FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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.
Slovenian: • ponovna ocena ustreznosti zdravljenja z botulinskim toksinom tipa A. Učinkovitost in varnost ponovnih injiciranj v obdobju, ki bi presegalo 12 mesecev, nista bili ocenjeni.
English: It is used in adults less than 65 years of age in whom those facial lines have an important psychological impact.
Slovenian: Uporablja se pri odraslih, mlajših od 65 let, pri katerih imajo navedene obrazne gube pomemben psihološki vpliv.
English: Uncommon events occurred in between 2 and 7 subjects.
Slovenian: Občasni primeri so se pojavili pri dveh do sedmih osebah.
English: Number Percentage 4.2% 82.8% 87.2% 78.6% 83.1% 4.4%
Slovenian: 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 =
English: Only clear, colorless solution without particles should be used.
Slovenian: Uporabi se lahko samo bistra, brezbarvna raztopina brez delcev.
English: 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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
English: 4 Units
Slovenian: 4 enote
English: The usual dose of NUCEIVA is 20 Units.
Slovenian: Običajni odmerek zdravila NUCEIVA je 20 enot.
English: Most side effects are of mild to moderate severity.
Slovenian: Večina neželenih učinkov je blagih do zmernih.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose; this means it is essentially ‘sodium- free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni „brez natrija“.
English: Note: Of the 1659 subjects treated with NUCEIVA, rare events occurred in 1 subject only.
Slovenian: Opomba: Od 1659 oseb, zdravljenih z zdravilom NUCEIVA, so se redki primeri pojavili pri samo eni osebi.
English: Signs of overdose may not be apparent immediately post-injection.
Slovenian: Znaki prevelikega odmerjanja se morda ne pokažejo takoj po injiciranju.
English: Injection into vulnerable anatomical structures, such as nerves and blood vessels, must be avoided.
Slovenian: Preprečiti je treba injiciranje v ranljive anatomske strukture, kot so živci in krvne žile.
English: These instructions for use, handling and disposal should be strictly followed.
Slovenian: Ta navodila za uporabo, rokovanje in odlaganje je treba dosledno upoštevati.
English: Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise.
Slovenian: Bolnikom ali skrbnikom je treba svetovati, naj poiščejo takojšnjo zdravniško pomoč, če se pojavijo težave pri požiranju, govoru ali dihanju.
English: Clinical signs are manifest within 2-3 days, with peak effect seen within 4 weeks of injection.
Slovenian: Klinični znaki se pokažejo v dveh do treh dneh, največji učinek pa je viden v štirih tednih po injiciranju.
English: In order to reduce the complication of eyelid ptosis the following steps should be taken:
Slovenian: Za zmanjšanje zapletov zaradi ptoze očesne veke je treba sprejeti naslednje ukrepe:
English: 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.
Slovenian: 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.
English: In general, side effects occur within the first few days after injection and are temporary.
Slovenian: Neželeni učinki se na splošno pojavijo v prvih nekaj dneh po injiciranju in so začasni.
English: Toxin spread
Slovenian: Širjenje toksina
English: Once reconstituted, the solution should be visually inspected prior to use.
Slovenian: Po rekonstituiranju je treba raztopino pred uporabo vizualno pregledati.
English: Intraocular pressure test
Slovenian: Preskus intraokularnega tlaka
English: There is a risk of eyelid ptosis following treatment (see section 4.2).
Slovenian: Obstaja tveganje ptoze očesne veke po zdravljenju (glejte poglavje 4.2).
English: CF31 3RT, United Kingdom
Slovenian: CF31 3RT, Velika Britanija
English: • The toxin is very sensitive to heat and certain chemical agents.
Slovenian: • toksin je zelo občutljiv na toploto in nekatera kemična sredstva;
English: 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.
Slovenian: 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.
English: Improvement of severity of the lines between the eyebrows generally occurs within a few days of treatment.
Slovenian: Zmanjšanje izraženosti gub med obrvmi na splošno nastopi v nekaj dneh po zdravljenju.
English: GLS=1 at Day 30 at Maximum Contraction
Slovenian: GLS = 1 na 30. dan pri najmočnejšem mrščenju
English: 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.
Slovenian: 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.
English: NUCEIVA (N=245) GLS=0 at Day 30 at Maximum Contraction
Slovenian: NUCEIVA (N=245) GLS = 0 na 30. dan pri najmočnejšem mrščenju
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila nacionalnemu centru za poročanje, ki je naveden v Prilogi V.
English: The use of NUCEIVA is not recommended in individuals under 18 years.
Slovenian: Uporaba zdravila NUCEIVA ni priporočljiva pri osebah, mlajših od 18 let.
English: Recommendations in the event of an accident when handling botulinum toxin:
Slovenian: Priporočila v primeru nesreče pri rokovanju z botulinskim toksinom:
English: 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.
Slovenian: 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.
English: Reproduction toxicity
Slovenian: Toksičnost za razmnoževanje
English: Store in a refrigerator (2°C - 8°C).
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 °C-8 °C).
English: Duration of response in the phase 3 study was 139 days, based on a 1 point GLS improvement.
Slovenian: Odziv na podlagi izboljšanja za 1 točko na lestvici GLS je v tretji fazi študije trajal 139 dni.
English: 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.
Slovenian: 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.
English: There are limited clinical data with NUCEIVA in patients older than 65 years (see section 5.1).
Slovenian: Za zdravilo NUCEIVA pri bolnikih, starejših od 65 let, so na voljo omejeni klinični podatki (glejte poglavje 5.1).
English: - The toxin is very sensitive to heat and certain chemical agents.
Slovenian: - toksin je zelo občutljiv na toploto in nekatera kemična sredstva;
English: KOREA, REPUBLIC OF
Slovenian: REPUBLIKA KOREJA
English: What NUCEIVA is and what it is used for 2.
Slovenian: Kaj je zdravilo NUCEIVA in za kaj ga uporabljamo 2.
English: Patients receiving recommended doses may have exaggerated muscle weakness.
Slovenian: Bolniki, ki prejmejo priporočene odmerke, imajo lahko preveč oslabele mišice.
English: Procedure to follow for safe disposal of vials, syringes and materials used:
Slovenian: Postopek za varno odlaganje uporabljenih vial, brizg in materiala:
English: 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.
Slovenian: 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)
English: After injection, there is an initial rapid high-affinity binding of toxin to specific cell surface receptors.
Slovenian: Po injiciranju pride najprej do hitre, visokoafinitetne vezave toksina na specifične receptorje na celični površini.
English: Other medicines and NUCEIVA
Slovenian: Druga zdravila in zdravilo NUCEIVA
English: • Examination of the causes of failure, e.g. inappropriate injection technique, incorrect muscles injected, and formation of botulinum toxin-neutralising antibodies.
Slovenian: • proučitev vzrokov za neuspeh, npr. neustrezna tehnika injiciranja, injiciranje v neprave mišice in nastajanje protiteles, ki nevtralizirajo botulinski toksin;
English: 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.
Slovenian: Skupno 922 bolnikov je sodelovalo v dveh enoletnih odprtih nekontoliranih študijah.
English: There is a potential risk for asthenia, muscle weakness, dizziness and visual disturbance, which could affect driving and the operation of machinery.
Slovenian: Obstaja potencialno tveganje za astenijo, mišično oslabelost, omotico in motnje vida, kar lahko vpliva na vožnjo in upravljanje strojev.
English: No specific dose adjustment is required for use in the elderly.
Slovenian: Za uporabo pri starejših odmerka ni treba posebej prilagoditi.
English: Further, the effects of NUCEIVA on psychological wellbeing and patient reported outcomes were comparable to BOTOX, the active control used in the pivotal study.
Slovenian: 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.
English: What you need to know before NUCEIVA is used 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo NUCEIVA 3.
English: 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.
Slovenian: Uporabljenih vial, brizg in materiala ne izpraznite; odstranite jih v ustrezne posode in zavrzite kot biološko nevarni medicinski odpadek v skladu z lokalnimi predpisi.
English: Recovery after intramuscular injection takes place normally within 12 weeks of injection as nerve terminals sprout and reconnect with the endplates.
Slovenian: Po intramuskularnem injiciranju se prvotno stanje običajno vzpostavi v 12 tednih po injiciranju, ko vzbrstijo živčni končiči in se ponovno povežejo z motoričnimi ploščicami.
English: This is followed by transfer of the toxin across the plasma membrane by receptor-mediated endocytosis.
Slovenian: Temu sledi prehod toksina prek celične membrane z receptorsko posredovano endocitozo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Po rekonstituiranju je treba raztopino za injiciranje pred uporabo vizualno preveriti, ali je bistra, brezbarvna in brez delcev.
English: The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown.
Slovenian: Učinek hkratnega dajanja različnih serotipov botulinskega nevrotoksina ali dajanja v nekajmesečnem razmiku ni znan.
English: Needle-related pain and/or anxiety have resulted in vasovagal responses, including transient symptomatic hypotension and syncope.
Slovenian: Bolečina in/ali anksioznost zaradi injekcijske igle sta povzročili vazovagalne reakcije, vključno s prehodno simptomatsko hipotenzijo in sinkopo.
English: Number
Slovenian: Število
English: Caution should be exercised when NUCEIVA is used in patients with bleeding disorders as injection may lead to bruising.
Slovenian: Previdnost je potrebna, če se zdravilo NUCEIVA uporablja pri bolnikih s hemoragičnimi motnjami, saj injiciranje lahko povzroči modrice.
English: 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.
Slovenian: 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.
English: For any information about this medicine, please contact the the Marketing Authorisation Holder
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: 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.
Slovenian: V primeru nesreče pri rokovanju z zdravilom, bodisi v obliki vakuumsko posušenega praška ali rekonstituirane raztopine, je treba takoj izvesti ustrezne spodaj opisane ukrepe:
English: Vial (Type I glass) fitted with a stopper (chlorobutyl rubber) and a seal (aluminium).
Slovenian: Viala (steklo tipa I) z zamaškom (klorobutilni kavčuk) in (aluminijasto) zaporko.
English: 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.
Slovenian: 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.
English: Used vials, syringes and materials should not be emptied and must be discarded into appropriate containers and disposed of according to local regulations.
Slovenian: Uporabljenih vial, brizg in materiala ne izpraznite; odstranite jih v ustrezne posode in zavrzite v skladu z lokalnimi predpisi.
English: Overdose of NUCEIVA depends upon dose, site of injection, and underlying tissue properties.
Slovenian: Preveliko odmerjanje zdravila NUCEIVA je odvisno od odmerka, mesta injiciranja in osnovnih lastnosti tkiva.
English: The effect of NUCEIVA on human fertility is unknown.
Slovenian: Učinek zdravila NUCEIVA na plodnost pri ljudeh ni znan.
English: 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.
Slovenian: 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.
English: Caution should be taken if complications have resulted with previous botulinum toxin injections.
Slovenian: Previdnost je potrebna, če je prišlo do zapletov pri predhodnih injiciranjih botulinskega toksina.
English: Physical manipulation (such as rubbing) of the injection site in the immediate post-administration period should be avoided.
Slovenian: Preprečiti je treba fizično dotikanje (npr. drgnjenje) mesta injiciranja takoj po dajanju zdravila.
English: What NUCEIVA is and what it is used for
Slovenian: Kaj je zdravilo NUCEIVA in za kaj ga uporabljamo
English: There are no adequate data from the use of botulinum toxin type A in pregnant women.
Slovenian: Ustreznih podatkov o uporabi botulinskega toksina tipa A pri nosečnicah ni.
English: The potential impact of NUCEIVA on fertility has not been investigated in animals.
Slovenian: Morebitni učinek zdravila NUCEIVA na razmnoževanje pri živalih ni bil raziskan.
English: Baseline GLS Category at Rest
Slovenian: Izhodiščna kategorija GLS v mirovanju
English: Human albumin, sodium chloride
Slovenian: SEZNAM POMOŽNIH SNOVI Humani albumin, natrijev klorid
English: NUCEIVA should not be used during breast-feeding.
Slovenian: Zdravilo NUCEIVA se ne sme uporabljati med dojenjem.
English: (listed in section 6); - if you have myasthenia gravis or Eaton Lambert syndrome (chronic diseases affecting the muscles);
Slovenian: - če imate miastenijo gravis ali Lambert-Eatonov sindrom (kronični bolezni, ki prizadeneta mišice);
English: Application related undesirable effects that have been reported following administration of NUCEIVA are uncommon events individually, common when added together.
Slovenian: Neželeni učinki, povezani z aplikacijo, o katerih so poročali po dajanju zdravila NUCEIVA, so posamezno občasni, če se seštejejo, pa pogosti.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of acute and repeat dose toxicity.
Slovenian: Neklinični podatki na osnovi običajnih študij akutne toksičnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
English: Percentage
Slovenian: Odstotek
English: Each vial contains 100 Units botulinum toxin type A After reconstitution each 0.1 mL of the solution contains 4 Units
Slovenian: Ena viala vsebuje 100 enot botulinskega toksina tipa A. Po rekonstituciji 0,1 ml raztopine vsebuje 4 enote.
English: Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Slovenian: Prekomerna živčno-mišična oslabelost se lahko stopnjuje, če se uporabi drug botulinski toksin pred prenehanjem učinkovanja predhodno uporabljenega botulinskega toksina.
English: Pre-existing neuromuscular disorders
Slovenian: Predhodne živčno-mišične motnje
English: There is no information on whether NUCEIVA is excreted in human breast milk.
Slovenian: Informacij, ali se zdravilo NUCEIVA izloča v materino mleko, ni na voljo.
English: NUCEIVA should only be administered by physicians with appropriate qualifications and expertise in the treatment of glabellar lines and the use of required equipment.
Slovenian: Zdravilo NUCEIVA lahko dajo samo zdravniki, ki so ustrezno usposobljeni in imajo strokovno znanje o odpravljanju glabelarnih gub in uporabi potrebne opreme.
English: Injection of NUCEIVA is not recommended in patients with a history of dysphagia and aspiration.
Slovenian: Injiciranje zdravila NUCEIVA ni priporočljivo pri bolnikih, ki so že imeli disfagijo in aspiracijo.
English: Caution should also be exercised when botulinum toxin type A is used for treatment of patients with amyotrophic lateral sclerosis or with peripheral neuromuscular disorders.
Slovenian: Previdnost je potrebna tudi pri uporabi botulinskega toksina tipa A za zdravljenje bolnikov z amiotrofično lateralno sklerozo ali perifernimi živčno-mišičnimi motnjami.
English: The use of botulinum toxin is not recommended in association with aminoglycoside antibiotics, spectinomycin or other medicines that interfere with nerve impulses to the muscle.
Slovenian: Uporaba botulinskega toksina ni priporočljiva v povezavi z aminoglikozidnimi antibiotiki, spektinomicinom ali drugimi zdravili, ki motijo prenos živčnih impulzov do mišic.
English: • Injection near the levator palpebrae superioris should be avoided, particularly in patients with larger brow depressor complexes.
Slovenian: • preprečiti je treba injiciranje v bližino mišice dvigalke zgornje veke (m. levator palpebrae superioris), zlasti pri bolnikih z izrazitejšimi depresorji obrvi (m. depressor supercilii);
English: NUCEIVA is injected into your muscles (intramuscularly), directly into the affected area above and between the eyebrows.
Slovenian: Zdravilo NUCEIVA se injicira v mišice (intramuskularno), neposredno na prizadeti predel nad in med obrvema.
English: Too frequent or excessive dosing may enhance the risk of antibody formation.
Slovenian: S prepogostim ali prevelikim odmerjanjem se lahko poveča tveganje za nastanek protiteles, zaradi česar je lahko zdravljenje neuspešno.
English: Botulinum toxin type A (Clostridium botulinum neurotoxin) blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings, thereby leading to denervation of the muscle and a flaccid paralysis.
Slovenian: Botulinski toksin tipa A (nevrotoksin bakterije Clostridium botulinum) blokira periferno sproščanje acetilholina iz holinergičnih presinaptičnih živčnih končičev s cepljenjem proteina SNAP-25, ki je nujen za uspešno kopičenje in sproščanje veziklov iz mešičkov živčnih končičev.
English: • If a vial is broken, carefully collect the pieces of glass and wipe up the product as stated above, avoiding cuts to the skin.
Slovenian: • če se viala razbije, pazljivo zberite koščke stekla in zdravilo pobrišite, kot je navedeno zgoraj, pri čemer pazite, da se ne urežete;
English: In the event of treatment failure (no visible improvement of glabellar lines at maximum frown) one month after the first course of treatment, the following approaches may be considered:
Slovenian: Če se v enem mesecu po prvem injiciranju pokaže, da zdravljenje ni bilo uspešno (brez vidnega izboljšanja glabelarnih gub pri najmočnejšem mrščenju), pridejo v poštev naslednji pristopi:
English: If the injector injures himself (cuts, pricks himself), proceed as above and take the appropriate medical steps.
Slovenian: Če pri injiciranju zdravila poškodujete sebe (se urežete, zbodete), ukrepajte v skladu z zgoraj navedenim in sprejmite ustrezne medicinske ukrepe.
English: Dizziness, migraine, muscle tone disorder, speech disorder
Slovenian: Omotica, migrena, motnje mišičnega tonusa, motnje govora
English: Do not use NUCEIVA after the expiry date which is stated on the vial and the carton after EXP.
Slovenian: Zdravila NUCEIVA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake „Uporabno do“.
English: After reconstitution each 0.1 mL of the solution contains 4 Units.
Slovenian: Po rekonstituciji 0,1 ml raztopine vsebuje 4 enote.
English: Excessive doses may produce local or distant generalised and profound neuromuscular paralysis.
Slovenian: Preveliki odmerki lahko povzročijo generalizirano in globoko nevromuskulatorno paralizo na mestu injiciranja ali daleč od njega.