natgillin/translations-raw huggingface dataset:
Application of the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 results in an estimate of PECsurfacewater of 0.019 µg/l. 
Z uporabo smernice CVMP za oceno vpliva zdravil za uporabo v veterinarski medicini na okolje ob smernicah VICH GL6 in GL38 dobimo oceno PKOpovršinska voda 0,019 µg/l.
The seeds were placed in a natural sandy soil containing the test item at nominal concentrations of 10, 31.6, 100, 316 and 1000 mg enrofloxacin/kg dry soil (cucumber, lettuce, mung bean, oat and wheat) and 3, 12, 48, 192 and 768 mg enrofloxacin/kg dry soil (rye), respectively. 
Semena so položili v naravno peščeno prst, ki je vsebovala preskušano snov v nazivnih koncentracijah 10, 31,6, 100, 316 in 1 000 mg enrofloksacina/kg suhe prsti (kumara, zelena solata, fižol, oves in pšenica) oziroma 3, 12, 48, 192 in 768 mg enrofloksacina/kg suhe zemlje (rž).
Unisol 10% Oral Solution contains 100 mg enrofloxacin as active ingredient per 1 ml product. 
Unisol 10 % peroralna raztopina vsebuje 100 mg enrofloksacina kot zdravilne učinkovine na 1 ml zdravila.
As ciprofloxacin represents only 2% of the total outcome of the enrofloxacin metabolism in chickens it is assumed that any potential risk of metabolites is encompassed by using the total residue approach assuming that the total dose is excreted as parent compound or as metabolites with a toxicity that is similar to the parent compound. 
Ker ciprofloksacin predstavlja le 2 % skupne presnove enrofloksacina pri kokoših, se šteje, da so vsa možna tveganja presnovkov zajeta s pristopom vseh ostankov pri predpostavki, da se celotni odmerek izloči kot izhodna spojina ali kot presnovki s toksičnostjo, podobno izhodni spojini.
A study taken from the open literature, Knapp et al (2005)4, indicated that exposure is very low. 
Študija Knapp et al. (2005)4 iz dostopne literature kaže, da je izpostavljenost zelo majhna.
A study, published in the peer-reviewed and open literature (Nowara et al 1997)1 indicated that enrofloxacin and other fluoroquinolones are strongly adsorbed to soils with high content in clay minerals of montmorillonite and kaolinite, basically through electrostatic interactions between ionized carboxylated groups of fluoroquinolones and exchangeable cations within clay layers. 
V študiji, ki je bila objavljena v recenzirani in dostopni literaturi (Nowara et al 1997)1, ugotavljajo, da se enrofloksacin in drugi fluorokinoloni močno vežejo na zemljo z visoko vsebnostjo glinenih mineralov montmorilonita in kaolinita, predvsem z elektrostatskimi interakcijami med ioniziranimi karboksiliranimi skupinami fluorokinolonov ter zamenljivimi kationi v glinenih plasteh.
The applicant provided an environmental risk assessment for Unisol 10% Oral Solution that followed in general the established guidelines and recommendations. 
Predlagatelj je predložil oceno tveganja zdravila Unisol 10 % peroralna raztopina za okolje, v katerem je na splošno upošteval uveljavljene smernice in priporočila.
The Phase I environmental risk assessment following the VICH guideline results in Predicted Environmental Concentrations (PECs) in soil for Unisol 10% Oral Solution for broiler chickens (10 mg/kg bw/day, for 5 days) above 100 µg/kg, thus requiring a Phase II assessment. 
V fazi I ocene tveganja za okolje na podlagi smernic VICH so dobljene predvidene koncentracije v okolju (PKO) v zemlji za zdravilo Unisol 10 % peroralna raztopina pri brojlerjih (10 mg/kg telesne mase /dan, 5 dni) nad 100 µg/kg, kar pomeni, da je potrebna ocena faze II.
During the decentralised procedure concerns were raised that Unisol 10% Oral Solution may present a potential serious risk to the environment regarding risk to blue-green algae and to terrestrial plants. 
Med decentraliziranim postopkom so se pojavili zadržki, da bi lahko zdravilo Unisol 10% peroralna raztopina pomenila resno tveganje za okolje glede na modrozelene alge in kopenske rastline.
If the geometric mean of DT50 values from the four soils is used, the PECsoil-plateau is 506 µg/kg. 
Če uporabimo geometrično povprečje vrednosti DT50 štirih prsti, je PKOzemlja-plato 506 µg/kg.
2.1.2 Soil adsorption and desorption 
2.1.2 Adsorpcija in desorpcija v zemlji
Unisol 10% Oral solution 
Unisol 10 % peroralna raztopina Peroralna raztopina
However, a margin of more than 800 between the estimated PECsw and the EC50 calculated on the basis of the data in the Robinson et al paper indicates a very low exposure to cyanobacteria as a result of the use of this product, and gives reassurance that the actual risk to cyanobacteria is acceptable. 
Kljub temu meja več kot 800 med ocenjeno vrednostjo PKOsw in vrednostjo EC50, izračunano na podlagi podatkov iz prispevka Robinsona et al., kaže na zelo majhno izpostavljenost cianobakterijpri uporabi tega zdravila, ter zagotavlja, da je dejansko tveganje za cianobakterije sprejemljivo.
2.3.3 Fish Robinson et al. (2005)2 studied the toxicity of enrofloxacin to Pimephales promelas (fathead minnow). 
V študiji Robinsona et al. (2005)2 so proučili toksičnost enrofloksacina za Pimephales promelas (črnoglavega pisanca).
Using this PNEC value and the PECsoil established above (542.9 µg/kg) a risk quotient of 0.44 can be established for plants. 
S to vrednostjo PKBU in zgoraj določeno vrednostjo PKOzemlja (542,9 µg/kg) se lahko za rastline določi količnik tveganja 0,44.
Please tell your doctor if: 
Obvestite zdravnika, če:
Absolute Difference 
Absolutna razlika
This leaflet was last revised in{month YYYY}. 
Navodilo je bilo nazadnje revidirano dne{mesec LLLL}.
The interval between treatments will be decided by your doctor. 
Interval med zdravljenji vam bo določil zdravnik.
Do not drive or use machinery until such effects have cleared. 
Ne vozite in ne uporabljajte strojev, dokler ti učinki ne prenehajo.
Chemical and physical in-use stability has been demonstrated for 72 hours at 2 - 8°C. 
Kemična in fizikalna stabilnost med uporabo je bila dokazana za 72 ur pri 2 °C-8 °C.
To prevent this, there must be a gap of at least three months between doses. 
Da bi se to preprečilo, morajo med odmerki preteči najmanj trije meseci.
Following inactivation, dispose of in accordance with local requirements. 
Po inaktivaciji jo zavrzite v skladu z lokalnimi zahtevami.
Symptomatic treatment should be instigated if necessary. 
Po potrebi je treba začeti simptomatsko zdravljenje.
Effects on peri-/postnatal development have not been evaluated. 
Učinki na razvoj v perinatalnem/postnatalem obdobju niso bili ocenjeni.
The central part of the rubber cap should be cleaned with alcohol. 
Osrednji del gumijastega pokrovčka je treba očistiti z alkoholom.
- Ensure the injected volume/dose is accurate and where feasible kept to a minimum. 
- Zagotovite, da je injicirana količina/odmerek točen in po možnosti čim manjši.
- if you have an infection or inflammation at the proposed injection sites. 
- če imate okužbo ali vnetje na predlaganih mestih injiciranja.
Each pack contains 1 vial. 
Posamezno pakiranje vsebuje eno vialo.
Reconstitution should be performed in accordance with aseptic technique principles. 
Rekonstitucijo je treba opraviti v skladu z načeli aseptične tehnike.
Manufacturers 
Proizvajalci
Swallowing and breathing difficulties are serious and can result in death. 
Težave s požiranjem in dihanjem so resne in se lahko končajo s smrtjo.
Absorption, distribution, biotransformation and elimination (ADME) studies on the active substance have not been performed due to the nature of this product. 
Študije absorpcije, porazdelitve, biotransformacije in izločanja (ADME) za učinkovino niso bile opravljene zaradi narave tega zdravila.
Reconstitution should be performed in accordance with good clinical practice, particularly with respect to aseptic technique. 
Rekonstitucijo je treba opraviti v skladu z dobro klinično prakso, zlasti ob upoštevanju aseptične tehnike.
It works by blocking the nerve impulses to the muscles in which it has been injected. 
Deluje z blokiranjem prenosa živčnih impulzov do mišic, v katere je bilo injicirano.
• Re-evaluation of the appropriateness of treatment with botulinum toxin type A. The efficacy and safety of repeat injections beyond 12 months has not been evaluated. 
• ponovna ocena ustreznosti zdravljenja z botulinskim toksinom tipa A. Učinkovitost in varnost ponovnih injiciranj v obdobju, ki bi presegalo 12 mesecev, nista bili ocenjeni.
It is used in adults less than 65 years of age in whom those facial lines have an important psychological impact. 
Uporablja se pri odraslih, mlajših od 65 let, pri katerih imajo navedene obrazne gube pomemben psihološki vpliv.
Uncommon events occurred in between 2 and 7 subjects. 
Občasni primeri so se pojavili pri dveh do sedmih osebah.
Number Percentage 4.2% 82.8% 87.2% 78.6% 83.1% 4.4% 
Število Odstotek 4,2 % 82,8 % 87,2 % 78,6 % 83,1 % 4,4 % (% CI) P-vrednost Lestvica za glabelarne gube (GLS - Glabellar Lines Score); 0 = brez gub, 1 = blaga izraženost, 2 =
Only clear, colorless solution without particles should be used. 
Uporabi se lahko samo bistra, brezbarvna raztopina brez delcev.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before you receive this medicine. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
4 Units 
4 enote
The usual dose of NUCEIVA is 20 Units. 
Običajni odmerek zdravila NUCEIVA je 20 enot.
Most side effects are of mild to moderate severity. 
Večina neželenih učinkov je blagih do zmernih.
This medicine contains less than 1 mmol sodium (23 mg) per dose; this means it is essentially ‘sodium- free'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni „brez natrija“.
Note: Of the 1659 subjects treated with NUCEIVA, rare events occurred in 1 subject only. 
Opomba: Od 1659 oseb, zdravljenih z zdravilom NUCEIVA, so se redki primeri pojavili pri samo eni osebi.
Signs of overdose may not be apparent immediately post-injection. 
Znaki prevelikega odmerjanja se morda ne pokažejo takoj po injiciranju.
Injection into vulnerable anatomical structures, such as nerves and blood vessels, must be avoided. 
Preprečiti je treba injiciranje v ranljive anatomske strukture, kot so živci in krvne žile.
These instructions for use, handling and disposal should be strictly followed. 
Ta navodila za uporabo, rokovanje in odlaganje je treba dosledno upoštevati.
Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise. 
Bolnikom ali skrbnikom je treba svetovati, naj poiščejo takojšnjo zdravniško pomoč, če se pojavijo težave pri požiranju, govoru ali dihanju.
Clinical signs are manifest within 2-3 days, with peak effect seen within 4 weeks of injection. 
Klinični znaki se pokažejo v dveh do treh dneh, največji učinek pa je viden v štirih tednih po injiciranju.
In order to reduce the complication of eyelid ptosis the following steps should be taken: 
Za zmanjšanje zapletov zaradi ptoze očesne veke je treba sprejeti naslednje ukrepe:
Tell your doctor if you have recently been injected with a medicine containing botulinum toxin (the active substance of NUCEIVA), as this may increase the effect of NUCEIVA excessively. 
Obvestite zdravnika, če so vam pred kratkim injicirali zdravilo, ki vsebuje botulinski toksin (učinkovino zdravila NUCEIVA), ker bi to lahko čezmerno povečalo učinek zdravila NUCEIVA.
In general, side effects occur within the first few days after injection and are temporary. 
Neželeni učinki se na splošno pojavijo v prvih nekaj dneh po injiciranju in so začasni.
Toxin spread 
Širjenje toksina
Once reconstituted, the solution should be visually inspected prior to use. 
Po rekonstituiranju je treba raztopino pred uporabo vizualno pregledati.
Intraocular pressure test 
Preskus intraokularnega tlaka
There is a risk of eyelid ptosis following treatment (see section 4.2). 
Obstaja tveganje ptoze očesne veke po zdravljenju (glejte poglavje 4.2).
CF31 3RT, United Kingdom 
CF31 3RT, Velika Britanija
• The toxin is very sensitive to heat and certain chemical agents. 
• toksin je zelo občutljiv na toploto in nekatera kemična sredstva;
The psychological impact of glabellar lines was confirmed at study entry and although a beneficial effect could not be demonstrated on psychological wellbeing, significant effects on patient reported outcomes were demonstrated as compared to placebo. 
Na začetku študij je bil potrjen psihološki vpliv glabelarnih gub in čeprav ugodnega vpliva na psihično dobro počutje ni bilo mogoče dokazati, so bili zabeleženi pomembni vplivi na rezultate, o katerih so poročali bolniki, v primerjavi s placebom.
Improvement of severity of the lines between the eyebrows generally occurs within a few days of treatment. 
Zmanjšanje izraženosti gub med obrvmi na splošno nastopi v nekaj dneh po zdravljenju.
GLS=1 at Day 30 at Maximum Contraction 
GLS = 1 na 30. dan pri najmočnejšem mrščenju
In the absence of adverse reactions during the initial treatment, an additional course of treatment can be performed subject to a minimum interval of 3 months between the initial and repeat treatment. 
Če se med prvim zdravljenjem ne pojavijo neželeni učinki, se lahko opravi dodatno zdravljenje, vendar pa morajo med prvim in ponovljenim zdravljenjem preteči najmanj trije meseci.
NUCEIVA (N=245) GLS=0 at Day 30 at Maximum Contraction 
NUCEIVA (N=245) GLS = 0 na 30. dan pri najmočnejšem mrščenju
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila nacionalnemu centru za poročanje, ki je naveden v Prilogi V.
The use of NUCEIVA is not recommended in individuals under 18 years. 
Uporaba zdravila NUCEIVA ni priporočljiva pri osebah, mlajših od 18 let.
Recommendations in the event of an accident when handling botulinum toxin: 
Priporočila v primeru nesreče pri rokovanju z botulinskim toksinom:
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions. 
Če pripravljene raztopine ne uporabite takoj, je za čas shranjevanja pripravljene raztopine in za pogoje pred uporabo odgovoren uporabnik; ta čas ne sme biti daljši od 24 ur pri temperaturi od 2 ºC do 8 ºC, razen če je bila rekonstitucija/razredčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
Reproduction toxicity 
Toksičnost za razmnoževanje
Store in a refrigerator (2°C - 8°C). 
6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 °C-8 °C).
Duration of response in the phase 3 study was 139 days, based on a 1 point GLS improvement. 
Odziv na podlagi izboljšanja za 1 točko na lestvici GLS je v tretji fazi študije trajal 139 dni.
Precaution to be taken before manipulating or administering the product For instructions for use, precaution before manipulating or administering the product, handling and disposal of the vials, see section 6.6. 
Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila Za navodila za uporabo, previdnostne ukrepe pred ravnanjem z zdravilom ali dajanjem zdravila, rokovanje z vialami in njihovo odlaganje glejte poglavje 6.6.
There are limited clinical data with NUCEIVA in patients older than 65 years (see section 5.1). 
Za zdravilo NUCEIVA pri bolnikih, starejših od 65 let, so na voljo omejeni klinični podatki (glejte poglavje 5.1).
- The toxin is very sensitive to heat and certain chemical agents. 
- toksin je zelo občutljiv na toploto in nekatera kemična sredstva;
What NUCEIVA is and what it is used for 2. 
Kaj je zdravilo NUCEIVA in za kaj ga uporabljamo 2.
Patients receiving recommended doses may have exaggerated muscle weakness. 
Bolniki, ki prejmejo priporočene odmerke, imajo lahko preveč oslabele mišice.
Procedure to follow for safe disposal of vials, syringes and materials used: 
Postopek za varno odlaganje uporabljenih vial, brizg in materiala:
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c (7)
After injection, there is an initial rapid high-affinity binding of toxin to specific cell surface receptors. 
Po injiciranju pride najprej do hitre, visokoafinitetne vezave toksina na specifične receptorje na celični površini.
Other medicines and NUCEIVA 
Druga zdravila in zdravilo NUCEIVA
• Examination of the causes of failure, e.g. inappropriate injection technique, incorrect muscles injected, and formation of botulinum toxin-neutralising antibodies. 
• proučitev vzrokov za neuspeh, npr. neustrezna tehnika injiciranja, injiciranje v neprave mišice in nastajanje protiteles, ki nevtralizirajo botulinski toksin;
A total of 922 patients participated in two 1 year open label uncontrolled studies, and over the course of these studies, the average patient received 3 treatments. 
Skupno 922 bolnikov je sodelovalo v dveh enoletnih odprtih nekontoliranih študijah.
There is a potential risk for asthenia, muscle weakness, dizziness and visual disturbance, which could affect driving and the operation of machinery. 
Obstaja potencialno tveganje za astenijo, mišično oslabelost, omotico in motnje vida, kar lahko vpliva na vožnjo in upravljanje strojev.
No specific dose adjustment is required for use in the elderly. 
Za uporabo pri starejših odmerka ni treba posebej prilagoditi.
Further, the effects of NUCEIVA on psychological wellbeing and patient reported outcomes were comparable to BOTOX, the active control used in the pivotal study. 
Poleg tega so bili vpliv na psihično dobro počutje in rezultati, o katerih so poročali bolniki, zdravila NUCEIVA primerljivi z zdravilom BOTOX, aktivno kontrolo, uporabljeno v študiji.
What you need to know before NUCEIVA is used 3. 
Kaj morate vedeti, preden boste uporabili zdravilo NUCEIVA 3.
Used vials, syringes, and materials should not be emptied and must be discarded into appropriate containers and disposed as a Medical Biohazardous Waste in accordance with local requirements. 
Uporabljenih vial, brizg in materiala ne izpraznite; odstranite jih v ustrezne posode in zavrzite kot biološko nevarni medicinski odpadek v skladu z lokalnimi predpisi.
Recovery after intramuscular injection takes place normally within 12 weeks of injection as nerve terminals sprout and reconnect with the endplates. 
Po intramuskularnem injiciranju se prvotno stanje običajno vzpostavi v 12 tednih po injiciranju, ko vzbrstijo živčni končiči in se ponovno povežejo z motoričnimi ploščicami.
This is followed by transfer of the toxin across the plasma membrane by receptor-mediated endocytosis. 
Temu sledi prehod toksina prek celične membrane z receptorsko posredovano endocitozo.
The most commonly reported adverse effects during treatment are headache, occurring in 9.0% of patients, followed by eyelid ptosis, occurring in 1.0% of patients. 
Neželeni učinki med zdravljenjem, o katerih so najpogosteje poročali, so glavobol, ki se je pojavil pri 9 % bolnikov, sledi pa mu ptoza očesne veke, ki se je pojavila pri 1 % bolnikov.
Once reconstituted, the solution for injection should be visually inspected prior to use to verify it is a clear, colourless solution free of particulate matter. 
Po rekonstituiranju je treba raztopino za injiciranje pred uporabo vizualno preveriti, ali je bistra, brezbarvna in brez delcev.
The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown. 
Učinek hkratnega dajanja različnih serotipov botulinskega nevrotoksina ali dajanja v nekajmesečnem razmiku ni znan.
Needle-related pain and/or anxiety have resulted in vasovagal responses, including transient symptomatic hypotension and syncope. 
Bolečina in/ali anksioznost zaradi injekcijske igle sta povzročili vazovagalne reakcije, vključno s prehodno simptomatsko hipotenzijo in sinkopo.
Number 
Število
Caution should be exercised when NUCEIVA is used in patients with bleeding disorders as injection may lead to bruising. 
Previdnost je potrebna, če se zdravilo NUCEIVA uporablja pri bolnikih s hemoragičnimi motnjami, saj injiciranje lahko povzroči modrice.
NUCEIVA is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age. 
Zdravilo NUCEIVA je indicirano za začasno izboljšanje videza zmerno do močno izraženih navpičnih gub med obrvmi, vidnih pri najmočnejšem mrščenju čela (glabelarne gube), če ima močna izraženost navedenih obraznih gub pri odraslih, mlajših od 65 let, pomemben psihološki vpliv.
For any information about this medicine, please contact the the Marketing Authorisation Holder 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
In the event of an accident when handling the product, whether in the vacuum-dried state or reconstituted, the appropriate measures described below must be initiated immediately. 
V primeru nesreče pri rokovanju z zdravilom, bodisi v obliki vakuumsko posušenega praška ali rekonstituirane raztopine, je treba takoj izvesti ustrezne spodaj opisane ukrepe:
Vial (Type I glass) fitted with a stopper (chlorobutyl rubber) and a seal (aluminium). 
Viala (steklo tipa I) z zamaškom (klorobutilni kavčuk) in (aluminijasto) zaporko.
Should accidental injection or ingestion occur, the patient should be medically monitored for several days for signs and symptoms of general weakness or muscle paralysis. 
Če pride do nenamernega injiciranja ali zaužitja, mora biti bolnik več dni pod zdravniškim nadzorom, da se ugotovijo morebitni znaki in simptomi splošne oslabelosti ali mišične paralize.
Used vials, syringes and materials should not be emptied and must be discarded into appropriate containers and disposed of according to local regulations. 
Uporabljenih vial, brizg in materiala ne izpraznite; odstranite jih v ustrezne posode in zavrzite v skladu z lokalnimi predpisi.
Overdose of NUCEIVA depends upon dose, site of injection, and underlying tissue properties. 
Preveliko odmerjanje zdravila NUCEIVA je odvisno od odmerka, mesta injiciranja in osnovnih lastnosti tkiva.
The effect of NUCEIVA on human fertility is unknown. 
Učinek zdravila NUCEIVA na plodnost pri ljudeh ni znan.
Serious undesirable effects that may occur following treatment with NUCEIVA include eyelid ptosis, an immune response, distant spread of toxin, development or exacerbation of a neuromuscular disorder, and hypersensitivity reactions. 
Resni neželeni učinki, ki se lahko pojavijo po zdravljenju z zdravilom NUCEIVA, vključujejo ptozo očesne veke, imunski odziv, širjenje toksina daleč od mesta injiciranja, razvoj ali poslabšanje živčno-mišične motnje in preobčutljivostne reakcije.
Caution should be taken if complications have resulted with previous botulinum toxin injections. 
Previdnost je potrebna, če je prišlo do zapletov pri predhodnih injiciranjih botulinskega toksina.
Physical manipulation (such as rubbing) of the injection site in the immediate post-administration period should be avoided. 
Preprečiti je treba fizično dotikanje (npr. drgnjenje) mesta injiciranja takoj po dajanju zdravila.
What NUCEIVA is and what it is used for 
Kaj je zdravilo NUCEIVA in za kaj ga uporabljamo
There are no adequate data from the use of botulinum toxin type A in pregnant women. 
Ustreznih podatkov o uporabi botulinskega toksina tipa A pri nosečnicah ni.
The potential impact of NUCEIVA on fertility has not been investigated in animals. 
Morebitni učinek zdravila NUCEIVA na razmnoževanje pri živalih ni bil raziskan.