FrancophonIA/ELRC3.0 huggingface dataset:
English: You will need to complete the current cycle and remove the third patch on the correct day.
Croatian: Trebate završiti trenutni ciklus i ukloniti treći flaster na pravi dan.
English: For more than one day (24 hours or more) or if you are not sure for how long:
Croatian: Ako je proteklo više od jednog dana (24 sata ili više) ili ako niste sigurni koliko je vremena proteklo:
English: EVRA must not be used in children and adolescents who have not yet had their first menstrual period.
Croatian: EVRA se ne smije primjenjivati u djece i adolescenata koji još nisu imali prvu menstruaciju.
English: • Normal activities such as having a bath or shower, using a sauna and exercising should not affect how well the patch works.
Croatian: • Uobičajene aktivnosti, poput kupanja ili tuširanja, boravak u sauni i tjelovježba, ne bi trebale imati utjecaja na dobro djelovanje flastera.
English: EU/1/02/223/001 EU/1/02/223/002
Croatian: EU/1/02/223/001 EU/1/02/223/002 EU/1/02/223/003
English: Exploratory analyses were performed to determine whether in the Phase III studies (n=3,319) the population characteristics of age, race and weight were associated with pregnancy.
Croatian: Provedene su istraživačke analize kako bi se utvrdilo jesu li u ispitivanjima faze III (n=3319) demografske karakteristike kao što su dob, rasa i tjelesna težina povezane s trudnoćom.
English: Using too many patches may cause you to have the following:
Croatian: Istodobno nošenje previše flastera, može prouzročiti sljedeće:
English: Therefore, the use of EVRA is not to be recommended until the breast-feeding mother has completely weaned her child.
Croatian: Stoga se primjena EVRE ne preporučuje sve dok majka dojilja doji svoje dijete.
English: • Premenstrual syndrome
Croatian: • predmenstrualni sindrom
English: The EVRA transdermal patch should not be cut, damaged or altered in any way as this may compromise contraceptive effectiveness.
Croatian: EVRA transdermalni flaster se ne smije rezati, oštetiti ni prepravljati na bilo koji način, jer se time može ugroziti kontracepcijska djelotvornost.
English: Other products such as EVRA may have up to twice this level of risk.
Croatian: Drugi lijekovi, kao što je EVRA, mogu nositi do dvostruko veći rizik.
English: Medicinal product exposure is more appropriately characterised by the pharmacokinetic profile (see section 5.2).
Croatian: Izloženost lijeku prikladnije je objašnjena farmakokinetičkim profilom (vidjeti dio 5.2).
English: • You have a hearing loss;
Croatian: • imate gubitak sluha;
English: • Weeks 1, 2 & 3: Put on one patch and leave it on for exactly seven days.
Croatian: • 1., 2. i 3. tjedan: Zalijepite jedan flaster i nosite ga točno sedam dana.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i potencijalne kancerogenosti.
English: • if you have ever had liver tumours or a liver disease because of which your liver does not function properly;
Croatian: • ako ste ikada prije imali tumor jetre ili bolest jetre zbog koje Vaša jetra ne funkcionira kako bi trebala;
English: • Anger or feeling frustrated
Croatian: • ljutnja ili osjećaj frustracije
English: • if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast.
Croatian: • ako trebate ići na operaciju ili ste dugo mirovali zbog ozljede ili bolesti ili imate nogu u gipsu.
English: Some women using hormonal contraceptives including EVRA have reported depression or depressed mood.
Croatian: Neke žene koje uzimaju hormonsku kontracepciju, uključujući EVRU prijavile su pojavu depresije ili depresivnog raspoloženja.
English: † See section 4.4.
Croatian: Vidjeti dio 4.4.
English: This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Croatian: Navedeno može smanjiti kontrolu napadaja; stoga mogu biti potrebne prilagodbe doze lamotrigina.
English: When using a combined hormonal contraceptive like EVRA you are advised to stop smoking.
Croatian: Kad uzimate kombinirani hormonski kontraceptiv poput EVRE, savjetuje se da prestanete pušiti.
English: • However, you should check that the patch has not fallen off after doing these activities.
Croatian: • Unatoč tome, trebali biste provjeriti da se flaster nije odlijepio nakon tih aktivnosti.
English: This usually happens in the first 3 months and especially if your periods were not regular before you started using this medicine.
Croatian: To se obično događa prva 3 mjeseca, a posebice ako su Vam menstruacije i prije početka korištenja ovog lijeka bile neredovite.
English: Accordingly, plasma and tissue concentrations may increase (e.g. ciclosporin).
Croatian: Prema tome, koncentracija u plazmi i tkivima može se povećati (npr. ciklosporin).
English: For initiation instructions see ‘How to start EVRA' below.
Croatian: Za upute o početku primjene, vidjeti pod „Kako početi primjenjivati EVRU“.
English: EVRA has no or negligible influence on the ability to drive and use machines.
Croatian: EVRA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The excess risk gradually disappears during the course of the 10 years after cessation of COC use.
Croatian: Povećan rizik postupno nestaje tijekom 10 godina nakon prestanka uzimanja KOK-a.
English: When you stop EVRA your risk of a blood clot returns to normal within a few weeks.
Croatian: Kad prestanete uzimati EVRU, Vaš rizik od krvnih ugrušaka vraća se na normalnu vrijednost unutar nekoliko tjedana.
English: • Abnormal breast milk production
Croatian: • abnormalna proizvodnja mlijeka
English: At the end of the cycle (Week Four/Day 22) - If the EVRA transdermal patch is not removed at the beginning of Week 4 (Day 22), it should be removed as soon as possible.
Croatian: Na kraju ciklusa (4. tjedan/22. dan) - ako EVRA transdermalni flaster nije skinut na početku 4. tjedna (22. dan), treba ga skinuti što je prije moguće.
English: If this happens you could get pregnant, or may experience unexpected bleeding.
Croatian: Ako do toga dođe, možete ostati trudni ili se može pojaviti neočekivano krvarenje.
English: You should not use EVRA if you have any of the conditions listed below.
Croatian: Ne smijete primjenjivati EVRU ako imate neko od niže navedenih stanja.
English: What EVRA is and what it is used for What you need to know before you use EVRA How to use EVRA
Croatian: Što je EVRA i za što se koristi Što morate znati prije nego počnete primjenjivati EVRU
English: it is no longer sticky it has become stuck to itself or another surface it has other material stuck to it it is the second time it has become loose or has fallen off.
Croatian: više nije ljepljiv se zalijepio sam za sebe ili drugu površinu se za njega zalijepio neki drugi materijal je po drugi put otpao ili prestao čvrsto prianjati uz kožu.
English: If you need to stop EVRA ask your doctor when you can start using it again;
Croatian: Ako trebate prestati uzimati EVRU, upitajte liječnika kada ga ponovno možete početi uzimati;
English: • if you have (or have ever had) a type of migraine called ‘migraine with aura';
Croatian: • ako imate (ili ste ikad imali) vrstu migrene koja se zove „migrena s aurom“;
English: • You had a skin rash with blisters during pregnancy (called ‘herpes gestationis');
Croatian: • imali ste kožni osip s mjehurićima tijekom trudnoće (nazvan „gestacijski herpes“);
English: Another method of contraception should be used to avoid unintentional pregnancy.
Croatian: Potrebno je primjenjivati drugu metodu kontracepcije da bi se izbjegla neplanirana trudnoća.
English: Do not wear more than 6 patches (so not more than 6 weeks) in a row.
Croatian: Nemojte primijeniti više od 6 flastera (dakle ne duže od 6 tjedana) za redom.
English: EVRA may make some other medicines less effective, such as:
Croatian: EVRA flaster može smanjiti djelotvornost nekih drugih lijekova, kao što su:
English: The overall risk of a blood clot in the leg or lung (DVT or PE) with EVRA is small.
Croatian: Ukupni rizik od nastanka krvnog ugruška u nozi ili plućima (DVT ili PE) uz EVRU je mali.
English: Always use condoms to protect yourself from these diseases.
Croatian: Za zaštitu od tih bolesti uvijek upotrebljavajte prezervative.
English: If you forget to take off your patch:
Croatian: Ako zaboravite ukloniti flaster:
English: In this case you could also have a higher risk of having a heart attack or stroke;
Croatian: U tom slučaju i Vi možete imati viši rizik od srčanog ili moždanog udara;
English: • You have epilepsy or any other problem that can cause fits (convulsions);
Croatian: • imate epilepsiju ili bilo koji drugi poremećaj koji može izazvati napadaje (konvulzije);
English: These subjects received six or 13 cycles of contraception (EVRA or oral contraceptive comparator), took at least one dose of study medicinal product and provided safety data.
Croatian: Ove ispitanice su dobile kontracepciju u šest ili 13 ciklusa (EVRA ili oralni kontraceptiv za usporedbu) i uzele su najmanje jednu dozu ispitivanog lijeka, čime su se dobili podaci o sigurnosti.
English: However, diabetic women should be carefully observed, particularly in the early stage of EVRA use.
Croatian: Međutim, žene koje boluju od dijabetesa treba pažljivo pratiti, posebice na početku primjene EVRE.
English: Pregnancy EVRA is not indicated during pregnancy.
Croatian: Trudnoća EVRA nije indicirana u trudnoći.
English: Although only 10-20% of the variability in pharmacokinetic data can be explained by weight (see section 5.2), the greater proportions of pregnancies among women at or above 90 kg was statistically significant and indicates the EVRA is less effective in these women.
Croatian: Iako se tek 10-20% varijabilnosti u farmakokinetičkim podacima može objasniti utjecajem tjelesne težine (vidjeti dio 5.2), statistički značajno veći postotak trudnoća javlja se u žena s 90 kg ili više i upućuje da je EVRA u te skupine žena manje djelotvoran.
English: These findings suggest that clinical efficacy would be maintained even if a scheduled change is missed for as long as 2 full days.
Croatian: Ti rezultati upućuju na to da bi klinička djelotvornost bila održana čak i ako se zakasni s promjenom flastera za 2 puna dana.
English: • medicines containing ciclosporin
Croatian: • lijekovi koji sadrže ciklosporin
English: The problem will usually go away but if it doesn't, check with your doctor or pharmacist.
Croatian: Ti problemi uobičajeno prestaju sami, ali ako ne prestanu, provjerite sa svojim liječnikom ili ljekarnikom.
English: If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.
Croatian: Ako imate više od jednog navedenog stanja ili je neko od tih stanja osobito teško, rizik od razvoja krvnog ugruška može biti još veći.
English: Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmissible diseases.
Croatian: Ženama treba objasniti da oralni kontraceptivi ne štite od infekcije HIV-om (AIDS-a) i drugih spolno prenosivih bolesti.
English: How to use the patch:
Croatian: Kako koristiti flaster:
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
Croatian: • Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: 10 seconds
Croatian: 10 sekundi.
English: • if you have ever had a heart attack or a stroke;
Croatian: • ako ste ikad imali srčani ili moždani udar;
English: The sticky adhesive side is stuck to the skin after removal of the clear, plastic, protective covering.
Croatian: Ljepljiva strana flastera ostaje pričvršćena za kožu nakon što je uklonjena prozirna, plastična, zaštitna folija.
English: Blood pressure should be measured and a physical examination should be performed guided by the contra-indications (see section 4.3) and warnings (see section 4.4).
Croatian: Potrebno je izmjeriti krvni tlak i napraviti fizikalni pregled, rukovodeći se kontraindikacijama (vidjeti dio 4.3) i upozorenjima (vidjeti dio 4.4).
English: Important information to follow when using the patch
Croatian: Važne informacije kojih se treba pridržavati za vrijeme korištenja flastera
English: Wear the patch for 7 days (one week).
Croatian: Nosite flaster 7 dana (jedan tjedan).
English: Put the patch on your skin.
Croatian: Postavite flaster na kožu.
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: Središnja točka raspona od 5-7 na 10 000 žena-godina, na temelju relativnog rizika za KOK-e koji sadrže levonorgestrel naspram njihovog neuzimanja koji iznosi približno 2,3 do 3,6
English: To achieve maximum contraceptive effectiveness, patients must be advised to use EVRA exactly as directed.
Croatian: Kako bi se postigla maksimalna kontracepcijska djelotvornost, ženama se mora savjetovati da koriste EVRU točno prema uputi.
English: However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below).
Croatian: Međutim, u pojedine žene taj rizik može biti daleko veći, ovisno o njezinim osnovnim čimbenicima rizika (vidjeti niže).
English: Your doctor may decide that EVRA needs to be stopped.
Croatian: Liječnik može odlučiti da je potrebno prekinuti primjenu EVRE.
English: DVT), your lungs (pulmonary embolus, PE) or other organs;
Croatian: DVT), pluća (plućna embolija, PE) ili drugih organa;
English: • Your “Patch Change Day” should remain the same.
Croatian: • “Dan izmjene flastera” treba ostati isti.
English: If you have an upset stomach
Croatian: Ako imate problema sa želucem
English: Non-hormonal causes should be considered and, if necessary, adequate diagnostic measures taken to rule out organic disease or pregnancy.
Croatian: Treba razmotriti nehormonske uzroke, te ako je potrebno, napraviti dijagnostičke pretrage kojima će se isključiti organska bolest ili trudnoća.
English: Effects of age, body weight, and body surface area
Croatian: Utjecaj dobi, tjelesne težine i površine tijela
English: Post-menopausal women
Croatian: Žene u postmenopauzi
English: Animal studies have shown undesirable effects during pregnancy and lactation (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su štetne učinke tijekom trudnoće i laktacije (vidjeti dio 5.3).
English: Limited data on the outcomes of exposed pregnancies in women using EVRA do not allow for conclusions about its safety during pregnancy.
Croatian: Ograničeni podaci o ishodima izloženih trudnoća žena koje koriste EVRU ne može se donijeti zaključak o sigurnosti primjene tijekom trudnoće.
English: Primary packaging material
Croatian: Materijal za primarno pakiranje
English: • Always put your patch on clean, dry, hairless skin
Croatian: • Uvijek stavljajte flaster na čistu, suhu kožu bez dlačica.
English: • Increased interest in sex
Croatian: • povećano zanimanje za spolni odnos
English: For this reason, a medical opinion on irregular blood loss will only be useful after an adjustment period of approximately three cycles.
Croatian: Zbog toga je te poremećaje krvarenja korisno medicinski procijeniti tek nakon razdoblja prilagodbe od oko tri ciklusa.
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 liječnika.
English: Hormonal contraceptives may affect the metabolism of certain other active substances.
Croatian: Hormonski kontraceptivi mogu utjecati na metabolizam i nekih drugih djelatnih tvari.
English: Following this, the regular application of EVRA is resumed.
Croatian: Nakon toga nastavlja se uobičajena primjena EVRE.
English: With respect to weight, 5 of the 15 pregnancies reported with EVRA were among women with baseline body weight equal or greater than 90 kg, which constituted < 3% of the study population.
Croatian: Vezano uz tjelesnu težinu, 5 od 15 trudnoća zabilježenih uz primjenu EVRE nastupilo je u žena s početnom tjelesnom težinom jednakom ili većom od 90 kg, odnosno <3% ispitivane populacije.
English: Your “Patch Change Day” will be on this day of the week every week.
Croatian: “Dan izmjene flastera” bit će na taj dan svaki sljedeći tjedan.
English: Other medical conditions associated with VTE
Croatian: Druga zdravstvena stanja povezana s VTE
English: • You may start this medicine on the first day of your next period.
Croatian: • Možete početi koristiti ovaj lijek prvi dan sljedeće menstruacije.
English: Other conditions - Contraceptive efficacy may be reduced in women weighing equal or greater than 90 kg (see sections 4.2 and 5.1).
Croatian: Ostala stanja - Kontracepcijska djelotvornost može biti smanjena u žena koje imaju 90 kg ili više (vidjeti dijelove 4.2 i 5.1).
English: It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”.
Croatian: Osobito je važno pročitati o simptomima krvnog ugruška - pogledajte dio 2 “Krvni ugrušci”.
English: In these situations it is advisable to discontinue the use of the patch (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.
Croatian: U tim se situacijama savjetuje prekinuti primjenu flastera/tableta/prstena (u slučaju elektivnog kirurškog zahvata, najmanje 4 tjedna prije) i nastaviti s primjenom tek nakon što prođu 2 tjedna od potpune remobilizacije.
English: In the middle of the cycle (Week Two/Day 8 or Week Three/Day 15) - for one or two days (up to 48 hours): The user should apply a new EVRA transdermal patch immediately.
Croatian: U sredini ciklusa (2. tjedan/8. dan ili 3. tjedan/15. dan) - jedan ili dva dana (do 48 sati): žena treba odmah primijeniti novi EVRA transdermalni flaster.
English: The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with EVRA, 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 primjeni nekog drugog lijeka umjesto onog za kojeg je poznato da ima najniži rizik od VTE treba donijeti samo nakon razgovora sa ženom kako bi se utvrdilo da razumije koliki je rizik od VTE uz EVRU i kako njezini trenutno prisutni čimbenici rizika utječu na taj rizik te da je njezin rizik od VTE najviši tijekom prve godine primjene.
English: Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins.
Croatian: Norelgestromin i norgestrel (serumski metabolit norelgestromina) imaju visok afinitet vezanja (> 97%) na serumske proteine.
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 KOK-a (koja može biti prodromalni znak cerebrovaskularnog događaja) može biti razlogom trenutačnog prekida primjene.
English: • Harmful blood clots in a vein or artery for example:
Croatian: • štetni krvni ugrušci u veni ili arteriji, na primjer:
English: • immediate loss of vision or;
Croatian: • trenutačni gubitak vida ili
English: • Open it by tearing it along the edge (do not use scissors)
Croatian: • Otvorite je tako da ju otrgnete uz rub (nemojte koristiti škare).
English: About 6-12 out of 10,000 women
Croatian: oko 6-12 na 10 000 žena
English: This corresponds to between about 6 and 12 VTEs in a year out of 10,000 women who use EVRA.
Croatian: To odgovara broju od približno 6 do 12 slučajeva VTE u godinu dana na 10 000 žena koje primjenjuju EVRU.
English: Adequate contraception should be initiated because of the teratogenicity of anti-coagulant therapy (coumarins).
Croatian: Treba započeti odgovarajuću metodu kontracepcije zbog teratogenog učinka antikoagulantne terapije (kumarini).
English: Based on these animal data, undesirable effects due to hormonal action of the active compounds cannot be excluded.
Croatian: Na temelju ovih podataka na životinjama, ne mogu se isključiti nuspojave zbog hormonskog djelovanja djelatnih komponenti.
English: Used transdermal patches should be discarded carefully in accordance with the instructions given in section 6.6.
Croatian: Upotrijebljene transdermalne flastere treba pažljivo odložiti prema uputi u dijelu 6.6.
English: • painless blurring of vision which can progress to loss of vision.
Croatian: • bezbolna zamućenost vida, koja može napredovati do gubitka vida.
English: EVRA is not indicated during pregnancy (see section 4.6).
Croatian: EVRA nije indicirana tijekom trudnoće (vidjeti dio 4.6).
English: • Increased appetite
Croatian: • pojačan apetit
English: Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Croatian: Kombinirani hormonski kontraceptivi (KOK-i) ne smiju se primjenjivati u sljedećim stanjima.
English: • severe pain in your stomach.
Croatian: • jaka bol u želucu.
English: • Always keep non-hormonal contraceptives (such as condoms, foam or sponge) as a back-up in case you make a mistake when using the patch.
Croatian: • Uvijek imajte nehormonska kontracepcijska sredstva (kao što su prezervativi, kontracepcijska pjena ili spužva) kao pomoćnu metodu u slučaju grešaka pri primjeni flastera.
English: EVRA can be restarted 2 weeks following completion of treatment with this combination drug regimen.
Croatian: EVRA se može ponovno početi primjenjivati 2 tjedna nakon završetka režima liječenja ovom kombinacijom.
English: EVRA is not indicated for post-menopausal women and is not intended for use as hormonal replacement therapy.
Croatian: EVRA nije indicirana u žena u postmenopauzi te nije namijenjena za hormonsko nadomjesno liječenje.
English: The risk of ovulation increases with each day beyond the recommended contraceptive-free period.
Croatian: Rizik nastanka ovulacije se povećava svakim prekoračenim danom nakon preporučenog razdoblja bez primjene kontraceptiva.
English: • sudden confusion, trouble speaking or understanding;
Croatian: • iznenadna smetenost, otežan govor ili razumijevanje;
English: Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of sex hormones and which may lead to breakthrough bleeding and/or contraceptive failure.
Croatian: Mogu se javiti interakcije s lijekovima koji induciraju mikrosomalne enzime koje mogu dovesti do povećanog klirensa spolnih hormona i koje mogu dovesti do probojnog krvarenja i/ili neuspjeha kontracepcije.
English: What you need to know before you use EVRA
Croatian: Što morate znati prije nego počnete primjenjivati EVRU
English: • Then peel away half of the clear protective covering (see picture).
Croatian: • Tada uklonite polovicu prozirne zaštitne folije (pogledajte sliku).
English: Overdose may cause nausea or vomiting.
Croatian: Predoziranje može uzrokovati mučninu i povraćanje.
English: • bosentan (a medicine for high blood pressure in the blood vessels in the lungs)
Croatian: • bosentan (lijek kojim se liječi visoki krvni tlak u krvnim žilama pluća)
English: After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
Croatian: Nakon prve godine, taj rizik postaje manji, ali uvijek ostaje nešto viši nego ako ne uzimate kombinirani hormonski kontraceptiv.
English: However, only a small fraction (10-20%) of the overall variability in the pharmacokinetics of the norelgestromin and EE following application of EVRA may be associated with any or all of the above demographic parameters.
Croatian: Međutim, samo mali udio (10-20%) ukupne varijabilnosti farmakokinetike norelgestromina i etinilestradiola nakon primjene EVRE može biti povezan s nekim ili sa svim gore navedenim demografskim parametrima.