FrancophonIA/ELRC3.0 huggingface dataset:
English: Breast cancer has been found more often in women who take combined hormonal contraceptives.
Slovenian: Rak materničnega vratu se pogosteje pojavi pri ženskah, ki uporabljajo kombinirane hormonske kontraceptive.
English: If one or more days have elapsed since your miscarriage or abortion when you start this medicine, talk to your doctor about temporarily using a non-hormonal contraceptive.
Slovenian: Če je od spontanega ali umetnega splava pretekel dan ali več dni, se pred uporabo tega zdravila s svojim zdravnikom pogovorite o začasni uporabi nehormonskega kontraceptiva.
English: • Hepatic adenomas or carcinomas
Slovenian: • jetrni adenomi ali karcinomi
English: • You must use back-up contraception for the first week of your new cycle.
Slovenian: • V prvem tednu novega cikla morate uporabljati dodatno kontracepcijo.
English: The other ingredients are: backing layer: low-density pigmented polyethylene outer layer, polyester inner layer; middle layer: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate; third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.
Slovenian: - Druge sestavine zdravila so: zaščitna plast: obarvana zunanja plast iz polietilena nizke gostote, notranja plast iz poliestra; srednja plast: poliizobutilen/ polibuten kot lepilo, krospovidon, lavrillaktat, netkan poliesterski material; tretja plast: film iz polietilen tereftalata (PET), obloga iz polidimetilsiloksana.
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, vendar pa je v primerjavi z neuporabo kombiniranega hormonskega kontraceptiva še vedno blago povečano.
English: • On the first “Patch Change Day”, Day 8, take off the used patch • Put on a new patch immediately.
Slovenian: • Prvi dan zamenjave obliža, torej na 8. dan, uporabljeni obliž odstranite.
English: • High levels of fats in the blood (such as cholesterol or triglycerides)
Slovenian: • visoke koncentracije maščob (holesterol ali trigliceridi) v krvi
English: • Do not cut or tamper with the patch in any way.
Slovenian: • Obliža ne smete rezati ali kakorkoli drugače poškodovati.
English: If you switch from the oral contraceptive pill to EVRA If you are switching from an oral contraceptive pill to this medicine:
Slovenian: Če začnete uporabljati obliž EVRA namesto peroralnih kontracepcijskih tablet Če začnete uporabljati to zdravilo namesto peroralnih kontracepcijskih tablet:
English: • If the patch is put on after the first day of your period, use a non-hormonal contraceptive until Day 8, when you change your patch
Slovenian: • Če obliž namestite po 1. dnevu menstruacijskega cikla, morate uporabljati nehormonski kontraceptiv do 8. dneva, ko zamenjate obliž.
English: • Do not put a new patch on the same area of skin as the old patch.
Slovenian: • Novega obliža ne namestite na isti predel kože, s katerega ste pravkar odstranili prejšnji obliž.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Janssen-Cilag International NV Turnhoutseweg, 30, B-2340 Beerse, Belgium.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: Janssen-Cilag International NV, Turnhoutseweg, 30, B-2340 Beerse, Belgija.
English: This may include curettage.
Slovenian: To lahko vključuje odvzem brisa.
English: - Worsening of endogenous depression, of epilepsy, of Crohn's disease and of ulcerative colitis has been reported during COC use.
Slovenian: - Med uporabo KPKS so poročali o poslabšanju endogene depresije, epilepsije, Crohnove bolezni in ulceroznega kolitisa.
English: The outside of the backing layer is beige and heat-stamped “EVRA”.
Slovenian: Zunanja zaščitna plast je kožne barve, s toplotno vtisnjenim napisom “EVRA”.
English: • You do not need to use extra contraception if you have an upset stomach.
Slovenian: • Če imate težave z želodcem, vam ni treba uporabiti dodatne kontracepcijske zaščite.
English: Hypertension Obesity (body mass index over 30 kg/m
Slovenian: Debelost (indeks telesne mase več kot 30 kg/m
English: It is recommended that users visually check their transdermal patch daily to ensure continued proper adhesion.
Slovenian: Priporočamo, da ženske vsak dan preverijo, ali je transdermalni obliž še vedno na svojem mestu.
English: EVRA is contraindicated in women with hepatic impairment (see section 4.3).
Slovenian: Obliž EVRA je pri ženskah z okvaro jeter kontraindiciran (glejte poglavje 4.3).
English: If you've had sex since delivery of your baby, wait for your first period or see your doctor to make sure you are not pregnant before starting this medicine.
Slovenian: Če ste po porodu že imeli spolni odnos, morate pred začetkom uporabe tega zdravila počakati do naslednje menstruacije ali obiskati zdravnika, da se izključi možnost, da ste noseči.
English: After an abortion or miscarriage that occurs before 20 weeks gestation, EVRA may be started immediately.
Slovenian: Če do umetnega ali spontanega splava pride pred 20. tednom nosečnosti, lahko ženska začne obliž EVRA uporabljati takoj.
English: Fertility Women may experience a delay in conception following discontinuation of EVRA.
Slovenian: Plodnost Po prenehanju uporabe obliža EVRA lahko pri ženskah pride do kasnejše zanositve.
English: Short-term
Slovenian: Kratkotrajno
English: No additional contraceptive is needed.
Slovenian: Dodatna kontracepcija ni potrebna.
English: EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch norelgestromin/ethinyl estradiol
Slovenian: EVRA 203 mikrogramov/24 ur + 33,9 mikrogramov/24 ur transdermalni obliž norelgestromin/etinilestradiol
English: For EE, slight increases were observed due to treadmill and other aerobic exercise; however, the Css values following these treatments were within the reference range.
Slovenian: Opazili so rahlo zvečanje vrednosti etinilestradiola pri hoji po tekočem traku in drugih aerobnih vajah, medtem ko so bile vrednosti Css podobne referenčnim.
English: In case of any doubt, an additional barrier contraceptive method should be used by women on protease inhibitor or non-nucleoside reverse transcriptase inhibitor therapy.
Slovenian: V primeru dvomov morajo ženske, ki se zdravijo z zaviralci proteaz ali nenukleozidnimi zaviralci reverzne transkriptaze, uporabljati dodatno pregradno metodo kontracepcije.
English: • Arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris);
Slovenian: • Arterijska trombembolija - obstoječa arterijska trombembolija, arterijska trombembolija v anamnezi (npr. miokardni infarkt) ali prodromalna stanja (npr. angina pektoris)
English: Users with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using EVRA.
Slovenian: Ženske, ki so nagnjene h kloazmi, naj se med uporabo obližev EVRA izogibajo soncu ali ultravijoličnem sevanju.
English: After miscarriage or abortion before 20 weeks of pregnancy
Slovenian: Po spontanem ali umetnem splavu po 20. tednom nosečnosti
English: If one of these disorders occurs during the use of EVRA, EVRA must be discontinued immediately.
Slovenian: Če se pri ženski med uporabo obliža EVRA pojavi eno izmed teh stanj, ga mora takoj prenehati uporabljati.
English: Some users may experience amenorrhoea or oligomenorrhoea after discontinuing hormonal contraception, especially when such a condition was pre-existent.
Slovenian: Pri nekaterih ženskah, ki so prenehale uporabljati hormonsko kontracepcijo, se lahko pojavi amenoreja ali oligomenoreja, še posebej, če je bilo pri njih to stanje prisotno že prej.
English: The used transdermal patch should be placed within the open disposal label so that the sticky surface covers the shaded area on the sachet.
Slovenian: Uporabljeni transdermalni obliž damo pod odlepljeno nalepko, tako da lepljiva stran pokriva zasenčeni del blazinice.
English: • Then peel away half of the clear protective covering (see picture).
Slovenian: • Nato odstranite polovico prozorne zaščitne plasti, kot prikazuje slika.
English: Symptoms of deep vein thrombosis (DVT) can include: - unilateral swelling of the leg and/or foot or along a vein in the leg; - pain or tenderness in the leg which may be felt only when standing or walking; - increased warmth in the affected leg; red or discoloured skin on the leg.
Slovenian: Simptomi globoke venske tromboze (DVT) lahko vključujejo: - enostransko otekanje nog in/ali stopal ali vzdolž nožnih ven; - bolečina ali občutljivost nog, ki se lahko čuti le med stanjem ali hojo, - povečanje občutka toplote v prizadeti nogi; pordelost ali spremenjena barva kože na nogi.
English: • Cerebrovascular disease - current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA);
Slovenian: • Cerebrovaskularna bolezen - obstoječa možganska kap, možganska kap v anamnezi ali prodromalno stanje (npr. prehoden ishemični napad (TIA, transient ischaemic attack))
English: In the middle of your patch cycle (Week 2 or 3):
Slovenian: V sredini cikla (2. teden/8.
English: What can happen if a blood clot forms in a vein?
Slovenian: Kaj se lahko zgodi, če v veni nastane krvni strdek?
English: • To work properly the patch must stick firmly to your skin.
Slovenian: • Obliž mora biti tesno prilepljen na kožo, da deluje pravilno.
English: heart attack stroke mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack
Slovenian: • majhna možganska kap ali začasni, kapi podobni simptomi, znani kot prehodni ishemični napad (TIA, transient ischaemic attack)
English: Each 20 cm2 transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE).
Slovenian: En 20 cm2 transdermalni obliž vsebuje 6 mg norelgestromina (NGMN) in 600 mikrogramov etinilestradiola (EE).
English: How to use EVRA
Slovenian: Kako uporabljati zdravilo EVRA
English: If therapy starts after the first day of withdrawal bleeding, a non-hormonal contraceptive must be used concurrently for 7 days.
Slovenian: Če z uporabo obliža prične po prvem dnevu prekinitvene krvavitve, mora 7 dni sočasno uporabljati še nehormonski kontraceptiv.
English: • rapid or irregular heartbeats.
Slovenian: • hiter ali nepravilen srčni utrip;
English: • Vomiting or diarrhoea
Slovenian: • bruhanje ali driska
English: • Start a new four week cycle immediately by putting on a new patch.
Slovenian: • Takoj začnite nov štiritedenski cikel, tako da namestite nov obliž.
English: EVRA is contraindicated if a woman has multiple risk factors that put her at high risk of venous thrombosis (see section 4.3).
Slovenian: Zdravilo EVRA je kontraindicirano pri ženskah z več dejavniki tveganja, ki žensko izpostavijo visokemu tveganju za vensko trombozo (glejte poglavje 4.3).
English: Only one transdermal patch should be worn at a time.
Slovenian: Hkrati se lahko uporablja le en transdermalni obliž.
English: The metabolites of norelgestromin and ethinyl estradiol are eliminated by renal and faecal pathways.
Slovenian: Metaboliti norelgestromina in etinilestradiola se izločajo preko ledvic in z blatom.
English: Musculoskeletal and connective tissue disorders common
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti mišični krči
English: A new contraceptive cycle begins on the next day following transdermal patch-free week; the next EVRA transdermal patch should be applied even if there has been no withdrawal bleeding or if withdrawal bleeding has not yet stopped.
Slovenian: Naslednji transdermalni obliž EVRA mora ženska namestiti, tudi če krvavitev ni nastopila oz. še ni prenehala.
English: For your next four week cycle.
Slovenian: Na začetku naslednjega štiritedenskega cikla:
English: In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of COCs.
Slovenian: V redkih primerih so pri ženskah, ki uporabljajo KPKS, poročali o benignih tumorjih na jetrih, še redkeje pa o malignih tumorjih na jetrih.
English: Therefore, the prescribing information of concomitant HIV medications should be consulted to identify potential interactions and any related recommendations.
Slovenian: Zato je treba za prepoznavanje možnih interakcij in s tem povezanih priporočil prebrati navodila za predpisovanje sočasno uporabljenih zdravil za zdravljenje okužbe s HIV.
English: An additional method of contraception is not needed if EVRA is started immediately.
Slovenian: Če začne obliž EVRA uporabljati takoj, dodatna kontracepcijska metoda ni potrebna.
English: No additional contraceptive use is required.
Slovenian: Uporaba dodatne kontracepcije ni potrebna.
English: • Problems where the patch has been on the skin such as skin rash with blisters or ulcers
Slovenian: • težave na mestu aplikacije obliža, kot je kožni izpuščaj z mehurji ali razjedami
English: Contact lens intolerance*
Slovenian: Očesne bolezni redki intoleranca za kontaktne leče*
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using EVRA.
Slovenian: Če menite, da kaj od naštetega velja tudi za vas se pred uporabo obliža EVRA pogovorite z zdravnikom ali farmacevtom.
English: The patch should be applied immediately upon removal from the protective sachet.
Slovenian: Transdermalni obliž moramo namestiti takoj, ko ga vzamemo iz zaščitne blazinice.
English: • There is a clear protective covering on the patch
Slovenian: • Na obližu je prozorna zaščitna plast.
English: • Start your next cycle on your normal “Patch Change Day”, the day after Day 28.
Slovenian: • Nov cikel začnite na običajni dan zamenjave (na dan po 28. dnevu).
English: Etoricoxib has been shown to increase plasma levels of ethinyl estradiol (50 to 60%) when taken concomitantly with an oral triphasic hormonal contraceptive.
Slovenian: Dokazano je, da etorikoksib ob sočasnem jemanju s peroralnimi trifaznimi hormonskimi kontraceptivi, zveča koncentracijo etinilestradiola v plazmi (za 50 do 60%).
English: EVRA has not been studied in women with hepatic impairment.
Slovenian: Obliža EVRA niso proučevali pri ženskah z okvaro jeter.
English: If pregnancy occurs during use of EVRA, EVRA should be stopped immediately.
Slovenian: Če ženska zanosi med uporabo obližev EVRA, jih mora takoj prenehati uporabljati.
English: • Do not use this medicine if you are pregnant or think you may be pregnant.
Slovenian: • Če ste noseči ali mislite, da ste noseči, tega zdravila ne smete uporabljati.
English: If you have absent or irregular bleeding with EVRA This medicine may cause unexpected vaginal bleeding or spotting during the weeks when you are wearing the patch.
Slovenian: Če krvavitev izostane ali imate ob uporabi zdravila EVRA neredne krvavitve V tednih, ko uporabljate to zdravilo lahko pride do vmesnih krvavitev ali kapljičnih krvavitev.
English: If you are not sure, talk to your doctor, pharmacist or nurse before using this medicine.
Slovenian: Če ste negotovi, se pred uporabo tega zdravila posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Talk with your doctor before deciding to delay your period.
Slovenian: Preden se odločite za preložitev menstruacije, se posvetujte s svojim zdravnikom.
English: • Nausea
Slovenian: • otekline
English: Third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.
Slovenian: Tretja plast: film iz polietilen tereftalata (PET), obloga iz polidimetilsiloksana.
English: In case of suspected or confirmed thrombosis, hormonal contraceptive use should be discontinued.
Slovenian: Ob sumu na trombozo, ali če je le-ta potrjena, mora ženska prenehati z uporabo hormonskih kontraceptivov.
English: Breakthrough bleeding or spotting may occur.
Slovenian: Lahko se pojavi vmesna krvavitev ali kapljična krvavitev (spotting).
English: Antithrombotic treatment should be considered if EVRA has not been discontinued in advance.
Slovenian: Če jemanje zdravila EVRA ni prekinjeno vnaprej, je treba razmisliti o antitrombotičnem zdravljenju.
English: Supplemental adhesives or bandages should not be used to hold the EVRA transdermal patch in place.
Slovenian: Za pričvrstitev transdermalnega obliža EVRA ne uporabljamo dodatnih lepil ali obvez.
English: • Place the used patch within the open disposal label so that the sticky surface covers the shaded area.
Slovenian: • Uporabljen obliž položite pod nalepko tako, da z lepljivo stranjo prekrijete osenčeno površino.
English: Other medicines and EVRA
Slovenian: Druga zdravila in obliž EVRA
English: Third layer polyethylene terephthalate (PET) film polydimethylsiloxane coating.
Slovenian: Tretja plast film iz polietilen tereftalata (PET), obloga iz polidimetilsiloksana.
English: • Do not use tapes or wrapping to keep the patch in place.
Slovenian: • Za pričvrstitev obliža ne uporabljajte nobenih dodatnih trakov ali ovojev.
English: - for more than one day (24 hours or more) or if the user is not aware when the transdermal patch has lifted or become detached: the user may not be protected from pregnancy: The user should stop the current contraceptive cycle and start a new cycle immediately by applying a new EVRA transdermal patch.
Slovenian: - več kot en dan (24 ur ali več) ali če ženska ne ve, kdaj se je transdermalni obliž privzdignil ali odlepil: ni zaščite pred zanositvijo.
English: • Put on your next patch on your normal “Patch Change Day”.
Slovenian: • Naslednji obliž namestite na vaš običajni dan zamenjave obliža.
English: • Change EVRA on the same day of each week.
Slovenian: • Obliž EVRA zamenjajte na isti dan vsak teden, saj deluje 7 dni.
English: If intercourse has occurred during such an extended pill-free interval, the possibility of pregnancy should be considered.
Slovenian: Če je med podaljšanim premorom imela spolni odnos, je treba upoštevati možnost zanositve.
English: Important things to know about combined hormonal contraceptives (CHCs): - They are one of the most reliable reversible methods of contraception if used correctly.
Slovenian: • Če se jih uporablja pravilno, so ena najbolj zanesljivih reverzibilnih metod kontracepcije.
English: • Increased interest in sex
Slovenian: • zvečanje spolne sle
English: If you switch from the progestogen-only pill, an implant or an injectable to EVRA
Slovenian: Če začnete uporabljati obliž EVRA namesto tablet s progestogenom (mini tabletke), implantata ali injekcije
English: When there has been no hormonal contraceptive use in the preceding cycle Contraception with EVRA begins on the first day of menses.
Slovenian: Če ženska v prejšnjem ciklu ni uporabljala hormonskega kontraceptiva Ženska začne uporabljati obliž EVRA kot kontracepcijsko zaščito na prvi dan menstruacije.
English: You may have spotting or light bleeding or breast tenderness or may feel sick during the first 3 cycles.
Slovenian: V prvih 3 ciklih se lahko pojavijo vmesne ali kapljične krvavitve, občutljivost dojk ali slabost.
English: Under no circumstances should there be more than a 7-day transdermal patch-free interval between dosing cycles.
Slovenian: Premor med cikli odmerjanja v nobenem primeru ne sme biti daljši od 7 dni.
English: Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of sex hormones and which may lead to breakthrough bleeding and/or contraceptive failure.
Slovenian: Posledica je lahko zvečan očistek spolnih hormonov in pojav vmesnih krvavitev in/ali neučinkovitost kontraceptivov.
English: Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products.
Slovenian: Pred zdravljenjem s temi zdravili vam bo zdravnik lahko predpisal drugo obliko kontracepcije.
English: Adequate contraception should be initiated because of the teratogenicity of anti-coagulant therapy (coumarins).
Slovenian: Ker je zdravljenje z antikoagulanti teratogeno (kumarini), mora začeti uporabljati drugo ustrezno kontracepcijo.
English: • Acne, skin rash, skin itching or skin irritation
Slovenian: • akne, izpuščaj na koži, srbenje ali draženje kože
English: • You must put on a new patch as soon as you remember.
Slovenian: • namestite novega, takoj ko se spomnite.
English: Following this, the regular application of EVRA is resumed.
Slovenian: Po tem z uporabo transdermalnega obliža EVRA nadaljuje kot običajno.
English: At the start of any patch cycle (Week 1 (Day 1)):
Slovenian: Če pozabite zamenjati transdermalni obliž na začetku kateregakoli cikla (1. teden (1. dan)):
English: • Close the label sealing the used patch within and discard, keeping out of reach of children.
Slovenian: • Nalepko za uporabljene obliže prilepite nazaj in zavrzite tako, da obliž ne bo dosegljiv otrokom.
English: To prevent interference with the adhesive properties of the transdermal patch, no make-up, creams, lotions, powders or other topical products should be applied to the skin area where the transdermal patch is placed or where it will be applied shortly.
Slovenian: Da ne bi vplivali na lepljivost transdermalnega obliža, na predel kože, kjer je nameščen obliž ali bomo v kratkem namestili obliž, ne smemo nanašati ličil, krem, losjonov, pudrov ali drugih izdelkov za lokalno uporabo.
English: ** Includes adverse reactions reported in clinical trials and post-marketing reports.
Slovenian: * poročila v obdobju trženja zdravila ** vključno z neželenimi učinki, poročanimi v kliničnih študijah in v obdobju trženja zdravila † glejte poglavje 4.4.
English: • Breast problems such as pain, enlargement or lumps in the breast
Slovenian: • spremembe v dojkah, kot je bolečina, povečane dojke ali zatrdline v dojkah
English: It may be that women taking the combined hormonal contraceptive are examined more often.
Slovenian: Morda je več raka dojke odkritega pri ženskah, ki uporabljajo kombinirane hormonske kontraceptive, ker jih zdravniki pogosteje pregledajo.
English: Each 20 cm2 transdermal patch contains 6 mg norelgestromin and 600 micrograms ethinyl estradiol.
Slovenian: Vsak 20 cm2 transdermalni obliž vsebuje 6 mg norelgestromina in 600mikrogramov etinilestradiola.
English: The effects of age, body weight, and body surface area on the pharmacokinetics of norelgestromin and ethinyl estradiol were evaluated in 230 healthy women from nine pharmacokinetic studies of single 7-day applications of EVRA.
Slovenian: Pri 230 zdravih ženskah, ki so sodelovale v 9 farmakokinetičnih raziskavah in so obliž EVRA uporabljale samo 7 dni, so proučevali vpliv starosti, telesne mase in telesne površine na farmakokinetiko norelgestromina in etinilestradiola.
English: Heart attack
Slovenian: • srčni infarkt
English: How to use the patch:
Slovenian: Pri odstranjevanju obližev:
English: Each consecutive transdermal patch should be applied to a different place on the skin to help avoid potential irritation, although they may be kept within the same anatomic site.
Slovenian: Vsak naslednji obliž moramo namestiti na drugo mesto (lahko pa na isti del telesa), saj se s tem izognemo morebitnemu draženju.
English: • However, you should check that the patch has not fallen off after doing these activities.
Slovenian: • Kljub temu priporočamo, da po njih preverite, ali je obliž še vedno na svojem mestu.
English: In the middle of the cycle (Week Two/Day 8 or Week Three/Day 15) - for one or two days (up to 48 hours): The user should apply a new EVRA transdermal patch immediately.
Slovenian: dan) - en ali dva dni (do 48 ur): Ženska mora takoj namestiti nov transdermalni obliž EVRA.
English: If Cycle 1 therapy starts after first day of the menstrual cycle, a non-hormonal contraceptive should be used concurrently for the first 7 consecutive days of the first treatment cycle only.
Slovenian: Če ženska prične uporabljati obliž v 1. ciklu po prvem dnevu menstruacijskega cikla, mora prvih 7 dni sočasno uporabljati še nehormonski kontraceptiv (in sicer samo v prvem ciklu).
English: The active substances are released over 7 days with an average of 203 micrograms norelgestromin and 34 micrograms ethinyl estradiol being released each 24 hours.
Slovenian: Učinkovini se sprostita v 7 dneh, in sicer povprečno 203 mikrogrami norelgestromina in 33,9 mikrogramov etinilestradiola vsakih 24 ur.