FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria [a disease of the blood], herpes gestationis [skin rash with vesicles during pregnancy], Sydenham's chorea [a disease of the nerves in which sudden movements of the body occur] (see in section 2 ‘When should you contact your doctor');
Slovenian: • če imate bolezen ali motnjo, ki se je prvič pojavila ali poslabšala med nosečnostjo ali med prejšnjo uporabo spolnih hormonov (npr. izgubo sluha, porfirijo [krvna bolezen], herpes gestationis [kožni izpuščaj z mehurčki med nosečnostjo], Sydenhamovo horejo [bolezen živcev s trzajočimi telesnimi gibi] (glejte poglavje 2 "V katerih primerih se morate posvetovati z zdravnikom");
English: In this case you could have a hereditary blood clotting disorder;
Slovenian: V takšnem primeru imate morda dedno motnjo strjevanja krvi;
English: Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
Slovenian: Hipertrigliceridemija je povezana s povečanim tveganjem za nastanek pankreatitisa (vnetja trebušne slinavke);
English: The contraceptive effect of Zoely is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion.
Slovenian: Kontracepcijski učinek zdravila Zoely temelji na medsebojnem vplivu različnih dejavnikov, od katerih so najpomembnejše zavora ovulacije in spremembe sekrecije iz materničnega vratu.
English: Maximum serum concentrations of estradiol are about 90 pg/mL and are reached 6 h after dosing.
Slovenian: Največja serumska koncentracija estradiola znaša približno 90 pg/ml in je dosežena 6 h po zaužitju zdravila.
English: After a miscarriage or an abortion Follow the advice of your doctor.
Slovenian: Po spontanem ali umetnem splavu Upoštevajte nasvet zdravnika.
English: • if you have (or have ever had) a type of migraine called ‘migraine with aura';
Slovenian: • če imate (ali ste kdaj imeli) vrsto migrene, ki ji pravimo "migrena z avro";
English: If you are not sure what to do, consult your doctor.
Slovenian: Če niste prepričani, kdaj začeti, se posvetujte z zdravnikom.
English: In animal studies, reproductive toxicity has been observed with the nomegestrol acetate / estradiol combination (see preclinical safety data in section 5.3).
Slovenian: V študijah na živalih so opažali vpliv na sposobnost razmnoževanja pri uporabi kombinacije nomegestrolacetata in estradiola (glejte predklinične podatke o varnosti v poglavju 5.3).
English: In the clinical trial performed with Zoely in the United States the following Pearl Indices for the age class 18-35 years were calculated:
Slovenian: V kliničnem preskušanju, opravljenem z zdravilom Zoely v Združenih državah, so izračunali naslednje Pearlove indekse za starostno skupino 18 do 35 let:
English: To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming yellow placebo tablet phase with a maximum of 4 days.
Slovenian: Če želi ženska prestaviti menstruacijo na drug dan v tednu, kot je bila navajena pri obstoječem režimu jemanja tablet, ji lahko svetujete, naj skrajša prihajajočo fazo jemanja rumenih placebo tablet za največ 4 dni.
English: If you want to start Zoely after having a baby and are breast-feeding, see also section 2 ‘Pregnancy and Breast-feeding'.
Slovenian: Če želite začeti z jemanjem zdravila Zoely po porodu in dojite, glejte tudi poglavje 2 "Nosečnost in dojenje".
English: Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking COCs.
Slovenian: Ženske, ki so nagnjene k pojavu kloazme, se morajo med jemanjem COC izogibati izpostavljenosti soncu ali ultravijoličnemu sevanju.
English: The situation is similar to if you forget a white active tablet.
Slovenian: To je podobno, kot če bi pozabili vzeti belo aktivno tableto.
English: Consult your doctor before you start with the next blister.
Slovenian: Posvetujte se z zdravnikom, preden nadaljujete z jemanjem tablet iz naslednjega pretisnega omota.
English: The extension can be carried on for as long as wished until the end of the white active tablets in the second pack.
Slovenian: To podaljšanje lahko traja tako dolgo, kot ženska želi, vse do konca jemanja belih tablet z zdravilno učinkovino iz drugega pretisnega omota.
English: There is a dynamic equilibrium between estradiol, estrone and estrone-Sulfate due to various enzymatic activities including estradiol-dehydrogenases, sulfotransferases and aryl sulfatases.
Slovenian: Med estradiolom, estronom in estron sulfatom obstaja dinamično ravnovesje zaradi delovanja različnih encimov, na primer estradiol dehidrogenaz, sulfotransferaz in aril sulfataz.
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 uporabo katerih koli CHC napotiti po nasvet k specialistu.
English: • Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal, or retinal veins and arteries.
Slovenian: • Pri uporabnicah CHC so izredno redko poročali o nastanku tromboze tudi v drugih krvnih žilah, npr. v jetrnih, mezenteričnih, ledvičnih, mrežničnih venah in arterijah.
English: If absence of withdrawal bleeding occurs and Zoely has been taken according to the instructions as described in section 4.2, it is unlikely that the woman is pregnant.
Slovenian: Če ženska nima odtegnitvene krvavitve, čeprav je zdravilo Zoely jemala v skladu z navodili iz poglavja 4.2, je malo verjetno, da bi bila noseča.
English: It is important to remember that the overall risk of a harmful blood clot due to Zoely is small.
Slovenian: Zavedati se je treba, da je celokupno tveganje za nevarne krvne strdke zaradi jemanja zdravila Zoely majhno.
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 bližjih družinskih članov krvni strdek v nogi, pljučih ali kakšnem drugem organu v mlajših letih (npr. pred približno 50. letom starosti).
English: You can also start, at the latest, on the day you would have started using the next ring or patch.
Slovenian: Z jemanjem zdravila lahko začnete najpozneje na dan, ko bi začeli uporabljati naslednji obroček ali obliž.
English: • if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
Slovenian: • če imate Crohnovo bolezen ali ulcerozni kolitis (kronična vnetna bolezen črevesja);
English: Positive family history (venous thromboembolism ever in a sibling or parent especially at a relatively early age, e.g., before 50)
Slovenian: Pozitivna družinska anamneza (venska trombembolija kadar koli pri sorojencu ali staršu, še zlasti v razmeroma zgodnji starosti, npr. pred 50. letom)
English: Picture
Slovenian: Slika
English: When changing from a progestogen-only pill (minipill) You can stop taking the minipill any day and start taking Zoely the next day.
Slovenian: Prehod z jemanja izključno progestogenske tabletke (mini tabletke) Mini tabletko lahko prenehate jemati kateri koli dan in začnete jemati zdravilo Zoely naslednji dan.
English: With all COCs, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.
Slovenian: Pri vseh COC lahko nastopijo neredne krvavitve (krvavi madeži ali vmesne krvavitve), še posebej v prvih mesecih uporabe.
English: What can happen if a blood clot forms in an artery?
Slovenian: Kaj se lahko zgodi, če nastane krvni strdek v arteriji?
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 of VTE should be considered.
Slovenian: Če ima ženska več kot en dejavnik tveganja, je lahko povečanje tveganja večje od seštevka posameznih dejavnikov - v takšnem primeru je treba upoštevati njeno celotno tveganje za VTE.
English: Stickers marked with the 7 days of the week are provided.
Slovenian: Zdravilu so priložene nalepke, označene s posameznimi dnevi tedna.
English: Zoely contains estradiol instead of ethinylestradiol.
Slovenian: Zdravilo Zoely namesto etinilestradiola vsebuje estradiol.
English: • It is not yet known how the risk of VTE with CHCs that contain nomegestrol acetate in combination with estradiol compares with the risk with low dose levonorgestrel-containing CHCs.
Slovenian: • Ni še znano, kakšno je tveganje za VTE pri CHC, ki vsebujejo nomegestrolacetat v kombinaciji z estradiolom, v primerjavi s tveganjem pri CHC, ki vsebujejo majhen odmerek levonorgestrela.
English: Place the label on the blister over the words ‘Place day label here'.
Slovenian: Oznako prilepite na pretisni omot čez besede "sem prilepite nalepko z dnevnimi oznakami".
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 povezale uporabo CHC s povečanim tveganjem za arterijsko trombembolijo (miokardni infarkt) ali cerebrovaskularni dogodek (npr. tranzitorna ishemična ataka, možganska kap).
English: The decision to prescribe Zoely should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Zoely compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Slovenian: Pri odločitvi, da predpišete zdravilo Zoely, je treba upoštevati trenutne dejavnike tveganja pri posameznici, zlasti za vensko trombembolijo (VTE) in kakšno je tveganje za VTE pri zdravilu Zoely v primerjavi z drugimi kombiniranimi hormonskimi kontraceptivi (CHC - combined hormonal contraceptives) (glejte poglavji 4.3 in 4.4).
English: • dry eye; contact lens intolerance
Slovenian: • suho oko, neprenašanje kontaktnih leč
English: No epidemiological data on the risk of cervical cancer in users of Zoely are available.
Slovenian: Epidemiološki podatki o tveganju za nastanek raka materničnega vratu pri uporabnicah zdravila Zoely niso na voljo.
English: The shorter the interval, the higher the risk that she does not have a withdrawal bleed and may experience breakthrough-bleeding and spotting during the subsequent pack (just as when delaying a period).
Slovenian: Krajši ko je ta čas, večje je tudi tveganje, da ne bo imela odtegnitvene krvavitve in bo lahko imela vmesne krvavitve in krvave madeže med jemanjem tablet iz naslednjega pretisnega omota (enako kot pri odložitvi menstruacije).
English: • Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
Slovenian: • Zelo redko se strdki pojavijo v veni drugega organa, kot je oko (tromboza mrežnične vene).
English: If you want to stop Zoely because you want to get pregnant, see in section 3 ‘If you stop taking Zoely'.
Slovenian: Če želite prenehati z uporabo zdravila Zoely, ker želite zanositi, glejte poglavje 3 "Če prenehate z jemanjem zdravila Zoely".
English: When no hormonal contraceptive has been used in the past month Start taking Zoely on the first day of your cycle (i.e. the first day of your menstrual bleeding).
Slovenian: Če v preteklem mesecu niste uporabljali hormonskega kontraceptiva Zdravilo Zoely začnite jemati na prvi dan ciklusa (tj. na prvi dan menstrualne krvavitve).
English: • Estradiol, the oestrogen in Zoely, is identical to the hormone produced by your ovaries during a menstrual cycle.
Slovenian: • Estradiol, to je estrogen v zdravilu Zoely, je popolnoma enak hormonu, ki nastaja v jajčnikih v času menstrualnega ciklusa.
English: • change in colour of the skin on the leg e.g. turning pale, red or blue
Slovenian: • spremenjena barva kože na nogi, npr. bleda, pordela ali pomodrela koža,
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and oestrogens, fixed combinations, ATC code: G03AA14.
Slovenian: Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, progestogeni in estrogeni, enofazni pripravki, oznaka ATC: G03A A14
English: Stop taking the white active tablets and start taking the yellow placebo tablets for a maximum of 3 days so that the total number of placebo plus missed white active tablets is not more than 4.
Slovenian: Prenehajte z jemanjem belih aktivnih tablet in začnite z jemanjem rumenih placebo tablet za največ 3 dni, tako da skupno število placebo tablet ter pozabljenih belih aktivnih tablet ni več kot 4.
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 za nastanek 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: • There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.
Slovenian: • O možni vlogi varikoznih ven in povrhnjega tromboflebitisa pri pojavu ali napredovanju venske tromboze ni soglasja.
English: The percentage of women using Zoely experiencing intracyclic bleeding after this adaptation period ranged from 15-20 %.
Slovenian: Odstotek žensk, ki jemljejo zdravilo Zoely in imajo krvavitve v času posameznega ciklusa tudi po tem obdobju prilagajanja na zdravilo, se je gibal med 15 % in 20 %.
English: • Nomegestrol acetate, the progestogen in Zoely, is derived from the hormone progesterone.
Slovenian: • Nomegestrolacetat, to je progestogen v zdravilu Zoely, nastane iz hormona progesterona.
English: • golden brown pigment patches, mostly in the face; excessive hair growth
Slovenian: • rumeno rjave pigmentne lise, večinoma na obrazu, čezmerna poraščenost
English: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, e.g., corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
Slovenian: Uporaba kontracepcijskih steroidov lahko vpliva na izvide določenih laboratorijskih preiskav, vključno z biokemičnimi parametri delovanja jeter, ščitnice, nadledvične žleze in ledvic, plazemskimi koncentracijami (prenašalnih) proteinov, npr. vezavnega globulina za kortikosteroide in lipidno/lipoproteinsko frakcijo, parametri presnove ogljikovih hidratov ter parametri koagulacije in fibrinolize.
English: The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time.
Slovenian: Tveganje za nastanek krvnega strdka v veni je največje v prvem letu prvega jemanja kombiniranega hormonskega kontraceptiva.
English: Deep vein thrombosis
Slovenian: Globoka venska tromboza
English: Risk factors for VTE
Slovenian: Dejavniki tveganja za VTE
English: • if you have liver disease (for instance jaundice) or gallbladder disease (for instance gallstones);
Slovenian: • če imate bolezen jeter (na primer zlatenico) ali bolezen žolčnika (na primer žolčne kamne);
English: • if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50).
Slovenian: • če je imel vaš bližnji sorodnik srčni infarkt ali možgansko kap v mlajših letih (pred približno 50. letom starosti).
English: Nomegestrol acetate is excreted via urine and faeces.
Slovenian: Nomegestrolacetat se izloča prek urina in blata.
English: The pharmacokinetics of nomegestrol acetate (primary objective) after single oral dosing of Zoely in healthy postmenarcheal female adolescents and adult subjects were similar.
Slovenian: Farmakokinetika nomegestrolacetata (primarni cilj) po enkratnem peroralnem odmerku zdravila Zoely pri zdravih mladostnicah po menarhi je bila podobna kot pri odraslih preiskovankah.
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, kajti nekatere od teh simptomov, kot sta kašelj ali kratka sapa, je mogoče zamenjati za kakšno blažjo motnjo, kot je okužba dihal (npr. "navaden prehlad").
English: Average steady state plasma concentrations are 4 ng/mL.
Slovenian: Povprečna plazemska koncentracija zdravila v stanju dinamičnega ravnovesja je 4 ng/ml.
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 nogah ali v predelu medenice, nevrokirurška operacija ali večja poškodba
English: Factors that increase your risk of a blood clot in a vein The risk of a blood clot with Zoely is small but some conditions will increase the risk.
Slovenian: Dejavniki, ki povečujejo tveganje za nastanek krvnega strdka v veni Tveganje za nastanek krvnega strdka je z zdravilom Zoely majhno, vendar pa nekatera stanja to tveganje povečajo.
English: What Zoely is and what it is used for What you need to know before you use Zoely How to use Zoely
Slovenian: Kaj je zdravilo Zoely in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zoely Kako uporabljati zdravilo Zoely Možni neželeni učinki
English: If you have taken your tablets correctly in the 7 days prior to the missed tablet, the protection against pregnancy is not reduced, and you do not need to use extra precautions.
Slovenian: Če ste pravilno jemali tablete v 7 dneh pred pozabljeno tableto, zaščita pred zanositvijo ni zmanjšana, zato dodatni ukrepi niso potrebni.
English: The woman should choose the sticker that starts with the day she begins taking the tablets and stick it on the blister.
Slovenian: Ženska naj izbere nalepko z dnevom v tednu, ko začne jemati tablete, in jo prilepi na pretisni omot.
English: Cycle control
Slovenian: Nadzor menstrualnega ciklusa
English: If this is not the case, she should follow the first of these two options and use extra precautions for the next 7 days as well.
Slovenian: V nasprotnem primeru se mora držati prve od obeh možnosti in naslednjih 7 dni uporabljati še dodatno kontracepcijsko metodo.
English: Each yellow placebo film-coated tablet contains 61.76 mg of lactose monohydrate.
Slovenian: Ena rumena placebo filmsko obložena tableta vsebuje 61,76 mg laktoze monohidrata.
English: COC tablets (including Zoely tablets) no longer required should not be disposed via wastewater or the municipal sewage system.
Slovenian: COC tablet (vključno s tabletami Zoely), ki jih ne uporabljate več, ne smete odvreči v odpadne vode ali v sistem javne kanalizacije.
English: • if you are going to use other medicines (see also in section 2 ‘Other medicines and Zoely');
Slovenian: • če boste jemali druga zdravila (glejte tudi poglavje 2 "Druga zdravila in zdravilo Zoely");
English: • if you have any of the following diseases 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 povečajo tveganje za nastanek strdka v arterijah: hudo sladkorno bolezen s poškodovanimi krvnimi žilami zelo visok krvni tlak zelo visoko koncentracijo maščob v krvi (holesterola ali trigliceridov) motnjo, imenovano hiperhomocisteinemija;
English: • if you are very overweight (body mass index or BMI over 30 kg/m
Slovenian: • če imate zelo prekomerno telesno maso (indeks telesne mase [ITM] več kot 30 kg/m
English: Women using medications containing oestrogens other than ethinylestradiol, such as estradiol, had a rate of ALT elevation similar to those not receiving any oestrogens; however, due to the limited number of women taking these other oestrogens, caution is warranted for co-administration with the combination drug regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
Slovenian: Pri ženskah, ki so jemale zdravila z drugim estrogenom, z izjemo etinilestradiola, kot je na primer estradiol, je bilo zvišanje vrednosti ALT podobno kot pri ženskah, ki niso prejemale estrogenov; zaradi omejenega števila žensk, ki so jemale druge estrogene, je potrebna previdnost pri sočasnem jemanju kombinacije učinkovin ombitasvir/paritaprevir/ritonavir z dasabuvirjem ali brez.
English: • disease of the gallbladder
Slovenian: • bolezen žolčnika
English: Your doctor will discuss with you what other form of birth control would be more appropriate.
Slovenian: Zdravnik se bo z vami pogovoril o drugih, bolj primernih načinih preprečevanja neželene nosečnosti.
English: For breast-feeding women see section 4.6.
Slovenian: Za doječe matere glejte poglavje 4.6.
English: If, after having a baby, you have had sexual intercourse before starting Zoely, be sure that you are not pregnant or wait until the next menstrual period.
Slovenian: Če ste po porodu imeli spolne odnose pred začetkom jemanja zdravila Zoely, morate preveriti, ali ste noseči, oziroma počakati do naslednje menstruacije.
English: • in the arteries (referred to as an ‘arterial thrombosis', ‘arterial thromboembolism' or ATE).
Slovenian: • v arterijah (govorimo o "arterijski trombozi", "arterijski trombemboliji" ali ATE).
English: Risk increases substantially as BMI increases.
Slovenian: Tveganje se z naraščanjem ITM bistveno povečuje.
English: If you want to change the starting day of your period If you take the tablets according to the instructions, then your period will begin during the placebo days.
Slovenian: Če želite spremeniti datum začetka menstruacije Če tablete jemljete v skladu z navodili, se vam bo menstruacija začela v dneh jemanja placebo tablet.
English: You must not use Zoely if you have any of the conditions listed below.
Slovenian: Zdravila Zoely ne smete uporabljati, če imate katero od spodaj naštetih stanj.
English: The Zoely blister contains 28 tablets: 24 white tablets with the active substances (number 1-24) and 4 yellow tablets without active substances (number 25-28).
Slovenian: Pretisni omot zdravila Zoely vsebuje 28 tablet: 24 belih tablet z zdravilnima učinkovinama (številke 1-24) in 4 rumene tablete brez zdravilnih učinkovin (številke 25-28).
English: The last 4 yellow tablets of the fourth row are placebo tablets which do not contain active substances.
Slovenian: Zadnje 4 rumene tablete v četrti vrsti so placebo tablete, ki ne vsebujejo zdravilnih učinkovin.
English: If you discover that a child has taken Zoely, ask your doctor for advice.
Slovenian: Če ugotovite, da je otrok zaužil zdravilo Zoely, se posvetujte z zdravnikom.
English: • The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss.
Slovenian: • Poročali so, da se naslednje bolezni ali motnje pojavijo ali poslabšajo med nosečnostjo in med uporabo COC, vendar dokazi o povezavi s COC niso dokončni: zlatenica in/ali pruritus povezan s holestazo, nastanek žolčnih kamnov, porfirija, sistemski eritematozni lupus, hemolitično uremični sindrom, Sydenhamova horeja, herpes gestationis, izguba sluha zaradi otoskleroze.