natgillin/translations-raw huggingface dataset:
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.
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.
It is important to remember that the overall risk of a harmful blood clot due to Zoely is small.
Zavedati se je treba, da je celokupno tveganje za nevarne krvne strdke zaradi jemanja zdravila Zoely majhno.
• if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g., below the age of about 50).
• če je imel kdo od bližjih družinskih članov krvni strdek v nogi, pljučih ali kakšnem drugem organu v mlajših letih (npr. pred približno 50. letom starosti).
You can also start, at the latest, on the day you would have started using the next ring or patch.
Z jemanjem zdravila lahko začnete najpozneje na dan, ko bi začeli uporabljati naslednji obroček ali obliž.
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• če imate Crohnovo bolezen ali ulcerozni kolitis (kronična vnetna bolezen črevesja);
Positive family history (venous thromboembolism ever in a sibling or parent especially at a relatively early age, e.g., before 50)
Pozitivna družinska anamneza (venska trombembolija kadar koli pri sorojencu ali staršu, še zlasti v razmeroma zgodnji starosti, npr. pred 50. letom)
When changing from a progestogen-only pill (minipill) You can stop taking the minipill any day and start taking Zoely the next day.
Prehod z jemanja izključno progestogenske tabletke (mini tabletke) Mini tabletko lahko prenehate jemati kateri koli dan in začnete jemati zdravilo Zoely naslednji dan.
With all COCs, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.
Pri vseh COC lahko nastopijo neredne krvavitve (krvavi madeži ali vmesne krvavitve), še posebej v prvih mesecih uporabe.
What can happen if a blood clot forms in an artery?
Kaj se lahko zgodi, če nastane krvni strdek v arteriji?
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.
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.
Stickers marked with the 7 days of the week are provided.
Zdravilu so priložene nalepke, označene s posameznimi dnevi tedna.
Zoely contains estradiol instead of ethinylestradiol.
Zdravilo Zoely namesto etinilestradiola vsebuje estradiol.
• 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.
• 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.
Place the label on the blister over the words ‘Place day label here'.
Oznako prilepite na pretisni omot čez besede "sem prilepite nalepko z dnevnimi oznakami".
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).
Epidemiološke študije so povezale uporabo CHC s povečanim tveganjem za arterijsko trombembolijo (miokardni infarkt) ali cerebrovaskularni dogodek (npr. tranzitorna ishemična ataka, možganska kap).
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).
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).
• dry eye; contact lens intolerance
• suho oko, neprenašanje kontaktnih leč
No epidemiological data on the risk of cervical cancer in users of Zoely are available.
Epidemiološki podatki o tveganju za nastanek raka materničnega vratu pri uporabnicah zdravila Zoely niso na voljo.
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).
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).
• Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).
• Zelo redko se strdki pojavijo v veni drugega organa, kot je oko (tromboza mrežnične vene).
If you want to stop Zoely because you want to get pregnant, see in section 3 ‘If you stop taking Zoely'.
Če želite prenehati z uporabo zdravila Zoely, ker želite zanositi, glejte poglavje 3 "Če prenehate z jemanjem zdravila Zoely".
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).
Če v preteklem mesecu niste uporabljali hormonskega kontraceptiva Zdravilo Zoely začnite jemati na prvi dan ciklusa (tj. na prvi dan menstrualne krvavitve).
• Estradiol, the oestrogen in Zoely, is identical to the hormone produced by your ovaries during a menstrual cycle.
• Estradiol, to je estrogen v zdravilu Zoely, je popolnoma enak hormonu, ki nastaja v jajčnikih v času menstrualnega ciklusa.
• change in colour of the skin on the leg e.g. turning pale, red or blue
• spremenjena barva kože na nogi, npr. bleda, pordela ali pomodrela koža,
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and oestrogens, fixed combinations, ATC code: G03AA14.
Farmakoterapevtska skupina: spolni hormoni in zdravila za uravnavanje delovanja spolovil, progestogeni in estrogeni, enofazni pripravki, oznaka ATC: G03A A14
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.
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.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives.
Povečano tveganje 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.
• There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.
• O možni vlogi varikoznih ven in povrhnjega tromboflebitisa pri pojavu ali napredovanju venske tromboze ni soglasja.
The percentage of women using Zoely experiencing intracyclic bleeding after this adaptation period ranged from 15-20 %.
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 %.
• Nomegestrol acetate, the progestogen in Zoely, is derived from the hormone progesterone.
• Nomegestrolacetat, to je progestogen v zdravilu Zoely, nastane iz hormona progesterona.
• golden brown pigment patches, mostly in the face; excessive hair growth
• rumeno rjave pigmentne lise, večinoma na obrazu, čezmerna poraščenost
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.
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.
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.
Tveganje za nastanek krvnega strdka v veni je največje v prvem letu prvega jemanja kombiniranega hormonskega kontraceptiva.
Deep vein thrombosis
Globoka venska tromboza
Risk factors for VTE
Dejavniki tveganja za VTE
• if you have liver disease (for instance jaundice) or gallbladder disease (for instance gallstones);
• če imate bolezen jeter (na primer zlatenico) ali bolezen žolčnika (na primer žolčne kamne);
• if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50).
• če je imel vaš bližnji sorodnik srčni infarkt ali možgansko kap v mlajših letih (pred približno 50. letom starosti).
Nomegestrol acetate is excreted via urine and faeces.
Nomegestrolacetat se izloča prek urina in blata.
The pharmacokinetics of nomegestrol acetate (primary objective) after single oral dosing of Zoely in healthy postmenarcheal female adolescents and adult subjects were similar.
Farmakokinetika nomegestrolacetata (primarni cilj) po enkratnem peroralnem odmerku zdravila Zoely pri zdravih mladostnicah po menarhi je bila podobna kot pri odraslih preiskovankah.
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').
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").
Average steady state plasma concentrations are 4 ng/mL.
Povprečna plazemska koncentracija zdravila v stanju dinamičnega ravnovesja je 4 ng/ml.
Prolonged immobilisation, major surgery, any surgery to the legs or pelvis, neurosurgery, or major trauma
Dolgotrajna imobilizacija, večji kirurški poseg, vsak kirurški poseg na nogah ali v predelu medenice, nevrokirurška operacija ali večja poškodba
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.
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.
What Zoely is and what it is used for What you need to know before you use Zoely How to use Zoely
Kaj je zdravilo Zoely in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Zoely Kako uporabljati zdravilo Zoely Možni neželeni učinki
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.
Če ste pravilno jemali tablete v 7 dneh pred pozabljeno tableto, zaščita pred zanositvijo ni zmanjšana, zato dodatni ukrepi niso potrebni.
The woman should choose the sticker that starts with the day she begins taking the tablets and stick it on the blister.
Ženska naj izbere nalepko z dnevom v tednu, ko začne jemati tablete, in jo prilepi na pretisni omot.
Cycle control
Nadzor menstrualnega ciklusa
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.
V nasprotnem primeru se mora držati prve od obeh možnosti in naslednjih 7 dni uporabljati še dodatno kontracepcijsko metodo.
Each yellow placebo film-coated tablet contains 61.76 mg of lactose monohydrate.
Ena rumena placebo filmsko obložena tableta vsebuje 61,76 mg laktoze monohidrata.
COC tablets (including Zoely tablets) no longer required should not be disposed via wastewater or the municipal sewage system.
COC tablet (vključno s tabletami Zoely), ki jih ne uporabljate več, ne smete odvreči v odpadne vode ali v sistem javne kanalizacije.
• if you are going to use other medicines (see also in section 2 ‘Other medicines and Zoely');
• če boste jemali druga zdravila (glejte tudi poglavje 2 "Druga zdravila in zdravilo Zoely");
• 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
• 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;
• if you are very overweight (body mass index or BMI over 30 kg/m
• če imate zelo prekomerno telesno maso (indeks telesne mase [ITM] več kot 30 kg/m
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.
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.
• disease of the gallbladder
• bolezen žolčnika
Your doctor will discuss with you what other form of birth control would be more appropriate.
Zdravnik se bo z vami pogovoril o drugih, bolj primernih načinih preprečevanja neželene nosečnosti.
For breast-feeding women see section 4.6.
Za doječe matere glejte poglavje 4.6.
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.
Če ste po porodu imeli spolne odnose pred začetkom jemanja zdravila Zoely, morate preveriti, ali ste noseči, oziroma počakati do naslednje menstruacije.
• in the arteries (referred to as an ‘arterial thrombosis', ‘arterial thromboembolism' or ATE).
• v arterijah (govorimo o "arterijski trombozi", "arterijski trombemboliji" ali ATE).
Risk increases substantially as BMI increases.
Tveganje se z naraščanjem ITM bistveno povečuje.
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.
Če želite spremeniti datum začetka menstruacije Če tablete jemljete v skladu z navodili, se vam bo menstruacija začela v dneh jemanja placebo tablet.
You must not use Zoely if you have any of the conditions listed below.
Zdravila Zoely ne smete uporabljati, če imate katero od spodaj naštetih stanj.
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).
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).
The last 4 yellow tablets of the fourth row are placebo tablets which do not contain active substances.
Zadnje 4 rumene tablete v četrti vrsti so placebo tablete, ki ne vsebujejo zdravilnih učinkovin.
If you discover that a child has taken Zoely, ask your doctor for advice.
Če ugotovite, da je otrok zaužil zdravilo Zoely, se posvetujte z zdravnikom.
• 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.
• 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.
You may not have your period until you take the yellow placebo tablets at the end of the second blister, but you may have spotting (drops or flecks of blood) or breakthrough bleeding while taking the white active tablets.
Morda ne boste dobili menstruacije, dokler ne boste začeli jemati rumenih placebo tablet ob koncu drugega pretisnega omota, vendar boste lahko imeli krvave madeže (kapljice ali lise krvi) ali vmesne krvavitve med jemanjem belih aktivnih tablet.
Do not start the next blister of Zoely until your doctor has checked that you are not pregnant.
Nemudoma se posvetujte z zdravnikom in ne začnite z jemanjem tablet iz naslednjega pretisnega omota zdravila Zoely, dokler vam zdravnik ne potrdi, da niste noseči.
Six multi-centre clinical trials of up to one year duration were used to evaluate safety of Zoely.
Za ovrednotenje varnosti zdravila Zoely so izvedli šest multicentričnih kliničnih preskušanj v trajanju do enega leta.
In case of long-term treatment with hepatic enzyme-inducing substances another method of contraception should be considered.
V primeru dolgotrajnega zdravljenja z učinkovinami, ki inducirajo jetrne encime, je bolje uporabiti drugo metodo kontracepcije.
If vomiting occurs within 3-4 hours after white tablet-taking, the tablet should be considered as missed and a new tablet should be taken as soon as possible.
Če ženska bruha v času 3 do 4 ur po zaužitju bele tablete, mora ravnati kot v primeru izpuščene tablete in čim prej vzeti novo tableto.
The most appropriate MedDRA term to describe a certain adverse reaction is listed.
Za opis določenega neželenega učinka je uporabljen najprimernejši izraz v skladu z MedDRA terminologijo.
If you vomit or have severe diarrhoea within 3-4 hours of taking a yellow tablet, the reliability of Zoely is maintained.
Če bruhate ali imate hudo drisko v času 3-4 ur po zaužitju rumene tablete, se zanesljivost zdravila Zoely ne spremeni.
• if you have any unexplained bleeding from the vagina.
• če imate kakršne koli nepojasnjene krvavitve iz nožnice;
[In front of day labels intended for second blister:] Blister 2 [In front of day labels intended for third blister:] Blister 3
[pred dnevnimi oznakami za drugi pretisni omot:] 2. pretisni omot [pred dnevnimi oznakami za tretji pretisni omot:] 3. pretisni omot
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.
Če pa je vmes že imela spolni odnos, je treba najprej izključiti nosečnost, preden lahko ženska začne jemati kombinirane peroralne kontraceptive, oziroma mora ženska počakati na prvo menstruacijo.
Reproductive toxicity studies performed with the combination have shown foetotoxicity which is consistent with estradiol exposure.
Študije vpliva na sposobnost razmnoževanja, opravljene s kombinacijo obeh učinkovin, so pokazale fetotoksičnost, ki je ustrezala stopnji izpostavljenosti estradiolu.
Medicinal product interaction studies were not performed with Zoely, but two studies with rifampicin and ketoconazole, respectively, were performed with a higher dosed nomegestrol acetate-estradiol combination (nomegestrol acetate 3.75 mg + 1.5 mg estradiol) in post-menopausal women.
Študij medsebojnih delovanj zdravila Zoely z drugimi zdravili niso izvedli, opravljeni pa sta bili dve študiji z rifampicinom oziroma ketokonazolom ter uporabo kombinacije nomegestrolacetata in estradiola v večjih odmerkih (3,75 mg nomegestrolacetata + 1,5 mg estradiola) pri ženskah po menopavzi.
Active film-coated tablets: white, round and coded ‘ne' on both sides.
Aktivne filmsko obložene tablete so bele in okrogle ter imajo oznako "ne" na obeh straneh.
Risk factors for ATE
Dejavniki tveganja za ATE
• The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use.
• Uporaba katerega koli kombiniranega hormonskega kontraceptiva (CHC) poveča tveganje za nastanek venske trombembolije (VTE) v primerjavi z ženskami, ki CHC ne uporabljajo.
The new tablet should be taken within 24 hours of the usual time of tablet-taking if possible.
Če je mogoče, mora novo tableto vzeti v 24 urah po običajnem času za zaužitje tablete.
In the event of aggravation, or first appearance of any of these conditions or risk factors, the woman should be advised to contact her doctor to determine whether the use of Zoely should be discontinued.
Ženski je treba svetovati, da naj se v primeru poslabšanja ali prvega pojava katerega od navedenih stanj ali dejavnikov tveganja posvetuje z zdravnikom, ki bo presodil, ali je treba uporabo zdravila Zoely prekiniti.
It is important to draw a woman's attention to the information on venous and arterial thrombosis, including the risk of Zoely 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.
Žensko je treba opozoriti na informacije o venski in arterijski trombozi, vključno s tveganjem, ki spremlja zdravilo Zoely v primerjavi z drugimi CHC, s simptomi VTE in ATE, znanimi dejavniki tveganja in z ukrepanjem v primeru suma na trombozo.
• The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis).
• Uporaba kombiniranih hormonskih kontraceptivov je bila povezana z večjim tveganjem za krvne strdke v veni (vensko trombozo).
The risk of arterial thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors (see table).
Tveganje za arterijske trombembolične zaplete ali cerebrovaskularni dogodek je med uporabnicami CHC večje pri ženskah z dejavniki tveganja (glejte preglednico).
• in veins (referred to as ‘venous thrombosis', ‘venous thromboembolism' or VTE)
• v venah (govorimo o "venski trombozi", "venski trombemboliji" ali VTE)
She should then take placebo tablets from the last row for a maximum of 3 days such that the total number of placebo plus missed white active tablets is not more than 4, and subsequently continue with the next blister pack.
Nato mora jemati placebo tablete iz zadnje vrste največ 3 dni, tako da skupno število placebo tablet ter pozabljenih belih aktivnih tablet ni več kot 4, potem pa naj nadaljuje s tabletami iz naslednjega pretisnega omota.
• if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see “Blood clots” section below).
• če opazite možne znake krvnega strdka, ki lahko pomenijo pojav krvnega strdka v nogi (tj. globoka venska tromboza), krvnega strdka v pljučih (tj. pljučna embolija), srčnega infarkta ali možganske kapi (glejte poglavje "Krvni strdki" spodaj).
• if you have (had), or if you may have, cancer of the breast or the genital organs;
• če imate, ste imeli kdaj v preteklosti oziroma bi lahko imeli raka dojk ali spolnih organov;