FrancophonIA/ELRC3.0 huggingface dataset:
English: Day 18-24 of white active tablet intake (see picture and schedule) There is a particularly high risk of becoming pregnant if you miss white active tablets close to the yellow placebo tablet interval.
Croatian: 18.- 24. dan uzimanja bijelih tableta s djelatnim tvarima (pogledajte sliku i raspored) Postoji osobito visoki rizik od trudnoće ako propustite bijele tablete s djelatnim tvarima oko razdoblja uzimanja žutih tableta placeba.
English: After vomiting or diarrhoea, you must take another white active tablet from a reserve blister as soon as possible.
Croatian: Nakon povraćanja ili proljeva morate što prije uzeti drugu bijelu tabletu s djelatnim tvarima iz rezervnog blistera.
English: If you have taken Zoely every day according to these directions, it is unlikely that you are pregnant (see also section 3 ‘If you have missed one or more periods').
Croatian: Ako ste uzimali Zoely svaki dan u skladu s ovim uputama, vrlo vjerojatno niste trudni (vidjeti u dijelu 3 'Ako Vam je izostala jedna ili više mjesečnica').
English: Zoely has no or negligible influence on the ability to drive and use machines.
Croatian: Zoely ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Temporary symptoms suggest the event is a transient ischaemic attack (TIA).
Croatian: Prolazni simptomi ukazuju na to da se radi o tranzitornoj ishemijskoj ataki (TIA).
English: It is not known whether an increase in ALT liver enzyme can occur when using Zoely with this HCV combination drug regimen.
Croatian: Nije poznato može li povišenje jetrenog enzima ALT-a nastati kad se Zoely uzima s ovim kombiniranim režimom liječenja HCV-a.
English: On the basis of general experience with combined oral contraceptives, symptoms that may occur are: nausea, vomiting and, in young girls, slight vaginal bleeding.
Croatian: Na temelju općeg iskustva s kombiniranim oralnim kontraceptivima, mogu se pojaviti sljedeći simptomi: mučnina, povraćanje te blago vaginalno krvarenje u mlađih djevojaka.
English: If you cannot remember how many white active tablets you have missed, follow the first option, use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row, and contact your doctor (as you may not have been protected from being pregnant).
Croatian: Ako se ne možete sjetiti koliko ste bijelih tableta s djelatnim tvarima propustili, pridržavajte se prve opcije, koristite mehaničku metodu, primjerice kondom, kao dodatnu mjeru opreza sve dok niste ispravno uzeli tablete tijekom 7 uzastopnih dana i obratite se svom liječniku (jer možda niste bili zaštićeni od trudnoće).
English: Choose from the 7 stickers with day indicators the one in the grey column that begins with your starting day.
Croatian: Između 7 naljepnica s oznakama za dane u tjednu u sivom stupcu odaberite onu koja počinje s oznakom Vašeg početnog dana.
English: You can also start later, but never later than the day following the tablet-free break of your present pill (or the day after the last inactive tablet of your present pill).
Croatian: Možete početi i kasnije, ali nikada kasnije od dana nakon stanke u uzimanju dosadašnjih tableta (ili dana nakon uzimanja posljednje neaktivne tablete dosadašnjeg kontraceptiva).
English: If you vomit within 3-4 hours of taking a white active tablet, or you have severe diarrhoea, the active ingredients of your Zoely tablet may not have been completely absorbed into your body.
Croatian: Ako povraćate unutar 3-4 sata nakon uzimanja bijele tablete s djelatnim tvarima ili imate teški proljev, djelatne tvari iz tablete lijeka Zoely možda se neće potpuno apsorbirati u Vaše tijelo.
English: For example, if you start on a Wednesday, use the day label sticker that starts with ‘WED'.
Croatian: Primjerice, ako počinjete uzimati tablete u srijedu, uzmite naljepnicu koja počinje sa 'SRI'.
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 Zoely, 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 Zoely, molimo obratite se svom liječniku.
English: What can happen if a blood clot forms in an artery?
Croatian: Što se može dogoditi ako krvni ugrušak nastane u arteriji?
English: Blood clots can develop
Croatian: Krvni ugrušci mogu nastati
English: If this is not the case, she should follow the first of these two options and use extra precautions for the next 7 days as well.
Croatian: Ako to nije slučaj, žena se mora pridržavati prve od ovih dviju opcija te koristiti dodatne kontracepcijske mjere tijekom sljedećih 7 dana.
English: If possible take it within 24 hours of when you normally take your pill.
Croatian: Ako je moguće, uzmite je unutar 24 sata od uobičajenog vremena uzimanja pilule.
English: The risk of reduced reliability is imminent because of the forthcoming yellow placebo tablet phase.
Croatian: Rizik od smanjene pouzdanosti je neminovan zbog predstojećeg razdoblja uzimanja žutih tableta placeba.
English: • The 4 yellow tablets are inactive tablets that do not contain hormones and are called placebo tablets.
Croatian: • Četiri žute tablete su neaktivne tablete koje ne sadrže hormone i nazivaju se tablete placeba.
English: • Estradiol, the oestrogen in Zoely, is identical to the hormone produced by your ovaries during a menstrual cycle.
Croatian: • Estradiol, estrogen u lijeku Zoely, identičan je hormonu kojeg stvaraju jajnici tijekom mjesečnog ciklusa.
English: Nomegestrol acetate is metabolized into several inactive hydroxylated metabolites by liver cytochrome P450 enzymes, mainly CYP3A4 and CYP3A5 with possible contribution of CYP2C19 and CYP2C8.
Croatian: Nomegestrolacetat se metabolizira u nekoliko neaktivnih hidroksiliranih metabolita putem jetrenih enzima citokroma P450, uglavnom putem CYP3A4 i CYP3A5, uz mogući doprinos CYP2C19 i CYP2C8.
English: The distribution of exogenous and endogenous estradiol is similar.
Croatian: Distribucija egzogenog i endogenog estradiola je podjednaka.
English: In the clinical trial performed with Zoely in the United States the following Pearl Indices for the age class 18-35 years were calculated:
Croatian: U kliničkom ispitivanju provedenom s lijekom Zoely u SAD-u izračunati su sljedeći Pearlovi indeksi za dobnu skupinu od 18 do 35 godina:
English: You may need to use sanitary protection, but keep taking your tablets as usual.
Croatian: Možda ćete trebati koristiti higijenske uloške, ali nastavite uzimati tablete kao i do tada.
English: Like a blood clot in a vein, a clot in an artery can cause serious problems.
Croatian: Kao i krvni ugrušak u veni, ugrušak u arteriji može uzrokovati ozbiljne probleme.
English: • rapid or irregular heartbeats
Croatian: • ubrzani ili nepravilni otkucaji srca
English: • if you have systemic lupus erythematosus (SLE - a disease affecting your natural defence system);
Croatian: • ako imate sistemski lupus eritematosus (SLE - bolest koja zahvaća prirodni obrambeni sustav);
English: • if you are going to use other medicines (see also in section 2 ‘Other medicines and Zoely');
Croatian: • ako namjeravate uzimati druge lijekove (pogledajte u dijelu 2 "Drugi lijekovi i Zoely");
English: If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding.
Croatian: Ako ste uzeli nekoliko tableta odjednom, možete imati mučninu, povraćanje ili krvarenje iz rodnice.
English: If you wish to use the pill while breast-feeding, please seek the advice of your doctor.
Croatian: Ako želite koristiti pilulu dok dojite, posavjetujte se sa svojim liječnikom.
English: The increased risk of VTE during the postpartum period should be considered when re-starting Zoely (see section 4.2 and 4.4).
Croatian: Treba uzeti u obzir povećani rizik od VTE u postpartalnom razdoblju prilikom ponovnog uvođenja lijeka Zoely (vidjeti dijelove 4.2 i 4.4).
English: It is not yet known how the risk with Zoely compares with these lower risk products.
Croatian: Nije još poznato koliki je rizik uz Zoely u usporedbi s ovim lijekovima s nižim rizikom.
English: • sweating, nausea, vomiting or dizziness;
Croatian: • znojenje, mučnina, povraćanje ili omaglica;
English: If you stop taking Zoely 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 Zoely jer želite zatrudnjeti, preporučuje se da pričekate do početka Vaše prirodne mjesečnice prije nego pokušate zatrudnjeti.
English: If, after having a baby, you have had sexual intercourse before starting Zoely, 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 Zoely, morate biti sigurni da niste trudni ili pričekati do sljedeće mjesečnice.
English: • dry eye; contact lens intolerance
Croatian: • suhe oči; nepodnošenje kontaktnih leća
English: Reproductive toxicity studies performed with the combination have shown foetotoxicity which is consistent with estradiol exposure.
Croatian: Ispitivanja reproduktivne toksičnosti provedena s kombinacijom ovih dvaju lijekova pokazala su fetotoksičnost, što je u skladu s izloženošću estradiolu.
English: However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.
Croatian: Međutim, ako je žena već imala spolni odnos, prije stvarnog početka uzimanja kombiniranih oralnih kontraceptiva treba isključiti trudnoću ili žena treba pričekati prvu menstruaciju.
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 ugljikohidrata i parametre koagulacije i fibrinolize.
English: See also in section 3 ‘If you vomit or have severe diarrhoea' or in section 2 ‘Other medicines and Zoely'.
Croatian: Pogledajte u dijelu 3 'Ako povraćate ili imate jaki proljev' ili u dijelu 2 'Drugi lijekovi i Zoely'.
English: • in the arteries (referred to as an ‘arterial thrombosis', ‘arterial thromboembolism' or ATE).
Croatian: • u arterijama (što se naziva "arterijska tromboza", "arterijska tromboembolija" ili ATE).
English: Method failure: 1.22 (upper limit 95 % confidence interval 2.18) Method and user failure: 1.16 (upper limit 95 % confidence interval 2.08)
Croatian: Neuspjeh metode: 1,22 (gornja granica 95%-tnog intervala pozdanosti: 2,18) Neuspjeh metode i korisnika: 1,16 (gornja granica 95%-tnog intervala pozdanosti: 2,08)
English: Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer.
Croatian: S obzirom da je rak dojke rijedak u žena mlađih od 40 godina, dodatni broj dijagnoza raka dojke u žena koje trenutno koriste ili su nedavno koristile KOK malen je u odnosu na ukupan rizik od raka dojke.
English: • if you have epilepsy (see in section 2 ‘Other medicines and Zoely');
Croatian: • ako imate epilepsiju (pogledajte u dijelu 2 'Drugi lijekovi i Zoely').
English: With all combined pills, for the first few months, you can have some irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods.
Croatian: Kod svih kombiniranih pilula, u prvim mjesecima, možete imati neredovito krvarenje iz rodnice (točkasto ili probojno krvarenje) između mjesečnica.
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 contact your doctor');
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: The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).
Croatian: Rizik od venskih tromboembolijskih komplikacija u korisnica KHK-a može biti znatno povećan u žena s dodatnim čimbenicima rizika, osobito ako je prisutan veći broj čimbenika rizika (vidjeti tablicu).
English: • Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
Croatian: • Od 10 000 žena, koje ne uzimaju niti jedan kombinirani hormonski kontraceptiv i nisu trudne, približno 2 će razviti krvni ugrušak u godinu dana.
English: The following advice only refers to missed white active tablets:
Croatian: Sljedeći savjeti odnose se samo na propuštene bijele tablete s djelatnim tvarima:
English: Nomegestrol acetate is a highly selective progestogen derived from the naturally occurring steroid hormone, progesterone.
Croatian: Nomegestrolacetat je visoko selektivan progestagen koji se dobiva iz prirodnog steroidnog hormona progesterona.
English: If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors - in this case her total risk should be considered.
Croatian: Ako žena ima više od jednog čimbenika rizika, povećanje rizika može biti veće od zbroja pojedinačnih čimbenika - u tom slučaju treba razmotriti njezin ukupni rizik.
English: Method failure: 0.40 (upper limit 95 % confidence interval 1.03) Method and user failure: 0.38 (upper limit 95 % confidence interval 0.97)
Croatian: Neuspjeh metode: 0,40 (gornja granica 95%-tnog intervala pozdanosti: 1,03) Neuspjeh metode i korisnika: 0,38 (gornja granica 95%-tnog intervala pozdanosti: 0,97)
English: Repeat dose toxicity studies with estradiol, nomegestrol acetate or combination have indicated expected oestrogenic and gestagen effects.
Croatian: Ispitivanja toksičnosti ponovljenih doza estradiola, nomegestrolacetata ili njihove kombinacije ukazala su na očekivane učinke estrogena i gestagena.
English: Your period will start during the 4 days that you use the yellow placebo tablets (so-called withdrawal bleeding).
Croatian: Dobit ćete mjesečnicu tijekom četiri dana uzimanja žutih tableta placeba (tzv. prijelomno krvarenje).
English: • Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal, or retinal veins and arteries.
Croatian: • U korisnica KHK-a iznimno rijetko je prijavljen nastanak tromboze u drugim krvnim žilama, npr. jetrenim, mezenterijalnim, bubrežnim ili retinalnim venama i arterijama.
English: The woman should start with Zoely preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
Croatian: Žena treba početi uzimati Zoely po mogućnosti dan nakon uzimanja posljednje djelatne tablete (posljednje tablete koja sadrži djelatne tvari) svog prethodnog KOK-a, no najkasnije na dan nakon uobičajenog intervala bez tableta ili intervala s placebom prethodnog KOK-a.
English: • Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
Croatian: • Od 10 000 žena koje uzimaju kombinirani hormonski kontraceptiv koji sadrži levonorgestrel, noretisteron ili norgestimat, njih oko 5-7 razvit će krvni ugrušak u godinu dana.
English: The percentage of women using Zoely experiencing intracyclic bleeding after this adaptation period ranged from 15-20 %.
Croatian: Postotak žena koje su koristile Zoely i nakon ovog razdoblja prilagodbe imale intraciklično krvarenje bio je u rasponu od 15 do 20%.
English: • It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC about 6
Croatian: • Procijenjeno je da će od 10 000 žena koje uzimaju KHK koji sadrži levonorgestrel, njih približno 6
English: • if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
Croatian: • ako imate Crohnovu bolest ili ulcerozni kolitis (kroničnu upalnu bolest crijeva);
English: In addition to the above mentioned adverse reactions, hypersensitivity reactions have been reported in Zoely users (frequency unknown).
Croatian: Osim gore navedenih nuspojava, u korisnica koje uzimaju Zoely prijavljene su i reakcije preosjetljivosti (učestalost nepoznata).
English: • A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs.
Croatian: • U metaanalizi 54 epidemiološka ispitivanja prijavljeno je da žene koje trenutno koriste KOK imaju blago povećan relativan rizik (RR = 1,24) za dijagnosticiranje raka dojke.
English: • if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing;
Croatian: • ako osjetite simptome angioedema kao što su otečeno lice, jezik i/ili grlo i/ili otežano gutanje ili koprivnjača uz otežano disanje;
English: • increased appetite; fluid retention (oedema)
Croatian: • pojačan tek; zadržavanje tekućine (edem)
English: She then continues to take tablets at her usual time.
Croatian: Potom nastavlja uzimati tablete u uobičajeno vrijeme.
English: An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives.
Croatian: Povećan rizik od krvnih ugrušaka u venama (venska tromboembolija (VTE)) ili krvnih ugrušaka u arterijama (arterijska tromboembolija (ATE)) prisutan je kod svih žena koje uzimaju kombinirane hormonske kontraceptive.
English: A subsequent pack is started immediately after finishing the previous pack, without a break in daily tablet intake and irrespective of presence or absence of withdrawal bleeding.
Croatian: Korisnica počinje uzimati tablete iz sljedećeg pakiranja odmah nakon završetka prethodnog pakiranja, bez prekida svakodnevnog uzimanja tableta i bez obzira na prisutnost ili odsutnost prijelomnog krvarenja.
English: • Women with hypertriglyceridaemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
Croatian: • Žene s hipertrigliceridemijom ili obiteljskom anamnezom hipertrigliceridemije mogu biti izložene povećanom riziku od pankreatitisa prilikom primjene KOK-a.
English: If you vomit or have severe diarrhoea within 3-4 hours of taking a yellow tablet, the reliability of Zoely is maintained.
Croatian: Ako povraćate ili imate jaki proljev unutar 3-4 sata nakon uzimanja žute tablete, pouzdanost lijeka Zoely je održana.
English: • if you miss periods and suspect you may be pregnant (do not start the next blister pack until your doctor tells you, see also in section 3 ‘If you have missed one or more periods').
Croatian: • ako Vam je izostala mjesečnica i sumnjate da biste mogli biti trudni (nemojte započinjati sa sljedećim blisterom dok Vam to ne kaže liječnik, pogledajte u dijelu 2 "Ako Vam je izostala jedna ili više mjesečnica").
English: Although data in renal impaired patients are not available, renal impairment is unlikely to affect the elimination of nomegestrol acetate and estradiol.
Croatian: Iako nema podataka za korisnice s oštećenjem funkcije bubrega, nije vjerojatno da će oštećenje funkcije bubrega utjecati na eliminaciju nomegestrolacetata i estradiola.
English: You can start taking Zoely the day after you have taken the last tablet from your present pill blister (this means no tablet-free break).
Croatian: Možete započeti uzimati Zoely dan nakon što ste uzeli zadnju tabletu iz dosadašnjeg blistera s pilulama (to znači da nema stanke u uzimanju tableta).
English: • In women with hereditary angioedema, exogenous oestrogens may induce or exacerbate symptoms of angioedema.
Croatian: • U žena s nasljednim angioedemom, egzogeni estrogen može izazvati ili pogoršati simptome angioedema.
English: Therefore, a hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in women taking COCs.
Croatian: Stoga treba uzeti u obzir tumore jetre prilikom diferencijalne dijagnoze kod pojave snažnih bolova u gornjem dijelu abdomena, uvećanja jetre ili znakova intraabdominalnog krvarenja u žena koje uzimaju kombinirane oralne kontraceptive.
English: If any of these conditions appear for the first time while using Zoely, stop taking it at once and tell your doctor.
Croatian: Ako se bilo koje od ovih stanja pojavi prvi put dok uzimate Zoely, odmah prestanite s uzimanjem lijeka i obavijestite svog liječnika.
English: • if you have (or have ever had) chloasma [yellowish-brown pigment patches, so called ‘pregnancy patches', particularly on the face].
Croatian: • ako imate (ili ste ikada imali) kloazmu [žućkasto-smeđe mrlje na koži, takozvanu 'trudničke mrlje', osobito na licu].
English: • if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g., below the age of about 50).
Croatian: • ako je netko od članova Vaše uže obitelji imao krvni ugrušak u nozi, plućima ili drugom organu u mlađoj dobi (npr. prije približno 50. godine života).
English: Users of Zoely may also miss their withdrawal bleeding although not being pregnant.
Croatian: Korisnicama lijeka Zoely prijelomno krvarenje može i izostati iako nisu trudne.
English: • if you have hereditary angioedema.
Croatian: • ako bolujete od nasljednog angioedema.
English: Women using medications containing oestrogens other than ethinylestradiol, such as estradiol, had a rate of ALT elevation similar to those not receiving any oestrogens; however, due to the limited number of women taking these other oestrogens, caution is warranted for co-administration with the combination drug regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
Croatian: Žene koje su uzimale lijekove koji umjesto etinilestradiola sadrže druge estrogene, kao što je estradiol, imale su stopu povišenja ALT-a sličnu onoj u žena koje nisu primale nikakve estrogene; međutim, zbog ograničenog broja žena koje su uzimale te druge estrogene, opravdan je oprez kod istodobne primjene s kombiniranim režimom liječenja ombitasvirom/paritaprevirom/ritonavirom s dasabuvirom ili bez njega.
English: Driving and using machines Zoely has no or negligible effect on your ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Zoely ne utječe ili zanemarivo utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: The extension can be carried on for as long as wished until the end of the white active tablets in the second pack.
Croatian: Produljenje se može nastaviti po želji, sve dok se ne potroše sve bijele tablete s djelatnim tvarima u drugom pakiranju.
English: • With the use of the higher-dosed COCs (50 g ethinylestradiol) the risk of endometrial and ovarian cancer is reduced.
Croatian: • Uz primjenu kombiniranih oralnih kontraceptiva s višim dozama (50 µg etinilestradiola) smanjuje se rizik od raka endometrija i jajnika.