FrancophonIA/ELRC3.0 huggingface dataset:
English: Another method of contraception should be used to avoid unintentional pregnancy.
Slovenian: Za preprečitev neželene nosečnosti je treba uporabiti drugi način kontracepcije.
English: • The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis).
Slovenian: • Uporabo kombiniranih hormonskih kontraceptivov so povezovali z večjim tveganjem krvnih strdkov v venah (venska tromboza).
English: In rare cases a blood clot can block blood vessels and cause serious problems.
Slovenian: V redkih primerih lahko krvni strdek zamaši krvno žilo in povzroči resne težave.
English: Animal studies have shown undesirable effects during pregnancy and lactation (see section 5.3).
Slovenian: Študije na živalih so v obdobju brejosti in laktacije pokazale neželene učinke (glejte poglavje 5.3).
English: • if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA - temporary stroke symptoms);
Slovenian: • če imate (ali ste kadar koli imeli) angino pektoris (stanje, ki povzroča hude bolečine v prsnem košu in je lahko prvi znak srčnega infarkta) ali prehodni ishemični napad [kratka epizoda nevroloških znakov, TIA, temporary stroke symptoms])
English: • if you have ever had liver tumours or a liver disease because of which your liver does not function properly;
Slovenian: • če ste imeli tumor jeter ali bolezni jeter, zaradi katerih vaša jetra ne delujejo kot bi morala
English: • if you know you have a disorder affecting your blood clotting - for instance, protein C
Slovenian: • če veste, da imate bolezen, ki vpliva na strjevanje krvi, na primer pomanjkanje proteina C,
English: Medical tests
Slovenian: Zdravstveni testi
English: At the end of your patch cycle (Week 4):
Slovenian: ob koncu cikla (4. teden):
English: Symptoms of VTE (deep vein thrombosis and pulmonary embolism) In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC.
Slovenian: Simptomi VTE (globoke venske tromboze in pljučne embolije) Če se pojavijo simptomi, je treba ženski svetovati, da poišče nujno medicinsko pomoč in obvesti zdravstvenega delavca da jemlje CHC.
English: There is no clinical evidence indicating that a transdermal patch is, in any aspect, safer than combined oral contraceptives.
Slovenian: Kliničnega dokaza, da je transdermalni obliž iz kateregakoli vidika varnejši od kombiniranih peroralnih kontraceptivov, ni.
English: It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of EVRA compared with other CHCs, the symptoms of VTE and ATE, the known risk factors and what to do in the event of a suspected thrombosis.
Slovenian: Pomembno je, da se pozornost ženske usmeri na informacije glede venske in arterijske tromboze, vključno s tveganjem zdravila EVRA v primerjavi z drugimi CHC, simptomi VTE in ATE, znanimi dejavniki tveganja in kaj je treba narediti ob sumu na trombozo.
English: EVRA has not been studied in children and adolescents under 18 years of age.
Slovenian: Obliža EVRA pri otrocih in mladostnicah, mlajših od 18 let niso preučevali.
English: • You should have your period during this time
Slovenian: • V tem času bi morali dobiti menstruacijo.
English: After miscarriage or abortion after 20 weeks of pregnancy • Talk to your doctor.
Slovenian: Po spontanem ali umetnem splavu pred 20. tednom nosečnosti • Posvetujte se s svojim zdravnikom.
English: • Sometimes patches can stick to the inside of the sachet - be careful not to accidentally remove the clear covering as you remove the patch
Slovenian: • Včasih se obliž prilepi na notranjo stran blazinice - pazite, da ponesreči ne odstranite prozorne plasti, ko obliž vzamete ven.
English: It is important to remember that the overall risk of a harmful blood clot due to EVRA is small.
Slovenian: Pomembno je, da veste, da je skupno tveganje za nevarne krvne strdke zaradi uporabe zdravila EVRA majhno.
English: Do not use EVRA if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme).
Slovenian: Ne uporabljajte obliža EVRA, če imate hepatitis C in jemljete zdravila, ki vsebujejo ombitasvir/paritaprevir/ritonavir in dasabuvir, ker lahko zvečajo rezultate krvnih testov jetrne funkcije (zvečanje vrednosti ALT jetrnih encimov).
English: blood clots in the liver, stomach/intestine, kidneys or eye.
Slovenian: • krvni strdki v jetrih, želodcu/črevesju, ledvicah ali očesu.
English: To achieve maximum contraceptive effectiveness, patients must be advised to use EVRA exactly as directed.
Slovenian: Za maksimalno učinkovitost kontracepcije, ženskam svetujemo, da obliž EVRA uporabljajo natančno po navodilih.
English: You may start this medicine on Day 21 following the abortion or miscarriage, or on the first day of your next period, whichever comes first.
Slovenian: To zdravilo lahko začnete uporabljati na 21. dan po splavu ali na prvi dan naslednje menstruacije, kateri koli je prej.
English: • Then take off the other half of the covering
Slovenian: • Nato odstranite še drugo polovico zaščitne plasti.
English: • if you have SLE (systemic lupus erythematosus; a disease affecting your natural defence system);
Slovenian: • če imate sistemski eritematozni lupus (bolezen, ki vpliva na naravni obrambni sistem);
English: During Week 4, you may pick a new Change Day and apply the first patch on that day.
Slovenian: V 4. tednu si lahko izberete nov dan zamenjave in namestite prvi obliž na ta dan.
English: If you do you are more likely to cause irritation.
Slovenian: Če to naredite, je bolj verjetno, da bo prišlo do draženja kože.
English: Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
Slovenian: Dolgotrajna imobilizacija, večji kirurški poseg, vsak kirurški poseg na nogi ali v predelu medenice, nevrološka operacija ali velika poškodba
English: • Do this no matter when your period begins or ends.
Slovenian: • Obliž namestite ne glede na to, kdaj ste dobili menstruacijo in kdaj se je končala.
English: During the transdermal patch-free week a new Change Day may be selected by applying the first EVRA transdermal patch of the next cycle on the first occurrence of the desired day.
Slovenian: V tednu premora lahko nov dan zamenjave izbere tako, da prvi transdermalni obliž EVRA naslednjega cikla namesti na želeni dan.
English: (Week 2)
Slovenian: (2. teden)
English: • if a member of your immediate family has had a heart attack or stroke at a young age (less then about 50).
Slovenian: • če je imel bližnji sorodnik srčni infarkt ali možgansko kap v mladih letih (manj kot 50 let).
English: Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of an extremity.
Slovenian: Drugi znaki zapore žilja lahko vključujejo: nenadna bolečina, oteklost in nekoliko modrikava barva okončine.
English: • On Day 15 (Week 3), take off the used patch • Put on another new one.
Slovenian: • 15. dan (3. teden) odstranite uporabljeni obliž.
English: Effect of EVRA on other medicinal products
Slovenian: Učinek obliža EVRA na druga zdravila
English: See enclosed leaflet for disposal instructions.
Slovenian: Za navodila za odlaganje obližev glejte navodilo za uporabo.
English: • if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);
Slovenian: • če imate vi ali vaš bližnji sorodnik visoko koncentracijo maščob v krvi (holesterol ali trigliceridi);
English: In the event of symptoms women should be advised to seek urgent medical attention and to inform the healthcare professional that she is taking a CHC.
Slovenian: Če se pojavijo simptomi, je treba ženski svetovati, da poišče nujno medicinsko pomoč in obvesti zdravstvenega delavca da jemlje CHC.
English: Prior to the initiation or reinstitution of EVRA a complete medical history (including family history) should be taken and pregnancy should be ruled out.
Slovenian: Preden začne ženska jemati zdravilo EVRA ali pred njegovo ponovno uvedbo, se mora zdravnik seznaniti z njeno anamnezo (tudi z družinsko) in izključiti nosečnost.
English: An increased risk of cervical cancer in long-term users of COCs has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
Slovenian: V nekaterih epidemioloških raziskavah so pri ženskah, ki so dalj časa jemale KPKS, poročali o zvečanem tveganju za raka na materničnem vratu, še vedno pa ni enotnega mnenja o tem, v kolikšni meri lahko to ugotovitev pripišemo sočasnim učinkom spolnega vedenja in drugih dejavnikov, npr. papilomavirusu (HPV - Human Papilloma Virus).
English: • A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4);
Slovenian: • Višje tveganje za vensko trombembolijo zaradi prisotnosti več dejavnikov tveganja (glejte poglavje 4.4)
English: Hepatic metabolism of norelgestromin occurs and metabolites include norgestrel, which is largely bound to SHBG, and various hydroxylated and conjugated metabolites.
Slovenian: Norelgestromin se presnavlja v jetrih, metaboliti pa vključujejo norgestrel (ki se v veliki meri veže na SHBG) in različne hidroksilirane in konjugirane metabolite.
English: • if you have ever had a heart attack or a stroke;
Slovenian: • če ste kadar koli imeli srčni infarkt ali možgansko kap
English: What to do if the transdermal patch comes off or partly detaches If the EVRA transdermal patch partly or completely detaches and remains detached, insufficient medicinal product delivery occurs.
Slovenian: Kaj storiti, če se transdermalni obliž deloma ali povsem odlepi Če se transdermalni obliž EVRA deloma ali povsem odlepi in ga ne prilepimo nazaj, se v telo ne sprosti zadostna količina učinkovine.
English: Epidemiological studies indicate no increased risk of birth defects in children born to women who used combined oral contraceptives prior to pregnancy.
Slovenian: Epidemiološke raziskave niso pokazale zvečanega tveganja za prirojene anomalije pri otrocih žensk, ki so pred nosečnostjo jemale kombinirane peroralne kontraceptive.
English: You will need to complete the current cycle and remove the third patch on the correct day.
Slovenian: Zaključiti morate trenutni cikel in tretji obliž odstraniti na dan, ki je za to določen.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and estrogens, fixed combination; ATC-code: G03AA13.
Slovenian: Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, gestageni in estrogeni, enofazna zdravila, oznaka ATC: G03AA13.
English: In the event of aggravation, or first appearance of any of the conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of EVRA should be discontinued.
Slovenian: Ob poslabšanju ali prvem pojavi katerega od teh stanj je treba ženski svetovati, da se posvetuje s svojim zdravnikom in ugotovi, ali je treba uporabo zdravila EVRA prekiniti.
English: Epidemiological studies have associated the use of CHCs with an increased risk for arterial thromboembolism (myocardial infarction) or for cerebrovascular accident (e.g. transient ischaemic attack, stroke).
Slovenian: Epidemiološke študije so uporabo CHC povezale z večjim tveganjem za arterijsko trombembolijo (miokardni infarkt) ali cerebrovaskularni dogodek (npr. prehodni ishemični napad, možganska kap).
English: Pregnancy EVRA is not indicated during pregnancy.
Slovenian: Nosečnost Obliž EVRA je kontraindiciran med nosečnostjo.
English: Pulmonary embolism
Slovenian: pljučna embolija
English: EVRA is not indicated during pregnancy (see section 4.6).
Slovenian: Med nosečnostjo uporaba obliža EVRA ni indicirana (glejte poglavje 4.6).
English: • Abnormal taste
Slovenian: • nenavaden okus
English: • if you have unexplained vaginal bleeding
Slovenian: • če imate nepojasnjene krvavitve iz nožnice
English: Sachets are wrapped per three in a transparent perforated plastic film and packed in a cardboard carton.
Slovenian: Po tri blazinice so zavite v prozoren perforiran plastičen film in zapakirane v škatli iz lepenke.
English: deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
Slovenian: pomanjkanje proteina S, pomanjkanje antitrombina III, faktor V Leiden ali antifosfolipidna protitelesa
English: What EVRA is and what it is used for What you need to know before you use EVRA How to use EVRA
Slovenian: Kaj je zdravilo EVRA in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo EVRA Kako uporabljati zdravilo EVRA Možni neželeni učinki
English: Other conditions - Contraceptive efficacy may be reduced in women weighing equal or greater than 90 kg (see sections 4.2 and 5.1).
Slovenian: Druga stanja - Pri ženskah s telesno maso 90 kg ali več se učinkovitost kontracepcije lahko zmanjša (glejte poglavji 4.2 in 5.1).
English: Used patches still contain some active hormones.
Slovenian: Uporabljeni obliži še vedno vsebujejo hormone.
English: A woman on short-term treatment with medicinal products that induce hepatic drug metabolising enzymes or individual active substances that induce these enzymes should temporarily use a barrier method in addition to EVRA, i.e. during the time of concomitant medicinal product administration and for 28 days after their discontinuation.
Slovenian: Ženske, ki se kratek čas zdravijo z zdravili, ki inducirajo jetrne encime, ki presnavljajo zdravila ali s posameznimi učinkovinami, ki inducirajo te encime, morajo med jemanjem teh zdravil in še 28 dni po prenehanju jemanja le-teh, poleg obližev EVRA uporabljati še mehansko kontracepcijsko metodo.
English: This can cause bleeding inside the body with very bad pain in the stomach area.
Slovenian: Ti tumorji lahko povzročijo notranje krvavitve z zelo hudimi bolečinami v trebuhu.
English: The user should stop the current contraceptive cycle and start a new four-week cycle immediately by putting on a new EVRA transdermal patch.
Slovenian: Trenutni kontracepcijski cikel mora prekiniti in takoj začeti z novim 4-tedenskim ciklom, tako da namesti nov transdermalni obliž EVRA.
English: If you use more EVRA than you should (more than one EVRA patch at any one time) Take the patches off and talk to a doctor immediately.
Slovenian: Če ste uporabili več obližev EVRA, kot bi smeli (več kot en obliž EVRA na enkrat) Če ste nalepili več obližev, kot so vam jih predpisali, jih odstranite in se takoj obrnite na zdravnika.
English: • If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.
Slovenian: • Če krvni strdek potuje po nogi in pride v pljuča, lahko povzroči pljučno embolijo.
English: If a woman has more than one risk factor, it is possible that the increase in risk is greater than the sum of the individual factors - in this case her total risk should be considered.
Slovenian: Če ima ženska več kot en dejavnik tveganja, se lahko tveganje poveča za več, kot je seštevek posameznih dejavnikov; v tem primeru je treba upoštevati njeno skupno tveganje.
English: After an abortion or miscarriage that occurs at or after 20 weeks gestation, EVRA may be started either on Day 21 post-abortion or on the first day of the first spontaneous menstruation, whichever comes first.
Slovenian: Če do umetnega ali spontanega splava pride v ali po 20. tednu nosečnosti, lahko ženska začne obliž EVRA uporabljati bodisi na 21. dan po splavu bodisi na 1. dan, ko se pojavi prva spontana menstruacija, katerikoli je prej.
English: The transdermal patch Change Day will be on this day every week (cycle Days 8, 15, 22 and Day 1 of the next cycle).
Slovenian: Transdermalni obliž zamenja na ta dan vsak teden znova (8. in 15. dan cikla ter 1. dan naslednjega cikla).
English: Like a blood clot in a vein, a clot in an artery can cause serious problems.
Slovenian: Kot krvni strdek v veni lahko tudi strdek v arteriji povzroči resne težave.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: Generalised oedema Oedema peripheral Application site reactions**
Slovenian: občasni generaliziran edem periferni edem reakcije na mestu aplikacije**
English: • upper body discomfort radiating to the back, jaw, throat,
Slovenian: • nelagodje v zgornjem delu trupa, ki se širi v hrbet, čeljust,
English: • Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
Slovenian: • Zelo redko lahko strdek nastane v veni drugega organa, kot je na primer oko (tromboza mrežnične vene).
English: In a study comparing EVRA to an oral contraceptive containing norgestimate (parent drug of norelgestromin) 250 mcg/ethinyl estradiol 35 mcg, Cmax values were 2-fold higher for NGMN and EE in subjects administered the oral contraceptive compared to EVRA, while overall exposure (AUC and Css) was comparable in subjects treated with EVRA.
Slovenian: V raziskavi, ki je primerjala obliž EVRA s peroralnim kontraceptivom, ki je vseboval norgestimat (norelgestrominu sorodna učinkovina) 250 mcg/etinil estradiol 35 mcg, so bile Cmax vrednosti 2-krat višje pri NGMN in EE, pri bolnicah, ki so prejemale peroralni kontraceptiv v primerjavi z obližem EVRA, medtem, ko je bila celokupna izpostavljenost (AUC in Css) pri bolnicah, ki so prejemale obliže EVRA primerljiva.
English: Lamotrigine: Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when coadministered likely due to induction of lamotrigine glucuronidation.
Slovenian: Lamotrigin: Ob sočasni uporabi kombiniranih hormonskih kontraceptivov z lamotriginom le-ti pomembno zmanjšajo plazemske koncentracije lamotrigina, verjetno zaradi indukcije glukuronidacije lamotrigina.
English: • if you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition.
Slovenian: • če imate zvišane ravni maščob v krvi (hipertrigliceridemijo) ali pozitivno družinsko anamnezo te bolezni.
English: About 6-12 out of 10,000 women
Slovenian: Približno 6-12 od 10.000 žensk
English: • in the arteries (referred to as an ‘arterial thrombosis', ‘arterial thromboembolism' or ATE).
Slovenian: • v arterijah (imenujejo se "arterijska tromboza", "arterijska trombembolija" ali ATE).
English: Particularly above 35 years
Slovenian: Zlasti nad starostjo 35 let
English: This may make the patch come loose.
Slovenian: To lahko povzroči, da obliž popusti.
English: • Skin rash with tender red nodules on the shins and legs
Slovenian: • kožni izpuščaj z občutljivimi rdečimi vozliči na golenicah in nogah
English: The risk of arterial thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors (see table).
Slovenian: Tveganje za arterijske trombembolične zaplete ali za cerebrovaskularni dogodek pri uporabnicah CHC se pri ženskah z dejavniki tveganja poveča (glejte preglednico).
English: • if you have a disease that may increase your risk of a clot in the arteries: severe diabetes with blood vessel damage very high blood pressure a very high level of fat in the blood (cholesterol or triglycerides) a condition known as hyperhomocysteinaemia
Slovenian: • če imate katero od naslednjih bolezni, ki lahko poveča tveganje za nastanek strdkov v arterijah: hudo sladkorno bolezen s poškodovanimi krvnimi žilami zelo visok krvni tlak zelo visoko koncentracijo maščob v krvi (holesterola ali trigliceridov) stanje, znano kot hiperhomocisteinemija
English: Vaginal bleeding may occur in some females.
Slovenian: Pri nekaterih ženskah se lahko pojavi vaginalna krvavitev.
English: Following removal of a transdermal patch, the mean elimination half-lives of norelgestromin and ethinyl estradiol were approximately 28 hours and 17 hours, respectively.
Slovenian: Po odstranitvi transdermalnega obliža je bil povprečen razpolovni čas izločanja norelgestromina in etinilestradiola približno 28 oz. 17 ur.
English: If you need to stop EVRA ask your doctor when you can start using it again;
Slovenian: EVRA, se z zdravnikom posvetujte o tem, kdaj ga lahko ponovno začnete uporabljati.
English: EVRA, because hormonal contraceptives can affect the results of some tests.
Slovenian: Hormonski kontraceptivi lahko namreč vplivajo na izvide nekaterih testov.
English: In cases of suspected overdose, all transdermal contraceptive systems should be removed and symptomatic treatment given.
Slovenian: Ob sumu na preveliko odmerjanje je treba odstraniti transdermalno kontracepcijo v celoti in začeti s simptomatskim zdravljenjem.
English: If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold').
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, saj je mogoče nekatere od teh simptomov, kot sta kašljanje ali zasoplost, zamenjati za bolj blago stanje, kot je okužba dihal (npr. prehlad).
English: If the condition develops, or gets worse while you are using EVRA, you must tell your doctor.
Slovenian: Če se razvije katero od stanj ali se med uporabo obliža EVRA poslabša, morate to povedati zdravniku.
English: • Mistakes in using your patches can also cause spotting and light bleeding.
Slovenian: • Tudi napačna uporaba obližev lahko povzroči kapljične krvavitve in manjše krvavitve.
English: • If you've had a baby and are not breast-feeding, you should not start using this medicine sooner than 4 weeks after delivery.
Slovenian: • Če ste rodili in otroka ne dojite, lahko začnete uporabljati to zdravilo šele 4 tedne po rojstvu otroka.
English: If you do not get your period within 5 days of taking the last contraceptive pill, check with your doctor before starting this medicine.
Slovenian: Če v 5 dneh od zaužitja zadnje kontracepcijske tablete ne dobite menstruacije, se morate pred uporabo tega zdravila posvetovati s svojim zdravnikom.
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden začnete uporabljati to zdravilo.
English: The pharmacokinetic profiles of transdermal and oral combined hormonal contraceptives are different and caution should be exercised when making a direct comparison of these PK parameters.
Slovenian: Transdermalni kontraceptivi v primerjavi s peroralnimi Farmakokinetični profili transdermalnih in peroralnih kombiniranih hormonskih kontraceptivov se med seboj razlikujejo, zato je potrebna previdnost pri neposredni primerjavi farmakokinetičnih parametrov.
English: If a hereditary predisposition is suspected, the woman should be referred to a specialist for advice before deciding about any CHC use.
Slovenian: Če obstaja sum na dedno nagnjenost, je treba žensko pred odločitvijo za jemanje CHC napotiti po nasvet k specialistu.
English: The shorter the transdermal patch-free interval, the higher the risk that the user does not have a withdrawal bleed and may experience breakthrough bleeding and spotting during the subsequent treatment cycle.
Slovenian: Krajši, kot je premor, večje je tveganje, da se prekinitvena krvavitev ne pojavi, v naslednjem ciklu pa se lahko pojavi vmesna krvavitev ali kapljična krvavitev.
English: • Carcinoma of the endometrium or other known or suspected oestrogen-dependent neoplasia
Slovenian: • karcinom endometrija ali drugi znani, od estrogena odvisni tumorji ali sum nanje
English: it is no longer sticky it has become stuck to itself or another surface it has other material stuck to it it is the second time it has become loose or has fallen off.
Slovenian: če se je nanj prilepila druga snov ali če je že drugič popustil ali odpadel.