FrancophonIA/ELRC3.0 huggingface dataset:
English: Esmya is to be taken daily during treatment courses of up to 3 months continuously.
Slovenian: Zdravilo Esmya je treba jemati neprekinjeno vsak dan v času cikla zdravljenja, ki traja po največ 3 mesece.
English: Endometrium
Slovenian: Endometrij
English: A majority of women taking a therapeutic dose of ulipristal acetate have anovulation, however, the level of fertility while taking multiple doses of ulipristal acetate has not been studied.
Slovenian: Pri večini žensk, ki jemljejo terapevtske odmerke ulipristalacetata, se pojavi anovulacija, vendar stopnje plodnosti pri jemanju večkratnih odmerkov ulipristalacetata niso raziskovali.
English: In addition, reversible increase of the endometrium thickness may occur under treatment.
Slovenian: Poleg tega se lahko med zdravljenjem pojavi reverzibilna odebelitev endometrija.
English: One tablet contains 5 mg of ulipristal acetate.
Slovenian: Ena tableta vsebuje 5 mg ulipristalacetata.
English: The treating physician should explain to the patient the requirement for treatment free intervals.
Slovenian: Lečeči zdravnik mora bolnici pojasniti, zakaj potrebuje obdobja brez zdravljenja.
English: Ulipristal acetate is excreted in human milk.
Slovenian: Ulipristalacetat se izloča v mleko pri človeku.
English: • reminder of the effect of ulipristal acetate on the endometrium.
Slovenian: • opomnik o učinku ulipristalacetata na endometrij,
English: Study 3 was on open-label study assessing ulipristal acetate 10 mg, where each of the 3-month treatment was followed by 10 days of double-blind treatment with progestin or placebo.
Slovenian: Študija 3 je bila odprta študija, v kateri so ocenili 10 mg odmerek ulipristalacetata; vsakemu 3-mesečnemu ciklu zdravljenja je sledilo 10 dni dvojno slepega zdravljenja s progestinom ali placebom.
English: Thus hormonal contraceptives and progestagens are likely to reduce ulipristal acetate efficacy by competitive action on the progesterone receptor.
Slovenian: Verjetno je, da bodo ta hormonska kontracepcijska sredstva in progestageni prek kompetitivnega delovanja na receptor za progesteron zmanjšali učinkovitost ulipristalacetata.
English: In study 2, the reduction in menstrual blood loss was comparable for the patients treated with ulipristal acetate and the gonadotrophin releasing hormone-agonist (leuprorelin).
Slovenian: V drugi študiji je bilo zmanjšanje izgube menstrualne krvi pri bolnicah, ki so prejemale ulipristalacetat in agonist gonadoliberina (levprorelinom), primerljivo.
English: During treatment with Esmya, your doctor will carry out regular blood tests to check your liver function.
Slovenian: Med zdravljenjem z zdravilom Esmya boste po navodilu zdravnika opravljali redne krvne preiskave za preverjanje delovanja jeter.
English: Leuprorelin 3.75 mg/ month N=93
Slovenian: Levprorelin 3,75 mg/mesec N=93
English: Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.
Slovenian: Za ženske s hudo obliko astme, ki je neustrezno nadzorovana s peroralnimi glukokortikoidi, uporaba zdravila ni priporočljiva.
English: Median PBAC at baseline
Slovenian: Mediana PBAC ob izhodišču
English: • inform the patients on the need to warn their physicians on any liver problems they may have.
Slovenian: • bolnice obvestite, da morajo svojim zdravnikom povedati o morebitnih težavah z jetri.
English: In about 10-15% of patients treated with ulipristal acetate the endometrium may thicken (> 16 mm) during the first 3-month treatment course.
Slovenian: Pri približno 10-15 % bolnic, ki se zdravijo z ulipristalacetatom, se lahko v prvem 3-mesečnem ciklu zdravljenja endometrij odebeli (> 16 mm).
English: NA N=202 N=192
Slovenian: N=202 N=192
English: Esmya can cause side effects although not everybody gets them.
Slovenian: Zdravilo Esmya lahko povzroči neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
English: If during the treatment you experience any liver related signs such as feeling of being sick (nausea or vomiting), fatigue, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache, you should stop treatment and immediately contact a doctor, who will check the functioning of your liver and decide if you can continue the treatment.
Slovenian: Če se vam med zdravljenjem pojavijo znaki, povezani z delovanjem jeter, kot so slabost (siljenje na bruhanje) ali bruhanje, utrujenost, huda utrujenost, zlatenica (porumenelost oči ali kože), temen urin, srbenje ali bolečina v zgornjem delu trebuha, morate o tem takoj obvestiti zdravnika, ki bo preveril delovanje vaših jeter in se odločil, ali boste z zdravljenjem nadaljevali.
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.
Slovenian: Ulipristalacetat se hitro pretvori v farmakološko aktivni presnovek z vrednostjo Cmax 9,0 ± 4,4 ng/ml in 20,6 ± 10,9 ng/ml približno eno uro po zaužitju ter AUC0-∞ 26,0 ± 12,0 ng.h/ml oziroma 63,6 ± 30,1 ng.h/ml.
English: Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment (see sections 4.4 and 4.5).
Slovenian: Pri večini žensk, ki jemljejo terapevtske odmerke ulipristalacetata, ovulacija izostaja, kljub temu pa je med zdravljenjem priporočljivo uporabljati nehormonsko kontracepcijsko metodo (glejte poglavji 4.4 in 4.5).
English: Median change in myoma volume from baseline a Treatment course 2 assessment corresponds to Treatment course 2 plus one menstrual bleeding.
Slovenian: Mediana sprememba prostornine leiomiomov glede na izhodišče a Ocena 2. cikla zdravljenja ustreza 2. ciklu zdravljenja in eni menstruacijski krvavitvi.
English: This effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.
Slovenian: Ni pričakovati, da bi bil učinek zdravil, ki povečajo pH v želodcu, klinično pomemben za dnevno uporabo tablet ulipristalacetata.
English: You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards.
Slovenian: Vedeti morate, da med zdravljenjem in nekaj tednov po njem večina žensk nima menstrualnih krvavitev (perila).
English: • Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Esmya
Slovenian: • Izobraževalno gradivo za zdravnike, ki predpisujejo zdravilo (ginekologi), ki vsebuje: o spremno pismo, o povzetek glavnih značilnosti zdravila, o vodnik za predpisovanje zdravila Esmya za zdravnike.
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.
Slovenian: Varnost ulipristalacetata so ocenili pri 1053 ženskah z materničnimi leiomiomi, ki so jih v študijah III. faze zdravili s 5 mg ali 10 mg ulipristalacetata.
English: Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator characterised by a tissue-specific partial progesterone antagonist effect.
Slovenian: Ulipristalacetat je peroralno delujoči, sintetični selektivni modulator progesteronskih receptorjev, za katerega je značilen za tkivo značilni, delni progesteronski antagonistični učinek.
English: Concomitant use of progestagen-only pills, a progestagen-releasing intrauterine device or combined oral contraceptive pills is not recommended (see section 4.5).
Slovenian: Sočasna uporaba tablet, ki vsebujejo samo progestagen, materničnega vložka, ki sprošča progestagen ali kombiniranih peroralnih kontracepcijskih tablet ni priporočljiva (glejte poglavje 4.5).
English: Potential for ulipristal acetate to affect other medicinal products:
Slovenian: Možnost vpliva ulipristalacetata na druga zdravila:
English: If you forget to take Esmya
Slovenian: Če ste pozabili vzeti zdravilo Esmya
English: Do not take Esmya if you have liver problems.Tell your doctor if you know that you have problems with your liver or if you have any doubts about the condition of your liver.
Slovenian: Povejte svojemu zdravniku, če veste, da imate težave z jetri ali če imate kakšne pomisleke glede stanja jeter.
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.
Slovenian: Podatki in vitro kažejo, da ulipristalacetat pri klinično pomembnih koncentracijah lahko zavira P-gp v steni prebavil med absorpcijo.
English: Treatments should only be initiated when menstruation has occurred: - The first treatment course should start during the first week of menstruation.
Slovenian: Cikli se smejo začeti samo ob nastopu menstruacije: - prvi cikel zdravljenja se mora začeti v prvem tednu menstruacije.
English: When daily administration of a 5 mg dose is commenced during a menstrual cycle most subjects (including patients with myoma) will complete their first menstruation but will not menstruate again until after treatment is stopped.
Slovenian: Če se jemanje odmerka 5 mg dnevno začne med menstruacijskim ciklom, se bo pri večini bolnic (vključno z bolnicami z miomom) prva menstruacija normalno končala, vendar do konca zdravljenja ne bodo imele več mesečne krvavitve.
English: Alopecia** Dry skin Hyperhidrosis
Slovenian: Bolezni kože in podkožja akne alopecija** suha koža hiperhidroza angioedem
English: • nausea (feeling sick)
Slovenian: • slabost (siljenje na bruhanje)
English: You need blood tests before starting each treatment course to find out how your liver is working.
Slovenian: Pred vsakim začetkom cikla zdravljenja boste opravili krvne preiskave, da se ugotovi, kako delujejo vaša jetra.
English: If endometrial thickness persists after return of menstruations during off-treatment periods or beyond 3 months following the end of treatment courses, it may need to be investigated as per usual clinical practice to exclude other underlying conditions.
Slovenian: Če odebelitev endometrija vztraja tudi po ponovnem pojavu menstruacije v obdobjih brez zdravljenja ali več kot 3 mesece po koncu ciklov zdravljenja, bo to morda potrebno raziskati skladno z običajno klinično prakso, da se izključijo druge obstoječe bolezni.
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.
Slovenian: Odmerek ulipristalacetata 5 mg dnevno zavira ovulacijo pri večini bolnic, kar se kaže z vzdrževanjem ravni progesterona pri približno 0,3 ng/ml.
English: Among these 1,053 women, the safety of repeated intermittent treatment courses (each limited to 3 months) has been evaluated in 551 women with uterine fibroids treated with 5 or 10 mg ulipristal acetate in two phase III studies (including 446 women exposed to four intermittent treatment courses of whom 53 were exposed to eight intermittent treatment courses) and demonstrated a similar safety profile to that observed for one treatment course.
Slovenian: Pri 551 ženskah od 1053 z materničnimi leiomiomi, ki so se zdravile s 5 ali 10 mg ulipristalacetata, so ocenili varnost ponavljajočih se intermitentnih ciklov zdravljenja (vsakega omejenega na 3 mesece) v dveh študijah III. faze (vključenih je bilo 446 žensk, ki so prejele 4 intermitentne cikle zdravljenja; 53 od njih je prejelo osem intermitentnih ciklov zdravljenja) in ugotovili podoben varnostni profil kot pri enem ciklu zdravljenja.
English: It is therefore recommended that co-administration of ulipristal acetate and P-gp substrates (e.g. dabigatran etexilate, digoxin, fexofenadine) should be separated in time by at least 1.5 hours.
Slovenian: Zaradi tega se pri sočasni uporabi ulipristalacetata in substratov P-gp (dabigatran eteksilat, digoksin, feksofenadin) priporoča vsaj 1,5 urni razmik.
English: There are no or limited amount of data from the use of ulipristal acetate in pregnant women.
Slovenian: Podatkov o uporabi ulipristalacetata pri nosečnicah ni, ali pa so omejeni.
English: Ulipristal acetate may interfere with the action of hormonal contraceptive medicinal products (progestagen only, progestagen releasing devices or combined oral contraceptive pills) and progestagen administered for other reasons.
Slovenian: Ulipristalacetat lahko vpliva na delovanje hormonskih kontracepcijskih sredstev (ki vsebujejo samo progestagen, vložkov, ki sproščajo progestagen ali kombiniranih peroralnih kontracepcijskih tablet) in progestagena, ki se uporablja zaradi drugih razlogov.
English: Liver function tests must be performed before starting treatment.
Slovenian: Pred začetkom zdravljenja je treba opraviti preiskave delovanja jeter.
English: After treatment course 4 (four times 3 months of treatment)
Slovenian: Po 4. ciklu zdravljenja (štirikratno 3-mesečno zdravljenje)
English: During the post-marketing experience, cases of liver injury and hepatic failure were reported (see section 4.3).
Slovenian: Po začetku trženja so poročali o primerih okvare in odpovedi jeter (glejte poglavje 4.3).
English: Ulipristal acetate has a steroid structure and acts as a selective progesterone receptor modulator with predominantly inhibitory effects on the progesterone receptor.
Slovenian: Ulipristalacetat ima steroidno zgradbo in deluje kot selektivni modulator progesteronskih receptorjev z večinoma zaviralnim učinkom nanje.
English: SIGNS AND SYMPTOMS OF POSSIBLE LIVER PROBLEMS Stop treatment and contact a doctor right away if you observe any of the following signs or symptoms:
Slovenian: ZNAKI IN SIMPTOMI MOREBITNIH TEŽAV Z JETRI Če opazite katerega od naslednjih znakov ali simptomov, takoj prekinite zdravljenje in o tem obvestite svojega zdravnika:
English: • the need to investigate as per usual clinical practice persistence of endometrial thickening following treatment discontinuation and return of menstruation to exclude other underlying conditions.
Slovenian: • informacija, da je treba skladno z običajno klinično prakso raziskati odebelitev endometrija, ki ne izgine po prekinitvi zdravljenja in ponovnem pojavu menstruacije, da se izločijo druge obstoječe bolezni,
English: • liver function must be monitored monthly during the first 2 treatment courses, and thereafter when clinically indicated.
Slovenian: • med zdravljenjem je treba v obdobju prvih dveh ciklov enkrat mesečno opraviti preiskave delovanja jeter, kasneje pa kot je klinično indicirano.
English: Very common (may affect more than 1 in 10 people) side effects: - reduction or absence of menstrual bleeding (amenorrhea) - thickening of the lining of the womb (endometrial thickening).
Slovenian: Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 osebi od 10): - zmanjšanje ali odsotnost menstrualne krvavitve (amenoreja), - odebelitev maternične sluznice (odebelitev endometrija).
English: If you stop taking Esmya
Slovenian: Če ste prenehali jemati zdravilo Esmya
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.
Slovenian: Po peroralni uporabi enkratnega 5- ali 10-miligramskega odmerka se ulipristalacetat hitro absorbira, pri čemer je vrednost Cmax 23,5 ± 14,2 ng/ml, približno 1 uro po zaužitju pa 50,0 ± 34,4 ng/ml, in AUC0-∞ 61,3 ± 31,7 ng.h/ml oziroma 134,0 ± 83,8 ng.h/ml.
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.
Slovenian: Ocenili so, da je končna razpolovna doba ulipristalacetata v plazmi po enkratnem odmerku 5 mg ali 10 mg približno 38 ur, povprečni peroralni očistek (CL/F) pa približno 100 l/h.
English: - Re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion.
Slovenian: - ponovna zdravljenja se lahko začnejo šele v prvem tednu druge menstruacije po zaključenem prejšnjem ciklu zdravljenja.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in na pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: What Esmya contains - The active substance is ulipristal acetate.
Slovenian: Kaj vsebuje zdravilo Esmya - Učinkovina je ulipristalacetat.
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.
Slovenian: • če bolnica med zdravljenjem kaže znake ali simptome, ki nakazujejo okvaro jeter, je treba zdravljenje prekiniti, bolnico pa nemudoma pregledati in opraviti preiskave delovanja jeter.
English: The MAH shall ensure that, at launch and thereafter, all prescribers of Esmya and pathologists who review samples from Esmya-treated patients, as well as patients treated with Esmya, are provided with educational material.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je ob prihodu zdravila na trg in ves čas trženja zdravila vsem zdravnikom, ki predpisujejo zdravilo Esmya, patologom, ki pregledujejo vzorce bolnic, ki se zdravijo z zdravilom Esmya, in bolnicam, ki se zdravijo z zdravilom Esmya, na voljo izobraževalno gradivo.
English: Esmya is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4).
Slovenian: Zdravilo Esmya je kontraindicirano pri bolnicah z jetrno boleznijo (glejte poglavji 4.3 in 4.4).
English: Urinary incontinence
Slovenian: Bolezni sečil urinarna inkontinenca
English: nausea or vomiting, severe tiredness, jaundice (yellowing of the eyes or skin), dark urine, itching or upper stomach ache.
Slovenian: - slabost ali bruhanje, huda utrujenost, zlatenica (porumenelost oči ali kože), temen urin, srbenje ali bolečina v zgornjem delu trebuha.
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.
Slovenian: • zdravljenje se ne sme uvesti pri bolnicah z vrednostjo alanin transaminaze (ALT) ali aspartat aminotransferaze (AST) > 2 x ZMN (same ali v kombinaciji z bilirubinom > 2 x ZMN).
English: Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Slovenian: Ulipristalacetat je indiciran za en cikel predoperacijskega zdravljenja zmernih do hudih simptomov materničnih leiomiomov pri odraslih ženskah v rodni dobi.
English: Treatment with Esmya usually leads to a significant reduction or may even stop your menstrual bleeding (your ‘period') within the first 10 days of treatment.
Slovenian: Zdravljenje z zdravilom Esmya ponavadi v prvih 10 dneh zdravljenja bistveno zmanjša menstrualne krvavitve (mesečno perilo) ali jih lahko celo ustavi.
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.
Slovenian: Pri 10-15 % bolnic, ki so prejemale ulipristalacetat, so do konca prvega 3-mesečnega cikla zdravljenja opazili odebelitev endometrija (> 16 mm ob ultrazvoku ali MRI na koncu zdravljenja).
English: Treatments should only be initiated when menstruation has occurred: the first treatment course should start during the first week of menstruation, re-treatment courses should start at the earliest during the first week of the second menstruation following the previous treatment course completion.
Slovenian: Cikli se smejo začeti samo ob nastopu menstruacije: prvi cikel zdravljenja se mora začeti v prvem tednu menstruacije, ponovna zdravljenja pa se lahko začnejo šele v prvem tednu druge menstruacije po zaključenem prejšnjem ciklu zdravljenja.
English: If a patient during treatment shows signs or symptoms compatible with liver injury (fatigue, asthenia, nausea, vomiting, right hypochondrial pain, anorexia, jaundice), treatment should be stopped and the patient should be investigated immediately, and liver function tests performed.
Slovenian: Če bolnica kaže znake ali simptome, ki nakazujejo okvaro jeter (utrujenost, astenija, navzea, bruhanje, bolečina v desnem hipohondriju, anoreksija, zlatenica), je treba zdravljenje prekiniti, bolnico pa nemudoma pregledati in opraviti preiskave delovanja jeter.
English: Administration of ulipristal acetate (30 mg tablet) together with a high-fat breakfast resulted in approximately 45% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean AUC0-∞ compared with administration in the fasted state.
Slovenian: Uporaba ulipristalacetata (30-miligramske tablete) skupaj z zajtrkom z veliko maščobami je povzročila približno 45 % manjšo povprečno vrednost Cmax, poznejši čas tmax ( z mediane 0,75 ure na 3 ure) in 25 % večjo povprečno vrednost AUC0-∞ v primerjavi z uporabo na tešče.
English: • in addition, liver testing should be performed within 2-4 weeks after treatment has stopped.
Slovenian: • poleg tega je treba opraviti preiskave jeter 2-4 tedne po prenehanju zdravljenja.
English: • inform the patients not to take Esmya in case of liver problems.
Slovenian: • bolnice opozorite, da ne smejo jemati zdravila Esmya, če imajo težave z jetri.
English: The efficacy of fixed doses of ulipristal acetate 5 mg and 10 mg once daily was evaluated in two Phase 3 randomised, double-blind, 13 week studies recruiting patients with very heavy menstrual bleeding associated with uterine fibroids.
Slovenian: Učinkovitost fiksnih odmerkov ulipristalacetata 5 mg in 10 mg enkrat dnevno so ocenjevali v dveh randomiziranih, dvojno slepih, 13-tedenskih študijah III. faze, v katerih so sodelovale bolnice z zelo močno menstruacijsko krvavitvijo, povezano z materničnimi leiomiomi.
English: Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment.
Slovenian: Pri večini žensk, ki jemljejo terapevtske odmerke ulipristalacetata, ovulacija izostaja, kljub temu pa je med zdravljenjem priporočljivo uporabljati nehormonsko kontracepcijsko metodo.
English: In case of repeated treatment courses, endometrial thickening was less frequently observed (4.9% of patients after second treatment course and 3.5% after fourth treatment course).
Slovenian: Ob ponavljajočih se ciklih zdravljenja so redkeje opazili odebelitev endometrija (pri 4,9 % bolnic po drugem ciklu zdravljenja in pri 3,5 % bolnic po četrtem ciklu zdravljenja).
English: Tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines can affect Esmya or be affected by Esmya: - Certain medicines which are used to treat the heart (e.g. digoxin).
Slovenian: Povejte zdravniku ali farmacevtu, če jemljete katero koli od spodaj navedenih zdravil, saj ta zdravila lahko vplivajo na zdravilo Esmya, ali pa zdravilo Esmya vpliva nanje: - nekatera zdravila za zdravljenje bolezni srca (npr. digoksin), - nekatera zdravila za preprečevanje možganske kapi in krvnih strdkov (npr. dabigatraneteksilat), - nekatera zdravila za zdravljenje epilepsije (npr. fenitoin, fosfenitoin, fenobarbital,
English: Esmya 5 mg tablets
Slovenian: Esmya 5 mg tablete
English: Ulipristal acetate exerts a direct action on fibroids reducing their size through inhibition of cell proliferation and induction of apoptosis.
Slovenian: Ulipristalacetat deluje neposredno na leiomiome, saj z zaviranjem proliferacije celic in indukcijo apoptoze zmanjša njihovo velikost.