FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 3ml vial contains 0.1-300 GBq, corresponding to 0.005-15 micrograms of Yttrium (90Y), at reference date and time.
Maltese: Kull kunjett ta' 3ml fih 0.1-300 GBq, li jikkorrispondi għal 0.005-15 mikrogrammi ta' Yttrium (90Y),
English: It is not intended for direct use in patients.
Maltese: Mhux intenzjonat li jingħata b'mod dirett fil-pazjenti.
English: The theoretical specific activity is 20 GBq/microgram of Yttrium (90Y) (see section 6.5).
Maltese: GBq/mikrogrammi ta' Yttrium (90Y)
English: The dosimetry table below is presented in order to evaluate the contribution of non-conjugated Yttrium (90Y) to the radiation dose following the administration of Yttrium (90Y)-labelled medicinal product or resulting from an accidental intravenous injection of Yttriga.
Maltese: Id-doża ta' radjazzjoni li tingħata lill-organi varji wara l-għoti ġol-vini ta' prodott mediċinali Yttrium (90Y)-ittikkettat tiddependi mill-prodott mediċinali speċifiku li ser ikun radjutikkettat.
English: 9.99 E-01 1.50 E+00 3.50 E+00 5.00 E+00 9.99 E+00 3.00 E+01 Urinary bladder 3.62 E-01 5.44 E-01 1.27 E+00 1.81 E+00 3.62 E+00 1.09 E+01 Uterus
Maltese: 9.99 E-01 1.50 E+00 3.50 E+00 5.00 E+00 9.99 E+00 3.00 E+01
English: Colourless clear sterile solution.
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: If you have missed a period, you should assume to be pregnant until a pregnancy test conducted is negative.
Maltese: Jekk ma jiġikx ilpirjid għandek tassumi li inti tqila sakemm test tat-tqala li jsir ikun negattiv.
English: Pregnancy
Maltese: Karkassa
English: The pharmacodynamic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Maltese: Il-proprjetatijiet farmakodinamiċi ta' prodotti mediċinali Yttrium (90Y)-ittikkettati ppreparati bir radjutikkettar b'Yttriga, qabel l-għoti, ser jiddependu min-natura tal-prodott mediċinali li ser ikun radjutikkettat.
English: The contents of the vial of Yttriga is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates.
Maltese: Il-kontenut tal-kunjett ta' Yttriga m'għandux jingħata direttament lill-pazjent imma jrid jintuża għarradjutikkettar tal-molekuli carrier, bħal antikorpi monoklonali, peptidi jew sottostrati oħra.
English: Cal.: {DD/MM/YYYY} (12h CET)
Maltese: DATA TA' META JISKADI JIS {XX/SSSS} (12h CET)
English: The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Yttriga will lead to increased bone marrow toxicity and haematopoietic stern cell damage.
Maltese: Il-preżenza ta' Yttrium (90Y) chloride liberu fil-ġisem wara l-għoti bi żball ta' Yttriga ser iwassal għal żieda fit-tossiċità fil-mudullun ta' l-għadam u ħsara fiċ-ċelluli staminali ematopoetiċi.
English: The dosimetry estimates were based on a rat distribution study and the calculations were effected in accordance with MIRD/ICRP 60 recommendations.
Maltese: L-istimi tad-dożimetrija kienu bbażati fuq studju tad-distribuzzjoni fil-firien u l-kalkoli kienu affettwati skond is-60 rakkomandazzjoni ta' MIRD/ICRP.
English: Yttriga radiopharmaceutical precursor, solution.
Maltese: Tagħtix Yttriga direttament lill-pazjent.
English: The pharmacokinetic properties of Yttrium (90Y)-labelled medicinal products prepared by radiolabelling with Yttriga, prior to administration, will be dependent on the nature of the medicinal product to be radiolabelled.
Maltese: It-tagħrif farmakokinetiku tal-prodott mediċinali Yttrium (90Y)-ittikkettati ppreparati bir radjutikkettar b'Yttriga, qabel l-għoti, ser jiddependi min-natura tal-prodott mediċinali li ser ikun radjutikkettat.
English: Thymus
Maltese: Milsa
English: Femur
Maltese: Ġilda
English: There are no data available on the toxicity of Yttrium (90Y) chloride nor on its effects on reproduction in animals or its mutagenic or carcinogenic potential.
Maltese: M'hemm l-ebda tagħrif dwar it-tossiċità ta' Yttrium (90Y) chloride, u lanqas dwar l-effetti tiegħu fuq ir-riproduzzjoni fil-bhejjem jew tal-potenzjal mutaġeniku jew karkinoġeniku.
English: Carcass
Maltese: MHUX
English: EXPIRY DATE EXP (12h CET) BATCH NUMBER
Maltese: {JJ/XX/SSSS} (12h CET) Attività speċifika waqt il-kalibrazzjoni:
English: 1. clinically relevant literature references on the prevention and management of IFIS;
Maltese: 1. referenzi għal-letteratura klinikament relevanti dwar il-prevenzjoni u l-immaniġġjar ta' IFIS;
English: • the Direct Healthcare Professional Communication (DHPC) on the association of Silodosin with Intraoperative Floppy Iris Syndrome and the two literature references mentioned in the text of the communication (at launch);
Maltese: • il-Komunikazzjoni Professjonali tal-Kura tas-Saħħa Diretta (Direct Healthcare Professional Communication, DHPC) dwar l-assoċjazzjoni ta' silodosin b'Sindromu tal-Iris Mitluqa Waqt Operazzjoni (IFIS) u ż-żewġ referenzi tal-letteratura msemmija fit-test tal-komunikazzjoni (fittnedija);
English: 3. recommendation to surgeons and ophthalmic teams: discontinuing treatment with α1adrenoceptor antagonists 2 weeks prior to cataract surgery has been recommended, but the benefit and duration of stopping therapy prior to cataract surgery has not yet been established.
Maltese: 3. rakkomandazzjoni għall-kirurgi u t-tim tagħhom: ġie rrakkomandat it-twaqqif tal-kura b'antagonisti tal-adrenoriċetturi-α1, ġimagħtejn qabel operazzjoni tal-katarretti, iżda lbenefiċċji u għal kemm żmien għandha titwaqqaf il-kura qabel operazzjoni tal-katarretti għadhom ma ġewx stabbiliti.
English: • an educational program on the prevention and management of IFIS (at launch and after launch); covering the following topics:
Maltese: • programm edukattiv dwar il-prevenzjoni u l-immaniġġjar ta' IFIS (fit-tnedija u wara t-tnedija); li jkopri s-suġġetti li ġejjin:
English: 2. pre-operative assessment: eye surgeons and ophthalmic teams should establish whether patients scheduled for cataract surgery are being or have been treated with silodosin in order to ensure that appropriate measures are in place to manage IFIS during surgery.
Maltese: 2. valutazzjoni ta' qabel l-operazzjoni: kirurgi tal-għajnejn u t-tim tagħhom għandhom jistabbilixxu jekk pazjenti skedati għal kirurġija tal-katarretti humiex qegħdin jiġu jew ġewx ikkurati b'silodosin sabiex jiġi żgurat li jkunu fis-seħħ il-miżuri xierqa għall-ġestjoni ta' IFIS matul il-kirurġija.
English: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK
Maltese: AT, BE, BG, CY, CZ, DK, EE, IE, EL, FI, FR, HR, HU, IE, IS, LT, LU, LV, MT, NL, NO, PL, PT, RO, SE, SI, SK Shionogi B.V.
English: Kingsfordweg 151 1043GR Amsterdam Netherlands
Maltese: Kingsfordweg 151 1043GR Amsterdam
English: Manufacturing Packaging Farmaca (MPF) B.V. Appelhof 13
Maltese: Manufacturing Packaging Farmaca (MPF) B.V.
English: Shionogi B.V. Tel/Tel./Te./Tlf/Tél/Puh/Sími/ :
Maltese: Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:
English: Symptoms (subjective measures)
Maltese: Sintomi (miżuri suġġettivi)
English: Date of first authorisation: 15 January 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 ta' Jannar 2015
English: Venous thromboembolic events (VTEs)
Maltese: Avvenimenti tromboemboliċi venużi (VTEs)
English: Elderly (>65 years old)
Maltese: Anzjani (>65 sena):
English: EU/1/14/978/001 EU/1/14/978/002 EU/1/14/978/003
Maltese: EU/1/14/978/002
English: Trial 1 Trial 2
Maltese: Prova 1 Prova 2
English: Clinical Safety
Maltese: Sigurtà Klinika
English: EU/1/14/978/001 7 film-coated tablets EU/1/14/978/002 28 film-coated tablets EU/1/14/978/003 84 film-coated tablets
Maltese: EU/1/14/978/002 28 pilloli miksija b'rita EU/1/14/978/003 84 pilloli miksija b'rita
English: Cerebro-vascular events
Maltese: Avvenimenti ċerebrovaskulari
English: Rifampicin, a strong CYP3A / CYP2C9 enzyme inducer, decreased the AUC of ospemifene by 58%.
Maltese: Rifampicin, induttur qawwi tal-enzima CYP3A/CYP2C9, naqqas l-AUC ta' ospemifene bi 58%.
English: Endometrial findings
Maltese: Sejbiet endometrijali
English: No clinically meaningful differences in ospemifene pharmacokinetics have been observed over the age range studied (40-80) years of age.
Maltese: L-ebda differenzi klinikament sinifikanti fil-farmakokinetika ta' ospemifene ma ġew osservati fuq ilmedda ta' età studjata (40-80) sena.
English: Senshio contains the active substance ospemifene.
Maltese: Senshio fih is-sustanza attiva ospemifene.
English: Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI>30 kg/m2) and systemic lupus erythematosus (SLE).
Maltese: Fatturi ta' riskju ġeneralment rikonoxxuti għal VTE jinkludu età avvanzata, storja medika fil-familja, obesità severa (BMI ta' >30 kg/m2) u lupus erythematosus sistemiku (SLE).
English: Plasma/blood cell partitioning of [14C]-Ospemifene (< 3%) and [14C]-4-hydroxyospemifene (< 2%) is low.
Maltese: Id-diviżjoni tal-plażma/taċ-ċelluli tad-demm ta' [14C]-Ospemifene (< 3%) u ta' [14C]-4-hydroxyospemifene (< 2%) hija baxxa.
English: Colloidal silicon dioxide (E 551) Magnesium stearate (E 578) Mannitol (E 421) Microcrystalline cellulose (E 460) Povidone (E 1201) Pregelatinised starch (maize) Sodium starch glycolate (type A)
Maltese: Colloidal silicon dioxide (E 551) Magnesium stearate (E 578) Mannitol (E 421) Microcrystalline cellulose (E 460) Povidone (E 1201) Pregelatinised starch (maize) Sodium starch glycolate (tip A)
English: The incidence of endometrial hyperplasia was 0.3% (1 case out of 317 biopsies) after 1 year of treatment with an upper 95% confidence limit of 1.74% (see section 5.1).
Maltese: L-inċidenza ta' iperplasija endometrijali kienet ta' 0.3% (1 każ minn 317-il bijopsija) wara l-1 sena ta' trattament b'upper 95% confidence limit ta' 1.74% (ara sezzjoni 5.1).
English: Film coating: Hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin (E 1518), polyethylene glycol (E 1521).
Maltese: Hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin (E 1518), polyethylene glycol (E 1521).
English: Therefore, ospemifene may increase concentrations of medicinal products which are substrates of OCT1 (e.g. metformin, acyclovir, ganciclovir and oxaliplatin).
Maltese: Għalhekk, ospemifene jista' jżid il-konċentrazzjonijiet ta' prodotti mediċinali li huma substrati ta' OCT1 (eż. metformin, acycovir, ganciclovir and oxaliplatin).
English: Dyspareunia 60 mg OSP Placebo p-value 60 mg OSP Placebo p-value
Maltese: Dispareunija 60 mg OSP Plaċebo valur p 60 mg OSP Plaċebo valur p
English: Ospemifene and 4-hydroxyospemifene are highly (both >99%) bound to serum proteins.
Maltese: Ospemifene u 4-hydroxyospemifene jeħlu ħafna (it-tnejn >99%) mal-proteini tas-serum.
English: Senshio 60 mg tablets ospemifene
Maltese: Senshio 60 mg pilloli ospemifene
English: Mean ospemifene Cmax and AUC0-24hr were 785 ng/mL and 5,448 ng•hr/mL, respectively, after repeat doses of 60 mg ospemifene once daily in the fed state.
Maltese: Il-medja tas-Cmax u lAUC0-24hr ta' ospemifene kienu 785 ng/mL u 5,448 ng•hr/mL, rispettivament, wara dożi ripetuti ta' 60 mg ospemifene darba kuljum fl-istat mhux sajjem.
English: Substantial improvement 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
Maltese: OSP Plaċebo 60 mg OSP Plaċebo 60 mg OSP Plaċebo
English: The apparent volume of distribution is 448 l.
Maltese: Il-volum apparenti tad-distribuzzjoni hu ta' 448 l.
English: Across all placebo-controlled clinical trials of ospemifene, deep vein thrombosis occurred at a frequency of approximately 3.65 cases per 1,000 patient years on 60 mg ospemifene (95% confidence interval of 0.44 to 13.19) versus 3.66 cases per 1,000 patient years for placebo (95% confidence interval of 0.09 to 20.41; relative risk is 1.0).
Maltese: Fil-provi kliniċi kollha kkontrollati bil-plaċebo ta' ospemifene, trombożi tal-vini profondi seħħet bi frekwenza ta' madwar 3.65 każijiet għal kull 1,000 sena ta' trattament lill-pazjenti fuq 60 mg ta' ospemifene (95% intervall ta' kunfidenza ta' 0.44 sa 13.19) kontra 3.66 każijiet għal kull 1,000 sena ta' trattament lill-pazjenti għall-plaċebo (95% intervall ta' kunfidenza ta' 0.09 sa 20.
English: - You are seriously overweight (BMI >30 kg/m2).
Maltese: - Jekk għandek ħafna piż żejjed (BMI ta' >30 kg/m2).
English: In in vitro studies, ospemifene and 4-hydroxyospemifene did not inhibit P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), organic anion transporter polypeptide (OATP)1B1, OATP1B3, OCT2, organic anion transporter (OAT)1, OAT3, or bile salt export pump (BSEP) transporters at clinically relevant concentrations.
Maltese: Fl-istudji in vitro, ospemifene u 4-hydroxyospemifene ma inibixxewx P-glikoproteina (Pgp), proteina tar-reżistenza tal-kanċer tas-sider (BCRP), trasportatur enajoniku organiku polypeptide (OATP)1B1, OATP1B3, OCT2, trasportatur enajoniku organiku (OAT)1, OAT3, jew trasportaturi talpompa ta' esportazzjoni tal-melħ biljari (BSEP) f'konċentrazzjonijiet klinikament rilevanti.
English: Ospemifene has been administered to subjects in single doses for up to 800 mg day and repeat doses up to 240 mg/day for 7 days and up to 200 mg/day for 12 weeks.
Maltese: Ospemifene ingħata lil individwi f'dożi waħidhom għal sa 800 mg kuljum u dożi ripetuti sa 240 mg/jum għal 7 ijiem u sa 200 mg/jum għal 12-il ġimgħa.
English: In in vitro studies ospemifene is a weak inhibitor for CYP2B6, CYP2C9, CYP2C19, CYP2C8 and CYP2D6.
Maltese: Fi studji in-vitro ospemifene hu inibitur dgħajjef għal CYP2B6, CYP2C9, CYP2C19, CYP2C8 u CYP2D6.
English: Pharmacokinetic differences due to race have been studied in 1,091 postmenopausal women, including 93.1% White, 3.9% Black, 1.8% Asian and 1.1% other in VVA trials.
Maltese: Differenzi farmakokinetiċi minħabba r-razza ġew studjati f'1,091 mara li diġà għaddew millmenopawsa, li jinkludu 93.1% Bojod, 3.9% Suwed, 1.8% Asjatiċi u 1.1% ta' razez oħrajn, fi provi dwar VVA.
English: - The other ingredients are: Tablet core: Colloidal silicon dioxide (E 551), magnesium stearate (E 578), mannitol (E 421), microcrystalline cellulose (E 460), povidone (E 1201), pregelatinised starch (maize), sodium starch glycolate (type A).
Maltese: Qalba tal-pillola: Colloidal silicon dioxide (E 551), magnesium stearate (E 578), mannitol (E 421), microcrystalline cellulose (E 460), povidone (E 1201), pregelatinized starch (maize), sodium starch glycolate (tip A).
English: CYP3A4 and CYP2C19.
Maltese: (midazolam), CYP2C19, u CYP3A4
English: Ganciclovir used to treat infections caused by a virus called cytomegalovirus.
Maltese: o Ganciclovir li jintuża biex jittratta infezzjonijiet ikkawżati minn virus imsejjaħ cytomegalovirus.
English: Caution is recommended when co-administering ospemifene with fluconazole (see section 4.5).
Maltese: Il-kawtela hi rakkomandata meta ospemifene jingħata flimkien ma' fluconazole (ara sezzjoni 4.5).
English: Shionogi SLU Tel: +34 911 239 258 contacta@shionogi.eu
Maltese: SLU Tel: +34 911 239 258 contacta@shionogi.eu
English: Endometrial safety in women was assessed at baseline and 12 weeks in the two 12-week phase III studies (trials 1 and 2: ospemifene, n=302; placebo, n= 301).
Maltese: Is-sigurtà endometrijali f'nisa ġiet evalwata fil-linja bażi u wara 12-il ġimgħa fiż-żewġ studji ta' fazi III li damu 12-il ġimgħa (provi 1 u 2: ospemifene, n=302; plaċebo, n= 301).
English: The fate of remaining fraction is unknown but can probably be explained by formation of glucuronide metabolites.
Maltese: Mhuwiex magħruf x'sar mill-bqija tal-frazzjoni iżda dan probabbli jista' jiġi spjegat mill-formazzjoni tal-metaboliti ta' glucuronide.
English: The incidence of abnormal, but not clinically significant, findings on breast palpation and mammography decreased in the ospemifene 60 mg population during the 1-year study (trial 3) from 1.6% to 0.6% and from 11.8% to 8.1% respectively.
Maltese: L-inċidenza ta' sejbiet anormali, imma mhux klinikament sinifikanti, fuq palpazzjoni tas-sider u mammografija naqsu fil-popolazzjoni li kienet fuq 60 mg ta' ospemifene matul l-istudju ta' sena (prova 3) minn 1.6% għal 0.6% u minn 11.8% għal 8.1% rispettivament.
English: The mean age of participants was 61.7 years in the ospemifene 60 mg group and 62.9 years in the placebo group.
Maltese: L-età medja tal-parteċipanti kienet ta' 61.7 snin filgrupp ta' ospemifene 60 mg u 62.9 sena fil-grupp tal-plaċebo.
English: Systemic exposure (AUC) at the administered doses was 0.3-, 1.0- and 1.2-times the AUC in postmenopausal woman administered 60 mg/day.
Maltese: L-esponiment sistemiku (AUC) fid-dożi mogħtija kien ta' 0.3, 1.0 u 1.2 darbiet aktar mill-AUC f'nisa li diġà għaddew mill-menopawsa li ngħataw 60 mg/jum.
English: CYP2C9 poor metabolisers
Maltese: Metabolizzaturi batuti ta' CYP2C9
English: It may harm them,
Maltese: Meta jiġri dan, il-ħitan vaġinali jistgħu jirqaqu.
English: Ospemifene and its major metabolite, 4-hydroxyospemifene, are metabolised by multiple metabolic pathways, the main enzymes involved are UGT1A3, UGT2B7, UGT1A1 and UGT1A8, and CYP2C9,
Maltese: Ospemifene u l-metabolit maġġuri tiegħu, 4-hydroxyospemifene, huma metabolizzati b'mogħdijiet metaboliċi multipli, l-enzimi ewlenin involuti huma UGT1A3, UGT2B7, UGT1A1 u UGT1A8, u CYP2C9, CYP3A4 and CYP2C19.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, selective estrogen receptor modulators, ATC code: G03XC05.
Maltese: Ormoni sesswali u modulaturi tas-sistema ġenitali, modulaturi selettiv tar-riċettur tal-estroġenu; Kodiċi ATC:
English: Ospemifene was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests.
Maltese: Ospemifene ma kienx mutaġeniku jew klastoġeniku meta ġie evalwat f'sensiela standard ta' testijiet in vitro u in vivo.
English: In the ovary, there was an increase in sex-cord stromal tumours, tubulostromal tumours, granulosa cell tumours and luteomas in all treatment groups.
Maltese: Fl-ovarji, kien hemm żieda fit-tumuri stromali tas-sex-cord, tumuri tubulostromali, tumuri taċ-ċelluli granulosa u luteomi fil-gruppi kollha ta' trattament.
English: - You have an autoimmune condition called systemic lupus erythematosus (SLE).
Maltese: - Jekk għandek kundizzjoni awtoimmuni imsejħa lupus erythematosus sistematiku (SLE).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Pack sizes of 7, 28 or 84 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 7, 28 jew 84 pillola miksija b'rita.
English: Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
Maltese: Senshio huwa indikat għat-trattament ta' atrofija vulvari u vaġinali sintomatika moderata sa severa (VVA) f'nisa li diġà għaddew mill-menopawsa li mhumiex kandidati għal terapija b'oestrogen vaġinali lokali.
English: The relative contribution of the metabolite to the pharmacological effect is estimated to be approximately 40%.
Maltese: Il-kontribuzzjoni relattiva tal-metabolit għalleffett farmakoloġiku hi stmata li hi ta' madwar 40%.
English: In the two 12 weeks studies (trials 1 and 2), 739 patients received ospemifene and 724 patients received placebo.
Maltese: Fiż-żewġ studji ta' 12-il ġimgħa (provi 1 u 2), 739 pazjenta rċivew ospemifene u 724 pazjenta rċivew plaċebo.
English: Ospemifene and its major metabolite, 4-hydroxyospemifene, inhibited organic cation transporter (OCT)1 in vitro at clinically relevant concentrations.
Maltese: Ospemifene u l-metabolit maġġuri tiegħu, 4-hydroxyospemifene, inibixxa t-trasportatur organiku talketajoni (OCT)1 in vitro f'konċentrazzjonijiet klinikament rilevanti.
English: Hypromellose (E 464) Lactose monohydrate Titanium dioxide (E 171) Triacetin (E 1518) Macrogols (E 1521)
Maltese: Hypromellose (E 464) Lactose monohydrate Titanium dioxide (E 171)
English: For subjects completing the trial 1 extension study (ospemifene, n=41; placebo, n= 18) and for subjects in the long-term 52-week safety study (trial 3: ospemifene, n=276; placebo, n=46), endometrial safety was assessed by endometrial biopsy at baseline and at 12 months.
Maltese: Għal individwi li lestew listudju ta' estensjoni ta' prova 1 (ospemifene, n=41; plaċebo, n=18) u għal individwi fl-istudju fit-tul dwar is-sigurtà li dam 52 ġimgħa (prova 3: ospemifene, n=276; plaċebo, n=46), is-sigurtà endometrijali ġiet evalwata permezz ta' bijopsija endometrijali fil-linja bażi u wara 12-il xahar.
English: In those trials, a total of 1,102 subjects received 60 mg of ospemifene and 787 subjects received placebo.
Maltese: F'dawk ilprovi, total ta' 1,102 mara rċivew 60 mg ta' ospemifene u 787 mara rċivew plaċebo.
English: Both CYP2C9 and CYP3A4 are involved in the metabolism of ospemifene.
Maltese: Kemm CYP2C9 kif ukoll CYP3A4 huma involuti fil-metaboliżmu ta' ospemifene.
English: Oestrogens.
Maltese: • Estroġeni.
English: Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Maltese: Storja medika attiva jew storja medika fil-passat ta' avvenimenti tromboemboliċi venużi (VTEs), li jinkludu trombożi tal-vini profondi, emboliżmu pulmonari u trombożi tal-vini tar-retina.
English: The pharmacokinetics of ospemifene is only mildly affected by mild and moderate hepatic impairment (Child Pugh scores 5-9) when compared to healthy matched controls.
Maltese: Il-farmakokinetika ta' ospemifene tiġi affettwata b'mod ħafif biss minn indeboliment ħafif u moderat tal-fwied (punteġġi Child Pugh ta' 5-9) meta mqabbla ma' kontrolli mqabbla b'saħħithom.
English: In contrast, abnormal, not clinically significant, findings on mammography increased in the placebo population from 6.5% to 8.3%.
Maltese: B'kuntrast ma' dan, sejbiet anormali u mhux klinikament sinifikanti fuq ilmammografija żdiedu fil-popolazzjoni fuq plaċebo minn 6.5% għal 8.3%.
English: In the liver hepatocyte hypertrophy or increased glycogen storage, increase in alanine aminotransferase (ALT) and alkaline phosphatase (ALP) were observed.
Maltese: Fil-fwied, ġew osservati ipertrofija epatoċita jew żieda fil-ħażna ta' glycogen, żieda f'alanine aminotransferase (ALT) u alkaline phosphatase (ALP).
English: Ospemifene is primarily metabolised by the liver.
Maltese: Ospemifene jiġi metabolizzat u eliminat primarjament mill-fwied.
English: The apparent terminal half-life of ospemifene in post-menopausal women is approximately 25 hours.
Maltese: Il-half-life terminali apparenti ta' ospemifene f'nisa li diġà għaddew mill-menopawsa hi ta' madwar 25 siegħa.
English: The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective estrogen receptor modulators (SERMs).
Maltese: Ir-riskju ta' VTE (trombożi tal-vini profondi u emboliżmu pulmonari) jiżdied b'modulaturi tarriċetturi selettivi tal-oestroġenu (SERMs) oħrajn.
English: Inhibition of UGT1A3, UGT2B7, UGT1A1, or UGT1A8 may potentially affect the glucuronidation of ospemifene and/or 4-hydroxyospemifene.
Maltese: L-inibizzjoni ta' UGT1A3, UGT2B7, UGT1A1, jew UGT1A8 tista' potenzjalment taffettwa lglukuronidazzjoni ta' ospemifene u/jew ta' 4-hydroxyospemifene.
English: Orlistat sometimes used to treat obesity.
Maltese: o Orlistat li xi kultant tintuża għal trattament ta' obesità.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Tel: +39 06 94 805 118 contattaci@shionogi.eu
Maltese: Shionogi Srl Tel: +39 06 94 805 118 contattaci@shionogi.eu