FrancophonIA/ELRC3.0 huggingface dataset:
English: In study 1, a statistically significant difference was observed in reduction in menstrual blood loss in favour of the patients treated with ulipristal acetate compared to placebo (see Table 1 below), resulting in faster and more efficient correction of anaemia than iron alone.
Slovenian: V prvi študiji so opazili statistično pomembno razliko v zmanjšanju izgube menstruacijske krvi v korist bolnic, ki so jih zdravili z ulipristalacetatom, v primerjavi s placebom (glejte spodnjo preglednico 1), kar je povzročilo hitrejšo in učinkovitejšo korekcijo anemije kot monoterapija z železom.
English: • inform the patients about the need for monitoring of liver function before starting each treatment course, monthly during treatment and within a few weeks after the treatment has stopped.
Slovenian: • bolnice obvestite, da je treba opraviti preiskave delovanja jeter pred začetkom vsakega cikla zdravljenja, mesečno med zdravljenjem in v nekaj tednih po prenehanju zdravljenja.
English: A few cases have been reported during ulipristal acetate treatment or within 2-3 months after ulipristal acetate treatment was stopped.
Slovenian: O nekaj primerih so poročali med zdravljenjem z ulipristalacetatom ali 2-3 mesece po koncu zdravljenja z ulipristalacetatom.
English: In case of hyperplasia (without atypia), monitoring as per usual clinical practice (e.g. a follow-up control 3 months later) would be recommended.
Slovenian: V primeru hiperplazije endometrija (brez atipičnosti) se priporoča spremljanje skladno z običajno klinično prakso (npr. kontrolni pregled čez 3 mesece).
English: When comparing repeated treatment courses, overall adverse reactions rate was less frequent in subsequent treatment courses than during the first one and each adverse reaction was less frequent or remained in the same frequency category (except for dyspepsia which was classified as uncommon in treatment course 3 based on one patient occurence).
Slovenian: Pri primerjavi ponavljajočih se ciklov zdravljenja so bili neželeni učinki na splošno manj pogosti pri nadaljnjih ciklih zdravljenja kot med prvim in vsak neželeni učinek je bil manj pogost ali je ostal v isti skupini pogostnosti (razen dispepsije, ki je bila na podlagi pojavnosti pri eni bolnici opredeljena kot občasna v 3. ciklu zdravljenja).
English: Patients in this study were required to be anaemic at Study entry (Hb < 10.2 g/dl) and all patients were to receive oral iron 80 mg Fe++ in addition to study medicinal product.
Slovenian: Bolnice, vključene v to študijo, so morale biti ob vključevanju v študijo anemične (Hb < 10,2 g/dl), vse bolnice pa so morale poleg preiskovanega zdravila peroralno prejemati tudi železo, 80 mg Fe++.
English: DATE
Slovenian: DATUM
English: Available toxicological data in animals have shown excretion of ulipristal acetate in milk (for details see section 5.3).
Slovenian: Toksikološki podatki, ki so na voljo, so pokazali, da se ulipristalacetat izloča v mleko (podrobnosti so v poglavju 5.3).
English: • recommendation of a periodic monitoring of the endometrium in case of repeated intermittent treatment.
Slovenian: • priporočilo rednega spremljanja stanja endometrija pri ponavljajočem se intermitentnem zdravljenju.
English: • key effects of Esmya on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
Slovenian: • ključni učinki zdravila Esmya na spremembe endometrija, povezane z modulatorji progesteronskih receptorjev (PAEC- Progesterone Receptor Modulator Associated Endometrial Changes) in kako se ti učinki razlikujejo od učinkov neoviranega estrogena,
English: - The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, talc and magnesium stearate.
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, manitol, premreženi natrijev karmelozat, smukec in magnezijev stearat.
English: In vitro data indicate that ulipristal acetate and its active metabolite do not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, or induce CYP1A2 at clinically relevant concentrations.
Slovenian: Podatki in vitro kažejo, da ulipristalacetat in njegovi aktivni presnovki pri klinično pomembnih koncentracijah ne zavirajo encimov CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 in 3A4 ali inducirajo CYP1A2.
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.
Slovenian: In vivo rezultati kažejo, da ulipristalacetat (uporaba v obliki ene 10 mg tablete) 1,5 ure pred uporabo substrata P-gp feksofenadina (60 mg) nima klinično pomembnih učinkov na farmakokinetiko feksofenadina.
English: Esmya is likely to make some hormonal contraceptives less effective (see “Other medicines and Esmya”).
Slovenian: Zdravilo Esmya lahko zmanjša učinkovitost nekaterih hormonskih kontracepcijskih sredstev (glejte poglavje »Druga zdravila in zdravilo Esmya«).
English: Renal impairment is not expected to significantly alter the elimination of ulipristal acetate.
Slovenian: Ni pričakovati, da bi ledvična okvara bistveno spremenila izločanje ulipristalacetata.
English: Patients with heavy menstrual bleeding due to uterine fibroids are at risk of excessive bleeding, which may require surgical intervention.
Slovenian: Bolnice z močnimi menstruacijami zaradi materničnih leiomiomov so izpostavljene tveganju čezmerne krvavitve, pri kateri je lahko potrebna kirurška intervencija.
English: Should the excessive bleeding persist, patients should notify their physician.
Slovenian: Če čezmerne krvavitve ne prenehajo, morajo bolnice obvestiti svojega zdravnika.
English: In vitro data indicate that this is predominantly mediated by the cytochrome P450 3A4 isoform (CYP3A4).
Slovenian: Podatki in vitro kažejo, da to večinoma poteka prek izoforme 3A4 citokroma P450 (CYP3A4).
English: Repeated intermittent treatment has been studied up to 4 intermittent treatment courses.
Slovenian: Pri ponavljajočem se intermitentnem zdravljenju so preučili do 4 intermitentne cikle zdravljenja.
English: Based on pooled data from four phase III studies in patients with uterine fibroids treated for 3 months, the following adverse reactions have been reported.
Slovenian: Na podlagi združenih podatkov štirih študij III. faze pri bolnicah z materničnimi leiomiomi, ki so jih zdravili 3 mesece, so poročali o naslednjih neželenih učinkih.
English: Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Slovenian: Čeprav niso opazili nobenega teratogenega potenciala, študije na živalih niso zadostne za oceno vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Study 2 contained the active comparator, leuprorelin 3.75 mg given once per month by intramuscular injection.
Slovenian: Druga študija je vključevala primerjalno zdravilno učinkovino, levprorelin, 3,75 mg enkrat na mesec v obliki intramuskularnega injiciranja.
English: Patients starting treatment course 2 or 4
Slovenian: Bolnice, ki so začele 2. ali 4. cikel zdravljenja
English: • detailed recommendations for management of endometrial thickening.
Slovenian: • podrobna priporočila za obravnavanje odebelitve endometrija,
English: Reproduction studies performed in rats at doses giving exposure in the same range as the human dose have revealed no evidence of impaired fertility due to ulipristal acetate in treated animals or the offspring of treated females.
Slovenian: Študije razmnoževanja in plodnosti, ki so jih opravili na podganah pri odmerkih, pri katerih je bila izpostavljenost v enakem razponu kot odmerjanje pri človeku, niso pokazale nobenih dokazov zmanjšane plodnosti zaradi ulipristalacetata pri zdravljenih živalih in potomcih zdravljenih samic.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progesterone receptor modulators.
Slovenian: Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, modulatorji progesteronskih receptorjev.
English: Adverse reactions during treatment course 1 Very common Common
Slovenian: Neželeni učinki v 1. ciklu zdravljenja Zelo pogosti
English: If hysterectomy or endometrial biopsy specimens are sent for histology, then the pathologist should be informed that the patient has taken ulipristal acetate (see sections 4.4 and 5.1).
Slovenian: Če se vzorci histerektomije ali biopsije endometrija pošljejo na histološke preiskave, je treba patologa obvestiti, da bolnica jemlje ulipristalacetat (glejte poglavji 4.4 in 5.1).
English: Ulipristal acetate may have minor influence on the ability to drive or use machines as mild dizziness has been observed after ulipristal acetate intake.
Slovenian: Ulipristalacetat ima lahko manjši vpliv na sposobnost vožnje ali upravljanja strojev, saj so pri zaužitju ulipristalacetata opazili blago omotico.
English: Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Esmya treatment.
Slovenian: Zato uporaba hormonskih kontracepcijskih sredstev ni priporočljiva in morate med zdravljenjem z zdravilom Esmya uporabiti drugo zanesljivo pregradno kontracepcijsko metodo, kot je kondom.
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.
Slovenian: Študiji 3 in 4 sta dokazali učinkovitost pri nadzoru simptomov leiomiomov (npr. krvavitve iz maternice) ter zmanjšanju velikosti leiomiomov po 2 in 4 ciklih zdravljenja.
English: • inform the patients about potential adverse reactions related to liver that could be caused by the use of Esmya.
Slovenian: • bolnice obvestite o možnih neželenih učinkih, povezanih z jetri, ki jih lahko povzroči jemanje zdravila Esmya.
English: You should always start taking Esmya within the first week of your menstrual period.
Slovenian: Zdravilo Esmya vedno začnite jemati v prvem tednu menstruacije.
English: In both studies menstrual blood loss was assessed using the Pictorial Bleeding Assessment Chart (PBAC).
Slovenian: V obeh študijah se je izguba krvi med menstruacijo ocenjevala s Slikovno lestvico za ocenjevanje krvavitve (Pictorial Bleeding Assessment
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.
Slovenian: Ulipristalacetat in njegov aktivni mono-N-demetilirani presnovek se izločata v materinem mleku s povprečnim razmerjem AUCt mleko/plazma, ki znaša 0,74 ±0,32 za ulipristalacetat.
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.
Slovenian: Omejenemu številu preskušancev so dajali enkratne odmerke do 200 mg in dnevne odmerke 50 mg v 10 zaporednih dneh, vendar niso poročali o nobenih hudih ali resnih neželenih učinkih.
English: Likewise, patients treated with ulipristal acetate had a greater reduction in myoma size, as assessed by MRI.
Slovenian: Bolnice, ki so prejemale ulipristalacetat, so imele prav tako večje zmanjšanje miomov, ki so ga ocenili z MRI.
English: Thus administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
Slovenian: Zato ni verjetno, da bo uporaba ulipristalacetata spremenila očistek zdravil, ki jih presnavljajo ti encimi.
English: Potential for other medicinal products to affect ulipristal acetate:
Slovenian: Možnost vpliva drugih zdravil na ulipristalacetat:
English: Esmya with food and drink You should avoid drinking grapefruit juice while on treatment with Esmya.
Slovenian: Zdravilo Esmya skupaj s hrano in pijačo Med jemanjem zdravila Esmya se izogibajte uživanju soka grenivke.
English: This includes annual ultrasound to be performed after resumption of menstruation during off-treatment period.
Slovenian: To vključuje letni pregled z ultrazvokom po ponovnem pojavu menstruacije v obdobju brez zdravljenja.
English: What you need to know before you take Esmya
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Esmya
English: Patients should be informed that treatment with ulipristal acetate usually leads to a significant reduction in menstrual blood loss or amenorrhea within the first 10 days of treatment.
Slovenian: Bolnice je treba obvestiti, da ulipristalacetat v prvih 10 dneh zdravljenja ponavadi povzroči bistveno zmanjšanje menstrualnih krvavitev ali amenorejo.
English: Due to the CYP-mediated metabolism, hepatic impairment is expected to alter the elimination of ulipristal acetate, resulting in increased exposure.
Slovenian: Zaradi presnavljanja prek CYP pričakujejo, da bo jetrna okvara spremenila izločanje ulipristalacetata, kar bo povzročilo povečano izpostavljenost.
English: Depending on the result of these tests, the doctor will decide if treatment with Esmya is suitable for you.
Slovenian: Glede na rezultate teh preiskav bo zdravnik odločil, ali je zdravljenje z zdravilom Esmya za vas primerno.
English: Anxiety Emotional disorder
Slovenian: Psihiatrične motnje tesnoba čustvene motnje
English: Esmya is likely to make some hormonal contraceptives less effective.
Slovenian: Zdravilo Esmya lahko zmanjša učinkovitost nekaterih hormonskih kontracepcijskih sredstev.
English: Marketing Authorisation Holder Gedeon Richter Plc.
Slovenian: Imetnik dovoljenja za promet Gedeon Richter Plc.
English: You should nonetheless ask your doctor or pharmacist for advice if you take more Esmya than you should.
Slovenian: Kljub temu pa se posvetujte s svojim zdravnikom ali farmacevtom, če ste vzeli večji odmerek zdravila Esmya, kot bi smeli.
English: Asthma patients
Slovenian: Bolnice z astmo
English: For further treatment courses, your liver will be checked once before each new treatment course and if you experience any of the symptoms described below.
Slovenian: Za nadaljnje cikle zdravljenja pa se bodo preiskave delovanja vaših jeter opravljale pred vsakim novim ciklom zdravljenja in če se bo pri vas pojavil kateri od simptomov, opisanih spodaj.
English: Pregnancy and breastfeeding.
Slovenian: Nosečnost in dojenje.
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.
Slovenian: Med zdravljenjem in po njem so pri 1,0 % bolnic opazili funkcionalne ciste jajčnikov, od katerih jih je večina izginila v nekaj tednih.
English: Study 1 was double-blind placebo controlled.
Slovenian: Prva študija je bila dvojno slepa in nadzorovana s placebom.
English: One possible side effect is serious damage to your liver.
Slovenian: Eden izmed možnih neželenih učinkov je resna okvara jeter.
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.
Slovenian: Pri histološkem pregledu se običajno kaže neaktivni epitelij, ki se slabo razmnožuje in je povezan z asimetrijo med stromalno in epitelijsko rastjo, kar povzroča močno cistično razširjene žleze in dodatne estrogenske (mitotske) in progestinske (sekrecijske) epitelijske učinke.
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.
Slovenian: V nadzorovani študiji s primerjalno zdravilno učinkovino je bil delež v skupini z ulipristalacetatom 24 % (10,5 %zmernih ali hudih), v skupini bolnic, ki so jih zdravili z levprorelinom pa 60,4 % (39,6 % zmernih ali hudih).
English: This kinetic effect of food is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.
Slovenian: Ni pričakovati, da bi bil kinetični učinek hrane klinično pomemben za dnevno uporabo tablet ulipristalacetata.
English: What Esmya is and what it is used for What you need to know before you take Esmya How to take Esmya
Slovenian: Kaj je zdravilo Esmya in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Esmya Kako jemati zdravilo Esmya Možni neželeni učinki
English: Endometrial changes
Slovenian: Spremembe na endometriju
English: These tests will be repeated monthly for the first 2 treatment courses.
Slovenian: Te preiskave se bodo v prvih dveh ciklih zdravljenja izvajale enkrat mesečno.
English: If a patient misses a dose, the patient should take ulipristal acetate as soon as possible.
Slovenian: Če bolnica pozabi vzeti odmerek, mora vzeti ulipristalacetat čim prej.
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).
Slovenian: Zdravljenje se ne sme uvesti, če vrednost transaminaz (alanin transaminaze (ALT) ali aspartat aminotransferaze (AST) preseže 2 x ZMN (same ali v kombinaciji z bilirubinom > 2 x ZMN).
English: • the contraindications of pregnancy and breastfeeding, genital bleeding of unknown aetiology or for reasons other than uterine fibroids, and uterine, cervical, ovarian or breast cancer as well as underlying hepatic disorder.
Slovenian: • kontraindikacije: nosečnost in dojenje, krvavitve iz spolovil z neznano etiologijo ali zaradi drugih razlogov razen materničnih leiomiomov, rak maternice, materničnega vratu, jajčnikov ali dojke, kot tudi osnovna bolezen jeter,
English: It is used either before an operation of your fibroids or for long term treatment of your fibroids to reduce their size, to stop or reduce bleeding and to increase your red blood cell count.
Slovenian: Uporablja se pred kirurškim posegom zaradi leiomiomov ali dolgoročno za zmanjševanje velikosti leiomiomov, za ustavitev ali zmanjševanje krvavitev in za povečevanje števila eritrocitov.
English: Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, high density lipoprotein and low density lipoprotein.
Slovenian: Ulipristalacetat se v veliki meri veže (> 98 %) na beljakovine v plazmi, vključno z albuminom, glikoproteinom kisline alfa-l, lipoproteinom velike gostote in lipoproteinom majhne gostote.
English: NA N=199 N=191
Slovenian: N=199 N=191
English: • Educational material for patients which contains o Patient card
Slovenian: • Izobraževalno gradivo za bolnice, ki vsebuje: o opozorilno kartico za bolnico.
English: Co-administration of moderate or potent CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.4).
Slovenian: Sočasna uporaba zmernih ali močnih zaviralcev CYP3A4 in ulipristalacetata ni priporočljiva (glejte poglavje 4.4).
English: The direct action on the endometrium results in class-specific changes in histology termed PAEC.
Slovenian: Neposredno delovanje na endometrij povzroči za razred značilne spremembe histologije, ki se imenujejo spremembe PAEC.
English: If the dose was missed by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Slovenian: Če je odmerek zamudila za več kot 12 ur, ne sme vzeti izpuščenega odmerka, ampak mora preprosto nadaljevati običajni razpored odmerjanja.
English: After treatment course 2 (two times 3 months of treatment)
Slovenian: Po 2. ciklu zdravljenja (dvakratno 3-mesečno zdravljenje)
English: Mechanism of action Ulipristal acetate exerts a direct effect on the endometrium.
Slovenian: Mehanizem delovanja Ulipristalacetat ima neposreden učinek na endometrij.
English: Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids.
Slovenian: Zdravljenje z zdravilom Esmya morajo uvesti in nadzorovati zdravniki, z izkušnjami pri diagnosticiranju in zdravljenju materničnih leiomiomov.
English: If you have been prescribed several courses of Esmya 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion.
Slovenian: Če so vam predpisali več ciklov trimesečnega zdravljenja z zdravilom Esmya, lahko začnete vsak cikel šele med drugo menstruacijo po koncu prejšnjega zdravljenja.
English: In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Esmya less effective.
Slovenian: Poleg tega lahko hormonska kontracepcijska sredstva in progestageni (npr. noretindron ali levonorgestrel) zmanjšajo učinek zdravila Esmya.
English: c N and % include withdrawn patients d Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding (not including days of spotting) during the last 2 months of a treatment course.
Slovenian: d Nadzorovana krvavitev je bila opredeljena kot odsotnost epizod močnih krvavitev in največ 8 dni krvavitve (ne vključuje dni pojavljanja madežev) v zadnjih 2 mesecih cikla zdravljenja.
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.
Slovenian: V prvem 3-mesečnem ciklu zdravljenja v dveh dolgotrajnih kliničnih preskušanjih III. faze je bila pogostnost oblivov pri uporabi ulipristalacetata 5,3 % oz. 5,8 %.
English: White to off-white, round biconvex tablet of 7 mm engraved with “ES5” on one face.
Slovenian: Bela do umazano bela okrogla bikonveksna tableta s premerom 7 mm, z vtisnjenim napisom »ES5« na eni strani.
English: It is used to treat moderate to severe symptoms of uterine fibroids (commonly known as myomas), which are non-cancerous tumours of the uterus (womb).
Slovenian: Uporablja se za zdravljenje zmernih do hudih simptomov leiomiomov maternice (znanih kot miomi), ki so nerakasti tumorji v maternici.
English: Therefore concomitant administration of medicinal products containing progestagen is not recommended (see sections 4.4 and 4.6).
Slovenian: Zato sočasna uporaba zdravil, ki vsebujejo progestagen, ni priporočljiva (glejte poglavji 4.4 in 4.6).
English: Ulipristal acetate is readily converted to its mono-N-demethylated and subsequently to its di-N-demethylated metabolites.
Slovenian: Ulipristalacetat se hitro pretvori v mono-N-demetilirane, potem pa še v di-N-demetilirane presnovke.
English: A daily dose of ulipristal acetate 5 mg partially suppresses FSH levels but serum oestradiol levels are maintained in the mid-follicular range in the majority of patients and are similar to levels in patients who received placebo.
Slovenian: Odmerek ulipristalacetata 5 mg dnevno delno zmanjša ravni FSH, ravni estradiola v serumu pa se pri večini bolnic vzdržujejo v srednjefolikularnem razponu in so podobne ravnem pri bolnicah, ki so prejemale placebo.
English: Myoma size reduction was generally maintained during this follow-up period in patients originally treated with ulipristal acetate but some re-growth occurred in patients treated with leuprorelin.
Slovenian: Zmanjšanje velikosti miomov se je med sledenjem navadno ohranilo pri bolnicah, ki so izvirno prejemale ulipristalacetat, pri bolnicah, ki so prejemale levprorelin, pa je prišlo do nekaj ponovnih rašč.
English: In some women, uterine fibroids may cause heavy menstrual bleeding (your ‘period'), pelvic pain (discomfort in the belly) and create pressure on other organs.
Slovenian: Pri nekaterih ženskah lahko maternični leiomiomi povzročijo močne menstrualne krvavitve (»mesečno perilo«) in bolečine v medenici (neprijeten občutek v trebuhu) ter pritiskajo na druge organe.
English: Medicinal products affecting gastric pH
Slovenian: Zdravila, ki vplivajo na pH v želodcu
English: There is no relevant use of ulipristal acetate in the paediatric population.
Slovenian: Ulipristalacetat ni primeren za uporabo pri pediatrični populaciji.
English: Your period should generally return within 4 weeks after treatment with Esmya is stopped.
Slovenian: Mesečno perilo se ponavadi povrne v 4 tednih po prekinitvi zdravljenja z zdravilom Esmya.