FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic (hypersensitive) reactions have been reported in users of Zoely, but the frequency cannot be estimated from the available data.
Croatian: U korisnica koje uzimaju Zoely prijavljene su alergijske reakcije (reakcije preosjetljivosti), ali se njihova učestalost ne može procijeniti iz dostupnih podataka.
English: o History of migraine with focal neurological symptoms.
Croatian: o Migrene sa žarišnim neurološkim simptomima u anamnezi.
English: • if a close relative has or has ever had breast cancer;
Croatian: • ako netko od Vaših bliskih krvnih srodnika ima ili je ikada imao rak dojke;
English: • If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.
Croatian: • Ako krvni ugrušak otputuje iz noge i zaustavi se u plućima, može uzrokovati plućnu emboliju.
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 of VTE 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 od VTE.
English: The risk of arterial thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors (see table).
Croatian: Rizik od arterijskih tromboembolijskih komplikacija ili cerebrovaskularnog incidenta u korisnica KHK-a povećan je u žena s čimbenicima rizika (vidjeti tablicu).
English: • Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
Croatian: • Akutni ili kronični poremećaji funkcije jetre mogu uvjetovati prekid uzimanja kombiniranih oralnih kontraceptiva sve dok se pokazatelji funkcije jetre ne vrate na normalne vrijednosti.
English: • chest pain, discomfort, pressure, heaviness
Croatian: • bol u prsištu, nelagoda, pritisak, težina
English: Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions.
Croatian: Pod uvjetom da je žena uzimala tablete na pravilan način tijekom 7 dana koji su prethodili prvoj propuštenoj tableti, nije potrebno koristiti dodatne kontracepcijske mjere.
English: • If you have not taken all the tablets correctly, or if your expected period does not happen twice in a row, you may be pregnant.
Croatian: • Ako niste uzeli sve tablete na pravilan način ili ne dobijete očekivanu mjesečnicu dva puta uzastopno, možda ste trudni.
English: Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity.
Croatian: Drugi znakovi okluzije krvne žile mogu uključivati: iznenadnu bol, oticanje i plavičastu obojanost ekstremiteta.
English: If you start later than day 28, you should also use a barrier method of contraception during the first 7 days of Zoely use.
Croatian: Ako počnete kasnije od 28. dana, trebate koristiti mehaničku metodu kontracepcije tijekom prvih 7 dana uzimanja lijeka Zoely.
English: BLOOD CLOTS IN A VEIN
Croatian: KRVNI UGRUŠCI U VENI
English: Musculoskeletal and connective tissue disorders sensation of heaviness
Croatian: Poremećaji mišićnokoštanog i vezivnog tkiva osjećaj težine
English: • The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below).
Croatian: • Rizik od krvnog ugruška varira ovisno o osobnoj povijesti bolesti (pogledajte ispod u dijelu "Čimbenici koji Vam povećavaju rizik od krvnog ugruška" ).
English: You may not have your period until you take the yellow placebo tablets at the end of the second blister, but you may have spotting (drops or flecks of blood) or breakthrough bleeding while taking the white active tablets.
Croatian: Možda nećete dobiti mjesečnicu sve dok ne dovršite uzimanje žutih tableta placeba na kraju drugog blistera, ali ćete možda imati točkasto (kapi ili mrlje krvi) ili probojno krvarenje dok uzimate bijele tablete s djelatnim tvarima.
English: • Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
Croatian: • Vrlo rijetko, krvni ugrušak može nastati u veni nekog drugog organa, kao što je oko (tromboza retinalne vene).
English: 4.6 % of the women did not have a withdrawal bleeding in the first three cycles of use and the occurrences of absence of withdrawal bleeding in the later cycles of use were high in this subgroup, ranging from 76 % to 87 % of women.
Croatian: U prva tri ciklusa uzimanja lijeka 4,6% žena nije imalo prijelomno krvarenje, a u toj je podskupini izostanak prijelomnog krvarenja u kasnijim ciklusima bio visok, u rasponu od 76% do 87% žena.
English: The pharmacokinetics of nomegestrol acetate (primary objective) after single oral dosing of Zoely in healthy postmenarcheal female adolescents and adult subjects were similar.
Croatian: Farmakokinetika nomegestrolacetata (primarni cilj) nakon jedne peroralne doze lijeka Zoely bila je podjednaka u zdravih adolescentica koje su imale menarhu i odraslih ispitanica.
English: Multiple doses up to five times the daily dose of Zoely 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 Zoely te pojedinačne doze do 40 puta veće od dnevne doze nomegestrolacetata bez utjecaja na sigurnost primjene.
English: Please note: If the user is not sure about the number or colour of tablets missed and what advice to follow, a barrier method should be used until she has completed 7 days of uninterrupted white active tablet-taking.
Croatian: Važna napomena: ako korisnica nije sigurna koji je broj ili boja propuštenih tableta te koje upute slijediti, potrebno je koristiti mehaničku kontracepciju sve dok korisnica ne završi 7-dnevno neprekinuto uzimanje bijelih tableta s djelatnim tvarima.
English: Nervous system disorders headache, migraine cerebrovascular accident, transient ischaemic attack, disturbance in attention
Croatian: Poremećaji živčanog sustava glavobolja, migrena cerebrovaskularni incident, tranzitorna ishemijska ataka, poremećaj pozornosti
English: To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming yellow placebo tablet phase with a maximum of 4 days.
Croatian: Kako bi pomaknula menstruaciju na dan u tjednu različit od onog prema postojećem rasporedu, korisnici se može preporučiti da skrati nadolazeću fazu uzimanja žutih tableta placeba za najviše 4 dana.
English: Where considered appropriate, COC use may be resumed if normotensive values can be achieved with antihypertensive therapy.
Croatian: Kada se to ocijeni prikladnim, primjena KOK-a može se nastaviti ako se antihipertenzivima mogu postići normalne vrijednosti krvnog tlaka.
English: • Nomegestrol acetate, the progestogen in Zoely, is derived from the hormone progesterone.
Croatian: • Nomegestrolacetat, progestagen u lijeku Zoely, dobiva se iz hormona progesterona.
English: Maximum serum concentrations of estradiol are about 90 pg/mL and are reached 6 h after dosing.
Croatian: Maksimalne koncentracije estradiola u serumu iznose približno 90 pg/ml, a postižu se 6 sati nakon doziranja.
English: Start using Zoely when your next injection is due or on the day that your implant or IUS is removed.
Croatian: Počnite uzimati Zoely na dan kada ste trebali primiti sljedeću injekciju ili na dan uklanjanja implantata odnosno IUS-a.
English: • changes to menstrual periods (e.g. absence or irregularity)
Croatian: • promjene mjesečnog ciklusa (na primjer izostanak mjesečnice ili neredovite mjesečnice)
English: • The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
Croatian: • Primjena bilo kojeg kombiniranog hormonskog kontraceptiva (KHK-a) povećava rizik od venske tromboembolije (VTE) u odnosu na nekorištenje lijeka.
English: The new tablet should be taken within 24 hours of the usual time of tablet-taking if possible.
Croatian: Novu tabletu po mogućnosti treba uzeti unutar 24 sata od uobičajenog vremena uzimanja tablete.
English: The woman may switch any day from the minipill and Zoely should be started on the next day.
Croatian: Žena može prijeći s minipilule bilo koji dan, a s uzimanjem lijeka Zoely treba započeti sljedećeg dana.
English: • It is not yet known how the risk of a blood clot with Zoely compares to the risk with a combined hormonal contraceptive that contains levonorgestrel.
Croatian: • Još nije poznato koliki je rizik od krvnog ugruška uz Zoely u odnosu na rizik uz kombinirani hormonski kontraceptiv koji sadrži levonogestrel.
English: You can start Zoely between 21 and 28 days after having a baby.
Croatian: Možete započeti s uzimanjem lijeka Zoely između 21. i 28. dana nakon poroda.
English: During the extension the woman may experience breakthrough-bleeding or spotting.
Croatian: Tijekom produljenja ciklusa žena može imati probojno ili točkasto krvarenje.
English: Start taking your next blister immediately after the last yellow tablet, even if your period hasn't finished.
Croatian: Počnite uzimati tablete iz sljedećeg blistera odmah nakon što uzmete posljednju žutu tabletu, čak i ako Vam mjesečnica nije završila.
English: • if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see “Blood clots” section below).
Croatian: • ako opazite moguće znakove krvnog ugruška što može značiti da bolujete od krvnog ugruška u nozi (tj. duboke venske tromboze), krvnog ugruška u plućima (tj. plućne embolije), srčanog ili moždanog udara (pogledajte dio "Krvni ugrušci" niže).
English: Consult your doctor immediately 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: Obratite se svom liječniku ako osjetite simptome angioedema poput otečenog lica, jezika i/ili grla i/ili otežanog gutanja ili koprivnjače uz otežano disanje.
English: Nomegestrol acetate has a strong affinity for the human progesterone receptor and has an anti-gonadotropic activity, a progesterone receptor-mediated anti-oestrogenic activity, a moderate anti-androgenic activity, and is devoid of any oestrogenic, androgenic, glucocorticoid or mineralocorticoid activity.
Croatian: Nomegestrolacetat ima jak afinitet vezivanja za progesteronske receptore u ljudi te iskazuje antigonadotropnu aktivnost, antiestrogenu aktivnost posredovanu progesteronskim receptorima te umjerenu antiandrogenu aktivnost, dok nema nikakvo estrogeno, androgeno, glukokortikoidno niti mineralokortikoidno djelovanje.
English: Concomitant administration of strong (e.g. ketoconazole, itraconazole, clarithromycin) or moderate (e.g. fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors may increase the serum concentrations of oestrogens or progestogens.
Croatian: Istodobna primjena jakih (npr. ketokonazola, itrakonazola, klaritromicina) ili umjerenih (npr. flukonazola, diltiazema, eritromicina) inhibitora CYP3A4 može povisiti koncentracije estrogena i progestagena u serumu.
English: Nomegestrol acetate causes in vitro no notable induction or inhibition of any cytochrome P450 enzymes and has no clinically relevant interaction with the P-gp transporter.
Croatian: Nomegestrolacetat in vitro ne uzrokuje zamjetnu indukciju niti inhibiciju bilo kojeg enzima citokroma P450, a nema ni klinički značajnih interakcija s prijenosnicima P-glikoproteina.
English: If the woman missed tablets and subsequently has no withdrawal bleed in the placebo tablet phase, the possibility of a pregnancy should be considered.
Croatian: Ako je žena propustila uzeti tablete te nakon toga u razdoblju uzimanja tableta placeba ne dobije prijelomno krvarenje, treba uzeti u obzir mogućnost trudnoće.
English: Symptoms of a cerebrovascular accident can include: - sudden numbness or weakness of the face, arm or leg, especially on one side of the body; - sudden trouble walking, dizziness, loss of balance or coordination; - sudden confusion, trouble speaking or understanding; - sudden trouble seeing in one or both eyes; - sudden, severe or prolonged headache with no known cause; - loss of consciousness or fainting with or without seizure.
Croatian: Simptomi cerebrovaskularnog incidenta mogu uključivati: - iznenadnu utrnulost ili slabost lica, ruke ili noge, osobito na jednoj strani tijela; - iznenadne poteškoće s hodanjem, omaglica, gubitak ravnoteže ili koordinacije; - iznenadnu smetenost, poteškoće s govorom ili razumijevanjem; - iznenadne poteškoće s vidom na jedno ili oba oka; - iznenadna, jaka ili dugotrajna glavobolja bez poznatog uzroka; - gubitak svijesti ili nesvjestica s ili bez napadaja.
English: Each yellow placebo film-coated tablet contains 61.76 mg of lactose monohydrate.
Croatian: Jedna žuta filmom obložena tableta placeba sadrži 61,76 mg laktoze hidrata.
English: Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking COCs.
Croatian: Žene sklone razvoju kloazme trebaju izbjegavati izlaganje suncu ili ultraljubičastom zračenju dok uzimaju kombinirane oralne kontraceptive.
English: Factors that increase your risk of a blood clot in a vein The risk of a blood clot with Zoely is small but some conditions will increase the risk.
Croatian: Čimbenici koji Vam povećavaju rizik od krvnog ugruška u veni Rizik od nastanka krvnog ugruška uz Zoely je mali, ali neka će ga stanja povećati.
English: Your doctor may decide that Zoely needs to be stopped.
Croatian: Liječnik može odlučiti da je potrebno prekinuti primjenu lijeka Zoely.
English: • Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia.
Croatian: • Pankreatitis ili anamneza pankreatitisa povezanog s teškom hipertrigliceridemijom.
English: Stick it on the blister, just above the row of white active tablets where it reads ‘Place day label here'.
Croatian: Nalijepite je na blister, odmah iznad reda bijelih tableta s djelatnim tvarima gdje stoji 'Ovdje nalijepite naljepnicu s oznakama dana'.
English: Therefore, the use of COCs should not be recommended until the breastfeeding mother has completely weaned her child and an alternative contraceptive method should be proposed to women wishing to breastfeed.
Croatian: Stoga se ne preporučuje primjena KOK-a sve do potpunog prestanka dojenja, a majkama koje žele nastaviti dojiti treba preporučiti drugu metodu kontracepcije.
English: • extreme weakness, anxiety, or shortness of breath;
Croatian: • izrazita slabost, tjeskoba ili nedostatak zraka;
English: o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4).
Croatian: o Visoki rizik od venske tromboembolije zbog prisutnosti višestrukih čimbenika rizika (vidjeti dio 4.4).
English: Starting your first pack of Zoely
Croatian: Kada započeti s prvim pakiranjem lijeka Zoely
English: By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly.
Croatian: Ako se korisnica pridržava jedne od sljedećih opcija, nema potrebe za korištenjem dodatnih kontracepcijskih mjera pod uvjetom da je tijekom 7 dana koji su prethodili prvoj propuštenoj tableti uzela sve tablete na pravilan način.
English: • If you are taking medicines or herbal products that might make Zoely less effective, a barrier contraceptive method should also be used.
Croatian: • Ako uzimate lijekove ili biljne lijekove koji mogu smanjiti učinkovitost lijeka Zoely, potrebno je koristiti i mehaničku metodu kontracepcije.
English: Should any of the conditions appear for the first time during Zoely use, the medicinal product should be stopped immediately.
Croatian: Ako se bilo koje od stanja navedenih u nastavku pojavi prvi put tijekom uzimanja lijeka Zoely, primjena lijeka se mora odmah obustaviti.
English: Stickers marked with the 7 days of the week are provided.
Croatian: U pakiranju lijeka nalaze se naljepnice s oznakama za 7 dana u tjednu.
English: Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g., transient ischaemic attack, stroke).
Croatian: Epidemiološka ispitivanja povezala su primjenu KHK-a s povećanim rizikom od arterijske tromboembolije (infarkt miokarda) ili cerebrovaskularnog incidenta (npr. tranzitorna ishemijska ataka, moždani udar).
English: If you forget to take Zoely The following advice only refers to missed white active tablets.
Croatian: Ako ste zaboravili uzeti Zoely Sljedeći savjeti odnose se samo na propuštene bijele tablete s djelatnim tvarima:
English: The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time.
Croatian: Rizik od razvoja krvnog ugruška u veni najveći je tijekom prve godine primjene kombiniranog hormonskog kontraceptiva kad se uzima prvi put u životu.
English: Picture
Croatian: Slika
English: 28 % of the women experienced absence of withdrawal bleeding in at least one of the cycles 2, 3 and 4, associated with higher occurrences of absence of withdrawal bleeding in the later cycles of use, ranging from 51 % to 62 %.
Croatian: Prijelomno krvarenje izostalo je u barem jednom u 2., 3. ili 4. ciklusu u 28% žena, što je bilo povezano s većom učestalošću izostanka prijelomnog krvarenja u kasnijim ciklusima, u rasponu od 51% do 62%.
English: You can delay your period by not taking the yellow placebo tablets and going straight to a new blister of Zoely.
Croatian: Možete odgoditi mjesečnicu tako da ne uzimate žute tablete placeba i odmah započnete s novim blisterom lijeka Zoely.
English: The Zoely blister contains 28 tablets: 24 white tablets with the active substances (number 1-24) and 4 yellow tablets without active substances (number 25-28).
Croatian: Blister s lijekom Zoely sadrži 28 tableta: 24 bijele tablete s djelatnim tvarima (brojevi 1-24) i 4 žute tablete bez djelatnih tvari (brojevi 25-28).
English: The use of Zoely may need to be stopped several weeks before surgery or while you are less mobile.
Croatian: Možda ćete trebati prestati s primjenom lijeka Zoely nekoliko tjedana prije operacije ili za vrijeme mirovanja.
English: Breastfeeding may be influenced by COCs as they may reduce the quantity and change the composition of breast milk.
Croatian: Kombinirani oralni kontraceptivi mogu utjecati na dojenje jer mogu smanjiti količinu mlijeka i promijeniti njegov sastav.
English: Using a combined hormonal contraceptive such as Zoely increases your risk of developing a blood clot compared with not using one.
Croatian: Primjena kombiniranog hormonskog kontraceptiva kao što je Zoely povećava rizik od razvoja krvnog ugruška u odnosu na to kad se ne uzima.
English: Average steady state plasma concentrations are 4 ng/mL.
Croatian: Prosječne koncentracije u plazmi u stanju dinamičke ravnoteže iznose 4 ng/ml.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake "Rok valjanosti" ili kratice "EXP".
English: When doing so, no additional contraceptive measures are necessary.
Croatian: U tom slučaju nije potrebno koristiti dodatne kontracepcijske mjere.
English: No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding).
Croatian: S uzimanjem tableta treba početi prvog dana ženina prirodnog ciklusa (tj. prvog dana menstrualnog krvarenja).
English: • The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis).
Croatian: • Primjena kombiniranih hormonskih kontraceptiva povezana je s povećanjem rizika od krvnih ugrušaka u veni (venska tromboza).
English: • Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
Croatian: • Prisutnost ili anamneza teške bolesti jetre sve dok se vrijednosti parametara funkcije jetre ne vrate na normalu.
English: Gastrointestinal disorders nausea abdominal distension dry mouth
Croatian: Poremećaji probavnog sustava mučnina distenzija abdomena suha usta
English: She should then take placebo tablets from the last row for a maximum of 3 days such that the total number of placebo plus missed white active tablets is not more than 4, and subsequently continue with the next blister pack.
Croatian: Potom treba uzimati tablete placeba iz posljednjeg reda najviše 3 dana tako da ukupni broj tableta placeba plus propuštene bijele tablete s djelatnim tvarima nije veći od 4, a zatim nastavlja s tabletama iz idućeg blister pakiranja.
English: If any of the conditions or risk factors mentioned below is present, the suitability of Zoely should be discussed with the woman.
Croatian: Ako je prisutno neko od niže navedenih stanja ili čimbenika rizika, potrebno je razgovarati sa ženom o prikladnosti lijeka Zoely.
English: Regular intake of Zoely is then resumed after the yellow placebo tablets have been taken of the second pack.
Croatian: Redovito uzimanje lijeka Zoely nastavlja se nakon što je žena uzela žute tablete placeba iz drugog pakiranja.
English: The last 4 yellow tablets of the fourth row are placebo tablets which do not contain active substances.
Croatian: Posljednje 4 žute tablete u četvrtom redu su tablete placeba koje ne sadrže djelatne tvari.
English: Pregnancy Zoely is not indicated during pregnancy.
Croatian: Trudnoća Zoely nije indiciran za uporabu tijekom trudnoće.
English: However, steroid hormones may be poorly metabolized in women with impaired liver function.
Croatian: Međutim, žene s oštećenom funkcijom jetre možda će slabo metabolizirati steroidne hormone.
English: Yellow placebo film-coated tablets: The tablet does not contain active substances.
Croatian: Žute filmom obložene tablete placeba: Tableta ne sadrži djelatne tvari.
English: • if you have unusual, heavy vaginal bleeding;
Croatian: • ako imate neuobičajena i jaka krvarenja iz rodnice;
English: o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
Croatian: o Poznata nasljedna ili stečena sklonost arterijskoj tromboemboliji, kao što je hiperhomocisteinemija i antifosfolipidna protutijela (antikardiolipinska protutijela, lupus antikoagulant).
English: If you want to start Zoely after having a baby and are breast-feeding, see also section 2 ‘Pregnancy and Breast-feeding'.
Croatian: Ako želite početi uzimati Zoely nakon poroda, a dojite, pogledajte u dijelu 2 'Trudnoća i dojenje'.
English: COC tablets (including Zoely tablets) no longer required should not be disposed via wastewater or the municipal sewage system.
Croatian: Tablete KOK-a (uključujući tablete lijeka Zoely) koje više nisu potrebne ne smiju se bacati u otpadne vode ili javnu kanalizaciju.
English: She then continues to take tablets at her usual time until the active tablets are used up.
Croatian: Potom nastavlja uzimati tablete u uobičajeno vrijeme sve dok ne potroši sve tablete s djelatnim tvarima.
English: • It is not yet known how the risk of VTE with CHCs that contain nomegestrol acetate in combination with estradiol compares with the risk with low dose levonorgestrel-containing CHCs.
Croatian: • Još nije poznato koliki je rizik od VTE uz KHK-e koji sadrže nomegestrolacetat u kombinaciji s estradiolom u usporedbi s rizikom uz KHK-e koji sadrže nisku dozu levonorgestrela.
English: BLOOD CLOTS IN AN ARTERY
Croatian: KRVNI UGRUŠCI U ARTERIJI