FrancophonIA/ELRC3.0 huggingface dataset:
English: Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some
Slovenian: Potovanje z letalom (> 4 ure) lahko začasno poveča tveganje za nastanek krvnih strdkov, še zlasti, če imate še kakšne druge naštete dejavnike.
English: 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 IOA, please talk to your doctor.
Slovenian: Če 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 IOA, se posvetujte z zdravnikom.
English: If any of the conditions or risk factors mentioned below is present, the suitability of IOA should be discussed with the woman .
Slovenian: Če je prisotno katero od spodaj navedenih stanj ali dejavnikov tveganja, se je treba z žensko pogovoriti o ustreznosti zdravila IOA.
English: • IOA may also interfere with the working of other medicines - such as the anti-epileptic
Slovenian: • Tudi zdravilo IOA lahko moti delovanje drugih zdravil, npr. antiepileptika lamotrigina.
English: The apparent volume of distribution of nomegestrol acetate at steady-state is 1,645 ± 576 l.
Slovenian: Navidezni porazdelitveni volumen nomegestrolacetata v stanju dinamičnega ravnovesja je 1.645 ± 576 l.
English: Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you
Slovenian: Včasih so lahko simptomi možganske kapi kratkotrajni, s skoraj takojšnjim in popolnim okrevanjem; tudi v takšnem primeru morate poiskati nujno zdravniško pomoč, ker obstaja tveganje za ponovno možgansko kap.
English: If you forget to take IOA
Slovenian: Če ste pozabili vzeti zdravilo IOA
English: • With the use of the higher-dosed COCs (50 µg ethinylestradiol) the risk of endometrial and ovarian cancer is reduced.
Slovenian: • Pri uporabi visoko odmernih KPK (50 µg etinilestradiola) je tveganje za rak endometrija ali jajčnikov zmanjšano.
English: How to store IOA Contents of the pack and other information
Slovenian: Shranjevanje zdravila IOA Vsebina pakiranja in dodatne informacije
English: All data presented below are based upon epidemiological data obtained with CHCs containing ethinylestradiol.
Slovenian: Vsi navedeni podatki temeljijo na epidemioloških podatkih, zbranih pri uporabi KHK, ki vsebujejo etinilestradiol.
English: • if you forgot two tablets or more in the first week of the blister pack and had intercourse in the seven days before (see also in section 3 ‘If you forget to take IOA');
Slovenian: • če ste pozabili vzeti dve tableti ali več v prvem tednu jemanja tablet iz pretisnega omota in ste imeli spolni odnos v sedmih dneh pred tem (glejte tudi poglavje 3 "Če ste pozabili vzeti zdravilo IOA");
English: Orally administered nomegestrol acetate is rapidly absorbed.
Slovenian: Peroralno uporabljen nomegestrolacetat se hitro absorbira.
English: Estradiol circulates in the blood bound to SHBG (37 %) and to albumin (61 %), while only approximately
Slovenian: Estradiol kroži v krvi vezan na SHBG (globulin, ki veže spolne hormone) (37 %) in na albumin (61 %), le približno 1 do 2 % ga je nevezanega.
English: If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant.
Slovenian: Če ste imeli spolni odnos v tednu, preden ste pozabili vzeti tablete, obstaja možnost, da boste zanosili,
English: • 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).
Slovenian: • V nekaterih epidemioloških študijah so pri ženskah, ki so dalj časa (> 5 let) uporabljale KPK, 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).
English: If more than 12 hours elapse, the advice concerning missed tablets, as given in section 4.2 "Management of missed tablets", is applicable.
Slovenian: Če preteče več kot 12 ur, pridejo v poštev nasveti v poglavju 4.2 "Ravnanje v primeru pozabljenih tablet".
English: 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 ethinylestradiolcontaining COCs were taken inadvertently during early pregnancy.
Slovenian: Večina epidemioloških študij ni pokazala niti povečanega tveganja za prirojene napake pri dojenčkih žensk, ki so pred nosečnostjo uporabljale KPK z etinilestradiolom, niti teratogenih učinkov pri tistih ženskah, ki so nevede uporabljale KPK z etinilestradiolom na začetku nosečnosti.
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
Slovenian: • 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);
English: It is unknown whether the amount of estradiol in IOA is sufficient to maintain adequate levels of estradiol in adolescents, especially for bone mass accrual (see section 5.2).
Slovenian: Pediatrična populacija Ni znano, če količina estradiola v zdravilu IOA zadostuje za vzdrževanje ustrezne ravni estradiola pri mladostnikih, še posebej za prirastek kostne mase (glejte poglavje 5.2).
English: • if you have any unexplained bleeding from the vagina.
Slovenian: • če imate kakršne koli nepojasnjene krvavitve iz nožnice.
English: In a randomized, open label trial, 32 women were treated for 6 cycles with IOA.
Slovenian: V randomiziranem, odprtem preskušanju je 32 žensk jemalo zdravilo IOA v času 6 ciklusov.
English: The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the
Slovenian: Verjetnost za nastanek krvnega strdka je lahko večja, če imate še kakšno drugo stanje, ki poveča tveganje (za več informacij o stanjih, ki povečajo tveganje za krvne strdke, in o simptomih krvnih strdkov glejte poglavje 2).
English: IOA is not usually recommended for use during breast-feeding.
Slovenian: Zdravilo IOA običajno ni priporočeno za uporabo med dojenjem.
English: Repeat dose toxicity studies with estradiol, nomegestrol acetate or combination have indicated expected estrogenic and gestagen effects.
Slovenian: Študije toksičnosti večkratnih odmerkov z estradiolom, nomegestrolacetatom ali kombinacijo obeh so pokazale pričakovane estrogenske in gestagenske učinke.
English: If vomiting occurs within 3-4 hours after white tablet-taking, a new tablet should be taken as soon as possible.
Slovenian: Če ženska bruha v času 3 do 4 ur po zaužitju bele tablete, mora čim prej vzeti novo tableto.
English: 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 IOA”).
Slovenian: 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 IOA").
English: Interactions between oral contraceptives and enzyme-inducing medicinal products may lead to breakthrough bleeding and even contraceptive failure.
Slovenian: Interakcije med peroralnimi kontraceptivi in zdravili, ki inducirajo encime, lahko vodijo do pojava vmesnih krvavitev in celo do neučinkovitosti kontracepcije.
English: If absence of withdrawal bleeding occurs and IOA 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 IOA jemala v skladu z navodili iz poglavja 4.2, je malo verjetno, da bi bila noseča.
English: Users of IOA may also miss their withdrawal bleeding although not being pregnant.
Slovenian: Uporabnice zdravila IOA včasih lahko tudi nimajo odtegnitvenih krvavitev, čeprav niso noseče.
English: Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use IOA.
Slovenian: Tudi vsem drugim zdravnikom ali zobozdravnikom, ki vam predpišejo kakršno koli drugo zdravilo (ter farmacevtu, ki vam ta zdravila izda v lekarni), morate povedati, da jemljete zdravilo IOA.
English: In addition, a barrier method such as a condom should be used for the next 7 days.
Slovenian: Poleg tega naj naslednjih 7 dni uporablja tudi pregradno metodo kontracepcije, na primer kondom.
English: • The risk of having a blood clot will vary according to your personal medicinal history (see “Factors that increase your risk of a blood clot” below).
Slovenian: • Tveganje za pojav krvnega strdka je odvisno od vaše osebne zdravstvene preteklosti (glejte "Dejavniki, ki povečujejo tveganje za nastanek krvnega strdka v veni” spodaj)
English: It is important to remember that the overall risk of a harmful blood clot due to IOA is small.
Slovenian: Zavedati se je treba, da je celokupno tveganje za nevarne krvne strdke zaradi jemanja zdravila IOA majhno.
English: Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of IOA in these women is not indicated as long as liver function values have not returned to normal (see section 4.3).
Slovenian: Ker je lahko pri ženskah s hudo jetrno boleznijo okvarjena presnova steroidnih hormonov, pri njih uporaba zdravila IOA ni indicirana, dokler se vrednosti izvidov za oceno delovanja jeter ne povrnejo na normalne vrednosti (glejte poglavje 4.3).
English: • 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
Slovenian: • 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.
English: 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.
Slovenian: Če pa se med uporabo KPK pojavi trajna, klinično pomembna hipertenzija, potem je smiselno, da zdravnik pri ženski ustavi uporabo tablet in ji začne zdraviti hipertenzijo.
English: The contraceptive effect of IOA 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 IOA temelji na medsebojnem vplivu različnih dejavnikov, od katerih so najpomembnejše zavora ovulacije in spremembe sekrecije iz materničnega vratu.
English: For example, it may be that tumours are found more in women on combined pills because they are examined by the doctor more often.
Slovenian: da pri ženskah, ki jemljejo kombinirane kontracepcijske tablete, tumorje pogosteje najdejo zato, ker jih zdravniki pogosteje pregledujejo.
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 KPK izogibati izpostavljenosti soncu ali ultravijoličnemu sevanju.
English: The percentage of women using IOA experiencing intracyclic bleeding after this adaptation period ranged from 15-20 %.
Slovenian: Odstotek žensk, ki jemljejo zdravilo IOA in imajo krvavitve v času posameznega ciklusa tudi po tem obdobju prilagajanja na zdravilo, se je gibal med 15 % in 20 %.
English: In such cases, absence of withdrawal bleeding was not associated with a higher occurrence of breakthrough bleeding/spotting in the subsequent cycles.
Slovenian: teh primerih odsotnost odtegnitvenih krvavitev ni bila povezana z večjo pogostnostjo vmesnih krvavitev ali krvavih madežev v naslednjih ciklusih.
English: See also in section 3 ‘If you vomit or have severe diarrhoea' or in section 2 ‘Other medicines and IOA'.
Slovenian: Glejte tudi poglavje 3 "Če bruhate ali imate hudo drisko" ali poglavje 2 " Druga zdravila in zdravilo IOA".
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 CHC napotiti po nasvet k specialistu.
English: No formal studies were performed to assess pharmacokinetics in ethnic groups.
Slovenian: Etnične skupine Uradnih študij za oceno farmakokinetike pri posameznih etničnih skupinah niso izvedli.
English: If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered.
Slovenian: 7 dneh spolni odnos, je treba upoštevati možnost, da je zanosila.
English: Clinical data on a limited number of exposed pregnancies indicate no adverse effect of IOA on the foetus or neonate.
Slovenian: Klinični podatki na majhnem številu zdravilu izpostavljenih nosečnic niso pokazali nobenega neželenega učinka zdravila IOA na plod ali novorojenčka.
English: If you want to start IOA after having a baby and are breast-feeding, see also section 2 ‘Pregnancy and Breast-feeding'.
Slovenian: Če želite začeti z jemanjem zdravila IOA po porodu in dojite, glejte tudi poglavje 2 "Nosečnost in dojenje".
English: In two randomized, open-label, comparative efficacy-safety trials, more than 3,200 women have been treated for up to 13 consecutive cycles with IOA and more than 1,000 women with drospirenone 3 mg - ethinylestradiol 30 μg (21/7 regimen).
Slovenian: 3.200 žensk v obdobju do 13 zaporednih ciklusov jemalo zdravilo IOA, več kot 1.000 žensk pa drospirenon 3 mg - etinilestradiol 30 μg (21/7 režim).
English: Nomegestrol
Slovenian: Nomegestrolacetat
English: • The more ‘white active tablets' are missed and the closer the missed tablets are to the 4 yellow placebo tablets, the higher the risk of a pregnancy.
Slovenian: • več belih tablet z zdravilno učinkovino, ko je ženska pozabila vzeti, in bližje ko so le-te 4 rumenim placebo tabletam, večje je tveganje za zanositev.
English: You can start IOA between 21 and 28 days after having a baby.
Slovenian: Z jemanjem zdravila IOA lahko začnete med 21. in 28. dnem po porodu.
English: • In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms
Slovenian: • Pri ženskah z dednim angioedemom lahko eksogeni estrogeni sprožijo ali poslabšajo simptome angioedema.
English: Rarely, there may be serious lasting effects or, very
Slovenian: Redko lahko ostanejo resne trajne posledice, zelo redko pa je izid lahko smrten.
English: • if you have systemic lupus erythematosus (SLE - a disease affecting your natural defense system);
Slovenian: • če imate sistemski eritematozni lupus (bolezen, ki prizadene naravni obrambni sistem telesa);
English: The pharmacokinetics of nomegestrol acetate (primary objective) after single oral dosing of IOA in healthy postmenarcheal female adolescents and adult subjects were similar.
Slovenian: Farmakokinetika nomegestrolacetata (primarni cilj) po enkratnem peroralnem odmerku zdravila IOA pri zdravih mladostnicah po menarhi je bila podobna kot pri odraslih preiskovankah.
English: You should ask your doctor how soon after delivery you can start taking IOA.
Slovenian: Vprašajte zdravnika, kako zgodaj po porodu lahko začnete jemati zdravilo IOA.
English: The efficacy of COCs may be reduced in the event of e.g., missed tablets (see section 4.2), gastrointestinal disturbances during active tablet-taking (see section 4.2) or use of concomitant medicinal
Slovenian: Učinkovitost KPK je lahko zmanjšana v primeru npr. pozabljenih tablet (glejte poglavje 4.2), prebavnih težav med jemanjem tablet z zdravilno učinkovino (glejte poglavje 4.2) ali sočasne uporabe drugih zdravil (glejte poglavje 4.5).
English: If, after having a baby, you have had sexual intercourse before starting IOA, 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 IOA, morate preveriti, ali ste noseči, oziroma počakati do naslednje menstruacije.
English: Therefore, the use of COCs should not be recommended until the nursing mother has completely weaned her child and an alternative contraceptive method should be proposed
Slovenian: Zato se uporabe KPK ženskam ne sme priporočiti, dokler popolnoma ne prenehajo dojiti, ženskam, ki želijo dojiti svojega otroka, pa je treba priporočiti kakšno drugo metodo kontracepcije.
English: It is not yet known how the risk with IOA compares with these lower risk products.
Slovenian: Ni še znano, kakšno je tveganje pri zdravilu IOA v primerjavi s temi zdravili, pri katerih je tveganje manjše.
English: Your doctor may decide that IOA needs to be stopped.
Slovenian: Zdravnik bo morda presodil, da je treba uporabo zdravila IOA prekiniti.
English: Although data in renal impaired patients are not available, renal impairment is unlikely to affect the elimination of nomegestrol acetate and estradiol.
Slovenian: Ledvična okvara Čeprav podatki o bolnicah z ledvično okvaro niso na voljo, je malo verjetno, da bi ledvična okvara vplivala na izločanje nomegestrolacetata in estradiola.
English: Medicinal product interaction studies were not performed with IOA, 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.
Slovenian: Študij medsebojnih delovanj zdravila IOA 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.
English: 4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed with IOA.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študij vpliva zdravila IOA na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: Oral contraceptives may affect the metabolism of other medicinal products.
Slovenian: Peroralni kontraceptivi lahko vplivajo na presnovo drugih zdravil.
English: If you discover that a child has taken IOA, ask your doctor for advice.
Slovenian: Če ugotovite, da je otrok zaužil zdravilo IOA, se posvetujte z zdravnikom.
English: The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in COC users, the biological effects of COCs or a
Slovenian: Opaženo povečano tveganje bi lahko bilo posledica zgodnejše diagnoze raka dojke pri uporabnicah KPK, bioloških učinkov KPK ali pa kombinacije obeh dejavnikov.
English: Other medicines and IOA
Slovenian: Druga zdravila in zdravilo IOA
English: A prospective observational study to assess in particular the risk of Venous thromboembolic events (VTE) and ATE in nomegestrol/estradiol users compared with the VTE risk in users of combined oral contraceptives containing levonorgestrel.
Slovenian: Prospektivna opazovalna študija za oceno tveganja za nastanek venskih tromboemboličnih dogodkov (VTE) in ATE pri uporabnicah nomegestrola/estradiola v primerjavi s tveganjem za nastanek VTE pri uporabnicah peroralnih kontraceptivov, ki vsebujejo levonorgestrel.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progestogens and estrogens, 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: Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of COCs.
Slovenian: V primeru ponovitve holestatske zlatenice, ki se je prvič pojavila med nosečnostjo ali med predhodno uporabo steroidnih spolnih hormonov, mora ženska prenehati z uporabo KPK.
English: When changing from a progestogen-only pill (minipill) You can stop taking the minipill any day and start taking IOA the next day.
Slovenian: Prehod z jemanja izključno progestogenske tabletke (mini tabletke) Mini tabletko lahko prenehate jemati kateri koli dan in začnete jemati zdravilo IOA naslednji dan.
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 ter plazemskimi koncentracijami proteinov (prenašalcev), npr. globulinom, ki veže kortikosteroide, in lipidno/lipoproteinsko frakcijo, parametri presnove ogljikovih hidratov ter parametri koagulacije in fibrinolize.
English: With all COCs, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use.
Slovenian: Pri vseh KPK lahko nastopijo neredne krvavitve (krvavi madeži ali vmesne krvavitve), še posebej v prvih mesecih uporabe.
English: If you vomit within 3-4 hours of taking a white active tablet, or you have severe diarrhoea, the active ingredients of your IOA tablet may not have been completely absorbed into your body.
Slovenian: Če ste 3-4 ure po zaužitju bele aktivne tablete bruhali ali imeli hudo drisko, se zdravilni učinkovini iz tablete IOA morda nista popolnoma absorbirali.
English: In these situations it is advisable to discontinue use of the pill (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation.
Slovenian: V takšnih okoliščinah je uporabo kontracepcijskih tablet priporočljivo prekiniti (v primeru elektivne operacije vsaj štiri tedne prej)
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
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: If you vomit or have severe diarrhoea within 3-4 hours of taking a yellow tablet, the reliability of IOA is maintained.
Slovenian: Če bruhate ali imate hudo drisko v času 3-4 ur po zaužitju rumene tablete, se zanesljivost zdravila IOA ne spremeni.
English: In case of long-term treatment with hepatic enzyme-inducing substances another method of contraception should
Slovenian: V primeru dolgotrajnega zdravljenja z učinkovinami, ki inducirajo jetrne encime, je bolje uporabiti drugo metodo kontracepcije.
English: Other signs of vascular occlusion can include: sudden pain, swelling and slight blue discoloration of
Slovenian: Drugi znaki zapore žile lahko vključujejo: nenadno bolečino, oteklost ali modrikavost uda.
English: Average steady state plasma concentrations are 4 ng/ml.
Slovenian: Povprečna plazemska koncentracija zdravila v stanju dinamičnega ravnovesja je 4 ng/ml.