FrancophonIA/ELRC3.0 huggingface dataset:
English: • Epidemiological studies in women who use low dose (<50 µg ethinylestradiol) combined hormonal contraceptives have found that out of 10,000 women between 6 and 12 will develop a
Croatian: • Epidemiološka ispitivanja u žena koje uzimaju nisku dozu kombiniranih hormonskih kontraceptiva (< 50 µg etinilestradiola), pronašla su da će između 6 i 12 žena na njih 10 000
English: The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the
Croatian: Vjerojatnost da razvijete krvni ugrušak može biti veća ako imate neka druga zdravstvena stanja koja povećavaju taj rizik (pogledajte dio 2 za dodatne informacije o stanjima koja povećavaju rizik od krvnih ugrušaka i simptome krvnog ugruška).
English: Excretion of nomegestrol acetate was nearly complete after 10 days and amounts excreted were higher in feces than in urine.
Croatian: Izlučivanje nomegestrolacetata bilo je gotovo potpuno nakon 10 dana, a izlučene su količine u fecesu bile veće nego u mokraći.
English: She should then take placebo tablets from the last row for up to 4 days, including the days she missed tablets, and subsequently continue with the next blister pack.
Croatian: Potom treba uzimati tablete placeba iz posljednjeg reda najdulje 4 dana, uključujući dane kad je propustila tablete, a zatim nastavlja s tabletama iz idućeg blister pakiranja.
English: If you forgot to take one of these tablets the reliability of IOA is maintained.
Croatian: Ako ste zaboravili uzeti jednu od tih tableta, pouzdanost djelovanja lijeka IOA je održana.
English: Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some
Croatian: Putovanje avionom (duže od 4 sata) može Vam privremeno povećati rizik od krvnog ugruška, osobito ako imate neke druge od navedenih čimbenika.
English: In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of IOA should be discontinued.
Croatian: U slučaju pogoršanja ili prve pojave nekog od ovih stanja ili čimbenika rizika, ženi treba savjetovati da se obrati svom liječniku kako bi utvrdio treba li prekinuti primjenu lijeka IOA.
English: Further information on the possible side effect changes to menstrual periods (e.g. absence or irregular) during the use of IOA is described in section 3 ‘When and how to take the tablets', ‘If you have unexpected bleeding' and ‘If you have missed one or more periods').
Croatian: Dodatne informacije o mogućim promjenama mjesečnog ciklusa (npr. izostanku mjesečnice ili neredovitim mjesečnicama) tijekom uporabe lijeka IOA opisane su u dijelu 3 'Kako i kada uzimati tablete', 'Ako imate neočekivano krvarenje' i 'Ako Vam je izostala jedna ili više mjesečnica').
English: Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of IOA in these women is not indicated as long as liver function values have not returned to normal (see section 4.3).
Croatian: S obzirom da korisnice s teškom bolesti jetre mogu imati poremećaj metabolizma steroidnih hormona, primjena lijeka IOA u tih žena nije indicirana sve dok se jetrene funkcije ne vrate na normalne vrijednosti (vidjeti dio 4.3).
English: • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more
Croatian: • Malo povećavaju rizik od nastanka krvnog ugruška u venama i arterijama, osobito u prvoj godini primjene ili kad se ponovno počinje s primjenom kombiniranog hormonskog kontraceptiva nakon stanke od 4 ili više tjedana.
English: What you need to know before you use IOA
Croatian: Što morate znati prije nego počnete uzimati IOA
English: Schedule: if you are more than 12 hours late taking white tablets
Croatian: Raspored: ako je prošlo više od 12 sati otkad ste posljednji put uzeli bijele tablete
English: You should also tell your doctor if a close relative has, or ever had breast cancer (see section 2 “When to take special care with IOA”).
Croatian: Morate također reći svom liječniku ako netko od Vaših bliskih krvnih srodnika ima ili je imao rak dojke (pogledajte u dijelu 2 "Kada je potreban poseban oprez sa lijekom IOA").
English: You can start IOA between 21 and 28 days after having a baby.
Croatian: Možete započeti s uzimanjem lijeka IOA između 21. i 28. dana nakon poroda.
English: Clinical data on a limited number of exposed pregnancies indicate no adverse effect of IOA on the foetus or neonate.
Croatian: Klinički podaci iz ograničenog broja izloženih trudnoća nisu ukazali na štetne učinke lijeka IOA na fetus ili novorođenče.
English: • Worsening of depression, Crohn's disease and ulcerative colitis have been associated with COC use.
Croatian: • Pogoršanje depresije, Crohnova bolest i ulcerozni kolitis povezuju se s primjenom KOK-a.
English: In case you use a vaginal ring or transdermal patch, it is best to start using IOA on the day you remove the ring or patch.
Croatian: U slučaju da koristite vaginalni prsten ili transdermalni flaster, najbolje je početi koristiti IOA na dan uklanjanja prstena ili flastera.
English: The overall risk of a blood clot in the leg or lung (DVT or PE) with IOA is small.
Croatian: Ukupni rizik od nastanka krvnog ugruška u nozi ili plućima (DVT ili PE) uz IOA je mali.
English: • loss of consciousness or fainting with or without seizure.
Croatian: - gubitak svijesti ili nesvjestica s ili bez napadaja.
English: Rarely, there may be serious lasting effects or, very
Croatian: Rijetko mogu zaostati ozbiljne trajne posljedice ili, vrlo rijetko, može završiti smrtnim ishodom.
English: The apparent volume of distribution of nomegestrol acetate at steady-state is 1,645 ± 576 l.
Croatian: Prividan volumen distribucije nomegestrolacetata u stanju dinamičke ravnoteže iznosi 1,645 ± 576 l.
English: In two randomized, open-label, comparative efficacy-safety trials, more than 3,200 women have been treated for up to 13 consecutive cycles with IOA and more than 1,000 women with drospirenone 3 mg - ethinylestradiol 30 μg (21/7 regimen).
Croatian: U dva randomizirana, otvorena, komparativna ispitivanja djelotvornosti i sigurnosti je više od 3200 žena tijekom 13 uzastopnih ciklusa primalo IOA, a više od 1000 žena kombinaciju drospirenona u dozi od 3 mg i etinilestradiola u dozi od 30 µg (režim 21/7).
English: IOA is unlikely to affect your ability to drive or use machines.
Croatian: Nije vjerojatno da će IOA utjecati na Vašu sposobnost upravljanja vozilima i rada na strojevima.
English: IOA, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any
Croatian: IOA, kao ni drugi hormonski kontraceptivi, ne štiti od infekcije HIV-om (AIDS) ili bilo koje druge spolno prenosive bolesti.
English: No formal studies were performed to assess pharmacokinetics in ethnic groups.
Croatian: Nisu provedena formalna ispitivanja radi ocjene farmakokinetike u etničkim skupinama.
English: • Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using low-dose COCs (containing < 0.05 mg ethinylestradiol).
Croatian: • Iako kombinirani oralni kontraceptivi mogu utjecati na perifernu inzulinsku rezistenciju i toleranciju glukoze, nema dokaza da je potrebno mijenjati terapijski režim u žena sa šećernom bolešću koje koriste KOK u niskim dozama (koji sadrži < 0,05 mg etinilestradiola).
English: • if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack ) or transient ischaemic attack (TIA - temporary stroke
Croatian: • ako imate (ili ste ikada imali) anginu pektoris (stanje koje uzrokuje jaku bol u prsištu i može biti prvi znak srčanog udara) ili prolazni ishemijski napadaj (TIA - prolazni simptomi moždanog udara);
English: If you want to stop IOA because you want to get pregnant, see in section 3 ‘If you stop taking IOA'.
Croatian: Ako želite prestati uzimati IOA jer želite zatrudnjeti, pogledajte u dijelu 3 'Ako prestanete uzimati IOA'.
English: Your doctor may decide that IOA needs to be stopped.
Croatian: Liječnik može odlučiti da je potrebno prekinuti primjenu lijeka IOA.
English: If so, avoid too much exposure to the sun or
Croatian: U tom slučaju izbjegavajte prekomjerno izlaganje suncu ili ultraljubičastoj svjetlosti;
English: If vomiting occurs within 3-4 hours after white tablet-taking, a new tablet should be taken as soon as possible.
Croatian: Dođe li do povraćanja unutar 3-4 sata nakon uzimanja bijele tablete, čim prije treba uzeti novu tabletu.
English: If, after having a baby, you have had sexual intercourse before starting IOA, be sure that you are not pregnant or wait until the next menstrual period.
Croatian: Ako ste nakon poroda imali spolni odnos prije početka uzimanja lijeka IOA, morate biti sigurni da niste trudni ili pričekati do sljedeće mjesečnice.
English: An implant or IUS may be removed any day, and IOA should be started on the day of its removal.
Croatian: Implantat ili IUS mogu se ukloniti bilo koji dan, a uzimanje lijeka IOA treba započeti na dan njihovog uklanjanja.
English: For any information about this medicine, please contact the local representative of the Marketing
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet :
English: The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a
Croatian: Opaženi uzorak povećanog rizika može biti posljedica ranije dijagnoze raka dojke u korisnica KOK-a, bioloških učinaka KOK-a ili kombinacije obaju čimbenika.
English: Dose-linearity was observed in the range 0.625-5 mg (assessed in fertile and post-menopausal
Croatian: Linearnost doza primijećena je u rasponu od 0,625-5 mg (ispitano na plodnim ženama i ženama u postmenopauzi).
English: However, it must be borne in mind that sex steroids can promote the growth of certain hormone
Croatian: Međutim, treba imati na umu da spolni steroidi mogu potaknuti rast određenih tkiva i tumora koji su ovisni o hormonima.
English: Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you
Croatian: Ponekad simptomi moždanog udara mogu biti kratkotrajni uz gotovo neposredan i potpuni oporavak, ali i u tom slučaju morate potražiti hitnu medicinsku pomoć jer možete biti pod rizikom od drugog moždanog udara.
English: Contact your doctor if you have unusual severe
Croatian: Obratite se liječniku ako imate neuobičajeno jake bolove u trbuhu.
English: Endometrial histology was investigated in a subgroup of women (n=32) in one clinical study after 13 cycles of treatment.
Croatian: Histologija endometrija ispitivana je u podskupini žena (n=32) u jednom kliničkom ispitivanju nakon
English: • sudden trouble walking, dizziness, loss of balance or coordination;
Croatian: - iznenadne poteškoće s hodanjem, omaglica, gubitak ravnoteže ili koordinacije;
English: In a randomized, open label trial, 32 women were treated for 6 cycles with IOA.
Croatian: U randomiziranom otvorenom ispitivanju 32 su žene primale IOA tijekom 6 ciklusa.
English: Most epidemiological studies have revealed neither an increased risk of birth defects in infants born to women who used ethinylestradiol-containing COCs prior to pregnancy, nor a teratogenic effect when ethinylestradiolcontaining COCs were taken inadvertently during early pregnancy.
Croatian: Većina epidemioloških studija nije otkrila povećan rizik od prirođenih anomalija u novorođenčadi čije su majke prije trudnoće uzimale KOK koji je sadržavao etinilestradiol kao ni teratogene učinke kod slučajnog uzimanja KOK-a u ranoj trudnoći.
English: All adverse reactions are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000).
Croatian: (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) te rijetko (≥ 1/10 000 i < 1/1000).
English: The risk of reduced reliability is imminent because of the forthcoming placebo tablet phase.
Croatian: Rizik od smanjene pouzdanosti je neminovan zbog predstojećeg razdoblja uzimanja tableta placeba.
English: The effectiveness of the pill is maintained, but tell your doctor if you are using anti-fungal medicines
Croatian: Djelotvornost pilule je održana, ali obavijestite svog liječnika ako koristite lijekove protiv gljivica koji sadrže ketokonazol.
English: Comment
Croatian: Co.
English: You should not use IOA if you have any of the conditions listed below.
Croatian: Kada ne smijete uzimati IOA Ne smijete uzimati IOA ako imate neko od niže navedenih stanja.
English: In rare cases a blood clot can block blood vessels and cause serious
Croatian: U rijetkim slučajevima krvni ugrušak može začepiti krvnu žilu i prouzročiti ozbiljne tegobe.
English: In case of long-term treatment with hepatic enzyme-inducing substances another method of contraception should
Croatian: U slučaju dugotrajnog liječenja lijekovima koji induciraju jetrene enzime treba razmotriti drugu metodu kontracepcije.
English: If you get any side effect, particularly if severe or persistent, or have any change to your health that you think may be due to IOA, please talk to your doctor.
Croatian: Ako razvijete neku nuspojavu, osobito ako je teška ili dugo traje, ili je došlo do promjene Vašeg zdravstvenog stanja za koje mislite da bi moglo biti posljedica lijeka IOA, molimo obratite se svom liječniku.
English: Like all medicines, IOA can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, IOA može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: See also in section 3 ‘If you vomit or have severe diarrhoea' or in section 2 ‘Other medicines and IOA'.
Croatian: Pogledajte u dijelu 3 'Ako povraćate ili imate jaki proljev' ili u dijelu 2 'Drugi lijekovi i IOA'.
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed with IOA.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja učinaka lijeka IOA na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and estrogens, fixed combinations, ATC code: G03AA14.
Croatian: Farmakoterapijska skupina: Spolni hormoni i ostali pripravci koji djeluju na spolni sustav, progestageni i estrogeni, fiksne kombinacije, ATK oznaka: G03AA14.
English: • if you are going to use other medicines (see also in section 2 ‘Other medicines and IOA');
Croatian: • ako namjeravate uzimati druge lijekove (pogledajte u dijelu 2 "Drugi lijekovi i IOA");
English: The increased risk of VTE during the postpartum period should be considered when re-starting IOA (see section 4.2 and 4.4).
Croatian: Treba uzeti u obzir povećani rizik od VTE u postpartalnom razdoblju prilikom ponovnog uvođenja lijeka IOA (vidjeti dijelove 4.2 i 4.4).
English: You should ask your doctor how soon after delivery you can start taking IOA.
Croatian: Upitajte svog liječnika kada najranije nakon porođaja možete početi uzimati IOA;
English: • if you have systemic lupus erythematosus (SLE - a disease affecting your natural defense system);
Croatian: • ako imate sistemski lupus eritematosus (SLE - bolest koja zahvaća prirodni obrambeni sustav);
English: • It is not yet known how the risk of a blood clot with IOA compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.
Croatian: • Još nije poznato koliki je rizik od krvnog ugruška uz IOA u odnosu na rizik uz kombinirani hormonski kontraceptiv koji sadrži levonogestrel.
English: Multiple doses up to five times the daily dose of IOA and single doses up to 40 times the daily dose of nomegestrol acetate alone have been used in women without safety concern.
Croatian: Primijenjene su višestruke doze i do 5 puta veće od dnevne doze lijeka IOA te pojedinačne doze do 40 puta veće od dnevne doze nomegestrolacetata bez utjecaja na sigurnost primjene.
English: Note: Temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors.
Croatian: Napomena: privremena imobilizacija uključujući putovanje avionom >4 sata također može biti čimbenik rizika za
English: Nomegestrol
Croatian: Nomegestrolacetat
English: Repeat dose toxicity studies with estradiol, nomegestrol acetate or combination have indicated expected estrogenic and gestagen effects.
Croatian: Ispitivanja toksičnosti ponovljenih doza estradiola, nomegestrolacetata ili njihove kombinacije ukazala su na očekivane učinke estrogena i gestagena.
English: If you stop taking IOA because you want to get pregnant, you are recommended to wait until you have had a natural period before trying to conceive.
Croatian: Ako prestanete uzimati IOA jer želite zatrudnjeti, preporučuje se da pričekate do početka Vaše prirodne mjesečnice prije nego pokušate zatrudnjeti.
English: If the condition develops, or gets worse while you are using IOA, you should also tell your doctor.
Croatian: Ako se neko od navedenih stanja razvije ili pogorša dok uzimate IOA, također trebate o tome obavijestiti svog liječnika.
English: • change in colour of the skin on the leg e.g. turning pale, red or
Croatian: • promjena boje kože na nozi, npr. ako poblijedi, pocrveni ili poplavi
English: • if you have epilepsy (see in section 2 ‘Other medicines and IOA');
Croatian: • ako imate epilepsiju (pogledajte u dijelu 2 'Drugi lijekovi i IOA').
English: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, e.g., corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
Croatian: Uporaba steroidnih kontraceptiva može utjecati na rezultate nekih laboratorijskih testova, uključujući biokemijske parametre funkcije jetre, štitne žlijezde, nadbubrežne žlijezde i bubrega, plazmatske razine proteina (nosača), primjerice globulina koji vežu kortikosteroide i frakcija lipida/lipoproteina, parametre metabolizma ugljikokohidrata i parametre koagulacije i fibrinolize.
English: If possible take it within 12 hours of when you normally take your pill.
Croatian: Ako je moguće, uzmite je unutar 12 sati od uobičajenog vremena uzimanja pilule.
English: The pharmacokinetics of nomegestrol acetate (primary objective) after single oral dosing of IOA in healthy postmenarcheal female adolescents and adult subjects were similar.
Croatian: Farmakokinetika nomegestrolacetata (primarni cilj) nakon jedne peroralne doze lijeka IOA bila je podjednaka u zdravih adolescentica koje su imale menarhu i odraslih ispitanica.
English: • The herbal product St. John's wort may also stop IOA from working properly.
Croatian: • Biljni lijek gospina trava također može spriječiti pravilno djelovanje lijeka IOA.
English: Also HIV protease inhibitors with an inducing potential (e.g. ritonavir and nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine and efavirenz), may affect hepatic metabolism.
Croatian: Inhibitori HIV proteaze s induktivnim potencijalom (npr. ritonavir i nelfinavir) te nenukleozidni inhibitori reverzne transkriptaze (npr. nevirapin i efavirenz) također mogu utjecati na jetreni metabolizam.
English: Adverse reaction in MedDRA Term1
Croatian: Nuspojave prema MedDRA terminologiji1
English: In the IOA group, acne was reported by 15.4 % of the women (versus 7.9 % in the comparator group), weight increased was reported by 8.6 % of the women (versus 5.7 % in the comparator group), and abnormal withdrawal bleeding (predominantly absence of withdrawal bleeding) was reported by 10.5 % of the women (versus 0.5 % in the comparator group).
Croatian: U skupini koja je primala IOA akne su prijavljene u 15,4% žena (naspram 7,9% u skupini koja je primala usporedni lijek), porast tjelesne težine prijavljen je u 8,6% žena (naspram 5,7% u skupini koja je primala usporedni lijek), a poremećaj prijelomnog krvarenja (uglavnom izostanak krvarenja)
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2.
English: Influence of other medicinal products on IOA
Croatian: Utjecaj drugih lijekova na IOA
English: The efficacy of COCs may be reduced in the event of e.g., missed tablets (see section 4.2), gastrointestinal disturbances during active tablet-taking (see section 4.2) or use of concomitant medicinal
Croatian: Djelotvornost kombiniranih oralnih kontraceptiva može biti smanjena u slučaju npr. propuštenih tableta (vidjeti dio 4.2), probavnih poremećaja tijekom uzimanja tableta s djelatnim tvarima (vidjeti dio 4.2) ili istodobnog uzimanja lijekova (vidjeti dio 4.5).
English: However, if she has missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.
Croatian: No, ako je propustila više od jedne tablete, ženi treba preporučiti korištenje dodatnih kontracepcijskih mjera tijekom sljedećih 7 dana.
English: If you have to change this day, reduce the number of placebo days - when you take the yellow placebo tablets - (but never increase them - 4 is the maximum).
Croatian: Ako morate promijeniti taj dan, smanjite broj dana kada uzimate žute tablete placeba (ali nemojte
English: The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.
Croatian: Rizik može također biti povećan ako ponovno počnete uzimati kombinirani hormonski kontraceptiv (isti ili neki drugi) nakon stanke od
English: See also ‘General Notes' in section 2
Croatian: Pogledajte i 'Opće napomene' u dijelu 2 u prethodnom tekstu.
English: • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial
Croatian: • ako imate tegobe sa srcem (poremećaj zalistaka, poremećaj srčanog ritma koji se zove fibrilacija atrija);
English: In this case you could have a hereditary blood clotting
Croatian: U tom slučaju možete imati nasljedni poremećaj zgrušavanja krvi;
English: If any of these conditions appear for the first time while using IOA, stop taking it at once and tell your doctor.
Croatian: Ako se bilo koje od ovih stanja pojavi prvi put dok uzimate IOA, odmah prestanite s uzimanjem lijeka i obavijestite svog liječnika.
English: • if you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a disease of the blood], herpes gestationis [skin rash with vesicles during pregnancy], Sydenham's chorea [a disease of the nerves in which sudden movements of the body occur] (see in section 2 ‘When should you
Croatian: • ako imate neku bolest koja se prvi put javila ili se pogoršala tijekom trudnoće ili prethodne uporabe spolnih hormona (npr. gubitak sluha, porfiriju [bolest krvi], gestacijski herpes [osip kože s mjehurićima tijekom trudnoće], Sydenhamovu koreju [bolest živaca u kojoj dolazi do naglih nevoljnih pokreta tijela] (pogledajte u dijelu 2 'Kada se trebate obratiti svom liječniku');
English: IOA is not indicated during pregnancy.
Croatian: IOA nije indiciran za uporabu tijekom trudnoće.