natgillin/translations-raw huggingface dataset:
During clinical trials, absence of withdrawal bleeding ranged over the cycles 1-12 from 18 % to 32 %.
V kliničnih preskušanjih je bila odsotnost odtegnitvene krvavitve v ciklusih 1-12 od 18 % do 32 %.
The use of Zoely may need to be stopped several weeks before surgery or while you are less mobile.
Uporabo zdravila Zoely je lahko treba prekiniti več tednov pred kirurškim posegom ali v času zmanjšane gibljivosti.
• if you have (had) severe liver disease and your liver is not yet working normally;
• če imate (oziroma ste kdaj imeli) hudo bolezen jeter in vam jetra še ne delujejo normalno;
Women should be advised to start between day 21 and 28 after delivery or second-trimester abortion.
Ženski svetujte, naj začne tablete jemati med 21. in 28. dnevom po porodu ali splavu v drugem trimesečju.
• If you have taken all the tablets correctly, and you have not vomited or had severe diarrhoea, or used other medicines, then it is very unlikely that you are pregnant.
• Če ste vse tablete vzeli pravilno in niste vmes bruhali ali imeli hude driske oziroma niste jemali drugih zdravil, potem je zelo malo verjetno, da ste noseči.
Tell your doctor if any of the following conditions apply to you.
Povejte zdravniku, če se katero koli od spodnjih stanj nanaša na vas.
The chance of having a blood clot may be higher if you have any other conditions that increase this risk.
Verjetnost za nastanek krvnega strdka je lahko večja, če imate še kakšno drugo stanje, ki poveča tveganje.
Therefore, the evaluation of any irregular bleeding is only meaningful after an adaptation interval of about 3 cycles.
Zato je ocena vseh nerednih krvavitev smiselna šele po končanem obdobju prilagajanja telesa na zdravilo, ki traja približno 3 cikluse.
• if you get migraines, especially migraines with aura;
• če imate migrene, zlasti migrene z avro;
The absolute bioavailability of nomegestrol acetate after a single dose is 63 %.
Absolutna biološka uporabnost nomegestrolacetata po enkratnem odmerku je 63 %.
See ‘Cycle control' in section 4.4.
Glejte tudi "Nadzor ciklusa" v poglavju 4.4.
• painless blurring of vision which can progress to loss of vision
• neboleča zameglitev vida, ki lahko napreduje v izgubo vida;
It is important to note that the risk of a heart attack or stroke from using Zoely is very small but can increase:
Zavedati se je treba, da je tveganje za srčni infarkt ali možgansko kap zaradi uporabe zdravila Zoely zelo majhno, a se lahko poveča:
Progesterone is produced by your ovaries during a menstrual cycle.
Progesteron nastaja v jajčnikih v času menstrualnega ciklusa.
o 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:
o Veliko tveganje za arterijsko trombembolijo zaradi večih dejavnikov tveganja (glejte poglavje 4.4) ali prisotnosti enega resnega dejavnika tveganja, kot je:
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 najmanjšim tveganjem za VTE.
Pack sizes: 28, 84, 168 and 364 film-coated tablets.
Velikosti pakiranj: 28, 84, 168 in 364 filmsko obloženih tablet.
• With the use of the higher-dosed COCs (50 g ethinylestradiol) the risk of endometrial and ovarian cancer is reduced.
• Pri uporabi visoko odmernih COC (50 g etinilestradiola) je tveganje za rak endometrija ali jajčnikov zmanjšano.
EU/1/11/690/001 28 film-coated tablets EU/1/11/690/002 84 film-coated tablets EU/1/11/690/003 168 film-coated tablets EU/1/11/690/004 364 film-coated tablets
EU/1/11/690/001 28 filmsko obloženih tablet EU/1/11/690/002 84 filmsko obloženih tablet EU/1/11/690/003 168 filmsko obloženih tablet EU/1/11/690/004 364 filmsko obloženih tablet
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 je pri ženskah, mlajših od 40 let, rak dojke redka bolezen, je dodatno število diagnoz raka dojke pri ženskah, ki trenutno uporabljajo COC oz. so jih uporabljale pred kratkim, v resnici majhno glede na celokupno tveganje za rak dojke.
For information on return to fertility, see section 5.1.
Za informacije glede ponovne plodnosti glejte poglavje 5.1.
If you get any side effect, particularly if severe or persistent, or have any change to your health that you think may be due to Zoely, please talk to your doctor.
Če se pri vas pojavi kateri koli neželen učinek, zlasti, če je resen ali trdovraten, ali če opazite kakršno koli spremembo svojega zdravstvenega stanja, za katero menite, da bi lahko bila posledica jemanja zdravila Zoely, se posvetujte z zdravnikom.
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 znova začnete jemati kombiniran hormonski kontraceptiv (isto ali kakšno drugo zdravilo) po presledku, ki je trajal 4 tedne ali več.
In the Zoely group, acne was reported by 15.4 % of the women (versus 7.9 % in the comparator group), weight increased was reported by 8.6 % of the women (versus 5.7 % in the comparator group), and abnormal withdrawal bleeding (predominantly absence of withdrawal bleeding) was reported by 10.5 % of the women (versus 0.5 % in the comparator group).
V skupini, ki je jemala zdravilo Zoely, je o aknah poročalo 15,4 % žensk (proti 7,9 % v primerjalni skupini), o povečanju telesne mase 8,6 % žensk (proti 5,7 % v primerjalni skupini) in o nenormalnih odtegnitvenih krvavitvah (predvsem o odsotnosti odtegnitvene krvavitve) 10,5 % žensk (proti 0,5 % v primerjalni skupini).
The following side effects have been linked with the use of Zoely:
Naslednje neželene učinke so povezali z uporabo zdravila Zoely:
In such situations you should not have sexual intercourse or you should take extra non-hormonal contraceptive precautions, e.g., use a condom or another barrier method.
V takšnih primerih ne smete imeti spolnih odnosov oziroma morate uporabljati dodatno nehormonsko kontracepcijo, npr. kondom ali kako drugo pregradno kontracepcijsko metodo.
If your present pill blister also contains inactive (placebo) tablets you can start Zoely on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist).
Če vaš trenutni pretisni omot s tabletami vsebuje tudi neaktivne tablete (placebo), lahko z jemanjem zdravila Zoely začnete dan po tem, ko ste vzeli zadnjo aktivno tableto (če niste prepričani, katera tableta je to, se posvetujte z zdravnikom ali farmacevtom).
Further information on the possible side effect changes to menstrual periods (e.g. absence or irregular) during the use of Zoely is described in section 3 ‘When and how to take the tablets', ‘If you have unexpected bleeding' and ‘If you have missed one or more periods').
Dodatne informacije o možnih neželenih učinkih, ki se kažejo v spremembah menstruacijskega ciklusa (npr. odsotnost menstruacije ali neredne menstruacije) med jemanjem zdravila Zoely so podane v poglavju 3 "Kdaj in kako jemati tablete", "Če imate nepričakovano krvavitev" in "Če niste dobili ene ali več menstruacij").
Another method of contraception should be used to avoid unintentional pregnancy.
Za preprečitev neželene nosečnosti je treba uporabiti drug način kontracepcije.
Most epidemiological studies have revealed neither an increased risk of birth defects in infants born to women who used ethinylestradiol-containing COCs prior to pregnancy, nor a teratogenic effect when ethinylestradiol-containing COCs were taken inadvertently during early pregnancy.
Večina epidemioloških študij ni pokazala niti povečanega tveganja za prirojene napake pri dojenčkih žensk, ki so pred nosečnostjo uporabljale COC z etinilestradiolom, niti teratogenih učinkov pri tistih ženskah, ki so nevede uporabljale COC z etinilestradiolom na začetku nosečnosti.
In two randomized, open-label, comparative efficacy-safety trials, more than 3,200 women have been treated for up to 13 consecutive cycles with Zoely and more than 1,000 women with drospirenone 3 mg - ethinylestradiol 30 μg (21/7 regimen).
V dveh randomiziranih, odprtih primerjalnih preskušanjih učinkovitost in varnosti je več kot 3.200 žensk v obdobju do 13 zaporednih ciklusov jemalo zdravilo Zoely, več kot 1.000 žensk pa drospirenon 3 mg - etinilestradiol 30 μg (21/7 režim).
Allergic (hypersensitive) reactions have been reported in users of Zoely, but the frequency cannot be estimated from the available data.
Pri uporabnicah zdravila Zoely so poročali o alergijskih (preobčutljivostnih) reakcijah, vendar pogostnosti iz razpoložljivih podatkov ni mogoče oceniti.
• Epidemiological studies in women who use low dose (< 50 µg ethinylestradiol) combined hormonal contraceptives have found that out of 10,000 women between 6 and 12 will develop a VTE in one year.
• Epidemiološke študije pri ženskah, ki jemljejo nizkoodmerne kombinirane peroralne kontraceptive (< 50 µg etinilestradiola), so pokazale, da se VTE v enem letu pojavi pri 6 do 12 od 10.000 žensk.
• 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 potrebujete kirurški poseg ali če zaradi poškodbe ali bolezni dolgo časa niste na nogah ali če imate nogo v mavcu.
These methods can be unreliable because the pill alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.
Te metode so lahko nezanesljive, ker tablete spremenijo običajno mesečno spreminjanje telesne temperature in značilnosti sluzi materničnega vratu.
Although data in renal impaired patients are not available, renal impairment is unlikely to affect the elimination of nomegestrol acetate and estradiol.
Čeprav podatki o bolnicah z okvaro ledvic niso na voljo, je malo verjetno, da bi okvara ledvic vplivala na izločanje nomegestrolacetata in estradiola.
• increased liver enzymes
• povečane vrednosti jetrnih encimov
When is the risk of developing a blood clot in a vein highest?
Kdaj je tveganje za nastanek krvnega strdka v veni največje?
Management of missed tablets
Ravnanje v primeru pozabljenih tablet
If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Če je ocenjeno razmerje med koristmi in tveganji negativno, se CHC ne sme predpisati (glejte poglavje 4.3).
If bleeding irregularities persist or occur after previously regular cycles, then non-hormonal causes should be considered and adequate diagnostic measures are indicated to exclude malignancy or pregnancy.
Če neredne krvavitve ne prenehajo ali če se pojavijo po predhodno rednih ciklusih, je treba pomisliti na nehormonske vzroke in opraviti ustrezne diagnostične preiskave za izključitev rakave bolezni ali nosečnosti, na primer kiretažo.
If you vomit or have severe diarrhoea
Če bruhate ali imate hudo drisko
There is a particularly high risk of becoming pregnant if you miss white active tablets at the beginning or at the end of the blister.
Tveganje za zanositev je še posebej veliko, če ste pozabili vzeti belo aktivno tableto na začetku ali na koncu pretisnega omota.
Oestrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs.
Estrogeni se obsežno porazdelijo po telesu in so običajno v večjih koncentracijah navzoči v tarčnih organih za spolne hormone.
Influence of Zoely on other medicinal products
Vpliv zdravila Zoely na druga zdravila
• sudden unexplained breathlessness or rapid breathing;
• nenaden pojav nepojasnjene zadihanosti ali hitrega dihanja;
When using a combined hormonal contraceptive like Zoely you are advised to stop smoking.
Če uporabljate kombiniran hormonski kontraceptiv, kot je zdravilo Zoely, je priporočljivo, da prenehate kaditi.
• The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below).
• Tveganje za pojav krvnega strdka je odvisno od vaše osebne zdravstvene preteklosti (glejte "Dejavniki, ki povečujejo tveganje za nastanek krvnega strdka v veni” spodaj)
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", "kašelj") niso specifični in jih je mogoče zmotno razlagati kot običajne in manj hude dogodke (npr. okužbo dihal).
It is important to check your breasts regularly and you should contact your doctor if you feel any lump.
Pomembno je, da si redno pregledujete dojke in če opazite kakršno koli bulico, se morate posvetovati z zdravnikom.
Therefore, the use of COCs should not be recommended until the breastfeeding mother has completely weaned her child and an alternative contraceptive method should be proposed to women wishing to breastfeed.
Zato se uporabe COC ženskam ne sme priporočiti, dokler popolnoma ne prenehajo dojiti, ženskam, ki želijo dojiti svojega otroka, pa je treba priporočiti kakšno drugo metodo kontracepcije.
After discontinuation of Zoely, return to ovulation in the first 28 days after last tablet intake was observed in 79 % of the women.
Po prekinitvi jemanja zdravila Zoely so pri 79 % žensk opazili povrnitev ovulacije v prvih 28 dneh po zaužitju zadnje tablete.
Important things to know about combined hormonal contraceptives (CHCs):
Pomembne informacije, ki jih morate vedeti o kombiniranih hormonskih kontraceptivih (CHCcombined hormonal contraceptives):
Zoely contains 17β-estradiol.
Zdravilo Zoely vsebuje 17β-estradiol.
All data presented below are based upon epidemiological data obtained with CHCs containing ethinylestradiol.
Vsi navedeni podatki temeljijo na epidemioloških podatkih, zbranih pri uporabi CHC, ki vsebujejo etinilestradiol.
• sharp chest pain which may increase with deep breathing;
• ostra bolečina v prsih, ki se lahko poveča med globokim dihanjem;
Tablets must be taken every day at about the same time without regard to meals.
Tableto mora ženska vzeti vsak dan ob približno istem času, ne glede na obroke.
When you stop Zoely your risk of a blood clot returns to normal within a few weeks.
Ko prenehate jemati zdravilo Zoely, se tveganje za nastanek krvnega strdka v nekaj tednih vrne na normalno raven.
In this case you could also have a higher risk of having a heart attack or stroke;
V takšnem primeru imate morda tudi vi večje tveganje za srčni infarkt ali možgansko kap.
• sudden weakness or numbness of the face, arm or leg, especially on one side of the body;
• nenadna šibkost ali omrtvelost obraza, roke ali noge, zlasti na eni strani telesa;
Please note: If the user is not sure about the number or colour of tablets missed and what advice to follow, a barrier method should be used until she has completed 7 days of uninterrupted white active tablet-taking.
Prosimo, upoštevajte: Če uporabnica ni prepričana o številu ali barvi pozabljenih tablet in kateremu nasvetu slediti, mora uporabljati pregradno metodo, dokler ne zaključi 7-dnevnega obdobja neprekinjenega jemanja belih aktivnih tablet.
What are you possibly suffering from?
Za kaj lahko gre?
If bleeding continues, becomes heavy or starts again, contact your doctor.
Če krvavitev ne preneha, če postane močnejša ali se ponovi, to povejte zdravniku.
28 film-coated tablets 84 film-coated tablets 168 film-coated tablets 364 film-coated tablets
28 filmsko obloženih tablet 84 filmsko obloženih tablet 168 filmsko obloženih tablet 364 filmsko obloženih tablet
You may not have any bleeding during the shortened period of yellow placebo tablet intake.
Morda ne boste imeli nobene krvavitve v skrajšanem času jemanja rumenih placebo tablet.
After having a baby
Po porodu
Dose-linearity was observed in the range 0.625-5 mg (assessed in fertile and post-menopausal women).
Linearno odvisnost so opazili v razponu od 0,625 do 5 mg (merjeno pri plodnih ženskah in pri ženskah po menopavzi).
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).
• Bodite pozorni in pojdite k zdravniku, če menite, da imate simptome krvnega strdka (glejte poglavje 2 "Krvni strdki").
• In women with hereditary angioedema, exogenous oestrogens may induce or exacerbate symptoms of angioedema.
• Pri ženskah z dednim angioedemom lahko eksogeni estrogeni sprožijo ali poslabšajo simptome angioedema.
After drug therapy is discontinued, enzyme induction can last for about 28 days.
Po prenehanju uporabe zdravila lahko indukcija encimov traja še približno 28 dni.
If you have forgotten to take white active tablets in a blister, and you do not have the expected monthly period while taking the yellow placebo tablets from the same blister, you may be pregnant.
Če ste pozabili vzeti bele aktivne tablete iz pretisnega omota in ne dobite pričakovane menstruacije med jemanjem rumenih placebo tablet iz istega pretisnega omota, ste morda noseči.
• swelling of one leg or along a vein in the leg or foot especially when accompanied by:
• oteklost ene noge ali vzdolž vene v nogi ali stopalu, zlasti če jo spremlja:
Schedule: if you are 24 or more hours late taking white tablets
Shema: Če ste zamudili z jemanjem belih tablet 24 ur ali več
• An increased risk of cervical cancer in long-term users of COCs (> 5 years) 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).
• V nekaterih epidemioloških študijah so pri ženskah, ki so dalj časa (> 5 let) uporabljale COC, poročali o povečanem tveganju za nastanek raka materničnega vratu, vendar pa še teče polemika o tem, v kolikšni meri je to odkritje pripisati sočasnim dejavnikom spolnega obnašanja in drugim dejavnikom, kot je na primer humani papiloma virus (HPV).
• as you get older (particularly above about 35 years);
• z višjo starostjo (zlasti nad 35 let);
Start using Zoely when your next injection is due or on the day that your implant or IUS is removed.
Zdravilo Zoely začnite uporabljati, ko bi bila na vrsti naslednja injekcija ali na dan, ko vam odstranijo vsadek ali IUS.
However, if a sustained clinically significant hypertension develops during the use of a COC, then it is prudent for the physician to suspend the intake of the tablets and treat the hypertension.
Če pa se med uporabo COC pojavi trajna, klinično pomembna hipertenzija, potem je smiselno, da zdravnik pri ženski ustavi uporabo tablet in ji začne zdraviti hipertenzijo.
If any of the conditions or risk factors mentioned below is present, the suitability of Zoely should be discussed with the woman.
Če je prisotno katero od spodaj navedenih stanj ali dejavnikov tveganja, se je treba z žensko pogovoriti o ustreznosti zdravila Zoely.
Hepatic metabolism: Interactions can occur with substances that induce CYP450 enzymes, resulting in reduced concentrations of sex hormones and decreased effectiveness of combined oral contraceptives, including Zoely.
Jetrna presnova: Interakcije lahko nastopijo z učinkovinami, ki inducirajo encime CYP450, kar povzroči znižane koncentracije spolnih hormonov in zmanjšano učinkovitost kombiniranih peroralnih kontraceptivov, vključno z zdravilom Zoely.
If the woman missed tablets and subsequently has no withdrawal bleed in the placebo tablet phase, the possibility of a pregnancy should be considered.
Če je ženska izpustila tablete in zato ni imela odtegnitvene krvavitve v fazi jemanja placebo tablet, je treba upoštevati možnost, da je zanosila.
Psychiatric disorders decreased libido, depression/ depressed mood, mood altered increased libido
Psihiatrične motnje zmanjšan libido, depresija oziroma depresivno razpoloženje, spremembe razpoloženja povečan libido
If you need to stop Zoely ask your doctor when you can start using it again.
Če morate prenehati jemati zdravilo Zoely, zdravnika vprašajte, kdaj ga lahko znova začnete uporabljati.
Temporary symptoms suggest the event is a transient ischaemic attack (TIA).
Začasni simptomi kažejo, da gre za tranzitorno ishemično atako (TIA).
• 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);
• če imate (ali ste kdaj imeli) angino pektoris (motnjo, ki povzroči hude bolečine v prsih in je lahko prvi znak srčnega infarkta) ali prehodne ishemične napade (TIA (transient ischemic attack) - prehodni simptomi možganske kapi);
• sudden cough without an obvious cause, which may bring up blood;
• nenaden kašelj, brez očitnega razloga, lahko z izkašljevanjem krvi;
Stick it on the blister, just above the row of white active tablets where it reads ‘Place day label here'.
Prilepite jo na pretisni omot, tik nad vrsto belih aktivnih tablet, kjer piše "sem prilepite nalepko z dnevnimi oznakami".
No clinical studies have been performed in patients with hepatic insufficiency.
Klinične študije pri bolnicah z jetrno insuficienco niso bile opravljene.
• if you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing;
• če imate simptome angioedema, kot so oteklost obraza, jezika in/ali žrela in/ali težave pri požiranju ali koprivnico, skupaj s težavami z dihanjem;
The distribution of exogenous and endogenous estradiol is similar.
Porazdelitev eksogenega in endogenega estradiola je podobna.
In a randomized, open label trial, 32 women were treated for 6 cycles with Zoely.
V randomiziranem, odprtem preskušanju je 32 žensk jemalo zdravilo Zoely v času 6 ciklusov.
Pulmonary embolism
Pljučna embolija
o blood clots in the liver, stomach/intestine, kidneys or eye.
o krvni strdki v jetrih, želodcu/črevesju, ledvicah ali očeh.
Orally administered nomegestrol acetate is rapidly absorbed.
Absorpcija Peroralno uporabljen nomegestrolacetat se hitro absorbira.
In such cases, absence of withdrawal bleeding was not associated with a higher occurrence of breakthrough bleeding/spotting in the subsequent cycles.
V teh primerih odsotnost odtegnitvenih krvavitev ni bila povezana z večjo pogostnostjo vmesnih krvavitev ali krvavih madežev v naslednjih ciklusih.
Other medical conditions associated with adverse vascular events
Druga klinična stanja, povezana z neželenimi žilnimi dogodki
Endometrial histology was investigated in a subgroup of women (n=32) in one clinical study after 13 cycles of treatment.
V eni od kliničnih študij so proučevali rezultate histološke preiskave endometrija pri podskupini žensk (n=32) po 13 ciklusih zdravljenja.
Since the effect of another medicine on Zoely may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long.
Ker učinek drugega zdravila na zdravilo Zoely lahko traja do 28 dni po prenehanju jemanja zdravila, je treba dodatno pregradno metodo kontracepcije uporabljati še tako dolgo.
You should ask your doctor how soon after delivery you can start taking Zoely.
Vprašajte zdravnika, kako zgodaj po porodu lahko začnete jemati zdravilo Zoely.
Zoely is not usually recommended for use during breast-feeding.
Zdravilo Zoely običajno ni priporočeno za uporabo med dojenjem.
You should also tell your doctor if a close relative has, or ever had breast cancer (see section 2 “When to take special care with Zoely”).
Zdravniku morate povedati tudi, če ima kdo od vaših bližnjih sorodnikov raka dojk ali ga je imel kadar koli v preteklosti (glejte poglavje 2 "Kdaj morate biti posebej pozorni pri jemanju zdravila Zoely").
• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)
• če imate težave s srcem (okvaro srčnih zaklopk, motnjo srčnega ritma, ki jo imenujemo atrijska fibrilacija);
What you need to know before you use Zoely
Kaj morate vedeti, preden boste uporabili zdravilo Zoely