FrancophonIA/ELRC3.0 huggingface dataset:
English: Population pharmacokinetic analyses showed that age (range: 18 to 94 years) does not have a clinically meaningful influence on the pharmacokinetics of apalutamide.
Slovenian: Rezultati populacijske farmakokinetične analize kažejo, da starost (v okviru od 18 do 94 let) nima klinično pomembnega vpliva na farmakokinetiko apalutamida.
English: • falls or fractures (broken bones) - these are very common (may affect more than 1 in
Slovenian: • padci ali zlomi (zlom kosti) - lahko so zelo pogosti (pojavijo se lahko pri več kot 1 od
English: • If you forget to take Erleada for more than one day - talk to your doctor straight away.
Slovenian: • Če ste zdravilo Erleada pozabili vzeti več kot en dan - se takoj posvetujte z zdravnikom.
English: The risk of seizure may be increased in patients receiving concomitant medicinal products that lower the seizure threshold.
Slovenian: Tveganje za konvulzije je lahko povečano pri bolnikih, ki sočasno prejemajo zdravila, ki znižujejo prag za konvulzije.
English: • If you are having sex with a pregnant woman - use a condom to protect the unborn baby.
Slovenian: • Če imate spolne odnose z nosečnico, morate uporabljati kondom, da boste zaščitili nerojenega otroka.
English: • Erleada must not be taken by women who are pregnant, may become pregnant, or who are breast-feeding.
Slovenian: • Zdravilo Erleada ne smejo jemati ženske, ki so noseče, bi lahko bile noseče, ali dojijo.
English: Erleada works by blocking the activity of hormones called androgens (such as testosterone).
Slovenian: Zdravilo Erleada zavira aktivnost hormonov, ki jih imenujemo androgeni (kot je testosteron).
English: The reduction in plasma concentrations can be substantial, and lead to lost or reduced clinical effect.
Slovenian: Lahko pride do precejšnjega znižanja koncentracij v plazmi, kar lahko vodi v izgubo ali zmanjšanje njihovega kliničnega učinka.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: • blood test showing high level of cholesterol in the blood
Slovenian: • preiskave krvi pokažejo povišano koncentracija holesterola v krvi
English: Adverse reactions in the event of an overdose has not yet been observed, it is expected that such reactions would resemble the adverse reactions listed in section 4.8.
Slovenian: Neželenih učinkov v primeru prevelikega odmerjanja še niso opazili, verjetno pa bi bili podobni neželenim učinkom, ki so navedeni v poglavju 4.8.
English: Among patients with skin rash, dose interruption occurred in 28% and dose reduction occurred in 12% (see section 4.2).
Slovenian: Bolniki s kožnim izpuščajem so odmerjanje zdravila prekinili v 28%, v 12% pa so zmanjšali odmerek zdravila (glejte poglavje 4.2).
English: • you are a woman who is pregnant or may become pregnant (see the Pregnancy and contraception section below for more information).
Slovenian: - če ste ženska, ki je noseča ali bi lahko zanosila (za več informacij glejte spodaj poglavje z naslovom Nosečnost in informacije o kontracepciji za moške in ženske).
English: Adverse reaction and frequency
Slovenian: Neželeni učinek in pogostnost
English: Use contraception during treatment and for 3 months after stopping.
Slovenian: Kontracepcijo morate uporabljati med zdravljenjem in še 3 mesece po prekinitvi.
English: If you are taking any medicines, talk to your doctor or pharmacist to see if they are associated with an increased risk of seizure, bleeding, or heart condition.
Slovenian: Pogovorite se z zdravnikom ali farmacevtom, če jemljete katero koli zdravilo, da se prepričate ali so morda povezana s povečanim tveganjem za epileptične napade, krvavitve ali boleznimi srca.
English: (1) Press and hold
Slovenian: (1) Pritisnite in držite.
English: Effects on male rats were reversible after 8 weeks from the last apalutamide administration.
Slovenian: Spremembe pri samcih podgan so v 8 tednih po zadnjem odmerku apalutamida izzvenele.
English: The mean apparent volume of distribution at steady-state of apalutamide is about 276 L. The volume of distribution of apalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Slovenian: Povprečni navidezni volumen porazdelitve apalutamida v stanju dinamičnega ravnovesja je približno 276 l. Volumen porazdelitve apalutamida je večji od volumna celotne količine vode v telesu, kar kaže na obsežno zunajžilno porazdelitev.
English: Бизнес Парк София, сграда 4 София 1766
Slovenian: Бизнес Парк София, сграда 4
English: • If you are having sex with a woman who can become pregnant - use a condom and another highly effective method of contraception.
Slovenian: • Če imate spolne odnose z žensko, ki lahko zanosi, morate uporabljati kondom in še eno zelo učinkovito metodo kontracepcije.
English: • under-active thyroid which can make you feel more tired and have difficulty getting started in the morning, and blood tests may also show an under-active thyroid
Slovenian: • zmanjšano delovanje ščitnice, zaradi česar se lahko počutite bolj utrujeni in zjutraj težko vstanete, in tudi preiskave krvi lahko pokažejo zmanjšano delovanje ščitnice
English: For the most common adverse reactions, see section 4.8.
Slovenian: Za najbolj pogoste neželene učinke glejte poglavje 4.8.
English: Time to symptomatic progression was defined as time from randomization to development of a skeletal related event, pain/symptoms requiring initiation of a new systemic anti-cancer therapy, or loco-regional tumor progression requiring radiation/surgery.
Slovenian: Čas do simptomatskega napredovanja je bil definiran kot čas od randomizacije do razvoja z okostjem povezanih dogodkov, bolečine/simptomov, ki so zahtevali uvedbo novega sistemskega zdravljenja raka, ali lokalno-regionalno napredovanje tumorja, ki je zahteval obsevanje/operacijo.
English: By blocking the effect of androgens, apalutamide stops prostate cancer cells from growing and dividing.
Slovenian: Z zaviranjem učinka androgenov apalutamid preprečuje celicam raka prostate, da bi se razmnoževale in delile.
English: PSA results were blinded and were not used for treatment discontinuation.
Slovenian: Izvidi PSA so bili slepljeni in jih niso uporabljali za odločanje o prekinitvi zdravljenja.
English: Elderly No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2).
Slovenian: Starostniki Starejšim bolnikom odmerka ni treba prilagajati (glejte poglavji 5.1 in 5.2).
English: Apalutamide treatment decreases tumor cell proliferation and increases apoptosis leading to potent antitumor activity.
Slovenian: Zdravljenje z apalutamidom zmanjša proliferacijo tumorskih celic in poveča obseg apoptoze, kar povzroči močno protitumorsko delovanje.
English: Co-administration with warfarin and coumarin-like anticoagulants should be avoided.
Slovenian: Sočasni uporabi z varfarinom ali kumarinskimi antikoagulansi se je treba izogibati.
English: • feeling very tired
Slovenian: • huda utrujenost
English: Mean absolute oral bioavailability is approximately 100%, indicating that apalutamide is completely absorbed after oral administration.
Slovenian: Povprečje absolutne biološke razpoložljivosti je približno 100%, kar pomeni, da se apalutamid po peroralnem odmerjanju v celoti absorbira.
English: The potential effect of severe renal impairment or end stage renal disease (eGFR ≤29 mL/min/1.73 m2) have not been established due to insufficient data.
Slovenian: Morebiten vpliv hude okvare ledvic oziroma končne ledvične odpovedi (z oceno hitrosti glomerulne filtracije ≤29 ml/min/1,73 m2) ni potrjen, ker je na voljo premalo podatkov.
English: Grade 3 skin rashes (defined as covering > 30% body surface area [BSA]) were reported with Erleada treatment in 5.2% of patients.
Slovenian: O kožnih izpuščajih 3. stopnje (opredeljenih kot izpuščajih, ki pokrivajo > 30% telesne površine [BSA - body surface area]) pri uporabi zdravila Erleada so poročali pri 5,2% bolnikov.
English: You may have an increased risk of side effects.
Slovenian: Poveča se vam lahko tveganje za neželene učinke.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Slovenian: Če niste prepričani, se pogovorite z zdravnikom ali farmacevtom, preden začnete jemati to zdravilo.
English: Extra tablets should not be taken to make up the missed dose.
Slovenian: Dodatnih tablet za nadomestitev pozabljenega odmerka se ne sme vzeti.
English: Half of the patients experienced a fall within 7 days before the fracture event in both treatment groups.
Slovenian: V obeh skupinah je pri približno polovici bolnikov v 7 dneh pred zlomom prišlo do padca.
English: It is not known whether apalutamide or its metabolites are present in semen.
Slovenian: Ni znano, ali so apalutamid ali njegovi presnovki prisotni v spermi.
English: Cardiac disorders not known: QT prolongation (see sections 4.4 and 4.5)
Slovenian: Srčne bolezni neznana: podaljšanje intervala QT (glejte poglavji 4.4 in
English: Long-term animal studies have not been conducted to evaluate the carcinogenic potential of apalutamide.
Slovenian: Dolgotrajnih študij za oceno karcinogenega potenciala apalutamida na živalih niso izvedli.
English: An exposure-QT analysis suggested a concentration-dependent increase in QTcF for apalutamide and its active metabolite.
Slovenian: Analiza izpostavljenosti-QT je pokazala od koncentracije odvisno povečanje QTcF apalutamida in njegovega aktivnega presnovka.
English: Administration of apalutamide to healthy subjects under fasting conditions and with a high-fat meal resulted in no clinically relevant changes in Cmax and AUC.
Slovenian: Dajanje apalutamida zdravim osebam na tešče oziroma skupaj z obrokom z veliko vsebnostjo maščob ni povzročilo klinično pomembnih sprememb Cmax in AUC.
English: Following repeat once-daily dosing, apalutamide exposure (Cmax and area under the concentration curve [AUC]) increased in a dose-proportional manner across the dose range of 30 to 480 mg.
Slovenian: Po ponavljajočem enkrat dnevnem odmerjanju se je izpostavljenost apalutamidu (Cmax in površina pod krivuljo koncentracije [AUC]) povečala sorazmerno z odmerkom v okviru odmerjanja od 30 do 480 mg.
English: The most common adverse reactions are fatigue (30%), skin rash (24% of any grade and 5% Grade 3 or 4), weight decreased (16%), arthralgia (16%), and fall (16%).
Slovenian: Najpogostejši neželeni učinki so utrujenost (30%), kožni izpuščaj (24% vseh stopenj in 5% 3. ali 4. stopnje), zmanjšanje telesne mase (16%), artralgija (16%) in padci (16%).
English: Tell your healthcare provider right away if you notice any of the serious side effects above.
Slovenian: Takoj obvestite zdravnika, če opazite katerega koli od zgoraj navedenih resnih neželenih učinkov.
English: Treatment with apalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer.
Slovenian: Zdravljenje z apalutamidom mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem raka prostate.
English: • blood test showing high level of a type of fat called “triglycerides” in the blood
Slovenian: • preiskave krvi pokažejo povišano koncentracijo vrste maščob, ki jo imenujemo “trigliceridi”, v krvi
English: In the event of an overdose, Erleada should be stopped and general supportive measures should be undertaken until clinical toxicity has been diminished or resolved.
Slovenian: V primeru prevelikega odmerjanja je treba prekiniti jemanje zdravila Erleada in uvesti splošne podporne ukrepe, dokler se klinični znaki toksičnega delovanja zdravila ne zmanjšajo oziroma ne izzvenijo.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Erleada in all subsets of the paediatric population in advanced prostate cancer.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Erleada za vse podskupine pediatrične populacije pri raku prostate.
English: This medicine contains less than 1 mmol sodium (23 mg) per 240 mg dose (4 tablets), that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 240 mg odmerek (4 tablete), kar v bistvu pomeni ‘brez natrija'.
English: These studies excluded patients with a history of seizure or predisposing factors for seizure.
Slovenian: V te študije niso vključevali bolnikov z anamnezo konvulzij ali predispozicijskih dejavnikov za konvulzije.
English: Endocrine disorders common: hypothyroidism*
Slovenian: Bolezni endokrinega sistema pogosti: hipotiroidizem*
English: If a dose is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day.
Slovenian: V primeru izpuščenega odmerka je treba zdravilo vzeti čimprej še isti dan, naslednji dan pa naj odmerjanje nadaljuje po običajnem razporedu.
English: Potential for other medicinal products to affect apalutamide exposures
Slovenian: Možnost vpliva drugih zdravil na izpostavljenost apalutamidu
English: Erleada is indicated in adult men for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC) who are at high risk of developing metastatic disease (see section 5.1).
Slovenian: Zdravilo Erleada je indicirano za zdravljenje odraslih moških z nemetastatskim, na kastracijo odpornim rakom prostate (NM-CRPC - non-metastatic castration-resistant prostate cancer), pri katerih obstaja veliko tveganje za razvoj metastatske bolezni (glejte poglavje 5.1).
English: Based on animal studies, Erleada may decrease fertility in males of reproductive potential (see section 5.3).
Slovenian: Na podlagi študij na živalih lahko zdravilo Erleada zmanjša plodnost pri reproduktivno sposobnih moških (glejte poglavje 5.3).
English: The effect of apalutamide 240 mg once daily on the QTc interval was assessed in an open-label, uncontrolled, multi-center, single-arm dedicated QT study in 45 patients with CRPC.
Slovenian: Učinek 240 mg apalutamida enkrat na dan, na interval QTc so ocenili v odprti, nenadzorovani, multicentrični, QT študiji z enim krakom pri 45 bolnikih s CRPC.
English: There are no data available from the use of Erleada in pregnant women.
Slovenian: Podatkov o uporabi zdravila Erleada pri nosečnicah ni na voljo.
English: If a ≥ Grade 3 toxicity or an intolerable adverse reaction is experienced by the patient, dosing should be held rather than permanently discontinuing treatment until symptoms improve to ≤ Grade 1 or original grade, then should be resumed at the same dose or a reduced dose (180 mg or 120 mg), if warranted.
Slovenian: Če se pri bolniku pojavijo toksični učinki ≥ 3. stopnje ali nesprejemljivi neželeni učinki, je treba uporabo zdravila prekiniti začasno in ne dokončno, dokler se simptomi ne izboljšajo na ≤ 1. stopnjo oziroma na začetno stopnjo, nato pa z zdravljenjem nadaljevati z enakim ali manjšim odmerkom (180 mg ali 120 mg), če je potrebno.
English: Following administration of 240 mg once daily, apalutamide steady state was achieved after 4 weeks and the mean accumulation ratio was approximately 5-fold relative to a single dose.
Slovenian: Po odmerjanju 240 mg enkrat na dan je apalutamid dosegel stanje dinamičnega ravnovesja po 4 tednih, povprečno razmerje kopičenja pa je bilo približno 5-kratno v primerjavi z dajanjem enkratnega odmerka.
English: Based on population pharmacokinetic analysis, there were no clinically relevant differences in apalutamide pharmacokinetics between White (Caucasian or Hispanic or Latino; N=761), Black (of African heritage or African American; N=71), Asian (non-Japanese; N=58) and Japanese (N=58).
Slovenian: Na osnovi populacijske farmakokinetične analize niso opazili klinično pomembnih razlik glede farmakokinetike apalutamida med pripadniki bele rase (kavkaškega, hispanskega ali latinskoameriškega porekla), N=761), črne rase (afriškega porekla ali Afroameričanov, N=71), azijske rase (z izjemo Japoncev, N=58) in Japonci (N=58).
English: Apalutamide is a potent enzyme inducer and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected.
Slovenian: Apalutamid je močan induktor encimov in povečuje sintezo mnogih encimov in prenašalcev, zato je mogoče pričakovati interakcije z mnogimi pogosto uporabljanimi zdravili, ki so substrati encimov ali prenašalcev.
English: If treatment is started, patients should be monitored for the adverse reactions listed in section 4.8 and dose reduce as per section 4.2 Posology and method of administration.
Slovenian: Če se je zdravljenje že začelo je treba bolnike spremljati glede neželenih učinkov, navedenih v poglavju 4.8 in zmanjšati odmerek po navodilih v poglavju 4.2 Odmerjanje in način uporabe.
English: • If you forget to take Erleada for the whole day - take your usual dose the following day.
Slovenian: • Če zdravila Erleada niste vzeli že cel dan - vzemite svoj običajni odmerek naslednji dan.
English: What Erleada is and what it is used for
Slovenian: Kaj je zdravilo Erleada in za kaj ga uporabljamo
English: Medicinal products utilised included topical corticosteroids, systemic corticosteroids and oral anti-histamines.
Slovenian: Med zdravili, ki so jih pri tem uporabljali, so bili lokalni kortikosteroidi, sistemski kortikosteroidi in peroralni antihistaminiki.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Erleada.
Slovenian: Če karkoli od zgoraj navedenega velja za vas (ali o tem niste prepričani), se pogovorite z zdravnikom ali farmacevtom, preden začnete jemati zdravilo Erleada.
English: The dose of Erleada or any other medicines that you are taking may need to be changed.
Slovenian: Morda vam bo moral spremeniti odmerek zdravila Erleada ali katerega od drugih zdravil, ki jih jemljete.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: Metabolism is the main route of elimination of apalutamide.
Slovenian: Presnova je glavna pot izločanja apalutamida.
English: Danmark Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
Slovenian: Janssen-Cilag A/S Bregnerødvej 133 DK-3460 Birkerød Tlf: +45 45 94 82 82
English: Metastasis-free survival (MFS) was the primary endpoint, defined as the time from randomisation to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first.
Slovenian: Primarni cilj študije je bilo preživetje brez metastaz (MFS - metastasis-free survival), ki je bilo opredeljeno kot čas od randomizacije do prvega znaka z BICR potrjene prisotnosti oddaljenih metastaz v kosteh ali mehkih tkivih oziroma do smrti iz katerega koli vzroka (kar je nastopilo prej).
English: Apalutamide is an inducer of enzymes and transporters and may lead to an increase in elimination of many commonly used medicinal products.
Slovenian: Apalutamid je induktor encimov in prenašalcev in lahko povzroči povečan obseg odstranjevanja številnih pogosto uporabljanih zdravil.
English: No in vitro inhibition of organic anion transporter 1 (OAT1) was observed.
Slovenian: In vitro niso opazili zaviranja prenašalca organskih anionov 1 (OAT1 - organic anion transporter 1).
English: In Study ARN-509-003, fracture was reported for 11.7% of patients treated with Erleada and 6.5% of patients treated with placebo.
Slovenian: V študiji ARN-509-003 so o zlomih poročali pri 11,7% bolnikov, ki prejemali zdravilo Erleada, in pri 6,5% bolnikov, ki so prejemali placebo.
English: A major metabolite, N-desmethyl apalutamide, exhibited one-third the in vitro activity of apalutamide.
Slovenian: Njegov poglavitni presnovek, N-desmetil apalutamid, izkazuje tretjino in vitro aktivnosti apalutamida.
English: What you need to know before you take Erleada
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Erleada
English: Based on systemic exposure, relative potency, and pharmacokinetic properties, N-desmethyl apalutamide likely contributed to the clinical activity of apalutamide.
Slovenian: Na osnovi sistemske izpostavljenosti, relativne jakosti delovanja in farmakokinetičnih lastnosti N-desmetil apalutamid po vsej verjetnosti prispeva h klinični aktivnosti apalutamida.
English: An increase in apparent clearance (CL/F) was observed with repeat dosing, likely due to induction of apalutamide's own metabolism.
Slovenian: Pri ponavljajočem odmerjanju so opazili povečanje navideznega očistka (CL/F), verjetno zato, ker je apalutamid povzročil indukcijo lastnega metabolizma.
English: Apalutamide is a potent enzyme inducer and may lead to loss of efficacy of many commonly used medicinal products (see section 4.5).
Slovenian: Apalutamid je močan induktor encimov, kar lahko vodi do zmanjšanja učinkovitosti številnih pogosto uporabljanih zdravil (glejte poglavje 4.5).
English: This is because Erleada can affect the way some other medicines work.
Slovenian: To je pomembno zato, ker zdravilo Erleada lahko vpliva na delovanje nekaterih drugih zdravil, pa tudi nekatera druga zdravila lahko vplivajo na delovanje zdravila Erleada.
English: Concomitant use of apalutamide with medicinal products that are sensitive substrates of many metabolising enzymes or transporters (see section 4.5) should generally be avoided if their therapeutic effect is of large importance to the patient, and if dose adjustments cannot easily be performed based on monitoring of efficacy or plasma concentrations.
Slovenian: Sočasni uporabi apalutamida z zdravili, ki so občutljivi substrati več presnovnih encimov ali prenašalcev (glejte poglavje 4.5), se je načeloma treba izogibati, če je terapevtski učinek teh zdravil za bolnika zelo pomemben in njihovega odmerjanja ni mogoče enostavno prilagajati na osnovi spremljanja učinkovitosti ali koncentracij v plazmi.
English: There is no known specific antidote for apalutamide overdose.
Slovenian: Za preveliko odmerjanje apalutamida ni znanega specifičnega antidota.
English: Consistent improvement in MFS with Erleada was observed for all prespecified subgroups, including age, race, region of the world, nodal status, prior number of hormonal therapies, baseline PSA, PSA doubling time, baseline ECOG status and use of bone-sparing agents.
Slovenian: Konzistentno izboljšanje v MFS z zdravilom Erleada so opazili pri vseh vnaprej določenih podskupinah, vključno s starostjo, raso, geografskim področjem, stanjem bezgavk, predhodnim številom hormonskih zdravljenj, začetnim PSA, časom podvojitve PSA, začetnim statusom ECOG in uporabo učinkovin, ki ohranjajo kosti).
English: After oral administration, median time to achieve peak plasma concentration (tmax) was 2 hours (range: 1 to 5 hours).
Slovenian: Po peroralnem odmerjanju je bil mediani čas do dosežene najvišje koncentracije (tmax) 2 uri (od 1 do 5 ur).
English: For patients having sex with female partners of reproductive potential, a condom should be used along with another highly effective contraceptive method during treatment and for 3 months after the last dose of Erleada.
Slovenian: Bolniki, ki imajo spolne odnose z žensko v rodni dobi, morajo med zdravljenjem in še 3 mesece po zadnjem odmerku zdravila Erleada uporabljati kondome skupaj s še katero od drugih visoko učinkovitih metod kontracepcije.
English: Hypothyroidism was reported for 8.1% of patients treated with Erleada and 2.0% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months.
Slovenian: O hipotiroidizmu so poročali pri 8,1% bolnikov, ki prejemali zdravilo Erleada, in pri 2,0% bolnikov, ki so prejemali placebo, in sicer na osnovi meritve vrednosti tirotropina (TSH - tiroideo stimulirajočega hormona), ki so jo izvajali vsake 4 mesece.
English: Erleada may reduce male fertility.
Slovenian: Zdravilo Erleada lahko zmanjša plodnost pri moških.