natgillin/translations-raw huggingface dataset:
Refer also to sections “Do not take Ketek”, “Other medicines and Ketek” and “Driving and using
Glejte tudi poglavja "Ne jemljite zdravila Ketek", "Druga zdravila in zdravilo Ketek" in "Vpliv na sposobnost upravljanja vozil in strojev".
What Ketek looks like and contents of the pack
Izgled zdravila Ketek in vsebina pakiranja
As for macrolides, H. influenzae is classified as intermediately susceptible.
Tako kot pri makrolidih se H. influenzae uvršča med srednje občutljive.
No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, however the experience in patients with impaired hepatic function is limited.
Pri bolnikih z blago, zmerno ali hudo okvaro jeter odmerka ni treba prilagoditi, vendar so izkušnje z bolniki, ki imajo okvarjeno delovanje jeter, omejene.
Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.
Bolnikom je treba naročiti, naj prekinejo zdravljenje in se posvetujejo s svojim zdravnikom v primeru pojava znakov in simptomov bolezni jeter kot so anoreksija, zlatenica, temen urin, pruritus ali
Caution is warranted when Ketek is administered to patients taking other medicinal products with the potential to prolong the QT interval (see section 4.4).
Previdnost je potrebna med uporabo zdravila Ketek pri bolnikih, ki jemljejo druga zdravila s potencialom za podaljšanje QT intervala (glejte poglavje 4.4).
Telithromycin has been shown to decrease the Cmax by 34 % and AUC of sotalol by 20 % due to
Dokazano je, da telitromicin zniža Cmax sotalola za 34 %, AUC pa za 20%, zaradi zmanjšane
Ketek is an antibiotic of the type macrolides.
Ketek je makrolidni antibiotik.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Če je lokalna prevalenca odpornosti takšna, da je uporabnost tega zdravila vprašljiva pri vsaj nekaterih vrstah okužb, je po potrebi treba poiskati nasvet strokovnjaka.
• ketoconazole or fluconazole (anti-fungal treatment)
• ketokonazol ali flukonazol (antimikotično zdravljenje),
Visual disturbances included blurred vision, difficulty focusing, and diplopia.
Motnje vida so vključevale zamegljen vid, težave s fokusiranjem in dvojni vid.
Ketek is not recommended as first choice in patients with severe renal impairment (creatinine clearance <30 ml/min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
Ketek se ne priporoča kot zdravilo prve izbire pri hudi okvari ledvic (očistek kreatinina < 30 ml/min) ali pri bolnikih tako s hudo okvaro ledvic kot s hkratno okvaro jeter, saj optimalni odmerek (600 mg) ni na voljo.
Light orange, oblong, biconvex tablet, imprinted with ‘H3647' on one side and ‘400' on the other.
Svetlo oranžne, podolgovate, bikonveksne tablete z oznako ‘H3647' na eni strani in ‘400' na drugi.
When metoprolol (a CYP2D6 substrate) was coadministered with Ketek, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Med sočasno uporabo metoprolola (substrata CYP2D6) in zdravila Ketek, sta se Cmax in AUC metoprolola zvišali za okrog 38%, vendar ni bilo učinka na razpolovno dobo izločanja metoprolola.
In both studies, higher renal elimination was observed in the hepatically impaired patients.
V obeh študijah so pri bolnikih z okvaro jeter opažali večje izločanje skozi ledvice.
If you accidentally take several tablets too many, contact your doctor or pharmacist.
Če po nesreči vzamete nekaj tablet preveč, se posvetujte s svojim zdravnikom ali farmacevtom.
The recommended dose of Ketek for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).
Priporočeni odmerek zdravila Ketek za odrasle in otroke od 12. leta dalje je dve 400 mg tableti enkrat na dan (800 mg enkrat na dan).
If you have kidney problems (severe renal insufficiency) you should take alternating daily doses of 800 mg (two tablets of 400 mg) and 400 mg (one tablet of 400 mg), starting with the 800 mg dose.
Če imate težave z ledvicami (hudo ledvično popuščanje), jemljite izmenično dnevni odmerek 800 mg (dve 400 mg tableti) in 400 mg (ena 400 mg tableta), z začetnim odmerkom 800 mg.
To reduce the potential impact of visual disturbances take the tablets before going to bed (see also
Da zmanjšate možen vpliv težav z vidom, zaužijte zdravilo Ketek pred spanjem (glejte tudi poglavje
• terfenadine or astemizole (allergic problems)
• terfenadin ali astemizol (pri alergijskih težavah)
After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
Po peroralni uporabi radioaktivno označenega telitromicina so določili 76% radioaktivnosti v blatu in 17 % v urinu.
Rapid distribution of telithromycin into tissues results in significantly higher telithromycin concentrations in most target tissues than in plasma.
Zaradi hitre porazdelitve v tkiva je koncentracija telitromicina v večini ciljnih tkiv pomembno višja kot v plazmi.
Diarrhoea, particularly if severe, persistent and /or bloody, during or after treatment with Ketek may be caused by pseudomembranous colitis (see section 4.8).
Driska, zlasti če je huda, trdovratna in/ali krvava, je lahko med zdravljenjem z zdravilom Ketek ali po njem posledica psevdomembranskega kolitisa (glejte poglavje 4.8).
- medicines containing digoxin (for heart disorders) or dabigatran (for prevention of blood clots)
- zdravila, ki vsebujejo digoksin (za zdravljenje srčnih motenj) ali dabigatran (za preprečevanje
- if you have had a liver disease (hepatitis and/or jaundice) while taking Ketek in the past.
- če ste imeli jetrno bolezen (hepatitis in/ali zlatenico) med jemanjem zdravila Ketek kdaj v
Angioneurotic oedema, anaphylactic reactions including anaphylactic shock, hypersensitivity Confusion, hallucination
angionevrotični edem, anafilaktične reakcije vključno z anafilaktičnim šokom, preobčutljivost
Ketek 400 mg tablets are light orange, oblong, biconvex, film-coated tablets imprinted with “H3647” on one side and “400” on the other.
Ketek 400 mg tablete so svetlo oranžne, podolgovate, bikonveksne, filmsko obložene tablete z oznako "H3647" na eni strani in "400" na drugi.
In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
In vivo raziskave s simvastatinom, midazolamom in cisapridom so pokazale močno inhibicijo črevesnega CYP3A4 in zmerno inhibicijo jetrnega CYP3A4.
In in vitro studies the activity of telithromycin was reduced against organisms that express the erythromycin erm(B) or mef(A) related resistance mechanisms.
V študijah in vitro je bila aktivnost telitromicina zmanjšana proti organizmom, ki imajo eksprimirane z erm (B) ali mef (A) povezane mehanizme odpornosti proti eritromicinu.
- if you have kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), do not take Ketek while taking other medicines containing any of the following active substances:
- če imate težave z ledvicami (hudo okvaro ledvic) in/ali težave z jetri (hudo okvaro jeter), ne jemljite zdravila Ketek skupaj z zdravili, ki vsebujejo katero od naslednjih zdravilnih učinkovin:
Colchicine intoxication, including fatal cases, has been reported in patients treated with colchicine and strong CYP 3A4 inhibitors.
O zastrupitvah s kolhicinom, vključno s smrtnimi primeri, so poročali pri bolnikih, zdravljenih s kolhicinom in močnimi zaviralci CYP3A4.
If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking
Če se vam zdi, da imate kakšen neželen učinek, to takoj povejte zdravniku, da vam bo svetoval,
- some calcium channel blockers (e.g. verapamil, nifedipine, felodipine) (for heart disorders).
- nekatere zaviralce kalcijevih kanalčkov (npr. verapamil, nifedipin, felodipin) (za srčne motnje).
For those benzodiazepines which are not metabolised by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Ketek is unlikely.
Pri benzodiazepinih, ki se ne presnavljajo s CYP3A4 (temazepam, nitrazepam, lorazepam), medsebojno delovanje z zdravilom Ketek ni verjetno.
The recommended European Committee for Antimicrobial Susceptibility Testing (EUCAST) MIC clinical breakpoints are presented below:
Spodaj so prikazane priporočene klinične mejne vrednosti MIC po EUCAST (European Committee on
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally been associated with serious underlying diseases or concomitant medicinal products), have been reported (see section 4.8).
V postmarketinškem obdobju so poročali o primerih hudega hepatitisa in odpovedi jeter, vključno s smrtnimi primeri (ki so bili praviloma povezani z resnimi osnovnimi boleznimi ali sočasnimi zdravili) (glejte poglavje 4.8).
This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Posledica so lahko podaljšanje QT intervala in motnje srčnega ritma, vključno z ventrikularno tahikardijo, ventrikularno fibrilacijo in torsade de pointes.
Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Ketek and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
Derivati alkaloidov ergot (kot sta ergotamin in dihidroergotamin) Po ekstrapolaciji z eritromicina A in josamicina bi lahko sočasno zdravljenje z zdravilom Ketek in alkaloidnimi derivati povzročilo hudo vazokonstrikcijo ("ergotizem") z možno nekrozo okončin.
Due to limited experience in patients with decreased metabolic capacity of the liver, Ketek should be used with caution in patients with hepatic impairment (see also section 4.4).
Zaradi omejenih izkušenj pri bolnikih z zmanjšano presnovno kapaciteto jeter je treba zdravilo Ketek pri bolnikih z jetrno okvaro uporabljati previdno (glejte tudi poglavje 4.4).
Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
Telitromicin je zaviralec CYP3A4 in šibki zaviralec CYP2D6.
During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
Med sočasnim zdravljenjem z rifampicinom in telitromicinom v ponavljajočih se odmerkih se je Cmax telitromicina v povprečju znižala za 79%, njegova AUC pa za 86%.
The total clearance (mean ±SD) is approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 22% of this.
Skupni očistek (povprečje ± SD) po intravenski uporabi je približno 58 ± 5 l/h, pri čemer gre okoli 22% tega na račun ledvičnega očistka.
Ketek is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4.
Ketek je zaviralec CYP3A4, zato se ga sme le v posebnih okoliščinah uporabiti med zdravljenjem z drugimi zdravili, ki se presnavljajo s CYP3A4.
If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on,
Če je kateri od teh neželenih učinkov moteč, hud ali med nadaljevanjem zdravljenja ne mine, povejte
Treatment with these agents should be interrupted during Ketek treatment (see section 4.5).
Zdravljenje s temi zdravili je treba med zdravljenjem z zdravilom Ketek prekiniti (glejte poglavje 4.5).
Ketek may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation.
Zdravilo Ketek lahko povzroči motnje vida, še posebej upočasnitev sposobnosti za akomodacijo in sprostitve akomodacije.
Thus, when initiating telithromycin in patients already receiving any of theses immunosuppressive agents, cyclosporin, tacrolimus or sirolimus levels must be carefully monitored and their doses decreased as necessary.
Če se torej telitromicin uvede pri bolnikih, ki že dobivajo katero od teh imunosupresivnih zdravil, je treba koncentracije ciklosporina, takrolimusa ali sirolimusa natančno nadzorovati in njihove odmerke zmanjšati, če je potrebno.
Streptococcus pyogenes that show high-level resistance to erythromycin A are cross-resistant to
Streptococcus pyogenes, ki kažejo veliko odpornost proti eritromicinu A, so navzkrižno odporni proti
In case the combination is considered necessary, the dose of the calcium channel blocker should be reduced and close clinical monitoring of efficacy and safety in the patient should be exercised.
V primeru, da je kombinacija nujna, je treba zmanjšati odmerek zaviralca kalcijevih kanalčkov in pri bolniku skrbno spremljati klinično
Strong CYP3A4 inhibitors must not be co-administered with Ketek in patients with severe renal/or hepatic dysfunction (see section 4.3).
Močni inhibitorji encima CYP-3A4 se ne smejo sočasno uporabljati z zdravilom Ketek pri bolnikih s hudo renalno ali jetrno disfunkcijo (glejte poglavje 4.3).
Very rare side effects (may affect up to 1 in 10,000 people)
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Hence, Ketek should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse reactions can be closely monitored.
Zato se zdravila Ketek ne sme uporabljati med zdravljenjem z zdravili, ki so substrati CYP3A4, razen kadar je mogoče natančno nadzorovati plazemske koncentracije, učinkovitost ali neželene učinke takšnega substrata.
• ergotamine or dihydroergotamine (tablets or inhaler for migraine)
• ergotamin ali dihidroergotamin (tablete ali inhalatorje pri migreni),
No carcinogenicity studies have been conducted with telithromycin.
Raziskav kancerogenosti s telitromicinom ni bilo.
Magyarország sanofi-aventis zrt., Magyarország Tel.: +36 1 505 0050
Magyarország sanofi-aventis zrt., Magyrország Tel: +36 1 505 0050
The exposure of pravastatin, rosuvastatin and to a lesser extent fluvastatin, may be increased due to possible involvement of transporters proteins, but this increase is expected to be lesser than interactions involving CYP3A4 inhibition.
Zdravilo Ketek lahko zaradi možne vpletenosti transportnih proteinov zveča izpostavljenost pravastatinu, rosuvastatinu in v manjši meri fluvastatinu, vendar se pričakuje, da bo to zvečanje manjše kot pri interakcijah, ki vključujejo inhibicijo CYP3A4.
Ketek may produce a similar interaction with lovastatin and atorvastatin which are also mainly metabolised by CYP3A4.
Zdravilo Ketek lahko povzroči podobne interakcije z lovastatinom in atorvastatinom, ki se v glavnem presnavljata s CYP3A4.
In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/2 of telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects.
V študiji posamičnega odmerka (800 mg) pri 12 bolnikih in študiji večkratnih odmerkov (800 mg) pri 13 bolnikih z blago do hudo insuficienco jeter (razred A, B in C po Child-Pughu), so bili Cmax, AUC in t1/2 telitromicina podobni kot pri zdravih preiskovancih, po starosti in spolu usklajenih z bolniki.
No dosage adjustment is required in elderly patients based on age alone.
Starejša populacija: Pri starejših bolnikih odmerka ni treba prilagajati zgolj zaradi starosti.
Concomitant treatment with these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5).
Med sočasno uporabo teh zdravil obstaja možnost za pojav subterapevtskih koncentracij telitromicina in s tem za neuspeh zdravljenja (glejte poglavje 4.5).
When simvastatin was coadministered with Ketek, there was a 5.3-fold increase in simvastatin Cmax, an 8.9-fold increase in simvastatin AUC, a 15-fold increase in simvastatin acid Cmax and an 11-fold increase in simvastatin acid AUC.
Med sočasno uporabo simvastatina in zdravila Ketek so ugotovili 5,3-kratno zvišanje Cmax simvastatina in 8,9-kratno zvišanje njegove AUC ter 15-kratno zvišanje Cmax simvastatinske kisline in 11-kratno zvišanje njene AUC.
There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose triphasic oral contraceptives in healthy subjects.
Pri zdravih preiskovankah ni farmakodinamičnih ali klinično pomembnih farmakokinetičnih interakcij z nizkoodmernimi trifaznimi peroralnimi kontraceptivi.
>0.5 mg/l
Odporni > 0,5 mg/l > 0,5 mg/l > 8 mg/l > 0,5 mg/l
If possible take the tablets before going to bed, to reduce the potential impact of visual disturbances and loss of consciousness.
Če je možno tablete jemljite pred spanjem, da bi se tako zmanjšal možen vpliv na motnje vida in izgubo zavesti.
Concomitant administration with simvastatin, atorvastatin, and lovastatin.
Sočasna uporaba s simvastatinom, atorvastatinom in lovastastinom.
Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
Zaradi potenciala za zaviranje CYP3A4 lahko telitromicin zviša koncentracije teh substratov CYP3A4 v krvi.
If telithromycin treatment is deemed necessary, these patients may be treated with alternating daily doses of 800 mg and 400 mg, starting with the 800 mg
Če je zdravljenje s telitromicinom potrebno, je treba bolnike zdraviti alternirajoče, z izmeničnimi dnevnimi odmerki 800 mg in 400 mg in začetnim odmerkom 800 mg.
Plasma exposures based on free fraction of active substance, at the no observed adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure.
Glede na prosto frakcijo zdravilne učinkovine, je bila plazemska izpostavljenost ob koncentracijah, pri katerih ni opaznih neželenih učinkov, od 1,6- do 13-kratne pričakovane klinične izpostavljenosti.
Because of potential visual difficulties, loss of consciousness, confusion or hallucination, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Ketek.
Zaradi možnih težav z vidom, izgube zavesti, zmedenosti ali halucinacije morajo bolniki med zdravljenjem z zdravilom Ketek omejiti aktivnosti, kot so vožnja motornih vozil, upravljanje s težkimi stroji ali vključevanje v druge nevarne aktivnosti.
These medicines must not be taken with Ketek: - medicinal products to control the blood level of cholesterol or other lipids like simvastatin, atorvastatin, or lovastatin, as the side effects of the medicinal products could be increased.
Z zdravilom Ketek ne smete uporabljati naslednjih zdravil: - zdravila za obvladovanje koncentracije holesterola ali drugih maščob v krvi,kot je simvastatin, atorvastatin ali lovastatin, ker se lahko neželeni učinki zdravil povečajo.
The major CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4.
Glavni encim CYP450, udeležen v presnovi telitromicina, je CYP3A4.
When telithromycin is discontinued, cyclosporin, tacrolimus or sirolimus levels must be again carefully monitored and their dose increased as necessary.
Po koncu uporabe telitromicina je treba koncentracije ciklosporina, takrolimusa ali sirolimusa znova natančno nadzorovati in njihove odmerke zvečati, če je potrebno.
• Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).
Pri bolnikih, starih 12 let in starejših: - Tonzilitisa/faringitisa, ki ga povzroča Streptococcus pyogenes, kot alternativa, kadar betalaktamski antibiotiki niso primerni v državah/regijah s signifikantno prevalenco proti makrolidom odpornega S. pyogenes, če je odpornost posledica ermTR ali mefA (glejte
Streptococcus pneumoniae does not demonstrate cross-resistance between erythromycin A and
Streptococcus pneumoniae ne kaže navzkrižne odpornosti med eritromicinom A in telitromicinom.
Therefore the MIC breakpoint for telithromycin was set to categorise wild-type H. influenzae as having intermediate susceptibility.
Zato je bila mejna vrednost MIC za telitromicin postavljena tako, da opredeljuje občutljivost divjega tipa H. influenzae
If you are breast-feeding do not take Ketek.
Če dojite, ne jemljite zdravila Ketek.
The correlation between macrolide MICs and clinical outcome is weak for H. influenzae.
1Pri H. influenzae je korelacija med MIC makrolidov in kliničnim izidom šibka.
Ketek may cause adverse reactions such as visual disturbances, confusion or hallucination which may reduce the capacity for the completion of certain tasks.
Ketek lahko povzroči neželene učinke, kot so motnje vida, zmedenost ali halucinacije, ki lahko zmanjšajo zmožnost za opravljanje nekaterih nalog.
In some organisms that are resistant to erythromycin A due to inducible expression of the MLSB resistance determinant, the affinity of telithromycin for the 50S ribosomal subunit is more than 20
Pri nekaterih organizmih, ki so zaradi inducibilne ekspresije determinante odpornosti MLSB odporni proti eritromicinu A, je afiniteta telitromicina za ribosomsko podenoto 50S več kot 20-krat tolikšna kot afiniteta eritromicina A.
In patients with severely impaired renal and/or hepatic function, concomitant administration of Ketek and strong CYP3A4 inhibitors, such as protease inhibitors or azole antifungals (e.g. ketoconazole, fluconazole), is contraindicated.
Pri bolnikih s hudo okvarjenim delovanjem ledvic in/ali jeter je sočasna uporaba zdravila Ketek in močnih inhibitorjev CYP3A4, kot so npr. zaviralci proteaz ali azolski antimikotiki (npr. ketokonazol, flukonazol), kontraindicirana.
- The other ingredients are microcrystalline cellulose, povidone (K25), croscarmellose sodium, magnesium stearate in the tablet core as well as talc, macrogol (8000 ), hypromellose (6 cp), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) in the film-coating.
- Pomožne snovi v jedru tablete so mikrokristalna celuloza, povidon (K25), premreženi natrijev karmelozat, magnezijev stearat ter v filmski oblogi smukec, makrogol (8000), hipromeloza (6 cp), titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9,
Telitromicin je zaviralec CYP3A4 in CYP2D6, na CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 in 2E1 pa ima majhen učinek ali ga sploh nima.
There were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified.
V kliničnem programu niso poročali o torsade de pointes ali drugih resnih ventrikularnih aritmijah ali s tem povezanih sinkopah; prav tako niso odkrili nobenih
Calcium channel blockers that are metabolized by CYP3A4
Zaviralci kalcijevih kanalčkov, ki se presnavljajo s CYP3A4
itching, loss of appetite or abdominal pain (uncommon).
izguba apetita ali bolečine v trebuhu (občasno).
Reproduction toxicity studies showed reduced gamete maturation in rat and adverse effects on fertilization.
Raziskave vpliva na sposobnost razmnoževanja so pri podganah pokazale zmanjšano dozorevanje gamet in neželene učinke na oploditev.