FrancophonIA/ELRC3.0 huggingface dataset:
English: Ospemifene-related changes included ovarian follicular cysts, endometrial stromal atrophy and endometrial hypertrophy/hyperplasia which are consistent with the pharmacologic activity of ospemifene in the intact, normally cycling animal.
Maltese: Tibdil relatat ma' ospemifene kien jinkludi ċisti follikulari tal-ovarji, atrofija stromali endometrijali u ipertrofija/iperplasija endometrijali li huma konsistenti mal-attività farmakoloġika ta' ospemifene fl-annimal intatt, normalment ċiklat.
English: Systemic exposure (AUC) at these doses was 2.1-, 4.0- and 4.7-times the AUC in postmenopausal woman administered 60 mg/day.
Maltese: L-esponiment sistemiku (AUC) f'dawn id-dożi kien ta' 2.1, 4.0 u 4.7 darbiet aktar mill-AUC f'nisa li diġà għaddew millmenopawsa li ngħataw 60 mg/jum.
English: Therefore, co-administration of ospemifene with strong enzyme inducers like carbamazepine, phenytoin, St John's wort and rifabutin would be expected to decrease the exposure of ospemifene, which may decrease the clinical effect.
Maltese: Għalhekk, l-għoti flimkien ta' ospemifene ma' indutturi qawwija tal-enzimi bħal carbamazepine, phenytoin, St.John's Wort u rifabutin, se jkunu mistennija li jnaqqsu l-esponiment ta' ospemifene, li jista' jnaqqas l-effett kliniku.
English: The major metabolite, 4-hydroxyospemifene, was seen to undergo formation rate-limited elimination (with t1/2 similar to the parent compound) in a human mass balance study.
Maltese: Il-metabolit maġġuri, 4-hydroxyospemifene, ġie osservat li jgħaddi minn eliminazzjoni limitata mir-rata ta' formazzjoni (b't1/2 simili għall-kompost ġenitur) fi studju dwar il-bilanċ tal-piż tal-bniedem.
English: Ospemifene and 4-hydroxyospemifene accounted for approximately 20% and 14% of the total radioactivity in serum, respectively.
Maltese: Ospemifene u 4-hydroxyospemifene ammontaw għal madwar 20% u 14% tar-radjuattività totali fis-serum, rispettivament.
English: Paediatric population Pharmacokinetic studies have not been performed with ospemifene in the paediatric population.
Maltese: Ma sarux studji farmakokinetiċi b'ospemifene fil-popolazzjoni pedjatrika.
English: Ospemifene is not indicated for fertile women.
Maltese: Ospemifene mhuwiex indikat għal nisa fertili.
English: In patients with moderate hepatic impairment the exposure of ospemifene and 4-hydroxyospemifene was approximately 30% and 70% higher.
Maltese: F'pazjenti b'indeboliment moderat tal-fwied, l-esponiment ta' ospemifene u 4-hydroxyospemifene kien madwar 30% u 70% ogħla.
English: In two separate 12 week pivotal trials (trials 1 and 2), ospemifene was associated with a statistically significant mean decrease from baseline in the percentage of parabasal cells and vaginal pH and a statistically significant mean increase from baseline in the percentage of superficial cells, compared with placebo (P<0.001 for each parameter) at weeks 4 and 12.
Maltese: F'żewġ provi separati importanti ħafna li damu 12-il ġimgħa (provi 1 u 2), ospemifene ġie assoċjat ma' tnaqqis medju statistikament sinifikanti mil-linja bażi fil-perċentwali ta' ċelluli parabażali u pH vaġinali, u żieda medja statistikament sinifikanti mil-linja bażi fil-perċentwali ta' ċelluli superfiċjali, meta mqabbla ma' plaċebo (P<0.
English: Ketoconazole, a strong CYP3A4 inhibitor and moderate P-glycoprotein inhibitor, increased the AUC of ospemifene by 1.4-fold.
Maltese: Ketoconazole, inibitur qawwi ta' CYP3A4 u inibitur moderat ta' P-glikoproterina, żied l-AUC ta' ospemifene b'1.4 drabi.
English: Across all placebo controlled clinical trials, there was no significant difference in breast related adverse events between ospemifene and placebo.
Maltese: Tul il-provi kliniċi kollha kkontrollati bil-plaċebo, ma kien hemm ebda differenza sinifikanti f'avvenimenti avversi relatati mas-sider bejn ospemifene u plaċebo.
English: Relief
Maltese: Solliev
English: Tel +44 (0)20 3053 4190 contact@shionogi.eu
Maltese: 3053 4190 contact@shionogi.eu
English: Suspected or active sex-hormone dependent malignancy (e.g. endometrial cancer).
Maltese: Tumur malinn issuspettat jew attiv dipendenti mill-ormoni tas-sess (eż. kanċer endometrijali).
English: Senshio contains sodium
Maltese: Senshio fih is-sodium
English: Oxaliplatin, an anti-cancer medicine for advanced (metastatic) cancer of the large bowel (colon) or back passage (rectum).
Maltese: o Oxaliplatin, mediċina kontra l-kanċer għal kanċer (metastatiku) avvanzat tal-musrana lkbira (il-kolon) jew tal-warrani (ir-rektum).
English: In the mammary gland, they have a predominantly oestrogen antagonist effect.
Maltese: Filglandola mammarja, għandhom predominantament effett antagonista fuq l-estroġenu.
English: Interaction studies were performed with probe substrates for CYP2C9 (warfarin), CYP3A4 (midazolam), CYP2C19, and CYP3A4 (omeprazole) and CYP2B6 (bupropion).
Maltese: Studji dwar interazzjonijiet twettqu b'substrati probe għal CYP2C9 (warfarin), CYP3A4
English: The most bothersome symptom (MBS) was assessed at baseline, 4 and 12 weeks with the severity scored as follows: None=0, Mild=1, Moderate=2, Severe=3.
Maltese: Xejn=0, Ħafifa=1, Moderata=2, Severa=3.
English: The risk of cerebrovascular events is possibly increased with other SERMs.
Maltese: Ir-riskju ta' avvenimenti ċerebrovaskulari possibbilment jiżdied b'SERMs oħrajn.
English: In case of impaired tolerance of ospemifene, the latter should be stopped as long as treatment with fluconazole lasts.
Maltese: F'każ ta' indeboliment fittolleranza ta' ospemifene, dan għandu jitwaqqaf sakemm idum it-trattament bi fluconazole.
English: The pharmacokinetics of ospemifene has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class score >9).
Maltese: Ilfarmakokinetika ta' ospemifene ma ġietx evalwata f'pazjenti b'indeboliment sever tal-fwied (punteġġ tal-Klassi Child-Pugh ta' >9).
English: PVC/PVdC-Aluminium blister.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folja tal-PVC/PVdC-Aluminju.
English: In vitro, ospemifene and 4-hydroxyospemifene did not inhibit or induce the activity of CYP450 enzymes at clinically relevant concentrations.
Maltese: In vitro, ospemifene u 4-hydroxyospemifene ma inibixxewx jew induċew l-attività tal-enzimi CYP450 f'konċentrazzjonijiet klinikament rilevanti.
English: Table 1: Primary efficacy analysis - change from baseline to week 12 in most bothersome symptom (ITT, LOCF)
Maltese: Tabella 1: Analiżi tal-effikaċja primarja - bidla mil-linja bażi sa ġimgħa 12 fl-iktar sintomu ta' dwejjaq (ITT, LOCF)
English: In post-menopausal women who received ospemifene treatment up to 1 year, benign endometrial polyps were reported in 0.4% compared to 0.2% in women who received placebo treatment.
Maltese: F'nisa li diġà għaddew mill-menopawsa li rċivew trattament b'ospemifene għal sa sena, polipi endometrijali beninni ġew irrappurtati f'0.4% meta mqabbla ma' 0.2% f'nisa li rċivew trattament bi plaċebo.
English: The absolute bioavailability of ospemifene has not been established.
Maltese: Il-bijodisponibilità assoluta ta' ospemifene ma ġietx stabbilita.
English: Of the 426 subjects enrolled in the study, 363 (85.2%) subjects were randomised to once-daily oral doses of ospemifene 60 mg and 63 (14.8%) subjects were randomised to placebo.
Maltese: 2%) tal-individwi intgħażlu b'mod każwali biex jieħdu dożi orali ta' ospemifene 60 mg darba kuljum u 63 (14.8%) talindividwi ntgħażlu b'mod każwali għal plaċebo.
English: The risk of VTE is temporarily increased with prolonged immobilisation, major trauma or major surgery.
Maltese: Ir-riskju ta' VTE jiżdied temporanjament b'immobilizzazzjoni fit-tul, trawma serja jew operazzjoni serja.
English: The clinical efficacy and safety of ospemifene was determined primarily from two multi-centre, placebo-controlled trials of 12 weeks duration (trials 1 and 2) and a third long-term safety trial of 52 weeks duration (trial 3) in post-menopausal patients with VVA.
Maltese: L-effikaċja u s-sigurtà klinika ta' ospemifene ġew determinati primarjament minn żewġ studji multiċentriċi, ikkontrollati bi plaċebo, li damu 12-il ġimgħa (provi 1 u 2) u t-tielet prova dwar sigurtà fit-tul li damet 52 ġimgħa (prova 3) f'pazjenti li diġà għaddew mill-menopawsa b'VVA.
English: Senshio tablets are oval biconvex, white to off-white, film-coated tablets (approximately 12 mm long by 6.45 mm wide) debossed with “60” on one side.
Maltese: Il-pilloli Senshio huma pilloli miksija b'rita, ovali, bikonvessi, ta' kulur abjad sa abjad jagħti fil-griż, (bejn wieħed u ieħor 12 mm twal b'6.45 mm wiesgħa) imnaqqxin b'“60” fuq naħa waħda.
English: The glycogen content of vaginal epithelial cells also decreases, resulting in reduced colonisation by lactobacilli and increased vaginal pH.
Maltese: Il-kontenut ta' glycogen ta' ċelluli epiteljali vaġinali jonqos ukoll, u dan jirriżulta fi tnaqqis fil-kolonizzazzjoni minn lactobacilli u żieda fil-pH vaġinali.
English: Therefore, caution is recommended when ospemifene is combined with orlistat.
Maltese: Għalhekk, il-kawtela hi rakkomandata meta ospemifene jiġi kombinat ma' orlistat.
English: Senshio contains lactose
Maltese: Senshio fih il-lactose
English: Following a single oral administration of 60 mg ospemifene in the fed state, 17.9%, 10.0% and 1.4% of the administered dose was excreted in faeces as ospemifene, 4hydroxyospemifene and 4'-hydroxyospemifene, respectively.
Maltese: 0% u 1.4% tad-doża ġew eliminati fl-ippurgar bħala ospemifene, 4-hydroxyospemifene u 4'hydroxyospemifene, rispettivament.
English: Each film-coated tablet contains 60 mg ospemifene.
Maltese: Kull pillola miksija b'rita fiha 60 mg ta' ospemifene.
English: 7 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 7 pilloli miksija b'rita
English: Patients with suspected breast cancer or patients undergoing active treatment (including adjuvant therapy) for breast cancer (see section 4.4).
Maltese: Pazjenti b'kanċer tas-sider issuspettat jew pazjenti li jkun għaddejjin minn trattament attiv (inkluż terapija adjuvanti) għal kanċer tas-sider (ara sezzjoni 4.4).
English: Other medicines and Senshio
Maltese: INFORMAZZJONI BIL-BRAILLE Senshio
English: Oval biconvex, white to off-white, film-coated tablets of dimensions 12 mm x 6.45 mm, debossed with “60” on one side.
Maltese: Pilloli miksija b'rita, ovali, bikonvessi, ta' kulur abjad sa abjad jagħti fil-griż b'qisien ta' 12 mm x 6.45 mm, imnaqqxin b'“60” fuq naħa waħda.
English: The reproductive effects observed are considered to be related to oestrogen receptor activity of ospemifene.
Maltese: L-effetti riproduttivi osservati huma kkunsidrati li huma relatati ma' attività tar-riċettur tal-estroġenu ta' ospemifene.
English: In the F0 maternal generation, a significant prolonged gestation was observed.
Maltese: Fil-ġenerazzjoni materna F0, ġiet osservata ġestazzjoni mtawla b'mod sinifikanti.
English: - If you experience signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, difficulty in breathing or a stroke while taking Senshio, stop taking Senshio and see a doctor immediately.
Maltese: - Jekk ikollok sinjali ta' emboli tad-demm magħqud, bħal nefħa bl-uġigħ u ħmura fir-riġlejn, uġigħ fis-sider li jiġi f'daqqa, diffikultà biex tieħu n-nifs jew aċċessjoni waqt li tkun qed tieħu Senshio, għandek tieqaf tieħu Senshio u tara tabib immedjatament.
English: There was a single subject (0.3%) who developed endometrial hyperplasia in the ospemifene group (simple hyperplasia without atypia) 88 days after the last dose of study drug.
Maltese: Kien hemm mara waħda (0.3%) li żviluppat iperplasija endometrijali fil-grupp ta' ospemifene (iperplasija sempliċi mingħajr atipija) 88 jum wara l-aħħar doża tal-mediċina tal-istudju.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-fojl wara “EXP”.
English: The risk of VTE associated with ospemifene cannot be excluded.
Maltese: Ir-riskju ta' VTE assoċjat ma' ospemifene ma jistax jiġi eskluż.
English: Following oral administration of [3-H]-ospemifene in the fasted state, approximately 75% and 7% of the dose was excreted in faeces and urine respectively.
Maltese: Wara l-għoti orali ta' [3-H]-ospemifene fl-istat sajjem, madwar 75% u 7% tad-doża tneħħiet fl-ippurgar u fl-awrina, rispettivament.
English: In the uterus ospemifene and its major metabolite have weak partial agonist/antagonist effects.
Maltese: Fl-utru, ospemifene u l-metabolit maġġuri tiegħu għandhom effetti agonisti/antagonisti dgħajfa parzjali.
English: Fluconazole, a moderate CYP3A / moderate CYP2C9 / strong CYP2C19 inhibitor, increased the AUC of ospemifene by 2.7-fold.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effetti ta' prodotti mediċinali oħrajn fuq ospemifene Fluconazole, inibitur moderat ta' CYP3A/moderat ta' CYP2C9 moderata/qawwi ta' CYP2C19, żied lAUC ta' ospemifene bi 2.7 darbiet.
English: There were four co-primary endpoints for which change from baseline was assessed: percentage parabasal cells and superficial cells in the vaginal smear, vaginal pH, and MBS of VVA (dryness or dyspareunia).
Maltese: Kien hemm erba' punti aħħarin primarji li għalihom il-bidla mil-linja bażi ġiet evalwata: perċentwali ta' ċelluli parabażali u ta' ċelluli superfiċjali fis-smear vaġinali, pH vaġinali, u MBS ta' VVA (nixfa jew uġigħ waqt l-att sesswali).
English: In vitro, ospemifene and 4-hydroxyospemifene inhibited glucuronidation via UGT1A3 and UGT1A9 at clinically relevant concentrations.
Maltese: In vitro, ospemifene u 4-hydroxyospemifene inibixxew ilglukuronidazzjoni permezz ta' UGT1A3 u UGT1A9 f'konċentrazzjonijiet klinikament rilevanti.
English: Risk management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: These changes in pharmacokinetics of ospemifene by moderate hepatic impairment are not considered to be clinically significant in consideration of inherent pharmacokinetic variability of ospemifene.
Maltese: Din iż-żieda mhijiex ikkunsidrata li hi klinikament sinifikanti minħabba lvarjabilità farmakokinetika inerenti ta' ospemifene.
English: This is known as vulvar and vaginal atrophy.
Maltese: Dan hu magħruf bħala atrofija vulvari u vaġinali.
English: No clinically important pharmacokinetic differences between subjects with severe renal impairment and healthy subjects were observed.
Maltese: Ma ġew osservati l-ebda differenzi farmakokinetiċi klinikament importanti bejn individwi b'indeboliment sever tal-kliewi u individwi b'saħħithom.
English: Ospemifene belongs to a group of medicines that do not contain hormones called Selective Estrogen Receptor Modulators (SERMs).
Maltese: Ospemifene jappartjeni għal grupp ta' mediċini li ma fihomx ormoni msejħa Modulaturi tar-Riċetturi Selettivi tal-Estroġenu (SERMs).
English: Dryness
Maltese: FARMAĊEWTIKU
English: Senshio contains lactose.
Maltese: Senshio fih il-lactose.
English: The risk of cerebrovascular events associated with ospemifene cannot be excluded.
Maltese: Ir-riskju ta' avvenimenti ċerebrovaskulari assoċjati ma' ospemifene ma jistax jiġi eskluż.
English: They are packed in blisters and are available in pack sizes of 7, 28 or 84 film-coated tablets.
Maltese: Huma ppakkjati f'folji u huma disponibbli f'daqsijiet tal-pakkett ta' 7, 28 jew 84 pillola miksija b'rita.
English: Coadministration of ospemifene with strong/moderate CYP3A4 inhibitors should be avoided in patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates.
Maltese: L-għoti ta' ospemifene flimkien ma' inibituri qawwija/moderati ta' CYP3A4 għandu jiġi evitat f'pazjenti li huma magħrufa, jew issuspettati li huma metabolizzaturi dgħajfin ta' CYP2C9, ibbażat fuq genotyping jew storja medika/esperjenza preċedenti b'substrati oħrajn ta' CYP2C9.
English: Common side effects (may affect up to 1 in 10 people): - An infection of the genitals caused by a fungus (thrush) - Hot flushes - Muscle cramps - Vaginal or genital discharge - Rash
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni): - Infezzjoni tal-partijiet ġenitali kkawżata minn fungu (tbajja' bojod).
English: If necessary, because of impaired tolerance, ospemifene should be stopped as long as treatment with fluconazole lasts.
Maltese: Jekk ikun meħtieġ, minħabba indeboliment fit-tolleranza, ospemifene għandu jitwaqqaf sakemm idum it-trattament bi fluconazole.
English: Shionogi Srl
Maltese: FIS-SUQ Shionogi
English: Less than 0.2% of the ospemifene dose was excreted unchanged in urine.
Maltese: Inqas minn 0.2% tad-doża ta' ospemifene tneħħiet mhux mibdula fl-awrina.
English: Non-interventional post-authorisation safety study (PASS): An observational retrospective cohort study of ospemifene to assess the incidence of venous thromboembolism and other safety concerns as agreed in the risk management plan, in VVA patients treated with ospemifene compared to 1) patients newly prescribed SERMs for oestrogen-deficiency conditions or breast cancer prevention, and 2) the incidence in untreated VVA patients.
Maltese: Studju retrospettiv osservazzjonali dwar koorti ta' ospemifene biex jevalwa linċidenza ta' tromboemboliżmu fil-vini u problemi oħrajn tas-sigurtà kif maqbul fil-pjan ta' ġestjoni tar-riskju, f'pazjenti b'VVA ttrattati b'ospemifene meta mqabbla ma' 1) pazjenti li ngħataw għall-ewwel darba SERMs għal kundizzjonijiet ta' defiċjenza ta' estroġenu jew prevenzjoni ta' kanċer tas-sider, u 2) l-inċidenza f'pazjenti VVA mhux ittrattati.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: Senshio is used to treat women with moderate to severe post-menopausal symptoms in and outside the vagina, such as itching, dryness, burning and pain during sex (dyspareunia) if local oestrogen therapy is not suitable.
Maltese: Senshio jintuża għal trattament ta' nisa b'sintomi moderati sa severi ġewwa u barra l-vaġina ta' wara l-menopawsa, bħal ħakk, nixfa, ħruq u wġigħ waqt attività sesswali (uġigħ waqt l-att sesswali) jekk terapija lokali bl-estroġeni ma tkunx adattata.
English: Due to its lipophilic nature and absorption characteristics, an interaction between ospemifene and medicinal products like orlistat, cannot be ruled out.
Maltese: Minħabba n-natura lipofilika tiegħu u l-karatteristiċi tal-assorbiment, interazzjoni bejn ospemifene u prodotti mediċinali bħal orlistat, ma tistax tiġi eskluża.
English: Renal impairment
Maltese: Fwawar jaħarqu
English: In the adrenal gland, there was an increased incidence of adrenal subcapsular cell and adrenal cortical tumours in animals dosed at high dose.
Maltese: Fil-glandola adrenali, kien hemm żieda fl-inċidenza ta' ċelluli subkapsulari adrenali u tumuri kortikali adrenali f'annimali li ngħataw doża għolja.
English: Your doctor may recommend that you stop treatment at least 4 to 6 weeks prior to major surgery or during a long period of bed rest e.g. injury or illness.
Maltese: It-tabib tiegħek jista' jirrakkomanda li inti twaqqaf it-trattament għal mill-inqas 4 sa 6 ġimgħat qabel operazzjoni maġġuri, jew matul perjodu twil ta' serħan fissodda, eż. korriment jew mard.
English: Co-administration with fluconazole
Maltese: L-għoti flimkien ma' fluconazole
English: Ospemifene should be discontinued at least 4 to 6 weeks prior to and during prolonged immobilisation (e.g., post-surgical recovery, prolonged bed rest).
Maltese: Ospemifene għandu jitwaqqaf mill-inqas 4 sa 6 ġimgħat qabel u waqt immobilizzazzjoni fit-tul (eż,
English: Ospemifene (OSP) improved post-menopausal physiologic changes.
Maltese: Ospemifene (OSP) tejjeb it-tibdil fiżjoloġiku wara l-menopawsa.
English: In repeat dose toxicity studies in mouse, rat, dog and the cynomolgus monkey main target organs of toxicity were the ovary, uterus and the liver.
Maltese: Fi studji dwar tossiċità kkawżata minn dożi ripetuti fil-ġrieden, firien, klieb u xadini cynomolgus, lorgani prinċipali fil-mira tat-tossiċità kienu l-ovarji, l-utru u l-fwied.
English: There is no specific antidote for ospemifene.
Maltese: M'hemm l-ebda antidot speċifiku għal ospemifene.
English: Percentage of patients with improvement, relief or substantial improvement of MBS after 12 weeks on ospemifene vs. placebo (ITT, LOCF)
Maltese: Perċentwali ta' pazjenti b'titjib, solliev jew titjib sostanzjali ta' MBS wara 12-il ġimgħa fuq ospemifene vs plaċebo (ITT, LOCF)
English: In clinical studies, a mean increase of 0.8 mm in endometrial thickness after 12 months (as assessed by protocol-specified ultrasonography) was observed and there was no increase in vaginal bleeding or spotting in the ospemifene-treated group compared to the placebo-treated group.
Maltese: Fi studji kliniċi, ġiet osservata żieda medja ta' 0.8 mm fil-ħxuna endometrijali wara 12-il xahar (kif evalwat minn ultrasonografija speċifikata mill-protokoll) u ma kien hemm l-ebda żieda fil-ħruġ ta' demm vaġinali jew spotting fil-grupp ittrattat b'ospemifene meta mqabbel mal-grupp ittrattat bilplaċebo.
English: Hot flushes
Maltese: Spażmi tal-muskoli
English: - If you have excessive thickening of the womb lining such as endometrial hyperplasia.
Maltese: - Jekk għandek ħxuna eċċessiva tar-rita tal-utru, bħal iperplasija endometrijali.
English: If VTE develops after initiating therapy, the treatment should be discontinued.
Maltese: Jekk VTE jiżviluppa wara li tinbeda t-terapija, it-trattament għandu jitwaqqaf.
English: The safety of using ospemifene concomitantly with oestrogens or other SERMS, such as tamoxifen, toremifene, bazedoxifene and raloxifene, has not been studied and its concurrent use is not recommended.
Maltese: Is-sigurtà tal-użu ta' ospemifene flimkien ma' estroġeni jew SERMs oħrajn, bħal tamoxifen, toremifene, bazedoxifene u raloxifene, ma ġietx studjata, u l-użu konkomitanti tiegħu mhuwiex rakkomandat.
English: Pharmacokinetics in subpopulations
Maltese: GĦAMLA FARMAĊEWTIKA
English: Fluconazole (an oral medicine used to treat fungal infections) as this may increase the amount of ospemifene in your blood.
Maltese: fluconazole), ikun mistenni li jżid l-esponiment ta' ospemifene b'mod simili.
English: In CYP2C9 poor metabolizers, co-administration of CYP3A4 inhibitors may increase systemic concentration of ospemifene to a larger extent.
Maltese: F'metabolizzaturi batuti ta' CYP2C9, l-għoti flimkien ta' inibituri ta' CYP3A4 jista' jżid ilkonċentrazzjoni sistemika ta' ospemifene sa grad akbar.
English: Ospemifene did not cause a clinically meaningful change in the exposure to the substrates, indicating that ospemifene does not affect those enzyme activities in vivo to a clinically significant extent.
Maltese: Ospemifene ma kkawżax bidla klinikament sinifikanti fl-esponiment għas-substrati, li jindika li ospemifene ma jaffettwax dawk lattivitajiet tal-enzimi in vivo sa grad klinikament sinifikanti.
English: Ospemifene has not been studied in patients with severe hepatic impairment, therefore Senshio is not recommended for use in such patients (see section 5.2).
Maltese: Ospemifene ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied, u għalhekk Senshio mhuwiex rakkomandat f'dawn il-pazjenti (ara sezzjoni 5.2).
English: Trial 1 Dyspareunia
Maltese: ISTRUZZJONIJIET DWAR L-UŻU
English: Adverse reactions are listed below by MedDRA preferred term system organ class and by frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt skont it-terminu ppreferut tas-sistema tal-klassifika tal-organi MedDRA u skont il-frekwenza.
English: Ospemifene exhibits linear pharmacokinetics in the fed state within the dose range of 60 mg to 240 mg.
Maltese: Ospemifene juri farmakokinetika lineari fl-istat mhux sajjem fil-medda tad-doża ta' 60 mg sa 240 mg. Farmakokinetika fis-sottopopolazzjonijiet
English: Table 1 shows the mean change in severity score in MBS after 12 weeks with the associated statistical testing for the difference vs. placebo for trials 1 and 2.
Maltese: Tabella 1 turi l-bidla medja fil-punteġġ tas-severità fl-MBS wara 12-il ġimgħa bl-ittestjar statistiku assoċjat għad-differenza kontra l-plaċebo għal provi 1 u 2.