FrancophonIA/ELRC3.0 huggingface dataset:
English: Women over 35 who continue to smoke should be strongly advised to use a different method of contraception.
Slovenian: Ženskam, ki so starejše od 35 let in še naprej kadijo, je treba odločno svetovati, naj uporabljajo drugačen način kontracepcije.
English: EU/1/11/690/001 EU/1/11/690/002 EU/1/11/690/003 EU/1/11/690/004
Slovenian: EU/1/11/690/001 EU/1/11/690/002 EU/1/11/690/003
English: • if you have high blood pressure;
Slovenian: • če imate visok krvni tlak;
English: Zoely must not be used by women who are pregnant, or who think they may be pregnant.
Slovenian: Zdravila Zoely ne smejo uporabljati ženske, ki so noseče ali menijo, da bi lahko bile noseče.
English: How to shift periods or how to delay a period
Slovenian: Kako prestaviti ali odložiti menstruacijo
English: • if you are to be immobilised or are to have surgery (tell your doctor at least four weeks in advance);
Slovenian: • če boste imobilizirani ali boste imeli operacijo (o tem morate zdravnika obvestiti najmanj štiri tedne vnaprej);
English: If you have missed one or more periods Clinical trials with Zoely have shown that you may occasionally miss your regular monthly period after Day 24.
Slovenian: Če niste dobili ene ali več menstruacij Klinična preskušanja z zdravilom Zoely so pokazala, da vam lahko občasno izostane redna mesečna menstruacija po 24. dnevu.
English: Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
Slovenian: Redko lahko ostanejo resne trajne posledice, zelo redko pa je izid lahko smrten.
English: All adverse reactions are listed by system organ class and frequency; very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100) and rare ( 1/10,000 to < 1/1,000).
Slovenian: Vsi neželeni učinki so navedeni po organskim sistemih in pogostnosti; zelo pogosti (≥ 1/10), pogosti (1/100 do <1/10), občasni (1/1.000 do <1/100) in redki (1/10.000 do <1/1.000).
English: A relationship between COC use and clinical hypertension has not been established.
Slovenian: Povezava med uporabo COC in klinično hipertenzijo še ni bila ugotovljena.
English: • if you have depression;
Slovenian: • če imate depresijo;
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, vključno s potovanjem z letalom, ki traja > 4 ure, je lahko dejavnik tveganja za VTE zlasti pri ženskah, ki imajo še druge dejavnike tveganja.
English: If you do not want to become pregnant, first ask your doctor about other methods of birth control.
Slovenian: Če ne želite zanositi, najprej vprašajte zdravnika o drugih metodah kontracepcije.
English: Do not use rhythm or temperature methods.
Slovenian: Ne uporabljajte koledarske metode ali metode merjenja bazalne telesne temperature.
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 Zoely”.
Slovenian: Za podrobnejše informacije o različnih tveganjih jemanja kombiniranih hormonskih kontraceptivov glejte poglavje 2, "Kaj morate vedeti, preden boste uporabili zdravilo Zoely".
English: No data on efficacy and safety are available in adolescents below 18 years.
Slovenian: Podatkov o učinkovitosti in varnosti pri mladostnicah, mlajših od 18 let, ni na voljo.
English: After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
Slovenian: Po prvem letu se tveganje zmanjša, a je vedno malenkost večje, kot če ne bi uporabljali kombiniranega hormonskega kontraceptiva.
English: • sudden confusion, trouble speaking or understanding;
Slovenian: • nenadna zmedenost, težave z govorom ali razumevanjem;
English: • sudden trouble seeing in one or both eyes;
Slovenian: • nenadna motnja vida na enem ali obeh očesih;
English: If you have to change this day, reduce the number of placebo days - when you take the yellow placebo tablets - (but never increase them - 4 is the maximum).
Slovenian: Če morate ta dan premakniti, zmanjšajte število dni jemanja placebo tablet - ko boste jemali rumene placebo tablete - (nikoli pa ga ne smete povečati - 4 je največje število teh dni).
English: Approximately 80 % of the dose is excreted in urine and faeces within 4 days.
Slovenian: V 4 dneh se z urinom in blatom izloči približno 80 % odmerka.
English: • Contraceptive pills that contain two different hormones, like Zoely, are called ‘combined pills'.
Slovenian: • Kontracepcijske tablete, ki vsebujejo dva različna hormona, kakršne so tablete Zoely, imenujemo "kombinirane kontracepcijske tablete".
English: The effectiveness of the pill is maintained, but tell your doctor if you are using anti-fungal medicines containing ketoconazole.
Slovenian: Učinkovitost kontracepcijske tablete je ohranjena, vendar morate zdravniku povedati, če jemljete antimikotike (protiglivična zdravila), ki vsebujejo ketokonazol.
English: Enzyme induction can occur after a few days of treatment.
Slovenian: Indukcija encimov se lahko pojavi po nekaj dneh zdravljenja.
English: • Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare.
Slovenian: • Čeprav so pri mnogih ženskah, ki jemljejo COC, poročali o majhnem povečanju krvnega tlaka, pa je klinično pomembno povečanje redko.
English: Steady-state is achieved after 5 days.
Slovenian: Stanje dinamičnega ravnovesja je doseženo po 5 dneh.
English: Children and adolescents No data on efficacy and safety are available in adolescents below 18 years.
Slovenian: Otroci in mladostniki Podatki o učinkovitosti in varnosti pri mladostnicah do 18. leta starosti niso na voljo.
English: • immediate loss of vision or
Slovenian: • takojšnja izguba vida ali
English: You may need to use sanitary protection, but keep taking your tablets as usual.
Slovenian: Lahko bo potrebna uporaba higienskih vložkov, vendar nadaljujte z jemanjem tablet kot običajno.
English: See section 4.5.
Slovenian: Glejte poglavje 4.5.
English: Average serum concentrations are 50 pg/mL and these estradiol levels correspond with the early and late phase of a woman's menstrual cycle.
Slovenian: Povprečna serumska koncentracija je 50 pg/ml in ta koncentracija estradiola ustreza zgodnji in pozni fazi menstruacijskega ciklusa pri ženski.
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
Slovenian: Srednja točka razpona 5-7 na 10.000 žensk-let glede na relativno tveganje za CHC, ki vsebujejo levonorgestrel v primerjavi s približno 2,3 do 3,6 za neuporabo
English: For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Slovenian: Za opis simptomov teh resnih neželenih učinkov glejte "Kako prepoznati krvni strdek".
English: • They are one of the most reliable reversible methods of contraception if used correctly.
Slovenian: • Če se jih uporablja pravilno, so eden od najzanesljivejših reverzibilnih načinov kontracepcije.
English: Breastfeeding may be influenced by COCs as they may reduce the quantity and change the composition of breast milk.
Slovenian: COC bi lahko vplivali na dojenje, ker lahko zmanjšajo količino materinega mleka in spremenijo njegovo sestavo.
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.
Slovenian: Povečanje pogostnosti ali izrazitosti migrene med uporabo CHC (to je lahko prodrom cerebrovaskularnega dogodka) je lahko razlog za takojšnjo prekinitev uporabe.
English: The decision to use any product other than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, 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 tistih, ki imajo najmanjše tveganje za VTE, se je treba odločiti le po pogovoru z žensko, da razume tveganje za VTE med uporabo CHC, kako njeni trenutni dejavniki tveganja vplivajo na to tveganje in da je njeno tveganje za VTE največje v prvem letu uporabe.
English: However, after single oral dosing, for the estradiol component (secondary objective), the exposure was 36 % lower in adolescents versus adult subjects.
Slovenian: Vendar pa je bila po enkratnem peroralnem odmerku izpostavljenost estradiolni komponenti (sekundarni cilj) pri mladostnicah za 36 % manjša kot pri odraslih osebah.
English: • Zoely may also interfere with the working of other medicines - such as the anti-epileptic lamotrigine.
Slovenian: • Tudi zdravilo Zoely lahko moti delovanje drugih zdravil, npr. antiepileptika lamotrigina.
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; tudi v takšnem primeru morate poiskati nujno zdravniško pomoč, ker obstaja tveganje za ponovno možgansko kap.
English: (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot.)
Slovenian: (Za več informacij o stanjih, ki povečajo tveganje za krvne strdke, in o simptomih krvnih strdkov glejte poglavje 2.)
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 kajenja ne morete opustiti in ste starejši od 35 let, vam bo zdravnik morda svetoval drugačno vrsto kontracepcije.
English: Maximal enzyme induction is generally observed within a few weeks.
Slovenian: Največjo indukcijo encimov je običajno zaznati v nekaj tednih.
English: In this leaflet, several situations are described where you should stop taking the pill, or where the reliability of the pill may be decreased.
Slovenian: V tem navodilu je opisanih več primerov, v katerih morate prenehati z uporabo tablet oziroma v katerih so tabletke lahko manj zanesljive.
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: Potovanje z letalom (> 4 ure) lahko začasno poveča tveganje za nastanek krvnih strdkov, še zlasti, če imate še kakšne druge naštete dejavnike.
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 tudi nekateri dokazi, da se tveganje poveča v primeru ponovnega začetka uporabe CHC po presledku, ki je trajal 4 tedne ali več.
English: The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given.
Slovenian: Ženski je treba naročiti tudi, naj natančno prebere navodilo za uporabo in naj upošteva dobljena navodila.
English: • severe pain in your stomach;
Slovenian: • huda bolečina v trebuhu;
English: If you are having any blood or urinary test, tell your doctor that you are using Zoely as it may affect the results of some tests.
Slovenian: Če imate kakršno koli preiskavo krvi ali urina, povejte zdravniku, da uporabljate zdravilo Zoely, saj bi lahko le-to vplivalo na izvide nekaterih preiskav.
English: If you forgot to take one of these tablets the reliability of Zoely is maintained.
Slovenian: Tudi če ste pozabili vzeti eno od teh tablet, je zanesljivost zdravila Zoely ohranjena.
English: The management of missed tablets can be guided by the following two basic rules:
Slovenian: Za ravnanje v primeru pozabljene tablete veljata naslednji dve osnovni pravili:
English: Small amounts of the contraceptive steroids and/or their metabolites may be excreted with the breast milk, but there is no evidence that this adversely affects infant health.
Slovenian: V materino mleko se lahko izločajo majhne količine kontracepcijskih steroidov in/ali njihovih presnovkov, vendar ni nobenih dokazov, da bi to negativno vplivalo na zdravje dojenčka.
English: Increasing age
Slovenian: Naraščajoča starost
English: However, in any individual woman, the risk may be far higher, depending on her underlying risk factors (see below).
Slovenian: Kljub temu je pri vsaki posamezni ženski tveganje lahko veliko večje, odvisno od njenih osnovnih dejavnikov tveganja (glejte spodaj).
English: The duration of the withdrawal bleeding in women using Zoely is on average 3-4 days.
Slovenian: Trajanje odtegnitvene krvavitve pri ženskah, ki jemljejo zdravilo Zoely, je v povprečju 3 do 4 dni.
English: • if you are allergic to estradiol or nomegestrol acetate, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na estradiol ali nomegestrolacetat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Excretion of nomegestrol acetate was nearly complete after 10 days and amounts excreted were higher in faeces than in urine.
Slovenian: Izločanje nomegestrolacetata je bilo skoraj popolno po 10 dneh, njegove izločene količine pa so bile večje v blatu kot v urinu.
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.
Slovenian: Opaženo povečano tveganje bi lahko bilo posledica zgodnejše diagnoze raka dojke pri uporabnicah COC, bioloških učinkov COC ali pa kombinacije obeh dejavnikov.
English: Some women using hormonal contraceptives including Zoely have reported depression or depressed mood.
Slovenian: Nekatere ženske, ki uporabljajo hormonska kontracepcijska sredstva, vključno z zdravilom Zoely, so poročale o depresiji ali depresivnem razpoloženju.
English: Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
Slovenian: Ženskam je treba pojasniti, da hormonski kontraceptivi ne varujejo pred okužbo s HIV (aidsom) in drugimi spolno prenosljivimi boleznimi.
English: • harmful blood clots in a vein or artery, for example:
Slovenian: • škodljivi krvni strdki v veni ali arteriji, na primer:
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 za trombembolijo med nosečnostjo in še zlasti v 6-tedenskem obdobju po porodu (za informacije o nosečnosti in dojenju glejte poglavje 4.6).
English: Day 18-24
Slovenian: 18. do 24. dan
English: Estradiol circulates in the blood bound to SHBG (37 %) and to albumin (61 %), while only approximately 1-2 % is unbound.
Slovenian: Estradiol kroži v krvi vezan na SHBG (globulin, ki veže spolne hormone) (37 %) in na albumin (61 %), le približno 1 do 2 % ga je nevezanega.
English: If you do have any of the conditions listed below, you must tell your doctor.
Slovenian: Če imate katero od spodaj naštetih stanj, morate to povedati zdravniku.
English: It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”.
Slovenian: Posebej pomembno je, da preberete simptome krvnega strdka - glejte poglavje 2 "Krvni strdki".
English: • Undiagnosed vaginal bleeding.
Slovenian: • Nediagnosticirana vaginalna krvavitev.
English: Prior to the initiation or reinstitution of Zoely use a complete medical history (including family history) should be taken and pregnancy must be ruled out.
Slovenian: Pred začetkom ali ponovno uvedbo zdravila Zoely se je treba seznaniti s celotno anamnezo (vključno z družinsko) in izključiti nosečnost.
English: Most frequently, they occur in the first year of use of a combined hormonal contraceptive.
Slovenian: Najpogosteje se pojavijo v prvem letu uporabe kombiniranega hormonskega kontraceptiva.
English: • if you notice any changes in your own health, especially involving any of the items mentioned in this leaflet (see also in section 2 ‘When you should not use Zoely'; do not forget about the changes in the health of your immediate family);
Slovenian: • če opazite kakršne koli spremembe v svojem zdravju, še posebej pa motnje, ki so omenjene v tem navodilu (glejte tudi poglavje 2 " Kdaj ne smete uporabljati zdravila Zoely" ter ne pozabite na spremembe v zdravju svojih bližnjih družinskih članov);
English: • sudden trouble walking, dizziness, loss of balance or coordination;
Slovenian: • nenadne težave s hojo, omotica, izguba ravnotežja ali koordinacije;
English: Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 months).
Slovenian: Neredne krvavitve iz nožnice običajno prenehajo, ko se telo navadi na jemanje tablet (običajno po približno 3 mesecih).
English: • headache or migraine
Slovenian: • glavobol ali migrena
English: Before you start using Zoely you should read the information on blood clots (thrombosis) in section 2.
Slovenian: Pred začetkom uporabe zdravila Zoely morate prebrati informacije o krvnih strdkih (trombozi) v poglavju 2.
English: Whether this also applies to 17β-estradiol-containing COCs remains to be confirmed.
Slovenian: Če to velja tudi za COC, ki vsebujejo 17β-estradiol, je treba še potrditi.
English: It is unknown whether the amount of estradiol in Zoely is sufficient to maintain adequate levels of estradiol in adolescents, especially for bone mass accrual (see section 5.2).
Slovenian: Ni znano, če količina estradiola v zdravilu Zoely zadostuje za vzdrževanje ustrezne ravni estradiola pri mladostnikih, še posebej za prirastek kostne mase (glejte poglavje 5.2).
English: The hormonal active ingredients in the tablet may have harmful effects if they reach the aquatic environment.
Slovenian: Hormonsko aktivne učinkovine v tableti imajo lahko škodljiv učinek, če pridejo v okoljske vode.
English: Blood pressure should be measured and a physical examination should be performed, guided by the contraindications (see section 4.3) and warnings (see section 4.4).
Slovenian: Izmeriti je treba krvni tlak in opraviti klinični pregled, ki naj ga usmerjajo kontraindikacije (glejte poglavje 4.3) in opozorila (glejte poglavje 4.4).
English: • They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks.
Slovenian: • Rahlo povečajo tveganje za nastanek krvnih strdkov v venah in arterijah, zlasti v prvem letu uporabe ali ob ponovnem začetku uporabe kombiniranega hormonskega kontraceptiva po presledku, ki je trajal 4 tedne ali več.
English: • sudden, severe or prolonged headache with no known cause;
Slovenian: • nenaden, hud ali dolgotrajen glavobol brez znanega vzroka;
English: Following delivery or second-trimester abortion
Slovenian: Po porodu ali splavu v drugem trimesečju
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 zapora pojavi v očesu, se simptomi lahko kažejo kot neboleča zameglitev vida, ki lahko napreduje vse do izgube vida.
English: Contains lactose monohydrate
Slovenian: Vsebuje laktozo monohidrat.
English: Nomegestrol acetate is not genotoxic.
Slovenian: Nomegestrolacetat ni genotoksičen.
English: • Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
Slovenian: • Pri akutnih ali kroničnih motnjah delovanja jeter je lahko potrebna ukinitev uporabe COC, dokler se kazalci delovanja jeter ne povrnejo na normalo.
English: If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered.
Slovenian: Če je imela v preteklih 7 dneh spolni odnos, je treba upoštevati možnost, da je zanosila.
English: Your period will start during the 4 days that you use the yellow placebo tablets (so-called withdrawal bleeding).
Slovenian: Začetek menstruacije bo v tistih 4 dneh, ko boste jemali rumene placebo tablete (tako imenovana odtegnitvena krvavitev).
English: The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased.
Slovenian: Več zaporednih tablet, ko ste pozabili, večje je tveganje, da bo kontracepcijska učinkovitost zdravila zmanjšana.
English: You can stop taking Zoely at any time.
Slovenian: Zdravilo Zoely lahko prenehate jemati kadarkoli.
English: If this is not possible or 24 or more hours have passed, you should follow the advice given under "If you forget to take Zoely".
Slovenian: Če to ni mogoče ali je minilo že 24 ur ali več, morate slediti navodilom v poglavju "Če ste pozabili vzeti zdravilo Zoely".
English: For example, it may be that tumours are found more in women on combined pills because they are examined by the doctor more often.
Slovenian: Možno je namreč, da pri ženskah, ki jemljejo kombinirane kontracepcijske tablete, tumorje pogosteje najdejo zato, ker jih zdravniki pogosteje pregledujejo.
English: Risk of arterial thromboembolism (ATE)
Slovenian: Tveganje za arterijsko trombembolijo (ATE)
English: [Box for placing day label stating:] Place day label here [Day numbering for each individual tablet:] Start,2, ….28 [Arrows indicating the sequence of the tablets:] 
Slovenian: [okvirček za dnevno oznako z napisom:] sem prilepite nalepko z dnevnimi oznakami [številka dneva za vsako posamezno tableto:] začetek, 2, ….28 [puščice kažejo zaporedje jemanja tablet:] 
English: After vomiting or diarrhoea, you must take another white active tablet from a reserve blister as soon as possible.
Slovenian: Po bruhanju ali driski, morate čim prej vzeti še eno belo aktivno tableto iz rezervnega pretisnega omota.
English: • A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are currently using COCs.
Slovenian: • Po meta-analizi 54 epidemioloških študij so poročali o rahlo povečanem relativnem tveganju (RR = 1,24), da bodo pri ženski, ki trenutno jemlje COC, odkrili rak dojke.
English: 28 % of the women experienced absence of withdrawal bleeding in at least one of the cycles 2, 3 and 4, associated with higher occurrences of absence of withdrawal bleeding in the later cycles of use, ranging from 51 % to 62 %.
Slovenian: 28 % žensk je odsotnost odtegnitvene krvavitve doživelo v vsaj enem od ciklusov 2, 3 in 4, kar je bilo povezano z večjo pojavnostjo odsotnosti odtegnitvene krvavitve v poznejših ciklusih uporabe in sicer od 51 % do 62 %.
English: If you follow these instructions, it is not necessary to use an additional contraceptive method.
Slovenian: Če upoštevate ta navodila, vam ni treba uporabljati dodatnih kontracepcijskih sredstev.
English: • pain or tenderness in the leg which may be felt only when standing or walking
Slovenian: • bolečina ali občutljivost v nogi, ki je lahko prisotna le stoje ali med hojo,
English: After stopping the combined pill, the increased risk gradually reduces.
Slovenian: Po prenehanju jemanja kombiniranih kontracepcijskih tablet se povečano tveganje postopoma zmanjša.
English: Ethnic groups No formal studies were performed to assess pharmacokinetics in ethnic groups.
Slovenian: Etnične skupine Uradnih študij za oceno farmakokinetike pri posameznih etničnih skupinah niso izvedli.
English: • swelling and slight blue discolouration of an extremity; • severe pain in your stomach (acute abdomen).
Slovenian: • oteklost in rahla modrikavost uda; • močna bolečina v trebuhu (akutni abdomen).
English: In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages.
Slovenian: V osamljenih primerih so ti tumorji vodili do pojava smrtno nevarnih intraabdominalnih krvavitev.
English: For example, it can cause a heart attack or a stroke.
Slovenian: Povzroči lahko npr. srčni infarkt ali možgansko kap.
English: • There are medicines that can make Zoely less effective in preventing pregnancy, or can cause unexpected bleeding.
Slovenian: • Obstajajo zdravila, ki lahko zmanjšajo učinkovitost zdravila Zoely pri preprečevanju nosečnosti in lahko povzročajo nepričakovane krvavitve.