FrancophonIA/ELRC3.0 huggingface dataset:
English: • The increased risk of thromboembolism in pregnancy, and particularly the 6-week period of the puerperium, must be considered (for information on "Pregnancy and lactation" see section 4.6).
Croatian: • Mora se uzeti u obzir povećani rizik od tromboembolije u trudnoći, a osobito u razdoblju 6 tjedana babinja (za informacije o "Trudnoći i dojenju" vidjeti dio 4.6).
English: The decision to use any product other than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
Croatian: Odluku o primijeni nekog drugog lijeka umjesto onog za kojeg je poznato da ima najniži rizik od VTE treba donijeti tek nakon razgovora sa ženom, kako bi se utvrdilo da razumije koliki je rizik od VTE uz KHK-e i kako njezini trenutno prisutni čimbenici rizika utječu na taj rizik, te da je njezin rizik od VTE najviši tijekom prve godine primjene.
English: Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Croatian: Srednja točka raspona od 5 do 7 na 10 000 žena-godina, na temelju relativnog rizika za KOK-e koji sadrže levonorgestrel naspram njihovog neuzimanja od približno 2,3 do 3,6
English: • if you are allergic to estradiol or nomegestrol acetate, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na estradiol ili nomegestrolacetat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Dose-linearity was observed in the range 0.625-5 mg (assessed in fertile and post-menopausal women).
Croatian: Linearnost doza primijećena je u rasponu od 0,625-5 mg (ispitano na plodnim ženama i ženama u postmenopauzi).
English: Therefore, the evaluation of any irregular bleeding is only meaningful after an adaptation interval of about 3 cycles.
Croatian: Stoga procjena neredovitog krvarenja ima smisla samo nakon razdoblja prilagodbe lijeku od približno 3 ciklusa.
English: Average serum concentrations are 50 pg/mL and these estradiol levels correspond with the early and late phase of a woman's menstrual cycle.
Croatian: Prosječne koncentracije u serumu iznose 50 pg/ml i te razine estradiola odgovaraju ranoj i kasnoj fazi ženina menstrualnog ciklusa.
English: • if you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also in section 2 ‘When you should not use Zoely'; do not forget about the changes in the health of your immediate family);
Croatian: • ako primijetite bilo kakve promjene svog zdravstvenog stanja, osobito one koje uključuju stavke navedene u ovoj uputi (pogledajte u dijelu 2 "Kada ne smijete uzimati Zoely"; ne zaboravite na promjene u zdravstvenom stanju Vaših bliskih krvnih srodnika);
English: It has been reported to occur more often in women using the pill for more than 5 years.
Croatian: Prijavljeno je da se on javlja češće u žena koje koriste pilulu dulje vrijeme.
English: Prior to the initiation or reinstitution of Zoely use a complete medical history (including family history) should be taken and pregnancy must be ruled out.
Croatian: Prije uvođenja ili ponovnog uvođenja lijeka Zoely, mora se uzeti cjelokupna anamneza (uključujući obiteljsku anamnezu) i isključiti trudnoću.
English: Yellow placebo tablets missed
Croatian: Propuštene žute tablete placeba
English: When using a combined hormonal contraceptive like Zoely you are advised to stop smoking.
Croatian: Kad uzimate kombinirani hormonski kontraceptiv poput lijeka Zoely, savjetuje se da prestanete pušiti.
English: So contact your doctor immediately.
Croatian: Stoga se odmah obratite svom liječniku.
English: The most appropriate MedDRA term to describe a certain adverse reaction is listed.
Croatian: Naveden je najprikladniji MedDRA pojam za opis određene nuspojave.
English: The woman may also be advised to discontinue active tablet-taking from the current blister pack.
Croatian: Ženi se također može preporučiti da prekine uzimanje djelatnih tableta iz trenutnog blister pakiranja.
English: If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision.
Croatian: Ako okluzija nastane u oku, simptomi se mogu kretati u rasponu od bezbolne zamućenosti vida koja može napredovati do gubitka vida.
English: Important things to know about combined hormonal contraceptives (CHCs):
Croatian: Važni podaci koje treba znati o kombiniranim hormonskim kontraceptivima:
English: The duration of the withdrawal bleeding in women using Zoely is on average 3-4 days.
Croatian: Prijelomno krvarenje u žena koje koriste Zoely u prosjeku traje 3 do 4 dana.
English: Cervical cancer is caused by an infection with the human papilloma virus (HPV).
Croatian: Rak vrata maternice uzrokovan je infekcijom humanim papiloma virusom (HPV).
English: • if you get migraines, especially migraines with aura;
Croatian: • ako imate migrene, osobito migrene s aurom;
English: Each time you start a new blister of Zoely, take the number 1 white active tablet in the left-hand top corner (see ‘Start').
Croatian: Svaki put kada započinjete s novim blisterom lijeka Zoely, uzmite bijelu tabletu pod brojem 1 u gornjem lijevom kutu (tamo gdje stoji 'Početak').
English: • loss of consciousness or fainting with or without seizure.
Croatian: • gubitak svijesti ili nesvjestica s napadajima ili bez njih.
English: The following side effects have been linked with the use of Zoely:
Croatian: Sljedeće nuspojave povezane su s uporabom lijeka Zoely:
English: Management of missed tablets
Croatian: Postupak u slučaju propuštenih tableta
English: • if you have ever had a heart attack or a stroke;
Croatian: • ako ste ikada imali srčani ili moždani udar;
English: Air travel (> 4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.
Croatian: Putovanje avionom (duže od 4 sata) može Vam privremeno povećati rizik od krvnog ugruška, osobito ako imate neke druge od navedenih čimbenika.
English: Excretion of nomegestrol acetate was nearly complete after 10 days and amounts excreted were higher in faeces 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: Zoely contains 17β-estradiol.
Croatian: Zoely sadrži 17-estradiol.
English: Some users may not have their period every month during the intake of the yellow tablets.
Croatian: Neke korisnice možda neće dobiti mjesečnicu svakog mjeseca tijekom uzimanja žutih tableta.
English: Submission of final study report
Croatian: Podnijeti završni izvještaj studije.
English: • decreased interest in sex; depression/depressed mood; mood changes
Croatian: • smanjeno zanimanje za spolni odnos; depresija/depresivno raspoloženje; promjene raspoloženja
English: If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming or being pregnant.
Croatian: Ako ste imali spolni odnos u tjednu prije propuštanja tableta, postoji mogućnost da ćete postati ili jeste trudni.
English: Risk of arterial thromboembolism (ATE)
Croatian: Rizik od arterijske tromboembolije (ATE)
English: Contact your doctor immediately.
Croatian: Odmah se obratite svom liječniku.
English: There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more.
Croatian: Također postoje neki dokazi da je rizik povećan kad se KHK-i ponovno počnu primjenjivati nakon stanke od 4 ili više tjedana.
English: See ‘Cycle control' in section 4.4.
Croatian: Vidjeti 'Kontrola ciklusa' u dijelu 4.4.
English: If you have missed one or more periods Clinical trials with Zoely have shown that you may occasionally miss your regular monthly period after Day 24.
Croatian: Ako Vam je izostala jedna ili više mjesečnica Klinička ispitivanja lijeka Zoely pokazala su da je moguć povremeni izostanak redovitih mjesečnica nakon 24. dana.
English: • sudden cough without an obvious cause, which may bring up blood;
Croatian: • iznenadni kašalj bez očitog uzroka, uz moguće iskašljavanje krvi;
English: Zoely is a contraceptive pill that is used to prevent pregnancy.
Croatian: Zoely je kontracepcijska pilula koja se koristi za sprječavanje trudnoće.
English: • sudden weakness or numbness of the face, arm or leg, especially on one side of the body;
Croatian: • iznenadna slabost ili obamrlost lica, ruke ili noge, osobito na jednoj strani tijela;
English: In this case you could have a hereditary blood clotting disorder;
Croatian: U tom slučaju možete imati nasljedni poremećaj zgrušavanja krvi;
English: A relationship between COC use and clinical hypertension has not been established.
Croatian: Nije ustanovljen odnos između KOK-a i kliničke hipertenzije.
English: If you do have any of the conditions listed below, you must tell your doctor.
Croatian: Ako imate neko od niže navedenih stanja, morate o tome obavijestiti svog liječnika.
English: See also ‘General Notes' in section 2 above.
Croatian: Pogledajte i 'Opće napomene' u dijelu 2 u prethodnom tekstu.
English: Your doctor will discuss with you what other form of birth control would be more appropriate.
Croatian: Liječnik će razgovarati s Vama o drugim, za Vas pogodnijim oblicima kontrole začeća.
English: Most frequently, they occur in the first year of use of a combined hormonal contraceptive.
Croatian: Najčešće nastaju tijekom prve godine primjene kombiniranih hormonskih kontraceptiva.
English: • increased warmth in the affected leg
Croatian: • povećana toplina zahvaćene noge
English: Nomegestrol acetate is extensively bound to albumin (97-98 %), but does not bind to sex hormone binding globulin (SHBG) or corticoid binding globulin (CBG).
Croatian: Nomegestrolacetat se u velikoj mjeri veže za albumin (97-98%), ali se ne veže za globulin koji veže spolne hormone (SHBG) niti na globulin koji veže kortikoide (CBG).
English: In case you use a vaginal ring or transdermal patch, it is best to start using Zoely on the day you remove the ring or patch.
Croatian: U slučaju da koristite vaginalni prsten ili transdermalni flaster, najbolje je početi koristiti Zoely na dan uklanjanja prstena ili flastera.
English: [Second day label sheet for box of 3 blisters stating, twice:]
Croatian: [Drugi list s oznakama za dane za kutiju s 3 blistera, na kojemu stoji dva puta:]
English: Progesterone is produced by your ovaries during a menstrual cycle.
Croatian: Progesteron stvaraju jajnici tijekom mjesečnog ciklusa.
English: • if you have (or have ever had) a type of migraine called ‘migraine with aura';
Croatian: • ako imate (ili ste imali) vrstu migrene koja se zove "migrena s aurom";
English: • if you have (had) severe liver disease and your liver is not yet working normally;
Croatian: • ako imate (ili ste imali) tešku bolest jetre i Vaša jetra ne radi normalno;
English: • if you forgot one or more tablets in the first week of the blister pack and had unprotected intercourse in the seven days before (see also in section 3 ‘If you forget to take Zoely');
Croatian: • ako ste zaboravili uzeti jednu ili više tableta u prvom tjednu korištenja novog blister pakiranja, a imali ste nezaštićeni spolni odnos u prethodnih sedam dana (pogledajte u dijelu 3 "Ako ste zaboravili uzeti Zoely");
English: The shorter the interval, the higher the risk that she does not have a withdrawal bleed and may experience breakthrough-bleeding and spotting during the subsequent pack (just as when delaying a period).
Croatian: Što je kraći interval, veći je rizik da žena neće imati prijelomno krvarenje i da može imati probojno i točkasto krvarenje tijekom uzimanja tableta iz drugog pakiranja (baš kao i kod odgode menstruacije).
English: After drug therapy is discontinued, enzyme induction can last for about 28 days.
Croatian: Nakon prekida medikamentozne terapije, indukcija enzima može trajati oko 28 dana.
English: • sharp chest pain which may increase with deep breathing;
Croatian: • oštra bol u prsištu koja se može pojačati kod dubokog disanja;
English: • Crohn's disease, ulcerative colitis, and worsening of depression have been associated with COC use.
Croatian: • Crohnova bolest, ulcerozni kolitis i pogoršanje depresije povezuju se s primjenom KOK-a.
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: • 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 weeks.
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 Zoely is and what it is used for What you need to know before you use Zoely How to use Zoely
Croatian: Što je Zoely i za što se koristi Što morate znati prije nego počnete uzimati Zoely Kako uzimati Zoely
English: An increase in frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation.
Croatian: Povećana učestalost ili težina migrene tijekom primjene KHK-a (koja može biti prodromalni znak cerebrovaskularnog događaja) može biti razlogom trenutačnog prekida primjene.
English: • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: • Korisnice s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi trebale uzimati ovaj lijek.
English: • if you have (had), or if you may have, cancer of the breast or the genital organs;
Croatian: • ako imate (ili ste imali) ili biste mogli imati rak dojke ili spolnih organa;
English: [In front of day labels intended for second blister:] Blister 2 [In front of day labels intended for third blister:] Blister 3
Croatian: [Ispred naljepnica s oznakama za dane namijenjenih za drugi blister:] 2. blister [Ispred naljepnica s oznakama za dane namijenjenih za treći blister:] 3. blister
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use.
Croatian: Ako se sumnja na nasljednu sklonost, ženu treba uputiti po savjet specijalista prije nego što se donese odluka o primjeni bilo kojeg KHK-a.
English: The overall risk of a blood clot in the leg or lung (DVT or PE) with Zoely is small.
Croatian: Ukupni rizik od nastanka krvnog ugruška u nozi ili plućima (DVT ili PE) uz Zoely je mali.
English: In case of long-term treatment with hepatic enzyme-inducing substances another method of contraception should be considered.
Croatian: U slučaju dugotrajnog liječenja lijekovima koji induciraju jetrene enzime treba razmotriti drugu metodu kontracepcije.
English: Oestrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs.
Croatian: Estrogeni se opsežno raspodjeljuju u tijelu te se općenito mogu naći u višim koncentracijama u ciljnim organima djelovanja spolnih hormona.
English: If bleeding continues, becomes heavy or starts again, contact your doctor.
Croatian: Ako se krvarenje nastavi, pojača ili se ponovi, obratite se svom liječniku.
English: The absolute bioavailability of nomegestrol acetate after a single dose is 63 %.
Croatian: Apsolutna bioraspoloživost nomegestrolacetata nakon jedne doze iznosi 63%.
English: If you discover that a child has taken Zoely, ask your doctor for advice.
Croatian: Ako saznate da je dijete uzelo Zoely, obratite se liječniku za savjet.
English: The woman should choose the sticker that starts with the day she begins taking the tablets and stick it on the blister.
Croatian: Žena treba odabrati naljepnicu koja počinje s danom kada je počela uzimati tablete i nalijepiti je na blister.
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 Zoely 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 Zoely.
English: Nomegestrol acetate is not genotoxic.
Croatian: Nomegestrolacetat nije genotoksičan.
English: In such situations you should not have sexual intercourse or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method.
Croatian: U takvim situacijama ne smijete stupati u spolne odnose ili morate koristiti dodatne nehormonske kontracepcijske mjere, primjerice kondom ili drugu metodu mehaničke kontracepcije.
English: • sudden, severe or prolonged headache with no known cause;
Croatian: • iznenadna, jaka ili dugotrajna glavobolja bez poznatog uzroka;
English: The next blister pack must be started right away.
Croatian: Treba odmah započeti sa sljedećim blister pakiranjem.
English: It is important to note that the risk of a heart attack or stroke from using Zoely is very small but can increase:
Croatian: Važno je zapamtiti da je rizik od srčanog ili moždanog udara zbog primjene lijeka Zoely vrlo mali, ali može se povećati:
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 VTE in one year.
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 razviti VTE u godinu dana.
English: In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages.
Croatian: U izoliranim slučajevima ti su tumori uzrokovali po život opasna intraabdominalna krvarenja.
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 4 tjedna ili više.
English: EU/1/11/690/001 28 film-coated tablets EU/1/11/690/002 84 film-coated tablets EU/1/11/690/003 168 film-coated tablets EU/1/11/690/004 364 film-coated tablets
Croatian: EU/1/11/690/001 28 filmom obloženih tableta EU/1/11/690/002 84 filmom obložene tablete EU/1/11/690/003 168 filmom obloženih tableta EU/1/11/690/004 364 filmom obložene tablete
English: • There are medicines that can make Zoely less effective in preventing pregnancy, or can cause unexpected bleeding.
Croatian: • Postoje lijekovi koji mogu smanjiti učinkovitost lijeka Zoely u sprječavanju trudnoće ili uzrokovati neočekivano krvarenje.
English: Hepatic metabolism: Interactions can occur with substances that induce CYP450 enzymes, resulting in reduced concentrations of sex hormones and decreased effectiveness of combined oral contraceptives, including Zoely.
Croatian: Jetreni metabolizam: Mogu nastati interakcije s tvarima koje induciraju enzime CYP450, što dovodi do smanjenja koncentracija spolnih hormona i smanjene učinkovitosti kombiniranih oralnih kontraceptiva, uključujući Zoely.
English: However, in any individual woman, the risk may be far higher, depending on her underlying risk factors (see below).
Croatian: Međutim, taj rizik u pojedine žene može biti daleko veći, ovisno o njezinim osnovnim čimbenicima rizika (vidjeti niže).
English: Day 18-24
Croatian: 18. - 24. dan
English: If you need to stop Zoely ask your doctor when you can start using it again.
Croatian: Ako trebate prestati uzimati Zoely, upitajte liječnika kada ga ponovno možete početi uzimati.
English: If you forgot to take one of these tablets the reliability of Zoely is maintained.
Croatian: Ako ste zaboravili uzeti jednu od tih tableta, pouzdanost djelovanja lijeka Zoely je održana.
English: Further information on the possible side effect changes to menstrual periods (e.g. absence or irregular) during the use of Zoely 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 Zoely opisane su u dijelu 3 'Kako i kada uzimati tablete', 'Ako imate neočekivano krvarenje' i 'Ako Vam je izostala jedna ili više mjesečnica').
English: If bleeding irregularities persist or occur after previously regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures are indicated to exclude malignancy or pregnancy.
Croatian: Ako neredovita krvarenja potraju ili uslijede nakon prethodnih redovitih ciklusa, treba razmotriti hormonalne uzroke i poduzeti odgovarajuće dijagnostičke mjere kako bi se isključile maligne bolesti ili trudnoća.
English: • severe pain in your stomach;
Croatian: • jaka bol u želucu;
English: • Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).
Croatian: • Molimo budite oprezni i posjetite liječnika ako mislite da imate simptome kakve izaziva krvni ugrušak (pogledajte dio 2 "Krvni ugrušci").
English: o blood clots in the liver, stomach/intestine, kidneys or eye.
Croatian: o krvni ugrušci u jetri, želucu/crijevima, bubrezima ili oku.
English: If you have forgotten to take white active tablets in a blister, and you do not have the expected monthly period while taking the yellow placebo tablets from the same blister, you may be pregnant.
Croatian: Ako ste zaboravili uzeti bijele tablete s djelatnim tvarima i niste dobili očekivanu mjesečnicu dok ste uzimali žute tablete placeba iz istog blistera, možda ste trudni.
English: Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of COCs.
Croatian: Ponovna pojava kolestatske žutice koja je prvi put nastupila u trudnoći ili kod prethodne primjene spolnih steroida zahtijeva obustavu uzimanja KOK-a.
English: Consult your doctor before you start with the next blister.
Croatian: Obratite se svom liječniku prije nego počnete uzimati tablete iz sljedećeg blistera.
English: Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
Croatian: Ženama treba objasniti da hormonski kontraceptivi ne štite od infekcije HIV-om (AIDS-a) niti drugih spolno prenosivih bolesti.
English: Estradiol is rapidly transformed in the gut and the liver in several metabolites, mainly estrone, which are subsequently conjugated and undergo entero-hepatic circulation.
Croatian: Estradiol se ubrzano transformira u crijevima i jetri u nekoliko metabolita, pretežno estron, koji se zatim konjugiraju i ulaze u enterohepatičku cirkulaciju.
English: If vomiting occurs within 3-4 hours after white tablet-taking, the tablet should be considered as missed and a new tablet should be taken as soon as possible.
Croatian: Dođe li do povraćanja unutar 3-4 sata nakon uzimanja bijele tablete, tableta se mora smatrati propuštenom i čim prije treba uzeti novu tabletu.
English: These are nomegestrol acetate (a progestogen) and estradiol (an oestrogen).
Croatian: To su nomegestrolacetat (progestagen) i estradiol (estrogen).
English: • if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50).
Croatian: • ako je član Vaše uže obitelji imao srčani ili moždani udar u mlađoj dobi (prije približno 50.
English: This will help you to determine when the baby will be due.
Croatian: To će Vam pomoći odrediti termin poroda.