FrancophonIA/ELRC3.0 huggingface dataset:
English: - Although combined hormonal contraceptives may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetes during use of combined hormonal contraceptives.
Croatian: - Premda kombinirani hormonski kontraceptivi mogu utjecati na razvoj periferne inzulinske rezistencije te na toleranciju glukoze, nema dokaza u prilog potrebe za promjenom načina liječenja dijabetesa uz primjenu kombiniranih hormonskih kontraceptiva.
English: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, e.g. corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
Croatian: Kontracepcijski steroidi mogu utjecati na rezultate nekih laboratorijskih pretraga, uključujući biokemijske parametre jetrene, tiroidne, adrenalne i bubrežne funkcije, razinu proteina (nosača) u plazmi, npr. globulina koji veže kortikosteroide i lipidno / lipoproteinsku frakciju, pokazatelje metabolizma ugljikohidrata te vrijednosti koagulacije i fibrinolize.
English: Table 1 below reflects the adverse reactions reported in clinical trials and from post-marketing experience.
Croatian: U tablici 1 dolje prikazane su nuspojave zabilježene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet.
English: If one of these disorders occurs during the use of EVRA, EVRA must be discontinued immediately.
Croatian: Ako za vrijeme primjene EVRE nastupi jedan od navednih poremećaja, primjena EVRE mora se odmah prekinuti.
English: Diabetes mellitus, hyperhomocysteinaemia, valvular heart disease and atrial fibrillation, dyslipoproteinaemia, systemic lupus erythematosus.
Croatian: Šećerna bolest, hiperhomocisteinemija, valvularna bolest srca i atrijska fibrilacija, dislipoproteinemija i sistemski lupus eritematodes.
English: The day the first transdermal patch is applied (Day 1/Start Day) determines the subsequent Change Days.
Croatian: Prema prvom danu primjene prvog transdermalnog flastera (1. dan / dan početka) određuju se sljedeći dani izmjene flastera.
English: • Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see sections 4.4 and 4.5).
Croatian: • Istodobna primjena s lijekovima koji sadrže ombitasvir/paritaprevir/ritonavir i dasabuvir (vidjeti dijelove 4.4 i 4.5).
English: Following application of EVRA, norelgestromin and ethinyl estradiol levels in serum reach a plateau by approximately 48 hours.
Croatian: Nakon primjene EVRE serumske vrijednosti norelgestromina i etinilestradiola postižu svoj plato za približno 48 sati.
English: Therefore, the used transdermal patch should be discarded carefully.
Croatian: Zbog toga se upotrijebljeni transdermalni flaster mora odmah pažljivo odložiti.
English: Results from an EVRA study of extended wear of single contraceptive transdermal patch for 7 days and 10 days indicated that target Css of norelgestromin and ethinyl estradiol were maintained during a 3-day period of extended wear of EVRA (10 days).
Croatian: Rezultati ispitivanja duljeg nošenja jednog kontracepcijskog EVRA transdermalnog flastera tijekom 7 i 10 dana pokazali su da su se ciljne vrijednosti Css norelgestromina i etinilestradiola održale tijekom razdoblja produljenog nošenja EVRE (10 dana).
English: • Do not use this medicine if you are pregnant or think you may be pregnant.
Croatian: • Nemojte primjenjivati ovaj lijek ako ste trudni ili sumnjate na trudnoću.
English: Hepatic metabolism of norelgestromin occurs and metabolites include norgestrel, which is largely bound to SHBG, and various hydroxylated and conjugated metabolites.
Croatian: Norelgestromin se metabolizira u jetri, a metaboliti uključuju norgestrel koji je najviše vezan na SHBG te razne hidroksilirane i konjugirane metabolite.
English: - Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
Croatian: Od 10 000 žena koje ne uzimaju nikakav kombinirani hormonski kontraceptiv i nisu trudne, oko 2 će razviti krvni ugrušak u godinu dana.
English: (Week 2)
Croatian: (2. tjedan)
English: Effects of other medicinal products on EVRA
Croatian: Učinci drugih lijekova na EVRU
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 KOK-a s povećanim rizikom od arterijske tromboembolije (infarkt miokarda) ili cerebrovaskularnog incidenta (npr. tranzitorna ishemijska ataka, moždani udar).
English: • Do not use creams, oils, lotions, powder or makeup on the skin where you are placing a patch or near a patch you are wearing.
Croatian: • Nemojte stavljati kreme, ulja, losione, puder ili šminku na dio kože na koji stavljate flaster ili blizinu mjesta na kojem nosite flaster, jer se flaster može zbog toga odlijepiti.
English: • if you have ever been told you might have breast cancer or cancer of the womb, cervix or vagina;
Croatian: • ako su Vam ikad prije rekli da postoji sumnja na rak dojke, maternice, grlića maternice ili rodnice;
English: The absorption of norelgestromin and ethinyl estradiol following application of EVRA was studied under conditions encountered in a health club (sauna, whirlpool, treadmill and other aerobic exercise) and in a cold water bath.
Croatian: Apsorpcija norelgestromina i etinilestradiola nakon primjene EVRE ispitivana je u uvjetima koji se očekuju na mjestima za promicanje zdravlja (sauna, hidromasažna kada ili bazen, traka za trčanje i druge aerobne vježbe) te u kupkama s hladnom vodom.
English: The outside of the backing layer is beige and heat-stamped “EVRA”.
Croatian: Vanjska strana potpornog sloja je bež boje i ima toplinom otisnut naziv „EVRA“.
English: Data for combination of norgestimate (precursor of norelgestromin) with ethinyl estradiol indicate for female animals a decrease in fertility and implantation efficiency (rat), an increase in foetal resorption (rat, rabbit) and, with high dosages, a decrease in viability and fertility of female offspring (rat).
Croatian: Podaci za kombinaciju norgestimata (prekursor norelgestromina) i etinilestradiola pokazuju smanjenje plodnosti i učinkovitosti implantacije u ženki životinja (štakor), povećanje resorpcije fetusa (štakor, kunić) i, uz visoke doze, smanjenu sposobnost preživljavanja i smanjenu plodnost ženske mladunčadi (štakor).
English: In women on long-term treatment with enzyme-inducing active substances, another reliable, non-hormonal, method of contraception is recommended.
Croatian: Žene koje se dugotrajno liječe djelatnim tvarima koje induciraju enzime preporučuje se druga pouzdana nehormonska metoda kontracepcije.
English: • Breast tenderness.
Croatian: • napetost dojki.
English: • If you cannot get a patch back on, put on a new patch immediately.
Croatian: • Ako se flaster ne može ponovno zalijepiti, odmah stavite novi.
English: If, during the use of combined hormonal contraceptives in pre-existing hypertension, constantly elevated blood pressure values or a significant increase in blood pressure do not respond adequately to antihypertensive treatment, the combined hormonal contraceptive must be withdrawn.
Croatian: Ako se kod primjene kombiniranih hormonskih kontraceptiva tijekom već postojeće hipertenzije javljaju kontinuirano povišene vrijednosti krvnog tlaka ili značajno povišen krvni tlak, koji ne reagiraju na antihipertenzivnu terapiju, uzimanje kombiniranih hormonskih kontraceptiva se mora prekinuti.
English: Ethinyl estradiol is extensively bound to serum albumin.
Croatian: Etinilestradiol se opsežno veže za serumski albumin.
English: • Abnormal blood sugar or insulin levels
Croatian: • abnormalna razina šećera ili inzulina u krvi
English: • You have a problem of the nervous system involving sudden movements of the body called
Croatian: • imate poremećaj živčanog sustava koja izaziva iznenadne pokrete tijela nazvan Sydenhamova koreja;
English: • You must put on a new patch as soon as you remember.
Croatian: • Morate staviti novi flaster čim se sjetite.
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 clot [thrombosis] section below).
Croatian: • ako primijetite moguće znakove krvnog ugruška koji mogu značiti da imate krvni ugrušak u nozi (tj. duboku vensku trombozu), krvni ugrušak u plućima (tj. plućnu emboliju), srčani ili moždani udar (pogledajte dio „Krvni ugrušak“ [tromboza] niže).
English: • if you have a disease that may increase your risk of a clot in the arteries: severe diabetes with blood vessel damage very high blood pressure a very high level of fat in the blood (cholesterol or triglycerides) a condition known as hyperhomocysteinaemia
Croatian: • ako imate neku od sljedećih bolesti koja može povećati rizik od stvaranja ugruška u arterijama: teška šećerna bolest s oštećenjem krvnih žila vrlo visok krvni tlak vrlo visoke vrijednosti masnoća u krvi (kolesterola ili triglicerida) stanje koje se zove hiperhomocisteinemija
English: An increased risk of cervical cancer in long-term users of COCs has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
Croatian: U nekim epidemiološkim ispitivanjima zabilježen je povećan rizik razvoja karcinoma grlića maternice uz dugotrajnu primjenu kombiniranih oralnih kontraceptiva, no mišljenja se još uvijek razlikuju o tome u kolikoj se mjeri taj nalaz može pripisati spolnom ponašanju i drugim čimbenicima, kao što je humani papiloma virus (HPV).
English: For breast-feeding women, see section 4.6.
Croatian: Za žene koje doje vidjeti dio 4.6.
English: • Known or suspected carcinoma of the breast
Croatian: • Potvrđen ili sumnja na karcinom dojke.
English: • Bleeding from the vagina.
Croatian: • krvarenje iz rodnice.
English: Women should be advised not to smoke if they wish to use a CHC.
Croatian: Ženama treba savjetovati da ne puše ako žele koristiti kombiniranu hormonsku kontracepciju.
English: At the start of any patch cycle (Week 1 (Day 1)):
Croatian: Na početku svakog ciklusa nošenja flastera (1. tjedan (1. dan)):
English: • Press the patch down firmly until the edges stick well.
Croatian: • Flaster pritisnite čvrsto dok se rubovi dobro ne nalijepe.
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use.
Croatian: Ako se sumnja na nasljednu sklonost, ženu treba uputiti po savjet specijalista prije nego što se donese odluka o primjeni bilo kojeg KOK-a.
English: The pharmacokinetic profiles of transdermal and oral combined hormonal contraceptives are different and caution should be exercised when making a direct comparison of these PK parameters.
Croatian: Transdermalni i oralni kombinirani hormonski kontraceptivi imaju različite farmakokinetičke profile (PK), stoga je potreban oprez pri izravnoj usporedbi njihovih farmakokinetičkih parametara.
English: Blood glucose decreased*† Blood glucose abnormal*†
Croatian: rijetko snižena glukoza u krvi*† abnormalan nalaz glukoze u krvi*†
English: - Although small increases of blood pressure have been reported in many women using hormonal contraceptives, clinically relevant increases are rare.
Croatian: - Premda je u mnogih žena koje koriste hormonske kontraceptive zabilježeno blago povišenje krvnog tlaka, klinički značajno povećanje je rijetko.
English: Table 1: Frequency of adverse reactions System Organ Class
Croatian: Tablica 1: Učestalost nuspojava Klasifikacija organskih sustava Učestalost
English: • You have diabetes;
Croatian: • imate šećernu bolest;
English: EVRA is available in the following pack sizes: Cartons containing 3, 9 or 18 patches in individual foil-lined sachets, wrapped per three in a transparent perforated plastic film.
Croatian: EVRA je dostupna u sljedećim veličinama pakiranja: kutije s 3, 9 ili 18 flastera u pojedinačnim vrećicama obloženima folijom.
English: • Put on the first patch of your new cycle as soon as you remember.
Croatian: • Stavite prvi flaster kojim započinjete novi ciklus čim se sjetite.
English: • Make sure that the edges stick well.
Croatian: • Provjerite jesu li rubovi dobro zalijepljeni.
English: The patch should be applied immediately upon removal from the protective sachet.
Croatian: Flaster treba primijeniti odmah nakon vađenja iz zaštitne vrećice.
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 obamrlost ili slabost lica, ruke ili noge, osobito na jednoj strani tijela; - iznenadne poteškoće s hodanjem, omaglica, gubitak ravnoteže ili koordinacije; - iznenadnu smetenost, otežan govor ili razumijevanje; - iznenadne poteškoće s vidom na jedno ili oba oka; - iznenadna, jaka ili dugotrajna glavobolja bez poznatog uzroka; - gubitak svijesti ili nesvjestica sa ili bez napadaja.
English: • chest pain, discomfort, pressure, heaviness;
Croatian: • bol u prsištu, nelagoda, pritisak, težina;
English: Note: The prescribing information of concomitant medicinal products should be consulted to identify potential interactions.
Croatian: Napomena: Potrebno je provjeriti upute za propisivanje lijekova koji se istovremeno primjenjuju, kako bi se procijenile moguće interakcije.
English: The transdermal patch should be pressed down firmly until the edges stick well.
Croatian: Transdermalni flaster treba čvrsto pritisnuti sve dok se rubovi dobro ne nalijepe na mjesto primjene.
English: If any of the above conditions change while you are using EVRA, for example you start smoking, 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, počnete pušiti, član uže obitelji razvije trombozu iz nepoznatog razloga ili se jako udebljate, obavijestite svog liječnika.
English: Recurrence of cholestatic-related pruritus, which occurred during a previous pregnancy or previous use of sex steroids necessitates the discontinuation of combined hormonal contraceptives.
Croatian: Ponovno javljanje kolestatskog svrbeža koji je bio prisutan u prethodnoj trudnoći ili prethodnog uzimanja spolnih steroidnih hormona, isto dovodi do prijeko potrebnog prekida primjene kombiniranih hormonskih kontraceptiva.
English: Women using EVRA
Croatian: Žene koje uzimaju EVRU
English: Combined hormonal contraceptive use may be resumed if normotensive values can be achieved with antihypertensive therapy.
Croatian: Kombinirani hormonski kontraceptivi se mogu ponovno primijeniti ako se uz primjenu antihipertenzivne terapije mogu postići normalne vrijednosti krvnog tlaka.
English: The results indicated that for norelgestromin there were no significant treatment effects on Css or AUC when compared to normal wear.
Croatian: Rezultati za norelgestromin pokazali su da nije bilo značajnog učinka tretmana na koncetraciju u stanju dinamičke ravnoteže (Css) ili na AUC u usporedbi s nošenjem flastera u normalnim uvjetima.
English: • if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
Croatian: • ako imate upalu potkožnih vena (superficialni tromboflebitis);
English: Inhibition of ethinyl estradiol metabolism
Croatian: Inhibicija metabolizma etinilestradiola
English: EVRA should be applied to clean, dry, hairless, intact healthy skin on the buttock, abdomen, upper outer arm or upper torso, in a place where it will not be rubbed by tight clothing.
Croatian: EVRU treba primjenjivati na čistu, suhu, zdravu, neoštećenu kožu bez dlačica u području stražnjice, trbuha, vanjskog dijela nadlaktice te gornjeg dijela torza, na mjestu gdje se flaster neće trljati o usku odjeću.
English: • High blood pressure or rise in blood pressure
Croatian: • visoki krvni tlak ili porast vrijednosti krvnog tlaka
English: • Problems where the patch has been on the skin such as skin rash with blisters or ulcers
Croatian: • problemi na mjestu gdje je flaster bio na koži, poput kožnog osipa s mjehurućima ili čirevima
English: In a study comparing EVRA to an oral contraceptive containing norgestimate (parent drug of norelgestromin) 250 mcg/ethinyl estradiol 35 mcg, Cmax values were 2-fold higher for NGMN and EE in subjects administered the oral contraceptive compared to EVRA, while overall exposure (AUC and Css) was comparable in subjects treated with EVRA.
Croatian: U ispitivanju u kojem je EVRA uspoređivana s oralnim kontraceptivom koji je sadržavao norgestimat (prekursor norelgestromina) 250 g/etinilestradiol 35 g, vrijednosti Cmax vrijednosti norelgestromina i etinilestradiola bile su dvostruko više u ispitanica koje su uzimale oralni kontraceptiv u usporedbi s EVROM, dok je ukupna izloženost (AUC i Css) bila usporediva s onom u ispitanica na terapiji EVROM.
English: - The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive: Jaundice and/or pruritus related to cholestasis; gallbladder disease including cholecystitis and cholelithiasis; porphyria; systemic lupus erythematosus; haemolytic ureamic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss.
Croatian: - Navedena stanja ili njihova pogoršanja bila su prijavljena u trudnoći i uz primjenu KOK-a, ali nije moguće izvući uvjerljive dokaze o njihovoj povezanosti s primjenom KOK-a: žutica i/ili svrbež povezani s kolestazom; bolest žučnog mjehura uključujući kolecistitis i kolelitijazu; porfirija; sistemski eritemski lupus; hemolitičko-uremički sindrom; Sydenhamova koreja; gestacijski herpes; gubitak sluha povezan s otosklerozom.
English: Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries.
Croatian: U korisnica KOK-a iznimno je rijetko bio zabilježen nastanak tromboze u drugim krvnim žilama, npr. jetrenim, mezenteričnim, bubrežnim ili retinalnim venama i arterijama.
English: • Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant);
Croatian: • Poznata nasljedna ili stečena sklonost arterijskoj tromboemboliji, kao što je hiperhomocisteinemija i antifosfolipidna protutijela (antikardiolipinska protutijela, lupus antikoagulant).
English: During clinical trials with patients treated for hepatitis C virus infections (HCV) with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin, transaminase (ALT) elevations higher than 5 times the upper limit of normal (ULN) occurred significantly more frequent in women using ethinyl estradiol-containing medications such as combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.5).
Croatian: Tijekom kliničkih ispitivanja s bolesnicima liječenim lijekovima koji sadrže ombitasvir/paritaprevir/ritonavir i dasabuvir s ili bez ribavirina radi infekcije virusom hepatitisa C (HCV), u žena koje su uzimale lijekove koje sadrže etinilestradiol, poput kombiniranih hormonskih kontraceptiva (KHK), značajno češće su se pojavili porasti transaminaze (ALT) viši od 5 puta gornje granice normale (GGN) (vidjeti dijelove 4.3 i 4.5).
English: The next cycle should begin on the usual “Change Day”, which is the day after Day 28.
Croatian: Sljedeći ciklus treba početi na predviđeni „dan izmjene“, a to je prvi dan nakon 28. dana.
English: Using a combined hormonal contraceptive such as EVRA increases your risk of developing a blood clot compared with not using one.
Croatian: Primjena kombiniranog hormonskog kontraceptiva kao što je EVRA povećava rizik od razvoja krvnog ugruška u odnosu na to kad se ne uzima.
English: Women who are not using a combined hormonal pill/patch/ring and are not pregnant
Croatian: Žene koje ne uzimaju kombinirane hormonske tablete/flaster/prsten i nisu trudne oko 2 na 10 000 žena
English: To help stop irritation, do not put the new patch on exactly the same area of your skin as your last patch.
Croatian: Kako biste izbjegli mogućnost nadraženosti kože, nemojte primjenjivati novi flaster na potpuno isto mjesto na koži s kojeg ste skinuli prethodni flaster.
English: However, if EVRA has not been taken according to these directions prior to the first missed withdrawal bleed or if two withdrawal bleeds are missed, pregnancy must be ruled out before EVRA use is continued.
Croatian: Međutim, ako EVRA nije korištena sukladno uputama, prije prvog izostalog prijelomnog krvarenja, odnosno ako je ono izostalo dvaput, prije daljnje primjene EVRE mora se isključiti trudnoća.
English: Data on reproductive toxicity of the combination of norelgestromin with ethinyl estradiol are not available.
Croatian: Nisu dostupni podaci o reproduktivnoj toksičnosti kombinacije norelgestromina i etinilestradiola.
English: If the user wishes to move the Change Day the current cycle should be completed, removing the third EVRA transdermal patch on the correct day.
Croatian: Ako žena želi pomaknuti „dan izmjene“, trenutni ciklus treba završiti te treći EVRA transdermalni flaster skinuti na predviđeni dan.
English: After an abortion or miscarriage that occurs before 20 weeks gestation, EVRA may be started immediately.
Croatian: Nakon prekida trudnoće induciranim ili spontanim pobačajem prije 20. gestacijskog tjedna, EVRA se odmah može početi primjenjivati.
English: • Swelling in the arms, hands, legs or feet.
Croatian: • oticanje ruku, dlanova, nogu ili stopala.
English: • There is a clear protective covering on the patch
Croatian: • Na flasteru se nalazi prozirna zaštitna folija.
English: Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Croatian: Istodobna primjena s lijekovima koje sadrže ombitasvir/paritaprevir/ritonavir i dasabuvir, s ili bez ribavirina može povećati rizik od porasta ALT-a (vidjeti dijelove 4.3 i 4.4).
English: If concomitant medicinal product administration extends beyond the end of the three-week patch period, the next transdermal patch should be applied without the usual transdermal patch-free interval.
Croatian: Ako istodobna primjena lijeka traje duže od završetka razdoblja od tri tjedna primjene flastera, sljedeći transdermalni flaster treba primijeniti bez uobičajenog razdoblja bez primjene transdermalnog flastera.
English: Driving and using machines You can drive or use machines while using this medicine.
Croatian: Za vrijeme primjene ovog lijeka možete upravljati vozilima i strojevima.
English: • some antiretroviral medicines used to treat HIV/AIDS and Hepatitis C virus infections (so called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such asritonavir,
Croatian: • neke antiretrovirusne lijekove koji se koriste za liječenje HIV-a/AIDS-a i infekcija virusom hepatitisa C (koji se zovu inhibitori proteaze i nenukleozidni inhibitori reverzne transkriptaze kao što su ritonavir, nevirapin, efavirenz)
English: If pregnancy occurs during use of EVRA, EVRA should be stopped immediately.
Croatian: Ako uz primjenu EVRE dođe do trudnoće, primjenu EVRE treba odmah prekinuti.
English: Risk increases substantially as BMI rises.
Croatian: Rizik se znatno povećava s povećanjem indeksa tjelesne mase.