactose, sucrose, polydextrose and maltitol liquid.
Maltese: Fih ukoll: lactose, sucrose, polydextrose u maltitol likwidu.
English: Exacerbation of epilepsy
Maltese: Aggravament tal-epilessija
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).
Maltese: Ir-reazzjonijiet avversi kienu kkategorizzati bħala komuni ħafna ( 1/10), komuni ( 1/100 sa < 1/10), mhux komuni ( 1/1 000 sa < 1/100) jew rari ( 1/10 000 sa < 1/1 000).
English: • if you are seriously overweight (BMI >30 kg/m
Maltese: • jekk għandek ħafna piż żejjed (BMI >30 kg/m
English: Conjugated oestrogens
Maltese: Estroġeni konjugati
English: This change in BMD was similar to that shown with bazedoxifene 20 mg alone (+1.35%) and less than that seen with CE 0.45 mg/ medroxyprogesterone 1.5 mg (+2.58%) in the same study.
Maltese: Din il-bidla fil-BMD kienet simili għal dak li ntwera b'bazedoxifene 20 mg waħdu (+1.35%) u inqas minn dak li kien osservat b'CE 0.45 mg/medroxyprogesterone 1.5 mg (+2.58%) fl-istess studju.
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.
Maltese: Bħala medja, meta mqabbla ma' nisa tal-età ta' 51 sa 64 sena (n=8), in-nisa tal-età ta' 65 sa 74 sena (n=8) urew żieda ta' 1.5 darbiet fl-AUC, u n-nisa ta' 75 sena (n=8) urew żieda ta' 2.6 darbiet fl-AUC.
English: Each modified-release tablet contains 96.9 mg sucrose (includes 0.7 mg sucrose as sucrose monopalmitate), 62.9 mg lactose (as monohydrate), 0.2 mg maltitol liquid, 0.0176 mg glucose, and 0.0088 mg sorbitol
Maltese: Kull pillola li terħi l-mediċina b'mod modifikat fiha 96.9 mg sukrożju (tinkludi 0.7 mg sukrożju bħala monopalmitate), 62.9 mg lattożju (bħala monoidrat), 0.2 mg maltitol likwidu, 0.0176 mg glukożju, u 0.0088 mg sorbitol
English: This medicine contains 0.0088 mg sorbitol in each tablet.
Maltese: Din il-mediċia fiha 0.0088 mg sorbitol f'kull pillola.
English: • migraine or severe headaches a rare disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE)
Maltese: • marda rari tas-sistema immuni li taffettwa ħafna organi tal-ġisem (lupus erythematosus sistemika, SLE)
English: Body mass index (BMI)
Maltese: Indiċi tal-massa tal-ġisem (BMI)
English: CE components, 17β-estradiol, estrone, and estriol are excreted in the urine, along with glucuronide and sulfate conjugates.
Maltese: Il-komponenti ta' CE, 17β-estradiol, estrone, u estriol joħorġu mal-awrina, flimkien mal-konjugati talglucuronide u s-sulfat.
English: Otosclerosis
Maltese: Otosklerożi
English: Date of first authorisation: 16 December 2014 Date of latest renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 16 ta' Diċembru 2014
English: BZA is highly bound (98% - 99%) to plasma proteins in vitro, but does not bind to sex hormone binding globulin (SHBG).
Maltese: BZA jorbot ħafna (98 % - 99 %) mal-proteini tal-plażma in vitro, iżda ma jorbotx malglubolin li jorbot mal-ormoni sesswali (SHBG).
English: • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir);
Maltese: • Mediċini għall-infezzjoni tal-HIV (bħal nevirapine, efavirenz, ritonavir u nelfinavir);
English: • Alopecia (hair loss)
Maltese: • Alopeċja (telf ta' xagħar)
English: Following intravenous administration of a 3 mg dose of BZA alone, the volume of distribution is 14.7 3.9 l/kg.
Maltese: Wara l-amministrazzjoni fil-vina ta' doża ta' 3 mg ta' BZA waħdu, il-volum ta' distribuzzjoni huwa 14.7  3.9 l/kg.
English: Endometrial hyperplasia and carcinoma
Maltese: Iperplasija u karċinoma endometrijali
English: DUAVIVE contains lactose, sucrose, maltitol liquid, glucose and sorbitol
Maltese: DUAVIVE fih il-lattożju, is-sukrożju, maltitol likwidu, il-glukożju u sorbitol
English: The metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, such as anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz).
Maltese: Il-metaboliżmu tal-estroġeni jista' jiżdied bl-użu konkomitanti ta' sustanzi magħrufa li jinduċu enżimi li jimmetabolizzaw il-mediċina, bħall-antikonvulsanti (eż. phenobarbital, phenytoin, carbamazepine) u l-antiinfettivi (eż., rifampicin, rifabutin, nevirapine, efavirenz).
English: Effects on bone mineral density (BMD)
Maltese: L-effetti fuq id-densità tal-minerali tal-għadam (BMD)
English: Venous thromboembolism (VTE)
Maltese: Tromboemboliżmu fil-vini (VTE)
English: • Feeling nervous
Maltese: • Tħossok nervuża
English: Bazedoxifene-5-glucuronide is the major circulating metabolite.
Maltese: Bazedoxifene-5-glucuronide huwa l-metabolit prinċipali li jiċċirkola.
English: Serious venous thromboembolic events may occur rarely (less than 1 case per 1,000 patients).
Maltese: Avvenimenti tromboemboliċi fil-vini serji jistgħu jseħħu rarament (anqas minn każ wieħed kull 1 000 pazjent).
English: Other side effects
Maltese: Effetti sekondarji addizzjonali
English: Glucose intolerance;
Maltese: Intolleranza għall-glukożju
English: CE/BZA pairs CE with the selective oestrogen receptor modulator (SERM), BZA, which is defined as a tissue selective oestrogen complex (TSEC).
Maltese: CE/BZA jifforma pari ta' CE mal-modulatur selettiv għar-riċetturi tal-estroġenu (SERM), BZA, li hu definit bħala kumpless ta' estroġeni selettivi għat-tessuti (TSEC).
English: • Feeling irritable
Maltese: • Tħossok irritabbli
English: DUAVIVE 0.45 mg/20 mg modified-release tablets conjugated oestrogens/bazedoxifene
Maltese: DUAVIVE 0.45 mg/20 mg pilloli li jerħu l-mediċina b'mod modifikat estroġeni konjugati/bazedoxifene
English: Bazedoxifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs).
Maltese: Bazedoxifene jappartjeni għal grupp ta' prodotti mediċinali mhux ormonali msejħa modulaturi selettivi għar-riċetturi tal-estroġenu (SERMs).
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.
Maltese: Ma hemm l-ebda interazzjoni farmakokinetika sinifikanti bejn bazedoxifene u l-prodotti mediċinali li ġejjin: ibuprofen, atorvastatin u azithromycin jew antiaċidi li fihom l-aluminju u l-magnesium hydroxide.
English: Pancreatitis; ischaemic colitis; vomiting
Maltese: Pankreatite; kolite iskemika; rimettar
English: Adverse reactions reported with CE and/or bazedoxifene monotherapy
Maltese: Reazzjonijiet avversi rrapportati b'monoterapija b'CE u/jew bazedoxifene
English: BZA was not genotoxic or mutagenic in a battery of tests, including in vitro bacterial reverse mutation assay, in vitro mammalian cell forward mutation assay at the thymidine kinase (TK/-) locus in L5178Y mouse lymphoma cells, in vitro chromosome aberration assay in Chinese hamster ovary (CHO) cells, and in vivo mouse micronucleus assay.
Maltese: BZA ma kienx ġenotossiku jew mutaġeniku fi grupp ta' testjiet speċifiċi, inkluż assaġġ ta' mutazzjoni riversibbli batteriku in vitro, assaġġ ta' mutazzjoni 'l quddiem taċ-ċelluli tal-mammali in vitro fil-locus tat-thymidine kinase (TK/-) fiċ-ċelluli tal-limfoma tal-ġrieden L5178Y, assaġġ ta' aberrazzjoni talkromosomi in vitro fiċ-ċelluli tal-ovarji tal-ħamster Ċiniż (CHO), u assaġġ tal-mikronuklei tal-ġrieden in vivo.
English: Little or no cytochrome P450-mediated metabolism is evident.
Maltese: Ftit li xejn jew l-ebda metaboliżmu medjat minn cytochrome P450 ma huwa evidenti.
English: • A worsening of chorea (an existing neurological disorder characterised by involuntary spasmodic movements of the body)
Maltese: • Aggravament tal-korea (disturb newroloġiku eżistenti kkaratterizzat minn movimenti spasmodiċi involontarji tal-ġisem)
English: pulmonary embolism, and retinal vein thrombosis).
Maltese: emboliżmu pulmonari u trombożi fil-vini tar-retina).
English: Risk ratio
Maltese: Proporzjon ta' riskju
English: The absolute bioavailability of BZA is approximately 6%.
Maltese: Il-bijodisponibbiltà assoluta ta' BZA hija ta' madwar 6 %.
English: The metabolism of bazedoxifene may be increased by concomitant use of substances known to induce uridine diphosphate glucuronosyltransferases (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 konkomitanti ta' sustanzi magħrufa li jinduċu luridine diphosphate glucuronosyltransferases (UGT), bħal rifampicin, phenobarbital, carbamazepine, u phenytoin, li jista' potenzjalment iwassal għal tnaqqis fil-konċentrazzjonijiet sistemiċi ta' bazedoxifene.
English: Conjugated oestrogens is a medicine that belongs to a group of medicines called hormone replacement therapy (HRT).
Maltese: L-estroġeni konjugati huwa prodott mediċinali li jappartjeni għal grupp ta' prodotti mediċinali msejħa terapija ta' sostituzzjoni tal-ormoni (HRT).
English: Reproductive toxicity and impairment of fertility studies with CE/BZA have not been conducted.
Maltese: Ma twettqux studji dwar it-tossiċità riproduttiva u l-indeboliment tal-fertilità b'CE/BZA.
English: • Vaginal inflammation
Maltese: • Infjammazzjoni vaġinali
English: In a 1 year study, CE 0.45 mg/BZA 20 mg showed a significant difference from baseline in lumbar spine BMD (+1.52%) at month 12 compared to placebo.
Maltese: Fi studju li dam sena, CE 0.45 mg/BZA 20 mg wera differenza sinifikanti mil-linja bażi fil-BMD tassinsla lumbari (+1.52%) f'xahar 12 meta mqabbla ma' plaċebo.
English: Negligible (1%) amounts of BZA are eliminated in urine.
Maltese: Ammonti negliġibbli (1%) ta' BZA kienu eliminati fl-awrina.
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).
Maltese: Ir-reazzjonijiet avversi kienu kkategorizzati bħala 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) jew mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: The table below lists the adverse reactions observed with CE/BZA (n = 3,168) in placebo-controlled clinical trials.
Maltese: It-tabella hawn taħt telenka r-reazzjonijiet avversi osservati b'CE/BZA (n = 3 168) fi provi kliniċi kkontrollati bi plaċebo.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system; estrogens, combinations with other drugs; ATC code: G03CC07
Maltese: Ormoni tas-sess u modulaturi tas-sistema ġenitali u, Estroġeni, kombinazzjonijiet ma' mediċini oħra; Kodiċi ATC:
English: Risk of ischaemic stroke
Maltese: Riskju ta' puplesija iskemika
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrapportati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: - Active or past history of arterial thromboembolic disease (e.g., myocardial infarction,
Maltese: ara sezzjoni 4.4). - Storja attiva jew fil-passat ta' mard tromboemboliku arterjali (eż. infart mijokardijaku,
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.
Maltese: Fatturi ta' riskju magħrufin b'mod ġenerali għall-VTE jinkludu l-użu ta' estroġeni, l-etajiet aktar avvanzati, il-kirurġiji maġġuri, l-immobilizzazzjoni fit-tul, l-obeżità , (BMI > 30 kg/m2), it-tqala/ilperjodu ta' wara t-twelid, il-lupus erythematosus sistemika (SLE), u l-kanċer.
English: The clearance of BZA is 0.4 ±0.1 L/h/kg based on intravenous administration.
Maltese: L-eliminazzjoni ta' BZA hija 0.4 ± 0.1 L/siegħa/kg bbażata fuq l-amministrazzjoni ġol-vini.
English: Estradiol only
Maltese: Estradiol biss
English: The use of oestrogen-only therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Maltese: L-użu ta' terapija bl-estroġeni biss huwa assoċjat ma' żieda ta' sa 1.5 darbiet fir-riskju relattiv ta' puplesija iskemika.
English: This medicinal product contains lactose, sucrose, glucose (in polydextrose and maltitol liquid) and sorbitol (in polydextrose).
Maltese: Dan il-prodott mediċinali fih il-lattożju, is-sukrożju, il-glukożju (f'polydextrose u maltitol likwidu) u sorbitol (f'polydextrose).
English: - Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radio-immunoassay).
Maltese: - L-estroġeni jżidu l-globulina li torbot mat-tirojde (TBG), li jwassal għal żieda fl-ormoni tat-tirojde totali li jiċċirkolaw, kif imkejjel mill-jodju marbut mal-proteini (PBI), il-livelli ta' T4 (bil-kolonna jew b'assaġġ radjuimmunoloġiku) jew il-livelli ta' T3 (b'assaġġ radjuimmunoloġiku).
English: Use of CE/BZA in this population is contraindicated (see sections 4.2, 4.3 and 4.4).
Maltese: L-użu ta' CE/BZA f'din il-popolazzjoni huwa kontraindikat (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: (thrombosis)'
Maltese: puplesija).
English: • Memory loss (dementia)
Maltese: • Telf ta' memorja (dimenzja)
English: • A worsening of epilepsy (seizures)
Maltese: • Aggravament tal-epilessija (aċċessjonijiet)
English: Other medicines and DUAVIVE
Maltese: Mediċini oħra u DUAVIVE
English: Pink, oval-shaped, modified-release tablet of 12 mm printed on one side with “0.45/20”.
Maltese: Pillola roża, ovali, li terħi l-mediċina b'mod modifikat ta' 12 mm stampata fuq naħa waħda b'“0.45/20”.
English: • any of the conditions mentioned under ‘Do not take DUAVIVE'
Maltese: • kwalunkwe kundizzjoni imsemmija taħt “Tiħux DUAVIVE”
English: Visual acuity reduced, blurred vision, photopsia, visual field defect, visual impairment, dry eye, eyelid oedema, blepharospasm, eye pain and eye swelling
Maltese: Tnaqqis fl-akutezza fil-vista, vista mċajpra, fotopsja, difetti fil-kamp viżiv, vista batuta, għajnejn xotti, edema fil-kappell tal-għajnejn, blefarospażmu, uġigħ flgħajnejn u nefħa fl-għajnejn
English: Medical examination/follow-up
Maltese: Eżami/insegwiment mediku
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.
Maltese: Pazjenti li għandhom mard ereditarju rari ta' intolleranza għal galattożju, id-defiċjenza totali ta' lactase, intolleranza għall-fruttożju, assorbiment ħażin ta' glukożju-galattożju jew insuffiċjenza ta' sucrase-isomaltase ma għandhomx jieħdu dan il-prodott mediċinali.
English: The most commonly reported adverse reaction is abdominal pain, occurring in more than 10% of patients in clinical trials.
Maltese: L-iżjed reazzjoni avversa komuni li ġiet irrapportata kienet uġigħ addominali, li seħħ f'aktar minn 10 % tal-pazjenti fil-provi kliniċi.
English: After 7 years, the VTE rate per 1,000 women-years was 2.06 in the bazedoxifene 20 mg group and 1.36 in the placebo group.
Maltese: 1 000 mara kull sena riproduttiva kienet ta' 2.06 fil-grupp b'bazedoxifene 20 mg u 1.36 fil-grupp bilplaċebo.
English: If you notice any of the following:
Maltese: Inti tingħata parir li:
English: Endometrial cancer risk
Maltese: Riskju ta' kanċer endometrijali
English: Following administration of BZA alone, 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 was observed.
Maltese: BZA waħdu, kienet osservata żieda lineari fil-konċentrazzjonijiet tal-plażma għal dożi uniċi minn 0.5 mg għal sa 120 mg u dożi multipli ta' kuljum minn 1 mg sa 80 mg.
English: The DUAVIVE 0.45 mg/20 mg modified-release tablet is a pink, oval-shaped, tablet marked on one side with “0.45/20”.
Maltese: DUAVIVE 0.45 mg/20 mg pillola li terħi l-mediċina b'mod modifikat hija roża, ovali, u mmarkata fuq naħa waħda b'“0.45/20”.
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.
Maltese: Min-numru totali ta' nisa fil-provi kliniċi tal-fażi 3 li rċevew CE/BZA 20 mg, 2.4.% (n=77) kienu fletà ta' ≥65 sena.
English: DUAVIVE 0.45 mg/20 mg modified-release tablets
Maltese: DUAVIVE 0.45 mg/20 mg pilloli li jerħu l-mediċina b'mod modifikat
English: Studies in rats with bazedoxifene have shown adverse effects on fertility (see section 5.3).
Maltese: Studji fil-firien b'bazedoxifene wrew effetti avversi fuq il-fertilità (ara sezzjoni 5.3).
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).
Maltese: Id-dispożizzjoni ta' doża unika ta' 20 mg ta' bazedoxifene kienet mqabbla f'nisa b'indeboliment talfwied (Klassi Child-Pugh A [n=6], B [n=6], u C [n=6]) u individwi b'funzjoni normali tal-fwied (n=18) Bħala medja, in-nisa b'indeboliment tal-fwied urew żieda ta' 4.3 darbiet fl-AUC meta mqabbla mal-indiviwi ta' paragun.
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%.
Maltese: Meta ngħataw dożi uniċi ta' CE 0.625 mg/BZA 20 mg flimkien ma' ikla b'kontenut għoli ta' xaħam, is-Cmax ta' bazedoxifene ma kienx affettwat, iżda ż-Żona taħt il-Kurva (Area Under Curve - AUC) żdiedet b'madwar 25 %.
English: • Depression
Maltese: • Dipressjoni
English: The recommended dose is 0.45 mg conjugated oestrogens (CE) and 20 mg bazedoxifene (BZA) taken as a single oral tablet, once daily.
Maltese: Id-doża rakkomandata hija ta' 0.45 mg estroġeni konjugati (CE) u 20 mg bazedoxifene (BZA) bħala pillola orali waħda, darba kuljum.
English: BZA is eliminated with a half-life of approximately 30 hours.
Maltese: BZA huwa eliminat b'half-life ta' madwar 30 siegħa.
English: Cholecystitis
Maltese: Koleċistite
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.
Maltese: Fi studju, l-amenorrea ġie rrapportat f'97% tan-nisa li rċivew CE 0.45 mg/BZA 20 mg matul xhur 10 sa 12.
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.
Maltese: Madankollu, fi studju kliniku ta' interazzjoni bejn mediċina u oħra, għoti ripetut ta' 200 mg ta' itraconazole, inibitur qawwi ta' CYP3A4, kellu impatt minimu fuq ilfarmakokinetika ta' CE (kif imkejjel minn estrone u equilin) u bazedoxifene meta jingħata flimkien ma' doża waħda ta' CE 0.45 mg/BZA 20 mg.
English: UPVC/ Monochlorotrifluorethylene blister packs containing 28 modified-release tablets.
Maltese: Pakketti b'folja tal-UPVC/Monochlorotriflueorethylene li fihom 28 pilloli li jerħu l-mediċina b'mod modifikat.
English: Ischaemic stroke
Maltese: Puplesija iskemika
English: Lactose, sucrose and glucose
Maltese: Lattożju, sukrożju u glukożju
English: There is some evidence of increased risk of probable dementia in women who start using continuous oestrogen-only therapy after the age of 65.
Maltese: Hemm xi evidenza ta' riskju miżjud ta' dimenzja probabbli f'nisa li jibdew jużaw terapija kontinwa ta' estroġeni biss wara l-età ta' 65 sena.
English: Growth potentiation of benign meningioma; fibrocystic breast disease
Maltese: Potenzjal ta' tkabbir ta' meninġjomi beninni; mard tas-sider fibroċistiku
English: If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe' (e.g., antithrombin, protein S, or protein C deficiencies or a combination of defects) hormone therapy is contraindicated.
Maltese: Jekk jiġi identifikat difett trombofiliku li jissegrega mat-trombożi f'membri tal-familja jew jekk id-difett huwa “sever” (eż. nuqqas ta' antitrombini, proteina S, jew proteina Ċ jew kombinazzjoni ta' difetti), itterapija bl-ormoni hija kontraindikata.
English: Longterm exposure to CE/BZA for up to 2 years was evaluated; 3,322 women were exposed to CE/BZA for at least 1 year, and 1,999 women were exposed for 2 years.
Maltese: 3 322 mara kienu esposti għal CE/BZA għal tal-anqas sena, u 1 999 mara kienu esposti għal sentejn.
English: • Muscle spasms (including leg cramps)
Maltese: • Spażmi fil-muskoli (inkluż bugħawwieġ fir-riġlejn)
English: Hypersensitivity Angioedema; anaphylactic/ana phylactoid reactions; urticaria
Maltese: Anġjoedema; reazzjonijiet anafilattiċi/anafi lattojdi; urtikarja
English: The modified-release tablets are provided in UPVC/Monochlorotrifluorethylene blister packs containing 28 tablets.
Maltese: Il-pilloli b'rilaxx modifikat huma pprovduti f'pakketti b'folja tal-UPVC/Monoklorotrifluworetilene li fihom 28 pillola.
English: The active substances are conjugated oestrogens and bazedoxifene.
Maltese: Is-sustanzi attivi huma estroġeni konjugati u bazedoxifene.
English: • Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids)
Maltese: • Għajn xotta, uġigħ fl-għajnejn, tnaqqis fl-akutezza fil-vista, vista batuta, blefarospażmu (anormali, teptip involontarju jew spażmu tal-kpiepel tal-għajnejn)
English: In the bazedoxifene osteoporosis treatment trial (mean age = 66.5 years), the VTE rate per 1,000 women-years through the 3-year study period was 2.86 in the bazedoxifene (20 mg) group and 1.76 in the placebo group and through the 5-year study period was 2.34 in the bazedoxifene 20 mg group and 1.56 in the placebo group.
Maltese: Fi prova ta' trattament tal-osteoporożi b'bazedoxifene (età medja - 66.5 snin), ir-rata ta' VTE għal kull 1 000 mara kull sena riproduttiva matul il-perjodu tal-istudju ta' 3 snin kienet ta' 2.86 fil-grupp b'bazedoxifene (20 mg) u 1.76 fil-grupp bil-plaċebo u matul il-perjodu ta' studju ta' ħames snin kienet ta' 2.34 fil-grupp b'bazedoxifene 20 mg u 1.56 fil-grupp bil-plaċebo.
English: Excipients content
Maltese: Kontenut tal-eċċipjenti
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.
Maltese: Wara diversi dożi ta' CE 0.45 mg/BZA 20 mg, il-medja tal-parametri farmakokinetiċi fi stat fiss għal CE u bazedoxifene (il-linja bażi aġġustata għall-estrone totali) hija mogħtija fil-qosor hawn taħt.
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: L-esponiment sistemiku (AUC) għal bazedoxifene f'dawn il-gruppi kien 2.6 u 6.6 darbiet dak ossevat f'nisa li għaddew mill-menopawża li rċevew 20 mg/jum għal 14-il jum.
English: Frequency of occurrence of adverse reactions
Maltese: Frekwenza ta' okkorrenza tar-reazzjonijiet avversi
English: Female rats were administered daily dosages of 0.3 to 30 mg/kg (0.15 to 14.6 times the human dose based on body surface area, mg /m2 [20 mg/kg dosage in humans is 12.3 mg/m2]) prior to and during mating with untreated males.
Maltese: Firien nisa ngħataw dożi ta' kuljum ta' 0.3 sa 30 mg/kg (0.15 sa 14.6 darbiet id-doża tal-bniedem abbażi tal-erja tal-wiċċ tal-ġisem, mg /m2 [doża ta' 20 mg/kg fil-bnedmin hija 12.3 mg/m2]) qabel u matul it-tgħammir ma' rġiel mhux ittrattati.