natgillin/translations-raw huggingface dataset:
If clinically indicated, urine protein testing (preferably using a first morning urine specimen) is recommended. 
Če je klinično indicirano, je priporočljivo testiranje beljakovin v urinu (po možnosti v prvem jutranjem vzorcu urina).
SMA is a progressive neuromuscular disease resulting from mutations in chromosome 5q in the SMN1 gene. 
SMA je progresivna živčnomišična bolezen, ki nastane zaradi mutacij na kromosomu 5q na genu SMN1.
Two events, angioedema and serum sickness, were considered serious and related. 
Dva neželena učinka, in sicer angioedem in serumsko bolezen, so ocenili kot resna in povezana.
Submission of study results: Q2 2024. 
Predložitev rezultatov študije: drugi kvartal 2024.
Median age at first dose was 22 days. 
Mediana starost pri prvem odmerku je bila 22 dni.
In toxicity studies in animals no effects on male or female fertility were observed (see section 5.3). 
V študijah toksičnosti na živalih niso ugotovili nikakršnih učinkov na plodnost pri moških ali ženskah (glejte poglavje 5.3).
Additional side effects not seen in clinical trials: 
Dodatni neželeni učinki, ki jih niso ugotavljali v kliničnih preskušanjih:
The exception was an acute, transient deficit in lower spinal reflexes which occurred at the highest dose levels in each study (3 or 4 mg per dose; equivalent to 30 or 40 mg per intrathecal dose in patients). 
Izjema je bil akuten prehoden deficit spodnjih spinalnih refleksov, ki se je v vsaki študiji pojavljal pri najvišjih ravneh odmerkov (3 ali 4 mg na odmerek; enakovredno 30 ali 40 mg na intratekalni odmerek pri bolnikih).
The recommended dosage is 12 mg (5 ml) per administration. 
Priporočeni odmerek je 12 mg (5 ml) na vsako uporabo.
The studies enrolled patients who were between 2 to 15 years of age at first dose. 
V študijo so bili vključeni bolniki, ki so bili stari 2 do 15 let, ko so prejeli prvi odmerek.
There is a risk of adverse reactions occurring as part of the lumbar puncture procedure (e.g. headache, back pain, vomiting; see section 4.8). 
Obstaja nevarnost neželenih učinkov, ki se pojavljajo v okviru postopka lumbalne punkcije (npr. glavobol, bolečina v hrbtu, bruhanje; glejte poglavje 4.8).
If you notice any symptoms of increase in head size, decreased consciousness, persistent nausea, vomiting or headache; or other symptoms that cause you concern, please inform your or your child's doctor to seek necessary treatment. 
Če opazite simptome, kot so povečanje obsega glave, motena zavest, trdovratna slabost s siljenjem na bruhanje, bruhanje ali glavobol, ali druge simptome, ki vam povzročajo skrbi, obvestite o tem svojega zdravnika ali zdravnika svojega otroka zaradi potrebnega zdravljenja.
Instructions for preparation of the medicinal product before administration 
Navodila za pripravo zdravila pred uporabo
If the vial remains unopened and the solution is not used, it should be returned back to the refrigerator (see section 6.4). 
Če viala ostane neodprta in raztopine ne uporabite, jo dajte nazaj v hladilnik (glejte poglavje 6.4).
The assessment of undesirable effects is based on the following frequency data: 
Seznam neželenih učinkov v obliki preglednice Ocena neželenih učinkov temelji na naslednjih podatkih o pogostnosti:
If you or your child misses an injection 
Če izpustite ali če vaš otrok izpusti injekcijo
The decision to treat should be based on an individualised expert evaluation of the expected benefits of treatment for that individual, balanced against the potential risk of treatment with Spinraza. 
Odločitev za zdravljenje mora temeljiti na individualizirani strokovni oceni pričakovanih koristi zdravljenja za tistega posameznika v primerjavi z možnim tveganjem zdravljenja z nusinersenom.
Tell your doctor if you or your child are taking, have recently taken any, or might take any other medicines in future. 
Obvestite zdravnika, če vi ali vaš otrok jemljete, ste vi ali vaš otrok pred kratkim jemali ali boste vi ali vaš otrok morda v prihodnosti začeli jemati katero koli drugo zdravilo.
CS3B was designed to assess the effect of Spinraza on motor function and survival. 
Študijo CS3B so načrtovali za ocenjevanje učinka zdravila Spinraza na motorično funkcijo in preživetje.
The need for continuation of therapy should be reviewed regularly and considered on an individual basis depending on the patient's clinical presentation and response to the therapy. 
Potrebo po nadaljevanju zdravljenja je treba redno proučevati in ocenjevati na individualni podlagi, odvisno od bolnikove klinične slike in odziva na zdravljenje.
The safety and efficacy in patients with renal impairment has not been established and they should be closely observed. 
Varnost in učinkovitost pri bolnikih z okvaro ledvic nista bili dokazani in je treba te bolnike natančno opazovati.
Secondary endpoints including functional measures and WHO motor milestone achievement were formally statistically tested and are described in Table 3. 
Sekundarni končni opazovani dogodki so vključevali funkcijske meritve in doseganje motoričnih mejnikov po SZO, so bili formalno statistično testirani in so opisani v preglednici 3.
The analysis included 28 patients who received their first dose in study CS2, and then transferred to the extension phase, study CS12. 
V analizo je bilo vključenih 28 bolnikov, ki so prejeli svoj prvi odmerek v študiji CS2, nato pa so prešli v podaljšano fazo, študijo CS12.
Presence of nusinersen was also demonstrated in neurons and other cell types in the spinal cord and brain, and peripheral tissues such as skeletal muscle, liver, and kidney. 
Prisotnost nusinersena so dokazali tudi v nevronih in drugih vrstah celic v hrbtenjači in možganih ter v perifernih tkivih, npr. v skeletnih mišicah, jetrih in ledvicah.
• Hydrocephalus (a build-up of too much fluid around the brain) 
• hidrocefalus (kopičenje prevelike količine tekočine okrog možganov)
If you have any questions about how Spinraza is given, ask your doctor. 
Če imate kakšna vprašanja o tem, kako se daje zdravilo Spinraza, se posvetujte z zdravnikom.
The extent of improvement in CHOP INTEND is shown in Figure 1 (change from baseline score for each subject). 
Obseg izboljšanja v CHOP INTEND kaže slika 1 (sprememba od izhodiščnega rezultata za vsakega preiskovanca).
5 Based on logistic regression with treatment effect and adjustment for each subject's age at screening and HFMSE score at baseline 
5 Temelji na logistični regresiji z učinkom zdravljenja in prilagoditvijo za starost vsakega preiskovanca pri presejanju in rezultatu HFMSE v izhodišču.
By binding, the ASO displaces splicing factors, which normally suppress splicing. 
ASO z vezavo izpodrine faktorje za izrezovanje, ki običajno zavirajo izrezovanje.
In Part 1 of the study, patients were followed for a median of 302 days. 
V 1. delu študije je mediana spremljanja bolnikov znašala 302 dni.
Of the 28 patients, 3 were at least 18 years of age at their last study visit. 
28 bolnikov so bili 3 ob zadnjem njihovem pregledu v študiji stari vsaj 18 let.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. 
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vam bodo dali to zdravilo.
Overall, the incidence of ADAs was low, with 15 (4%) patients classified as ADA positive overall, of which 4 had a transient response, 5 had a persistent response, and 6 patients had responses which could not be classified as transient or persistent at the time of data cut off. 
V celoti gledano je bila pogostnost ADA majhna; 15 (4 %) bolnikov je bilo razvrščenih kot ADA-pozitivni, od katerih so imeli 4 prehodni odziv, 5 jih je imelo trajni odziv, 6 bolnikov pa je imelo odzive, ki jih v času presečnega datuma zbiranja podatkov ni bilo mogoče opredeliti kot predhodne ali trajne.
It is unknown whether nusinersen/metabolites are excreted in human milk. 
Ni znano, ali se nusinersen/presnovki izločajo v materino mleko.
• Serious infection related to lumbar puncture (e.g. meningitis) 
• resne okužbe, povezane z lumbalno punkcijo (npr. meningitis)
This results in the loss of nerve cells in the spine, leading to weakness of the muscles in the shoulders, hips, thighs and upper back. 
Zato odmirajo živčne celice v hrbtenjači, kar povzroči šibkost mišic v ramenih, bokih, stegnih in zgornjem delu hrbta.
Spinraza has no or negligible influence on the ability to drive and use machines. 
Zdravilo Spinraza nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
At the time of interim analysis, 22 out of 24 patients (92%) were alive. 
V času vmesne analize je bilo 22 od 24 bolnikov (92 %) živih.
The vial should be taken out of the refrigerator and allowed to warm to room temperature (25°C) without using external heat sources, prior to administration. 
Pred uporabo vzemite vialo iz hladilnika in pustite, da se brez uporabe zunanjih virov toplote segreje na sobno temperaturo (25 °C).
A cumulative search of postmarketing data identified 37 possible hypersensitivity events; 20 medically confirmed. 
V kumulativnem iskanju podatkov iz obdobja trženja zdravila, je bilo ugotovljenih 37 možnih neželenih učinkov, povezanih s preobčutljivostjo; 20 od teh je bilo zdravniško potrjenih.
This may not be required every time you or your child are given Spinraza. 
Mogoče to ne bo potrebno vsakokrat, ko bodo vam ali vašemu otroku dali zdravilo Spinraza.
On the basis of the scientific conclusions for nusinersen the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing nusinersen is unchanged subject to the proposed changes to the product information 
Na podlagi znanstvenih zaključkov za nusinersen odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) nusinersen nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Spinraza treatment should be initiated as early as possible after diagnosis with 4 loading doses on Days 0, 14, 28 and 63. 
Zdravljenje z zdravilom Spinraza je treba uvesti čimprej po postavitvi diagnoze s 4 začetnimi (polnilnimi) odmerki na dan 0, 14, 28 in 63.
An interim analysis was conducted when patients had been on study for median of 27.1 months (15.135.5 months) and were of a median age at last visit of 26.0 months (14.0 -34.3 months). 
Vmesna analiza je bila opravljena po sodelovanju bolnikov v študiji 27,1 mediana mesecev (15,1-35,5 meseca), mediana starosti ob zadnjem obisku pa je bila 26,0 mesecev (14,0-34,3 meseca).
In the 53-week intrathecal dosing study in cynomolgus monkeys no toxicity effects were seen at levels up to 14-fold the recommended annual clinical maintenance dose. 
V 53-tedenski študiji intratekalnega odmerjanja nusinersena pri opicah Cynomolgus niso ugotovili učinkov toksičnosti pri ravneh do 14-kratnika priporočenega letnega kliničnega vzdrževalnega odmerka.
All patients who received Spinraza were alive as of the early termination of Part 1, however, one patient in the control arm died at Study Day 289. 
Vsi bolniki, ki so prejemali zdravilo Spinraza, so bili ob predčasni prekinitvi 1. dela živi, pri čemer je en bolnik iz kontrolne skupine umrl na 289. dan študije.
• Meningitis not caused by an infection (inflammation of the membrane around the spinal cord and brain, which may present as neck stiffness, headache, fever, nausea and vomiting) 
• meningitis, ki ga ne povzroči okužba (vnetje membrane okrog hrbtenjače in možganov, ki bi se pojavilo kot otrdelost vratu, glavobol, vročina, slabost in bruhanje)
There were no reports of a patient discontinuing treatment due to these events. 
Niso poročali o bolnikih, ki bi zaradi omenjenih neželenih učinkov prekinili zdravljenje.
This will be done by a doctor experienced in doing lumbar punctures. 
To bo naredil zdravnik, ki ima izkušnje z opravljanjem lumbalnih punkcij.
Time to death or permanent ventilation (≥ 16 hours ventilation/day continuously for > 21 days in the absence of an acute reversible event or tracheostomy) was assessed as the primary endpoint. 
Čas do smrti ali trajne ventilacije (≥ 16 ur ventilacije/dan neprekinjeno za > 21 dni v odsotnosti akutnega reverzibilnega dogodka ali traheostomije) je bil določen za primarni končni opazovani dogodek.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov v povezavi z reproduktivno toksičnostjo (glejte poglavje
At the time of a Study CS11 interim analysis, 61 out of 65 patients (94%) were alive. 
V času vmesne analize študije CS11 je bilo 61 od 65 bolnikov (94 %) živih.
Spinraza is not metabolised via the cytochrome P450 enzyme system in the liver, therefore dose adjustment is unlikely to be required in patients with hepatic impairment (see sections 4.5 and 5.2). 
Zdravilo Spinraza se ne presnavlja preko encimskega sistema citokroma P450, zato ni verjetno, da bo pri bolnikih z okvaro jeter potrebno prilagajanje odmerka (glejte poglavji 4.5 in 5.2).
Pre-symptomatic infants 
Predsimptomatični dojenčki
There is no accumulation in plasma exposure measures (Cmax and AUC) after multiple doses. 
Kazalca izpostavljenosti plazme (Cmax in AUC) se po večkratnih odmerkih ne nakopičita.
The remaining 2 events (rash and eosinophil count increased, both nonserious) were possibly related to nusinersen. 
Preostala dva neželena učinka (izpuščaj in povečanje števila eozinofilcev, oba opredeljena kot neresna) sta bila morda povezana z nusinersenom.
Following intrathecal administration trough plasma concentrations of nusinersen were relatively low compared to the trough CSF concentration. 
Po intratekalnem dajanju so bile najnižje plazemske koncentracije nusinersena relativno nizke v primerjavi z najnižjo koncentracijo v CSF.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Spinraza therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Spinraza, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Of the 346 patients who received Spinraza up to a maximum of 5 years, 258 patients received treatment for at least 1 year. 
Spinraza do največ 5 let, je 258 bolnikov prejemalo zdravljenje vsaj 1 leto.
What Spinraza is and what it is used for 2. 
Kaj je zdravilo Spinraza in za kaj ga uporabljamo 2.
Spinraza works by helping the body to produce more of the SMN protein that people with SMA are lacking. 
Zdravilo Spinraza deluje tako, da pomaga telesu izdelovati več beljakovine SMN, ki je ljudem s SMA primanjkuje.
Clear and colourless solution with pH of approximately 7.2. 
raztopina za injiciranje Bistra in brezbarvna raztopina s pH približno 7,2.
Mean plasma Cmax and AUC values increased approximately dose proportionally over the evaluated dose range. 
Srednje vrednosti plazemske Cmax in AUC so v ocenjenem razponu odmerkov naraščale približno proporcionalno odmerku.
5 ml in a Type I glass vial with bromobutyl rubber stopper and an aluminium over-seal and plastic cap. 
5 ml v viali iz stekla tipa I z zamaškom iz bromobutilne gume in aluminijasto prekrivno zaporko in plastično zaporko.
In repeat-dose toxicity studies (14-weeks and 53-weeks) of intrathecal administration to juvenile cynomolgus monkeys, nusinersen was well tolerated. 
V študijah toksičnosti s ponavljajočimi se odmerki (14-tedenskih in 53-tedenskih) intratekalnega dajanja nusinersena juvenilnim opicam Cynomolgus so živali nusinersen dobro prenašale.
Submission of study results: 
Predložitev rezultatov študije: april
Twelve out of 20 patients (60%) in the study met the primary endpoint with improvement in mean motor milestone achievement over time. 
V študiji je 12 od 20 bolnikov (60 %) doseglo primarni končni opazovani dogodek s postopnim izboljševanjem povprečnih motoričnih mejnikov skozi čas.
If no refrigeration is available, Spinraza may be stored in its original carton, protected from light at or below 30°C for up to 14 days. 
Če hlajenje ni na voljo, lahko zdravilo Spinraza shranjujete v originalni kartonski škatli, zaščiteno pred svetlobo, pri 30 °C ali nižji temperaturi do 14 dni.
The injection must not be administered in areas of the skin where there are signs of infection or inflammation. 
Injekcije se ne sme dati v predelih kože, kjer so vidni znaki okužbe ali vnetja.
Pack size of one vial per carton. 
Velikost pakiranja je ena viala na kartonsko škatlo.
The length of treatment ranged from 74 to 474 days (median 250 days) at the time of the interim analysis. 
V času vmesne analize je zdravljenje trajalo od 74 do 474 dni (mediana 250 dni).
In Study CS11 all patients received Spinraza, with the length of treatment ranging from 65 to 592 days (median 289 days) at the time of interim analysis. 
V študiji CS11 so vsi bolniki prejemali zdravilo Spinraza, v času vmesne analize pa je zdravljenje trajalo od 65 do 592 dni (mediana 289 dni).
Upon completion of Study CS4 (CHERISH) 125 patients enrolled in Study CS11 (SHINE), where all patients received Spinraza. 
Po zaključku študije CS4 (CHERISH) je bilo 125 bolnikov vključenih v študijo CS11 (SHINE), kjer so vsi prejemali zdravilo Spinraza.
Spinraza is given by injection into the lower back. 
Zdravilo Spinraza se daje z injekcijo v spodnji del hrbta.
*Adverse events considered related to the lumbar puncture procedure. 
*Neželeni učinki, za katere menijo, da so povezani s postopkom lumbalne punkcije.
Number of patients who died or received permanent ventilation Hazard ratio (95% CI) p-value6 
Število bolnikov, ki so umrli ali prejeli trajno ventilacijo Razmerje ogroženosti (95-% IZ) Vrednost p6
All patients had the ability to suck and swallow at last assessment, with 22 (88%) infants achieving a maximal score on the HINE Section 1. 
Vsi bolniki so bili ob zadnji oceni zmožni sesati in požirati, od teh je 22 (88 %) dojenčkov doseglo maksimalni rezultat v skladu s HINE, poglavje 1.
In vitro studies indicate that the likelihood for interactions with nusinersen due to competition for plasma protein binding, or competition with or inhibition of transporters is low. 
Študije in vitro kažejo, da je medsebojno delovanje z nusinersenom malo verjetno zaradi kompeticije za vezavo na plazemske beljakovine ali zaradi kompeticije s prenašalci ali inhibicije prenašalcev.
Initiation of treatment sooner after symptom onset resulted in earlier and greater improvement in motor function than those with delayed treatment initiation; however, both groups experienced benefit compared to sham-control. 
Uvedba zdravljenja kmalu po nastopu simptomov je posledično vodila v hitrejše in večje izboljšanje motorične funkcije v primerjavi s pozno uvedbo zdravljenja; vendar sta imeli obe skupini korist od zdravljenja v primerjavi s kontrolnimi bolniki na placebu.
Treatment should be administered by health care professionals experienced in performing lumbar punctures. 
Zdravljenje smejo izvajati zdravstveni delavci, ki imajo izkušnje z opravljanjem lumbalnih punkcij.
Reproductive toxicology studies were conducted using subcutaneous administration of nusinersen in mice and rabbits. 
Toksikološke študije vpliva na razmnoževanje so izvedli s subkutanim dajanjem nusinersena mišim in kuncem.
SMA is a clinical spectrum of disease with disease severity linked to fewer numbers of SMN2 gene copies and younger age of symptom onset. 
SMA je klinični spekter bolezni, kjer je resnost bolezni povezana z manjšim številom genskih kopij SMN2 in nastopom simptomov pri nižji starosti.
Some adverse events commonly associated with lumbar puncture (e.g. headache and back pain) could not be assessed in the infant population exposed to Spinraza due to the limited communication appropriate for that age group. 
Nekaterih neželenih dogodkov, ki so pogosto povezani z lumbalno punkcijo (npr. glavobol in bolečina v hrbtu), v populaciji dojenčkov, izpostavljenih zdravilu Spinraza, niso mogli oceniti zaradi omejene komunikacije, značilne za to starostno skupino.
At baseline, patients had a mean Hammersmith Functional Motor Scale Expanded (HFMSE) score of 21.6, a mean revised upper limb module (RULM) of 19.1, all had achieved independent sitting, and no patients had achieved independent walking. 
V izhodišču so imeli bolniki povprečen rezultat razširjene Hammersmithove lestvice gibalnih sposobnosti (Hammersmith Functional Motor Scale Expanded - HFMSE) 21,6, povprečen revidirani test modula zgornjih udov (revised upper limb module - RULM) 19,1, vsi so dosegli neodvisno sedenje in noben bolnik ni dosegel neodvisne hoje.
The majority of these side effects are reported within 72 hours of the procedure. 
O večini teh neželenih učinkov poročajo v 72 urah po postopku.
No serious complications of lumbar puncture, such as serious infections, have been observed in the clinical trials of Spinraza. 
Resnih zapletov pri lumbalni punkciji, na primer resnih okužb, v kliničnih preskušanjih zdravila Spinraza niso opazili.
The benefits and risks of continuing Spinraza whilst having a "ventriculo-peritoneal shunt" in place are not known at present. 
Koristi in tveganja nadaljevanja zdravljenja z zdravilom Spinraza, tačas ko ima bolnik nameščen “ventrikulo-peritonealni spoj”, trenutno niso znana.
This injection, called a lumbar puncture, is done by inserting a needle into the space around the spinal cord. 
To injekcijo, ki se imenuje lumbalna punkcija, damo tako, da zabodemo iglo v prostor okrog hrbtenjače.
Among patients treated with Spinraza by lumbar puncture, serious infection, such as meningitis, has been observed. 
Med bolniki, zdravljenimi z zdravilom Spinraza z lumbalno punkcijo, so opazili resne okužbe, kot je meningitis.
Each carton of Spinraza contains one vial. 
Ena kartonska škatla zdravila Spinraza vsebuje eno vialo.
Don't stop treatment with Spinraza unless your doctor tells you to. 
Ne prenehajte se zdraviti z zdravilom Spinraza, če vam tega ne naroči zdravnik.
Intrathecal injection of nusinersen into the CSF allows nusinersen to be fully available for distribution from the CSF to the target central nervous system (CNS) tissues. 
Intratekalno injicirani nusinersen v CSF je popolnoma na voljo za porazdelitev iz CSF v tarčna tkiva centralnega živčnega sistema (CŽS).
Communicating hydrocephalus, aseptic meningitis and hypersensitivity (e.g. angioedema, urticaria and rash) have also been reported. 
Poročali so tudi o komunikantnem hidrocefalusu, aseptičnem meningitisu in preobčutljivosti (npr. angioedem, urtikarija in izpuščaji).
Proportion of patients who achieved at least a 3 point improvement from baseline to month 152 
Delež bolnikov, ki so dosegli izboljšanje od izhodišča za vsaj 3 točke do 15. meseca2
Potential difficulties with this route of administration may be seen in very young patients and those with scoliosis. 
Možne težave pri tej poti uporabe zdravila se lahko pojavljajo pri zelo mladih bolnikih in pri tistih s skoliozo.
Your doctor will tell you how long you or your child need to receive Spinraza. 
Zdravnik vam bo povedal, kako dolgo morate ali mora vaš otrok prejemati zdravilo Spinraza.
Before you or your child are given Spinraza your doctor may decide to do a blood test to check that your or your child's blood can clot properly. 
Preden bodo vam ali vašemu otroku dali zdravilo Spinraza, se lahko zdravnik odloči, da bo naredil krvno preiskavo, s katero bo preveril, ali se vaša kri ali kri vašega otroka pravilno strjuje.
There have been a small number of reports of patients developing hydrocephalus (a build-up of too much fluid around the brain) after Spinraza is given. 
Obstaja majhno število poročil o bolnikih, pri katerih se je po dajanju zdravila Spinraza razvil hidrocefalus (kopičenje prevelike količine tekočine okrog možganov).
1 out of 28 patients had 2 SMN2 gene copies, 21 had 3 copies, and 6 had 4 copies. 
Eden od 28 bolnikov je imel 2 kopiji gena za SMN2, 21 jih je imelo po 3 kopije, 6 pa po 4 kopije.
No impact on male or female fertility, or embryo-foetal development, or pre/post-natal development was observed. 
Vpliva na plodnost samcev ali samic, na razvoj zarodka in ploda ali na pred/poporodni razvoj niso opazili.