FrancophonIA/ELRC3.0 huggingface dataset:
English: Bold values in shaded squares indicate that there was a significant difference in the comparisons between ulipristal acetate and the control.
Slovenian: Okrepljene vrednosti in osenčena polja pomenijo, da je bila pri primerjavi med ulipristalacetatom in kontrolo pomembna razlika, ki je bila vedno v korist ulipristalacetata.
English: For further treatment courses, liver function must be tested once before each new treatment course and when clinically indicated.
Slovenian: Pri nadaljnjih ciklih zdravljenja je treba preiskave delovanja jeter opraviti pred vsakim novim ciklom zdravljenja in kadar za to obstajajo klinične indikacije.
English: Ulipristal acetate is likely to adversely interact with progestagen-only pills, progestagen-releasing devices or combined oral contraceptive pills, therefore, concomitant use is not recommended.
Slovenian: Verjetno je, da bo ulipristalacetat imel škodljivi učinek na tablete, ki vsebujejo samo progestagen, maternične vložke, ki sproščajo progestagen ali kombinirane peroralne kontracepcijske tablete, zato sočasna uporaba ni priporočljiva.
English: A PBAC >100 within the first 8 days of menses is considered to represent excessive menstrual blood loss.
Slovenian: Chart - PBAC) Čezmerna izguba menstruacijske krvi je opredeljena kot vrednost PBAC > 100 v prvih 8 dneh menstruacije.
English: What Esmya looks like and contents of the pack Esmya is white to off-white, round curved tablet of 7 mm engraved with code “ES5” on one face.
Slovenian: Zdravilo Esmya je bela do umazano bela okrogla izbočena tableta s premerom 7 mm, z vtisnjenim napisom »ES5« na eni strani.
English: In the absence of specific studies, ulipristal acetate is not recommended in patients with severe renal impairment unless the patient is closely monitored (see sections 4.4 and 5.2).
Slovenian: Specifičnih študij niso opravili, zato uporaba ulipristalacetata pri bolnicah s hudo ledvično okvaro ni priporočljiva, razen če bolnico pozorno spremljate (glejte poglavji 4.4 in 5.2).
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.
Slovenian: Uporaba ulipristalacetata (10-miligramske tablete) skupaj z zaviralcem protonske črpalke, esomeprazolom (20 mg dnevno 6 dni), je povzročila približno 65 % manjšo povprečno vrednost Cmax, poznejši čas tmax (z mediane 0,75 ure na 1,0 ure) in 13 % večjo povprečno vrednost AUC.
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.
Slovenian: Ulipristalacetat je indiciran za intermitentno zdravljenje zmernih do hudih simptomov materničnih leiomiomov pri odraslih ženskah v rodni dobi, ki niso primerne ali ne želijo na operacijo.
English: Menstrual bleeding
Slovenian: Menstruacijska krvavitev
English: Weight increased Blood cholesterol increased
Slovenian: Preiskave povečanje telesne mase povišan holesterol v krvi povišani trigliceridi v krvi
English: In addition liver testing should be performed 2- 4 weeks after treatment has stopped.
Slovenian: Poleg tega je treba opraviti preiskave jeter od 2 do 4 tedne po prenehanju zdravljenja.
English: In subsequent treatment courses, endometrial thickening was less frequently observed (4.9% and 3.5% of patients by the end of second and fourth treatment course, respectively).
Slovenian: V naslednjih ciklih zdravljenja so odebelitev endometrija opazili manj pogosto (do konca drugega cikla zdravljenja pri 4,9 % bolnic in do konca četrtega cikla zdravljenja pri 3,5 % bolnic).
English: Before you start treatment with Esmya blood tests will be undertaken to find out how well your liver is working.
Slovenian: Opozorila in previdnostni ukrepi - pred uvedbo zdravljenja z zdravilom Esmya, boste opravili preiskave krvi, da se ugotovi, kako dobro delujejo vaša jetra.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti, ne kažejo posebnega tveganja za človeka.
English: Ulipristal acetate is contraindicated during pregnancy (see section 4.3).
Slovenian: Ulipristalacetat je med nosečnostjo kontraindiciran (glejte poglavje 4.3).
English: • the posology: 5 mg tablet once daily for treatment courses of up to 3 months each.
Slovenian: • odmerjanje: 5 mg tableta enkrat dnevno v ciklih zdravljenja, od katerih vsak traja do 3 mesece.
English: No pharmacokinetic studies with ulipristal acetate have been performed in women with impaired renal or hepatic function.
Slovenian: Pri ženskah z okvarjenim delovanjem ledvic ali jeter niso opravili nobenih farmakokinetičnih študij z ulipristalacetatom.
English: In the absence of specific studies, ulipristal acetate is not recommended for patients with severe renal impairment unless the patient is closely monitored (see section 4.2).
Slovenian: Specifičnih študij niso opravili, zato uporaba ulipristalacetata pri bolnicah s hudo ledvično okvaro ni priporočljiva, razen če bolnico pozorno spremljate (glejte poglavje 4.2).
English: These changes are reversible after treatment cessation.
Slovenian: Po koncu zdravljenja so te spremembe reverzibilne.
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.
Slovenian: Uporaba močnega induktorja CYP3A4, rifampicina (300 mg dvakrat dnevno 9 dni), je pri zdravih prostovoljkah znatno zmanjšala Cmax in AUC ulipristalacetata ter njegovega aktivnega presnovka za 90 % ali več in 2,2-kratno zmanjšala razpolovni čas ulipristalacetata, kar je enako približno 10kratnemu zmanjšanju izpostavljenosti ulipristalacetatu.
English: Method of administration Oral use.
Slovenian: Način uporabe Peroralna uporaba.
English: The lining of the uterus may thicken or change as a result of taking Esmya.
Slovenian: Jemanje zdravila Esmya lahko povzroči odebelitev ali spremembe maternične sluznice.
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.
Slovenian: Učinkovitost ponavljajočih se ciklov zdravljenja s stalnimi odmerki ulipristalacetata 5 mg ali 10 mg enkrat dnevno so ocenili v dveh študijah III. faze z največ štirimi 3-mesečnimi cikli intermitentnega zdravljenja pri bolnicah z močnimi menstrualnimi krvavitvami, povezanimi z leiomiomi.
English: Uterine, cervical, ovarian or breast cancer.
Slovenian: Rak maternice, materničnega vratu, jajčnikov ali dojke.
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.
Slovenian: - če trenutno jemljete hormonska kontracepcijska sredstva (na primer kontracepcijske tablete) (glejte poglavje »Druga zdravila in zdravilo Esmya«), morate med jemanjem zdravila Esmya uporabljati drugo zanesljivo pregradno kontracepcijsko metodo (na primer kondom); - če imate bolezen jeter ali ledvic, povejte svojemu zdravniku ali farmacevtu preden vzamete zdravilo Esmya; - če imate hudo astmo, zdravljenje z zdravilom Esmya morda ni primerno za vas.
English: • baseline liver function tests are required before treatment initiation, and before each new treatment course.
Slovenian: • pred uvedbo zdravljenja je treba opraviti izhodiščne preiskave delovanja jeter in nato pred vsakim novim ciklom zdravljenja.
English: The vast majority spontaneously reversed to normal endometrium after resumption of menstruation during the off-treatment period.
Slovenian: Pri veliki večini se je po ponovnem nastopu menstruacije v času brez zdravljenja endometrij spontano povrnil v normalno stanje.
English: Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
Slovenian: Krvavitve iz spolovil z neznano etiologijo ali krvavitve, katerih vzrok niso maternični leiomiomi.
English: The endometrial thickening reverses when treatment is stopped and menstrual periods resume.
Slovenian: Odebelitev endometrija se normalizira po koncu zdravljenja in ponovni vzpostavitvi menstruacije.
English: This thickening disappears after treatment is withdrawn and menstruation occurs.
Slovenian: Ta odebelitev izgine po koncu zdravljenja, ko nastopi menstruacijska krvavitev.
English: Ulipristal acetate is contraindicated during breastfeeding (see sections 4.3 and 5.2).
Slovenian: Ulipristalacetat je med dojenjem kontraindiciran (glejte poglavji 4.3 in 5.2).
English: If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted (see section "Bleeding pattern" below), investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Slovenian: Če opazimo odebelitev endometrija, ki ne izgine po ponovnem pojavu menstruacije v obdobju brez zdravljenja ali v več kot treh mesecih po koncu ciklov zdravljenja, in/ali če se vzorec krvavitev spremeni (glejte poglavje »Vzorec krvavitev« spodaj), bo to morda treba raziskati, med drugim z biopsijo endometrija, za izključitev morebitnih drugih obstoječih bolezni, tudi malignih sprememb endometrija.
English: Patients whose menstrual bleeding became normal (PBAC < 75) at week 13 Median change in myoma volume from baseline to week 13
Slovenian: Bolnice z amenorejo v 13. tednu Bolnice, pri katerih je menstruacijska krvavitev postala normalna (PBAC < 75) v 13. tednu Mediana spremembe prostornine miomov od izhodišča do 13. tedna a V prvi študiji so spremembo skupne prostornine miomov od izhodišča merili z MRI.
English: 5 mg/day N=213
Slovenian: 5 mg/ dan N=213
English: At the end of treatment course 4, 158 (69.6%) subjects and 164 (74.5%) subjects were assessed as being in amenorrhea, in the 5 mg dose and 10 mg dose respectively (p=0.290).
Slovenian: Ob koncu četrtega cikla zdravljenja so ocenili, da je imelo amenorejo 158 (69,6 %) bolnic, ki so dobivale odmerek 5 mg, in 164 (74,5 %) bolnic, ki so dobivale odmerek 10 mg (p = 0,290).
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).
Slovenian: Po dajanju močnega zaviralca CYP3A4, ketokonazola (400 mg enkrat dnevno v obdobju 7 dni) zdravim prostovoljkam, se je Cmax ulipristalacetata povečala za 2-krat, AUC pa za 5,9-krat ; AUC aktivnega metabolita ulipristalacetata se je povečala za 2,4-krat, medtem ko se je Cmax aktivnega metabolite zmanjšala (0,53-kratna sprememba).
English: In Study 2, a double-dummy method was used to maintain the blind.
Slovenian: V drugi študiji so za skrivanje skupin uporabili metodo dvojnega placeba.
English: Esmya contains the active substance ulipristal acetate.
Slovenian: Zdravilo Esmya vsebuje zdravilno učinkovino ulipristalacetat.
English: Co-administration of moderate (e.g. erythromycin, grapefruit juice, verapamil) or potent (e.g. ketoconazole, ritonavir, nefazodone, itraconazole, telithromycin, clarithromycin) CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.5).
Slovenian: Sočasna uporaba zmernih (npr. eritromicin, sok grenivke, verapamil) ali močnih (npr. ketokonazol, ritonavir, nefazodon, itrakonazol, telitromicin, klaritromicin) zaviralcev CYP3A4 in ulipristalacetata ni priporočljiva (glejte poglavje 4.5).
English: Uncommon (may affect up to 1 in 100 people) side effects: - drug allergy - anxiety - mood swings - dizziness - dry mouth, constipation - hair loss, dry skin, increased sweating - back pain - leakage of urine - bleeding from the womb (uterine bleeding), vaginal discharge, abnormal vaginal bleeding,
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri manj kot 1 osebi od 100): - alergija na zdravilo, - tesnoba, - nihanje razpoloženja, - omotica, - suha usta, zaprtost, - izpadanje las, suha koža, povečano potenje, - bolečina v hrbtu, - uhajanje urina, - krvavitve iz maternice, izloček iz nožnice, nenormalne krvavitve iz nožnice, - neprijeten občutek v dojkah, - otekanje zaradi zadrževanja tekočine (edem), - izjemna utrujenost (astenija), - povišanje ravni holesterola v krvi pri krvnih preiskavah, povišanje maščob (trigliceridov) v krvi pri krvnih preiskavah.
English: Physician's guide to prescribing
Slovenian: Vodnik za predpisovanje zdravila za zdravnike
English: How to take Esmya
Slovenian: Kako jemati zdravilo Esmya
English: During treatment, liver function tests must be performed monthly during the first 2 treatment courses.
Slovenian: Med zdravljenjem je v prvih dveh ciklih zdravljenja treba najmanj enkrat mesečno opraviti preiskave delovanja jeter.
English: Experience with Esmya when several doses are taken at once is limited.
Slovenian: Če ste vzeli večji odmerek zdravila Esmya, kot bi smeli Izkušnje z jemanjem večjega števila odmerkov zdravila Esmya so omejene.
English: Esmya may cause mild dizziness (see section 4 “Possible side effects”).
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Esmya lahko povzroči blago omotico (glejte poglavje 4 »Možni neželeni učinki«).
English: 10 mg/day N=176
Slovenian: 10 mg/ dan N=176
English: 10 mg/day N=207
Slovenian: 10 mg/ dan N=207
English: 5 mg/day N=178
Slovenian: 5 mg/ dan N=178
English: If endometrial thickening is noted, which persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, and/or an altered bleeding pattern is noted, investigation including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Slovenian: Če opazimo odebelitev endometrija, ki ne izgine po ponovnem pojavu menstruacije v obdobju brez zdravljenja ali v več kot treh mesecih po koncu ciklov zdravljenja, in/ali če se vzorec krvavitev spremeni, bo to morda treba raziskati, med drugim z biopsijo endometrija, za izključitev morebitnih drugih obstoječih bolezni, tudi malignih sprememb endometrija.
English: The recommended dose is one 5 mg tablet per day, for treatment courses of up to 3 months each..
Slovenian: Priporočeni odmerek je ena 5-miligramska tableta dnevno, zdravilo pa se jemlje v ciklih, ki trajajo po največ 3 mesece.
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.
Slovenian: Na podlagi podatkov pri 340 ženskah, ki so prejele do 4 cikle 5 ali 10 mg ulipristalacetata, in omejenih podatkov pri 43 ženskah, ki so prejele do 8 ciklov 10 mg ulipristalacetata, se incidenca hiperplazije ob ponavljajočih se ciklih zdravljenja ni povečala.
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.
Slovenian: V študiji 3 so dokazali učinkovitost zdravljenja po več kot 18 mesecih ponavljajočega se intermitentnega zdravljenja (4 cikli po 10 mg enkrat dnevno).
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).
Slovenian: Sočasna uporaba ulipristalacetata in močnih induktorjev CYP3A4 (npr. rifampicina, rifabutina, karbamazepina, okskarbazepina, fenitoina, fosfenitoina, fenobarbitala, primidona, šentjanževke, efavirenza, nevirapina, dolgotrajna uporaba ritonavirja) ni priporočljiva (glejte poglavje 4.4).
English: In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose, respectively, p=0.027).
Slovenian: V študiji 4 je skupno 61,9 % in 72,7 % bolnic imelo amenorejo ob koncu skupnega prvega in drugega cikla zdravljenja (s 5 mg oziroma 10 mg odmerkom, p = 0,032).
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).
Slovenian: Sočasna uporaba ulipristalacetata in močnih induktorjev CYP3A4 (npr. rifampicina, rifabutina, karbamazepina, okskarbazepina, fenitoina, fosfenitoina, fenobarbitala, primidona, šentjanževke, efavirenza, nevirapina, dolgotrajna uporaba ritonavirja) ni priporočljiva (glejte poglavje 4.5).
English: Microcrystalline cellulose Mannitol
Slovenian: 6.1 Seznam pomožnih snovi mikrokristalna celuloza manitol premreženi natrijev karmelozat smukec magnezijev stearat
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).
Slovenian: Po uporabi zmernega zaviralca CYP3A4, eritromicinpropionata (500 mg dvakrat dnevno, 9 dni) pri zdravih prostovoljkah, se je vrednost Cmax ulipristalacetata povečala 1,2-krat, vrednost AUC pa 2,9krat; vrednost AUC aktivnega presnovka ulipristalacetata se je povečala 1,5-krat, vrednost Cmax aktivnega presnovka pa se je zmanjšala (0,52-krat).
English: - Certain medicines to treat fungal infections (e.g. ketoconazole (except shampoo), itraconazole).
Slovenian: eritromicin, rifabutin), - nekatera zdravila za zdravljenje glivičnih okužb (npr. ketokonazol (razen v obliki šampona),
English: Similar results were obtained for the active mono-N-demethylated metabolite.
Slovenian: Pri aktivnem monoN-demetiliranem presnovku so dobili približno enake rezultate.
English: The treatment consists of one tablet of 5 mg to be taken once daily for treatment courses of up to 3 months each.
Slovenian: Bolnica jemlje eno 5-miligramsko tableto enkrat dnevno v ciklih zdravljenja, ki trajajo do 3 mesece.
English: No dose adjustment is recommended in patients with mild or moderate renal impairment.
Slovenian: Pri bolnicah z blago ali zmerno ledvično okvaro prilagoditev odmerka ni potrebna.
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)
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri manj kot 1 osebi od 10): - glavobol, - vrtoglavica (vertigo), - bolečine v trebuhu, slabost (navzea), - akne, - bolečine v mišicah in kosteh, - votlinice s tekočino v jajčnikih (ciste na jajčnikih), občutljive dojke/bolečine v dojkah, bolečine v spodnjem delu trebuha (medenici), vročinski oblivi, - utrujenost, - povečanje telesne mase.
English: Esmya 5 mg tablets Ulipristal acetate
Slovenian: Esmya 5 mg tablete ulipristalacetat
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vertigo
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.
Slovenian: V preskušanjih III. faze so pri 0,4 % bolnikov poročali o simptomih preobčutljivosti na zdravilo, kot so generalizirani edem, pruritus, izpuščaj, otekel obraz ali urtikarija.
English: If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding,
Slovenian: Če se med ponavljajočim se intermitentnim zdravljenjem po začetnem zmanjšanju krvavitev ali amenoreji pojavi trajno spremenjen ali nepričakovan vzorec krvavitev, kot so vmesne krvavitve, bo morda potreben pregled endometrija, vključno z biopsijo, za izključitev drugih bolezni, tudi malignih sprememb endometrija.
English: - Medicines used to treat certain bacterial infections (e.g. rifampicin, telithromycin,
Slovenian: karbamazepin, okskarbazepin, primidon), - nekatera zdravila za zdravljenje okužbe z virusom HIV (npr. ritonavir, efavirenz, nevirapin), - zdravila za zdravljenje bakterijskih okužb (npr. rifampicin, telitromicin, klaritromicin,
English: Hot flush
Slovenian: Vročinski oblivi
English: Rare (may affect up to 1 in 1,000 people) side effects: - nosebleed - indigestion, bloating - break of sac of fluid within the ovaries (ovarian cyst ruptured) - breast swelling.
Slovenian: Redki neželeni učinki (lahko se pojavijo pri manj kot 1 osebi od 1000): - krvavitev iz nosu, - prebavne motnje, napihnjenost, - predrtje votlinice s tekočino v jajčnikih (ciste na jajčnikih), - otekanje dojk.
English: How to store Esmya
Slovenian: Shranjevanje zdravila Esmya
English: Study 1
Slovenian: Prva študija
English: Angioedema
Slovenian: Hipofiza
English: • the need to inform the pathologist that patients were treated with Esmya if biopsy/surgical samples are to be sent for analysis.
Slovenian: • če se vzorci biopsije/kirurški vzorci pošiljajo na analizo, je treba patologe obvestiti, da so bolnice prejemale zdravilo Esmya, ,
English: Ulipristal acetate 10 mg/day N=94
Slovenian: Ulipristal acetat 10 mg/da n N=94
English: Concomitant treatments
Slovenian: Uporaba drugih zdravil
English: 2nd TEST (4 weeks after starting treatment) 3rd TEST (8 weeks after starting treatment) 4th TEST (12 weeks after starting treatment) 5th TEST (2- 4 weeks after stopping Esmya treatment)
Slovenian: PREISKAVA (2 - 4 tedne po prenehanju zdravljenja z zdravilom Esmya)
English: Ulipristal acetate 5 mg/day N=93
Slovenian: Ulipristal acetat 5 mg/dan N=93
English: No dose adjustment is considered necessary for administration of ulipristal acetate to patients receiving concomitant mild CYP3A4 inhibitors.
Slovenian: Pri bolnicah, ki sočasno prejemajo ulipristalacetat in blage zaviralce CYP3A4, odmerka ni treba prilagajati.
English: Ovarian cyst
Slovenian: • temen urin
English: Drug hypersensitivity
Slovenian: Preobčutljivost na zdravilo
English: Uterine haemorrhage
Slovenian: Cista jajčnikov
English: Drug hypersensitivity*
Slovenian: Bolezni imunskega sistema preobčutljivost na zdravilo*
English: swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties.
Slovenian: Prenehajte uporabljati zdravilo Esmya in nemudoma obiščite zdravnika, če imate katerega od naslednjih simptomov: - otekanje obraza, jezika ali grla; težave pri požiranju; koprivnica in težave z dihanjem.
English: Oedema Asthenia
Slovenian: Posebne skupine bolnikov
English: Ulipristal acetate 5 mg/day N=95
Slovenian: Ulipristal acetat 5 mg/dan N=95
English: Ulipristal acetate 10 mg/day N=95
Slovenian: Ulipristal acetat 10 mg/da n N=95
English: Underlying hepatic disorder.
Slovenian: Osnovna bolezen jeter.
English: Amenorrhea Endometrial thickening*
Slovenian: Motnje reprodukcije in dojk amenoreja odebelitev endometrija*