FrancophonIA/ELRC3.0 huggingface dataset:
English: 300 mg hard capsules Capsule cap
Croatian: Pregabalin Zentiva k.s. 300 mg tvrde kapsule
English: Printing ink Shellac
Croatian: • želatina Tinta za označavanje
English: 50 mg hard capsules
Croatian: Pregabalin Zentiva k.s. 50 mg hard capsules
English: 300 mg hard capsules
Croatian: Pregabalin Zentiva k.s. 300 mg hard capsules
English: 50 mg hard capsules Pregabalin Zentiva k.s.
Croatian: Pregabalin Zentiva k.s. 50 mg tvrde kapsule pregabalin
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: 75 mg hard capsules Capsule cap
Croatian: Pregabalin Zentiva k.s. 75 mg tvrde kapsule
English: 150 mg hard capsules
Croatian: Pregabalin Zentiva k.s. 150 mg hard capsules
English: Rash papular, urticaria, hyperhidrosis, pruritus
Croatian: Poremećaji kože i potkožnog tkiva Manje često papularni osip, urtikarija, hiperhidroza, svrbež
English: B. PACKAGE LEAFLET
Croatian: Zentiva logo
English: U Kabelovny 130 Dolni Měcholupy 102 37 Prague 10 Czech Republic
Croatian: U kabelovny 130 Dolni Měcholupy
English: 100 mg
Croatian: Kapsule od 100 mg
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je Vam je rekao liječnik.
English: • Risk Management Plan (RMP)
Croatian: • Plan upravljanja rizicima (RMP)
English: WHAT TO DO BEFORE DURING AND AFTER YOUR TREATMENT?
Croatian: ŠTO MORATE NAPRAVITI PRIJE, TIJEKOM I NAKON LIJEČENJA?
English: You should discuss this with your doctor.
Croatian: To trebate raspraviti sa svojim liječnikom.
English: Do not drive or use machines if you experience these symptoms.
Croatian: Nemojte voziti ili upravljati strojevima ako osjetite te simptome.
English: Median change at week 13
Croatian: Promjena medijana u 13. tjednu
English: Biotransformation/Elimination
Croatian: Biotransformacija/Eliminacija
English: Patients with controlled bleeding b,c, d
Croatian: Bolesnice s kontroliranim krvarenjem b,c, d
English: ATC code: G03XB02.
Croatian: ATK oznaka: G03XB02.
English: Tablets should be swallowed with water.
Croatian: Tablete treba progutati s vodom.
English: WHAT YOU NEED TO KNOW BEFORE USE?
Croatian: ŠTO MORATE ZNATI PRIJE UZIMANJA?
English: The educational material shall consist of the following:
Croatian: Edukacijski materijal sastojat će se od sljedećeg:
English: What Esmya is and what it is used for
Croatian: Što je Esmya i za što se koristi
English: Esmya is used in adult women (over 18 years of age) before they reach the menopause.
Croatian: Esmya se koristi u odraslih žena (starijih od 18 godina) prije nego uđu u menopauzu.
English: Educational material for pathologists
Croatian: Edukacijski materijal za patologe
English: P values: 1 = <0.001, 2 = 0.037, 3= <0.002, 4 = <0.006.
Croatian: P vrijednosti: 1 = <0,001, 2 = 0,037, 3= <0,002, 4 = <0,006.
English: The doctor should check your liver immediately and decide if you can continue the treatment.
Croatian: Liječnik mora odmah provjeriti Vašu jetru i odlučiti možete li nastaviti liječenje.
English: Alu/PVC/PE/PVDC or Alu/PVC/PVDC blister.
Croatian: Al/PVC/PE/PVDC ili Al/PVC/PVDC blister.
English: The safety and efficacy of ulipristal acetate was only established in women of 18 years and older.
Croatian: Djelotvornost i sigurnost ulipristalacetata utvrđena je samo u žena u dobi od 18 godina i starijih.
English: Repeated intermittent use:
Croatian: Ponovljena intermitentna primjena:
English: Date of first authorisation: 23 February 2012 Date of latest renewal: 14 November 2016
Croatian: Datum posljednje obnove odobrenja: 14. studenog 2016.
English: Do not throw away via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: During each course of treatment, do not stop taking your tablets without the advice of your doctor even if you feel better, as symptoms may re-occur later.
Croatian: Tijekom pojedinog ciklusa liječenja nemojte prestati uzimati tablete bez savjeta svog liječnika čak i ako se osjećate bolje jer se simptomi mogu pojaviti kasnije.
English: Frequencies are defined as very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).
Croatian: Učestalosti su definirane kao vrlo često (1/10), često (1/100 i <1/10), manje često (1/1000 i <1/100), rijetko (1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: These tests need to happen every month, including a few weeks after you finish a course of treatment (see schedule below).
Croatian: Te pretrage moraju se obavljati svaki mjesec, uključujući i nekoliko tjedana nakon što završite ciklus liječenja (vidjeti raspored u nastavku).
English: The safety for a human embryo is unknown.
Croatian: Neškodljivost lijeka za humani embrio nije poznata.
English: Treatment whilst pregnant might affect your pregnancy (it is not known if Esmya might harm your baby or whether can cause miscarriage).
Croatian: Liječenje za vrijeme trudnoće može utjecati na Vašu trudnoću (nije poznato može li Esmya naškoditi Vašem djetetu ili uzrokovati pobačaj).
English: • pain in the upper right stomach
Croatian: • bol u gornjem desnom dijelu trbuha
English: Tablets may be taken with or without food.
Croatian: Tablete se mogu uzeti s hranom ili bez nje.
English: A risk to the newborns/infants cannot be excluded.
Croatian: Rizik za novorođenče/dojenče ne može se isključiti.
English: Gedeon Richter Plc, 1103 Budapest Gyömrői út 19-21 Hungary
Croatian: Gedeon Richter Plc. 1103 Budimpešta Gyömrői út 19-21.
English: If you miss a dose by less than 12 hours, take it as soon as you remember.
Croatian: Ako propustite dozu za manje od 12 sati, uzmite je čim se sjetite.
English: 28 tablets 30 tablets 84 tablets
Croatian: 28 tableta 30 tablete 84 tablete
English: The educational material shall contain the following key elements:
Croatian: Edukacijski materijali sadržavat će sljedeće ključne stavke:
English: Esmya should not be taken by children under 18 years of age since safety and efficacy of ulipristal acetate has not been established in this age group.
Croatian: Esmyu ne smiju uzimati djeca mlađa od 18 godina jer sigurnost i djelotvornost ulipristalacetata za ovu dobnu skupinu još nije utvrđena.
English: 1st TEST (before treatment start) Start of treatment
Croatian: 1. PRETRAGA (prije početka liječenja) Početak liječenja
English: You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards.
Croatian: Trebate znati da većina žena nema menstrualno krvarenje (mjesečnicu) tijekom liječenja ovim lijekom te nekoliko tjedana nakon toga.
English: Other medicines and Esmya
Croatian: Drugi lijekovi i Esmya
English: Similar results were obtained for the active mono-N-demethylated metabolite.
Croatian: Slični su rezultati dobiveni za aktivni mono-N-demetilirani metabolit.
English: Have regular blood tests
Croatian: Redovito obavljati krvne pretrage
English: Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Croatian: Prije puštanja lijeka u promet u svakoj državi članici, nositelj odobrenja za stavljanje gotovog lijeka u promet (MAH) će usuglasiti sadržaj i oblik edukacijskih materijala s nadležnim državnim tijelom.
English: - if you have vaginal bleeding not caused by uterine fibroids.
Croatian: - ako imate vaginalno krvarenje koje nije uzrokovano fibroidima maternice.
English: Do not take Esmya if you are pregnant.
Croatian: Nemojte uzimati lijek Esmya ako ste trudni.
English: Pack of 28, 30 and 84 tablets.
Croatian: Pakiranje od 28, 30 i 84 tableta.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: The main route of elimination is through faeces and less than 10% is excreted in the urine.
Croatian: Glavni način eliminacije je kroz stolicu dok se manje od 10% izlučuje mokraćom.
English: A PBAC >100 within the first 8 days of menses is considered to represent excessive menstrual blood loss.
Croatian: Rezultat PBAC > 100 unutar prvih osam dana menstruacije smatra se prekomjernim gubitkom krvi kod menstruacije.
English: If you take more Esmya than you should
Croatian: Ako uzmete više Esmye nego što ste trebali
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: • Educational material for patients which contains o Patient card
Croatian: • Edukacijskog materijala za bolesnice koji sadrži o Karticu za bolesnicu
English: The effect on newborn/infants has not been studied.
Croatian: Učinak na novorođenčad/dojenčad nije ispitana.
English: Frequency Not known
Croatian: Manje često Rijetko Učestalost nepoznata
English: * see section "Description of selected adverse reactions" ** The verbatim term “mild hair loss” was coded to the term “alopecia”
Croatian: *vidjeti dio „Opis odabranih nuspojava“ ** Doslovni pojam „blažeg gubljenja kose“ zamijenjen je pojmom “alopecija”
English: One possible side effect is serious damage to your liver.
Croatian: Jedna od mogućih nuspojava je ozbiljno oštećenje jetre.
English: It is available in Alu/PVC/PE/PVDC blisters in cartons containing 28, 30 and 84 tablets or Alu/PVC/PVDC blisters in cartons containing 28 and 84 tablets.
Croatian: Dostupna je u Al/PVC/PE/PVDC blisterima u kutijama koje sadrže 28, 30 i 84 tablete ili Al/PVC/PVDC blisterima u kutijama koje sadrže 28 i 84 tablete.
English: • absence of safety data on the endometrium for continuous treatment longer than 3 months.
Croatian: • odsutnost podataka o sigurnosti kontinuiranog liječenja duljeg od 3 mjeseca za endometrij.
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).
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od lijekova u nastavku jer ovi lijekovi mogu utjecati na lijek Esmya ili Esmya može utjecati na njih: - Određeni lijekovi koji se koriste za liječenje srca (primjerice digoksin).
English: Pre-operative use:
Croatian: Preoperativna primjena:
English: clarithromycin, erythromycin, rifabutin).
Croatian: klaritromicin, eritromicin, rifabutin).
English: - if you are pregnant or if you are breastfeeding.
Croatian: - ako ste trudni ili dojite.
English: b Patients with missing values were exluded from the analysis.
Croatian: b Bolesnice za koje nedostaju podaci nisu uključene u analizu.
English: Therefore, do not breast-feed your baby while taking Esmya.
Croatian: Stoga nemojte dojiti svoju bebu dok uzimate Esmyu.
English: What Esmya is and what it is used for What you need to know before you take Esmya How to take Esmya
Croatian: Što se nalazi u ovoj uputi Što je Esmya i za što se koristi Što morate znati prije nego počnete uzimati Esmyu Kako uzimati Esmyu
English: Carcinogenicity studies (in rats and mice) showed that ulipristal acetate is not carcinogenic.
Croatian: Ispitivanja kancerogenosti (na štakorima i miševima) su pokazala kako ulipristat acetat nije kancerogen.
English: These are possible symptoms of angioedema (frequency not known).
Croatian: To su mogući simptomi angioedema (učestalost nepoznata).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Esmya in all subsets of the paediatric population in leiomyoma of uterus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Esmya u svim podskupinama pedijatrijske populacije s leiomiomima uterusa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Contraception in females
Croatian: Kontracepcija u žena
English: Table 1: Results of primary and selected secondary efficacy assessments in Phase III studies
Croatian: Tablica 1: Rezultati primarnih i odabranih sekundarnih procjena djelotvornosti u ispitivanjima faze III
English: If pregnancy is suspected prior to initiation of a new treatment course, a pregnancy test should be performed.
Croatian: Ako se prije početka novog ciklusa liječenja sumnja na trudnoću, treba napraviti test za utvrđivanje trudnoće.
English: Such a pattern has been observed in approximately 60% of patients treated with ulipristal acetate for 3 months.
Croatian: Takav je uzorak primijećen u otprilike 60% bolesnica koje su liječene ulipristalacetatom tijekom 3 mjeseca.
English: 17, Rue de Pontoise FR-95520 Osny France
Croatian: 17, Rue de Pontoise FR-95520 Osny Francuska
English: These blood tests will inform the doctor of the functioning of your liver and are vital when monitoring your treatment.
Croatian: Te krvne pretrage pružit će liječniku informacije o funkciji Vaše jetre i ključne su za praćenje Vašeg liječenja.
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.
Croatian: U slučaju hiperplazije (bez atipije) preporučuje se praćenje u skladu s uobičajenom kliničkom praksom (npr. kontrolni pregled nakon 3 mjeseca).
English: However, if you continue to experience excessive bleeding tell your doctor.
Croatian: Međutim, ako se nastavi prekomjerno krvarenje, obavijestite svog liječnika.
English: At doses which were low enough to maintain gestation in the animal species, no teratogenic potential was observed.
Croatian: Pri dozama koje su dovoljno niske za održavanje gestacije kod životinja nije zabilježen teratogeni učinak.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progesterone receptor modulators.
Croatian: Farmakoterapijska skupina: Spolni hormoni i modulatori genitalnog sustava, modulatori progesteronskih receptora.
English: EU/1/12/750/001 28 tablets EU/1/12/750/002 84 tablets EU/1/12/750/003 30 tablets EU/1/12/750/004 28 tablets EU/1/12/750/005 84 tablets
Croatian: EU/1/12/750/001 28 tablete EU/1/12/750/002 84 tablete EU/1/12/750/003 30 tablete EU/1/12/750/004 28 tablete EU/1/12/750/005 84 tablete
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.
Croatian: Funkcionalne ciste na jajnicima primijećene su tijekom i nakon liječenja u 1,0% bolesnica te su u većini slučajeva spontano nestale unutar nekoliko tjedana.
English: Due to its mechanism of action, ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg), guinea pigs and in monkeys.
Croatian: Zbog svog mehanizma djelovanja, ulipristalacetat ima letalne učinke na embrije štakora, kunića (pri ponovljenim dozama iznad 1 mg/kg), zamoraca i majmuna.
English: • the need to inform the pathologist that patients were treated with Esmya if biopsy/surgical samples are to be sent for analysis.
Croatian: • potrebu za informiranjem patologa da su bolesnice bile liječene lijekom Esmya ako se uzorci iz biopsije/kirurškog zahvata šalju na analizu
English: Most patients treated with ulipristal acetate stopped bleeding within the first week of treatment (amenorrhea).
Croatian: Većina bolesnica liječenih ulipristalacetatom prestala je krvariti unutar prvog tjedna liječenja (amenoreja).
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.
Croatian: Koristi se prije operacije fibroida ili kao dugotrajno liječenje fibroida kako bi se smanjila njihova veličina, zaustavilo ili smanjilo krvarenje te povećao broj crvenih krvnih stanica.
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.
Croatian: Bolesnice treba obavijestiti da liječenje ulipristalacetatom obično uzrokuje značajno smanjenje količine menstrualne krvi ili amenoreju unutar prvih 10 dana liječenja.
English: Esmya passes into the breast milk.
Croatian: Esmya se izlučuje u majčino mlijeko.
English: 17 rue de Pontoise F-95520 Osny France
Croatian: 17, Rue de Pontoise F-95520 Osny Francuska
English: - If you are currently taking hormonal contraception (for example birth control pills) (see “Other medicines and Esmya”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Esmya.
Croatian: - Ako trenutno uzimate hormonalnu kontracepciju (primjerice pilule za kontrolu začeća) (pogledajte „Drugi lijekovi i Esmya“), morate koristiti drugu pouzdanu metodu barijerne kontracepcije (poput kondoma) dok uzimate Esmyu.
English: The most common finding in clinical trials was amenorrhea (79.2%), which is considered as a desirable outcome for the patients (see section 4.4).
Croatian: Najčešći nalaz u kliničkim ispitivanjima bio je amenoreja (79,2%) koja se smatra poželjnim ishodom za bolesnice (vidjeti dio 4.4).
English: In case of repeated intermittent treatment, periodic monitoring of the endometrium is recommended.
Croatian: U slučaju ponovljenog intermitentnog liječenja preporučuje se periodičko praćenje endometrija.
English: About 5% of patients of reproductive age experiencing heavy menstrual bleeding have an endometrial thickness of greater than 16 mm.
Croatian: Približno 5% bolesnica reproduktivne dobi koje imaju obilne menstruacije imaju debljinu endometrija veću od 16 mm.
English: Esmya is likely to make some hormonal contraceptives less effective (see “Other medicines and Esmya”).
Croatian: Vjerojatno je da će Esmya smanjiti djelotvornost nekih hormonskih kontraceptiva (pogledajte „Drugi lijekovi i Esmya“).
English: EU/1/12/750/001 EU/1/12/750/002 EU/1/12/750/003 EU/1/12/750/004 EU/1/12/750/005
Croatian: EU/1/12/750/003 EU/1/12/750/004 EU/1/12/750/005
English: Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Croatian: Iako nije zamijećen teratogeni potencijal, podaci iz ispitivanja na životinjama nisu dostatni s obzirom na reproduktivnu toksičnost (vidjeti dio 5.3).
English: In Study 2, change in the volume of the three largest myomas was measured by ultrasound.
Croatian: U ispitivanju 2, promjena volumena tri najveća mioma mjerena je ultrazvukom.
English: Study 1 was double-blind placebo controlled.
Croatian: Ispitivanje 1 bilo je dvostruko slijepo i kontrolirano placebom.
English: The observed frequency is in line with control groups and prevalence reported in literature for symptomatic premenopausal women of this age group (mean of 40 years).
Croatian: Opažena učestalost odgovara podacima za kontrolne skupine i prevalenciji objavljenoj u literaturi za žene ove dobne skupine (prosjek od 40 godina) sa simptomima predmenopauze.
English: This card provides information on blood tests you will need throughout treatment and on what you should do if liver side effects occur.
Croatian: U ovoj kartici nalaze se informacije o krvnim pretragama koje ćete morati obavljati tijekom liječenja i o tome što morate učiniti ako se pojave nuspojave vezane uz jetru.
English: Ulipristal acetate should only be prescribed after careful diagnosis.
Croatian: Ulipristalacetat treba propisati samo nakon pažljivo utvrđene dijagnoze.
English: Esmya is to be taken daily during treatment courses of up to 3 months continuously.
Croatian: Esmya se mora neprekidno svakodnevno uzimati tijekom ciklusa liječenja od po najduže 3 mjeseca.
English: There is no relevant use of ulipristal acetate in the paediatric population.
Croatian: Nema relevantne primjene ulipristalacetata u pedijatrijskoj populaciji.
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.
Croatian: Ispitivanja 3 i 4 pokazala su djelotvornost u kontroli simptoma fibroida maternice (npr. krvarenja iz maternice) i smanjivanju veličine fibroida nakon 2, odnosno 4 ciklusa liječenja.
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.
Croatian: c N i % uključuju bolesnice isključene tijekom ispitivanja d Kontrolirano krvarenje definirano je kao izostanak epizoda teških krvarenja i najviše 8 dana krvarenja (ne uključujući dane u kojima se javlja točkasto krvarenje) tijekom posljednja 2 mjeseca pojedinog ciklusa liječenja.
English: In the placebo-controlled study, the rate of hot flushes was 1.0% for ulipristal acetate and 0% for placebo.
Croatian: U ispitivanju kontroliranom placebom, stopa pojava navala vrućine (valunga) iznosila je 1,0% za ulipristalacetat i 0% za placebo.
English: Patients starting treatment course 2 or 4
Croatian: Bolesnice koje započinju 2. ili 4. ciklus liječenja
English: Do not take Esmya - if you are allergic to ulipristal acetate or any of the other ingredients of Esmya (listed in section 6).
Croatian: Nemojte uzimati Esmyu - ako ste alergični na djelatnu(e) tvar(i) ili neki drugi sastojak lijeka Esmya (naveden u dijelu 6).
English: The size of the three largest myomas was assessed by ultrasound at the end of treatment (Week 13) and for another 25 weeks without treatment in patients who did not have hysterectomy or myomectomy performed.
Croatian: Veličina tri najveća mioma procijenjena je ultrazvukom na kraju liječenja (13. tjedan) te tijekom narednih 25 tjedana bez liječenja u bolesnica koje se nisu podvrgnule histerektomiji ili miomektomiji.
English: Esmya with food and drink You should avoid drinking grapefruit juice while on treatment with Esmya.
Croatian: Esmya s hranom i pićem Tijekom liječenja lijekom Esmya izbjegavajte piti sok od grejpa.
English: The tablet should be swallowed with water and may be taken with or without food.
Croatian: Tablete treba progutati s vodom te se mogu uzimati s hranom ili bez nje.
English: • the differential diagnosis between PAEC, unopposed oestrogen and endometrial hyperplasia.
Croatian: • Diferencijalnu dijagnozu između PAEC-a, neoponiranog estrogena i hiperplazije endometrija.
English: Patients with heavy menstrual bleeding due to uterine fibroids are at risk of excessive bleeding, which may require surgical intervention.
Croatian: Bolesnice s teškim menstrualnim krvarenjem zbog fibroida maternice su pod rizikom od prekomjernog krvarenja koje može zahtijevati kiruršku intervenciju.