FrancophonIA/ELRC3.0 huggingface dataset:
English: Also, you need to be particularly careful if you are taking any of the following: - gout medicines (allopurinol), - blood-thinning medicines (coumarin, warfarin), - medicines for seizures or tremors (phenytoin), - interferon alpha, - radiotherapy and certain medicines used to treat cancer (folinic acid, oxaliplatin, bevacizumab,
Maltese: Barra minn hekk, hemm bżonn li toqgħod attent b'mod speċjali jekk inti qed tieħu xi wieħed minn dawn li ġejjin: - mediċini għall-gotta (allopurinol), - mediċini biex traqqaq id-demm (coumarin, warfarin), - mediċini għall-aċċessjonijiet jew għar-rogħda (phenytoin), - interferon alpha, - radjuterapija u ċertu mediċini użati għat-trattament tal-kanċer (aċidu foliniku, oxaliplatin,
English: You must inform your doctor if you know that you have an allergy or over-reaction to this medicine, - if you previously have had severe reactions to fluoropyrimidine therapy (a group of anticancer medicines, such as fluorouracil), - if you are pregnant or breast-feeding, - if you have severely low levels of white cells or platelets in the blood (leucopenia, neutropenia or thrombocytopenia), - if you have severe liver or kidney problems, - if you know that you do not have any activity of the enzyme dihydropyrimidine dehydrogenase (DPD) - if you are being treated now or have been treated in the last 4 weeks with brivudine as part of herpes zoster (chickenpox or shingles) therapy.
Maltese: Għandek tgħarraf lit-tabib tiegħek jekk taf li għandek allerġija jew sensittività eċċessiva għal din il-mediċina, - jekk qabel kellek reazzjonijiet severi għal terapija ta' fluoropyrimidine (grupp ta' mediċini kontra l-kanċer bħal fluorouracil), - jekk inti tqila jew qed tredda', - jekk għandek livelli baxxi ħafna ta' ċelluli bojod jew ta' plejtlits fid-demm (lewkopenija, newtropenija jew tromboċitopenija), - jekk għandek problemi severi tal-fwied jew tal-kliewi, - jekk taf li għandek nuqqas komplut tal-attività tal-enzima dihydropyrimidine dehydrogenase (DPD) - jekk qed tiġi ttrattat issa jew kont ittrattat fl-aħħar 4 ġimgħat b'brivudine bħala parti minn terapija għal herpes zoster (ġidri r-riħ jew ħruq ta' Sant'Antnin).
English: Lower limb oedema, Hypertension, Embolism and thrombosis
Maltese: Disturbi vaskulari Edima fir-riġlejn, Pressjoni għolja, Emboliżmu u trombożi
English: Ventricular fibrillation (rare),
Maltese: 5-Fluorouracil:
English: Vertigo, Ear pain
Maltese: Vertigo, Uġigħ fil-widnejn
English: (see section 4.4), - During pregnancy and lactation, - In patients with severe leukopenia, neutropenia, or thrombocytopenia, - In patients with severe hepatic impairment, - In patients with severe renal impairment (creatinine clearance below 30 ml/min), - Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug-drug interaction),
Maltese: - Passat mediku ta' reazzjonijiet serji u mhux mistennija għat-terapija bi fluoropyrimidine, - Sensitività eċċessiva għal capecitabine, jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1, jew għal fluorouracil, - F'pazjenti b'nuqqas totali magħruf ta' attività ta' dihydropyrimidine dehydrogenase (DPD) (ara sezzjoni 4.4), - Waqt it-tqala u t-treddigħ, - F'pazjenti b'lewkopenja, newtropenja, jew tromboċitopenja severa, - F'pazjenti b'indeboliment sever tal-fwied, - F'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-krejatinina taħt 30 ml/min), - Trattament reċenti jew fl-istess waqt bi brivudine (ara sezzjonijiet 4.4 u 4.5 għall-interazzjoni bejn mediċina u oħra), - Jekk jeżistu kontra-indikazzjonijiet għal xi wieħed mill-prodotti mediċinali fil-programm ta'
English: Thrombophlebitis Deep vein thrombosis, Hypertension,
Maltese: Newtropenija bid-deni,
English: The XELIRI regimens included capecitabine 1000 mg/m twice daily on days 1 to 14 of a three-week cycle combined with irinotecan 250 mg/m2 on day1.
Maltese: Il-korsijiet ta' XELIRI kienu jinkludu capecitabine 1000 mg/m2 darbtejn kuljum fi ġranet 1 sa 14 ta' ċiklu ta' tliet ġimgħat flimkien ma' irinotecan 250 mg/m2 f'jum 1.
English: Biotransformation
Maltese: Sopravivenza Globali
English: Metabolism:
Maltese: Metaboliżmu:
English: Linearity/non-linearity:
Maltese: Linearità/nuqqas ta' linearità:
English: • The active substance is lasofoxifene.
Maltese: • Is-sustanza attiva hi lasofoxifene.
English: Abbreviations: n= number of patients; CI = Confidence Intervals a p < 0.0001; b p = 0.0004; c p = 0.0002; d p = 0.0020; e p = 0.0004
Maltese: Taqsir: n= numru ta' pazjenti; IK = Intervalli ta' Kunfidenza ap < 0.0001; b p = 0.0004; c p = 0.0002; d p = 0.0020; e p = 0.0004
English: Distribution:
Maltese: Distribuzzjoni:
English: Elimination:
Maltese: Eliminazzjoni:
English: The Manufacturer is Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Germany.
Maltese: Il-Manifattur huwa Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Il-Ġermanja.
English: Race:
Maltese: Razza:
English: FABLYN Placebo Relative risk reduction (95% CI) vs. placebo
Maltese: FABLYNPlacebo Tnqqis relattiv tarriskju (95% IK) vs. plaċebo
English: Effects on lipid metabolism and cardiovascular risk:
Maltese: Effetti fuq il-metaboliżmu tal-lipidi u riskju kardjovaskulari:
English: BATCH NUMBER Lot:
Maltese: NUMRU TAL-LOTT Lott:
English: INFORMATION IN BRAILLE FABLYN
Maltese: INFORMAZZJONI BIL-BRAILLE FABLYN
English: Absorption:
Maltese: Assorbiment:
English: Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Germany.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq huwa Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Ġermanja.
English: Effects on the endometrium:
Maltese: Effetti fuq l-endometriju:
English: The disposition of lasofoxifene was evaluated in 758 subjects in conventional clinical pharmacology studies.
Maltese: In natura ta' lasofoxifene ġiet evalwata f'758 suġġett fi studji kliniċi konvenzjonali tal-farmakoloġija.
English: • The other ingredients are lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica, colloidal anhydrous; magnesium stearate; sunset yellow FCF aluminium lake (E110); hypromellose; lactose monohydrate; titanium dioxide (E171) and triacetin.
Maltese: • Is-sustanzi l-oħra huma lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica; colloidal anhydrous; magnesium stearate; FCF aluminium lake (E110) ta' lewn isfar kulur inżul ix-xemx; hypromellose; lactose monohydrate; titanium dioxide (E171) u triacetin.
English: Name and address of the manufacturer responsible for batch release Pfizer Manufacturing Deutschland GmbH
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Pfizer Manufacturing Deutschland GmbH
English: Lasofoxifene is highly bound to proteins in human plasma (>99%).
Maltese: Lasofoxifene jeħel ħafna mal-proteini fil-plażma tal-bniedem (>99%).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 24 February 2009
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI 24 ta' Frar 2009
English: Pharmacotherapeutic group: Selective Estrogen Receptor Modulator (SERM), ATC code: {not yet assigned}
Maltese: Modulatur Selettiv tar-Riċetturi tal-Estroġenu (SERM), Kodiċi ATC:
English: Effects on vulvar and vaginal atrophy (VVA):
Maltese: Effetti fuq l-atrofija tal-vulva u tal-vaġina (VVA):
English: Adverse reactions are listed by system organ class and frequency (very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)).
Maltese: Ir-reazzjonijiet avversi huma mniżżla skont is-sistema tal-klassifikazzjoni tal-organi u l-frekwenza ((komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100) u rari (≥1/10,000 sa <1/1,000)).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U
English: Lasofoxifene has been associated with benign endometrial effects.
Maltese: Lasofoxifene ġie assoċjat ma' effetti beninni tal-endometriju.
English: Paediatric:
Maltese: Użu pedjatriku:
English: In clinical studies, lasofoxifene did not alter the metabolism of dextromethorphan (CYP2D6 substrate) and chlorzoxazone (CYP2E1 substrate) or the pharmacokinetics of warfarin (CYP2C9 substrate), methylprednisolone (CYP3A4 substrate) or digoxin (MDR1 P-glycoprotein substrate).
Maltese: Fi studji kliniċi, lasofoxifene ma biddilx il-metaboliżmu ta' dextromethorphan (substrat ta' CYP2D6) u chlorzoxazone (substrat ta' CYP2E1) jew il-farmakokinetika ta' warfarin (substrat ta' CYP2C9), methylprednisolone (substrat ta' CYP3A4) jew digoxin (substrat ta' glikoproteina P-MDR1).
English: Oxidation, by multiple cytochrome P450s including CYPs 2D6 and 3A4/5, and conjugation of lasofoxifene are the two primary mechanisms of elimination of lasofoxifene from the systemic circulation.
Maltese: L-ossidazzjoni, permezz taċ-ċitokroma P450 multipla, inklużi CYPs 2D6 u 3A4/5, u l-konjugazzjoni ta' lasofoxifene, huma ż-żewġ mekkaniżmi prinċipali tal-eliminazzjoni ta' lasofoxifene miċ-ċirkolazzjoni sistemika.
English: The MAH shall also provide access to educational programme for pathologists.
Maltese: L-MAH għandu wkoll jipprovdi aċċess għal programm edukattiv għal patoloġisti.
English: It belongs to a group of medicines called Selective Estrogen Receptor Modulators (SERM).
Maltese: Dan jifforma parti minn kategorija ta' mediċini msejħa Modulaturi Selettivi tar-Riċetturi talEstroġenu (SERM).
English: • Not known: frequency cannot be estimated from the available data
Maltese: • Mhux magħrufa: il-frekwenza ma tistax tiġi kkalkulata mill-informazzjoni eżistenti
English: Blister packs of 7, 28 or 30 tablets and bottles of 90 tablets.
Maltese: Pakketti b'folji ta' 7, 28 jew 30 pillola u fliexken ta' 90 pillola.
English: The number of hysterectomies in the FABLYN-treated group (27/2,302 patients, 1.2%) and the placebo-treated group (24/2,309 patients, 1.0%) were similar.
Maltese: In-numru ta' isterektomiji fil-grupp ta' nisa kkurati b'FABLYN (27/2,302 pazjenta, 1.2%) u fil-grupp ta' nisa kkurati bil-plaċebo (24/2,309 pazjenta, 1.0%) kien simili.
English: The recommended intake of vitamin D is 400-800 IU daily.
Maltese: L-ammont irrakkomandat ta' vitamina D hu ta' 400-800
English: The apparent volume of distribution (V/F) of lasofoxifene in postmenopausal women is approximately 1,350 l.
Maltese: Il-volum evidenti tad-distribuzzjoni (V/F) ta' lasofoxifene f'nisa li diġà għaddew mill-menopawsa huwa ta' bejn wieħed u ieħor 1,350 l.
English: All clinical fractures Percentage of patients with clinical fracture n=2,852
Maltese: Il-ksur kliniku kolluPerċentwal ta' pazjenti bi ksur kliniku n=2,852
English: Three metabolites of lasofoxifene were detected in plasma: the direct glucuronide conjugate, the glucuronide of a hydroxylated metabolite, and the methylated catechol.
Maltese: Instabu 3 metaboliti ta' lasofoxifene fil-plażma; l-akkopjat dirett ta' glucuronide, il-glucuronide ta' metabolit idrossilat, u methylated catechol.
English: Lasofoxifene exhibits linear pharmacokinetics over a wide dose range following single-dose (up to 100 mg) and multiple-dose (up to 20 mg once daily) administration.
Maltese: Lasofoxifene juri farmakokinetika lineari fuq skala ta' doża wiesgħa wara li tkun ingħatat doża singola (sa 100 mg) u doża multipla (sa 20 mg darba kuljum).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains lasofoxifene tartrate, equivalent to 500 microgram lasofoxifene.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha lasofoxifene tartrate, ekwivalenti għal 500 mikrogramma lasofoxifene.
English: Ketoconazole - The strong CYP3A4/5 inhibitor ketoconazole increased the systemic exposure of lasofoxifene by 20% which is not considered to be clinically meaningful.
Maltese: Ketoconazole - Ketoconazole, l-impeditur qawwi ta' CYP3A4/5, żied l-esponiment sistemiku ta' lasofoxifene b'20%, li mhux meqjus bħala li hu klinikament rilevanti.
English: 7 film-coated tablets
Maltese: FOLJA - 7 pilloli
English: Common side effects:
Maltese: Effetti sekondarji komuni:
English: The reduction in the incidence of non-vertebral fractures was also observed in postmenopausal women with severe osteoporosis (defined as a baseline lumbar spine BMD T-score ≤ -2.5 + prevalent fracture or BMD T-score ≤ -3) (p = 0.0183).
Maltese: It-tnaqqis fl-inċidenza ta' ksur li mhuwiex vertebrali kien osservat ukoll f'nisa li diġà għaddew mill-menopawsa li jbatu minn osteoporożi severa (kif definita bħala linja bażi tal-ispina lumbari BMD T-score ≤ -2.5 + ksur prevalenti jew BMD T-score ≤ -3) (p = 0.0183).
English: How to FABLYN
Maltese: Tieħux FABLYN
English: Anorexia, decreased appetite, hypertriglyceridaemia, hypoalbuminaemia,
Maltese: Anoressija, dijabete mellitus tat-2 tip, ipertrigliċeridemija, ipoalbuminemija, ipofosfatimija,
English: 30 film-coated tablets
Maltese: FOLJA - 30 pillola
English: The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing 90 tablets.
Maltese: Il-pilloli jiġu ġo pakkett tal-folji li jkun fih 7, 28 jew 30 pillola, u f'pakkett bi flixkun li jkun fih 90 pillola.
English: Mon Tue Wed Thu Fri Sat Sun
Maltese: Sewqan u tħaddim ta' magni
English: In a 3-year substudy of the PEARL study (n=760), FABLYN significantly increased BMD (compared to placebo) at lumbar spine (3.3%), total hip (3.0%), femoral neck (3.3%), greater trochanter (3.6%), intertrochanteric area (2.6%), Ward's triangle (5.9%) and forearm (1.8%) at 3 years.
Maltese: Fi studju ta' 3 snin li jifforma parti mill-istudju PEARL (n=760), FABLYN żied il-BMD b'mod sinifikanti (meta pparagunat mal-plaċebo) fl-ispina lumbari (3.3%), fil-ġenbejn kollha (3.0%), flgħonq femorali (3.3%), fil-trochanter il-kbir (3.6%), fl-arja intertrochanteric (2.6%), fit-triangolu Ward (5.9%) u fid-driegħ mill-minkeb sal-polz jew sat-truf tas-swaba'(1.8%) wara 3 snin.
English: Excipient: Each film-coated tablet contains 71.34 mg lactose.
Maltese: Kull pillola miksija b'rita fiha 71.34 mg lattosju.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: Lasofoxifene has a half-life of approximately 6 days.
Maltese: Lasofoxifene għandu half-life ta' bejn wieħed u ieħor 6 ijiem.
English: Skeletal effects:
Maltese: Effetti skeltrali:
English: Rare side effects:
Maltese: Effetti sekondarji rari li:
English: The number of subjects discontinuing treatment as a result of vaginal bleeding was low [FABLYN: 4 (0.1%), placebo: 0].
Maltese: In-numru ta' suġġetti li waqqfu l-kura minħabba l-ħruġ ta' demm mill-vaġina kien baxx [FABLYN: 4 (0.1%), plaċebo: 0].
English: Pregnancy
Maltese: Ġermanja
English: FABLYN must not be taken during lactation (see section 4.3).
Maltese: FABLYN m'għandux jittieħed waqt li mara tkun qiegħda tredda' (ara sezzjoni 4.3).
English: Elderly women (65 years and older):
Maltese: Nisa anzjani (65 sena u akbar):
English: Sunset yellow FCF aluminium lake (E110)
Maltese: FCF aluminium lake (E110) ta' lewn isfar kulur inżul ix-xemx Hypromellose
English: photosensitivity reaction, pruritus generalized, rash maculo-papular, rash pruritic,
Maltese: pigmentazzjoni eċċessiva fil-ġilda, raxx maculo-papulari, reazzjoni ta' fotosensittività,
English: Chronic obstructive pulmonary disease, pulmonary granuloma, vasomotor rhinitis Gastrointestinal disorders
Maltese: Granuloma pulmonari, mard kroniku ta' imblukkar fil-pulmun, rinite vasomotorja Disturbi gastro-intestinali
English: Arthropathy, bursitis, clubbing, coccydynia, costochondritis, dactylitis, exostosis, extremity contracture, haemarthrosis, joint stiffness, muscle contracture, muscle twitching, musculoskeletal discomfort, pain in jaw, periarthritis, rheumatoid arthritis,
Maltese: Artrite rewmatika, artropatija, bursite, caqliq involontarju fil-muskoli, clubbing, coccydynia, contracture fl-estremitajiet, dactylitis, ebusija tal-ġogi, eksostosi, emartrosi, kontrazzjoni talmuskoli, kostokondrite, periartrite, sindromu rotator cuff, skonfort muskolu-skeltrali,
English: This analysis included 2,049 postmenopausal women consisting of 85.5% Caucasian, 8.6% Hispanic, 3.4% Asian, and 1.9% African American.
Maltese: 5% tan-nisa Kawkażi (ta' ġilda bajda), 8.6% tan-nisa ta' razza tal-Amerikana Latina, 3.4% tan-nisa Asjatiċi, u 1.9% tan-nisa Afroamerikani.
English: FABLYN significantly decreased the incidence of all clinical fractures from 12.1% for placebo to 9.3% for FABLYN (relative risk reduction = 25%, p = 0.0004).
Maltese: FABLYN naqqas l-inċidenza tal-ksur kliniku kollu b'mod sinifikanti, minn 12.1% għall-plaċebo għal 9.3% għal FABLYN (tnaqqis relattiv tar-riskju = 25%, p = 0.0004).
English: Within this study, 3.2% of FABLYN-treated women and 8.0% of placebo-treated women discontinued therapy due to adverse events.
Maltese: Fi 3.2% tan-nisa li kienu kkurati b'FABLYN u 8.0% tan-nisa li kienu kkurati bil-plaċebo it-terapija twaqqfet minħabba effetti aversi li dehru.
English: Based on the absence of clinically relevant effects of cholestyramine (anion exchange resin), fluconazole (CYP2C9 inhibitor), ketoconazole (CYP3A4/5 inhibitor) and paroxetine (CYP2D6 inhibitor) on lasofoxifene pharmacokinetics, other anion exchange resins and other inhibitors of these CYP isoforms are unlikely to produce clinically meaningful alterations in FABLYN exposure and no dose adjustments are required.
Maltese: Minħabba n-nuqqas ta' effetti ta' rilevanza klinika ta' cholestyramine (anion exchange resin), fluconazole (impeditur tas-CYP2C9), ketoconazole (impeditur tas-CYP3A4/5) u paroxetine (impeditur tas-CYP2D6 ) fuq il-farmakokinetika ta' lasofoxifene, x'aktarx li anion exchange resin oħra u impedituri oħra ta' dawn l-iżoformi CYP ma jipproduċux tibdil fl-esponiment ta' FABLYN li hu ta' rilevanza klinika, u m'hemmx bżonn ta' aġġustament tad-doża.
English: The safety of FABLYN in the treatment of osteoporosis was also assessed in a Phase 2 placebocontrolled trial in Japanese, Korean and Taiwanese women.
Maltese: Is-sigurtà ta' FABLYN fil-kura tal-osteoporożi ġiet evalwata wkoll fi prova ta' Fażi 2 kontrollata bilplaċebo fuq nisa Ġappuniżi, Koreani u Tajwaniżi.
English: There were 0.51 events/100 patient-years for FABLYN-treated patients compared to 0.75 events/100 patient-years in placebo-treated patients (HR 0.68; 95% CI 0.50, 0.93, p= 0.016).
Maltese: Kien hemm 0.51 każ/100 sena ta' pazjenta fl-każ ta' pazjenti kkurati b'FABLYN meta pparagunati ma' 0.75 każ/100 sena ta' pazjenta f'pazjenti kkurati bil-palċebo (HR 0.68; 95% CI 0.50, 0.93, p= 0.016).
English: The safety of FABLYN in the treatment of osteoporosis was assessed in a large (8,556 patients) double-blind, randomized, placebo-controlled multinational Phase 3 fracture trial (the PEARL study).
Maltese: Is-sigurtà ta' FABLYN fil-kura tal-osteoporożi ġiet evalwata fi prova klinika kbira (8,556 pazjenta) multinazzjonali ta' Fażi 3 dwar il-ksur, li kienet double-blind, randomized, u kontrollata bil-plaċebo (listudju PEARL).
English: New radiographic vertebral fractures Percentage of patients with new fracture n=2,748
Maltese: Ksur vertebrali radjografiku ġdid Perċentwal ta' pazjenti bi ksur ġdid n=2,748
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini (EMEA) http://www.emea.europa.eu/.
English: Paroxetine - The strong CYP2D6 inhibitor paroxetine increased the systemic exposure of lasofoxifene by 35% which is not considered to be clinically meaningful.
Maltese: Paroxetine - Paoxetine, l-impeditur qawwi ta' CYP2D6, żied l-esponiment sistemiku ta' lasofoxifene b'35%, li mhux meqjus bħala li hu klinikament rilevanti.
English: RELEASE
Maltese: Tqala
English: Within this study, 12.9% of FABLYN-treated women and 12.3% of placebo-treated women discontinued therapy due to adverse events.
Maltese: F'dan l-istudju, 12.9% tan-nisa kkurati b' FABLYN u 12.3% tan-nisa kkurati bil-plaċebo waqqfu ttrattament minħabba effetti avversi.
English: FABLYN significantly decreased the incidence of new radiographic vertebral fractures (excluding worsening of previous fractures) from 9.3% for placebo to 5.6% for FABLYN (relative risk reduction = 41%, p < 0.0001).
Maltese: FABLYN naqqas l-inċidenza ta' ksur vertebrali radjografiku ġdid (eskluż ksur li diġà kien eżistenti qabel, u li mar għall-agħar) b'mod sinifikanti minn 9.3% għall-plaċebo għal 5.6% għal FABLYN (tnaqqis relattiv tar-riskju = 41%, p < 0.0001).
English: 28 film-coated tablets
Maltese: FOLJA - 28 pillola
English: Pharmacovigilance system
Maltese: Kategorija farmakoterapewtika:
English: The binding affinities of the major circulating metabolites of lasofoxifene were at least 31-fold and 18fold less than those of lasofoxifene for the estrogen receptor alpha and the estrogen receptor beta, respectively, indicating that these metabolites are unlikely to contribute to the pharmacologic activity of lasofoxifene.
Maltese: L-affinitajiet tat-tweħħil tal-metaboliti prinċipali ta' lasofoxifene li jiċċirkulaw kienu ta' mill-inqas 31 darba u 18-il darba inqas minn dawk ta' lasofoxifene għar-riċettur tal-estroġenu alfa u r-riċettur talestroġenu beta, rispettivament, u dan jindika li dawn il-metaboliti x'aktarx li ma jikkontribwixxux għall-attività farmakoloġika ta' lasofoxifene.
English: Statistically significant increases were seen for apolipoprotein A-1, which is associated with HDL cholesterol, and serum triglycerides (median changes vs. placebo 6.1% and 4.9%, respectively).
Maltese: Kien hemm żidiet li huma statistikament sinifikanti fil-każ ta' apolipoprotein A-1, li hi assoċjata mal-kolesterol tat-tip HDL, u t-trigliċeridi fis-serum (il-medja tal-bidliet meta pparagunat mal-plaċebo kienet ta' 6.1% u 4.9%, rispettivament).
English: Mean international normalized ratio (INR) AUC and maximum value of INR after single-dose warfarin administration with lasofoxifene were approximately 8% and 16% lower, respectively, than after warfarin alone.
Maltese: Il-medja talproporzjon normalizzat internazzjonali (INR) tal-AUC u l-valur massimu tal-INR wara li ngħatat doża waħda ta' warfarin flimkien ma' lasofoxifene, kienu ta' bejn wieħed u ieħor 8% u 16% inqas, rispettivament, milli kienu wara li ngħata warfarin waħdu.
English: The duration of treatment in postmenopausal women was 60 months, 2,852 were randomized to FABLYN and 2,852 were randomized to placebo.
Maltese: It-tul tal-kura f'nisa li diġà għaddew mill-menopawsa kien ta' 60 xahar, 2,852 pazjenta ġew randomized u ngħataw FABLYN u 2,852 pazjenta ġew randomised u ngħataw il-plaċebo.
English: PHARMACEUTICAL PARTICULARS
Maltese: TAL-PRODOTT MEDIĊINALI
English: Women enrolled in this study had a median age of 67 years (range 59 to 80) and a median time since menopause of 20 years.
Maltese: In-nisa li kienu qegħdin jipparteċipaw f'dan listudju kellhom età medja ta' 67 sena (medda minn 59 sa 80 sena) u medja ta' 20 sena minn meta kellhom il-menopawa.
English: Lasofoxifene produces tissue and cell-specific effects in estrogen-responsive tissues.
Maltese: Lasofoxifene jipproduċi effetti fuq it-tessuti u effetti relatati maċ-ċelluli fuq it-tessuti li juru rispons għall-estroġenu.
English: Lasofoxifene was not teratogenic in rats up to a dose of 10mg/kg (approximately 53 times the AUC in humans) or rabbits up to a dose of 3 mg/kg (below the level of systemic exposure in humans).
Maltese: Lasofoxifene ma kienx teratoġeniku fil-firien sa doża ta' 10 mg/kg (bejn wieħed u ieħor 53 darba aktar mill-AUC fil-bniedem) jew fil-fniek sa doża ta' 3 mg/kg (taħt il-livell ta' esponiment sistemiku filbniedem).
English: All women in the study received calcium (1,000 mg/day) and Vitamin D (400-800 IU/day).
Maltese: In-nisa kollha li kienu qegħdin jipparteċipaw fl-istudju ingħataw il-kalċju (1000 mg/kuljum) u l-Vitamina D (400-800
English: There is no specific antidote for FABLYN.
Maltese: M'hemm l-ebda antidotu speċifiku għal FABLYN.