FrancophonIA/ELRC3.0 huggingface dataset:
English: Thus hormonal contraceptives and progestagens are likely to reduce ulipristal acetate efficacy by competitive action on the progesterone receptor.
Croatian: Stoga je vjerojatno da će hormonski kontraceptivi i progestageni reducirati djelotvornost ulipristalacetatata kompetitivnim djelovanjem na progesteronske receptore.
English: Available toxicological data in animals have shown excretion of ulipristal acetate in milk (for details see section 5.3).
Croatian: Dostupni toksikološki podaci u životinja pokazuju da se ulipristalacetat izlučuje u mlijeko (za detalje vidjeti dio 5.3).
English: • Educational material for pathologists which contains o Pathologist's guide o USB stick or CD ROM with images of digital specimens (digital library with high resolution images) o SmPC
Croatian: • Edukacijskog materijala za patologe koji sadrži o Vodič za patologa o Prijenosnu memoriju USB ili CD ROM sa snimkama digitalnih uzoraka (digitalna knjižnica sa snimkama visoke rezolucije) o Sažetak opisa svojstava lijeka
English: DD/MM/YYYY
Croatian: DD/MM/GGGG
English: Anxiety Emotional disorder
Croatian: Psihijatrijski poremećaji anksioznost emocionalni poremećaj
English: The vast majority of adverse reactions were mild and moderate (95.0%), did not lead to discontinuation of the medicinal product (98.0%) and resolved spontaneously.
Croatian: Većina nuspojava bile su blage do umjerene (95,0%) te nisu dovele do prekida primjene lijeka (98,0%), a povukle su se spontano.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Croatian: Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
English: In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%).
Croatian: U svim ispitivanjima faze III, uključujući ispitivanja ponovljenog intermitentnog liječenja, hiperplazija je zamijećena u ukupno 7 od 789 ispitanica u kojih je provedena odgovarajuća biopsija (0,89%).
English: During treatment with Esmya, your doctor will carry out regular blood tests to check your liver function.
Croatian: Tijekom liječenja lijekom Esmya Vaš će liječnik redoviti obavljati krvne pretrage kako bi provjerio funkciju Vaše jetre.
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.
Croatian: Podaci iz in vitro ispitivanja pokazuju da ulipristalacetat i njegovi aktivni metaboliti ne inhibiraju CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 te 3A4 ili induciraju CYP1A2 u klinički značajnim koncentracijama.
English: • yellow skin/eyes
Croatian: • žutilo kože / žutilo očiju
English: What you need to know before you take Esmya
Croatian: Što morate znati prije nego počnete uzimati Esmyu
English: swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties.
Croatian: - oticanje lica, jezika ili grla, poteškoće s gutanjem, osip i poteškoće s disanjem.
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.
Croatian: MAH će osigurati da, u trenutku puštanja lijeka u promet i nakon toga, svi propisivači lijeka Esmya i patolozi koji analiziraju uzorke uzete od bolesnica liječenih lijekom Esmya, kao i bolesnice liječene lijekom Esmya, imaju dostupan edukacijski materijal.
English: The most frequent adverse reaction was hot flush.
Croatian: Najčešća nuspojava bile su navale vrućine (valunzi).
English: • recommendation of a periodic monitoring of the endometrium in case of repeated intermittent treatment.
Croatian: • preporuku za periodičko praćenje endometrija u slučaju ponovljenog intermitentnog liječenja.
English: Hot flushes were reported by 8.1% of patients but the rates varied across trials.
Croatian: Navale vrućine (valunzi) su bili prijavljene u 8,1% bolesnica, ali stope su varirale tijekom trajanja ispitivanja.
English: These changes should not be confused with endometrial hyperplasia.
Croatian: Te promjene ne treba zamijeniti s hiperplazijom endometrija.
English: Manufacturer Cenexi
Croatian: Proizvođač Cenexi
English: Bold values in shaded squares indicate that there was a significant difference in the comparisons between ulipristal acetate and the control.
Croatian: Vrijednosti izražene podebljanim fontom u sjenčanim odjeljcima ukazuju na postojanje značajne razlike pri uspoređivanju ulipristalacetata i kontrolne skupine.
English: Esmya is likely to make some hormonal contraceptives less effective.
Croatian: Vjerojatno je da će Esmya smanjiti djelotvornost nekih hormonskih kontraceptiva.
English: If you miss a dose by more than 12 hours, skip the missed tablet and take only a single tablet as usual.
Croatian: Ako propustite dozu za više od 12 sati, preskočite propuštenu tabletu i uzmite jednu tabletu kao i obično.
English: • the indications.
Croatian: • indikacije
English: - If you have liver or kidney disease tell your doctor or pharmacist before taking Esmya.
Croatian: - Ako imate bolest jetre ili bubrega, obavijestite svog liječnika ili ljekarnika prije nego uzmete Esmyu.
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.
Croatian: Bolesnice u ovom ispitivanju trebale su biti anemične prilikom ulaska u ispitivanje (Hb < 10,2 g/dl) i sve su trebale primati željezo peroralno 80 mg Fe++ pored ispitivanog lijeka.
English: • inform the patients about the symptoms and signs of possible liver injury so that they are aware of situations in which they should stop treatment and contact a physician in a timely manner.
Croatian: • informirati bolesnice o simptomima i znakovima mogućeg oštećenja jetre kako bi razumjele u kojim situacijama trebaju prestati uzimati lijek i na vrijeme se obratiti liječniku.
English: Medicinal products containing progestagen should not be taken within 12 days after cessation of ulipristal acetate treatment.
Croatian: Lijekove koji sadrže progestagen ne smiju se uzimati unutar 12 dana nakon prestanka liječenja ulipristalacetatom.
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)
Croatian: 2. PRETRAGA (4 tjedna nakon početka liječenja) 3. PRETRAGA (8 tjedana nakon početka liječenja) 4. PRETRAGA (12 tjedana nakon početka liječenja) 5. PRETRAGA (2 do 4 tjedna nakon prestanka uzimanja lijeka Esmya)
English: Headache Mild or moderate severity headache was reported in 5.8% of patients.
Croatian: Glavobolja Glavobolja blage ili umjerene jačine prijavljena je u 5,8% bolesnica.
English: This medicine acts by modifying the activity of progesterone, a naturally occuring hormone in the body.
Croatian: Ovaj lijek djeluje mijenjajući aktivnost progesterona, hormona koji se inače stvara u organizmu.
English: Patients in amenorrhea at week 13
Croatian: Bolesnice s amenorejom u 13. tjednu
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.
Croatian: Liječenje lijekom Esmya obično uzrokuje znatno smanjenje ili čak i prestanak menstrualnog krvarenja („mjesečnice“) unutar prvih 10 dana liječenja.
English: After treatment course 2 (two times 3 months of treatment)
Croatian: Nakon 2. ciklusa liječenja (dva puta po 3 mjeseca liječenja)
English: The treatment courses should each not exceed 3 months as the risk of adverse impact on the endometrium is unknown if treatment is continued without interruption.
Croatian: Nijedan ciklus liječenja ne bi smio biti dulji od 3 mjeseca jer nije moguće procijeniti rizik od štetnog utjecaja na endometrij u slučaju nastavka liječenja bez prekida.
English: In case of atypical hyperplasia, investigation and management as per usual clinical practice should be performed.
Croatian: U slučaju atipične hiperplazije treba obaviti pretrage i zbrinjavanje u skladu s uobičajenom kliničkom praksom.
English: THE TABLE BELOW HELPS YOU TO TRACK YOUR BLOOD TESTS:
Croatian: TABLICA U NASTAVKU OLAKŠAT ĆE VAM PRAĆENJE KRVNIH PRETRAGA
English: If a patient misses a dose, the patient should take ulipristal acetate as soon as possible.
Croatian: Ako bolesnica propusti dozu, treba uzeti ulipristalacetat što je prije moguće.
English: Most findings in general toxicity studies were related to its action on progesterone receptors (and at higher concentrations on glucocorticoid receptors), with antiprogesterone activity observed at exposures similar to therapeutic levels.
Croatian: Većina nalaza opće toksičnosti bila je povezana s njegovim djelovanjem na progesteronske receptore (te pri višim koncentracijama na glukokortikoidne receptore) s aktivnošću antiprogesterona primijećenom pri izloženosti sličnoj onoj pri terapijskim razinama.
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).
Croatian: Koristi se za liječenje umjerenih do teških simptoma fibroida maternice (poznatih pod nazivom miomi) koji su nekancerozni tumori uterusa (maternice).
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.
Croatian: Ako je doza propuštena za više od 12 sati, bolesnica ne smije uzeti propuštenu dozu već jednostavno nastaviti primjenjivati uobičajeni raspored doziranja.
English: Stop using Esmya and immediately contact a doctor if you experience any of the following symptoms:
Croatian: Prestanite uzimati Esmyu i odmah obavijestite liječnika ako osjetite neki od sljedećih simptoma:
English: If you do become pregnant during Esmya treatment, you should stop taking Esmya immediately and contact your doctor or pharmacist.
Croatian: Ako zatrudnite tijekom liječenja lijekom Esmya, odmah prekinite uzimanje lijeka i obratite se svom liječniku ili ljekarniku.
English: Ulipristal acetate does not affect serum levels of TSH, ACTH or prolactin.
Croatian: Ulipristalacetat ne utječe na serumske razine TSH-a, ACTH-a ili prolaktina.
English: Table 2: Results of primary and selected secondary efficacy assessments in long term Phase III studies Parameter
Croatian: Tablica 2: Rezultati primarnih i odabranih sekundarnih procjena djelotvornosti u dugotrajnim ispitivanjima faze III
English: Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.
Croatian: Primjena u žena s teškom astmom koja nije adekvatno kontrolirana oralnim glukokortikoidima nije preporučljiva.
English: • inform the patients about potential adverse reactions related to liver that could be caused by the use of Esmya.
Croatian: • informirati bolesnice o mogućim nuspojavama povezanima s jetrom koje bi mogle biti uzrokovane uzimanjem lijeka Esmya.
English: You need blood tests before starting each treatment course to find out how your liver is working.
Croatian: Trebate napraviti krvne pretrage prije početka svakog ciklusa liječenja kako biste provjerili kakva je funkcija Vaše jetre.
English: Esmya treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids.
Croatian: Liječenje lijekom Esmya trebaju započeti i nadzirati liječnici s iskustvom u dijagnosticiranju i liječenju fibroida maternice.
English: Medicinal products affecting gastric pH
Croatian: Lijekovi koji utječu na želučani pH
English: These tests will be repeated monthly for the first 2 treatment courses.
Croatian: Pretrage će se ponavljati jednom mjesečno u prva 2 ciklusa liječenja.
English: - The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, talc and magnesium stearate.
Croatian: - Drugi sastojci su mikrokristalična celuloza, manitol, umrežena karmelozanatrij, talk i magnezijev stearat.
English: These histological changes are denoted as “Progesterone Receptor Modulator Associated Endometrial Changes” (PAEC) and should not be mistaken for endometrial hyperplasia (see sections 4.8 and 5.1).
Croatian: Te se histološke promjene označavaju kao „Promjene endometrija povezane s primjenom modulatora progesteronskih receptora“ (PAEC) te ih se ne smije zamijeniti s hiperplazijom endometrija (vidjeti dijelove 4.8 i 5.1).
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.
Croatian: U nekih žena fibroidi maternice mogu uzrokovati obilno menstrualno krvarenje („mjesečnicu“), bol u zdjelici (nelagodu u trbuhu) te stvarati pritisak na druge organe.
English: DATE
Croatian: DATUM
English: You should nonetheless ask your doctor or pharmacist for advice if you take more Esmya than you should.
Croatian: Bez obzira na to morate pitati svog liječnika ili ljekarnika za savjet ako ste uzeli više lijeka Esmya nego što je to bilo potrebno.
English: Esmya may cause mild dizziness (see section 4 “Possible side effects”).
Croatian: Esmya može uzrokovati blagu omaglicu (pogledajte dio 4 „Moguće nuspojave“).
English: You should always start taking Esmya within the first week of your menstrual period.
Croatian: Lijek Esmya uvijek morate početi uzimati unutar prvog tjedna Vaše menstruacije.
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.
Croatian: Pojedinačne doze do 200 mg i dnevne doze od 50 mg tijekom 10 uzastopnih dana bile su primjenjivane na ograničenom broju ispitanica i nisu prijavljene ozbiljne ili teške nuspojave.
English: In vitro data indicate that ulipristal acetate and its active metabolite are not P-gp (ABCB1) substrates.
Croatian: Podaci iz in vitro ispitivanja pokazuju da ulipristalacetat i njegov aktivni metabolit nisu supstrati P-gp-a (ABCB1).
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.
Croatian: U kontroliranim ispitivanjima s djelatnim usporednim lijekom stope su iznosile 24% (10,5% umjereno ili teško) za ulipristalacetat i 60,4% (39,6% umjereno ili teško) za bolesnike liječene leuprorelinom.
English: • fatigue, severe tiredness
Croatian: • umor, teški zamor
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.
Croatian: Reprodukcijske studije provedene na štakorima pri dozama koje stvaraju izloženost u istom rasponu kao i humane doze nisu dokazale štetni utjecaj na plodnost u liječenih životinja ili na podmlatku liječenih ženki.
English: Study 2 contained the active comparator, leuprorelin 3.75 mg given once per month by intramuscular injection.
Croatian: Ispitivanje 2 sadržavalo je djelatni usporedni lijek, leuprorelin primijenjen u dozi od 3,75 mg jednom mjesečno putem intramuskularne injekcije.
English: Warnings and precautions
Croatian: Upozorenja i mjere opreza.
English: Pregnancy should be precluded prior to treatment.
Croatian: Prije liječenja treba isključiti trudnoću.
English: In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Esmya less effective.
Croatian: Osim toga hormonski kontraceptivi i progestageni (primjerice, noretindron ili levonorgestrel) također će vjerojatno smanjiti djelotvornost lijeka Esmya.
English: This kinetic effect of food is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.
Croatian: Ne očekuje se da će ovaj kinetički učinak hrane biti od kliničke važnosti za dnevnu primjenu tableta ulipristalacetata.
English: Your period should generally return within 4 weeks after treatment with Esmya is stopped.
Croatian: Vaša mjesečnica trebala bi se ponovno pojaviti unutar 4 tjedna nakon prekida liječenja lijekom Esmya.
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.
Croatian: Nakon početka dnevne primjene od 5 mg ulipristalacetata tijekom menstrualnog ciklusa većina ispitanica (uključujući bolesnice s miomom) dovršit će svoju prvu menstruaciju, ali neće imati više menstruaciju sve do prestanka liječenja.
English: After treatment course 4 (four times 3 months of treatment)
Croatian: Nakon 4. ciklusa liječenja (četiri puta po 3 mjeseca liječenja)
English: If you stop taking Esmya
Croatian: Ako prestanete uzimati Esmyu
English: Study 4 was a randomized, double-blind clinical study assessing ulipristal acetate 5 or 10 mg.
Croatian: Ispitivanje 4 bilo je randomizirano, dvostuko slijepo kliničko isptivanje u kojem se ocjenjivao ulipristalacetat od 5 ili 10 mg.
English: P-gp substrates
Croatian: Supstrati P-gp-a
English: Patients whose menstrual bleeding became normal (PBAC < 75) at week 13 Median change in myoma volume from baseline to week 13
Croatian: Bolesnice čije je menstrualno krvarenje postalo normalno (PBAC < 75) u 13. tjednu Medijan promjene u volumenu mioma od početka do 13.
English: Patients in amenorrhea b,c
Croatian: Bolesnice s amenorejom b,c
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.
Croatian: U ispitivanju 1 primijećena je statistički značajna razlika količine menstrualne krvi u korist bolesnica liječenih ulipristalacetatom u usporedbi s placebom (vidjeti tablicu 1 u nastavku) što je rezultiralo bržim i učinkovitijim liječenjem anemije nego kod primjene samog željeza.
English: No dose adjustment is considered necessary for administration of ulipristal acetate to patients receiving concomitant mild CYP3A4 inhibitors.
Croatian: Prilagodba doze ne smatra se nužnom pri primjeni ulipristalacetata u bolesnica koje istovremeno primaju slabe inhibitore CYP3A4.
English: In about 10-15% of patients treated with ulipristal acetate the endometrium may thicken (> 16 mm) during the first 3-month treatment course.
Croatian: Kod približno 10-15% bolesnica liječenih ulipristalacetatom endometrij se može zadebljati (> 16 mm) tijekom prvog 3-mjesečnog ciklusa liječenja.
English: Potential for other medicinal products to affect ulipristal acetate:
Croatian: Mogućnost utjecaja drugih lijekova na djelovanje ulipristalacetata:
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.
Croatian: U ispitivanju 3 djelotvornost liječenja dokazana je nakon > 18 mjeseci ponovljenog intermitentnog liječenja (4 ciklusa od 10 mg jednom dnevno), u 89,7% bolesnica postignuta je amenoreja na kraju 4. ciklusa liječenja.
English: When ulipristal acetate treatment is stopped, menstrual cycles generally resume within 4 weeks.
Croatian: Nakon prestanka liječenja ulipristalacetatom menstrualni se ciklusi uglavnom uspostave unutar 4 tjedna.
English: Menstrual bleeding
Croatian: Menstrualno krvarenje
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.
Croatian: Na temelju združenih podataka iz četiri ispitivanja faze III u bolesnica s fibroidima maternice koje su liječene tijekom tri mjeseca prijavljene su sljedeće nuspojave.
English: In addition, reversible changes to the endometrium are denoted PAEC and are different from endometrial hyperplasia.
Croatian: Uz to, reverzibilne promjene endometrija su obilježene kao PAEC te se razlikuju od hiperplazije endometrija.
English: • liver function must be monitored monthly during the first 2 treatment courses, and thereafter when clinically indicated.
Croatian: • jetrene funkcije moraju se pratiti jednom mjesečno tijekom prva 2 ciklusa liječenja, a nakon toga kad je klinički indicirano.
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.
Croatian: Incidencija hiperplazije nije se povećala s ponovljenim ciklusima liječenja, uključujući podatke za 340 žena koje su primale do 4 ciklusa ulipristalacetata od 5 ili 10 mg i ograničene podatke za 43 žene koje su primale do 8 ciklusa ulipristalacetata od 10 mg.
English: Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.
Croatian: Genitalno krvarenje nepoznate etiologije ili zbog uzroka različitih od fibroida maternice.
English: Endometrial changes
Croatian: Promjene endometrija
English: • key effects of Esmya on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
Croatian: • Ključne učinke lijeka Esmya na promjene endometrija povezane s modulatorom progesteronskih receptora (PAEC) te kako ih razlikovati od učinaka neoponiranog estrogena.
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.
Croatian: Tipično, histološki izgled odgovara inaktivnom i slabo proliferativnom epitelu s asimetričnim stromalnim i epitelnim rastom koji rezultira upadljivim cistično proširenim žlijezdama s primjesom učinaka estrogena (mitotski) i progestina (sekretorni) na epitel.
English: A few cases have been reported during ulipristal acetate treatment or within 2-3 months after ulipristal acetate treatment was stopped.
Croatian: Prijavljeno je nekoliko slučajeva takvog krvarenja tijekom liječenja ulipristalacetatom ili unutar 2-3 mjeseca nakon prestanka liječenja ulipristalacetatom.
English: Asthma patients
Croatian: Bolesnice s astmom
English: Likewise, patients treated with ulipristal acetate had a greater reduction in myoma size, as assessed by MRI.
Croatian: Slično tome bolesnice liječene ulipristalacetatom imale su veće smanjenje veličine mioma, što je procjenjivano MR-om.
English: There have been no reports of serious harmful effects from taking several doses of this medicine at once.
Croatian: Nisu prijavljeni ozbiljni štetni učinci prilikom uzimanja više doza lijeka Esmya istovremeno.
English: Pregnancy and breastfeeding.
Croatian: Trudnoća i dojenje.
English: Leuprorelin 3.75 mg/ month N=93
Croatian: leuprorelin 3,75 mg/ mjesec N=93
English: There are no or limited amount of data from the use of ulipristal acetate in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni ulipristalacetata u trudnica ograničeni.
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.
Croatian: • informirati bolesnice da moraju pratiti jetrenu funkciju prije početka svakog ciklusa liječenja, jednom mjesečno tijekom liječenja i unutar razdoblja od nekoliko tjedana nakon prestanka liječenja.