FrancophonIA/ELRC3.0 huggingface dataset:
English: If you take any of these medicines, you may need to use another method of birth control (such as a condom, diaphragm or foam).
Croatian: Ako uzimate bilo koji od navedenih lijekova, možda ćete morati koristiti neku drugu metodu kontrole začeća (poput prezervativa, dijafragme ili kontracepcijske pjene).
English: EVRA can be restarted approximately 2 weeks after completion of this treatment.
Croatian: EVRA se može ponovno početi primjenjivati otprilike 2 tjedna nakon završetka ovog liječenja.
English: If you want to change your “Patch Change Day” to a different day of the week talk to your doctor.
Croatian: Ako želite promijeniti “dan izmjene flastera” i pomaknuti ga na neki drugi dan u tjednu, razgovarajte o tome sa svojim liječnikom.
English: • medicines for infection (such as rifampicin and griseofulvin)
Croatian: • lijekove za liječenje infekcije (kao što su rifampicin i grizeofulvin)
English: • If you do not, you may increase your risk of getting pregnant.
Croatian: • U drugom slučaju, povećavate rizik da ostanete trudni.
English: With all combined hormonal contraceptives, irregular blood loss (spotting or breakthrough bleeding) can occur, especially during the initial months of usage.
Croatian: Uz sve kombinirane hormonske kontraceptive mogu se javiti nepravilnosti krvarenja (točkasto ili probojno krvarenje), posebice u prvim mjesecima primjene.
English: For less than one day (up to 24 hours):
Croatian: Ako je proteklo manje od jednog dana (do 24 sata):
English: If you forget to change your patch
Croatian: Ako zaboravite promijeniti flaster
English: • Sudden sharp increase in blood pressure (hypertensive crisis)
Croatian: • iznenadni nagli porast krvnog tlaka (hipertenzivna kriza)
English: Women using combined contraceptives should be emphatically advised to contact their physician in case of possible symptoms of thrombosis.
Croatian: Ženama koje koriste kombinirane kontraceptive treba jasno savjetovati da posjete svog liječnika u slučaju mogućih simptoma tromboze.
English: Adverse reactions that may occur at the beginning of treatment but usually diminish after the first three cycles include spotting, breast tenderness and nausea.
Croatian: Nuspojave koje se mogu pojaviti na početku primjene, ali se obično smanjuju nakon prva tri ciklusa, uključuju točkasto krvarenje, osjetljivost dojki i mučninu.
English: • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);
Croatian: • ako imate tegobe sa srcem (poremećaj zalistaka, poremećaj srčanog ritma koji se zove fibrilacija atrija);
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 ili više tjedana.
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 symptoms of a blood clot).
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: These spots may not go away completely, even after you stop using EVRA.
Croatian: Mrlje možda neće potpuno izbljediti, čak i nakon prestanka primjene EVRE.
English: A single transdermal patch is applied and worn for one full week (7 days).
Croatian: Primjenjuje se jedan transdermalni flaster, koji se nosi tijekom cijelog tjedna (7 dana).
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: Serious ill effects have not been reported following accidental ingestion of large doses of oral contraceptives.
Croatian: Ozbiljni štetni učinci nisu bili prijavljeni nakon slučajnog gutanja visokih doza oralnih kontraceptiva.
English: There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.
Croatian: Nema konsenzusa o mogućoj ulozi varikoznih vena i superficijalnog tromboflebitisa u nastanku ili napredovanju venske tromboze.
English: Infections and infestations common
Croatian: Infekcije i infestacije često
English: • Do not use this medicine if you are breast-feeding or planning to breast-feed (see also section 2
Croatian: • Nemojte primjenjivati ovaj lijek ako dojite ili planirate dojiti (također pogledajte dio 2
English: • Sometimes patches can stick to the inside of the sachet - be careful not to accidentally remove the clear covering as you remove the patch
Croatian: • Katkad flaster može biti zalijepljen za unutrašnjost vrećice - budite pažljivi, da slučajno ne uklonite prozirnu foliju, vadeći flaster.
English: • Swelling of face, mouth, throat, or tongue
Croatian: • oticanje lica, usta, grla ili jezika
English: With respect to the reproductive toxicity norelgestromin showed foetal toxicity in rabbits, but the safety margin for this effect was sufficiently high.
Croatian: S obzirom na reproduktivnu toksičnost, norelgestromin se pokazao toksičnim za fetuse kunića, ali granica sigurnosti za ovaj učinak bila je dovoljno visoka.
English: If you use more EVRA than you should (more than one EVRA patch at any one time) Take the patches off and talk to a doctor immediately.
Croatian: Ako primijenite više EVRE nego što ste trebali (više od jednog EVRA flastera odjednom) Uklonite flastere i odmah se javite svom liječniku.
English: Other medicines and EVRA
Croatian: Drugi lijekovi i EVRA
English: However, general experience with combined oral contraceptives during pregnancy did not provide evidence for an actual undesirable effect in humans.
Croatian: Međutim, općenito iskustvo s kombiniranim oralnim kontraceptivima tijekom trudnoće nije dokazalo stvarne nuspojave u ljudi.
English: If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to EVRA, please talk to your doctor.
Croatian: Ako dobijete neku nuspojavu, osobito ako je teška ili uporno traje, ili je došlo do promjene Vašeg zdravstvenog stanja za koje mislite da bi moglo biti posljedica EVRE, molimo obratite se svom liječniku.
English: The transdermal patch Change Day will be on this day every week (cycle Days 8, 15, 22 and Day 1 of the next cycle).
Croatian: Dan izmjene transdermalnog flastera isti je dan u svakom sljedećem tjednu (8., 15., 22. dan ciklusa te 1. dan sljedećeg ciklusa).
English: • You have or have had ‘pregnancy spots'.
Croatian: • imali ste „trudničke pjege“.
English: • Mood problems such as depression, change in mood or mood swings, anxiety, crying
Croatian: • poremećaj raspoloženja poput depresije, promijenjeno raspoloženje ili česte promjene raspoloženja, tjeskoba, plakanje
English: Secondary packaging material
Croatian: Materijal za sekundarno pakiranje
English: • You think you might be pregnant;
Croatian: • sumnjate na trudnoću;
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 symptoms);
Croatian: • ako imate (ili ste ikad 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: Ethinyl estradiol is also metabolised to various hydroxylated products and their glucuronide and sulfate conjugates.
Croatian: Etinilestradiol se također metabolizira do raznih hidroksiliranih produkata i njihovih glukuronidnih i sulfatnih konjugata.
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: • Hair loss
Croatian: • ispadanje kose
English: In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages.
Croatian: U izoliranim slučajevima ti su tumori doveli do za život opasnog intraabdominalnog krvarenja.
English: Some of these symptoms (e.g. “shortness of breath”, “coughing”) are non-specific and might be misinterpreted as more common or less severe events (e.g. respiratory tract infections).
Croatian: Neki od ovih simptoma (npr. “nedostatak zraka”, “kašalj”) nisu specifični i mogu se pogrešno zamijeniti za uobičajenije ili manje teške događaje (npr. infekciju dišnih puteva).
English: - Acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptives until markers of liver function return to normal.
Croatian: - Akutne ili kronične smetnje jetrenih funkcija mogu rezultirati neophodnim prekidom primjene kombiniranih hormonskih kontraceptiva sve dok se markeri jetrenih funkcija ne normaliziraju.
English: • Only wear one patch at a time.
Croatian: • Istodobno nosite samo jedan flaster.
English: Each used transdermal patch is removed and immediately replaced with a new one on the same day of the week (Change Day) on Day 8 and Day 15 of the cycle.
Croatian: Svaki upotrijebljeni transdermalni flaster treba skinuti te odmah zamjeniti novim, uvijek istog dana u tjednu (tzv. dan izmjene) na 8. i 15. dan ciklusa.
English: In the event of aggravation, or first appearance of any of the conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of EVRA should be discontinued.
Croatian: U slučaju pogoršanja ili pojave nekog od navedenih stanja ili čimbenika rizika, ženi treba savjetovati da se obrati svom liječniku kako bi utvrdio treba li prekinuti primjenu EVRE.
English: • Try to put it on again or put on a new patch immediately.
Croatian: • Odmah ga pokušajte ponovno zalijepiti ili stavite novi flaster.
English: ** Includes adverse reactions reported in clinical trials and post-marketing reports.
Croatian: ** Uključuje nuspojave prijavljenje u kliničkim ispitivanjima i prijave nakon stavljanja lijeka u promet.
English: It has not been shown that a transdermal patch like EVRA is safer than a combined birth control pill taken by mouth.
Croatian: Nije dokazano da je transdermalni flaster poput EVRE sigurniji od kombinirane kontracepcijske tablete koja se uzima kroz usta.
English: • However, if you miss two periods in a row, talk to your doctor or pharmacist as you may be pregnant.
Croatian: • Međutim, ako Vam izostanu dvije uzastopne menstruacije, razgovarajte sa svojim liječnikom ili ljekarnikom, jer postoji mogućnost da ste trudni.
English: The incidence of ovulation on Day 21 post abortion (at 20 weeks gestation) is not known.
Croatian: Incidencija ovulacije na 21. dan nakon pobačaja (ako se radilo o 20. gestacijskom tjednu) nije poznata.
English: Bleeding irregularities
Croatian: Nepravilnosti krvarenja
English: However, it is possible that the combined hormonal contraceptive is not the cause of more women having breast cancer.
Croatian: Međutim, moguće je da kombinirani hormonski kontraceptivi nisu uzrok višoj pojavnosti raka dojke u žena.
English: blood clots in the liver, stomach/intestine, kidneys or eye.
Croatian: • krvni ugrušci u jetri, želucu/crijevima, bubrezima ili oku.
English: Safety and efficacy have not been established in adolescents under 18 years of age.
Croatian: Sigurnost i djelotvornost u adolescentica mlađih od 18 godina nisu ustanovljene.
English: Pearl Index (95% CI)
Croatian: Broj ciklusa Ukupni Pearlov indeks (95% CI) Neuspjeh metode Pearlov indeks (95% CI)
English: During Week 4, you may pick a new Change Day and apply the first patch on that day.
Croatian: Tijekom 4. tjedna, možete odabrati novi “dan izmjene ” i na taj dan primijeniti prvi flaster.
English: Do not wear a patch on Week 4 (Day 22 through Day 28).
Croatian: Nemojte stavljati/nositi flaster tijekom 4. tjedna (od 22. do 28. dana).
English: Contains 1 transdermal patch
Croatian: Sadrži 1 transdermalni flaster
English: EVRA has not been studied in children and adolescents under 18 years of age.
Croatian: EVRA nije ispitana u djece i adolescenata mlađih od 18 godina starosti.
English: Lamotrigine: Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when coadministered likely due to induction of lamotrigine glucuronidation.
Croatian: Lamotrigin: pokazalo se da kombinirani hormonski kontraceptivi značajno snižavaju koncentracije lamotrigina u plazmi kada se primjenjuju istovremeno, vjerojatno zbog indukcije glukuronidacije lamotrigina.
English: You should ask your doctor how soon after delivery you can start taking EVRA;
Croatian: Upitajte svog liječnika kad najranije nakon porođaja možete početi uzimati EVRU;
English: • High levels of fats in the blood (such as cholesterol or triglycerides)
Croatian: • visoke razine masnoća u krvi (poput kolesterola ili triglicerida)
English: If EVRA remains even partly detached: - for less than one day (up to 24 hours): it should be re-applied to the same place or replaced with a new EVRA transdermal patch immediately.
Croatian: Ako je EVRA djelomično odlijepljena: - kraće od jednog dana (do 24 sata): mora se odmah ponovno staviti na isto mjesto ili odmah zamijeniti novim EVRA transdermalnim flasterom.
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 kombiniranu hormonsku kontracepciju.
English: The majority of recent studies also do not indicate a teratogenic effect when combined oral contraceptives are used inadvertently during early pregnancy.
Croatian: Većina novih ispitivanja također ne upućuje na teratogeni učinak kada se kombinirani oralni kontraceptivi nehotice koriste za vrijeme rane trudnoće.
English: Norelgestromin is bound to albumin and not to SHBG, while norgestrel is bound primarily to SHBG, which limits its biological activity.
Croatian: Norelgestromin se veže na albumin, a ne i na globulin koji veže spolne hormone (SHBG), dok se norgestrel primarno veže na SHBG što ograničava njegovo biološko djelovanje.
English: The primary mechanism of action is inhibition of the ovulation, but the alterations of the cervical mucus, and to the endometrium may also contribute to the efficacy of the product.
Croatian: Primarni mehanizam djelovanja jest inhibicija ovulacije, ali i promjene cervikalne sluzi te endometrija pridonose djelotvornosti lijeka.
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: Neki dokazi također pokazuju da je taj rizik povećan kad se KOK-i ponovno počnu primjenjivati nakon stanke u trajanju od 4 ili više tjedana.
English: • Fibroids in the womb (uterus)
Croatian: • fibroidi u maternici (uterusu)
English: EU/1/02/223/001: 3 transdermal patches EU/1/02/223/002: 9 transdermal patches EU/1/02/223/003: 18 transdermal patches
Croatian: EU/1/02/223/001: 3 transdermalna flastera EU/1/02/223/002: 9 transdermalnih flastera EU/1/02/223/003: 18 transdermalnih flastera
English: Breast-feeding may be influenced by combined hormonal contraceptives as they may reduce the quantity and change the composition of breast milk.
Croatian: Kombinirani hormonski kontraceptivi mogu utjecati na dojenje, jer mogu smanjiti količinu i promijeniti sastav majčinog mlijeka.
English: A woman on short-term treatment with medicinal products that induce hepatic drug metabolising enzymes or individual active substances that induce these enzymes should temporarily use a barrier method in addition to EVRA, i.e. during the time of concomitant medicinal product administration and for 28 days after their discontinuation.
Croatian: Žena koja se kratkotrajno liječi lijekovima koji induciraju jetrene enzime koji metaboliziraju lijekove ili individualne djelatne tvari koje induciraju te enzime, treba privremeno koristiti mehaničku metodu kontracepcije uz EVRU, odnosno tijekom razdoblja istodobne primjene lijekova i 28 dana nakon prestanka njihovog uzimanja.
English: In cases of suspected overdose, all transdermal contraceptive systems should be removed and symptomatic treatment given.
Croatian: U slučaju sumnje na predoziranje, svi transdermalni kontraceptivni sustavi trebaju se maknuti te treba započeti simptomatsko liječenje.
English: Body weight equal or greater than 90 kg Contraceptive efficacy may be decreased in women weighing equal or greater than 90 kg.
Croatian: Tjelesna težina 90 kg ili više Djelotvornost kontracepcije može biti smanjena u žena tjelesne težine 90 kg ili više.
English: When you should not use EVRA
Croatian: Kad ne smijete primjenjivati EVRU
English: • Abnormal liver function related to acute or chronic hepatocellular disease
Croatian: • Poremećaj jetrenih funkcija vezan uz akutnu ili kroničnu hepatocelularnu bolest.
English: If more than 7 days elapse after taking the last active oral contraceptive tablet, the woman may have ovulated and should, therefore, be advised to consult a physician before initiating treatment with EVRA.
Croatian: Ako je prošlo više od 7 dana od uzimanja zadnje aktivne tablete oralne kontracepcije, u žene je moglo doći do ovulacije, stoga je treba uputiti da se prije početka primjene EVRE savjetuje s liječnikom.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and estrogens, fixed combination; ATC-code: G03AA13.
Croatian: Farmakoterapijska skupina: Spolni hormoni i ostali pripravci koji djeluju na spolni sustav, progestageni i estrogeni, fiksne kombinacije; ATK oznaka: G03AA13.
English: If you switch from the progestogen-only pill, an implant or an injectable to EVRA
Croatian: Ako prelazite s tablete koja sadrži samo progesteron, implantata ili injekcije na EVRU
English: The analyses indicated no association of age and race with pregnancy.
Croatian: Analize su pokazale da nema povezanosti između dobi i rasne pripadnosti s trudnoćom.
English: Remaining hormonal active ingredients of the transdermal patch may have harmful effects if reaching the aquatic environment.
Croatian: Preostali hormonski djelatni sastojci transdermalnog flastera mogu imati štetan učinak ukoliko se nađu u vodenom okolišu.
English: If you forget to put on your patch, you may be at particularly high risk of becoming pregnant.
Croatian: Ako zaboravite staviti flaster, možete biti izloženi visokom riziku neželjene trudnoće.
English: • Do not put the patch on skin that is red, irritated or cut.
Croatian: • Ne stavljajte flaster na kožu koja je crvena, nadražena ili porezana.
English: 3 transdermal patches 9 transdermal patches 18 transdermal patches
Croatian: 3 transdermalna flastera 9 transdermalnih flastera 18 transdermalnih flastera
English: • Major surgery with prolonged immobilisation (see section 4.4);
Croatian: • Veliki kirurški zahvat s dugotrajnom imobilizacijom (vidjeti dio 4.4).
English: Etoricoxib has been shown to increase plasma levels of ethinyl estradiol (50 to 60%) when taken concomitantly with an oral triphasic hormonal contraceptive.
Croatian: Pokazalo se da etorikoksib povećava razine etinilestradiola (50 do 60%), kada se uzima istovremeno s oralnim trifaznim hormonskim kontraceptivom.
English: • Brown spots or patches on the face
Croatian: • smeđe pjege ili mrlje na licu
English: • if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);
Croatian: • ako Vi ili netko u Vašoj užoj obitelji ima visoke vrijednosti masnoća u krvi (kolesterol ili trigliceride);
English: The effects of age, body weight, and body surface area on the pharmacokinetics of norelgestromin and ethinyl estradiol were evaluated in 230 healthy women from nine pharmacokinetic studies of single 7-day applications of EVRA.
Croatian: Utjecaj dobi, tjelesne težine i površine tijela na farmakokinetiku norelgestromina i etinilestradiola procijenjen je na 230 zdravih žena iz 9 farmakokinetičkih ispitivanja jedne 7-dnevne primjene EVRE.
English: As the EVRA transdermal patch contains similar hormones to those used in combined birth control pills, it is likely to have the same risks.
Croatian: S obziom na to da EVRA transdermalni flaster sadrži hormone poput onih koje sadrže kontracepcijske tablete, vjerojatno imaju slične rizike.
English: Additionally, talk to your doctor, pharmacist or nurse before using EVRA if you have any of the following or they happen or get worse while using EVRA:
Croatian: Dodatno, prije primjene EVRE savjetujte se sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ukoliko imate bilo koje od dolje navedenih stanja ili se ona pogoršaju za vrijeme primjene EVRE:
English: Effect of EVRA on other medicinal products
Croatian: Učinak EVRE na druge lijekove
English: When you have worn 6 patches in a row (so for 6 consecutive weeks), do not put on a patch in week 7.
Croatian: Nakon što ste primijenili 6 flastera za redom (dakle 6 uzastopnih tjedana), 7. tjedan nemojte primijeniti flaster.
English: • if you have unexplained vaginal bleeding
Croatian: • ako imate neobjašnjeno krvarenje iz rodnice
English: • Do not put a new patch on the same area of skin as the old patch.
Croatian: • Ne stavljajte novi flaster na isto područje kože na kojem je bio prethodni flaster.
English: • Allergic reaction, hives
Croatian: • alergijske reakcije, koprivnjača
English: • A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as: - diabetes mellitus with vascular symptoms - severe hypertension - severe dyslipoproteinaemia
Croatian: • Visoki rizik od arterijske tromboembolije zbog prisutnosti većeg broja čimbenika rizika (vidjeti dio 4.4) ili jednog ozbiljnog čimbenika rizika kao što je: - šećerna bolest s krvožilnim simptomima - teška hipertenzija - teška dislipoproteinemija.
English: It is important to remember that the overall risk of a harmful blood clot due to EVRA is small.
Croatian: Važno je zapamtiti da je ukupni rizik od krvnog ugruška sa štetnim posljedicama zbog EVRE mali.
English: The use of EVRA may need to be stopped several weeks before surgery or while you are less mobile.
Croatian: S primjenom EVRE će možda trebati prestati nekoliko tjedana prije operacije ili za vrijeme mirovanja.
English: However, if intercourse has already occurred, pregnancy should be excluded before the actual start of EVRA or the woman has to wait for her first menstrual period.
Croatian: Međutim, ako je žena već imala spolni odnos, prije stvarnog početka primjene EVRE treba isključiti trudnoću ili žena treba pričekati do prvog menstruacijskog krvarenja.
English: • Stop using this medicine right away if you become pregnant.
Croatian: • Odmah prestanite primjenjivati ako ostanete trudni.