natgillin/translations-raw huggingface dataset:
Note: temporary immobilisation including air travel > 4 hours can also be a risk factor for VTE, particularly in women with other risk factors 
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
If you have an upset stomach 
Če imate želodčne težave
• If you forget to change your patch for more than 2 days, you may become pregnant. 
• Če pozabite namestiti obliž več kot 2 dneva, lahko zanosite.
Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins. 
Norelgestromin in norgestrel (serumski metabolit norelgestromina) se v veliki meri vežeta (> 97 %) na serumske proteine.
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). 
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.
If you have not used a hormonal contraceptive during your previous cycle 
Če v prejšnjem ciklu niste uporabljali hormonskega kontraceptiva
• 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. 
• če morate na kirurški poseg ali če ste dalj časa nepokretni zaradi poškodbe ali bolezni ali če imate nogo v mavcu.
Table 1: Frequency of adverse reactions System Organ Class 
Preglednica 1: Pogostnost neželenih učinkov Organski sistem
What you need to know before you use EVRA 
Kaj morate vedeti, preden boste uporabili obliž EVRA
When you stop EVRA your risk of a blood clot returns to normal within a few weeks. 
Ko prenehate uporabljati zdravilo EVRA, se vaše tveganje za krvni strdek v nekaj tedni vrne na normalno raven.
• severe pain in your stomach. 
• hude bolečine v želodcu.
• Only wear one patch at a time. 
• Nosite samo en obliž naenkrat.
A transdermal patch should not be re-applied if it is no longer sticky; a new transdermal patch should be applied immediately. 
Transdermalnega obliža ne smemo ponovno namestiti, če ni več lepljiv; takoj namestimo nov obliž.
Some women using hormonal contraceptives including EVRA have reported depression or depressed mood. 
Nekatere ženske, ki uporabljajo hormonska kontracepcijska sredstva, vključno z zdravilom EVRA, so poročale o depresiji ali depresivnem razpoloženju.
Your “Patch Change Day” will be on this day of the week every week. 
Dan zamenjave obliža bo na ta dan v tednu, vsak teden.
EVRA is intended for women of fertile age. 
Obliž EVRA je namenjen ženskam v rodni dobi.
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. 
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.
It is particularly important to read the symptoms of a blood clot - see section 2 “Blood clots”. 
Zlasti pomembno je, da preberete simptome krvnega strdka - glejte poglavje 2 "Krvni strdki").
This corresponds to between about 6 and 12 VTEs in a year out of 10,000 women who use EVRA. 
To ustreza med približno 6 in 12 VTE na leto na 10.000 žensk, ki uporabljajo zdravilo EVRA.
This might mean that there is a better chance of the breast cancer being noticed. 
Kar pomeni, da imajo večjo možnost za odkrivanje raka dojke.
Effects of age, body weight, and body surface area 
Vpliv starosti, telesne mase in telesne površine
When to take special care with EVRA When should you contact your doctor? 
Kdaj morate posebno pozorni pri uporabi obliža EVRA Kdaj se morate posvetovati z zdravnikom?
For example, it can cause a heart attack or a stroke. 
Povzroči lahko na primer srčni infarkt ali možgansko kap.
If the occlusion occurs in the eye symptoms can range from painless blurring of vision which can progress to loss of vision. 
Če se pojavi zapora v očesu, lahko simptomi segajo od zameglitve vida brez bolečine, ki lahko napreduje v izgubo vida.
Using too many patches may cause you to have the following: 
Preveč obližev lahko povzroči:
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). 
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)
• Major surgery with prolonged immobilisation (see section 4.4); 
• Večji kirurški poseg z dolgotrajno imobilizacijo (glejte poglavje 4.4)
• sudden, severe or prolonged headache with no known cause; 
• nenaden, hud ali podaljšan glavobol brez znanega razloga;
• sudden trouble walking, dizziness, loss of balance or coordination; 
• nenadne težave s hojo, omotičnost, izgubo ravnotežja ali koordinacije;
If this happens to you, talk to your doctor immediately. 
V takšnem primeru se nemudoma obrnite na svojega zdravnika.
A definitive relationship between hormonal contraceptive use and clinical hypertension has not been established. 
Zanesljive povezave med uporabo hormonskih kontraceptivov in klinično hipertenzijo niso ugotovili.
For breast-feeding women, see section 4.6. 
Za ženske, ki dojijo, glejte poglavje 4.6.
EVRA may make some other medicines less effective, such as: 
Obliž EVRA lahko zmanjša učinek nekaterih zdravil, kot so:
• You may start this medicine right away. 
• Takoj začnite uporabljati to zdravilo.
• Normal activities such as having a bath or shower, using a sauna and exercising should not affect how well the patch works. 
• Običajne telesne aktivnosti, kot so kopanje, prhanje, savna in telovadba, ne bi smele vplivati na učinkovitost obliža.
This may help prevent you from getting these spots or help prevent them from getting worse. 
To vam lahko prepreči pojav teh peg ali njihovo poslabšanje.
The problem will usually go away but if it doesn't, check with your doctor or pharmacist. 
Težava ponavadi izgine, v nasprotnem primeru pa se posvetujte s svojim zdravnikom ali farmacevtom.
Do not flush used or unused patches down the toilet. 
Uporabljenih ali neuporabljenih obližev ne smete odvreči v stranišče.
• immediate loss of vision or; 
• takojšnja izguba vida ali
Based on these animal data, undesirable effects due to hormonal action of the active compounds cannot be excluded. 
Na podlagi teh podatkov pri živalih, neželenih učinkov zaradi delovanja hormonov učinkovin, ne moremo izključiti.
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). 
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).
However, diabetic women should be carefully observed, particularly in the early stage of EVRA use. 
Vendar pa morajo biti ženske s sladkorno boleznijo pod skrbnim nadzorom, še posebej, ko začnejo uporabljati obliže EVRA.
Warnings and precautions Before using this medicine, you will need to see your doctor for a medical check-up. 
Opozorila in previdnostni ukrepi Pred uporabo tega zdravila boste morali na pregled k svojemu zdravniku.
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. 
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.
The results indicated that for norelgestromin there were no significant treatment effects on Css or AUC when compared to normal wear. 
Rezultati pri norelgestrominu niso pokazali pomembnih učinkov na Css ali AUC v primerjavi z običajno uporabo obliža.
About 5-7 out of 10,000 women 
Približno 5-7 od 10.000 žensk
The use of EVRA may need to be stopped several weeks before surgery or while you are less mobile. 
Uporabo zdravila EVRA bo morda treba nekaj tednov pred kirurškim posegom ali v času zmanjšane mobilnosti prekiniti.
Be advised that ovulation may occur within 10 days of an abortion or miscarriage. 
Upoštevati je treba, da ovulacija lahko nastopi v desetih dneh po umetnem ali spontanem splavu.
• Open it by tearing it along the edge (do not use scissors) 
• Odprite jo tako da jo odtrgate na koncu (ne uporabljajte škarij).
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 
* 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 +
Post-menopausal women 
Ženske po menopavzi
• 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. 
• Vedno imejte nehormonske kontraceptive (kot so kondomi, pena ali vaginalna gobica) za primer napake pri uporabi obliža.
If you want to change your “Patch Change Day” to a different day of the week talk to your doctor. 
Če želite zamenjati dan zamenjave za drugi dan v tednu, se pogovorite s svojim zdravnikom.
For initiation instructions see ‘How to start EVRA' below. 
Začetna navodila so podana v poglavju ‘Kako začeti z uporabo obliža EVRA'.
Ethinyl estradiol is extensively bound to serum albumin. 
Etinilestradiol se v veliki meri veže na serumski albumin.
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. 
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.
• Always put your patch on clean, dry, hairless skin 
• Obliž vedno namestite na čisto in suho kožo brez dlak.
Pharmacodynamic interactions 
Farmakodinanične interakcije
With all combined hormonal contraceptives, irregular blood loss (spotting or breakthrough bleeding) can occur, especially during the initial months of usage. 
Pri vseh kombiniranih hormonskih kontraceptivih se lahko pojavi nenormalna krvavitev (kapljična krvavitev ali vmesna krvavitev), zlasti v prvih mesecih njihove uporabe.
• Abnormal liver function related to acute or chronic hepatocellular disease 
• motnje v delovanju jeter, povezane z akutno ali kronično hepatocelularno boleznijo
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. 
Odmerka ni treba prilagajati, ker pa literatura navaja, da je nevezana frakcija etinilestradiola pri tej populaciji višja, obliža EVRA ne smejo uporabljati brez nadzora.
The day the first transdermal patch is applied (Day 1/Start Day) determines the subsequent Change Days. 
Z dnem namestitve prvega transdermalnega obliža (t.i. 1. dan/začetni dan) se določijo naslednji dnevi zamenjave.
• Make sure that the edges stick well. 
• Zagotovite, da so se robovi dobro nalepili.
• Harmful blood clots in a vein or artery for example: 
• škodljivi krvni strdki v venah ali arterijah, na primer:
What are you possibly suffering from? 
Kaj lahko povzroča te težave?
• Try to put it on again or put on a new patch immediately. 
• poskusite ga ponovno namestiti ali pa takoj namestite nov obliž.
Adverse reactions that may occur at the beginning of treatment but usually diminish after the first three cycles include spotting, breast tenderness and nausea. 
Neželeni učinki, ki se lahko pojavijo na začetku zdravljenja in navadno izzvenijo po prvih treh ciklih, vključujejo krvav izcedek, občutljivost dojk in navzeo.
The analyses indicated no association of age and race with pregnancy. 
Analize so pokazale, da nosečnost ni bila povezana s starostjo in raso.
Safety and efficacy have not been established in adolescents under 18 years of age. 
Varnost in učinkovitost pri mladostnikih, mlajših od 18 let nista bili dokazani.
• If you do not, you may increase your risk of getting pregnant. 
• Drugače lahko povečate tveganje za zanositev.
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). 
Izmeriti je treba krvni tlak in opraviti klinični pregled, voden s predpostavko kontraindikacij (glejte poglavje 4.3) in posebnih opozoril (glejte poglavje 4.4).
Women using combined contraceptives should be emphatically advised to contact their physician in case of possible symptoms of thrombosis. 
Ženskam, ki uporabljajo kombinirane kontraceptive, moramo nujno svetovati, da se v primeru možnih simptomov tromboze posvetujejo s svojim zdravnikom.
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate 
Ženske, ki uporabljajo tableto s kombiniranim hormonskim kontraceptivom, ki vsebuje levonorgestrel, noretisteron ali norgestimat
This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. 
To lahko zmanjša nadzor nad epileptičnimi napadi, zato bo morda potrebno prilagoditi odmerek lamotrigina.
EVRA can be restarted 2 weeks following completion of treatment with this combination drug regimen. 
Obliž EVRA lahko začnejo ponovno uporabljati 2 tedna po zaključku zdravljenja s to kombinacijo zdravil.
If you stop using EVRA 
Če ste prenehali uporabljati obliže EVRA
If you forget to put on your patch, you may be at particularly high risk of becoming pregnant. 
Če pozabite namestiti obliž, je lahko tveganje, da zanosite, še posebej veliko.
Ethinyl estradiol is also metabolised to various hydroxylated products and their glucuronide and sulfate conjugates. 
Etinilestradiol se prav tako presnovi v različne hidroksilirane produkte in njihove glukuronidne in sulfatne konjugate.
- 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. 
• 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.
• sudden unexplained breathlessness or rapid breathing; 
• nenadna nepojasnjena zasoplost ali hitro dihanje;
Use these stickers on your calendar to help you remember when to change your patch 
Nalepke prilepite na koledar, da si boste lažje zapomnile, kdaj je treba zamenjati obliž.
- 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. 
- 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.
The woman should also be instructed to carefully read the user leaflet and to adhere to the advice given. 
Ženski je treba svetovati, naj natančno prebere navodilo za uporabo in upošteva navodila.
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. 
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.
Current Cycle Next Cycle 
Naslednji cikel
In this case you could have a hereditary blood clotting disorder; 
V tem primeru imate morda dedno bolezen strjevanja krvi;
Your doctor may decide that EVRA needs to be stopped. 
Vaš zdravnik se bo morda odločil, da morate z uporabo zdravila EVRA prenehati.
• 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 
• 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
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. 
Ugotovljeni vzorec povečanega tveganja je lahko posledica zgodnejše diagnoze raka na prsih pri ženskah, ki jemljejo KPKS, bioloških učinkov KPKS ali pa kombinacije obojih.
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. 
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.
As the EVRA transdermal patch contains similar hormones to those used in combined birth control pills, it is likely to have the same risks. 
Ker zdravilo EVRA transdermalni obliž vsebuje podobne hormone kot kombinirane kontracepcijske tablete, ima verjetno ista tveganja.
Enzyme induction may be observed after a few days of treatment. 
Indukcija encimov se lahko opazi po nekajdnevnem zdravljenju.
• 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. 
• Ne uporabljajte krem, olj, losjonov, pudra ali ličil na koži, kamor boste nalepili obliž ali v bližini obliža, ki ga nosite.
Used transdermal patches should not be flushed down the toilet nor placed in liquid waste disposal systems. 
Uporabljenih transdermalnih obližev ne smemo odvreči v stranišče in niti v sisteme za odstranjevanje odplak.
• if you have (or have ever had) a type of migraine called ‘migraine with aura'; 
• če imate (ali ste kadar koli imeli) vrsto migrene, imenovane "migrena z avro"
(Week 3) 
(3. teden)
• Abnormal breast milk production 
• nenormalno nastajanje mleka
• loss of consciousness or fainting with or without seizure. 
• izguba zavesti ali omedlevica z napadi krčev ali brez njih.
EVRA can be restarted approximately 2 weeks after completion of this treatment. 
Obliž EVRA lahko ponovno začnete uporabljati približno 2 tedna po zaključku zdravljenja s temi zdravili.
In this case you could also have a higher risk of having a heart attack or stroke; 
tem primeru je morda pri vas tudi večje tveganje za srčni infarkt ali možgansko kap;
When using a combined hormonal contraceptive like EVRA you are advised to stop smoking. 
Če uporabljate kombinirani hormonski kontraceptiv, kot je zdravilo EVRA, se vam svetuje, da prenehate kaditi.
• Your “Patch Change Day” should remain the same. 
• Dan zamenjave obliža ostane isti.
3 transdermal patches 9 transdermal patches 18 transdermal patches 
3 transdermalni obliži 9 transdermalnih obližev 18 transdermalnih obližev
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. 
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.
• sharp chest pain which may increase with deep breathing; 
• ostre bolečine v prsnem košu, ki se lahko z globokim dihanjem poslabša;
Temporary symptoms suggest the event is a transient ischaemic attack (TIA). 
Začasni simptomi kažejo, da gre za prehodni ishemični napad (TIA).
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. 
Tveganje je lahko večje tudi, če boste kombinirani hormonski kontraceptiv (enako ali drugačno zdravilo) začeli jemati ponovno po 4- ali večtedenskem presledku.
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. 
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.
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. 
Osnovni mehanizem delovanja je preprečevanje ovulacije, vendar pa k učinkovitosti obliža lahko prav tako prispevajo spremembe cervikalne sluzi in endometrija.
Breast-feeding may be influenced by combined hormonal contraceptives as they may reduce the quantity and change the composition of breast milk. 
Kombinirani hormonski kontraceptivi lahko vplivajo na dojenje, saj lahko zmanjšajo količino mleka in spremenijo njegovo sestavo.
Risks of using combined hormonal contraceptives The following information is based on information about combined birth control pills. 
Tveganja pri uporabi kombiniranih hormonskih kontraceptivov Naslednje poglavje temelji na podatkih o kombiniranih kontracepcijskih tabletah.
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. 
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.
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. 
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.
If any of the conditions/risk factors mentioned below is present, the suitability of EVRA should be discussed with the woman. 
V prisotnosti katerega od spodaj navedenih stanj ali dejavnikov tveganja se je treba o ustreznosti zdravila EVRA pogovoriti z žensko.
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. 
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.
Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. 
Zdravila, ki vsebujejo levonorgestrel, norgestimat ali noretisteron, so povezana z nižjim tveganjem za VTE.
• However, if you miss two periods in a row, talk to your doctor or pharmacist as you may be pregnant. 
• Če pa vam izostaneta dve menstruaciji zapored, se posvetujte s svojim zdravnikom ali farmacevtom, saj ste morda noseči.
• 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). 
• 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).
EVRA is not indicated for post-menopausal women and is not intended for use as hormonal replacement therapy. 
Obliž EVRA ni indiciran pri ženskah po menopavzi in se ne uporablja za hormonsko nadomestno zdravljenje.
• Swelling of face, mouth, throat, or tongue 
• otečen obraz, usta, žrelo ali jezik