FrancophonIA/ELRC3.0 huggingface dataset:
English: • Hepatic adenomas or carcinomas
Croatian: • Adenomi ili karcinomi jetre.
English: Cancer, systemic lupus erythematosus, haemolytic uraemic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell disease.
Croatian: Karcinom, sistemski lupus eritematodes, hemolitičkouremijski sindrom, kronična upalna bolest crijeva (Crohnova bolest ili ulcerozni kolitis) i anemija srpastih stanica.
English: The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a combination of both.
Croatian: Uočeni trend povećanja rizika razvoja karcinoma dojke, mogao bi biti povezan s ranije postavljenom dijagnozom raka u žena koje uzimaju KOK, s njihovim biološkim učinkom ili kombinacijom tih dvaju čimbenika.
English: You may start this medicine on Day 21 following the abortion or miscarriage, or on the first day of your next period, whichever comes first.
Croatian: Možete početi primjenjivati ovaj lijek 21. dan nakon spontanog ili induciranog pobačaja, ili prvi dan Vaše sljedeće menstruacije, ovisno o tome što nastupi prvo.
English: EVRA acts through the mechanism of gonadotropin suppression by the estrogenic and progestational actions of ethinyl estradiol and norelgestromin.
Croatian: EVRA djeluje kroz mehanizam supresije lučenja gonadotropina putem estrogenog i progestagenog djelovanja etinilestradiola i norelgestromina.
English: • if you have SLE (systemic lupus erythematosus; a disease affecting your natural defence system);
Croatian: • ako imate sistemski lupus eritematodes (SLE - bolest koja zahvaća prirodni obrambeni sustav
English: • Less interest in sex
Croatian: • smanjeno zanimanje za spolni odnos
English: For your next four week cycle.
Croatian: Počnite sljedeći četverotjedni ciklus.
English: At the end of your patch cycle (Week 4):
Croatian: Na kraju ciklusa nošenja flastera (4. tjedan):
English: • If you've had a baby and are not breast-feeding, you should not start using this medicine sooner than 4 weeks after delivery.
Croatian: • Ako ste rodili i ne dojite, smijete početi primjenjivati ovaj lijek nakon što prođe 4 tjedna od poroda.
English: For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Croatian: Za opis simptoma ovih ozbiljnih nuspojava, molimo pročitajte
English: Other medical conditions associated with adverse vascular events
Croatian: Druga zdravstvena stanja povezana sa štetnim krvožilnim događajima
English: In order to postpone a menstrual period for one cycle, the woman must apply another transdermal patch at the beginning of Week 4 (Day 22) thus not observing the transdermal patch-free interval.
Croatian: Ako se menstruacija želi odgoditi za jedan ciklus, žena mora primijeniti transdermalni flaster i na početku 4. tjedna (22. dan), što znači da neće biti tjedna bez primjene transdermalnog flastera.
English: If one or more days have elapsed since your miscarriage or abortion when you start this medicine, talk to your doctor about temporarily using a non-hormonal contraceptive.
Croatian: Ako je prošao jedan ili više dana od spontanog ili induciranog pobačaja, na početku primjene ovog lijeka, razgovarajte sa svojim liječnikom o privremenom korištenju nehormonske kontracepcije.
English: Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer.
Croatian: Kako je karcinom dojke rijedak u žena mlađih od 40 godina, broj postavljenih dijagnoza karcinoma dojke u žena koje trenutno uzimaju ili su do nedavno uzimale kombinirane oralne kontraceptive malen je u odnosu na ukupni rizik karcionoma dojke.
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 (KOK-a) povećava rizik od venske tromboembolije (VTE) u odnosu na rizik kad se ne primjenjuje.
English: • Vaginal yeast infection, sometimes called thrush
Croatian: • gljivična infekcija rodnice, koja se ponekad zove kandidijaza
English: Following removal of a transdermal patch, the mean elimination half-lives of norelgestromin and ethinyl estradiol were approximately 28 hours and 17 hours, respectively.
Croatian: Nakon skidanja transdermalnog flastera, srednje poluvrijeme eliminacije norelgestromina iznosi otprilike 28 sati, a etinilestradiola otprilike 17 sati.
English: A definitive relationship between hormonal contraceptive use and clinical hypertension has not been established.
Croatian: Povezanost primjene hormonskih kontraceptiva i kliničke hipertenzije, nije definitivno utvrđena.
English: • if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);
Croatian: • ako imate hemolitičko-uremijski sindrom (HUS - poremećaj zgrušavanja krvi koji uzrokuje zatajenje bubrega);
English: After 10 years, the risk is the same as for people who have never used the combined hormonal contraceptive.
Croatian: Nakon 10 godina taj je rizik izjednačen s rizikom njegova nastanka u žena koje nikada nisu uzimale kombinirane hormonske kontraceptive.
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains etonorgestrel or norelgestromin such as EVRA between about 6 and 12 women will develop a blood clot in a year.
Croatian: - Od 10 000 žena koje uzimaju kombiniranu hormonsku kontracepciju koja sadrži etonorgestrel ili norelgestromin, kao što je EVRA, između 6 i 12 žena razvit će krvni ugrušak u godinu dana.
English: • if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots');
Croatian: • ako trebate ići na operaciju ili već dugo mirujete (pogledajte u dijelu 2 „Krvni ugrušci“).
English: EVRA should not be placed on the breasts or on skin that is red, irritated or cut.
Croatian: EVRU ne treba stavljati na grudi te na crvenu, nadraženu ili porezanu kožu.
English: • History of migraine with focal neurological symptoms;
Croatian: • Migrena s žarišnim neurološkim simptomima u povijesti bolesti.
English: The other ingredients are: backing layer: low-density pigmented polyethylene outer layer, polyester inner layer; middle layer: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate; third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.
Croatian: Drugi sastojci su: potporni sloj: vanjski sloj od pigmentiranog polietilena niske gustoće, unutarnji poliesterski sloj; srednji sloj: adheziv od poliizobutilena/polibutena, krospovidon, netkana poliesterska vlakna, laurillaktat; treći sloj: polietilentereftalatni (PET) film, polidimetilsiloksanska ovojnica.
English: Supplemental adhesives or bandages should not be used to hold the EVRA transdermal patch in place.
Croatian: Ne smije se koristiti dodatna ljepljiva sredstva ili zavoje kako bi se EVRA transdermalni flaster zadržao na mjestu.
English: After 6 consecutive weeks of transdermal patch wear, there should be a transdermal patch-free interval of 7 days.
Croatian: Nakon 6 uzastopnih tjedana primjene transdermalnog flastera, treba uslijediti razdoblje od 7 dana bez primjene transdermalnog flastera.
English: • Talk to your doctor, pharmacist or nurse.
Croatian: • Razgovarajte o tome sa svojim liječnikom, ljekarnikom ili medicinskom sestrom.
English: Steady state concentrations of norelgestromin and EE during one week of transdermal patch wear are approximately 0.8 ng/ml and 50 pg/ml, respectively.
Croatian: Koncentracije norelgestromina odnosno etinilestradiola u stanju dinamičke ravnoteže u tjedan dana nošenja transdermalnog flastera su otprilike 0,8 ng/ml odnosno 50 pg/ml.
English: EVRA is contraindicated in women with hepatic impairment (see section 4.3).
Croatian: EVRA je kontraindicirana u žena s oštećenjem jetre (vidjeti dio 4.3).
English: Do not use this medicine after the expiry date, which is stated on the label after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake “Rok valjanosti”.
English: EVRA is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3).
Croatian: EVRA je kontraindicirana ako žena ima jedan ozbiljan ili više čimbenika rizika za ATE zbog kojih je izložena većem riziku od arterijske tromboze (vidjeti dio 4.3).
English: • Undiagnosed abnormal genital bleeding
Croatian: • Abnormalno genitalno krvarenje bez potvrđene dijagnoze
English: • On the first “Patch Change Day”, Day 8, take off the used patch • Put on a new patch immediately.
Croatian: • Prvog “dana izmjene flastera”, tj. 8. dana, uklonite upotrijebljeni flaster.
English: The decision to prescribe EVRA should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with EVRA compares with other CHCs (see sections 4.3 and 4.4).
Croatian: Kod donošenja odluke o propisivanju EVRE treba uzeti u obzir čimbenike rizika prisutne u pojedine žene, osobito one za vensku tromboemboliju (VTE), te visinu rizika od VTE kod uzimanja EVRE u usporedbi s drugim kombiniranim hormonskim kontraceptivima (vidjeti dijelove 4.3 i 4.4).
English: • sensation of squeezing or fullness in the chest, arm or below the breastbone;
Croatian: • osjećaj stezanja ili punoće u prsištu, ruci ili iza prsne kosti;
English: • You may only use one patch at a time.
Croatian: • Istodobno koristite samo jedan flaster.
English: • in veins (referred to as a ‘venous thrombosis', ‘venous thromboembolism' or VTE)
Croatian: • u venama (što se naziva „venska tromboza“, „venska tromboembolija“ ili VTE)
English: • If the patch is put on after the first day of your period, use a non-hormonal contraceptive until Day 8, when you change your patch
Croatian: • Ako flaster stavite nakon prvog dana menstruacije, koristite nehormonsku kontracepciju do 8. dana, kada mijenjate flaster
English: All EVRA Subjects
Croatian: EVRA - Sve ispitanice
English: • swelling of one leg or along a vein in the leg or foot especially when accompanied by: - pain or tenderness in the leg which may be felt only when standing or walking; - increased warmth in the affected leg; - change in colour of the skin on the leg e.g. turning pale, red or blue.
Croatian: • oticanje jedne noge ili oticanje duž vene na nozi ili stopalu osobito ako je praćeno: - bolom ili osjetljivošću u nozi, koji se mogu osjećati samo pri stajanju ili hodanju; - povećana toplina zahvaćene noge; - promjena boje kože na nozi, npr. ako poblijedi, pocrveni ili poplavi.
English: Study Group
Croatian: Ispitivana skupina
English: • Breast problems such as pain, enlargement or lumps in the breast
Croatian: • problemi s dojkama poput bolnosti, povećanje dojki ili kvržice na dojkama
English: If your patch becomes loose, lifts at the edges or falls off
Croatian: Ako flaster prestane čvrsto prianjati uz kožu, odigne se na rubovima ili otpadne
English: Substances increasing the clearance of CHCs (diminished efficacy of CHCs by enzyme-induction),e.g.: Barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, modafinil and HIV medication ritonavir, nevirapine and efavirenz and possibly also felbamate, griseofulvin, oxcarbazepine, topiramate and products containing the herbal remedy St. John's Wort (hypericum perforatum).
Croatian: Tvari koje povećavaju klirens kombiniranih hormonskih kontraceptiva (smanjena djelotvornost kombiniranih hormonskih kontraceptiva putem indukcije enzima), npr: Barbiturati, bosentan, karbamazepin, fenitoin, primidon, rifampicin, modafinil i lijekovi za liječenje HIV-a ritonavir, nevirapin i efavirenz te također moguće felbamat, grizeofulvin, okskarbazepin, topiramat i lijekovi koji sadrže biljni pripravak gospinu travu (Hypericum perforatum).
English: • You have gallbladder disease including gallstones or inflammation of the gallbladder;
Croatian: • imate bolest žučnog mjehura uključujući žučne kamence ili upalu žučnog mjehura;
English: If the condition develops, or gets worse while you are using EVRA, you must tell your doctor.
Croatian: Ako dobijete neko od navedenih stanja ili se ono pogorša dok primjenjujete EVRU, o tome također morate obavijestiti svog liječnika.
English: • Do not cut or tamper with the patch in any way.
Croatian: • Ni u kojem slučaju nemojte rezati flaster ili postupati s flasterom na neodgovarajući način.
English: Transdermal patch changes may occur at any time on the scheduled Change Day.
Croatian: Transdermalni flaster može se zamijeniti u bilo koje doba tijekom dana izmjene.
English: If breakthrough bleeding persists, or breakthrough bleeding occurs after previously regular cycles, while EVRA has been used according to the recommended regimen, a cause other than EVRA should be considered.
Croatian: Ako probojna krvarenja uporno traju ili se javljaju nakon prethodno normalnih ciklusa, u kojima je EVRA primjenjivana prema preporučenom režimu, uz EVRU treba misliti i o drugim uzrocima nepravilnog krvarenja.
English: If any of the above conditions change while you are using EVRA, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
Croatian: Ako Vam se neko od gore navedenih stanja promijeni za vrijeme uzimanja EVRE, na primjer, netko od članova uže obitelji razvije trombozu iz nepoznatog razloga ili se jako udebljate, obavijestite svog liječnika.
English: • Put on your first patch during the first 24 hours of your period.
Croatian: • Stavite prvi flaster tijekom prvih 24 sata nakon početka menstruacije.
English: • Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency;
Croatian: • Poznata nasljedna ili stečena sklonost venskoj tromboemboliji, kao što je rezistencija na aktivirani protein C, (uključujući faktor V Leiden), nedostatak antitrombina III, nedostatak proteina C, nedostatak proteina S.
English: Female contraception
Croatian: Kontracepcija u žena.
English: After 7 days of not wearing a patch, apply a new patch and restart the cycle using this as Day 1.
Croatian: Nakon što protekne 7 dana za vrijeme kojih ne nosite flaster, primijenite novi flaster i neka Vam taj dan bude 1. dan.
English: A sachet is composed of four layers: a low-density polyethylene film (innermost layer), an aluminium foil, a low-density polyethylene film, and an outer layer of bleached paper.
Croatian: Vrećica se sastoji od četiri sloja: film od polietilena niske gustoće (prvi unutarnji sloj), aluminijska folija, film od polietilena niske gustoće i vanjski sloj od izbijeljenog papira.
English: • if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section “Other medicines and EVRA”).
Croatian: • ako imate hepatitis C i uzimate lijekove koji sadrže ombitasvir/paritaprevir/ritonavir i dasabuvir (pogledajte također dio
English: Symptoms of pulmonary embolism (PE) can include: - sudden onset of unexplained shortness of breath or rapid breathing; - sudden coughing which may associated with haemoptysis; - sharp chest pain; - severe light headedness or dizziness; - rapid or irregular heartbeat.
Croatian: Simptomi plućne embolije (PE) mogu uključivati: - iznenadni nastup neobjašnjivog nedostatka zraka ili ubrzanog disanja; - iznenadni kašalj koji može biti povezan s hemoptizom; - oštra bol u prsištu; - jaka ošamućenost ili omaglica; - ubrzani ili nepravilni otkucaji srca.
English: • Cerebrovascular disease - current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA);
Croatian: • Cerebrovaskularna bolest - sadašnji moždani udar, moždani udar u povijesti bolesti ili prodromalno stanje (npr. tranzitorna ishemijska ataka, TIA).
English: After miscarriage or abortion before 20 weeks of pregnancy
Croatian: Nakon spontanog ili induciranog pobačaja prije 20. tjedna trudnoće
English: Norelgestromin-containing CHC (6-12 events)
Croatian: Kombinirani hormonski kontraceptivi koji sadrže norelgestromin (6-12 događaja)
English: Pregnancy and breast-feeding).
Croatian: „Trudnoća i dojenje“).
English: In some women withdrawal bleeding may not occur during this transdermal patch free period.
Croatian: U nekih žena prijelomno krvarenje ne mora nastupiti u dijelu ciklusa u kojem se transdermalni flaster ne primjenjuje.
English: EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch
Croatian: EVRA 203 mikrograma/24 sata + 33,9 mikrograma/24 sata transdermalni flaster
English: What EVRA contains The active substances are norelgestromin and ethinyl estradiol.
Croatian: Što EVRA sadrži Djelatne tvari su norelgestromin i etinilestradiol.
English: Do not flush used or unused patches down the toilet.
Croatian: Upotrijebljene ili neupotrijebljene flastere ne bacati u zahodsku školjku.
English: The used transdermal patch should be placed within the open disposal label so that the sticky surface covers the shaded area on the sachet.
Croatian: Iskorišteni transdermalni flaster treba staviti unutar otvorene naljepnice za odlaganje, tako da ljepljiva strana pokrije obojenu površinu na vrećici.
English: With the use of higher dosed COCs (50 microgram ethinyl estradiol) the risk of endometrial and ovarian cancer is reduced.
Croatian: U primjeni visokodoznih kombiniranih oralnih kontraceptiva (50 g etinilestradiola) rizik je razvoja od karcinoma endometrija i jajnika smanjen.
English: • Then take off the other half of the covering
Croatian: • Zatim uklonite drugu polovicu prozirne zaštitne folije.
English: • Place the used patch within the open disposal label so that the sticky surface covers the shaded area.
Croatian: • Stavite iskorišteni flaster unutar otvorene naljepnice za odlaganje, tako da ljepljiva strana pokrije obojenu površinu.
English: The user should apply the first transdermal patch of the new cycle as soon as remembered.
Croatian: Prvi transdermalni flaster novog ciklusa žena treba primijeniti čim se sjeti.
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year.
Croatian: - Od 10 000 žena koje uzimaju kombinirani hormonski kontraceptiv koji sadrži levonorgestrel, noretisteron ili norgestimat, njih oko 5-7 razvit će krvni ugrušak u godinu dana.
English: To dispose of used patch: place used patch so that the sticky side covers the shaded area remove backing paper close adhesive label and seal discard with solid waste
Croatian: Kod odlaganja iskorištenog flastera: stavite flaster tako da ljepljiva strana pokrije obojenu površinu s prednje naljepnice odlijepite stražnju bijelu zaštitnu foliju zatvorite ljepljivu naljepnicu i zalijepite odložite na mjesto predviđeno za kruti otpad
English: • Arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris);
Croatian: • Arterijska tromboembolija - postojeća arterijska tromboembolija, arterijska tromboembolija u povijesti bolesti (npr. infarkt miokarda) ili prodromalno stanje (npr. angina pektoris).
English: • To work properly the patch must stick firmly to your skin.
Croatian: • Flaster se mora dobro prilijepiti na Vašu kožu, kako bi ispravno djelovao.
English: • You must use non-hormonal contraception as back up for the first week of your new cycle.
Croatian: • Morate koristiti nehormonsku kontracepciju kao dodatnu metodu za vrijeme prvog tjedna novog ciklusa.
English: Positive family history (arterial thromboembolism ever in a sibling or parent at relatively early age e.g. below 50)
Croatian: Pozitivna obiteljska anamneza (arterijska tromboemboija u braće, sestara ili roditelja osobito u relativno ranoj dobi, npr., prije 50. godine života).
English: If you have absent or irregular bleeding with EVRA This medicine may cause unexpected vaginal bleeding or spotting during the weeks when you are wearing the patch.
Croatian: Ovaj lijek može prouzročiti neočekivano vaginalno krvarenje ili točkasto krvarenje u tjednima kada nosite flaster.
English: • Acne, skin rash, skin itching or skin irritation
Croatian: • akne, kožni osip, svrbež kože ili nadraženost kože
English: The woman may switch any day from the progestogen-only pill (from an implant on the day of its removal, from an injectable when the next injection would be due), but a back-up barrier method of birth control must be used during the first 7 days.
Croatian: Ako je u prethodnom ciklusu korištena metoda u kojoj se primjenjuje samo progesteron Žena može početi primjenjivati flaster bilo koji dan uzimanja tablete koja sadrži samo progesteron (ako je riječ o implantatu - na dan njegovog odstranjenja, a ako je riječ o injekciji - u vrijeme kad bi se trebala primijeniti sljedeća injekcija), ali prvih 7 dana moraju se koristiti dodatne mehaničke metode kontracepcije.
English: • Close the label sealing the used patch within and discard, keeping out of reach of children.
Croatian: • Zalijepite naljepnicu kako biste zatvorili iskorišteni flaster u vrećicu i odložite ju izvan dohvata djece.
English: • Migraine
Croatian: • migrena
English: • St. John's wort (an herbal therapy used for depression)
Croatian: • gospinu travu (biljni preparat koji se koristi kod depresije).
English: • Changes in menstrual bleeding pattern, uterine cramps, painful periods, vaginal discharge
Croatian: • promjene uzorka menstrualnog krvarenja, grčevi maternice, bolne menstruacije, iscjedak iz rodnice
English: Get New Patch
Croatian: Stavite novi flaster
English: The disposal label should then be closed sealing the used transdermal patch within.
Croatian: Naljepnicu za odlaganje zatim treba čvrsto zalijepiti i tako zatvoriti iskorišteni transdermalni flaster.
English: • Vomiting or diarrhoea
Croatian: • povraćanje ili proljev
English: Users who choose not to breast-feed should start contraceptive therapy with EVRA no sooner than 4 weeks after child-birth.
Croatian: Žene koje odluče da neće dojiti ne trebaju započinjati kontracepciju EVROM u prva 4 tjedna od poroda.
English: Substances with variable effects on the clearance of CHCs When co-administered with CHCs, many combinations of HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors, including combinations with HCV inhibitors can increase or decrease plasma concentrations of estrogen or progestins.
Croatian: Tvari s promjenjivim učincima na klirens kombiniranih hormonskih kontraceptiva Mnoge kombinacije inhibitora HIV proteaze i nenukleozidnih inhibitora reverzne transkriptaze, uključujući kombinacije s inhibitorima HCV-a, mogu povećati ili smanjiti koncentracije estrogena ili progestina u plazmi kada se istodobno primjenjuju s kombiniranim hormonskim kontraceptivima.
English: EVRA has not been studied in women with hepatic impairment.
Croatian: EVRA nije bila ispitana u žena s oštećenjem jetre.
English: • Yellowing of the skin and whites of the eyes
Croatian: • žuta boja kože i bjeloočnica
English: Application site reactions* (e.g., abscess, erosion) Localised oedema*
Croatian: rijetko edem lica* tjestasti edem* oticanje reakcije na mjestu primjene* (npr. apsces, erozija) lokalizirani edem*
English: • Presence or risk of arterial thromboembolism (ATE)
Croatian: • Prisutnost rizika od arterijske tromboembolije (ATE)
English: in a leg or foot (i.e. DVT)
Croatian: • u nozi ili stopalu (tj. duboka venska tromboza)
English: • Scaly, flaky, itchy and red skin
Croatian: • ljuskice, perutanje, svrbež i crvenilo kože
English: See enclosed leaflet for disposal instructions.
Croatian: Za upute o zbrinjavanju vidjeti priloženu uputu o lijeku.
English: When starting later, the woman should be advised to additionally use a barrier method for the first 7 days.
Croatian: Nakon tog razdoblja ženi treba savjetovati da se u prvih 7 dana primjene EVRE koristi dodatnim mehaničkim metodama kontracepcije.