FrancophonIA/ELRC3.0 huggingface dataset:
English: Weight increased Blood cholesterol increased
Croatian: Pretrage povećana tjelesna težina povišen kolesterol u krvi povišeni trigliceridi u krvi
English: Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment.
Croatian: Iako većina žena koja uzima terapijsku dozu ulipristalacetata ne ovulira, tijekom liječenja se preporučuje nehormonalna metoda kontracepcije.
English: Renal impairment is not expected to significantly alter the elimination of ulipristal acetate.
Croatian: Ne očekuje se da će oštećenje bubrežne funkcije značajnije izmijeniti eliminaciju ulipristalacetata.
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).
Croatian: U nedostatku specifičnih ispitivanja ulipristalacetat ne preporučuje se u liječenju bolesnica s teškim oštećenjem bubrega osim ako bolesnica nije pod strogim nadzorom (vidjeti dio 4.2).
English: During the post-marketing experience, cases of liver injury and hepatic failure were reported (see section 4.3).
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi oštećenja jetre i zatajenja jetrene funkcije (vidjeti dio 4.3).
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.
Croatian: Recite svojem liječniku ako znate da imate problema s jetrom ili ako niste sigurni u stanje svoje jetre.
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.
Croatian: Ispitivanje 3 bilo je otvoreno ispitivanje, kojim se ocjenjivao ulipristalacetat od 10 mg pri čemu bi nakon svakog 3-mjesečnog razdoblja liječenja uslijedilo dvostruko slijepo liječenje progestinom ili placebom u trajanju od 10 dana.
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.
Croatian: Ako bolesnica tijekom liječenja pokaže znakove ili simptome koji odgovaraju oštećenju jetre (umor, astenija, mučnina, povraćanje, bol u desnom hipohondriju, anoreksija, žutica itd.), liječenje je potrebno prekinuti, odmah je pregledati i obaviti testove jetrene funkcije.
English: Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator characterised by a tissue-specific partial progesterone antagonist effect.
Croatian: Ulipristalacetat je peroralno aktivni sintetički selektivni modulator progesteronskih receptora kojeg karakterizira tkivno-specifični djelomično antagonistički učinak na progesteron.
English: Repeated intermittent treatment has been studied up to 4 intermittent treatment courses.
Croatian: Ponovljeno intermitentno liječenje ispitivano je u trajanju do 4 intermitentna ciklusa liječenja.
English: • inform the patients not to take Esmya in case of liver problems.
Croatian: • informirati bolesnice da ne uzimaju lijek Esmya ako imaju probleme s jetrom.
English: • baseline liver function tests are required before treatment initiation, and before each new treatment course.
Croatian: • potrebno je napraviti testove početne jetrene funkcije prije početka liječenja i prije svakog novog ciklusa liječenja.
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.
Croatian: Liječenje treba početi tek kada nastupi menstruacija: prvi ciklus liječenja treba početi tijekom prvog tjedna menstruacije, a ponovne cikluse liječenje treba početi najranije tijekom prvog tjedna druge menstruacije koja nastupi nakon završetka prethodnog ciklusa liječenja.
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).
Croatian: U slučaju ponovljenih ciklusa liječenja primijećena je manja učestalost zadebljanja endometrija (u 4,9% bolesnica nakon drugog ciklusa liječenja i u 3,5% nakon četvrtog ciklusa liječenja).
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.
Croatian: • ako bolesnica tijekom liječenja pokaže znakove ili simptome koji odgovaraju oštećenju jetre, treba prekinuti liječenje, odmah je pregledati i obaviti testove jetrene funkcije.
English: These changes are reversible after treatment cessation.
Croatian: Te su promjene reverzibilne i povlače se nakon prestanka liječenja.
English: Mechanism of action Ulipristal acetate exerts a direct effect on the endometrium.
Croatian: Ulipristalacetat ima izravan učinak na endometrij.
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.
Croatian: Primjena ulipristalacetata (tablete od 30 mg) skupa s doručkom s visokim sadržajem masnoća rezultirala je približno 45% nižom prosječnom Cmax, odgođenim tmax (od medijana od 0,75 sati do 3 sata) i 25% višom prosječnom AUC0-∞ u usporedbi s primjenom natašte.
English: The endometrial thickening reverses when treatment is stopped and menstrual periods resume.
Croatian: Zadebljanje endometrija povlači se kad se liječenje prekine, a menstrualni ciklus ponovno uspostavi.
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.
Croatian: Dnevna doza ulipristalacetata od 5 mg inhibira ovulaciju u većine bolesnica kako je to određeno razinama progesterona koje se održavaju na oko 0,3 ng/ml.
English: Repeated intermittent treatment has been studied up to 4 intermittent courses.
Croatian: Ponovljeno intermitentno liječenje ispitivano je u trajanju do 4 intermitentna ciklusa.
English: Esmya contains the active substance ulipristal acetate.
Croatian: Esmya sadrži djelatnu tvar ulipristalacetat.
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.
Croatian: • potrebu za ispitivanjem perzistentnog zadebljanja endometrija nakon prekida liječenja i ponovne uspostave menstrualnog krvarenja kako bi se isključile druge bolesti u podlozi, a prema standardnim kliničkim protokolima.
English: Ulipristal acetate is contraindicated during pregnancy (see section 4.3).
Croatian: Primjena ulipristalacetata je kontraindicirana tijekom trudnoće (vidjeti dio 4.3).
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta vertigo
English: Esmya 5 mg tablets
Croatian: Esmya 5 mg tablete
English: Uterine, cervical, ovarian or breast cancer.
Croatian: Karcinom maternice, cerviksa, jajnika ili dojke.
English: How to take Esmya
Croatian: Kako uzimati Esmyu
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.
Croatian: Ulipristalacetat je indiciran za intermitentno liječenje umjerenih do teških simptoma fibroida maternice u odraslih žena reproduktivne dobi koje nisu pogodne za operativni zahvat.
English: a a In Study 1, change from baseline in total myoma volume was measured by MRI.
Croatian: a tjedna a U ispitivanju 1, promjena ukupnog volumena mioma u odnosu na početak mjerena je MR-om.
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.
Croatian: Djelotvornost fiksne doze ulipristalacetata od 5 mg i 10 mg jednom dnevno proučavana je u dva randomizirana, dvostruko slijepa ispitivanja faze III koja su trajala 13 tjedana i u koja su uključene bolesnice s teškim menstrualnim krvarenjem povezanim s fibroidima maternice.
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.
Croatian: Djelotvornost ponovljenih ciklusa liječenja s fiksnom dozom ulipristalacetata od 5 mg ili 10 mg jednom dnevno procijenjena je u dva ispitivanja faze III u kojima su se ocjenjivala do 4 intermitentna 3-mjesečna ciklusa liječenja u bolesnica s teškim menstrualnim krvarenjima povezanim s fibroidima maternice.
English: This thickening disappears after treatment is withdrawn and menstruation occurs.
Croatian: Zadebljanje nestaje nakon prestanka liječenja i ponovne pojave menstruacije.
English: In addition, reversible increase of the endometrium thickness may occur under treatment.
Croatian: Osim toga, tijekom liječenja može doći do reverzibilnog zadebljanja endometrija.
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.
Croatian: Primjena ulipristalacetata (tablete od 10 mg) skupa s inhibitorom protonske pumpe esomeprazolom (20 mg dnevno tijekom 6 dana) rezultirala je približno 65% nižom prosječnom Cmax te odgođenim tmax (od medijana od 0,75 sati do 1 sat) te 13% višom prosječnom AUC-om.
English: The lining of the uterus may thicken or change as a result of taking Esmya.
Croatian: Stijenka maternice može se zadebljati kao rezultat uzimanja lijeka Esmya.
English: Underlying hepatic disorder.
Croatian: Podležeći poremećaj jetre.
English: Ulipristal acetate is contraindicated during breastfeeding (see sections 4.3 and 5.2).
Croatian: Primjena ulipristalacetata je kontraindicirana tijekom dojenja (vidjeti dijelove 4.3 i 5.2).
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.
Croatian: Vjerojatno je da će ulipristalacetat negativno interferirati s pilulalama koje sadrže samo progestagen, uređajima koji otpuštaju progestagen ili kombiniranim oralnim kontraceptivima pa se istovremena primjena ne preporučuje.
English: - Medicines used to treat certain bacterial infections (e.g. rifampicin, telithromycin,
Croatian: - Lijekovi koji se koriste za liječenje bakterijskih infekcija (primjerice, rifampicin, telitromicin,
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.
Croatian: • ne smiju se liječiti bolesnice koje imaju razine alanin transaminaze (ALT) ili aspartat aminotransferaze (AST) više od dvostruke vrijednosti gornje granice normale (GGN) (izolirano ili u kombinaciji s bilirubinom >2 x GGN-a).
English: Alopecia** Dry skin Hyperhidrosis
Croatian: Poremećaji kože i potkožnog tkiva akne alopecija** suha koža hiperhidroza angioedem
English: • in addition, liver testing should be performed within 2-4 weeks after treatment has stopped.
Croatian: • osim toga, testove jetrene funkcije treba provesti 2 do 4 tjedna nakon prestanka liječenja.
English: The treating physician should explain to the patient the requirement for treatment free intervals.
Croatian: Liječnik bolesnicu mora upozoriti na potrebu razdoblja bez liječenja.
English: In both studies menstrual blood loss was assessed using the Pictorial Bleeding Assessment Chart (PBAC).
Croatian: U oba ispitivanja količina menstrualne krvi procjenjivanja je uporabom usporedne analize higijenskih uložaka/tampona sa standardnim slikama uložaka/tampona (PBAC).
English: No dose adjustment is recommended in patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnica s blagim ili umjerenim oštećenjem bubrežne funkcije.
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.
Croatian: Ulipristalacetat je indiciran za jedan terapijski ciklus liječenja umjerenih do teških simptoma fibroida maternice prije operativnog zahvata u odraslih žena reproduktivne dobi.
English: - Certain medicines to treat fungal infections (e.g. ketoconazole (except shampoo), itraconazole).
Croatian: - Određeni lijekovi za liječenje gljivičnih infekcija (primjerice, ketokonazol (osim šampona),
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.
Croatian: Do kraja prvog 3-mjesečnog ciklusa liječenja zadebljanje endometrija (> 16 mm potvrđeno ultrazvukom ili MRI snimanjem na kraju liječenja) primijećeno je u 10 do 15% bolesnica koje su uzimale ulipristalacetat.
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:
Croatian: S JETROM Prestanite uzimati lijek i odmah se obratite liječniku ako uočite bilo koji od sljedećih znakova ili simptoma:
English: In addition liver testing should be performed 2- 4 weeks after treatment has stopped.
Croatian: Uz to, testove jetrene funkcije treba provesti 2 do 4 tjedna nakon prestanka liječenja.
English: - Certain medicines used to treat hypertension (e.g. verapamil).
Croatian: - Određeni lijekovi koji se koriste za smanjenje krvnog tlaka (npr. verapamil).
English: The recommended dose is one 5 mg tablet per day, for treatment courses of up to 3 months each..
Croatian: Preporučena doza je jedna tableta od 5 mg na dan za cikluse liječenja od po najdulje 3 mjeseca.
English: Concomitant treatments
Croatian: Istovremena primjena drugih lijekova
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.
Croatian: Esmya je bijela do bjelkasta, okrugla bikonveksna tableta promjera 7 mm, s utisnutim znakom “ES5” na jednoj strani.
English: Simultaneous administration of ulipristal acetate and a P-gp substrate has not been studied and an interaction cannot be excluded.
Croatian: P-gp-a nije istražena, pa se interakcija ne može isključiti.
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).
Croatian: Na kraju 4. ciklusa liječenja 158 (69,6%) ispitanica, odnosno 164 (74,5%) ispitanice koje su primale doze od 5 mg odnosno 10 mg bile su u amenoreji (p=0,290).
English: - Certain medicines used to treat HIV infection (e.g. ritonavir, efavirenz, nevirapine).
Croatian: - Određeni lijekovi za liječenje infekcija virusom HIV-a (primjerice ritonavir, efavirenz,
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
English: Therefore concomitant administration of medicinal products containing progestagen is not recommended (see section 4.4 and 4.6).
Croatian: Stoga se ne preporučuje istovremena primjena lijekova koji sadrže progestagen (vidjeti dio 4.4 i 4.6).
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,
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): - alergija na lijek - tjeskoba - promjene raspoloženja - omaglica - suha usta, zatvor - gubitak kose, suha koža, pojačano znojenje - bol u leđima - nemogućnost zadržavanja mokraće - krvarenje iz maternice, iscjedak iz vagine, nenormalno vaginalno krvarenje - nelagoda u dojkama - oticanje zbog zadržavanja tekućine (edem) - ekstremni umor (astenija) - povišen kolesterol u krvi što je vidljivo u krvnim pretragama, povišene masnoće u krvi
English: The treatment consists of one tablet of 5 mg to be taken once daily for treatment courses of up to 3 months each.
Croatian: Liječenje se sastoji od primjene jedne tablete od 5 mg jednom dnevno za cikluse liječenja od po najviše 3 mjeseca.
English: - if you have cancer of the uterus (womb), cervix (the neck of the womb), ovary or breast.
Croatian: - ako imate rak maternice, vrata maternice, jajnika ili dojke.
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.
Croatian: Ako se opazi zadebljanje endometrija koje perzistira nakon ponovne pojave menstruacije tijekom razdoblja bez liječenja ili dulje od 3 mjeseca nakon završetka ciklusa liječenja i/ili ako se opazi promijenjeni uzorak krvarenja (vidjeti dio “Uzorak krvarenja“ dalje u tekstu), treba provesti pretrage, uključujući biopsiju endometrija, kako bi se isključilo postojanje neke druge bolesti u podlozi, uključujući malignu bolest endometrija.
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).
Croatian: U nedostatku specifičnih ispitivanja ulipristalacetat ne preporučuje se u liječenju bolesnica s teškim oštećenjem bubrežne funkcije osim ako bolesnica nije pod strogim nadzorom (vidjeti dijelove 4.4 i
English: During treatment, liver function tests must be performed monthly during the first 2 treatment courses.
Croatian: Tijekom prva 2 ciklusa liječenja testovi jetrene funkcije se moraju provoditi jednom mjesečno.
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.
Croatian: Nakon primjene snažnog induktora CYP3A4 rifampicina (300 mg dvaput dnevno tijekom 9 dana) kod zdravih ženskih dobrovoljaca, Cmax i AUC ulipristalacetata i njegovog aktivnog metabolita izrazito su se smanjili za 90% ili više, a poluvijek za ulipristalacetat se smanjio za otprilike 2,2 puta što odgovara približnom smanjenju od 10 puta u izloženosti ulipristalacetatu.
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).
Croatian: Istovremena primjena umjerenih (npr. eritromicina, soka od grejpa, verapamila) ili snažnih inhibitora CYP3A4 (ketokonazola, ritonavira, nefazodona, itrakonazola, telitromicina, klaritromicina) i ulipristalacetata se ne preporučuje (vidjeti dio 4.5).
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).
Croatian: U narednim ciklusima liječenja učestalost zadebljanja endometrija bila je manja (u 4,9% bolesnica do kraja drugog odnosno u 3,5% bolesnica do kraja četvrtog ciklusa liječenja).
English: • treatment must be stopped if the patient develops ALT or AST > 3 x ULN.
Croatian: • liječenje se mora prekinuti ako razine ALT ili AST u bolesnice dosegnu više od trostruke vrijednosti GGN-a.
English: - If you suffer from severe asthma, treatment with Esmya may not be suitable for you.
Croatian: - Ako patite od teškog oblika astme, liječenje lijekom Esmya možda neće biti prikladno za Vas.
English: 5 mg/day N=213
Croatian: 5 mg/ dan N=213
English: Before you start treatment with Esmya blood tests will be undertaken to find out how well your liver is working.
Croatian: Upozorenja i mjere opreza - Prije nego što počnete uzimati lijek Esmya, obavit ćete krvne pretrage kako bi se utvrdilo kako radi Vaša jetra.
English: if you have an underlying hepatic disorder.
Croatian: - ako imate poremećaj jetre kao podležeću bolest.
English: • the posology: 5 mg tablet once daily for treatment courses of up to 3 months each.
Croatian: • doziranje: tableta od 5 mg jednom dnevno tijekom pojedinih ciklusa liječenja u trajanju od po najdulje 3 mjeseca svaki.
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.
Croatian: Ako se opazi zadebljanje endometrija koje perzistira nakon ponovne pojave menstruacije tijekom razdoblja bez liječenja ili dulje od 3 mjeseca nakon završetka ciklusa liječenja i/ili ako se opazi promijenjeni uzorak krvarenja, treba provesti pretrage, uključujući biopsiju endometrija, kako bi se isključilo postojanje neke druge bolesti u podlozi, uključujući malignu bolest endometrija.
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).
Croatian: Istovremena primjena ulipristalacetata i snažnih induktora CYP3A4 (primjerice rifampicina, rifabutina, karbamazepina, okskarbazepina, fenitoina, fosfenitoina, fenobarbitala, primidona, gospine trave, efavirenza, nevirapina, dogoročna uporaba ritonavira) se ne preporučuje (vidjeti dio 4.5).
English: 5 mg/day N=178
Croatian: 5 mg/ dan N=178
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).
Croatian: Nakon primjene snažnog inhibitora CYP3A4 ketokonazola (400 mg jednom dnevno tijekom 7 dana) kod zdravih ženskih dobrovoljaca, Cmax i AUC ulipristalacetata povećali su se za 2, odnosno 5,9 puta, a AUC aktivnog metabolita ulipristalacetata povećala se za 2,4 puta dok se Cmax aktivnog metabolita smanjila (za 0,53 puta).
English: Median PBAC at baseline
Croatian: Medijan PBAC na početku
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.
Croatian: Ako zadebljanje endometrija perzistira nakon ponovne pojave menstrualnog krvarenja tijekom razdoblja bez liječenja ili nakon 3 mjeseca od završetka ciklusa liječenja, možda će biti potrebne daljnje pretrage kako bi se isključilo postojanje neke druge bolesti u podlozi.