natgillin/translations-raw huggingface dataset:
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).
(≥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).
Patients in amenorrheab,c
Bolesnice s amenorejomb,c
EU/1/18/1309/001 28 tablets EU/1/18/1309/002 84 tablets EU/1/18/1309/003 30 tablets EU/1/18/1309/004 28 tablets EU/1/18/1309/005 84 tablets
EU/1/18/1309/001 28 tablete EU/1/18/1309/002 84 tablete EU/1/18/1309/003 30 tablete EU/1/18/1309/004 28 tablete EU/1/18/1309/005 84 tablete
Gedeon Richter (listed in section 6).
Richter (naveden u dijelu 6).
17, rue de Pontoise F-95520 Osny France
17, Rue de Pontoise F-95520 Osny Francuska
Gedeon Richter Plc, 1103 Budapest
Gedeon Richter Plc. 1103 Budimpešta
Treatment whilst pregnant might affect your pregnancy (it is not known if Ulipristal Acetate Gedeon Richter might harm your baby or whether can cause miscarriage).
Liječenje za vrijeme trudnoće može utjecati na Vašu trudnoću (nije poznato može li Ulipristal Acetate Gedeon Richter naškoditi Vašem djetetu ili uzrokovati pobačaj).
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.
• Periodička izvješća o neškodljivosti 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.
Ulipristal Acetate Gedeon Richter is used in adult women (over 18 years of age) before they reach the menopause.
Ulipristal Acetate Gedeon Richter se koristi u odraslih žena (starijih od 18 godina) prije nego uđu u menopauzu.
Headache Mild or moderate severity headache was reported in 5.8% of patients.
Glavobolja blage ili umjerene jačine prijavljena je u 5,8% bolesnica.
The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre-menopausal women of this age group (mean of 40 years).
Opažena učestalost odgovara podacima za kontrolne skupine i prevalenciji objavljenoj u literaturi za žene ove dobne skupine (prosjek od 40 godina) sa simptomima predmenopauze.
The European Medicines Agency has waived the obligation to submit the results of studies with Ulipristal Acetate Gedeon Richter in all subsets of the paediatric population in leiomyoma of uterus (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Ulipristal Acetate Gedeon Richter u svim podskupinama pedijatrijske populacije s leiomiomima uterusa (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Available toxicological data in animals have shown excretion of ulipristal acetate in milk (for details see section 5.3).
Dojenje Dostupni toksikološki podaci u životinja pokazuju da se ulipristalacetat izlučuje u mlijeko (za detalje vidjeti dio 5.3).
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.
Za daljnje cikluse liječenja Vaša jetra provjeravat će se jednom prije svakog novog ciklusa liječenja i ako osjetite bilo koji od simptoma navedenih u nastavku.
respectively, p=0.027).
10 mg, p=0,027).
Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
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.
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.
Treatment with Ulipristal Acetate Gedeon Richter usually leads to a significant reduction or may even stop your menstrual bleeding (your ‘period') within the first 10 days of treatment.
Liječenje lijekom Ulipristal Acetate Gedeon Richter obično uzrokuje znatno smanjenje ili čak i prestanak menstrualnog krvarenja („mjesečnice“) unutar prvih 10 dana liječenja.
• key effects of Ulipristal Acetate Gedeon Richter on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
• Ključne učinke lijeka Ulipristal Acetate Gedeon Richter na promjene endometrija povezane s modulatorom progesteronskih receptora (PAEC) te kako ih razlikovati od učinaka neoponiranog estrogena.
- The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium, talc and magnesium stearate.
Drugi sastojci su mikrokristalična celuloza, manitol, umrežena karmelozanatrij, talk i magnezijev stearat.
What Ulipristal Acetate Gedeon Richter looks like and contents of the pack Ulipristal Acetate Gedeon Richter is white to off-white, round curved tablet of 7 mm engraved with code “ES5” on one face.
Kako Ulipristal Acetate Gedeon Richter izgleda i sadržaj pakiranja Ulipristal Acetate Gedeon Richter je bijela do bjelkasta, okrugla bikonveksna tableta promjera 7 mm, s utisnutim znakom “ES5” na jednoj strani.
The MAH shall ensure that, at launch and thereafter, all prescribers of Ulipristal Acetate Gedeon Richter and pathologists who review samples from Ulipristal Acetate Gedeon Richter-treated patients, as well as patients treated with Ulipristal Acetate Gedeon Richter, are provided with educational material.
MAH će osigurati da, u trenutku puštanja lijeka u promet i nakon toga, svi propisivači lijeka Ulipristal Acetate Gedeon Richter i patolozi koji analiziraju uzorke uzete od bolesnica liječenih lijekom Ulipristal Acetate Gedeon Richter, kao i bolesnice liječene lijekom Ulipristal Acetate Gedeon Richter, imaju dostupan edukacijski materijal.
These tests need to happen every month, including a few weeks after you finish a course of treatment (see schedule below).
uključujući i nekoliko tjedana nakon što završite ciklus liječenja (vidjeti raspored u nastavku).
Do not take Ulipristal Acetate Gedeon Richter if you are pregnant.
Nemojte uzimati lijek Ulipristal Acetate Gedeon Richter ako ste trudni.
There is no relevant use of ulipristal acetate in the paediatric population.
Pedijatrijska populacija Nema relevantne primjene ulipristalacetata u pedijatrijskoj populaciji.
Patients whose menstrual bleeding became normal (PBAC < 75) at week 13 Median change in myoma volume from baseline to week 13a a In Study 1, change from baseline in total myoma volume was measured by MRI.
Bolesnice čije je menstrualno krvarenje postalo normalno (PBAC < 75) u 13. tjednu Medijan promjene u volumenu mioma od početka do 13. a tjedna a U ispitivanju 1, promjena ukupnog volumena mioma u odnosu na početak mjerena je MR-om.
Use in women with severe asthma insufficiently controlled by oral glucocorticoids is not recommended.
Bolesnice s astmom Primjena u žena s teškom astmom koja nije adekvatno kontrolirana oralnim glukokortikoidima nije preporučljiva.
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.
(95,0%) te nisu dovele do prekida primjene lijeka (98,0%), a povukle su se spontano.
Ulipristal Acetate Gedeon Richter 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.
Djeca i adolescenti Esmyu ne smiju uzimati djeca mlađa od 18 godina jer sigurnost i djelotvornost ulipristalacetata za ovu dobnu skupinu još nije utvrđena.
During treatment with Ulipristal Acetate Gedeon Richter, your doctor will carry out regular blood tests to check your liver function.
Tijekom liječenja lijekom Ulipristal Acetate Gedeon Richter Vaš će liječnik redoviti obavljati krvne pretrage kako bi provjerio funkciju Vaše jetre.
• 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.
• 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,
Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective (see “Other medicines and Ulipristal Acetate Gedeon Richter”).
Vjerojatno je da će Ulipristal Acetate Gedeon Richter smanjiti djelotvornost nekih hormonskih kontraceptiva (pogledajte „Drugi lijekovi i Ulipristal Acetate Gedeon Richter“).
If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding, investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Ako tijekom ponovljenog intermitentnog liječenja, nakon početnog smanjenja krvarenja ili amenoreje dođe do promijenjenog perzistentnog ili neočekivanog uzorka krvarenja kao što je intermenstrualno krvarenje treba napraviti pretrage endometrija, uključujući biopsiju endometrija, kako bi se isključilo postojanje neke druge bolesti u podlozi, uključujući malignu bolest endometrija.
• inform the patients about potential adverse reactions related to liver that could be caused by the use of Ulipristal Acetate Gedeon Richter.
• informirati bolesnice o mogućim nuspojavama povezanima s jetrom koje bi mogle biti uzrokovane uzimanjem lijeka Ulipristal Acetate Gedeon Richter.
Ulipristal Acetate Gedeon Richter treatment is to be initiated and supervised by physicians experienced in the diagnosis and treatment of uterine fibroids.
Liječenje lijekom Ulipristal Acetate Gedeon Richter trebaju započeti i nadzirati liječnici s iskustvom u dijagnosticiranju i liječenju fibroida maternice.
Depending on the result of these tests your doctor will decide if treatment with Ulipristal Acetate Gedeon Richter is suitable for you.
Ovisno o rezultatima tih pretraga, Vaš liječnik odlučit će je li liječenje lijekom Ulipristal Acetate Gedeon Richter prikladno za Vas.
In addition, hormonal contraceptives and progestagens (e.g. norethindrone or levonorgestrel) are also likely to make Ulipristal Acetate Gedeon Richter less effective.
Osim toga hormonski kontraceptivi i progestageni (primjerice, noretindron ili levonorgestrel) također će vjerojatno smanjiti djelotvornost lijeka Ulipristal Acetate Gedeon Richter.
Ulipristal Acetate Gedeon Richter is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4).
Lijek Ulipristal Acetate Gedeon Richter kontraindiciran je u bolesnica s poremećajem jetre (vidjeti dijelove 4.3 i 4.4).
If you have been prescribed several courses of Ulipristal Acetate Gedeon Richter 3-month treatment, you should start each course at the earliest during the second menstrual period following the previous treatment completion.
Vam je propisano nekoliko ciklusa 3-mjesečnog liječenja lijekom Ulipristal Acetate Gedeon Richter, svaki ciklus trebate početi najranije tijekom razdoblja druge menstruacije koja nastupi nakon završetka prethodnog ciklusa liječenja.
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.
(10,5% umjereno ili teško) za ulipristalacetat i 60,4% (39,6% umjereno ili teško) za bolesnike liječene leuprorelinom.
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 Ulipristal Acetate Gedeon Richter treatment)
2. PRETRAGA (4 tjedna nakon početka liječenja) 3. PRETRAGA (8 tjedana nakon početka liječenja) 4. PRETRAGA (12 tjedana nakon početka liječenja)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of ulipristal acetate.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 5 mg ulipristalacetata.
Therefore, do not breast-feed your baby while taking Ulipristal Acetate Gedeon Richter.
Stoga nemojte dojiti svoju bebu dok uzimate Esmyu.
Most patients treated with ulipristal acetate stopped bleeding within the first week of treatment (amenorrhea).
Većina bolesnica liječenih ulipristalacetatom prestala je krvariti unutar prvog tjedna liječenja
Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective.
Vjerojatno je da će Ulipristal Acetate Gedeon Richter smanjiti djelotvornost nekih hormonskih kontraceptiva.
If you do become pregnant during Ulipristal Acetate Gedeon Richter treatment, you should stop taking Ulipristal Acetate Gedeon Richter immediately and contact your doctor or pharmacist.
Ako zatrudnite tijekom liječenja lijekom Ulipristal Acetate Gedeon Richter, odmah prekinite uzimanje lijeka i obratite se svom liječniku ili ljekarniku.
Ulipristal Acetate Gedeon Richter may cause mild dizziness (see section 4 “Possible side effects”).
Ulipristal Acetate Gedeon Richter može uzrokovati blagu omaglicu (pogledajte dio 4 „Moguće nuspojave“).
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Mogućnost utjecaja drugih lijekova na djelovanje ulipristalacetata:
Before you start treatment with Ulipristal Acetate Gedeon Richter blood tests will be undertaken to find out how well your liver is working.
- Prije nego što počnete uzimati lijek Ulipristal Acetate Gedeon Richter, obavit ćete krvne pretrage kako bi se utvrdilo kako radi Vaša jetra.
• inform the patients not to take Ulipristal Acetate Gedeon Richter in case of liver problems.
• informirati bolesnice da ne uzimaju lijek Ulipristal Acetate Gedeon Richter ako imaju probleme s jetrom.
You should know that most women have no menstrual bleeding (period) during the treatment and for a few weeks afterwards.
Što morate znati prije nego počnete uzimati Esmyu Trebate znati da većina žena nema menstrualno krvarenje (mjesečnicu) tijekom liječenja ovim lijekom te nekoliko tjedana nakon toga.
You should always start taking Ulipristal Acetate Gedeon Richter within the first week of your menstrual period.
Lijek Ulipristal Acetate Gedeon Richter uvijek morate početi uzimati unutar prvog tjedna Vaše menstruacije.
Tell your doctor or pharmacist if you are taking any of the medicines listed below, as these medicines can affect Ulipristal Acetate Gedeon Richter or be affected by Ulipristal Acetate Gedeon Richter: - Certain medicines which are used to treat the heart (e.g. digoxin).
Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od lijekova u nastavku jer ovi lijekovi mogu utjecati na lijek Ulipristal Acetate Gedeon Richter ili Ulipristal Acetate Gedeon Richter može utjecati na njih:
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.
CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 te 3A4 ili induciraju CYP1A2 u klinički značajnim koncentracijama.
Keep this medicine out of the sight and reach of children.
Kako čuvati Esmyu Lijek čuvajte izvan pogleda i dohvata djece.
Ulipristal Acetate Gedeon Richter can cause side effects although not everybody gets them.
Lijek Ulipristal Acetate Gedeon Richter može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
What Ulipristal Acetate Gedeon Richter is and what it is used for
Što je Ulipristal Acetate Gedeon Richter i za što se koristi
Patients starting treatment course 2 or 4
Bolesnice koje započinju 2.
If you stop taking Ulipristal Acetate Gedeon Richter Ulipristal Acetate Gedeon Richter is to be taken daily during treatment courses of up to 3 months continuously.
Ulipristal Acetate Gedeon Richter se mora neprekidno svakodnevno uzimati tijekom ciklusa liječenja od po najduže 3 mjeseca.
Keep the blisters in the outer carton in order to protect from light.
Blistere čuvajte u vanjskoj kutiji radi zaštite od svjetlosti.
breast discomfort - swelling due to fluid retention (oedema) - extreme tiredness (asthenia) - increase in blood cholesterol seen in blood tests, increase in blood fats (triglycerides) seen in blood tests.
- ekstremni umor (astenija) - povišen kolesterol u krvi što je vidljivo u krvnim pretragama, povišene masnoće u krvi
Patient card
Kartica za bolesnicu
SPECIAL STORAGE CONDITIONS Keep the blisters in the outer carton in order to protect from light.
POSEBNE MJERE ČUVANJA Čuvati blistere u vanjskom pakiranju radi zaštite od svjetlosti.
Do not take Ulipristal Acetate Gedeon Richter - if you are allergic to ulipristal acetate or any of the other ingredients of Ulipristal Acetate
Nemojte uzimati Esmyu - ako ste alergični na djelatnu(e) tvar(i) ili neki drugi sastojak lijeka Ulipristal Acetate Gedeon
Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate.
Ulipristal Acetate Gedeon Richter sadrži djelatnu tvar ulipristalacetat.
- If you are currently taking hormonal contraception (for example birth control pills) (see “Other medicines and Ulipristal Acetate Gedeon Richter”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Ulipristal Acetate Gedeon Richter.
(pogledajte „Drugi lijekovi i Ulipristal Acetate Gedeon Richter“), morate koristiti drugu pouzdanu metodu barijerne kontracepcije (poput kondoma) dok uzimate Esmyu.
Following oral administration of a single dose of 5 or 10 mg, ulipristal acetate is rapidly absorbed, with a Cmax of 23.5 ± 14.2 ng/ml and 50.0 ± 34.4 ng/ml occurring approximately 1 h after ingestion, and with an AUC0-∞ of 61.3 ± 31.7 ng.h/ml and 134.0 ± 83.8 ng.h/ml, respectively.
23,5 ± 14,2 ng/ml i 50,0 ± 34,4 ng/ml koja se događa približno 1 sat nakon gutanja, i s AUC0-∞ od 61,3 ± 31,7 ng/ml odnosno s 134,0 ± 83,8 ng.h/ml.
If you forget to take Ulipristal Acetate Gedeon Richter If you miss a dose by less than 12 hours, take it as soon as you remember.
Ako propustite dozu za manje od 12 sati, uzmite je čim se sjetite.
Ulipristal Acetate Gedeon Richter passes into the breast milk.
Ulipristal Acetate Gedeon Richter se izlučuje u majčino mlijeko.
- If you suffer from severe asthma, treatment with Ulipristal Acetate Gedeon Richter may not be suitable for you.
Ako patite od teškog oblika astme, liječenje lijekom Ulipristal Acetate Gedeon Richter možda neće biti prikladno za Vas.
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.
astenija, mučnina, povraćanje, bol u desnom hipohondriju, anoreksija, žutica itd.), liječenje je potrebno prekinuti, odmah je pregledati i obaviti testove jetrene funkcije.
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,
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
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.
(te pri višim koncentracijama na glukokortikoidne receptore) s aktivnošću antiprogesterona primijećenom pri izloženosti sličnoj onoj pri terapijskim razinama.
INFORMATION IN BRAILLE Ulipristal Acetate Gedeon Richter
16. PODACI NA BRAILLEOVOM PISMU Ulipristal Acetate Gedeon Richter
In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose,
U ispitivanju 4, u 61,9% odnosno 72,7% bolesnica amenoreja je postignuta na kraju prvog i drugog ciklusa liječenja zajedno (doza od 5 mg, odnosno 10 mg, p=0,032).
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.
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
Stop using Ulipristal Acetate Gedeon Richter and immediately contact a doctor if you experience any of the following symptoms:
Prestanite uzimati Esmyu i odmah obavijestite liječnika ako osjetite neki od sljedećih simptoma:
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.
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
Other medicines and Ulipristal Acetate Gedeon Richter Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Microcrystalline cellulose
6.1 Popis pomoćnih tvari celuloza, mikrokristalična manitol karmelozanatrij, umrežena talk magnezijev stearat
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: DD month YYYY Date of latest renewal: DD month YYYY
DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
You should nonetheless ask your doctor or pharmacist for advice if you take more Ulipristal Acetate Gedeon Richter than you should.
Bez obzira na to morate pitati svog liječnika ili ljekarnika za savjet ako ste uzeli više lijeka Ulipristal
Hot flush
navale vrućine
The educational material shall consist of the following:
Edukacijski materijal sastojat će se od sljedećeg: • Edukacijskog materijala za propisivače (ginekologe) koji sadrži:
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.
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,
NAME OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Gedeon Richter
Ulipristal Acetate Gedeon Richter 5 mg tablets Ulipristal acetate
Ulipristal Acetate Gedeon Richter 5 mg tablete ulipristalacetat
- If you have liver or kidney disease tell your doctor or pharmacist before taking Ulipristal Acetate Gedeon Richter.
Ako imate bolest jetre ili bubrega, obavijestite svog liječnika ili ljekarnika prije nego uzmete