FrancophonIA/ELRC3.0 huggingface dataset:
English: Used transdermal patches should be discarded carefully in accordance with the instructions given in section 6.6.
Slovenian: Uporabljene transdermalne obliže moramo zavreči previdno, v skladu z navodili iz poglavja 6.6.
English: Clinical efficacy and safety Pearl Indices (see table):
Slovenian: Klinična učinkovitost in varnost Pearlov indeks (glejte preglednico):
English: • Talk to your doctor.
Slovenian: • Posvetujte se s svojim zdravnikom.
English: How many patches to use
Slovenian: Koliko obližev je treba uporabiti
English: • The patch is designed to stay in place during these types of activities.
Slovenian: • Obliž je oblikovan tako, da ostane na mestu tudi v času takšnih aktivnosti.
English: Safety was evaluated in 3,322 sexually active women who participated in three Phase III clinical trials, which were designed to evaluate contraceptive efficacy.
Slovenian: Varnost so ocenjevali pri 3.322 spolno aktivnih ženskah, vključenih v klinične študije faze III, v katerih so ocenjevali učinkovitost kontraceptiva.
English: Chloasma is often not fully reversible.
Slovenian: Kloazma pogosto ni popolnoma reverzibilna.
English: • if you have just given birth you are at an increased risk of blood clots.
Slovenian: • če ste pravkar rodili, obstaja pri vas povečano tveganje za krvne strdke.
English: Frequency MedDRA convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: Navedba pogostnosti neželenih učinkov po MedDRA: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
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.
Slovenian: Če imate več kot eno od teh stanj ali če je katero od njih posebno resno, se lahko tveganje za nastanek krvnega strdka še bolj poveča.
English: • Week 4:
Slovenian: • 4. teden:
English: • Keep using the patches even if you do not have sex very often.
Slovenian: • Ne prenehajte uporabljati obližev, tudi če nimate pogostih spolnih odnosov.
English: All combined birth control pills have risks, which may lead to disability or death.
Slovenian: Vse kombinirane kontracepcijske tablete prinašajo tveganje, ki lahko vodi v invalidnost ali smrt.
English: Try not to touch the sticky surface.
Slovenian: Pazite, da se ne dotaknete lepljive površine.
English: For this reason, a medical opinion on irregular blood loss will only be useful after an adjustment period of approximately three cycles.
Slovenian: Zdravniško mnenje o nenormalni krvavitvi bo zato smotrno šele po obdobju prilagajanja, ki traja približno 3 cikle.
English: Before you start using EVRA you should read the information on blood clots in section 2.
Slovenian: Preden začnete uporabljati obliž EVRA, morate prebrati informacije o krvnih strdkih v poglavju 2.
English: Other products such as EVRA may have up to twice this level of risk.
Slovenian: Pri drugih zdravilih, kot je zdravilo EVRA, je lahko raven tega tveganja do dvakrat večja.
English: These findings suggest that clinical efficacy would be maintained even if a scheduled change is missed for as long as 2 full days.
Slovenian: Te ugotovitve kažejo, da bi se klinična učinkovitost ohranila, tudi če bi ženska načrtovano zamenjavo zamudila za 2 dni.
English: Combined hormonal contraceptives and cancer
Slovenian: Kombinirani hormonski kontraceptivi in rak
English: Below 90 kg there was no association between body weight and pregnancy.
Slovenian: Pri ženskah z manj kot 90 kg ni bilo povezave med telesno maso in nosečnostjo.
English: The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
Slovenian: Tveganje je odvisno od vašega naravnega tveganja za VTE in vrste kombiniranega hormonskega kontraceptiva, ki ga jemljete.
English: • Take it off as soon as you remember.
Slovenian: • odstranite ga, takoj ko se spomnite.
English: Arterial thromboembolic events may be fatal.
Slovenian: Dogodki arterijske trombembolije so lahko smrtni.
English: Changes generally remain within the normal laboratory range.
Slovenian: Spremembe ponavadi ostanejo znotraj meja referenčnih vrednosti.
English: If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;
Slovenian: Če ne morete prenehati kaditi in ste starejši kot 35 let, vam lahko zdravnik svetuje, da uporabljate drugo vrsto kontraceptiva;
English: Non-hormonal causes should be considered and, if necessary, adequate diagnostic measures taken to rule out organic disease or pregnancy.
Slovenian: Proučiti moramo nehormonske vzroke in, če je potrebno, uvesti ustrezne diagnostične teste, s katerimi izključimo organsko bolezen ali nosečnost.
English: Therefore, the use of EVRA is not to be recommended until the breast-feeding mother has completely weaned her child.
Slovenian: Zato uporabe obližev EVRA ne priporočamo, dokler mati popolnoma ne preneha z dojenjem.
English: Do not use this medicine after the expiry date, which is stated on the label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake “EXP”.
English: Your doctor may need to adjust the dose of the other medicine.
Slovenian: Zdravnik vam bo morda moral prilagoditi odmerek drugega zdravila.
English: Protect your skin from sunlight or ultraviolet radiation.
Slovenian: Kožo zaščitite pred sončno svetlobo ali ultravijoličnim sevanjem.
English: Risk of developing a blood clot in a year
Slovenian: Tveganje za razvoj krvnega strdka v enem letu
English: • sudden confusion, trouble speaking or understanding;
Slovenian: • nenadna zmedenost, težave z govorjenjem ali razumevanjem;
English: For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use EVRA”.
Slovenian: Za podrobnejše informacije o različnih tveganjih zaradi jemanja kombiniranih hormonskih kontraceptivov glejte poglavje 2 "Kaj morate vedeti, preden boste uporabili zdravilo EVRA".
English: • Never put the patch on your breasts.
Slovenian: • Obliža nikoli ne namestite na prsi.
English: Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
Slovenian: Včasih so lahko simptomi možganske kapi kratkotrajni s skoraj takojšnjim in popolnim okrevanjem, vendar morate kljub temu poiskati zdravniško pomoč, saj obstaja tveganje za ponovno možgansko kap.
English: Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
Slovenian: Ženskam je treba svetovati, naj pri spremembi razpoloženja in znakih depresije, vključno kmalu po začetku zdravljenja, stopijo v stik z zdravnikom.
English: The relevance of these data for human exposure is unknown as these effects have been seen as related to well-known pharmacodynamic or species-specific actions.
Slovenian: Pomembnost teh podatkov za uporabo pri človeku ni znana, saj so ugotovili, da so ti učinki povezani z dobro znano farmakodinamiko ali delovanjem, značilnim za posamezne vrste.
English: You should not use EVRA if you have any of the conditions listed below.
Slovenian: Obliža EVRA ne smete uporabljati, če imate katerega od spodaj opisanih stanj.
English: EVRA must not be used in children and adolescents who have not yet had their first menstrual period.
Slovenian: Obliža EVRA ne smejo uporabljati otroci in mladostnice, ki še niso imele prve menstruacije.
English: • medicines containing ciclosporin
Slovenian: • zdravila, ki vsebujejo ciklosporin
English: See section “When you should not use EVRA”.
Slovenian: Glejte poglavje “ Kdaj obliža EVRA ne smete uporabljati”.
English: • Swelling due to water retention in the body
Slovenian: • otekanje, ki je posledica zadrževanja vode v telesu
English: The EVRA transdermal patch should not be cut, damaged or altered in any way as this may compromise contraceptive effectiveness.
Slovenian: Transdermalnega obliža EVRA se ne sme rezati, poškodovati ali kakorkoli spremeniti, ker se lahko zmanjša učinkovitost kontracepcije.
English: The interfering effect of some of these medicines can last for up to 28 days after you have stopped taking them.
Slovenian: Učinek nekaterih od teh zdravil, ki lahko zmanjšajo učinkovitost obliža, lahko traja do 28 dni po tem, ko ste jih prenehali jemati.
English: • Problems when wearing contact lenses
Slovenian: • težave pri uporabi kontaktnih leč
English: These spots may not go away completely, even after you stop using EVRA.
Slovenian: Te pege morda ne bodo povsem izginile tudi, ko prenehate uporabljati obliž EVRA.
English: If EVRA has been taken according to the directions described in section 4.2, it is unlikely that the woman is pregnant.
Slovenian: Če je ženska obliže EVRA uporabljala skladno z navodili, opisanimi v poglavju 4.2, najverjetneje ni noseča.
English: • Continue using this medicine and if the bleeding lasts more than the first three cycles, talk to your doctor or pharmacist.
Slovenian: • Nadaljujte z uporabo tega zdravila, če pa krvavitev traja več kot tri cikle, se posvetujte s svojim zdravnikom ali farmacevtom.
English: Women who are not using a combined hormonal pill/patch/ring and are not pregnant
Slovenian: Ženske, ki ne uporabljajo kombinirane hormonske tablete/obliža/obročka in niso noseče
English: Air travel (> 4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.
Slovenian: Letenje (> 4 ure) lahko začasno poveča vaše tveganje za nastanek krvnih strdkov, zlasti, če imate tudi katere druge naštete dejavnike.
English: Norelgestromin is bound to albumin and not to SHBG, while norgestrel is bound primarily to SHBG, which limits its biological activity.
Slovenian: Norelgestromin se veže na albumin in ne na SHBG, medtem ko se norgestrel veže predvsem na SHBG, kar zmanjša njegovo biološko aktivnost.
English: Date of first authorisation: 22 August 2002.
Slovenian: Datum prve pridobitve dovoljenja za promet: 22. avgust 2002 Datum zadnjega podaljšanja dovoljenja za promet: 22. avgust 2012.
English: EU/1/02/223/001 EU/1/02/223/002
Slovenian: EU/1/02/223/001 EU/1/02/223/002 EU/1/02/223/003
English: If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Slovenian: Če se oceni, da je razmerje med koristmi in tveganji negativno, se CHC ne sme predpisati (glejte poglavje 4.3).
English: Sexually transmitted disease
Slovenian: Spolno prenosljive bolezni
English: • Premenstrual syndrome
Slovenian: • predmenstrualni sindrom
English: For more than one day (24 hours or more) or if you are not sure for how long:
Slovenian: in je od tedaj minil več kot en dan (24 ur ali več) ali pa niste prepričani, koliko časa
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.
Slovenian: Čeprav lahko le 10 do 20 % variabilnosti farmakokinetičnih podatkov utemeljimo s telesno maso (glejte poglavje 5.2) je bil večji delež nosečnosti med ženskami, ki so tehtale 90 kg ali več, statistično pomemben in nakazuje, da so obliži EVRA pri teh ženskah manj učinkoviti.
English: Wear the patch for 7 days (one week).
Slovenian: Obliž nosite 7 dni (en teden).
English: Medicinal product exposure is more appropriately characterised by the pharmacokinetic profile (see section 5.2).
Slovenian: Izpostavljenost zdravilu je natančneje opisana s farmakokinetičnim profilom (glejte poglavje 5.2).
English: However, in any individual woman the risk may be far higher, depending on her underlying risk factors (see below).
Slovenian: Vendar pa je lahko pri vsaki posamezni ženski tveganje veliko večje, kar je odvisno od njenih osnovnih dejavnikov tveganja (glejte spodaj).
English: Women over 35 who continue to smoke should be strongly advised to use a different method of contraception.
Slovenian: Ženskam, starim več kot 35 let, ki še naprej kadijo, je treba svetovati, da uporabijo drugačno metodo kontracepcije.
English: Maximal enzyme induction is generally seen in about 10 days but may then be sustained for at least 4 weeks after the cessation of medicinal product therapy.
Slovenian: Na splošno je maksimalna indukcija encimov vidna po 10 dneh in nato lahko traja najmanj 4 tedne po ukinitvi zdravljenja.
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.
Slovenian: V teh okoliščinah je priporočljivo uporabo obliža/tabletke/obročka prekiniti (vsaj štiri tedne pred načrtovanim kirurškim posegom) in jih ponovno začeti jemati šele dva tedna po popolni remobilizaciji.
English: What EVRA is and what is it used for
Slovenian: Kaj je zdravilo EVRA in za kaj ga uporabljamo
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.
Slovenian: Za uporabo katerega koli zdravila razen tistega z najnižjim tveganjem za VTE se je treba odločiti po pogovoru z žensko, da bo razumela tveganje za VTE, povezano z zdravilom EVRA, kako na to tveganje vplivajo njeni trenutni dejavniki tveganja in da je njeno tveganje za VTE najvišje v čisto prvem letu uporabe.
English: If you forget to change your patch for one or two days (up to 48 hours):
Slovenian: Če pozabite zamenjati obliž dan ali dva (do 48 ur):
English: Do not wear more than 6 patches (so not more than 6 weeks) in a row.
Slovenian: Ne uporabite več kot 6 obližev zaporedoma (torej ne več kot 6 tednov).
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
Slovenian: • preobčutljivost za zdravilne učinkovine ali katerokoli pomožno snov, navedeno v poglavju 6.1
English: • During this week you are protected from getting pregnant only if you start your next patch on time.
Slovenian: • V tem tednu ste zaščiteni pred nosečnostjo, le če nov obliž uporabite pravočasno.
English: After use the transdermal patch still contains substantial quantities of active ingredients.
Slovenian: Po uporabi transdermalni obliž še vedno vsebuje precejšnje količine učinkovin.
English: Accordingly, plasma and tissue concentrations may increase (e.g. ciclosporin).
Slovenian: Zato se lahko plazemske in tkivne koncentracije povečajo (npr. ciklosporin).
English: Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmissible diseases.
Slovenian: Ženske je treba poučiti, da peroralni kontraceptivi ne varujejo pred okužbo z virusom HIV (AIDS-em) in drugimi spolno prenosljivimi boleznimi.
English: • If you have been using this medicine correctly and you do not have a period, this does not necessarily mean that you are pregnant.
Slovenian: • Če ste to zdravilo uporabljali pravilno, a nimate menstruacije, to še ne pomeni, da ste noseči.
English: Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
Slovenian: V redkih primerih lahko ostanejo trajne posledice, zelo redko pa je izid lahko smrten.
English: If this is the first time you are using EVRA, wait until the day you get your menstrual period.
Slovenian: Če prvič uporabljate obliž EVRA, počakajte do dneva, ko dobite menstruacijo.
English: If you do have any of the conditions listed below, you must tell your doctor.
Slovenian: Če imate katerega od spodaj opisanih stanj, morate to povedati zdravniku.
English: Choose a place on your body to put the patch.
Slovenian: Izberite mesto na telesu, kamor boste namestili obliž.
English: • Weeks 1, 2 & 3: Put on one patch and leave it on for exactly seven days.
Slovenian: • 1., 2. in 3. teden: namestite en obliž in ga nosite natanko sedem dni
English: The most commonly reported adverse reactions in clinical trials were headache, nausea, and breast tenderness, occurring in approximately 21.0%, 16.6%, and 15.9% of patients, respectively.
Slovenian: V kliničnih preskušanjih so bili najpogosteje poročani neželeni učinki glavobol, slabost in občutljivost dojk, ki so se pojavljali pri 21,0%, 16,6%, oziroma 15,9% žensk.
English: EVRA has no or negligible influence on the ability to drive and use machines.
Slovenian: Obliž EVRA nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji
English: • sudden cough without an obvious cause, which may bring up blood;
Slovenian: • nenaden kašelj brez očitnega razloga, v katerem je lahko kri;
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.
Slovenian: Obstajajo nekateri dokazi, da se tveganje poveča, če se začne CHC ponovno uporabljati po 4 ali več tednih premora.
English: The incidence of ovulation on Day 21 post abortion (at 20 weeks gestation) is not known.
Slovenian: Pojavnost ovulacije na 21. dan po splavu (pri 20. tednu nosečnosti) ni znana.
English: Put the patch on your skin.
Slovenian: Obliž namestite na kožo
English: Note: temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors
Slovenian: Opomba: tudi začasna imobilizacija zaradi letenja, ki traja dlje kot 4 ure, je lahko dejavnik tveganja za VTE, zlasti pri ženskah z drugimi dejavniki tveganja
English: If you have an upset stomach
Slovenian: Če imate želodčne težave
English: • If you forget to change your patch for more than 2 days, you may become pregnant.
Slovenian: • Če pozabite namestiti obliž več kot 2 dneva, lahko zanosite.
English: Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins.
Slovenian: Norelgestromin in norgestrel (serumski metabolit norelgestromina) se v veliki meri vežeta (> 97 %) na serumske proteine.
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).
Slovenian: Upoštevati je treba povečano tveganje trombembolije med nosečnostjo in še zlasti v 6-tedenskem obdobju po porodu (za informacije o "Nosečnosti in dojenju" glejte poglavje 4.6.
English: If you have not used a hormonal contraceptive during your previous cycle
Slovenian: Če v prejšnjem ciklu niste uporabljali hormonskega kontraceptiva
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.
Slovenian: • če morate na kirurški poseg ali če ste dalj časa nepokretni zaradi poškodbe ali bolezni ali če imate nogo v mavcu.
English: Table 1: Frequency of adverse reactions System Organ Class
Slovenian: Preglednica 1: Pogostnost neželenih učinkov Organski sistem
English: What you need to know before you use EVRA
Slovenian: Kaj morate vedeti, preden boste uporabili obliž EVRA
English: When you stop EVRA your risk of a blood clot returns to normal within a few weeks.
Slovenian: Ko prenehate uporabljati zdravilo EVRA, se vaše tveganje za krvni strdek v nekaj tedni vrne na normalno raven.
English: • severe pain in your stomach.
Slovenian: • hude bolečine v želodcu.
English: • Only wear one patch at a time.
Slovenian: • Nosite samo en obliž naenkrat.
English: A transdermal patch should not be re-applied if it is no longer sticky; a new transdermal patch should be applied immediately.
Slovenian: Transdermalnega obliža ne smemo ponovno namestiti, če ni več lepljiv; takoj namestimo nov obliž.
English: Some women using hormonal contraceptives including EVRA have reported depression or depressed mood.
Slovenian: Nekatere ženske, ki uporabljajo hormonska kontracepcijska sredstva, vključno z zdravilom EVRA, so poročale o depresiji ali depresivnem razpoloženju.
English: Your “Patch Change Day” will be on this day of the week every week.
Slovenian: Dan zamenjave obliža bo na ta dan v tednu, vsak teden.
English: EVRA is intended for women of fertile age.
Slovenian: Obliž EVRA je namenjen ženskam v rodni dobi.
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.
Slovenian: Vendar pa lahko le majhen del (10-20 %) celotne variabilnosti v farmakokinetiki norelgestromina in etinilestradiola po namestitvi obliža EVRA povežemo s katerimkoli oz. vsemi zgoraj omenjenimi demografskimi parametri.
English: It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”.
Slovenian: Zlasti pomembno je, da preberete simptome krvnega strdka - glejte poglavje 2 "Krvni strdki").
English: This corresponds to between about 6 and 12 VTEs in a year out of 10,000 women who use EVRA.
Slovenian: To ustreza med približno 6 in 12 VTE na leto na 10.000 žensk, ki uporabljajo zdravilo EVRA.
English: This might mean that there is a better chance of the breast cancer being noticed.
Slovenian: Kar pomeni, da imajo večjo možnost za odkrivanje raka dojke.
English: Effects of age, body weight, and body surface area
Slovenian: Vpliv starosti, telesne mase in telesne površine
English: When to take special care with EVRA When should you contact your doctor?
Slovenian: Kdaj morate posebno pozorni pri uporabi obliža EVRA Kdaj se morate posvetovati z zdravnikom?
English: For example, it can cause a heart attack or a stroke.
Slovenian: Povzroči lahko na primer srčni infarkt ali možgansko kap.
English: If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision.
Slovenian: Če se pojavi zapora v očesu, lahko simptomi segajo od zameglitve vida brez bolečine, ki lahko napreduje v izgubo vida.
English: Using too many patches may cause you to have the following:
Slovenian: Preveč obližev lahko povzroči:
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).
Slovenian: Verjetnost za nastanek krvnega strdka, je lahko večja, če imate druga stanja, ki to tveganje povečujejo (glejte poglavje 2 za več informacij o stanjih, ki tveganje krvnih strdkov povečujejo, in o simptomih krvnega strdka)
English: • Major surgery with prolonged immobilisation (see section 4.4);
Slovenian: • Večji kirurški poseg z dolgotrajno imobilizacijo (glejte poglavje 4.4)
English: • sudden, severe or prolonged headache with no known cause;
Slovenian: • nenaden, hud ali podaljšan glavobol brez znanega razloga;
English: • sudden trouble walking, dizziness, loss of balance or coordination;
Slovenian: • nenadne težave s hojo, omotičnost, izgubo ravnotežja ali koordinacije;
English: If this happens to you, talk to your doctor immediately.
Slovenian: V takšnem primeru se nemudoma obrnite na svojega zdravnika.
English: A definitive relationship between hormonal contraceptive use and clinical hypertension has not been established.
Slovenian: Zanesljive povezave med uporabo hormonskih kontraceptivov in klinično hipertenzijo niso ugotovili.
English: For breast-feeding women, see section 4.6.
Slovenian: Za ženske, ki dojijo, glejte poglavje 4.6.
English: EVRA may make some other medicines less effective, such as:
Slovenian: Obliž EVRA lahko zmanjša učinek nekaterih zdravil, kot so:
English: • You may start this medicine right away.
Slovenian: • Takoj začnite uporabljati to zdravilo.