FrancophonIA/ELRC3.0 huggingface dataset:
English: - Herbal remedies containing St John's wort (Hypericum perforatum) used for depression or anxiety.
Maltese: - Rimedji erbali li fihom St John's wort (Hypericum perforatum) użati għal dipressjoni jew ansjetà.
English: 5 mg/day N=178
Maltese: 5 mg/kulj um N=178
English: Following oral administration of a single dose of 5 or 10 mg, ulipristal acetate is rapidly absorbed, with a Cmax of 23.5 ± 14.2 ng/ml and 50.0 ± 34.4 ng/ml occurring approximately 1 h after ingestion, and with an AUC0-∞ of 61.3 ± 31.7 ng.h/ml and 134.0 ± 83.8 ng.h/ml, respectively.
Maltese: Wara l-għoti orali ta' doża unika ta' 5 jew ta' 10 mg, ulipristal acetate jiġi assorbit malajr, b'Cmax ta' 23.5 ± 14.2 ng/ml u 50.0 ± 34.4 ng/ml li jseħħu madwar siegħa wara li jinbela', u b'AUC0-∞ ta' 61.3 ± 31.7 ng.h/ml u 134.0± 83.8 ng.h/ml, rispettivament.
English: What Esmya contains - The active substance is ulipristal acetate.
Maltese: X'fih Esmya - Is-sustanza attiva hija ulipristal acetate.
English: Ulipristal acetate is contraindicated during breastfeeding (see sections 4.3 and 5.2).
Maltese: Ulipristal acetate huwa kontraindikat matul it-treddigħ (ara sezzjonijiet 4.3 u 5.2).
English: About 5% of patients of reproductive age experiencing heavy menstrual bleeding have an endometrial thickness of greater than 16 mm.
Maltese: Madwar 5% tal-pazjenti f'età riproduttiva li jesperjenzaw tnixxija mestrwali qawwija għandhom ħxuna endometrijali ta' aktar minn 16 mm.
English: The incidence of hyperplasia did not increase with repeated treatment courses, including data on 340 women who received up to 4 courses of ulipristal acetate 5 or 10 mg and limited data of 43 women who received up to 8 courses of ulipristal acetate 10 mg.
Maltese: L-inċidenza ta' iperplażja ma żdiditx b'korsijiet ta' kura ripetuti, inkluż dejta dwar 340 mara li rċevew sa 4 korsijiet ta' ulipristal acetate 5 jew 10 mg u dejta limitata dwar 43 mara li rċevew sa 8 korsijiet ta' ulipristal acetate 10 mg.
English: * see section "Description of selected adverse reactions" ** The verbatim term “mild hair loss” was coded to the term “alopecia”
Maltese: * ara sezzjoni "Deskrizzjoni ta' reazzjonijiet avversi magħżula" ** It-terminu verbatim ta' telf ħafif ta' xagħar kien kodifikat għat-terminu ta' “alopeċja”
English: Endometrial thickening
Maltese: Tibdiliet endometrijali
English: Adverse reactions listed below are classified according to frequency and system organ class.
Maltese: Ir-reazzjonijiet avversi elenkati hawn taħt huma kklassifikati skont il-frekwenza u s-sistema ta' klassifika tal-organi.
English: Alopecia** Dry skin Hyperhidrosis
Maltese: Alopeċja ** Ġilda xotta Iperidrożi
English: Studies 3 and 4 showed efficacy in controlling uterine fibroid symptoms (e.g. uterine bleeding) and reducing fibroid size after 2 and 4 courses.
Maltese: Studji 3 u 4 urew effikaċja fil-kontroll tas-sintomi ta' fibrojodi fl-utru (eż. fsada fl-utru) u tnaqqis fiddaqs tal-fibrojdi wara
English: Potential for ulipristal acetate to affect other medicinal products:
Maltese: Il-potenzjal li ulipristal acetate jaffettwa lil prodotti mediċinali oħra:
English: Headache Mild or moderate severity headache was reported in 5.8% of patients.
Maltese: Uġigħ ta' ras Uġigħ ta' ras minn ħafifa sa moderata kienet irrapportata f'5.8% tal-pazjenti.
English: Esmya is likely to make some hormonal contraceptives less effective (see “Other medicines and Esmya”).
Maltese: Esmya huwa probabbli li jagħmel xi kontraċettivi ormonali inqas effettivi (ara “Mediċini oħra u Esmya”).
English: In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended.
Maltese: F'każ ta' kura intermittenti ripetuta, huwa rrakkomandat il-monitoraġġ perjodiku tal-endometriju.
English: Esmya contains the active substance ulipristal acetate.
Maltese: Esmya fih is-sustanza attiva ulipristal acetate.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progesterone receptor modulators.
Maltese: Ormoni sesswali u modulaturi tas-sistema ġenitali, modulaturi tarriċettur tal-proġesteron.
English: Ulipristal acetate and its active mono-N-demethylated metabolite are excreted in breast milk with a mean AUCt milk/plasma ratio of 0.74 ± 0.32 for ulipristal acetate.
Maltese: Ulipristal acetate u l-metabolit attiv tiegħu mono-N-demethylated jiġu eliminati mill-ħalib tas-sider bi proporzjon ta' AUCt medju fil-ħalib/plasma ta' 0.74 ± 0.
English: In both studies menstrual blood loss was assessed using the Pictorial Bleeding Assessment Chart (PBAC).
Maltese: Valutazzjoni bl-Istampi tat-Tnixxija ta' Demm (Pictorial Bleeding Assessment Chart (PBAC).
English: Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator characterised by a tissue-specific partial progesterone antagonist effect.
Maltese: Ulipristal acetate huwa modulatur sintetiku tar-riċettur selettiv tal-proġesteron oralment attiv ikkaratterizzat minn effett parzjalment antagonist ta' proġesteron speċfiku għat-tessut.
English: Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.
Maltese: Ulipristal acetate hu indikat għall-kura intermittenti ta' sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti f'età li fiha jistgħu jnisslu t-tfal li mhumiex eliġibbli għal kirurġija.
English: Ulipristal acetate is contraindicated during pregnancy (see section 4.3).
Maltese: Ulipristal acetate huwa kontraindikat matul it-tqala (ara sezzjoni 4.3).
English: In the placebo-controlled study, the rate of hot flushes was 1.0% for ulipristal acetate and 0% for placebo.
Maltese: Fl-istudju kkontrollat bi plaċebo, ir-rata ta' fwawar kienet ta' 1.0% għal ulipristal acetate u ta' 0% għal plaċebo.
English: In the first 3-month treament course of the two long term Phase III trials, the frequency was 5.3% and 5.8% for ulipristal acetate, respectively.
Maltese: III, ilfrekwenza kienet 5.3% u 5.8% għal ulipristal acetate, rispettivament.
English: Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC.
Maltese: L-għoti ta' ulipristal acetate (pillola ta' 10 mg) flimkien mal-inibitur tal-pompa tal-proton, esomeprazole (20 mg kuljum għal 6 ijiem) irriżulta f'Cmax bejn wieħed u ieħor 65% aktar baxx, tmax ittardjat (minn medjan ta' 0.75 sigħat għal 1.0 sigħat) u AUC medja 13% ogħla.
English: Esmya may cause mild dizziness (see section 4 “Possible side effects”).
Maltese: Esmya jista' jikkawża sturdament ħafif (ara sezzjoni 4 “Effetti sekondarji li jista' jkollu”).
English: In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations in the gastrointestinal wall during absorption.
Maltese: Dejta in vitro tindika li ulipristal acetate jista' jkun inibitur ta' P-gp f'konċentrazzjonijiet klinikament rilevanti fil-ħajt gastro-intestinali matul l-assorbiment.
English: 10 mg/day N=176
Maltese: 10 mg/ku ljum N=176
English: Administration of the potent CYP3A4 inducer rifampicin (300 mg twice daily for 9 days) to healthy female volunteers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite by 90% or more and decreased ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure.
Maltese: L-għoti tal-induttur ta' CYP3A4 qawwi rifampicin (300 mg darbtejn kuljum għal 9 ijiem) lil voluntiera nisa b'saħħithom naqqas b'mod sinifikanti is-Cmax u l-AUC ta' ulipristal acetate u lmetabolit attiv tiegħu b'90% jew aktar u naqqas il-half-life ta' ulipristal acetate bi 2.2 drabi u dan jikkorrespondi għal tnaqqis ta' madwar 10 darbiet tal-espożizzjoni ta' ulipristal acetate.
English: In study 3, treatment efficacy has been shown over > 18 months of repeated intermittent treatment (4 courses of 10 mg once daily), 89.7% of patients were in amenorrhea at the end of the treatment course 4.
Maltese: Fi studju 3, l-effikaċja klinika ntweriet wara > 18-il xahar ta' kura intermittenti ripetuta (4 korsijiet ta' 10 mg darba kuljum), 89.7% tal-pazjenti kienu f'amenorrea fi tmiem il-kors ta' kura 4.
English: In Study 2, a double-dummy method was used to maintain the blind.
Maltese: Fl-istudju 2, intuża metodu double-dummy biex jinżamm blind.
English: 10 mg/day N=132
Maltese: 10 mg/ku ljum N=132
English: • patients with alanine transaminase (ALT) or aspartate aminotransferase (AST) > 2 x ULN (isolated or in combination with bilirubin >2 x ULN) must not be treated.
Maltese: • pazjenti b'alanine transaminase (ALT) jew aspartate aminotransferase (AST) > 2 x ULN (waħedhom jew flimkien ma' bilirubina >2 x ULN) m'għandhomx jiġu ttrattati.
English: Ulipristal acetate is readily converted to its mono-N-demethylated and subsequently to its di-N-demethylated metabolites.
Maltese: Ulipristal acetate jiġi kkonvertit malajr fil-metaboliti mono-N-demethylated u sussegwentement filmetaboliti di-N-demethylated tiegħu.
English: Medicinal products affecting gastric pH
Maltese: Prodotti mediċinali li jaffettwaw il-pH gastriku
English: Adverse reactions during treatment course 1 Very common Common
Maltese: Reazzjonijiet avversi matul il-kors ta' kura 1 Komuni ħafna
English: In 10-15% of patients, thickening of the endometrium (> 16 mm by ultrasound or MRI at end of treatment) was observed with ulipristal acetate by the end of the first 3-month treatment course.
Maltese: F'10-15% tal-pazjenti, kien osservat tħaxxin tal-endometriju (> 16 mm permezz ta' ultrasound jew MRI fit-tmiem tal-kura) b'ulipristal acetate sa tmiem l-ewwel kors ta' kura ta' 3 xhur.
English: Concomitant use of ulipristal acetate and potent CYP3A4 inducers (e.g. rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John´s wort, efavirenz, nevirapine, long term use of ritonavir) is not recommended (see section 4.5).
Maltese: (eż. rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John´s wort, efavirenz, nevirapine, użu fit-tul ta' ritonavir) mhuwiex irrakkomandat (ara sezzjoni 4.5).
English: Ulipristal acetate has a steroid structure and acts as a selective progesterone receptor modulator with predominantly inhibitory effects on the progesterone receptor.
Maltese: Ulipristal acetate għandu struttura ta' sterojdi u jaġixxi bħala modulatur selettiv tar-riċettur talproġesteron b'effetti inibitorji predominanti fuq ir-riċettur tal-proġesteron.
English: Concomitant use of ulipristal acetate and potent CYP3A4 inducers (e.g. rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John´s wort, efavirenz, nevirapine, long term use of ritonavir) is not recommended (see section 4.4).
Maltese: (eż. rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, primidone, St John´s wort, efavirenz, nevirapine, użu fit-tul ta' ritonavir) mhuwiex rakkomandat (ara sezzjoni 4.4).
English: In the active comparator controlled study the rates were 24% (10.5% moderate or severe) for ulipristal acetate and 60.4% (39.6% moderate or severe) for leuprorelin-treated patients.
Maltese: Fl-istudju kkontrollat bil-komparatur attiv, ir-rati kienu ta' 24% (10.5% moderati jew severi) għal ulipristal acetate u ta' 60.4% (39.6% moderati jew severi) għal pazjenti li kienu qegħdin jirċievu kura b'leuprorelin.
English: Bold values in shaded squares indicate that there was a significant difference in the comparisons between ulipristal acetate and the control.
Maltese: Il-valuri b'tipa grassa fil-kaxex skuri jindikaw li kien hemm differenza sinifikanti fil-paraguni bejn ulipristal acetate u l-kontroll.
English: Posology
Maltese: SINJALI
English: Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and 2.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 1.5 fold while the Cmax of the active metabolite decreased (0.52 fold change).
Maltese: Wara l-għoti tal-inibitur moderat ta' CYP3A4 erythromycin propionate (500 mg darbtejn kuljum għal 9 ijiem) lil voluntiera nisa b'saħħithom, kien hemm żieda fis-Cmax u l-AUC ta' ulipristal acetate ta' 1.2 u 2.9 darbiet, rispettivament; l-AUC tal-metabolit attiv ta' ulipristal acetate żdied b'1.5 drabi filwaqt li s-Cmax tal-metabolit attiv naqas (bidla ta' 0.52 drabi).
English: Pituitary
Maltese: Pitwitarja
English: 10 mg/day N=207
Maltese: 10 mg/ku ljum N=207
English: In vivo results show that ulipristal acetate (administered as a single 10 mg tablet) 1.5 hour before administration of the P-gP substrate fexofenadine (60 mg) has no clinically relevant effects on the pharmacokinetic of fexofenadine.
Maltese: Riżultati in vivo juru li ulipristal acetate (mogħti bħala pillola waħda ta' 10 mg), siegħa u nofs qabel l-għoti ta' substrat ta' P-gP fexofenadine (60 mg) ma għandu l-ebda effett kliniku li huwa klinikament relevanti fuq il-farmakokinetika ta' fexofenadine.
English: 10 mg/day N=107
Maltese: 10 mg/ku ljum N=107
English: The safety of ulipristal acetate has been evaluated in 1,053 women with uterine fibroids treated with 5 mg or 10 mg ulipristal acetate during Phase III studies.
Maltese: Is-sigurtà ta' ulipristal acetate ġiet evalwata fuq 1,053 mara bil-fibrojdi fl-utru li kienu rċevew kura b'ulipristal acetate ta' 5 mg jew ta' 10 mg matul studji tal-Fażi III.
English: Dyspepsia Flatulence
Maltese: Popolazzjoni speċjali
English: Uterine haemorrhage* Metrorrhagia Genital discharge Breast discomfort
Maltese: Emorraġija fl-utru* Metrorraġija Tnixxija ġenitali Skumdità fissider
English: Typically, the histological appearance is an inactive and weakly proliferating epithelium associated with asymmetry of stromal and epithelial growth resulting in prominent cystically dilated glands with admixed oestrogen (mitotic) and progestin (secretory) epithelial effects.
Maltese: Tipikament, id-dehra istoloġika hija epitelju inattiv u li jipprolifika bil-mod assoċjat ma' tkabbir assimetriku stromali u epiteleali li jirriżulta fi glandoli prominenti dilatati permezz ta' ċisti b'taħlita ta' effetti epiteljali ta' estroġenu (mitotiċi) u ta' proġestin (sekretorji).
English: Musculoskeletal pain
Maltese: Disturbi psikjatriċi
English: • if a patient during treatment shows signs or symptoms compatible with liver injury, treatment should be stopped, and the patient should be investigated immediately, and liver function tests performed.
Maltese: • jekk waqt it-trattament pazjent juri sinjali jew sintomi kompatibbli ma' ħsara fil-fwied, ittrattament għandu jitwaqqaf, u l-pazjent għandu jiġi investigat immedjatament, u għandhom isiru testijiet tal-funzjoni tal-fwied.
English: Ulipristal acetate 10 mg/day N=94
Maltese: Ulipristal acetate 10 mg/jum N=94
English: Common (may affect up to 1 in 10 people) side effects: - headache - spinning sensation (vertigo) - stomach ache, feeling sick (nausea) - acne - muscle and bone (musculoskeletal) pain - sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): - uġigħ ta' ras - sensazzjoni ta' tidwir (vertigo) - uġigħ fl-istonku, tħossok ma tiflaħx (imdardra) - akne - uġigħ fil-muskoli u fl-għadam (muskuloskeletriċi) - borża ta' fluwidu fi ħdan l-ovarji (ċista fl-ovarji), sensittività/uġigħ fis-sider, uġigħ fin-naħa t'isfel tal-addome (fil-pelvis), fwawar - għejja - żieda fil-piż.
English: • key effects of Esmya on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
Maltese: • effetti ewlenin ta' Esmya fuq Tibdil Endometrijali Assoċjat ma' Modulatur tar-Riċettur talProgesterone (Progesterone Receptor Modulator Associated Endometrial Changes (PAEC)) u kif dawn huma differenti minn dawk ta' estroġenu mhux oppost.
English: Esmya is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4).
Maltese: Esmya huwa kontraindikat f'pazjenti b'disturb tal-fwied (ara sezzjoni 4.3 u 4.4).
English: The observed frequency is in line with control groups and prevalence reported in literature for symptomatic premenopausal women of this age group (mean of 40 years).
Maltese: Il-frekwenza osservata hija konformi ma' gruppi ta' kontroll u l-prevalenza rrapportata fid-dokumentazzjoni għal nisa qabel menopawża sintomatika ta' dan il-grupp ta' età (medja ta' 40 sena).
English: Study 2 contained the active comparator, leuprorelin 3.75 mg given once per month by intramuscular injection.
Maltese: L-istudju 2 kien fih il-komparatur attiv, leuprorelin 3.75 mg mogħti darba fix-xahar permezz ta' injezzjoni fil-muskolu.
English: Thus hormonal contraceptives and progestagens are likely to reduce ulipristal acetate efficacy by competitive action on the progesterone receptor.
Maltese: Għalhekk huwa probabbli li l-kontraċettivi ormonali u l-proġestaġeni jnaqqsu l-effikaċja ta' ulipristal b'azzjoni kompetittiva fuq ir riċettur tal-proġesteron.
English: A. LABELLING
Maltese: IT-TABELLA
English: Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Esmya treatment.
Maltese: Għaldaqstant, il-kontraċettivi ormonali mhumiex rakkomandati u inti għandek tuża metodu kontraċettiv b'barriera affidabbli alternattiv, bħal kondom, waqt li tkun fuq kura b'Esmya.
English: The vast majority of adverse reactions were mild and moderate (95.0%), did not lead to discontinuation of the medicinal product (98.0%) and resolved spontaneously.
Maltese: 0%), ma kinux iwasslu għall-waqfien tal-prodott mediċinali (98.0%) u għebu weħidhom b'mod spontanju.
English: Following administration of the potent CYP3A4 inhibitor ketoconazole (400 mg once daily for 7 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 2 and 5.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 2.4 fold while the Cmax of the active metabolite decreased (0.53 fold change).
Maltese: Wara l-għoti tal-inibitur qawwi ta' CYP3A4 ketoconazole (400 mg darba kuljum għal 7 ijiem) lil voluntiera nisa b'saħħithom, is-Cmax u l-AUC ta' ulipristal acetate żdiedu b'2 u 5.9 darbiet, rispettivament; l-AUC tal-metabolit attiv ta' ulipristal acetate żdied b'2.4 darbiet filwaqt li s-Cmax talmetabolit attiv naqas (bidla ta' 0.53 drabi).
English: - If you are currently taking hormonal contraception (for example birth control pills) (see “Other medicines and Esmya”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Esmya.
Maltese: (ara “Mediċini oħra u Esmya”), inti għandek tuża metodu kontraċettiv b'barriera affidabbli alternattiv (bħal kondom) waqt li tieħu Esmya.
English: Uterine haemorrhage
Maltese: Frekwenza mhux magħrufa
English: Hot flush* Pelvic pain Ovarian cyst* Breast tenderness/pain
Maltese: Ċisti fl-ovarji* Uġigħ/sensittività fis-sider
English: The terminal half-life of ulipristal acetate in plasma following a single dose of 5 or 10 mg is estimated to be about 38 hours, with a mean oral clearance (CL/F) of about 100 l/h.
Maltese: Il-half-life terminali ta' ulipristal acetate fil-plażma wara doża unika ta' 5 jew 10 mg huwa stmat li huwa ta' madwar 38 siegħa, bi tneħħija orali medja (CL/F) ta' madwar 100 l/h.
English: Ulipristal acetate is rapidly transformed into a pharmacologically active metabolite with a Cmax of 9.0 ± 4.4 ng/ml and 20.6 ± 10.9 ng/ml also occurring approximately 1 h after ingestion, and with an AUC0-∞ of 26.0 ± 12.0 ng.h/ml and 63.6 ± 30.1 ng.h/ml respectively.
Maltese: Ulipristal acetate jiġi trasformat malajr f'metabolit farmakoloġikament attiv b'Cmax ta' 9.0 ± 4.4 ng/ml u 20.6 ± 10.
English: See also section 2 Warnings and precautions.
Maltese: Ara wkoll sezzjoni 2 Twissijiet u prekawzjonijiet.
English: Ovarian cyst
Maltese: • awrina skura
English: Simultaneous administration of ulipristal acetate and a P-gp substrate has not been studied and an interaction cannot be excluded.
Maltese: L-għoti simultanju ta' ulipristal acetate u substrat ta' P-gp ma ġiex studjat u interazzjoni ma tistax tiġi eskluża.
English: Ulipristal acetate 5 mg/day N=93
Maltese: Ulipristal acetate 5 mg/jum N=93
English: Co-administration of moderate or potent CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.4).
Maltese: L-għoti flimkien ta' inibituri moderati jew qawwija ta' CYP3A4 flimkien ma' ulipristal acetate mhuwiex irrakkomandat (ara sezzjoni 4.4).
English: Pre-operative use:
Maltese: Użu ta' qabel l-operazzjoni:
English: A daily dose of ulipristal acetate 5 mg inhibits ovulation in the majority of patients as indicated by progesterone levels maintained at around 0.3 ng/ml.
Maltese: Doża ta' ulipristal acetate ta' 5 mg kuljum tinibixxi l-ovulazzjoni fil-maġġoranza tal-pazjenti kif indikat mil-livelli ta' proġesteron miżmuma f'madwar 0.3 ng/ml.
English: Drug hypersensitivity symptoms such as generalised oedema, pruritus, rash, swelling face or urticaria were reported by 0.4% of patients in Phase III trials.
Maltese: Sintomi ta' sensittività eċċessiva għall-mediċina bħal edema ġeneralizzata, prurite, raxx, nefħa fil-wiċċ jew urtikarja ġew irrapportati minn 0.4% tal-pazjenti fi provi ta' Fażi
English: Treatment must not be initiated if transaminases (alanine transaminase (ALT) or aspartate aminotransferase (AST)) exceed 2 x ULN (isolated or in combination with bilirubin >2 x ULN).
Maltese: It-trattament m'għandux jinbeda jekk it-transaminases (alanine transaminase (ALT) jew aspartate aminotransferase (AST)) jaqbżu 2 x ULN (waħedhom jew flimkien ma' bilirubina >2 x ULN).
English: Patients in amenorrhea at week 13
Maltese: Pazjenti f'amenorrea f'ġimgħa 13
English: Patients who develop transaminase levels (ALT or AST) > 3 times the upper limit of normal during treatment should stop treatment and be closely monitored.
Maltese: Pazjenti li jiżviluppaw livelli ta' transaminase (ALT jew AST) > 3 darbiet il-limitu ta' fuq tan-normal matul it-trattament għandhom iwaqqfu t-trattament u għandhom jiġu mmonitorjati mill-qrib.
English: Single doses up to 200 mg and daily doses of 50 mg for 10 consecutive days were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.
Maltese: Ingħataw dożi singoli sa 200 mg u dożi ta' kuljum ta' 50 mg għal 10 ijiem konsekuttivi lil numru limitat ta' individwi, u ma ġew irrapportati l-ebda reazzjonijiet avversi severi jew serji.
English: Esmya is used in adult women (over 18 years of age) before they reach the menopause.
Maltese: Esmya jintuża f'nisa adulti (akbar minn 18-il sena) qabel ma jaslu għall-menopawża.
English: Ulipristal acetate 5 mg/day N=95
Maltese: Ulipristal acetate 5 mg/jum N=95
English: Therefore concomitant administration of medicinal products containing progestagen is not recommended (see section 4.4 and 4.6).
Maltese: Għalhekk l-għoti konkomittanti ta' prodotti mediċinali li fihom proġestaġenmhuwiex irrakkomandat (ara sezzjoni 4.4 u 4.6).
English: Functional ovarian cysts were observed during and after treatment in 1.0% of patients and in most of the cases spontaneously disappeared within a few weeks.
Maltese: Ċisti funzjonali fl-ovarji kienu osservati matul u wara l-kura f'1.0% tal-pazjenti u f'ħafna mill-każijiet sparixxew spontanjament wara ftit ġimgħat.
English: The efficacy of repeated treatment courses fixed doses of ulipristal acetate 5 mg or 10 mg once daily was evaluated in two Phase 3 studies assessing up to 4 intermittent 3-month treatment courses in patients with heavy menstrual bleeding associated with uterine fibroids.
Maltese: L-effikaċja ta' dożi fissi b'korsijiet ta' kura ripetuti ta' ulipristal acetate 5 mg jew 10 mg darba kuljum kienet evalwata f'żewġ studji tal-Fażi 3 li jivvalutaw sa 4 korsijiet ta' kura intermittenti ta' 3 xhur f'pazjenti bi fsada mestrwali qawwija assoċjata ma' fibrojdi fl-utru.
English: - Certain medicines used to treat hypertension (e.g. verapamil).
Maltese: - Ċerti mediċini użati biex jikkuraw il-pressjoni għolja (eż. verapamil).