FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions listed below are classified according to frequency and system organ class using the following convention: 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 the available data).
Croatian: Niže prikazane nuspojave klasificirane su po učestalosti i organskim sustavima primjenom sljedeće konvencije: vrlo često (≥1/10), često (≥ 1/100 do <1/10), manje često (≥ 1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti na temelju dostupnih podataka).
English: How ellaOne works ellaOne contains the substance ulipristal acetate which acts by modifying the activity of the natural hormone progesterone which is necessary for ovulation to occur.
Croatian: Kako ellaOne djeluje ellaOne sadrži tvar ulipristalacetat koja mijenja aktivnost prirodnog hormona progesterona, koji je potreban kako bi došlo do ovulacije.
English: There is no relevant use of ulipristal acetate for children of prepubertal age in the indication emergency contraception.
Croatian: Nema relevantne primjene ulipristalacetata u djece pretpubertetske dobi u indikaciji hitne kontracepcije.
English: Most findings in general toxicity studies were related to its mechanism of action as a modulator of progesterone and glucocorticoid receptors, with antiprogesterone activity observed at exposures similar to therapeutic levels.
Croatian: Većina nalaza u ispitivanjima opće toksičnosti bila je povezana s mehanizmom djelovanja lijeka kao modulatora receptora progesterona i glukokortikoida uz antiprogesteronsku aktivnost opaženu pri izloženosti sličnim terapijskim razinama.
English: Pregnancy ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant (see section 4.2).
Croatian: Trudnoća ellaOne nije namijenjena za primjenu tijekom trudnoće i ne smiju je uzeti žene u kojih se sumnja ili se zna da su trudne (vidjeti dio 4.2).
English: What ellaOne is and what it is used for What you need to know before you take ellaOne How to take ellaOne
Croatian: Što je ellaOne i za što se koristi Što morate znati prije nego uzmete ellaOne Kako uzimati ellaOne Moguće nuspojave
English: There were no safety differences in these subjects in terms of incidence and severity of adverse reactions, change in duration or volume of menses or incidence of intermenstrual bleeding.
Croatian: Kod tih žena nije bilo razlika u sigurnosti s obzirom na incidenciju i težinu nuspojava, promjenu u trajanju i volumenu menstruacija te incidenciju intermenstruacijskih krvarenja.
English: What ellaOne is and what it is used for ellaOne is an emergency contraceptive ellaOne is a contraceptive intended to prevent pregnancy after unprotected sex or if your contraceptive method has failed.
Croatian: Što je ellaOne i za što se koristi ellaOne je hitni kontraceptiv ellaOne je kontraceptiv namijenjen sprječavanju trudnoće nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: When used for emergency contraception the mechanism of action is inhibition or delay of ovulation via suppression of the luteinising hormone (LH) surge.
Croatian: Kada se upotrebljava za hitnu kontracepciju, mehanizam djelovanja je inhibicija ili odgađanje ovulacije supresijom vala luteinizacijskog hormona (LH).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnice s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjele uzimati ovaj lijek.
English: Among the women who received ellaOne in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.
Croatian: Samo 0,4% žena koje su uzimale ellaOne tijekom ispitivanja faze III je prijavilo jako intermenstruacijsko krvarenje.
English: The meta-analysis of the four clinical studies conducted with ulipristral acetate presented below excluded women who had further acts of unprotected intercourse.
Croatian: Meta-analiza četiriju kliničkih ispitvanja provedenih s ulipristalacetatom u nastavku nije uključivala žene koje su imale daljnje nezaštićene spolne odnose.
English: Emergency contraception is not effective in every case.
Croatian: Hitna kontracepcija nije uvijek djelotvorna.
English: As a result, this medicine works by postponing ovulation.
Croatian: Na taj način ovaj lijek odgađa ovulaciju.
English: During this time, it is recommended to use a breast pump in order to maintain milk production, but throw away your breast milk.
Croatian: U tom se razdoblju preporučuje uporaba izdajalice kako bi se održalo stvaranje mlijeka, ali mlijeko bacite.
English: Speak to your doctor or pharmacist before using ellaOne when you use (or have recently used) any of the medicines stated above.
Croatian: Razgovarajte sa svojim liječnikom ili ljekarnikom prije uzimanja ellaOne ako uzimate (ili ste nedavno uzeli) bilo koji od gore navedenih lijekova.
English: Akacia Group, s.r.o.
Croatian: Česká republika Akacia Group, s.r.o.
English: There is some evidence that this medicine may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.
Croatian: Neki dokazi upućuju na to da se učinkovitost ovog lijeka može smanjivati porastom tjelesne težine ili indeksa tjelesne mase (ITM), no ti su podaci nedostatni za donošenje konačnih zaključaka.
English: Unprotected sex at any time during your cycle can lead to pregnancy.
Croatian: Nezaštićen snošaj u bilo kojem trenutku menstruacijskog ciklusa može dovesti do trudnoće.
English: If you have been told by your doctor or other healthcare professional that you have an intolerance to some sugars, tell your pharmacist before taking this medicine.
Croatian: Ako Vam je Vaš liječnik ili drugi zdravstveni djelatnik rekao da ne podnosite neke šećere, obratite se svom ljekarniku prije nego uzmete ovaj lijek.
English: This medicine is a contraceptive used to prevent a pregnancy from starting.
Croatian: Ovaj je lijek kontraceptiv koji sprječava da dođe do trudnoće.
English: In an open-label clinical trial, which enrolled women who presented for emergency contraception and were treated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rate of 2.1% (26/1241) was observed.
Croatian: U otvorenom kliničkom ispitivanju koje je uključilo žene podvrgnute hitnoj kontracepciji ulipristalacetatom između 48 i 120 sati nakon nezaštićenog snošaja opažena je stopa trudnoće od 2,1% (26/1241).
English: - If you are using one of the medicines that may prevent ellaOne from working properly (see section 2 “What you need to know before you take ellaOne”) or if you have used one of these medicines in the past 4 weeks, ellaOne may work less effectively for you.
Croatian: • Ako uzimate neki od lijekova koji mogu spriječiti pravilno djelovanje ellaOne (vidjeti dio 2 „Što morate znati prije nego uzmete ellaOne”) ili ako ste neki od tih lijekova uzimali u posljednja 4 tjedna, ellaOne može imati slabiji učinak.
English: If you have used certain other medicines in the last 4 weeks, in particular for epilepsy, tuberculosis, HIV infection or herbal medicines containing St. John´s wort (see leaflet), ellaOne may work less effectively.
Croatian: Ako ste uzimali neke druge lijekove u posljednja 4 tjedna, posebice za epilepsiju, tuberkulozu, infekciju HIV-om ili biljne pripravke koji sadrže gospinu travu (vidjeti uputu o lijeku), ellaOne može imati slabiji učinak.
English: If vomiting occurs within 3 hours of the tablet intake, another tablet should be taken.
Croatian: Javi li se povraćanje unutar 3 sata nakon uzimanja tablete, treba uzeti još jednu tabletu.
English: Such high doses were well-tolerated; however, these women had a shortened menstrual cycle (uterine bleeding occurring 2-3 days earlier than would be expected) and in some women, the duration of bleeding was prolonged, although not excessive in amount (spotting).
Croatian: Međutim, kod tih je žena došlo do skraćenog menstrualnog ciklusa (krvarenje iz maternice pojavljivalo se 2-3 dana ranije nego očekivano), a u nekih se žena krvarenje produljilo, iako ne u velikoj količini (krvavi iscjedak).
English: When the data from the two trials were combined via meta- analysis, the risk of pregnancy with ulipristal acetate was significantly reduced compared to levonorgestrel (p=0.046).
Croatian: Meta-analiza kombiniranih podataka dva ispitivanja pokazala je značajno smanjen rizik trudnoće s ulipristalacetatom u usporedbi s levonorgestrelom (p=0,046).
English: Diarrhoea Dry mouth Dyspepsia Flatulence
Croatian: Proljev Suha usta Dispepsija Flatulencija
English: Do not use this medicine after the expiry date which is on the carton and on the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza EXP.
English: The patient should be informed not to drive or use machines if they are experiencing such symptoms (see section 4.8).
Croatian: Bolesnice treba upozoriti da u slučaju pojave takvih simptoma ne upravljaju vozilima ili strojevima (vidjeti dio 4.8).
English: This medicine is suitable for any woman of childbearing age, including adolescents.
Croatian: Ovaj je lijek pogodan za sve žene u dobi u kojoj mogu zatrudnjeti, uključujući adolescentice.
English: This medicine will not protect you against HIV infection or any other sexually transmitted diseases (e.g. chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B and syphilis).
Croatian: Ovaj Vas lijek neće zaštititi od infekcije HIV-om ili drugih spolno prenosivih bolesti (npr. klamidije, genitalnog herpesa, kondiloma, gonoreje, hepatitisa B i sifilisa).
English: In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations.
Croatian: In vitro podaci pokazuju da ulipristalacetat i njegov aktivni metabolit u klinički značajnim koncentracijama bitno ne inhibiraju CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1 i 3A4.
English: Excipients with known effect Each tablet contains 237 mg of lactose (as monohydrate).
Croatian: Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 237 mg laktoze (u obliku hidrata).
English: Always take this medicine exactly as described in this leaflet or as your pharmacist, doctor or other healthcare professional has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao Vaš ljekarnik, liječnik ili drugi zdravstveni djelatnik.
English: Odds ratio [95% CI] of pregnancy risk, ulipristal acetate vs levonorgestrel2
Croatian: Omjer šansi [95% CI] za pojavu trudnoće: ulipristalacetat naspram levonorgestrela2
English: Some symptoms such as breast tenderness and abdominal (stomach) pain, throwing up (vomiting), feeling sick (nausea) are also possible signs of pregnancy.
Croatian: Neki simptomi kao što su osjetljivost dojki, bol u trbuhu, povraćanje i mučnina također mogu biti znakovi trudnoće.
English: Potential for ulipristal acetate to affect other medicinal products
Croatian: Mogućnost utjecaja ulipristalacetata na druge lijekove
English: In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
Croatian: Sve žene hitnu kontracepciju trebaju uzeti što ranije nakon nezaštićenog snošaja, bez obzira na tjelesnu težinu ili ITM.
English: LABORATOIRE HRA PHARMA 200 avenue de Paris 92320 CHATILLON France
Croatian: LABORATOIRE HRA PHARMA 200 avenue de Paris 92320 CHATILLON Francuska
English: The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea.
Croatian: Najčešće prijavljene nuspojave bile su glavobolja, mučnina, bolovi u abdomenu i dismenoreja.
English: Results from two independent randomised controlled trials (see Table) showed the efficacy of ulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure.
Croatian: Rezultati dva neovisna randomizirana kontrolirana ispitivanja (pogledati tablicu) pokazuju kako djelotvornost ulipristalacetata nije inferiorna djelotvornosti levonorgestrela u žena koje su podvrgnute hitnoj kontracepciji između 0 i 72 sata nakon nezaštićenog snošaja ili zatajenja kontracepcijske metode.
English: This medicine may make regular hormonal contraceptives, like pills and patches, temporarily less effective.
Croatian: Ovaj lijek može privremeno smanjiti učinkovitost redovnih hormonskih kontraceptiva kao što su kontracepcijske tablete i flasteri.
English: During this time it is recommended to express and discard the breast milk in order to stimulate lactation.
Croatian: Za to vrijeme preporučuje se izdajati i odbaciti izdojeno majčino mlijeko kako bi se potaknula laktacija.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The clinical relevance of this interaction for single dose administration of ulipristal acetate as emergency contraception is not known.
Croatian: Klinički značaj te interakcije na primjenu pojedinačne doze ulipristalacetata kao hitnog kontraceptiva nije poznat.
English: No data are available on the efficacy of ulipristal acetate when taken more than 120 hours (5 days) after unprotected intercourse.
Croatian: Nema podataka o djelotvornosti ulipristalacetata kada se uzme više od 120 sati (5 dana) nakon nezaštićenog snošaja.
English: *Symptom which could also be related to an undiagnosed pregnancy (or related complications) Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see section 4.2).
Croatian: *Simptomi koji mogu također biti povezani s neutvrđenom trudnoćom (ili povezanim komplikacijama) Adolescenti: sigurnosni profil opažen u žena mlađih od 18 godina tijekom ispitivanja i nakon stavljanja lijeka u promet, sličan je sigurnosnom profilu u odraslih žena tijekom ispitivanja faze III (vidjeti dio 4.2).
English: If you become pregnant despite taking this medicine, there is no evidence that it will affect your pregnancy.
Croatian: Ako zatrudnite iako ste uzeli ovaj lijek, nema dokaza da će on utjecati na trudnoću.
English: P-glycoprotein (P-gp) substrates
Croatian: Supstrati P-glikoproteina (P-gp)
English: Before taking this medicine, if your period is late, tell your pharmacist, doctor or other healthcare professional, or do a pregnancy test in order to make sure you are not already pregnant (see section “Warning and precautions”).
Croatian: Ako Vam menstruacija kasni, prije nego uzmete ovaj lijek, obratite se ljekarniku, liječniku ili drugom zdravstvenom djelatniku ili napravite test na trudnoću kako biste bili sigurni da već niste trudni (pogledajte dio „Upozorenja i mjere opreza”).
English: 17, rue de Pontoise 95520 Osny France
Croatian: 17, rue de Pontoise 95520 Osny Francuska
English: Pregnancy rate (%) within 72h of unprotected intercourse or contraceptive failure2
Croatian: Stopa trudnoće (%) unutar 72 sata od nezaštićenog snošaja ili zatajenja kontracepcijske metodeP2
English: Each carton contains one blister.
Croatian: Svaka kutija sadrži jedan blister.
English: Similar results were obtained for the active mono-demethylated metabolite.
Croatian: Slični rezultati dobiveni su i s aktivnim monodemetiliranim metabolitom.
English: In the absence of specific studies, ulipristal acetate is not recommended.
Croatian: Zbog nedostatka odgovarajućih ispitivanja, primjena ulipristalacetata se ne preporučuje.
English: In all women, emergency contraception should be taken as soon as possible after unprotected intercourse.
Croatian: Sve žene hitnu kontracepciju trebaju uzeti što prije nakon nezaštićenog spolnog odnosa.
English: Other contraceptives and ellaOne
Croatian: Drugi kontraceptivi i ellaOne
English: What you need to know before you take ellaOne Do not take ellaOne
Croatian: Što morate znati prije nego uzmete ellaOne
English: However, if your period is more than 7 days late; if it is unusually light or unusually heavy; or if you experience symptoms such as abdominal (stomach) pain, breast tenderness, vomiting or nausea, you may be pregnant.
Croatian: Međutim, ako Vaša menstruacija kasni više od 7 dana, ako je neuobičajeno oskudna ili neuobičajeno obilna, ili ako imate simptome kao što su bol u trbuhu, osjetljivost dojki, povraćanje ili mučnina, možda ste trudni.
English: Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
Croatian: Prema tome, nije vjerojatno da primjena ulipristalacetata mijenja klirens lijekova koji se metaboliziraju tim enzimima.
English: If you are already pregnant it will not interrupt an existing pregnancy.
Croatian: Ako ste već trudni, neće prekinuti postojeću trudnoću.
English: Ulipristal acetate also has high affinity for the glucocorticoid receptor and in vivo, in animals, antiglucocorticoid effects have been observed.
Croatian: Ulipristalacetat također ima visoki afinitet prema glukokortikoidnom receptoru te je u uvjetima in vivo, u pokusnih životinja opažen antiglukokortikoidni učinak.
English: In case the next menstrual period is more than 7 days late, if the menstrual period is abnormal in character or if there are symptoms suggestive of pregnancy or in case of doubt, a pregnancy test should be performed.
Croatian: U slučaju kašnjenja sljedeće menstruacije više od 7 dana, ako je menstruacija svojim značajkama abnormalna ili ako postoje simptomi koji ukazuju na trudnoću ili postoji sumnja na trudnoću, treba napraviti test na trudnoću.
English: Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, and high density lipoprotein.
Croatian: Ulipristalacetat se u visokom postotku (>98%) veže na proteine plazme, uključujući albumin, alfa-1kiseli glikoprotein i lipoprotein velike gustoće.
English: In vitro data indicate that ulipristal acetate may be an inhibitor of BCRP (Breast Cancer Resistance Protein) transporters at the intestinal level.
Croatian: In vitro podaci ukazuju da ulipristalacetat može biti inhibitor prijenosnika proteina rezistencije raka dojke na lijekove (BCRP) u crijevima.
English: LABORATOIRE HRA PHARMA 200 avenue de Paris
Croatian: Nositelj odobrenja za stavljanje lijeka u promet LABORATOIRE HRA PHARMA 200 avenue de Paris
English: Experience with ulipristal acetate overdose is limited.
Croatian: Iskustvo s predoziranjem ulipristalacetata je ograničeno.
English: The effects of CYP3A4 inhibitors are unlikely to have any clinical consequences.
Croatian: Nije vjerojatno da učinci CYP3A4 inhibitora imaju ikakve kliničke posljedice.
English: No pharmacokinetic studies with ulipristal acetate have been performed in females with impaired renal or hepatic function.
Croatian: Farmakokinetička ispitivanja s ulipristalacetatom nisu provedena u žena s poremećajem funkcije bubrega ili jetre.
English: In any case, women should be advised to adopt a regular method of contraception.
Croatian: Žene je uvijek potrebno savjetovati o primjeni jedne od metoda redovne kontracepcije.
English: Pharmacodynamic data show that even when taken immediately before ovulation is scheduled to occur (when LH has already started to rise), ulipristal acetate is able to postpone follicular rupture for at least 5 days in 78.6% of cases (p<0.005 vs. levonorgestrel and vs. placebo)
Croatian: Farmakodinamički podaci pokazuju da čak i kada se uzme neposredno prije ovulacije (nakon što se razina LH već počela povećavati) ulipristalacetat može odgoditi prsnuće folikula za najmanje 5 dana u 78,6% slučajeva (p<0,005 naspram levonorgestrela i naspram placeba) (vidjeti tablicu).
English: Other medicines and ellaOne
Croatian: Drugi lijekovi i ellaOne
English: When your period is late or when you have symptoms of pregnancy (heavy breasts, morning sickness) you should consult a doctor or other healthcare professional before taking the tablet.
Croatian: Ako Vaša menstruacija kasni ili ako imate simptome trudnoće (osjećaj težine u dojkama, jutarnje mučnine), morate se obratiti liječniku ili drugom zdravstvenom djelatniku prije uzimanja tablete.
English: - if you are allergic to ulipristal acetate or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati ellaOne − ako ste alergični na ulipristalacetat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se podnošenje periodičkog izvješća o neškodljivosti (PSUR) podudara s nadopunama Plana (RMP), oba dokumenta mogu biti podnesena istodobno.
English: Although the use of ulipristal acetate for emergency contraception does not contraindicate the continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (see section 4.5).
Croatian: Iako pri uzimanju ulipristalacetata kao hitne kontracepcije nije kontraindicirana daljnja primjena redovne hormonske kontracepcije, ellaOne može smanjiti njezino kontracepcijsko djelovanje (vidjeti dio 4.5).
English: Nausea*
Croatian: Mučnina*
English: IUD (intrauterine device)
Croatian: Intrauterini uložak (IUD)
English: Two trials provide efficacy data on ellaOne used up to 120 hours after unprotected intercourse.
Croatian: Dva ispitivanja pružaju rezultate djelotvornosti ellaOne primjenjene do 120 sati nakon nezaštićenog snošaja.
English: There is more information about contraception at the end of this leaflet.
Croatian: Na kraju ove upute možete pronaći više informacija o kontracepciji.
English: The adverse reactions reported in the phase III program of 2,637 women are provided in the table below.
Croatian: U tablici niže prikazane su nuspojave prijavljene tijekom kliničkog programa faze III koji je obuhvatio 2637 žena.
English: Results in vivo with the P-gp substrate fexofenadine were inconclusive.
Croatian: In vivo rezultati s P-gp supstratom feksofenadinom su bili neuvjerljivi.
English: Because ulipristal acetate binds to the progesterone receptor with high affinity, it may interfere with the action of progestogen-containing medicinal products: - Contraceptive action of combined hormonal contraceptives and progestogen-only contraception may be reduced - Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.4).
Croatian: Kako se s visokim afinitetom veže na receptore za progesteron, ulipristalacetat može utjecati na djelovanje lijekova koji sadrže progestagene: - kontracepcijsko djelovanje kombiniranih hormonskih kontraceptiva i kontracepcije koja sadrži samo progestagen može biti smanjeno - istodobna primjena ulipristalacetata i hitne kontracepcije koja sadrži levonorgestrel se ne preporučuje (vidjeti dio 4.4).
English: In addition, the second comparative trial described above also provides data on 100 women treated with ulipristal acetate from 72 to 120 hours after unprotected intercourse, in whom no pregnancies were observed.
Croatian: Dodatno, drugim komparativnim ispitivanjem opisanim gore također su dobiveni podaci o 100 žena koje su uzele ulipristalacetat između 72 i 120 sati nakon nezaštićenog snošaja u kojih nisu opažene trudnoće.
English: Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see section 4.2).
Croatian: Adolescenti: sigurnosni profil opažen u žena mlađih od 18 godina tijekom ispitivanja i nakon stavljanja lijeka u promet, sličan je sigurnosnom profilu u odraslih žena tijekom ispitivanja faze III (vidjeti dio 4.2).
English: Medicinal products affecting gastric pH
Croatian: Lijekovi koji utječu na pH želuca