FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution, the medicinal product should be used immediately due to the risk of microbiological contamination.
Croatian: Nakon rekonstitucije, lijek treba primijeniti odmah zbog rizika od mikrobiološke kontaminacije.
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Drugi lijekovi i NovoThirteen Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced cardiovascular model in cynomolgus monkey resulted in exaggerated pharmacology (thrombosis and death) at a lower dose level than when administering the individual compounds.
Croatian: Mogući sinergijski učinak kombiniranog liječenja s rFXIII i rFVIIa u uznapredovanom kardiovaskularnom modelu u makaki majmuna rezultirao je pretjeranom farmakološkom reakcijom (tromoboza i smrt) pri nižoj razini doze od one koja se primjenjuje za svaku komponentu pojedinačno.
English: 3 of the patients discontinued the study and returned to their previous treatment.
Croatian: 3 bolesnika su prekinula sudjelovanje u ispitivanju te su vraćeni na prethodnu terapiju.
English: What you need to know before you use NovoThirteen
Croatian: Što morate znati prije nego počnete primjenjivati NovoThirteen
English: Twenty-one children between the age of 6 to less than 18 years old and six children less than 6 years old have been treated with NovoThirteen for a total of 986 exposures.
Croatian: Dvadeset i jedno dijete u dobi između 6 do manje od 18 godina i šestero djece mlađih od 6 godina liječeno je lijekom NovoThirteen za ukupno 986 izlaganja.
English: What NovoThirteen is and what it is used for
Croatian: Što je NovoThirteen i za što se koristi
English: In clinical trials, NovoThirteen has been administered to 82 patients with congenital factor XIII Asubunit deficiency (3112 doses of NovoThirteen).
Croatian: U kliničkim ispitivanjima, NovoThirteen je bio primijenjen u 82 bolesnika s prirođenim nedostatkom A-podjedinice faktora XIII (3112 doze lijeka NovoThirteen).
English: Summary of the safety profile The most frequent adverse reaction is ‘headache' reported in 37% of patients.
Croatian: Najčešća nuspojava je glavobolja koja je prijavljena u 37% bolesnika.
English: Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the vial).
Croatian: Prije okretanja štrcaljke naopako, provjerite da li je klip potisnut do kraja (može se dogoditi da ga tlak u štrcaljki pogura prema van).
English: No clinical findings were associated with these antibodies.
Croatian: Nije bilo kliničkih nalaza povezanih s tim protutijelima.
English: All findings in the non-clinical safety programme have been related to expected exaggerated pharmacology (general thrombosis, ischaemic necrosis and ultimately mortality) of rFXIII and non-proteolytically activated recombinant FXIII at dose levels in excess (>48 fold) of the maximum recommended clinical dose of 35 IU/kg.
Croatian: Svi nalazi u nekliničkom programu sigurnosti odnosili su se na očekivanu pretjeranu farmakološku aktivnost (tromboze, ishemijska nekroza i u krajnjem slučaju smrtnost) rFXIII i neproteolitičkog aktiviranog rekombinantnog FXIII pri razinama doza koje prelaze (>48 puta) maksimalnu preporučenu kliničku dozu od 35 IU/kg.
English: • The risks associated with incorrect storage and mishandling
Croatian: • Rizike povezane s nepravilnim čuvanjem i rukovanjem
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: FXIII activity levels should be monitored in patients with severe hepatic impairment.
Croatian: Razine aktivnosti FXIII moraju se nadzirati u bolesnika s teškim oštećenjem jetre.
English: The reconstituted product must be handled in accordance with section 6.3.
Croatian: Rekonstituiranim lijekom mora se rukovati u skladu s uputama u dijelu 6.3.
English: NovoThirteen is used to prevent bleeding in patients who do not have enough or are missing part of factor XIII (that is called A-subunit).
Croatian: NovoThirteen se koristi za sprječavanje krvarenja u bolesnika koji nemaju dovoljno faktora XIII ili im nedostaje dio faktora XIII (koji se naziva A-podjedinica).
English: Hold the syringe with the vial upside down and pull the plunger to draw up the amount calculated for the injection.
Croatian: Držite štrcaljku s bočicom okrenutom naopako i povucite klip kako biste uvukli količinu izračunatu za injekciju.
English: This dose adjustment should be based on FXIII activity levels.
Croatian: Tada se prilagodba doze temelji na razini aktivnosti FXIII.
English: • Contraindication of hypersensitivity
Croatian: • Kontraindikacija u slučaju preosjetljivosti
English: None of the reported cases have shown any signs of illness.
Croatian: Niti u jednom od prijavljenih slučajeva nije bilo nikakvih komplikacija.
English: The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg) if bw > 24 kg or dose volume in ml = 0.117 x bw (kg) if bw < 24 kg).
Croatian: Volumen doze u mililitrima treba izračunati na temelju tjelesne težine svakog pojedinog bolesnika koristeći sljedeću formulu: Volumen doze u ml = 0,042 x TT bolesnika (kg) ako je TT >24 kg ili je volumen doze u ml = 0,117 x TT (kg) ako je TT <24 kg).
English: Any residual material of the diluted product has to be discarded immediately.
Croatian: Sav otpadni materijal od razrijeđenog lijeka mora se odmah baciti u otpad.
English: One continued to receive rFXIII and the antibodies decreased below detection limit.
Croatian: Jedan bolesnik je nastavio s primjenom rFXIII i titar protutijela se smanjio ispod granice detekcije.
English: It is unknown whether rFXIII is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se rFXIII u majčino mlijeko u ljudi.
English: The recommended dose is 35 IU/kg body weight (bw) once monthly (every 28 days ± 2 days), administered as an intravenous bolus injection.
Croatian: Preporučena doza je 35 IU/kg tjelesne težine (TT) jednom mjesečno (svakih 28 dana ± 2 dana), primijenjena intravenski bolus injekcijom.
English: • Headache (most common side effect)
Croatian: • Glavobolja (najčešća nuspojava)
English: Make sure not to aim the stream of solvent directly at the powder as this will cause foaming.
Croatian: Nemojte usmjeriti mlaz otapala izravno u prašak jer će to izazvati pjenjenje.
English: • Appropriate diagnostic procedures to confirm FXIII A-subunit deficiency
Croatian: • Odgovarajuće dijagnostičke postupke za potvrdu nedostatka A-podjedinice FXIII
English: In case of predisposition to conditions of thrombosis, caution should be exercised due to the fibrinstabilising effect of NovoThirteen.
Croatian: U slučaju povećane sklonosti za trombozu potreban je oprez zbog učinka lijeka NovoThirteen na stabilizaciju fibrina.
English: One patient with pre-existing neutropenia experienced a mild aggravation of neutropenia and leucopenia during treatment with NovoThirteen.
Croatian: Jedan bolesnik s postojećom neutropenijom imao je blago pogoršanje neutropenije i leukopenije tijekom liječenja lijekom NovoThirteen.
English: Patients should be informed of the early signs of hypersensitivity reactions (including hives, generalised urticaria, tightness of the chest, wheezing, hypotension) and anaphylaxis.
Croatian: Bolesnike je potrebno informirati o ranim znakovima reakcija preosjetljivosti (uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje pri disanju, hipotenziju) i anafilaksije.
English: Considering that the posology and the FXIII concentration in NovoThirteen are different from those of the other FXIII containing products, careful attention should be paid to the calculation of the appropriate dose for the individual patient (see dose volume formula provided in section 4.2).
Croatian: Uzimajući u obzir da se doziranje i koncentracija FXIII u lijeku NovoThirteen razlikuju u odnosu na druge lijekove koji sadrže FXIII potrebno je pažljivo izračunati odgovarajuću dozu za svakog bolesnika pojedinačno (vidjeti formulu za volumen doze u dijelu 4.2).
English: The active transglutaminase cross-links fibrin and other proteins resulting in increased mechanical strength and resistance to fibrinolysis of the fibrin clot and contributes to enhanced platelet and clot adhesion to the injured tissue.
Croatian: Aktivna transglutaminaza križnim vezama povezuje fibrin i druge proteine što rezultira povećanom mehaničkom čvrstoćom i otpornošću ugruška fibrina na fibrinolizu i pridonosi poboljšanju prijanjanja trombocita i ugruška uz ozlijeđeno tkivo.
English: Five bleeding episodes requiring treatment with a FXIII-containing product have been observed in four patients during treatment with rFXIII in the trial.
Croatian: Pet epizoda krvarenja koje je potrebno liječiti lijekovima koji sadrže FXIII javilo se tijekom ispitivanja u četiri bolesnika tijekom terapije s rFXIII.
English: General instructions for dilution
Croatian: Opće upute za razrjeđivanje
English: Please see NovoThirteen user instructions.
Croatian: Molimo pogledajte Upute za uporabu lijeka NovoThirteen.
English: Do not use this medicine after the expiry date which is stated on the label and the outer carton after ‘EXP.'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i vanjskoj kutiji iza oznake ‘Rok valjanosti'.
English: • Increased amount of small protein fragments caused by break down of blood clots
Croatian: • Bol u nogama i rukama • Povećana količina malih fragmenata proteina uzrokovana razbijanjem krvnih ugrušaka
English: Following discontinuation of NovoThirteen the patient's neutrophil count returned to levels similar to those prior to treatment with NovoThirteen.
Croatian: Nakon prekida primjene lijeka NovoThirteen broj neutrofila u bolesnika vratio se na razine slične onima prije liječenja lijekom NovoThirteen.
English: One healthy subject developed low-titer, transient non-neutralising antibodies after receiving the first dose of NovoThirteen.
Croatian: Jedan zdravi ispitanik razvio je prolazna ne-neutralizirajuća protutijela niskog titra nakon primanja prve doze lijeka NovoThirteen.
English: Dose adjustment can be considered necessary by the physician in certain situations where the prevention of bleeding is not appropriately covered by the recommended 35 IU/kg/month dose.
Croatian: Liječnik će možda morati prilagoditi dozu u stanjima u kojima nije postignuta zadovoljavajuća prevencija krvarenja uz preporučenu dozu od 35 IU/kg/mjesec.
English: These antibodies were seen at the start of treatment with NovoThirteen.
Croatian: Protutijela su primijećena na početku terapije lijekom NovoThirteen.
English: Although expressed in the same unit (IU), the posology of NovoThirteen is different from the dosing schedule of the other FXIII containing products (see section 4.4).
Croatian: Iako se izražava u istim jedinicama (IU), doziranje lijeka NovoThirteen različito je od sheme doziranja drugih lijekova koji sadrže FXIII (vidjeti dio 4.4).
English: The product is now ready for injection.
Croatian: Lijek je sada spreman za injiciranje.
English: • If you are allergic to catridecacog or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati NovoThirteen • Ako ste alergični na katridekakog ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • Correct handling and the risks associated with mishandling
Croatian: • Ispravno rukovanje i rizici povezani s nepravilnim rukovanjem
English: Non-neutralising antibodies have been seen in 4 of the 82 exposed patients with congenital FXIII deficiency.
Croatian: Ne-neutralizirajuća protutijela primijećena su kod 4 od 82 izložena bolesnika s prirođenim nedostatkom FXIII.
English: The half-life of NovoThirteen was assessed in the F13CD-1725 trial from a limited blood sampling scheme at 1 hour, 14 and 28 days post dose.
Croatian: Poluvijek lijeka NovoThirtheen ocijenjen je u ispitivanju F13CD-1725 na ograničenoj shemi uzimanja uzoraka krvi, 1 sat, 14 dana i 28 dana nakon primijenjene doze.
English: NovoThirteen may not be effective in patients with hepatic impairment if the hepatic impairment is severe enough to result in decreased levels of FXIII B-subunits.
Croatian: NovoThirteen možda neće biti učinkovit u bolesnika s oštećenjem jetre ako je ono dovoljno teško da rezultira sniženim razinama B-podjedinice
English: In patients with FXIII deficiency, NovoThirteen is not effective if used for monthly prophylactic treatment of bleeding in patients with congenital FXIII B-subunit deficiency.
Croatian: U bolesnika s nedostatkom FXIII, NovoThirteen nije učinkovit ako se koristi za mjesečnu profilaksu krvarenja u bolesnika s prirođenim nedostatkom B-podjedinice FXIII.
English: There is limited information on overdose with NovoThirteen.
Croatian: Postoje ograničeni podaci o predoziranju lijekom NovoThirteen.
English: Do not use this medicine if there are particles in it or it is discoloured when reconstituted.
Croatian: Ovaj lijek se ne smije koristiti ako su u njemu čestice ili ako je nakon pripreme za primjenu promijenio boju.
English: For instructions on reconstitution of the medicinal product prior to administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka prije primjene, vidjeti dio 6.6.
English: The dosing scheme used was 35 IU/kg/month (every 28 days ± 2 days).
Croatian: Korištena je shema doziranja od 35 IU/kg/mjesec (svakih 28 ±2 dana).
English: • Embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis
Croatian: • Pojava embolija i tromboza, uključujući povećani rizik od okluzije krvnih žila u bolesnika koji imaju povećan rizik od razvoja tromboze
English: FXIII B-subunit deficiency is associated with a much reduced half-life of the administered pharmacologically active A-subunit.
Croatian: Nedostatak B-podjedinice FXIII povezan je sa znatno kraćim poluvijekom primijenjene farmakološki aktivne A-podjedinice.
English: In this trial the mean volume of distribution at steady state was 47 ml/kg, mean residence time was 15.5 days and mean clearance was 0.13 ml/kg.
Croatian: U tom ispitivanju srednji volumen distribucije u stanju dinamičke ravnoteže bio je 47 ml/kg, srednje vrijeme zadržavanja bilo je 15,5 dana, a srednji klirens 0,13 ml/kg.
English: Based on the actual concentration of NovoThirteen, the volume (in millilitres) to be administered to patients weighing at least 24 kg can be calculated from the formula below:
Croatian: Na temelju stvarne koncentracije lijeka NovoThirteen, volumen (u mililitrima) koji treba primijeniti u bolesnika koji imaju tjelesnu težinu od najmanje 24 kg može se izračunati iz formule u nastavku:
English: Gently swirl the vial until all the powder is dissolved.
Croatian: Nježno vrtite bočicu, dok se sav prašak ne otopi.
English: The active substance is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Croatian: Djelatna tvar je proizvedena u stanicama kvasca (Saccharomyces cerevisiae) tehnologijom rekombinantne DNK.
English: However, based on the therapeutic need the use of NovoThirteen may be considered during pregnancy.
Croatian: Ovisno o terapijskoj potrebi pojedine bolesnice može se razmotriti primjena lijeka NovoThirteen tijekom trudnoće.
English: Take care not to touch the spike on the vial adapter.
Croatian: Pazite da ne dotaknete šiljak nastavka za bočicu.
English: No dose adjustment is required when NovoThirteen is used in paediatric patients and the dose of 35 IU/kg body weight should be used (see section 5.2 ‘Paediatric population').
Croatian: Nije potrebno prilagođavanje doze kad se NovoThirteen koristi u pedijatrijskih bolesnika te je potrebno primjenjivati dozu od 35 IU/kg tjelesne težine (vidjeti dio 5.2 ‘Pedijatrijska populacija').
English: In a post-authorisation safety study transient non-neutralising antibodies were seen in a child with congenital FXIII deficiency after several years of treatment with NovoThirteen.
Croatian: U ispitivanju sigurnosti primjene lijeka nakon dobivanja odobrenja uočena su prolazna ne neutralizirajuća protutijela u djeteta s prirođenim nedostatkom FXIII nakon nekoliko godina liječenja lijekom NovoThirteen.
English: If allergic or anaphylactic-type reactions occur, the administration should be immediately discontinued and further treatment with NovoThirteen should not be given.
Croatian: Ako nastupi alergijska ili anafilaktička reakcija, davanje lijeka treba odmah prekinuti i ne nastavljati s daljnjom terapijom lijekom NovoThirteen.
English: Based on the concentration of NovoThirteen solution, the dose volume to be injected (in millilitres) can be calculated from this formula:
Croatian: Na temelju koncentracije otopine lijeka NovoThirteen, volumen doze (u mililitrima) koju treba injicirati može se izračunati iz ove formule:
English: Powder (2500 IU) in a vial (glass type I) with rubber stopper (chlorobutyl) and 3.2 ml solvent in a vial (glass type I) with rubber stopper (bromobutyl) and a vial adapter for reconstitution.
Croatian: Prašak (2500 IU) u bočici (staklo tipa I) s gumenim čepom (klorbutil) i 3,2 ml otapala u bočici (staklo tipa I) s gumenim čepom (brombutil) i nastavak za bočicu za rekonstituciju.
English: In the primary endpoint analysis covering the referred period, the age-adjusted rate (number per subject year) of treatment-requiring bleeds during the rFXIII treatment period was 0.048/year (95% CI: 0.009 - 0.250; model-based estimate corresponding to the mean age of 26.4 years for the 41 patients).
Croatian: Analizom primarne mjere ishoda za navedeno razdoblje, stopa prilagođena dobi (broj ispitanika-godina) krvarenja za koje je potrebno liječenje tijekom terapije rFXIII bila je 0,048/godini (95% CI: 0,009 - 0,250; procjena na temelju modela odgovara srednjoj dobi od 26,4 godine za 41 bolesnika).
English: The product is now ready for injection in the vein.
Croatian: Lijek je sada spreman za injiciranje u venu.
English: • Pain where the injection is given
Croatian: • Bol na mjestu davanja injekcije
English: Four cases of non-neutralising antibodies were reported at the start of the treatment in patients from 6 to 18 years of age.
Croatian: Na početku liječenja prijavljena su četiri slučaja pojave ne-neutralizirajućih protutijela u bolesnika od 6 do 18 godina.
English: • Warning and precautions regarding anaphylaxis
Croatian: • Upozorenja i mjere opreza u slučaju anafilaksije
English: In this trial, the mean clearance in children was 0.15 ml/h/kg.
Croatian: U ovom ispitivanju, srednja vrijednost klirensa bila je 0,15 ml/h/kg.
English: Long term prophylactic treatment of bleeding in patients with congenital factor XIII A-subunit deficiency.
Croatian: Dugotrajno profilaktično liječenje krvarenja u bolesnika s prirođenim nedostatkom A-podjedinice faktora XIII.
English: NovoThirteen is a recombinant coagulation factor XIII A-subunit produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Croatian: NovoThirteen je rekombinantni koagulacijski faktor A-podjedinice FXIII proizvedene u stanicama kvasca (Saccharomyces cerevisiae) tehnologijom rekombinantne DNK.
English: • The other ingredients are for the powder sodium chloride, sucrose and polysorbate 20, L-histidine, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH adjustment) and for the solvent water for injections.
Croatian: • Drugi sastojci u prašku su natrijev klorid, saharoza i polisorbat 20, L-histidin, kloridna kiselina (za podešavanje pH), natrijev hidroksid (za podešavanje pH), a u otapalu je voda za injekcije.
English: There are no clinical data on the use of NovoThirteen in pregnant women.
Croatian: Nema dostupnih kliničkih podataka o primjeni lijeka NovoThirteen u trudnica.
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Croatian: Natrijev hidroksid (za podešavanje pH)
English: Before you can use NovoThirteen for injection you need to reconstitute the product.
Croatian: Prije nego što možete primijeniti NovoThirteen injekcijom, potrebno ga je pripremiti za primjenu.
English: The FXIII B-subunit acts as a carrier molecule for the FXIII A-subunit in circulation, and is present in excess in plasma.
Croatian: B-podjedinica FXIII djeluje kao molekula nosač za A-podjedinicu FXIII u cirkulaciji i prisutna je u većoj količini u plazmi.
English: Hold the syringe slightly tilted with the vial facing downwards.
Croatian: Držite štrcaljku lagano nagnutu s bočicom okrenutom prema dolje.
English: A pivotal prospective, open-label, single-arm phase 3 trial (F13CD-1725) including 41 patients with FXIII A-subunit deficiency was conducted to investigate the haemostatic efficacy of rFXIII in patients with congenital FXIII deficiency as reflected by the rate of bleeding episodes requiring treatment with a FXIII-containing product.
Croatian: Pivotalno, prospektivno, otvoreno, ispitivanje faze 3 na jednoj skupini (F13CD-1725) obuhvatilo je 41 bolesnika s nedostatkom A-podjedinice FXIII, a provedeno je kako bi se ispitala hemostatska djelotvornost rFXIII u bolesnika s prirođenim nedostatkom FXIII s obzirom na stopu epizoda krvarenja koje je potrebno liječiti lijekovima koji sadrže FXIII.
English: If you stop using NovoThirteen
Croatian: Ako prestanete primjenjivati NovoThirteen
English: If you forget to use NovoThirteen
Croatian: Ako ste zaboravili primijeniti NovoThirteen
English: Frequency descriptions of all adverse reactions identified from 82 patients with congenital FXIII deficiency exposed in clinical trials are presented in the below table by system organ class.
Croatian: Opis učestalosti svih nuspojava, utvrđenih kod 82 bolesnika s prirođenim nedostatkom FXIII koji su sudjelovali u kliničkim ispitivanjima, prikazana je u tablici u nastavku prema klasifikaciji organskih sustava.
English: The mean rate of treatment-requiring bleeds was determined to 0.138 per subject year.
Croatian: Utvrđena prosječna stopa krvarenja za koje je potrebno liječenje iznosila je 0,138 ispitanika-godina.
English: NovoThirteen has no influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima NovoThirteen ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Once prepared, NovoThirteen for injection should be used immediately.
Croatian: Nakon što je NovoThirteen pripremljen za injiciranje, mora se odmah primijeniti.
English: The antibodies had no inhibitory activity, and the subject did not experience any adverse events or bleeding in association with these antibodies.
Croatian: Protutijela nisu imala inhibitorno djelovanje, a u ispitanika se nisu pojavili nikakvi štetni događaji ili krvarenja povezana s tim protutijelima.
English: What NovoThirteen is
Croatian: Što je NovoThirteen
English: The subunit deficiency of patients should be determined prior to treatment by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping.
Croatian: Nedostatak podjedinice u bolesnika mora se potvrditi prije započinjanja liječenja odgovarajućim dijagnostičkim postupcima uključujući određivanje aktivnosti faktora XIII, imunoesejom i, ako je primjenjivo, genotipizacijom.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja rekonstituiranog lijeka, vidjeti dio 6.3.
English: The congenital factor XIII A-subunit deficiency should be confirmed by appropriate diagnostic procedures including factor XIII activity and immunoassay and if applicable genotyping.
Croatian: Prirođeni nedostatak A-podjedinice faktora XIII potrebno je potvrditi odgovarajućim dijagnostičkim postupcima uključujući određivanje aktivnosti faktora XIII, imunoesejom i, ako je primjenjivo, genotipizacijom.
English: No effects on reproductive organs have been seen in non-clinical studies.
Croatian: U nekliničkim ispitivanjima nisu zapaženi nikakvi učinci na reproduktivne organe.