FrancophonIA/ELRC3.0 huggingface dataset:
English: CE/BZA is contraindicated during breast-feeding (see section 4.3).
Maltese: CE/BZA hu kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: Very rare: may affect up to 1 in 10,000 people
Maltese: Rari ħafna: jistgħu jaffettwaw lil persuna 1 minn kull 10 000 persuna
English: • Dizziness
Maltese: • dijabete
English: • an irregular heartbeat
Maltese: • taħbit tal-qalb irregolari
English: • Pelvic pain
Maltese: • Uġigħ pelviku
English: BLISTER POUCH
Maltese: Kisja ċara
English: The bazedoxifene component of this medicine has been reported to cause problems with eyesight such as blurred vision.
Maltese: Il-komponent ta' bazedoxifene ta' din il-mediċina kien irrapportat li jikkawża problemi bil-vista bħal vista mċajpra.
English: - Porphyria.
Maltese: U LUŻU
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.
Maltese: Fi studju ieħor, l-amenorrea ġie rrapportat f'96% tan-nisa li rċivew CE 0.45 mg/BZA 20 mg matul xhur 10 sa 12.
English: Hormone therapy is associated with a 1.3-3 fold risk of developing VTE.
Maltese: It-terapija bl-ormoni hija assoċjata mar-riskju ta' 1.3-3 darbiet li jiżviluppa
English: Oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Maltese: It-terapija bl-estroġeni biss hija assoċjata ma' żieda ta' sa 1.5 darbiet fir-riskju ta' puplesija iskemika.
English: - Active or past history of venous thromboembolism (e.g., deep venous thrombosis,
Maltese: - Storja attiva jew fil-passat ta' tromboemboliżmu fil-vini (e. ż trombożi profonda fil-vini,
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata din dwar il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Maltese: Matul it-trattament, huma rakkomandati viżti perjodiċi ta' frekwenza u natura adatti għall-mara individwali.
English: • Thrush (vaginal yeast infection)
Maltese: • Traxx (infezzjoni vaġinali kkawżata minn fungi)
English: Each tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Maltese: Kull pillola fiha 0.45 mg ta' estroġeni konjugati u bazedoxifene acetate ekwivalenti għal 20 mg bazedoxifene.
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: L-osservazzjoni ta' tumuri beninni taċ-ċelluli granulosa tal-ovarji fi ġrieden u firien nisa li rċevew bazedoxifene huwa effett tal-klassi tas-SERMS relatat mal-farmakoloġija tiegħu f'annimali gerriema meta jiġu ttrattati matul il-ħajja riproduttiva tagħhom, meta l-ovarji tagħhom ikunu qed jiffunzjonaw u jirrispondu għal stimulazzjoni ormonali.
English: • A worsening of asthma
Maltese: • Aggravament tal-ażma
English: If prolonged immobilisation is to follow elective surgery temporarily stopping CE/BZA 4 to 6 weeks earlier is recommended.
Maltese: Jekk wara kirurġija elettiva se jkun hemm immobilizzazzjoni fit-tul, huwa rakkomandat li CE/BZA jitwaqqaf temporanjament minn 4 sa 6 ġimgħat qabel.
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 ta' 6 xhur dwar il-karċinoġeniċità fi ġrieden transġeniċi, kien hemm inċidenza miżjuda ta' tumuri beninni taċ-ċelluli granulosa tal-ovarji fi ġrieden nisa li rċevew 150 jew 500 mg/kg/jum.
English: These tumours are known to occur in aged nonhuman primates and were considered spontaneous in the aged monkeys and irrelevant to humans.
Maltese: Dawn it-tumuri huma magħrufa li jseħħu fi primati mhux umani anzjani u ġew meqjusa bħala spontanji fix-xadini anzjani u irrilevanti għall-bnedmin.
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.
Maltese: Ġew osservati karċinomi fiċ-ċelluli tal-kliewi fi studju dwar l-effikaċja tal-għadam ta' 18-il xahar f'xadini cynomolgus anzjani li tneħħewlhom l-ovarji fi proporzjonijiet ta' esponiment ta' 0.05 sa 16.3 darbiet, u proporzjonijiet tad-doża, ibbażati fuq l-erja tal-wiċċ (mg/m2) ta' madwar 0.2 sa 24 darba d-doża klinika ta' 20 mg.
English: If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
Maltese: - Jekk għandek disturb ta' emboli fid-demm (bħal nuqqas ta' proteina C, proteina S jew ta' antitrombini).
English: Exacerbation of asthma
Maltese: Aggravament tal-ażma
English: • increased risk of developing blood clots [see “Blood clots in a vein (thrombosis)”]
Maltese: • żieda fir-riskju ta' żvilupp ta' emboli [ara “Emboli fil-vini (trombożi)”]
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).
Maltese: Fi studji fuq il-fniek b'BZA, kien hemm abort u inċidenza miżjuda ta' anomaliji tal-qalb (difett septali ventrikulari) u tas-sistema skeletali (dewmien fl-ossifikazzjoni, għadam deformat jew allinjat ħażin, laktar tas-sinsla u l-kranju) fil-feti f'dożi tossiċi għall-omm ta'  0.5 mg/kg/jum (1.5 darbiet lesponiment tal-bniedem).
English: Use in this population is contraindicated (see sections 4.3, 4.4 and 5.2).
Maltese: L-użu f'din il-popolazzjoni huwa kontraindikat (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from 5 to 55 extra cases diagnosed in every 1,000 women between the ages of 50 and 65 years.
Maltese: Skont it-tul tal-użu ta' estroġeni biss u d-doża ta' estroġeni, iż-żieda fir-riskju ta' kanċer endometrijali fl-istudji epidemjoloġiċi varjat minn bejn 5 u 55 każ żejjed dijanjostikati f'kull 1 000 mara bl-etajiet ta' bejn 50 u 65 sena.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħrif farmakodinamiku
English: • gallstones
Maltese: • Sturdament
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: Lesponiment sistemiku (AUC) għal bazedoxifene f'dawn il-gruppi kien 35 u 69 darba dak f'nisa li għaddew mill-menopawża li rċevew 20 mg/jum għal 14-il jum.
English: Risk of venous thromboembolism
Maltese: Riskju ta' tromboemboliżmu fil-vini
English: The additional risk of ischaemic stroke over five years of use was assessed in the largest randomised trial in women without a uterus (WHI) from 50-59 years of age.
Maltese: Ir-riskju miżjud ta' puplesija iskemika fuq ħames snin ta' użu kien ivvalutat fl-ikbar prova aleatorja f'nisa mingħajr utru (WHI) mill-etajiet ta' 50-59 sena.
English: • Vomiting
Maltese: • Emigranja
English: In a pharmacokinetic study (n=24) BMI appeared to have little impact on systemic exposure to CE and BZA.
Maltese: Fi studju farmakokinetiku (n=24), il-BMI deher li għandu impatt żgħir fuq l-esponiment sistemiku għal CE u BZA.
English: Glucuronidation is the major metabolic pathway.
Maltese: Il-glukuronidazzjoni huwa l-passaġġ metaboliku prinċipali.
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jistgħu jaffettwaw lil persuna 1 minn kull 1 000 persuna
English: Oestrogens circulate in the blood largely bound to SHBG and albumin.
Maltese: L-estroġeni jiċċirkolaw fid-demm l-aktar marbuta mal-SHBG u l-albumina.
English: B. PACKAGE LEAFLET
Maltese: PAKKETT B'FOLJA
English: This might lead to irregular bleeding.
Maltese: Dan jista' jwassal għal fsada irregolari.
English: After a single dose of CE/BZA, bazedoxifene and baseline-adjusted total estrone were absorbed with a tmax of approximately 2 hours and 8.5 hours, respectively.
Maltese: Wara doża unika ta' CE/BZA, bazedoxifene u l-estrone totali aġġustat għal-linja bażi kienu assorbiti b' tmax ta' madwar sagħtejn u 8.5 siegħat, rispettivament.
English: DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and bazedoxifene.
Maltese: DIAVIVE huwa prodott mediċinali li fih żewġ sustanzi attivi msejħa estroġeni konjugati u bazedoxifene.
English: • Cervical erosion found on medical examination
Maltese: • Erożjoni ċervikali li tiġi skoperta f'eżami mediku
English: Pelvic pain
Maltese: Uġigħ pelviku
English: The distribution of exogenous oestrogens is similar to that of endogenous oestrogens.
Maltese: Id-distribuzzjoni ta' estroġeni eżoġeni hija simili għal dik tal-estroġeni endoġeni.
English: WHI Studies combined - Additional risk of ischaemic stroke* over 5 years use Age range (years) Incidence per 1,000 women in placebo arm over 5 years
Maltese: WHI kkombinati - Riskju miżjud ta' puplesija iskemika* fuq 5 snin ta' użu Firxa ta' etajiet (snin)
English: Asthma
Maltese: Ażma
English: - kidney problems - pre-existing high level of fat in your blood (triglycerides) - liver problems - asthma - seizures (epilepsy) - migraine - systemic lupus erythematosus (SLE - a rare disease of the immune system that affects many organs of the body) - fluid retention
Maltese: Jekk għandek kwalunkwe kundizzjoni minn dawn li ġejjin, it-tabib tiegħek għandu jimmonitorjak: problemi fil-kliewi livell għoli eżistenti minn qabel ta' xaħam fid-demm (trigliċeridi) problemi fil-fwied ażma aċċessjonijiet (epilessija) emigranja - lupus erythematosus sistemika (SLE - marda rari tas-sistema immuni li taffettwa ħafna organi tal-ġisem) ritenzjoni ta' fluwidi
English: Printing ink
Maltese: Pressjoni għolja
English: CE 0.45 mg/BZA 20 mg demonstrated similar changes in mammographic breast density compared to placebo over 1 year of treatment.
Maltese: CE 0.45 mg/BZA 20 mg wera bidliet simili fid-densità tas-sider mammografika meta mqabbla ma' plaċebo fuq perjodu ta' sena ta' trattament.
English: When you take DUAVIVE do not take additional oestrogens as this may increase the risk of endometrial hyperplasia.
Maltese: Meta tieħu DUAVIVE, tiħux estroġeni addizzjonali għaliex dan jista' jżid ir-riskju ta' iperplasija endometrijali.
English: Hirsutism; rash; pruritus; chloasma
Maltese: Xagħar eċċessiv; raxx; prurite; kloasma
English: This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use oestrogen therapy will increase with age (see section 4.4).
Maltese: CE/BZA fih bazedoxifene, li jnaqqas ir-riskju ta' iperplasja endometrijali li tista' sseħħ bl-użu ta' estroġeni biss (ara sezzjoni 4.4).
English: Impaired renal function showed little or no influence on bazedoxifene pharmacokinetics.
Maltese: L-indeboliment tal-funzjoni tal-kliewi wera ftit li xejn jew l-ebda influwenza fuq il-farmakokinetika ta' bazedoxifene.
English: Oestrogens are known to increase the risk of VTE (see section 4.4).
Maltese: L-estroġeni huma magħrufin li jżidu r-riskju ta' VTE (ara sezzjoni 4.4).
English: There is no specific antidote.
Maltese: Ma hemm l-ebda antidotu speċifiku.
English: BZA is extensively metabolised in women.
Maltese: BZA huwa metabolizzat b'mod estensiv fin-nisa.
English: • Worsening of porphyria, a rare blood disorder which is passed down in families (inherited).
Maltese: • Aggravament tal-porfirja, disturb rari tad-demm li jista' jintiret fil-familja.
English: • Dry mouth
Maltese: • tinqabad tqila
English: The pharmacokinetics of a 20 mg single dose of BZA were evaluated in a study in 26 healthy postmenopausal women.
Maltese: Il-farmakokinetika ta' doża unika ta' 20 mg ta' BZA ġiet evalwata fi studju f'26 mara b'saħħitha li għaddiet mill-menopawża.
English: There is some evidence of a higher risk of memory loss in women who start using oestrogen therapy after the age of 65.
Maltese: Hemm ftit evidenza ta' riskju ogħla ta' telf tal-memorja f'nisa li jibdew jużaw terapija bl-estroġeni wara l-età ta' 65.
English: In a 2-year carcinogenicity study in rats, an increased incidence of benign, ovarian granulosa-cell tumours was observed in female rats at dietary concentrations of 0.03% and 0.1%.
Maltese: Fi studju dwar il-karċinoġeniċità ta' sentejn fil-firien, kienet osservata inċidenza miżjuda ta' tumuri beninni taċ-ċelluli granulosa tal-ovarji f'firien nisa f'konċentrazzjonijiet djetetiċi ta' 0.03 % u 0.1 %.
English: • Increases in liver enzymes (identified in routine liver function testing)
Maltese: • Żieda fl-enżimi tal-fwied (identifikati fl-ittestjar ta' rutina tal-funzjoni tal-fwied)
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.
Maltese: Fsada u/jew fsada ħafifa rregolari kienu rrappurtati fil-grupp ta' CE 0.45 mg/BZA 20 mg minn 7% tan-nisa matul l-ewwel 3 xhur ta' trattament, u minn 3% tan-nisa matul xhur 10 sa 12
English: The pharmacokinetics of CE/BZA have not been evaluated in women over 75 years of age.
Maltese: Il-farmakokinetika ta' CE/BZA ma ġietx evalwata f'nisa li għandhom iżjed minn 75 sena.
English: • Headache
Maltese: • Dardir
English: Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Maltese: Kull pillola li terħi l-mediċina b'mod modifikat fiha 0.45 mg ta' estroġeni konjugati u bazedoxifene acetate ekwivalenti għal 20 mg bazedoxifene.
English: Modified-release tablet.
Maltese: Mhux applikabbli.
English: Vaginitis
Maltese: TIKKETTAR
English: Reasons for immediate withdrawal of therapy
Maltese: Raġunijiet għat-twaqqif immedjat tat-terapija
English: No overall differences in safety or efficacy were observed between women aged >65 years and younger women, but greater sensitivity of some older individuals cannot be ruled out.
Maltese: L-ebda differenza totali fis-sigurtà jew fl-effikaċja ma kienet osservata bejn nisa fletà ta' >65 sena u nisa iżgħar, iżda ma tistax tiġi eskluża l-possibbiltà ta' sensittività ikbar ta' ċerti individwi ta' età ikbar.
English: This medicinal product contains sorbitol which may affect the bioavailability of other concomitantly administered medicinal products.
Maltese: Dan il-prodott mediċinali fih is-sorbitol li jista' jaffettwa l-bijodisponibilità ta' prodotti mediċinali amministrati b'mod konkomitanti.
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.
Maltese: Iż-żieda rappurtata fir-riskju ta' kanċer endometrijali fost l-utenti ta' estroġeni biss tvarja minn 2 għal 12-il darba ikbar meta mqabbla ma' dawk li ma jużawhomx, skont it-tul tat-trattament u d-doża tal-estroġeni.
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Maltese: Proteini oħrajn li jorbtu jistgħu jkunu għoljin fis-serum, jiġifieri l-globulina li torbot mal-kortikojde (CBG), ilglobulina li torbot mal-ormoni sesswali (SHBG) li jwassal għal żieda fil-kortikosterojdi u l-isterojdi sesswali li jiċċirkolaw, rispettivament.
English: Inert filler coating
Maltese: Żidiet filpressjoni taddemm
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
Maltese: Bazedoxifene qanqal nefropatiji speċifiċi għall-far raġel (nefrokalċinożi kortikomedullari u żieda finnefropatija progressiva kronika spontanja ) u adenomi u karċinomi assoċjati fi proporzjonijiet ta' esponiment ta' 0.05 sa 4 darbiet, u proporzjonijiet tad-doża, ibbażati fuq l-erja tal-wiċċ (mg/m2), ta' madwar 0.6 sa 22 darba d-doża klinika ta' 20 mg.
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2,000 users.
Maltese: Għal nisa li għandhom minn 50 sa 54 sena li ilhom jieħdu l-HRT għal 5 snin, dan jirriżulta, f'madwar każ addizzjonali f'kull 2000 utent.
English: In clinical trials of up to 2 years duration in postmenopausal women with CE/BZA, cases of VTE have been reported (see section 4.8).
Maltese: Fi provi kliniċi li damu sa sentejn f'nisa li għaddew mill-menopawża b'CE/BZA, kienu rrapportati każijiet ta' VTE (ara sezzjoni 4.8).
English: 17β-estradiol is converted reversibly to estrone, and both can be converted to estriol, which is the major urinary metabolite.
Maltese: L-estroġeni li jiċċirkolaw jeżistu f'ekwilibriju dinamiku ta' interkonverżjonijiet metaboliċi. 17βestradiol huwa kkonvertit b'mod riversibbli għal estrone, u t-tnejn jistgħu jiġu kkonvertiti għal estriol, li huwa l-metabolit prinċipali tal-awrina.
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.
Maltese: Fsada u/jew fsada ħafifa rregolari kienu rrappurtati fil-grupp ta' CE 0.45 mg/BZA 20 mg minn 8% tan-nisa matul l-ewwel 3 xhur, u minn 4% tan-nisa matul xhur 10 sa 12
English: A reduction in bazedoxifene exposure may be associated with an increased risk of endometrial hyperplasia (see section 4.4).
Maltese: Tnaqqis fl-esponiment għal bazedoxifene jista' jkun assoċjat ma' riskju miżjud ta' iperplasja endometrijali (ara sezzjoni 4.4).
English: • go for regular breast screening and cervical smear tests, as recommended by your doctor.
Maltese: • tmur għal skrinjar regolari tas-sider u smear tests ċervikali, kif irrakkomandat mit-tabib tiegħek.
English: US WHI Oestrogen only (ET) arm - additional risk of breast cancer after 5 years use
Maltese: L-istudju bl-Estroġeni biss (ET) US WHI - riskju miżjud ta' kanċer tas-sider wara 5 snin ta' użu
English: Oestrogen dose proportionality was assessed in two studies of CE. Dose-proportional increases in both AUC and Cmax were observed across the dose range from 0.3 mg to 0.625 mg of CE for total (conjugated plus unconjugated) equilin, total estrone adjusted for baseline, and unconjugated estrone adjusted for baseline.
Maltese: Żidiet proporzjonali għad-doża kemm f'AUC kif ukoll Cmax kienu osservati tul il-firxa tad-dożi minn 0.3 mg sa 0.625 mg ta' CE għal equilin totali (konjugat kif ukoll mhux konjugat), estrone totali aġġustat għal-linja bażi u estrone mhux konjugat aġġustat għal-linja bażi.
English: • asthma
Maltese: • Stitikezza
English: Adverse reactions that have been observed with bazedoxifene monotherapy
Maltese: Ir-reazzjonijiet avversi li kienu osservati b'monoterapija b'bazedoxifene
English: Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.
Maltese: Ir-riżultati tal-ikbar prova klinika kontrollata bi plaċebo aleatorja (l-istudju WHI) u l-ikbar studju epidemjoloġiku (MWS) huma ppreżentati.
English: Oestrogens may be poorly metabolised in women with impaired liver function.
Maltese: L-estroġeni jistgħu ma jiġux metabolizzati sew f'nisa b'indeboliment fil-funzjoni tal-fwied.
English: The European Medicines Agency has waived the obligation to submit the results of studies with CE/BZA in all subsets of the paediatric population in the ‘treatment of oestrogen deficiency symptoms in postmenopausal women' (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'CE/BZA f'kull sett tal-popolazzjoni pedjatrika fit-“trattament ta' sintomi ta' nuqqas ta' estroġeni f'nisa li għaddew mill-menopawża” (ara sezzjoni 4.2 għall-informazzjoni dwar l-użu pedjatriku).
English: Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see section 4.8).
Maltese: Xi studji oħrajn, li jinkludu prova WHI, jissuġġerixxu li l-użu ta' HRTs flimkien jistgħu jiġu assoċjati ma' riskju simili jew ma' riskju daqsxejn iżgħar (ara Sezzjoni 4.8)
English: Adverse reactions that have been observed with CE monotherapy
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Patients with known thrombophilic states have an increased risk of VTE and hormone therapy may add to this risk.
Maltese: Pazjenti li għandhom stati trombofiliċi magħrufin għandhom riskju miżjud ta' VTE u t-terapija blormoni tista' żżid ma' dan ir-riskju.
English: Bazedoxifene active coating
Maltese: Kisja attiva ta' bazedoxifene
English: DUAVIVE alleviates these symptoms after menopause.
Maltese: DUAVIVE inaqqas dawn is-sintomi wara l-menopawża.
English: * Taken from baseline incidence rates in developed countries Overall risk ratio.
Maltese: * Meħud mir-rati ta' inċidenza tal-linja bażi fil-pajjiżi żviluppati Proporzjon ta' riskju totali.
English: Pfizer Hellas (Cyprus Branch) A.E. Τηλ: +357 22 817690
Maltese: Τηλ: +357 22 817690
English: If such symptoms occur, patients should avoid driving or use of machines that requires accurate visual perception until symptoms have resolved, or until they have received medical advice that it is safe to do so.
Maltese: Jekk it-tabib tiegħek qallek li inti intolleranti għal ċerti tipi ta' zokkor, kellem lit-tabib tiegħek qabel tibda tuża dan il-prodott mediċinali.
English: In a 12-week study, CE 0.45 mg/BZA 20 mg significantly reduced the number and severity of hot flushes compared to placebo at weeks 4 and 12.
Maltese: Fi studju li dam 12-il ġimgħa, CE 0.45 mg/BZA 20 mg naqqas b'mod sinifikanti n-numru u s-severità ta' fwawar meta mqabbla ma' plaċebo f'ġimgħat 4 u 12.
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.
Maltese: Jekk isseħħ fsada jew fsada ħafifa bejn il-mestrwazzjonijiet wara ċertu żmien li tkun inbdiet it-terapija, jew jekk din tkompli wara li t-trattament ikun twaqqaf, ir-raġuni għandha tiġi investigata, u din l-investigazzjoni tista' tinkludi bijopsija endometrijali sabiex jiġu esklużi t-tumuri malinni endometrijali.
English: Conjugated oestrogens tablet core
Maltese: Trombożi filvini tarretina
English: Manufacturer Eisai Manufacturing Limited Mosquito Way Hatfield
Maltese: Eisai Manufacturing Limited Mosquito Way Hatfield
English: System Organ Class (MedDRA terminology
Maltese: Sistema talKlassifika talOrgani (Terminoloġija MedDRA
English: Hypervitaminosis A.
Maltese: Ipervitaminosi A.
English: Date of latest renewal: 24 April 2006.
Maltese: Data tal-aħħar tiġdid: 24 ta' April, 2006.
English: 60528 Frankfurt am Main Germany
Maltese: 60528 Frankfurt am Main
English: 100 soft capsules
Maltese: 100 kapsula ratba
English: Effects on fertility cannot be excluded.
Maltese: L-effetti fuq fertilità ma jistgħux ikunu esklużi.
English: Contains sorbitol.
Maltese: Fih sorbitol.
English: Capsule content: macrogol polysorbate povidone butylated hydroxyanisole
Maltese: Kontenut tal-kapsula: macrogol polysorbate povidone butylated hydroxyanisole
English: Peripheral Oedema
Maltese: Edema Periferali
English: 60528 Frankfurt am Main Germany e-mail: medinfo_de@eisai.net
Maltese: 60528 Frankfurt am Main Il-Ġermanja e-mail: medinfo_de@eisai.net