FrancophonIA/ELRC3.0 huggingface dataset:
English: Over the 5 years of the PEARL study (involving 8,556 patients), FABLYN treatment compared to placebo reduced the risk of invasive breast cancer by 85% (placebo: 20 (0.7%), FABLYN: 3 (0.1%); HR 0.15 (CI 0.04, 0.50)), the risk of all breast cancer by 79% (placebo: 24 (0.9%), FABLYN: 5 (0.2%); HR 0.21 (CI 0.08, 0.55)), the risk of estrogen receptor (ER) positive invasive breast cancer by 83% (placebo: 18 (0.7%), FABLYN: 3 (0.1%); HR 0.17 (CI 0.05, 0.57)) and the risk of estrogen receptor (ER) positive breast cancer by 81% (placebo: 21 (0.8%), FABLYN: 4 (0.1%); HR 0.19 (CI 0.07, 0.56)).
Maltese: Matul il-5 snin tal-istudju PEARL (li kien jinvolvi 8,556 pazjenta), il-kura b'FABLYN meta pparagunata mal-plaċebo, naqqset ir-riskju tal-kanċer tas-sider li jinfirex minn fejn oriġina għal tessuti f'saħħithom b'85% (plaċebo: 20 (0.7%), FABLYN:
English: EXP:
Maltese: Sess:
English: Adult (postmenopausal women):
Maltese: Adulti (nisa li jkunu diġà għaddew mill-menopawsa):
English: NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets lasofoxifene
Maltese: FABLYN 500 mikrogramma pilloli miksija b'rita lasofoxifene
English: Through 5 years of follow-up, 37 FABLYN-treated women (1.3%, or 2.90 per 1,000 patients years) had a VTE compared to 18 placebo-treated women (0.6%, or 1.41 per 1,000 patients years) and the hazard ratio was 2.06 (95% CI: 1.17, 3.61).
Maltese: Matul 5 snin ta' osservazzjoni ta' wara l-kura, 37 mara li kienu kkurati f'FABLYN (1.3%, jew 2.90 kull 1,000 sena ta' pazjenta) kellhom VTE meta pparagunati ma' 18-il mara li kienu kkurati bil-plaċebo (0.6%, jew 1.41 kull 1,000 sena ta' pazjenta), u l-proporzjon tal-periklu kien ta' 2.06 (95% IK: 1.17, 3.61).
English: Lasofoxifene clearance may be increased in patients chronically treated with inducers of CYP3A4 and UGTs (eg, phenytoin, carbamazepine, barbiturates and St John's Wort) resulting in reduced steadystate concentrations and may result in reduced efficacy.
Maltese: It-tneħħija ta' lasofoxifene tista' tiżdied f'pazjenti li jiġu kkurati kronikament b' indutturi ta' CYP3A4 u UGTs (eż, phenytoin, carbamazepine, barbiturati u l-fexfiex tar-raba' (St John's Wort)) u dan iwassal għal tnaqqis fil-konċentrazzjonijiet fissi u jista' jwassal għal tnaqqis fl-effikaċja.
English: Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms of lasofoxifene.
Maltese: Kull pillola miksija b'rita fiha lasofoxifene tartrate, ekwivalenti għal 500 mikrogramma lasofoxifene.
English: Lasofoxifene has been administered to postmenopausal women at single doses as high as 100 mg (200 times the recommended unit dose) and multiple doses as high as 10 mg/day (20 times the recommended dose) for up to one year without dose-related serious adverse reactions.
Maltese: Lasofoxifene ingħata lil nisa li diġà għaddew mill-menopawsa permezz ta' dożi singoli sa 100 mg (200 darba aktar mid-doża rrakkomandata) u permezz ta' dożi multipli sa 10 mg/kuljum (20 darba aktar mid-doża rrakkomandata) għal massimu ta' sena mingħajr ma kien hemm reazzjonijiet avversi serji li huma relatati mad-dożaġġ.
English: Vaginal bleeding was reported in 74 (2.6%) FABLYN-treated women versus 37 (1.3%) placebo-treated women.
Maltese: Il-ħruġ tad-demm mill-vaġina ġie rrappurtat f'74 (2.6%) mara li kienu qegħdin jiġu kkurati b'FABLYN meta pparagunat ma' 37 (1.3%) mara li kienu qegħdin jiġu kkurati bil-plaċebo.
English: -Bone mineral density
Maltese: GĦAMLA KWALITATTIVA
English: In a population pharmacokinetic analysis, no discernible difference in lasofoxifene pharmacokinetics was detected in different racial groups.
Maltese: F'analiżi farmakokinetika tal-populazzjoni, ma dehret l-ebda differenza fil-farmakokinetika ta' lasofoxifene fi gruppi ta' razez differenti.
English: Renal insufficiency:
Maltese: Pazjenti b'indeboliment renali:
English: There were 0.48 events/100 patient years in the placebo group and 0.36 events/100 patient years among FABLYN-treated patients (HR = 0.75; 95% CI 0.51, 1.10, p = 0.140).
Maltese: Kien hemm 0.48 każ/100 sena ta' pazjenta fil-grupp ta' pazjenti kkurati bil-plaċebo u 0.36 każ/100 sena ta' pazjenta fil-pazjenti li kienu kkurati b'FABLYN (HR = 0.75; 95% CI 0.51, 1.10 p = 0.140).
English: Warfarin - Lasofoxifene had no effect on the pharmacokinetics of R- and S- warfarin.
Maltese: Warfarin - Lasofoxifene ma kellux effett fuq il-farmakokinetika ta' R- u S- warfarin.
English: In women with a prevalent vertebral fracture at baseline, FABLYN significantly reduced the incidence of new vertebral radiographic fractures from 14.2% for placebo to 8.7% for FABLYN (relative risk reduction = 42%, p = 0.0004).
Maltese: F'nisa bi ksur vertebrali prevalenti fil-linja bażi, FABLYN naqqas l-inċidenza ta' ksur vertebrali radjografiku ġdid b'mod sinifikanti, minn 14.2% għall-plaċebo għal 8.7% għal FABLYN (tnaqqis relattiv tar-riskju = 42%, p = 0.0004).
English: Following oral administration of 14C-labeled lasofoxifene in solution to humans, approximately 72% of the radioactive dose was recovered by day 24 (approximately 66% in feces and 6% in urine).
Maltese: Wara li ttieħed lasofoxifene tikettat 14 C mill-ħalq permezz ta' soluzzjoni, fil-bniedem instabet bejn wieħed u ieħor 72% tad-doża radjuattiva sa l-24 ġurnata (bejn wieħed u ieħor 66% fl-iskart tal-ġisem u 6% fl-awrina).
English: The duration of treatment in postmenopausal women was 12 months, 124 were exposed to FABLYN and 125 were exposed to placebo.
Maltese: It-tul tal-kura f'nisa li diġà għaddew millmenopawsa kien ta' 12-il xahar, 124 ġew esposti għal FABLYN u 125 ġew esposti għall-plaċebo.
English: Pharmacokinetic data from over 2,000 postmenopausal women including patients in selected osteoporosis clinical trials contributed to a population pharmacokinetic analysis.
Maltese: Tagħrif farmakokinetiku li rriżulta minn aktar minn 2,000 mara li diġà għaddew mill-menopawsa, inklużi pazjenti fi provi kliniċi magħżula tal-osteoporożi, ikkontribwixxa għal analiżi tal-populazzjoni farmakokinetika.
English: Blood and lymphatic system disorders Uncommon: Anaemia, macrocytosis, thrombocytopenia Rare:
Maltese: Anemija, makroċitosi, tromboċitopenija Rari:
English: Plasma lasofoxifene exposure was approximately the same in healthy subjects as in subjects with mild hepatic impairment (Child-Pugh Class A) and was modestly increased (38%) in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to healthy subjects.
Maltese: L-esponiment fil-plażma b'lasofoxifene kien bejn wieħed u ieħor l-istess f'suġġetti f'saħħithom u f'suġġetti li jbatu minn indeboliment tal-fwied ħafif (Child-Pugh Klassi A) u żdied b'ammont mhux kbir (38%) f'suġġetti li jbatu minn indeboliment talfwied moderat (Child-Pugh Klassi B) meta pparagunat ma' suġġetti f'saħħithom.
English: FABLYN significantly decreased the incidence of non-vertebral fractures from 10.4% for placebo to 8.1% for FABLYN (relative risk reduction = 24%, p = 0.0020).
Maltese: 4% għallplaċebo għal 8.1% għal FABLYN (tnaqqis relattiv tar-riskju = 24%, p = 0.0020).
English: • Web-based
Maltese: • KUNDIZZJONIJIET OĦRA
English: The pharmacokinetics of lasofoxifene have not been evaluated in a paediatric population.
Maltese: Il-farmakokinetika ta' lasofoxifene għadha ma ġietx evalwata fil-populazzjoni pedjatrika.
English: • Cough, difficulty breathing, stuffy nose, runny nose
Maltese: • Sogħla, diffikultà biex tieħu n-nifs, imnieħer miżdud, flisjoni
English: Metabolism and nutrition disorders Uncommon: Diabetes mellitus Rare:
Maltese: Anemija megaloblastika, ipokromasja Disturbi fis-sistema immuni Rari:
English: • Rare: affects 1 to 10 users in 10,000
Maltese: • Rari: jaffetwaw minn pazjent 1 sa 10 minn kull 10,000
English: In women without any prevalent vertebral fractures at baseline, the incidence of new radiographic vertebral fractures was significantly reduced from 7.4% for placebo to 4.4% for FABLYN (relative risk reduction = 41%, p = 0.0002).
Maltese: F'nisa li ma kellhomx ksur vertebrali prevalenti fil-linja bażi, linċidenza ta' ksur vertebrali radjografiku ġdid naqset b'mod sinifikanti, minn 7.4% għall-plaċebo għal 4.4% għal FABLYN (tnaqqis relattiv tar-riskju = 41%, p = 0.0002).
English: • Breast discharge, breast lump, vaginal pain, varicose vein
Maltese: • Tnixxija mis-sider, boċċa fis-sider, uġigħ fil-vaġina, vini varikużi
English: • Common: affects 1 to 10 users in 100
Maltese: • Komuni: jaffetwaw minn pazjent 1 sa 10 minn kull 100
English: * Endometrial hypertrophy is a MedDRA dictionary term that represents sonographic endometrial thickness findings.
Maltese: * Ipertrofija tal-endometriju hija terminoloġija tad-dizzjunarju MedDRA li tirrappreżenta r-riżultati dwar il-ħxuna sonografika tal-endometriju
English: Abdominal tenderness, anal fissure, anal spasm, cheilitis, cheilosis, colitis ulcerative, duodenal ulcer, duodenitis, dysphagia, gastric polyps, inguinal hernia, mouth ulceration, oesophagitis, oral pain, rectal polyp, rectal ulcer, stomach discomfort Hepatobiliary disorders Uncommon: Cholelithiasis, hepatic steatosis Rare:
Maltese: Disfaġija, duwodenite, fissura anali, ftuq ingwinali, keilite, keilosi, kolite bl-ulċeri, osefaġite, polipa fir-rektum, polipi fl-istonku, sensittività addominali, skonfort fl-istonku, spażmu anali, tiġriħ fil-ħalq, uġigħ fil-ħalq, ulċera duwodenali, ulċera fir-rektum Disturbi fil-fwied u fil-marrara Mhux komuni:
English: Lasofoxifene may be associated with benign endometrial effects: endometrial cystic change viewed on ultrasound and histological benign cystic atrophy (a variant of atrophic endometrium), contributing to approximately 1.5 mm increase in mean endometrial thickness.
Maltese: Lasofoxifene jista' jiġi assoċjat ma' effetti beninni tal-endometriju: bidla fiċ-ċesti tal-endometriju li tidher fl-eżami ultrasoniku u atrofija istoloġika bennina taċ-ċesti (varjant tal-atrofija tal-endometriju), li jikkontribwixxu għal żieda ta' bejn wieħed u ieħor 1.5 mm fil-ħxuna medja tal-endometriju.
English: Risk Management Plan
Maltese: IT-TABELLA
English: • Uncommon: affects 1 to 10 users in 1,000
Maltese: • Mhux komuni: jaffetwaw minn pazjent 1 sa 10 minn kull 1,000
English: These referrals were significantly less frequent in the FABLYN group (0.9%) than in the placebo group (3.3%).
Maltese: Dawn irreferenzi kienu inqas frekwenti b'mod sinifikanti fil-grupp li kien ikkurat b'FABLYN (0.9%) milli filgrupp li kien ikkurat bil-plaċebo (3.3%).
English: At steady state, the half-life of lasofoxifene in postmenopausal women is approximately 6 days, resulting in small fluctuations in concentrations over the 24-hour dosing interval.
Maltese: Fi steady state, il-half-life ta' lasofoxifene f'nisa li diġà għaddew mill-menopawsa, huwa ta' bejn wieħed u ieħor 6 ijiem, u fuq l-intervall ta' dożaġġ ta' 24 siegħa jkun hemm varjazzjonijiet żgħar filkonċentrazzjonijiet.
English: Venous Thromboembolic Events: The most serious adverse reaction related to FABLYN was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis).
Maltese: L-aktar reazzjoni avversa serja relatata ma' FABLYN kienet il-VTE (trombożi tal-vini l-fondi, emboliżmu pulmonari, u trombożi tal-vina tar-retina).
English: Malformation venous
Maltese: Dijabete mellitus
English: Cardiac failure, cardiomegaly, cor pulmonale, sinus arrest, supraventricular extrasystoles, tricuspid valve incompetence Vascular disorders Common: Hot flush Uncommon: Deep vein thrombosis, flushing, phlebitis, thrombophlebitis, thrombophlebitis superficial, venous stasis
Maltese: Attakk tal-qalb, cor pulmonale, ekstrasistoli supraventrikulari, inkompetenza tal-valvola tal qalb magħmula minn tliet segmenti trijangulari, kardiomegalija, sinus arrest Disturbi vaskulari
English: In two-year carcinogenicity studies conducted in rats (≥1 mg/kg/day; 7 times systemic exposure following a human dose of 0.5 mg/day based on plasma AUC) an increased incidence of renal tubular adenoma and carcinoma in males and granulosa cell tumours of the ovary in females was noted.
Maltese: Fi studji karċinoġeniċi sussegwenti li damu għaddejjin sentejn li saru fuq il-firien (≥1 mg/kg/kuljum; esponiment sistemiku ta' 7 darbiet aktar wara doża ta' 0.5 mg/kuljum li tingħata lill-bniedem ibbażata fuq l-AUC tal-plażma) ġiet osservata żieda fl-inċidenza ta' adenoma tubulari renali u tal-karċinoma fl-irġiel u tumuri granulożi ċellulari fl-ovarji fin nisa.
English: An analysis was conducted of the subjects who were referred to their physician for consideration of treatment with an alternative osteoporosis medicinal product if one of the following was observed: a) ≥7% BMD loss at LS or ≥10% BMD loss at femoral neck at Month 12; b) ≥11% BMD loss at lumbar spine (LS) or ≥14% BMD loss at femoral neck at Month 24; c) ≥2 on-study radiographic vertebral fractures by Month 24.
Maltese: Saru analiżi ta' dawk is-suġġetti li ġew referuti għand it-tabib tagħhom biex jikkunsidra li jagħtihom kura bi prodott mediċinali tal-osteoporożi ieħor jekk huwa jinnota wieħed mis-segwenti: a) telf ta' ≥7% tal-BMD tal-bażi tal-ispina lumbari jew telf ta' ≥10% tal-BMD tal-għonq femorali fit-12-il Xahar; b)telf ta' ≥11% tal-BMD tal-ispina femorali (LS) jew telf ta' ≥14% tal-BMD tal- għonq femorali fl-24
English: Bone turnover
Maltese: TAL-FLIXKUN
English: Steady-state pharmacokinetics of lasofoxifene are consistent with expectations from its single-dose pharmacokinetics.
Maltese: Il-farmakokinetika ta' koncetrazzjoni fissa ta' lasofoxifene hija konsistenti ma' dak li kien mistenni mill-farmakokinetika ta' doża waħda.
English: stomach ache
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: FABLYN-treated and placebo-treated groups had similar incidences of endometrial hyperplasia and endometrial cancer (see section 5.1).
Maltese: Gruppi li kienu qegħdin jingħataw FABLYN u gruppi li kienu qegħdin jingħataw il-plaċebo kellhom inċidenzi simili ta' iperplasija tal-endometriju u ta' kanċer flendometriju (ara sezzjoni 5.1).
English: 5-year results from large, multinational fracture trial (PEARL)
Maltese: Riżultati ta' perjodu ta' 5 snin tal-prova l-kbira multinazzjonali dwar il ksurl (PEARL)
English: The effect of FABLYN on the lipid profile was evaluated in a 3-year substudy of the PEARL study; the substudy enrolled 1,014 postmenopausal women.
Maltese: L-effett ta' FABLYN fuq il-profil tal-lipidi ġie evalwat fi studju ta' 3 snin li kien jifforma parti millistudju PEARL; dan l-istudju kien jinvolvi 1014-il mara li diġà għaddew mill-menopawsa.
English: In the corresponding 2-year study in mice (≥2 mg/kg/day; less than systemic exposure following a human dose of 0.5 mg/day based on plasma AUC), there was an increased incidence of adrenal cortical adenoma and carcinoma, interstitial cell tumors of the testis, benign and malignant ovarian tumors and benign uterine glandular polyps.
Maltese: Fl-istudju l-ieħor ta' sentejn fil-ġrieden (≥2 mg/kg/kuljum; inqas mill-esponiment sistemiku wara doża ta' 0.5 mg/kuljum li tingħata lill-bniedem bbażata fuq l-AUC tal-plażma), kien hemm żieda fl-inċidenza ta' adenoma adrenali kortikali u tal-karċinoma, tumuri ta' bejn iċ-ċelloli tat-testis, tumuri ovarji beninni u malinni u qarnit glandolari beninn tal-utru.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/500/001
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/500/001
English: At 5 years in the overall study population (N=8,556), the incidence of major coronary events, including coronary death, non-fatal myocardial infarction, new ischemic heart disease, hospitalization for unstable angina, and revascularisation procedures, was significantly lower.
Maltese: Wara 5 snin, fil-populazzjoni tal-istudju (N=8,556), l-inċidenzi ta' każijiet koronarji maġġuri li jinkludu mwiet, infart mijokardjali li mhuwiex fatali, mard iskemiku tal-qalb ġdid, dħul l-isptar minħabba anġina mhux stabbli, u proċeduri ta' revaskularizzazzjoni, kienu inqas b'mod sinifikanti.
English: Lactation
Maltese: LOTT
English: Postmenopausal women require an average of 1,500 mg/day of elemental calcium.
Maltese: Nisa li jkunu diġà għaddew millmenopawsa għandhom bżonn medja ta' 1,500 mg/kuljum ta' kalċju elementari.
English: In a subset of the study population designed to look at endometrial histology (1,080 patients) with a TVU at 3 years, histologically benign endometrial polyps were reported in 20 of 366 (5.5%) FABLYN-treated women and 12 of 360 (3.3%) placebo-treated women.
Maltese: F'parti millpopulazzjoni li kienet qiegħda tipparteċipa fl-istudju fejn kienet qiegħda tiġi osservata l-istoloġija talendometriju (1080 pazjent) permezz ta' TVU wara 3 snin, ġew irrappurtati polipi fl-endometriju li huma istoloġikament beninni f'20 minn 366 (5.5%) mara li kienu qegħdin jiġu kkurati b'FABLYN u fi 12 minn 360 (3.3%) mara li kienu qegħdin jiġu kkurati bil-plaċebo.
English: EXPIRY DATE
Maltese: Iperparatirojdiżmu
English: Uncommon side effects:
Maltese: Effetti sekondarji komuni ħafna:
English: All women in the study received calcium (600-1200 mg/day) and Vitamin D (400-800 IU/day).
Maltese: In-nisa kollha li kienu qegħdin jipparteċipaw fl-istudju kienu qegħdin jirċievu l-kalċju (600-1200 mg/kuljum) u lVitamina D (400-800
English: Non-vertebral fractures Percentage of patients with non-vertebral fracture n=2,852
Maltese: Ksur li mhuwiex vertebraliPerċentwal ta' pazjenti bi ksur li mhuwiex vertebrali n=2,852
English: • Diabetes (typical symptoms are excessive thirst, frequent urination)
Maltese: • Dijabete (is-sintomi tipiċi huma: ħafna għatx, għamil frekwenti tal-awrina)
English: The study population consisted of 8,556 postmenopausal women with osteoporosis as defined by low BMD (vertebral or hip BMD at least 2.5 standard deviations below the mean value for healthy young women).
Maltese: Il-populazzjoni li fuqha sar l-istudju kienet tikkonsisti fi 8556 mara li diġà għaddew mill-menopawsa li jbatu mill-osteoporożi kif jidher mill-BMD baxx tagħhom (il-BMD tas-sinsla tad-dahar jew tal-ġenbejn mill-inqas ikun 2.5 devjazzjonijiet standard inqas millvalur medju f'nisa ta' età żgħira li jkunu f'saħħithom).
English: Safety and efficacy of FABLYN have not been evaluated in patients with liver function test > 1.5 ULN; therefore, FABLYN should be used with caution in these patients.
Maltese: Is-sigurtà u leffikaċja ta' FABLYN ma ġewx evalwati f'pazjenti li kellhom riżultati tat-test tal-funzjoni tal-fwied > 1.5
English: Table 1: Adverse reactions observed in placebo-controlled osteoporosis treatment clinical trials in more FABLYN-treated women than in placebo-treated women
Maltese: Tabella 1: Reazzjonijiet avversi osservati fi provi kliniċi tal-kura tal-osteoporożi kontrollati bilplaċebo aktar fin-nisa kkurati b'FABLYN milli f'dawk ikkurati bil-plaċebo
English: NAME OF THE MEDICINAL PRODUCT FABLYN 500 microgram film-coated tablets.
Maltese: FABLYN 500 mikrogramma pilloli miksija b'rita.
English: • Very rare: affects less than 1 user in 10,000
Maltese: • Rari ħafna: jaffetwaw inqas minn pazjent 1 minn kull 10,000
English: The apparent oral clearance (CL/F) of lasofoxifene in postmenopausal women is approximately 6.6 l/hr.
Maltese: It-tneħħija evidenti ta' lasofoxifene mill-ħalq (CL/F) f'nisa li diġà għaddew mill-menopawsa hija ta' bejn wieħed u ieħor 6.6 l/siegħa.
English: The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology (see sections 4.3 and 4.8).
Maltese: Għandu jiġi kkunsidrat il-bilanċ bejn ir-riskju u l-benefiċju fil-każ ta' pazjenti li huma f'riskju li jkollhom każijiet ta' trombo-emboliżmu ta' kwalunkwe etjoloġija (ara sezzjoni 4.3 u 4.8).
English: Common: Aspartate aminotransferase increased Uncommon: Alanine aminotransferase increased, blood glucose increased, smear cervix abnormal,
Maltese: Komuni: Żieda fl-aspartate aminotransferase
English: FABLYN film-coated tablets are supplied in PVC blisters with aluminum foil backing or HDPE bottles with polyethylene/aluminum foil lined polypropylene child-resistant closures.
Maltese: Fil-provi kliniċi, nisa kkurati b'FABLYN kellhom riskju akbar ta' każijiet ta' trombo-emboliżmu filvini (trombożi tal-vini l-fondi u emboliżmu pulmonari) meta pparagunati mal-plaċebo.
English: Hypromellose
Maltese: Treddigħ
English: Five metabolic pathways of lasofoxifene have been identified: direct glucuronidation; direct sulfation; hydroxylation at the phenyl tetraline moiety (with subsequent conjugative metabolism of the catechol intermediates by methylation and glucuronidation); oxidation at the pyrrolidine ring; and phenyl hydroxylation.
Maltese: Ġew identifikati ħames passaġġi minn fejn lasofoxifene jiġi mmetabolizzat: ditossifikazzjoni diretta millfwied fejn jinqabad il-glucuronic acid biex jitneħħa mill-ġisem; ditossifikazzjoni diretta mill-fwied fejn jinqabad il-kubrit biex jitneħħa mill-ġisem;-idrossilazzjoni mal-parti phenyl tertaline tal-molekula (b'metaboliżmu successiv konjugattiv ta' intermedjarji ta' catechol bil- proċess ta' methylation u glucuronidation); ossidazzjoni fiċ-ċirku pyrrolidine; u phenyl idrossilazzjoni.
English: New radiographic vertebral fracture in patients without any prevalent fracture at baseline Percentage of patients with new fracture n=1,970
Maltese: Ksur vertebrali radjografiku ġdid f'pazjenti mingħajr ebda ksur prevalenti fil-linja bażi Perċentwal ta' pazjenti bi ksur ġdid n=1,970
English: Common: Cystocele, endometrial disorder, endometrial hypertrophy* (sonographic endometrial thickness), uterine polyp, vaginal discharge, vaginal disorder Uncommon: Breast disorder female, breast induration, breast pain, cervix disorder, cervical dysplasia, cervical polyp, colpocele, endometrial hyperplasia** (based on investigator reporting), genital discharge, genital haemorrhage, hydrometra, metrorrhagia, postmenopausal haemorrhage, rectocele, uterine cervical erosion, uterine prolapse, vaginal haemorrhage, vaginal prolapse, vulvovaginal pruritus
Maltese: Bużżieqa tal-awrina ipertonika, disturbi fis-sistema urinarja, emorraġija fl-uretra, ħaġra filbużżieqa tal-awrina, iperkalċurja, polipi fil-bużżieqa tal-awrina, sklerosi tal-kliewi Disturbi fis-sistema riproduttiva u fis-sider Komuni Cystocele, disturbi fil-vaġina, disturbi fl-endometriju, ipertrofija tal-endometriju* (ħxuna sonografika tal-endometriju), qarnita fl-utru, tnixxija mill-vaġina
English: Table 2: Fracture incidence in postmenopausal women over 5 years
Maltese: Tabella 2: Inċidenza ta' ksur fuq perjodu ta' 5 snin f'nisa li diġà għaddew mill-menopawsa
English: In the osteoporosis treatment trials, FABLYN therapy resulted in consistent, statistically significant suppression of bone resorption and bone formation, as reflected by changes in serum and urine markers of bone turnover (e.g., C-telopeptide and markers of bone formation: osteocalcin, procollagen type 1 N-terminal propeptide, and bone-specific alkaline phosphatase).
Maltese: Fil-provi tal-kura tal-osteoporożi, it-terapija b'FABLYN wasslet għal trażżin statistikament sinifikanti tal-assorbiment mill-ġdid mill-għadam u tal-formazzjoni tal-għadam, kif rifless mill-bidliet filmarkaturi tal-immudellar tal-għadam mill-ġdid fis-serum u fl-awrina (eż. C-telopeptide u markaturi tal-formazzjoni tal-għadam: osteocalcin, procollagen type 1 N-terminal propeptide, u alkaline phosphatase speċifikat għall-għadam).
English: Elderly:
Maltese: Anzjani:
English: • Breast stiffening, breast pain, vaginal bleeding, genital itching
Maltese: Emboliżmu pulmonari, rinite allerġika, sogħla
English: The overall incidence of vaginal bleeding was low (≤ 2.6% in all treatment groups).
Maltese: L-inċidenza globali tal-ħruġ tad-demm mill-vaġina kienet baxxa (≤ 2.6% fil-gruppi kollha li ngħataw kura).
English: Significantly fewer women treated with FABLYN experienced moderate or severe vertebral fractures (as determined by the Genant scale) compared to women treated with placebo (5.2% placebo-treated women versus 3.3% FABLYN-treated women; p = 0.0006).
Maltese: Ammont inqas sewwa ta' nisa kkurati b'FABLYN esperjenzaw ksur vertebrali moderat jew sever (kif determinat mill-iskala Genant) meta pparagunat man-nisa li ġew ikkurati bil-plaċebo (5.2% tan-nisa kkurati bil-plaċebo kontra 3.3% tan-nisa kkurati b'FABLYN;
English: Bone histomorphometry
Maltese: Disturbi psikjatriċi