FrancophonIA/ELRC3.0 huggingface dataset:
English: • Normal activities such as having a bath or shower, using a sauna and exercising should not affect how well the patch works.
Slovenian: • Običajne telesne aktivnosti, kot so kopanje, prhanje, savna in telovadba, ne bi smele vplivati na učinkovitost obliža.
English: This may help prevent you from getting these spots or help prevent them from getting worse.
Slovenian: To vam lahko prepreči pojav teh peg ali njihovo poslabšanje.
English: The problem will usually go away but if it doesn't, check with your doctor or pharmacist.
Slovenian: Težava ponavadi izgine, v nasprotnem primeru pa se posvetujte s svojim zdravnikom ali farmacevtom.
English: Do not flush used or unused patches down the toilet.
Slovenian: Uporabljenih ali neuporabljenih obližev ne smete odvreči v stranišče.
English: • immediate loss of vision or;
Slovenian: • takojšnja izguba vida ali
English: Based on these animal data, undesirable effects due to hormonal action of the active compounds cannot be excluded.
Slovenian: Na podlagi teh podatkov pri živalih, neželenih učinkov zaradi delovanja hormonov učinkovin, ne moremo izključiti.
English: Some of these symptoms (e.g. “shortness of breath”, “coughing”) are non-specific and might be misinterpreted as more common or less severe events (e.g. respiratory tract infections).
Slovenian: Nekateri od teh simptomov (npr. "kratka sapa", "kašljanje") niso specifični, zato jih je mogoče napačno razlagati kot bolj pogoste ali manj resne dogodke (npr. okužbe dihal).
English: However, diabetic women should be carefully observed, particularly in the early stage of EVRA use.
Slovenian: Vendar pa morajo biti ženske s sladkorno boleznijo pod skrbnim nadzorom, še posebej, ko začnejo uporabljati obliže EVRA.
English: Warnings and precautions Before using this medicine, you will need to see your doctor for a medical check-up.
Slovenian: Opozorila in previdnostni ukrepi Pred uporabo tega zdravila boste morali na pregled k svojemu zdravniku.
English: If EVRA remains even partly detached: - for less than one day (up to 24 hours): it should be re-applied to the same place or replaced with a new EVRA transdermal patch immediately.
Slovenian: Če je obliž EVRA deloma odlepljen: - manj kot en dan (do 24 ur): ga moramo ponovno namestiti na isto mesto ali ga takoj zamenjati z novim transdermalnim obližem EVRA.
English: The results indicated that for norelgestromin there were no significant treatment effects on Css or AUC when compared to normal wear.
Slovenian: Rezultati pri norelgestrominu niso pokazali pomembnih učinkov na Css ali AUC v primerjavi z običajno uporabo obliža.
English: About 5-7 out of 10,000 women
Slovenian: Približno 5-7 od 10.000 žensk
English: The use of EVRA may need to be stopped several weeks before surgery or while you are less mobile.
Slovenian: Uporabo zdravila EVRA bo morda treba nekaj tednov pred kirurškim posegom ali v času zmanjšane mobilnosti prekiniti.
English: Be advised that ovulation may occur within 10 days of an abortion or miscarriage.
Slovenian: Upoštevati je treba, da ovulacija lahko nastopi v desetih dneh po umetnem ali spontanem splavu.
English: • Open it by tearing it along the edge (do not use scissors)
Slovenian: • Odprite jo tako da jo odtrgate na koncu (ne uporabljajte škarij).
English: Pearl Index (95% CI) * DSG 150 mcg + 20 mcg EE ** 50 mcg LNG + 30 mcg for days 1 - 6, 75 mcg LNG + 40 mcg EE for days 7 - 11, 125 mcg LNG + 30 mcg EE for 12
Slovenian: * DSG 150 mcg + 20 mcg EE ** 50 mcg LNG + 30 mcg EE med 1. in 6. dnevom, 75 mcg LNG + 40 mcg EE med 7. in 11. dnevom, 125 mcg LNG +
English: Post-menopausal women
Slovenian: Ženske po menopavzi
English: • Always keep non-hormonal contraceptives (such as condoms, foam or sponge) as a back-up in case you make a mistake when using the patch.
Slovenian: • Vedno imejte nehormonske kontraceptive (kot so kondomi, pena ali vaginalna gobica) za primer napake pri uporabi obliža.
English: If you want to change your “Patch Change Day” to a different day of the week talk to your doctor.
Slovenian: Če želite zamenjati dan zamenjave za drugi dan v tednu, se pogovorite s svojim zdravnikom.
English: For initiation instructions see ‘How to start EVRA' below.
Slovenian: Začetna navodila so podana v poglavju ‘Kako začeti z uporabo obliža EVRA'.
English: Ethinyl estradiol is extensively bound to serum albumin.
Slovenian: Etinilestradiol se v veliki meri veže na serumski albumin.
English: Exploratory analyses were performed to determine whether in the Phase III studies (n=3,319) the population characteristics of age, race and weight were associated with pregnancy.
Slovenian: Z analizami raziskav so ugotavljali, ali je pri ženskah, ki so sodelovale v raziskavah faze III (n=3319), nosečnost povezana z njihovo starostjo, raso in telesno maso.
English: • Always put your patch on clean, dry, hairless skin
Slovenian: • Obliž vedno namestite na čisto in suho kožo brez dlak.
English: Pharmacodynamic interactions
Slovenian: Farmakodinanične interakcije
English: With all combined hormonal contraceptives, irregular blood loss (spotting or breakthrough bleeding) can occur, especially during the initial months of usage.
Slovenian: Pri vseh kombiniranih hormonskih kontraceptivih se lahko pojavi nenormalna krvavitev (kapljična krvavitev ali vmesna krvavitev), zlasti v prvih mesecih njihove uporabe.
English: • Abnormal liver function related to acute or chronic hepatocellular disease
Slovenian: • motnje v delovanju jeter, povezane z akutno ali kronično hepatocelularno boleznijo
English: No dose adjustment is necessary but as there is a suggestion in the literature that the unbound fraction of ethinyl estradiol is higher, EVRA should be used with supervision in this population.
Slovenian: Odmerka ni treba prilagajati, ker pa literatura navaja, da je nevezana frakcija etinilestradiola pri tej populaciji višja, obliža EVRA ne smejo uporabljati brez nadzora.
English: The day the first transdermal patch is applied (Day 1/Start Day) determines the subsequent Change Days.
Slovenian: Z dnem namestitve prvega transdermalnega obliža (t.i. 1. dan/začetni dan) se določijo naslednji dnevi zamenjave.
English: • Make sure that the edges stick well.
Slovenian: • Zagotovite, da so se robovi dobro nalepili.
English: • Harmful blood clots in a vein or artery for example:
Slovenian: • škodljivi krvni strdki v venah ali arterijah, na primer:
English: What are you possibly suffering from?
Slovenian: Kaj lahko povzroča te težave?
English: • Try to put it on again or put on a new patch immediately.
Slovenian: • poskusite ga ponovno namestiti ali pa takoj namestite nov obliž.
English: Adverse reactions that may occur at the beginning of treatment but usually diminish after the first three cycles include spotting, breast tenderness and nausea.
Slovenian: Neželeni učinki, ki se lahko pojavijo na začetku zdravljenja in navadno izzvenijo po prvih treh ciklih, vključujejo krvav izcedek, občutljivost dojk in navzeo.
English: The analyses indicated no association of age and race with pregnancy.
Slovenian: Analize so pokazale, da nosečnost ni bila povezana s starostjo in raso.
English: Safety and efficacy have not been established in adolescents under 18 years of age.
Slovenian: Varnost in učinkovitost pri mladostnikih, mlajših od 18 let nista bili dokazani.
English: • If you do not, you may increase your risk of getting pregnant.
Slovenian: • Drugače lahko povečate tveganje za zanositev.
English: Blood pressure should be measured and a physical examination should be performed guided by the contra-indications (see section 4.3) and warnings (see section 4.4).
Slovenian: Izmeriti je treba krvni tlak in opraviti klinični pregled, voden s predpostavko kontraindikacij (glejte poglavje 4.3) in posebnih opozoril (glejte poglavje 4.4).
English: Women using combined contraceptives should be emphatically advised to contact their physician in case of possible symptoms of thrombosis.
Slovenian: Ženskam, ki uporabljajo kombinirane kontraceptive, moramo nujno svetovati, da se v primeru možnih simptomov tromboze posvetujejo s svojim zdravnikom.
English: Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate
Slovenian: Ženske, ki uporabljajo tableto s kombiniranim hormonskim kontraceptivom, ki vsebuje levonorgestrel, noretisteron ali norgestimat
English: This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
Slovenian: To lahko zmanjša nadzor nad epileptičnimi napadi, zato bo morda potrebno prilagoditi odmerek lamotrigina.
English: EVRA can be restarted 2 weeks following completion of treatment with this combination drug regimen.
Slovenian: Obliž EVRA lahko začnejo ponovno uporabljati 2 tedna po zaključku zdravljenja s to kombinacijo zdravil.
English: If you stop using EVRA
Slovenian: Če ste prenehali uporabljati obliže EVRA
English: If you forget to put on your patch, you may be at particularly high risk of becoming pregnant.
Slovenian: Če pozabite namestiti obliž, je lahko tveganje, da zanosite, še posebej veliko.
English: Ethinyl estradiol is also metabolised to various hydroxylated products and their glucuronide and sulfate conjugates.
Slovenian: Etinilestradiol se prav tako presnovi v različne hidroksilirane produkte in njihove glukuronidne in sulfatne konjugate.
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: • Nekoliko povečajo tveganje za krvni strdek v venah in arterijah, zlasti prvo leto ali pri ponovnem jemanju kombiniranega hormonskega kontraceptiva po 4- ali večtedenski prekinitvi.
English: • sudden unexplained breathlessness or rapid breathing;
Slovenian: • nenadna nepojasnjena zasoplost ali hitro dihanje;
English: Use these stickers on your calendar to help you remember when to change your patch
Slovenian: Nalepke prilepite na koledar, da si boste lažje zapomnile, kdaj je treba zamenjati obliž.
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.
Slovenian: - Čeprav kombinirani hormonski kontraceptivi lahko vplivajo na periferno rezistenco za insulin in toleranco za glukozo, ni dokaza, da bi bilo treba pri sladkorni bolezni med uporabo kombiniranih hormonskih kontraceptivov spreminjati režim zdravljenja.
English: The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given.
Slovenian: Ženski je treba svetovati, naj natančno prebere navodilo za uporabo in upošteva navodila.
English: These subjects received six or 13 cycles of contraception (EVRA or oral contraceptive comparator), took at least one dose of study medicinal product and provided safety data.
Slovenian: Podatki o varnosti so bili pridobljeni pri preiskovankah, ki so prejele 6 ali 13 ciklov kontracepcije (obliž EVRA ali primerjalni peroralni kontraceptiv) in vzele vsaj en odmerek študijskega zdravila.
English: Current Cycle Next Cycle
Slovenian: Naslednji cikel
English: In this case you could have a hereditary blood clotting disorder;
Slovenian: V tem primeru imate morda dedno bolezen strjevanja krvi;
English: Your doctor may decide that EVRA needs to be stopped.
Slovenian: Vaš zdravnik se bo morda odločil, da morate z uporabo zdravila EVRA prenehati.
English: • A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as: - diabetes mellitus with vascular symptoms - severe hypertension - severe dyslipoproteinaemia
Slovenian: • Visoko tveganje arterijske trombembolije zaradi več dejavnikov tveganja (glejte poglavje 4.4) ali prisotnosti katerega od resnih dejavnikov tveganja, kot so: - sladkorna bolezen s simptomi na ožilju - huda hipertenzija - huda dislipoproteinemija
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: Ugotovljeni vzorec povečanega tveganja je lahko posledica zgodnejše diagnoze raka na prsih pri ženskah, ki jemljejo KPKS, bioloških učinkov KPKS ali pa kombinacije obojih.
English: With respect to weight, 5 of the 15 pregnancies reported with EVRA were among women with baseline body weight equal or greater than 90 kg, which constituted < 3% of the study population.
Slovenian: Kar zadeva telesno maso pa je pri 5 od 15 žensk, ki so zanosile med uporabo obliža EVRA, izhodiščna telesna masa znašala 90 kg ali več, kar predstavlja < 3 % proučevane populacije.
English: As the EVRA transdermal patch contains similar hormones to those used in combined birth control pills, it is likely to have the same risks.
Slovenian: Ker zdravilo EVRA transdermalni obliž vsebuje podobne hormone kot kombinirane kontracepcijske tablete, ima verjetno ista tveganja.
English: Enzyme induction may be observed after a few days of treatment.
Slovenian: Indukcija encimov se lahko opazi po nekajdnevnem zdravljenju.
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.
Slovenian: • Ne uporabljajte krem, olj, losjonov, pudra ali ličil na koži, kamor boste nalepili obliž ali v bližini obliža, ki ga nosite.
English: Used transdermal patches should not be flushed down the toilet nor placed in liquid waste disposal systems.
Slovenian: Uporabljenih transdermalnih obližev ne smemo odvreči v stranišče in niti v sisteme za odstranjevanje odplak.
English: • if you have (or have ever had) a type of migraine called ‘migraine with aura';
Slovenian: • če imate (ali ste kadar koli imeli) vrsto migrene, imenovane "migrena z avro"
English: (Week 3)
Slovenian: (3. teden)
English: • Abnormal breast milk production
Slovenian: • nenormalno nastajanje mleka
English: • loss of consciousness or fainting with or without seizure.
Slovenian: • izguba zavesti ali omedlevica z napadi krčev ali brez njih.
English: EVRA can be restarted approximately 2 weeks after completion of this treatment.
Slovenian: Obliž EVRA lahko ponovno začnete uporabljati približno 2 tedna po zaključku zdravljenja s temi zdravili.
English: In this case you could also have a higher risk of having a heart attack or stroke;
Slovenian: tem primeru je morda pri vas tudi večje tveganje za srčni infarkt ali možgansko kap;
English: When using a combined hormonal contraceptive like EVRA you are advised to stop smoking.
Slovenian: Če uporabljate kombinirani hormonski kontraceptiv, kot je zdravilo EVRA, se vam svetuje, da prenehate kaditi.
English: • Your “Patch Change Day” should remain the same.
Slovenian: • Dan zamenjave obliža ostane isti.
English: 3 transdermal patches 9 transdermal patches 18 transdermal patches
Slovenian: 3 transdermalni obliži 9 transdermalnih obližev 18 transdermalnih obližev
English: An increased risk of blood clots in your veins [venous thromboembolism (VTE)] or blood clots in your arteries [arterial thromboembolism (ATE)] is present for all women taking combined hormonal contraceptives.
Slovenian: Povečano tveganje krvnih strdkov v venah [venska trombembolija (VTE)] ali krvnih strdkov v arterijah [arterijska trombembolija (ATE)] je prisotno pri vseh ženskah, ki jemljejo kombinirane hormonske kontraceptive.
English: • sharp chest pain which may increase with deep breathing;
Slovenian: • ostre bolečine v prsnem košu, ki se lahko z globokim dihanjem poslabša;
English: Temporary symptoms suggest the event is a transient ischaemic attack (TIA).
Slovenian: Začasni simptomi kažejo, da gre za prehodni ishemični napad (TIA).
English: The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.
Slovenian: Tveganje je lahko večje tudi, če boste kombinirani hormonski kontraceptiv (enako ali drugačno zdravilo) začeli jemati ponovno po 4- ali večtedenskem presledku.
English: If more than 7 days elapse after taking the last active oral contraceptive tablet, the woman may have ovulated and should, therefore, be advised to consult a physician before initiating treatment with EVRA.
Slovenian: Če je od takrat, ko je ženska zaužila zadnjo kontracepcijsko tableto z učinkovino, minilo več kot 7 dni, je lahko imela ovulacijo in ji moramo zato svetovati, da se pred začetkom uporabe obliža EVRA posvetuje z zdravnikom.
English: The primary mechanism of action is inhibition of the ovulation, but the alterations of the cervical mucus, and to the endometrium may also contribute to the efficacy of the product.
Slovenian: Osnovni mehanizem delovanja je preprečevanje ovulacije, vendar pa k učinkovitosti obliža lahko prav tako prispevajo spremembe cervikalne sluzi in endometrija.
English: Breast-feeding may be influenced by combined hormonal contraceptives as they may reduce the quantity and change the composition of breast milk.
Slovenian: Kombinirani hormonski kontraceptivi lahko vplivajo na dojenje, saj lahko zmanjšajo količino mleka in spremenijo njegovo sestavo.
English: Risks of using combined hormonal contraceptives The following information is based on information about combined birth control pills.
Slovenian: Tveganja pri uporabi kombiniranih hormonskih kontraceptivov Naslednje poglavje temelji na podatkih o kombiniranih kontracepcijskih tabletah.
English: If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to EVRA, please talk to your doctor.
Slovenian: Če se pri vas pojavi kateri koli neželeni učinek, zlasti, če je resen ali trdovraten, ali če se vaše zdravje spremeni in menite, da je lahko to posledica zdravila EVRA, se posvetujte z zdravnikom.
English: Each used transdermal patch is removed and immediately replaced with a new one on the same day of the week (Change Day) on Day 8 and Day 15 of the cycle.
Slovenian: Vsak uporabljeni transdermalni obliž odstranimo in ga takoj, vedno na isti dan v tednu (t.i. dan zamenjave) zamenjamo z novim na 8. in 15. dan cikla.
English: If any of the conditions/risk factors mentioned below is present, the suitability of EVRA should be discussed with the woman.
Slovenian: V prisotnosti katerega od spodaj navedenih stanj ali dejavnikov tveganja se je treba o ustreznosti zdravila EVRA pogovoriti z žensko.
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.
Slovenian: Ker se rak na prsih redko pojavi pri ženskah, mlajših od 40 let, je presežek v številu diagnosticiranega raka na prsih pri ženskah, ki jemljejo ali so nedavno jemale KPKS, v primerjavi s celotnim tveganjem za raka na prsih majhen.
English: Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE.
Slovenian: Zdravila, ki vsebujejo levonorgestrel, norgestimat ali noretisteron, so povezana z nižjim tveganjem za VTE.
English: • However, if you miss two periods in a row, talk to your doctor or pharmacist as you may be pregnant.
Slovenian: • Če pa vam izostaneta dve menstruaciji zapored, se posvetujte s svojim zdravnikom ali farmacevtom, saj ste morda noseči.
English: • if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50).
Slovenian: • če je imel kdo od vaših bližnjih sorodnikov krvni strdek v nogi, pljučih ali v drugem organu v mladih letih (npr. pri starosti manj kot 50 let).
English: EVRA is not indicated for post-menopausal women and is not intended for use as hormonal replacement therapy.
Slovenian: Obliž EVRA ni indiciran pri ženskah po menopavzi in se ne uporablja za hormonsko nadomestno zdravljenje.
English: • Swelling of face, mouth, throat, or tongue
Slovenian: • otečen obraz, usta, žrelo ali jezik
English: • You can take it off and replace it with a new patch in a different place on your body until your next “Patch Change Day”
Slovenian: • ga lahko odstranite in nadomestite z novim, ki ga do vašega “dne zamenjave obliža” namestite na drugo mesto na koži.
English: Factors that increase your risk of a blood clot in an artery It is important to note that the risk of a heart attack or stroke from using EVRA is very small but can increase:
Slovenian: Dejavniki, ki povečajo tveganje za krvni strdek v arteriji Pomembno je povedati, da je tveganje srčnega infarkta ali možganske kapi zaradi uporabe zdravila EVRA zelo majhno, vendar se lahko poveča:
English: • Vaginal yeast infection, sometimes called thrush
Slovenian: • vaginalna glivična okužba, včasih imenovana tudi soor
English: EU/1/02/223/001: 3 transdermal patches EU/1/02/223/002: 9 transdermal patches EU/1/02/223/003: 18 transdermal patches
Slovenian: EU/1/02/223/001: 3 transdermalni obliži EU/1/02/223/002: 9 transdermalnih obližev EU/1/02/223/003: 18 transdermalnih obližev
English: - Although small increases of blood pressure have been reported in many women using hormonal contraceptives, clinically relevant increases are rare.
Slovenian: - Čeprav so poročali, da se je pri mnogih ženskah, ki uporabljajo hormonske kontraceptive, krvni tlak nekoliko zvišal, so klinično pomembna zvišanja redka.
English: • Sudden sharp increase in blood pressure (hypertensive crisis)
Slovenian: • nenadno močno zvišan krvni tlak (hipertenzivna kriza)
English: Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Slovenian: Kombiniranih kontraceptivov (CHC) ob naslednjih stanjih ni dovoljeno jemati.
English: • if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);
Slovenian: • če imate težave s srcem (okvaro srčnih zaklopk, motnje srčnega ritma, imenovane atrijske fibrilacije)
English: Pearl Index (95% CI)
Slovenian: Indeks neučinkovito sti metode po Pearlu (95% CI)
English: • High blood pressure or rise in blood pressure
Slovenian: • visok krvni tlak ali zvišanje krvnega tlaka
English: The risk for venous thromboembolic complications in CHC users may increase substantially in a woman with additional risk factors, particularly if there are multiple risk factors (see table).
Slovenian: Dejavniki tveganja za venske trombembolične zaplete pri uporabnicah CHC se lahko bistveno povečajo pri ženskah z dodatnimi dejavniki tveganja, zlasti, če je dejavnikov tveganja več (glejte preglednico).
English: B-2340 Beerse, Belgium
Slovenian: B-2340 Beerse, Belgija
English: With the use of higher dosed COCs (50 microgram ethinyl estradiol) the risk of endometrial and ovarian cancer is reduced.
Slovenian: Pri uporabi večjih odmerkov KPKS (50 mikrogramov etinilestradiola) se zmanjša tveganje za raka na endometriju in jajčniku.
English: • If you cannot get a patch back on, put on a new patch immediately.
Slovenian: • Če ga ne morete ponovno namestiti, takoj nalepite novega.
English: - Acute or chronic disturbances of liver function may necessitate the discontinuation of combined hormonal contraceptives until markers of liver function return to normal.
Slovenian: - Zaradi akutnih ali kroničnih motenj v delovanju jeter bo morda treba prekiniti z uporabo kombiniranih peroralnih kontraceptivov, dokler se vrednosti označevalcev jetrnih funkcij ne normalizirajo.
English: • swelling and slight blue discolouration of an extremity; • severe pain in your stomach (acute abdomen).
Slovenian: • oteklina in nekoliko modrikavo obarvanje okončine; • hude bolečine v želodcu (akutni abdomen)
English: • If one or more days have elapsed since the start of your period, talk to your doctor about temporarily using a non-hormonal contraceptive.
Slovenian: • Če je od začetka menstruacije pretekel dan ali več dni, se s svojim zdravnikom pogovorite o začasni uporabi nehormonskega kontraceptiva.
English: However, general experience with combined oral contraceptives during pregnancy did not provide evidence for an actual undesirable effect in humans.
Slovenian: Vendar izkušnje z uporabo peroralnih kontraceptivov med nosečnostjo, niso dokazale neželenega učinka pri ljudeh.