FrancophonIA/ELRC3.0 huggingface dataset:
English: In a population pharmacokinetic study, a 47 % decrease in lean body mass adjusted creatinine clearance resulted in a 17 % decrease in raloxifene clearance and a 15 % decrease in the clearance of raloxifene conjugates.
Maltese: Fi studju farmakokinetiku li sar fuq grupp ta' nies, tnaqqis ta' 47% fit-tneħħija tal-krejatinina, meta jitqies il-piż tal-ġisem mingħajr it-tessut xaħmi, irriżulta f'17% tnaqqis fit-tneħħija ta' raloxifene u 15% tnaqqis fit tneħħija tal-konjugi ta' raloxifene.
English: Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Maltese: Il-livelli ta' raloxifene jinżamm permezz tar-reċiklar enteroepatiku, li jirriżulta f'half-life fil-plażma ta' 27.7 sigħat.
English: In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/kg, and prostatic leiomyoblastoma in males given 210 mg/kg.
Maltese: Fi studju li sar fuq il-ġrieden dwar il- karċinoġeniċita`, li dam sejjer ta' 21 xahar, kien hemm żieda fl-inċidenza ta' tumuri taċ-ċelluli interstizjali tat-testikoli, adenomi tal-prostata u adenokarċinomi fl-annimali ta' sess maskil, meta ngħataw 41 jew 210 mg/kg,, u l-lejomajoblastoma tal-prostata fl-annimali ta' sess maskil li ngħataw 210 mg/kg.
English: The incidence of stroke mortality was 2.2 per 1,000 women per year for raloxifene versus 1.5 per 1,000 women per year for placebo (see section 4.4).
Maltese: L-inċidenza ta' mortalità minħabba attakk ta' puplesija kienet ta' 2.2 għal kull 1000 mara kull sena għal raloxifene kontra 1.5 għal kull 1000 mara kull sena għal plaċebo (ara sezzjoni 4.4).
English: Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in Optruma patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3 % Optruma and 18.2 % placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6 % for Optruma and 7.1 % placebo).
Maltese: Meta mqabbel mal-plaċebo, l-okkorrenza tal-vażodilatazzjoni (il-fwawar) kienet moderatament aktar komuni fil-pazjenti fuq Optruma (il-provi kliniċi għal-prevenzjoni ta' l-osteoporożi; minn 2 sa 8 snin wara l-menopawsa, 24.3% bl-Optruma u 18.2% bil-plaċebo, il-provi kliniċi għall-kura ta' losteoporożi, età medja ta' 66, 10.
English: Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8 % or 3.22 cases per 1,000 patient years.
Maltese: Tul il-provi kliniċi kollha ta' raloxifene fl-osteoporożi, ikkontrollati bl-użu tal-plaċebo, l-avvenimenti tromboembolitiċi fil-vini, inklużi t-trombożi tal-vini fondi, l-emboliżmu pulmonari u t-trombożi talvina tar-retina, okkorrew bi frekwenza ta' madwar 0.8% jew 3.22 każijiet għal kull 1,000 sena ta' l etajiet magħduda tal-pazjenti.
English: Over the 4 years of the osteoporosis treatment trial (involving 7,705 patients), Optruma treatment compared to placebo reduced the risk of total breast cancer by 62 % (RR 0.38; CI 0.21, 0.69), the risk of invasive breast cancer by 71 % (RR 0.29, CI 0.13, 0.58) and the risk of invasive oestrogen receptor (ER) positive breast cancer by 79 % (RR 0.21, CI 0.07, 0.50).
Maltese: Tul l-4 snin tal-prova rigward il-kura ta' l-osteoporożi (li nvolviet 7705 pazjenti), il-kura b'Optruma meta mqabbla mal-plaċebo naqqset ir-riskju totali ta' kanċer tas-sider b'62%, (RR 0.38, CI 0.21, 0.69) u r-riskju ta' kanċer mifrux tas-sider li jinfirex b'71% (RR 0.29, CI 0.13, 0.58) u r-riskju ta' kanċer tas-sider li jinfirex li hu pożittiv għar-riċettur ta' l-estroġenu (ER) b'79% (RR 0.21, CI 0.07, 0.50).
English: In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7 % of 581 Optruma treated patients and 11.1 % of 584 placebo-treated patients.
Maltese: F'pazjenti fejn Optruma intużat għall-prevenzjoni, kien hemm bżonn li titwaqqaf it-terapija minħabba xi reazzjoni avversa f'10.7% ta' 581 pazjenta fuq Optruma u 11.1% ta' 584 pazjenta fuq il-plaċebo.
English: Very common: Vasodilation (hot flushes) Uncommon: Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis, superficial vein thrombophlebitis, Arterial thromboembolic reactions a
Maltese: Komuni ħafna : Vażodilatazzjoni (fwawar) Mhux komuni : Avvenimenti tromboemboliċi fil-vini, inkluża t-trombożi tal-vini fondi,l-emboliżmu pulmonari, it-trombożi tal-vina tar-retina, it-tromboflebite tal-vini superfiċjali,
English: This increase was generally a 2 % increase in BMD compared to placebo.
Maltese: 2 % fil-BMD, komparata mal-plaċebo.
English: Frequently co-administered medicinal products included: paracetamol, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, ibuprofen, and naproxen), oral antibiotics, H1 antagonists, H2 antagonists, and benzodiazepines.
Maltese: is-sustanzi kontra l-infjammazzjoni li mhumiex sterojdi (bħal acethylsalicylic acid, ibuprofen u naproxen), l-antibijotiċi orali, l-antagonisti
English: In female mice, an increased incidence of ovarian tumours in animals given 9 to 242 mg/kg (0.3 to 32 times the AUC in humans) included benign and malignant tumours of granulosa/theca cell origin and benign tumours of epithelial cell origin.
Maltese: Fil-ġrieden ta' sess femminil, iż-żieda fl-inċidenza tat-tumuri tal-ovarji f'annimali li ngħataw 9 sa 242 mg/kg (0.3 sa 32 darba l-AUC filbniedem), kienet f'tumuri beninji u malinni ta' oriġini taċ-ċelluli tal-granuloża / tat-teka u tumuri beninji ta' oriġini taċ-ċelluli epitiljali.
English: Optruma belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
Maltese: Optruma tagħmel parti minn grupp ta' mediċini mhux ormonali msejħa Modulaturi Selettivi għarRiċetturi ta' l-Estroġenu (SERMs).
English: Optruma lowers total cholesterol and LDL ("bad") cholesterol.
Maltese: Optruma tbaxxilek il-livell totali tal-kolesterol u tal- kolesterol LDL (dak li hu ‘ħażin').
English: Laboratórios Vitória S.A. Tel: + 351- 21 4758300
Maltese: Tel: + 351- 21 4758300
English: Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Maltese: Kull pillola miksija b'rita fiha 60 mg raloxifene hydrochloride, ekwivalenti għal 56 mg ta' raloxifene bażi libera.
English: • If you have severe kidney problems.
Maltese: • Jekk għandek problemi serji fil-kliewi.
English: The clinically most important adverse reactions reported in postmenopausal women treated with Optruma were venous thromboembolic events (see section 4.4), which occurred in less than 1% of treated patients.
Maltese: Mil-lat kliniku, l-aktar reazzjonijiet avversi importanti li ġew irrapportati fin-nisa wara l-menopawża kkurati b'Optruma kienu avvenimenti tromboemboliċi tal-vini (ara sezzjoni 4.4), li seħħew f'inqas minn 1 % tal-pazjenti kkurati.
English: Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Maltese: Il-livelli tal-bilirubin fis-serum, gamma-glutamyl transferase, alkaline phosphatase, ALT u AST
English: Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (>5.6 mmol/l), raloxifene may be associated with a marked increase in serum triglycerides.
Maltese: Informazzjoni klinika limitata tissuġġerixxi, li f'pazjenti b'passat mediku ta' ipertrigliċeridimja (> 5.6 mmol/l), dovuti għall-estroġenu orali, raloxifene jista' jkun assoċjat ma' żieda qawwija fillivelli tat-trigliċeridi fis-serum.
English: Common side effects (affects 1 to 10 users in 100) are:
Maltese: Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 100) huma:
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/
English: The frequencies for postmarketing reports were calculated from placebo-controlled clinical trials (comprising a total of 15,234 patients, 7,601 on raloxifene 60 mg and 7,633 on placebo) in postmenopausal women with osteoporosis, or established coronary heart disease (CHD) or increased risk for CHD, without comparison to the frequencies of adverse events in the placebo assignment groups.
Maltese: Il-frekwenzi mir-rapporti wara li l-prodott tqiegħed fis-suq ġew ikkalkulati minn studji kliniċi kkontrollati bil-plaċebo (li kellhom total ta' 15,234 pazjent, 7601 fuq raloxifene 60 mg u 7633 fuq plaċebo) f'nisa wara l-menopawża b'osteoporożi li jew diġà kellhom mard koronarju tal-qalb (CHD) jew li kellhom żieda fir-riskju għal CHD, mingħajr ma tqabblu mal-frekwenzi ta' avvenimenti avversi fil-gruppi li ġew mogħtija plaċebo.
English: Common: Rash a
Maltese: Komuni: Raxxa
English: In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9 % compared to 0.3 % in women who received placebo treatment.
Maltese: Fin-nisa wara l menopawsa li ngħataw kura b'raloxifene għal 4 snin, il-qarnit beninju ta' l-endometriju kien irrapportat f'0.9% meta mqabbel ma' 0.3% fin-nisa li rċevew trattament bil-plaċebo.
English: Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00
Maltese: Tlf: + 47 22 88 18 00
English: Lot {number}
Maltese: OĦRA TAL
English: In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8 % of 2,557 Optruma treated patients and 11.1 % of 2,576 placebo treated patients.
Maltese: F'dawk il-pazjenti li kienu qegħdin jieħdu Optruma bħala kura, kien hemm bżonn li titwaqqaf it terapija minħabba kwalunkwe avveniment kliniku avvers, f'12.8% ta' 2,557 pazjenta li kienu ittrattati b'Optruma u 11.1% ta' 2,576 pazjenta ittrattati bil-plaċebo.
English: In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8 % in the raloxifene-treated patients and 4.7 % in the placebo-treated patients.
Maltese: Fi studju ta' 10,101 mara wara l-menopawża u li huwa dokumentat li għandhom mard tal-qalb koronarju jew li qegħdin f'riskju ogħla li jkollhom xi problemi koronarji (RUTH), l-okkorrenza talvażodilatazzjoni (il-fwawar) kienet ta' 7.8% f'pazjenti kkurati b'raloxifene u ta' 4.7% f'pazjenti kkurati bi plaċebo.
English: DD month YYYY
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: 14 film coated tablets 28 film coated tablets 84 film coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 84 pillola miksija b'rita
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, ta' difett filLapp lactase jew ta' nuqqas fl-assorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Maltese: L-espożizzjoni sistemika (AUC) ta' raloxifene f'dan il-grupp kien bejn wieħed u ieħor 400 darba akbar minn dik li tintlaħaq fin-nisa ta' wara l-menopawsa li jieħdu doża ta' 60 mg.
English: The increase correlated with total bilirubin concentrations.
Maltese: Din iż-żieda kienet korrelata mal-livelli totali tal-konċentrazzjoni tal-bilirubin.
English: The table below gives the adverse reactions and frequencies observed in treatment and prevention studies involving over 13,000 postmenopausal women along with adverse reactions arising from postmarketing reports.
Maltese: It-tabella aktar 'l isfel turi r-reazzjonijiet avversi u l-frekwenzi li ġew osservati f'studji ta' kura u prevenzjoni li involvew 'l fuq minn 13,000 mara wara l-menopawża flimkien mar-reazzjonijiet avversi li dehru f'rapporti wara li l-prodott tqiegħed fis-suq.
English: In clinical trials, Optruma did not stimulate the postmenopausal uterine endometrium.
Maltese: Fi provi kliniċi, Optruma ma stimulatx l-endometriju ta' l-utru fil-perijodu ta' wara l-menopawsa.
English: Eli Lilly Nederland B.V. Papendorpseweg 83
Maltese: Eli Lilly Nederland B.V. Papendorpseweg 83 3528 BJ Utrecht L-Olanda
English: Raloxifene comprises less than 1 % of the combined concentrations of raloxifene and the glucuronide metabolites.
Maltese: Raloxifene jagħmel inqas minn 1% tal-konċentrazzjonijiet ta' raloxifene u l-metaboli glukuronidi flimkien.
English: In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/kg).
Maltese: Fil-firien kien hemm ittardjar ta' l-iżvilupp tal-fetu, kustilji mgħawwġa u kavitajiet filkliewi (≥ 1 mg/kg).
English: Optruma are white, oval, film coated tablets which are marked with the number 4165.
Maltese: Optruma huma pilloli bojod, ovali, miksija b'rita u li għandhom in-numru 4165 stampat fuqhom.
English: Povidone
Maltese: Pożoloġija
English: Magnesium stearate
Maltese: Kif gћandek tieћu Optruma
English: In the RUTH study, leg cramps were observed in 12.1 % of raloxifene-treated patients and 8.3 % of placebo-treated patients.
Maltese: Fl-istudju kliniku RUTH, il-bugħawwiġijiet fir-riġlejn kienu osservati f'12.1% ta' pazjenti kkurati b'raloxifene u f'8.3% ta' pazjenti kkurati bi plaċebo.
English: Bottles contain 100 tablets.
Maltese: Il-fliexken huma ta' 100 pillola.
English: Uncommon: Fatal strokes
Maltese: Komuni: Bugħawwiġijiet tar-riġlejn
English: No other metabolites have been detected.
Maltese: Ma nstabux metaboli oħra.
English: In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3 % of patients treated with raloxifene and 2.6 % of patients treated with placebo.
Maltese: Fi studju kliniku (RUTH) ta' nisa wara l-menopawża u li huwa dokumentat li jbatu minn mard tal-qalb koronarju jew li qegħdin f'riskju ogħla li jkollhom xi problemi koronarji, reazzjoni avversa addizzjonali ta' kolelitjażi seħħet f'3.3% ta' pazjenti kkurati b'raloxifene u f'2.6% ta' pazjenti kkurati bi plaċebo.
English: Optruma therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Maltese: It-terapija b'Optruma għal 8 snin ma effetwatx b'mod sinifikanti r-riskju ta' avvenimenti kardjovaskulari f'pazjenti involuti fl-istudju dwar il-kura ta' l-osteoporożi.
English: Optruma contains lactose
Maltese: Optruma fiha l-lactose
English: Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Maltese: Kważi 3,000 eżami transvaġinali li saru bl-ultrasawnd (TVU) fuq 831 pazjenta,
English: The Cmax of digoxin increased by less than 5 %.
Maltese: Is-Cmax ta' digoxin żdiedet b'inqas minn 5%.
English: The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Maltese: L-effetti riproduttivi u dawk fuq l-iżvilupp, osservati fl-annimali, huma konsistenti mal-profil farmakoloġiku magħruf ta' raloxifene.
English: Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Maltese: Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10
English: This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1 % for Optruma and 1.9 % for placebo; and in the treatment population occurred at an incidence of 7.1 % for Optruma and 6.1 % for placebo.
Maltese: Din kienet l-edema periferali li okkorriet fil-grupp ta' prevenzjoni b'inċidenza ta' 3.1% għal Optruma u 1.8% għall-plaċebo; u fil-grupp ta' trattament l-inċidenza kienet ta' 7.1% għall-Optruma u 6.1% għall-plaċebo.
English: During an average follow-up of 5.6 years, 59 (1.2%) raloxifene-treated women died due to a stroke compared to 39 (0.8%) placebo-treated women.
Maltese: Meta reġgħu ġew eżaminati wara medja ta' 5.6 snin, 59 (1.2 %) mara kkurati b'raloxifene mietu minħabba attakk ta' puplesija meta mqabbla mad-39 (0.8 %) mara li mietu u li kienu kkurati bi plaċebo.
English: c) Effects on the endometrium and on the pelvic floor
Maltese: c) Effetti fuq l-endometriju u l-qiegħ tal-pelvis
English: Uncommon side effects (affects 1 to 10 users in 1000) are:
Maltese: Effetti sekondarji mhux komuni ( jaffettwaw minn 1 sa 10 pazjenti minn kull 1000) huma:
English: Esteve Pharmaceuticals, S.A. Tel: + 34-93 446 60 00
Maltese: Tel: + 34-93 446 60 00
English: Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Maltese: Passat mediku jew kundizzjoni preżenti ta' avvenimenti tromboemboliċi fil-vini (VTE), li jinkludu ttrombożi tal-vini fondi, emoboliżmu pulmonari u trombożi tal-vina tar-retina.
English: Endometrial biopsies taken after six months therapy with Optruma 60 mg daily demonstrated nonproliferative endometrium in all patients.
Maltese: Bijopsiji ta' l-endometriju meħudin wara terapija ta' 60 mg ta' Optruma kuljum għal sitt xhur, urew endometriju mhux proliferattiv fil-pazjenti kollha.
English: B. PACKAGE LEAFLET
Maltese: FOLJA (PAKKETTI KOLLHA
English: In the RUTH study, peripheral oedema occurred in 14.1 % of the raloxifene-treated patients and 11.7 % of the placebo-treated patients, which was statistically significant.
Maltese: Fl-istudju kliniku RUTH, l-edema periferali okkorriet f'14.1% ta' pazjenti kkurati b'raloxifene u fi
English: Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene.
Maltese: Kull pillola miksija b'rita għandha 60 mg ta' raloxifene hydrochloride, li huwa ekwivalenti għal 56 mg ta' raloxifene.
English: Other medicines and Optruma
Maltese: Mediċini oħra u Optruma
English: When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Maltese: Meta wieħed jagħżel bejn Optruma u terapiji oħra, inkluż l-estroġenu, għal mara li qiegħda fil menopawsa, fuq bażi individwali jridu jitqiesu s-sintomi tal-menopawsa, l-effetti fuq it-tessuti ta' lutru u s-sider, ir-riskji u l-benefiċji kardjovaskulari (ara sezzjoni 5.1).
English: Superficial vein thrombophlebitis occurred in a frequency of less than 1 %.
Maltese: It-tromboflebite tal-vini superfiċjali okkorriet bi frekwenza ta' inqas minn 1%.
English: In children, symptoms of accidental overdose included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
Maltese: Is-sintomi fit-tfal li bi żball ħadu doża eċċessiva jinkludu ataksja, sturdament, rimettar, raxx, dijarrea, tregħid u ħmura fil-wiċċ u żieda f'alkaline phosphatase.
English: In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0 % or 3.88 cases per 1,000 patient-years in the raloxifene group and 1.4 % or 2.70 cases per 1,000 patient-years in the placebo group.
Maltese: Fl-istudju kliniku RUTH, l-avvenimenti tromboembolitiċi fil-vini okkorrew bi frekwenza ta' madwar 2.0% jew 3.88 każijiet għal kull 1,000 sena ta' l-etajiet magħduda tal-pazjenti fil-grupp ta' raloxifene u
English: In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37 % decreased and 63 % increased; and for the total hip 29 % decreased and 71 % increased.
Maltese: żieda; u għall-għadam sħiħ tal-ġenbejn 29% tnaqqis u 71% żieda.
English: EXPIRY DATE
Maltese: ANNESS II
English: EXP {MM/YYYY}
Maltese: Icepharma hf.
English: Pharmacotherapeutic group: Selective Oestrogen Receptor Modulator, ATC code: G03XC01.
Maltese: calcium fl-awrina. iv) Ħistomorfometrija (il-kwalità ta' l-għadam).
English: How Optruma works
Maltese: Tieħux Optruma:
English: A. Menarini
Maltese: Anzjani:
English: Optruma 60 mg film coated tablets
Maltese: Optruma 60 mg pilloli miksija b'rita
English: There is no specific antidote for raloxifene hydrochloride.
Maltese: M'hemmx antidot speċifiku għal raloxifene hydrochloride.
English: Results from single oral doses of raloxifene predict multiple dose pharmacokinetics.
Maltese: Ir-riżultati minn dożi singoli orali ta' raloxifene jintużaw biex jitbassar il-komportament farmakokinetiku ta' dożi multipli.
English: In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Maltese: Fl-adulti, sintomi ta' bugħawwiġijiet fir-riġlejn u sturdament ġew irrapportati f'pazjenti li f'doża orali waħda ħadu iżjed minn 120mg.
English: One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
Maltese: Bidla oħra kienet innotata, li ma kenitx statistikament sinifikanti (p > 0.05), iżda li wriet inċidenza sinifikanti relatata mad-doża.
English: Other risk factors which may lead to the development of osteoporosis include early menopause; osteopenia (at least 1 SD below peak bone mass); thin body build; Caucasian or Asian ethnic origin; and a family history of osteoporosis.
Maltese: Fatturi oħra ta' riskju li jistgħu jwasslu għall-iżvilupp ta' l-osteoporożi jinkludu l-menopawsa minn kmieni, l-ostejopenja (mhux anqas minn 1 SD 'l isfel mill-ogħla massa ta' l-għadam); statura rqiqa tal-ġisem, oriġini etnika Kawkasja jew Asjatika, u passat mediku fil-familja ta' osteoporożi.
English: Raloxifene is distributed extensively in the body.
Maltese: Raloxifene jinfirex estensivament fil-ġisem.
English: Tablet coating:
Maltese: Indeboliment epatiku:
English: Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin
Maltese: Raloxifene jżid moderatament il-konċentrazzjonijiet tal-globulini li jaqbdu ma' l-ormoni, inklużi l glubulini li jaqbdu ma' l-ormoni sesswali sterojdi (SHBG), il-globulina li taqbad ma' l-ormon thyroxine (TBG) u l-globulina li taqbad mal-kortikosterojdi (CBG), b'żidiet korrispondenti filkonċentrazzjonijiet totali ta' l-ormoni.
English: Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
Maltese: RUTH, raloxifene meta mqabbel ma' plaċebo, ma effettwax l-inċidenza ta' attakki ta' qalb, ta' bżonn li wieħed jidħol l-isptar minħabba sindromu koronarju akut, ta' attakk ta' puplesija, jew ta'mortalità in ġenerali inkluż l-imwiet kardjovaskulari kollu, (għaż-żieda fir-riskju ta' puplesija fatali ara sezzjoni
English: Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy.
Maltese: Raloxifene huwa assoċjat ma' riskju miżjud ta' avvenimenti tromboembolitiċi fil-vini, li huwa simili għal dak irrappurtat li hu assoċjat ma' l-użu kurrenti tat-terapija bl-ormoni, bħala sostitut.
English: b. Tabulated summary of adverse reactions
Maltese: Sommarju f'forma tabulari tar-reazzjonijiet avversi
English: Optruma reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
Maltese: Optruma tnaqqas ir-riskju ta' ksur tal-vertebri fin-nisa bl-osteoporożi wara l-menopawsa.
English: • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
Maltese: • Sintomi gastro-intestinali bħal tqalligħ, rimettar, uġigħ addominali u stonku mqalleb