FrancophonIA/ELRC3.0 huggingface dataset:
English: Thiocolchicoside must not be used - in patients hypersensitive to the active substance or to any of the excipients listed in section 6.1 - during the entire pregnancy period - during lactation - in women of childbearing potential not using contraception.
Croatian: Tiokolhikozid se ne smije upotrebljavati: - u bolesnika preosjetljivih na djelatnu tvar i na bilo koju od pomoćnih tvari navedenih u dijelu 6.1, - za cijelo vrijeme trajanja trudnoće, - za vrijeme dojenja, - u žena fertilne dobi koje ne koriste kontracepciju.
English: Only two metabolites are observed: The pharmacologically active metabolite SL18.0740 and an inactive metabolite SL59.0955.
Croatian: Opažena su samo dva metabolita: Farmakološki aktivni metabolit SL18.0740 i neaktivni metabolit SL59.0955.
English: The presence of the aglycon metabolite (3-demethylthiocolchicine-SL59.0955) after intramuscular administration has never been assessed, therefore its formation using this route of administration can not be excluded.
Croatian: Prisutnost aglikon metabolita (3-demetiltiokolhicinSL59.0955) nakon intramuskularne primjene nije nikad procijenjena, prema tome njegov nastanak pomoću ovog puta primjene ne može se isključiti.
English: If you accidentally take more X than you should talk to your doctor, pharmacist or nurse.
Croatian: Ako slučajno uzmete više X nego što ste trebali, javite to svom liječniku, ljekarniku ili medicinskoj sestri.
English: In humans, this type of damage to cells is a risk factor for cancer, harm to the unborn child, and impairment of male fertility.
Croatian: Kod ljudi, ovaj tip oštećenja stanica predstavlja faktor rizika za rak, za oštećenja nerođenog djeteta i poremećaj muške plodnosti.
English: In the rabbit, thiocolchicoside showed maternotoxicity starting from 24 mg/kg/day.
Croatian: Kod kunića, tiokolhikozid je pokazao toksičnost za majku počevši od doze od 24 mg/kg/dan.
English: <Invented name> is contraindicated during pregnancy and in women of childbearing potential not using contraception (see section 4.3).
Croatian: <Zaštićeno ime> je kontraindiciran(a) za vrijeme trudnoće i u žena fertilne dobi koje ne koriste kontracepciju (vidjeti dio 4.3).
English: As a precautionary measure, use of the product at doses exceeding the recommended dose or long-term use should be avoided (see section 4.2).
Croatian: Kao mjera opreza, primjena lijeka u dozama većim od preporučene doze ili dugotrajna primjena moraju se izbjegavati (vidjeti dio 4.2).
English: Do not take X if: - you are allergic to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6) - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception - you are breast feeding
Croatian: Nemojte uzimati X ako: - ste alergični na tiokolhikozid ili bilo koji sastojak ovog lijeka (naveden u dijelu 6), - ste trudni, ako biste mogli biti trudni ili mislite da ste trudni, - ste žena u fertilnoj dobi i ne koristite kontracepciju, - dojite.
English: Aneuploidy is a modification in the number of chromosomes and loss of heterozygosity, which is recognized as a risk factor for teratogenicity, embryotoxicity/ spontaneous abortion, impaired male fertility, when impacting germ cells and a potential risk factor for cancer when impacting somatic cells.
Croatian: Aneuploidija je modifikacija broja kromosoma i gubitak heterozigotnosti, koji je prepoznat kao faktor rizika za teratogenost, embriotoksičnost/ spontani abortus i poremećaj muške plodnosti kad utječe na zametne stanice i potencijalni faktor rizika za rak kad utječe na somatske stanice.
English: In the rat, an oral dose of 12 mg/kg/day of thiocolchicoside caused major malformations along with foetotoxicity (retarded growth, embryo death, impairment of sex distribution rate).
Croatian: U štakora, peroralna doza tiokolhikozida od 12 mg/kg/dan uzrokovala je značajne malformacije i fetotoksičnost (usporeni rast, smrt zametka, poremećaj stope raspodjele spola).
English: After repeated administration, thiocolchicoside induced gastro-intestinal disorders (enteritis, emesis) by oral route and emesis by IM route.
Croatian: Nakon ponovljene primjene, tiokolhikozid je izazvao gastrointestinalne poremećaje (enteritis, emezu) kod primjene peroralnim putem i emezu kod intramuskularne primjene.
English: o Both for oral and for IM: Doses exceeding recommended doses or long-term use should be avoided (see section 4.4).
Croatian: Za peroralnu primjenu i za intramuskularnu primjenu: Doze koje prelaze preporučene doze ili dugotrajna primjena moraju se izbjegavati (vidjeti dio 4.4).
English: Thiocolchicoside profile has been assessed in vitro, and in vivo following parenteral and oral administration.
Croatian: Profil tiokolhikozida procijenjen je in vitro i in vivo nakon parenteralne i peroralne primjene.
English: The recommended and maximal dose is 8 mg every 12 hours (i.e. 16 mg per day).
Croatian: Preporučena i maksimalna doza je 8 mg svakih 12 sati (tj. 16 mg na dan).
English: SL59.0955 is then glucuroconjugated into SL18.0740 which has equipotent pharmacological activity to thiocolchicoside and thus supports the pharmacological activity after oral administration of thiocolchicoside.
Croatian: SL59.0955 se zatim glukurokonjugira u SL18.0740 koji ima ekvipotentnu farmakološku aktivnost na tiokolhikozid i tako potpomaže farmakološku aktivnost nakon peroralne primjene tiokolhikozida.
English: The aneugenic effect of SL18.0740 was observed at concentrations in the in vitro test and at AUC plasma exposures in the in vivo test higher (more than 10 fold based on AUC) than those observed in human plasma at therapeutic doses.
Croatian: Aneugenični učinak SL18.0740 bio je opažen pri koncentracijama u in vitro testu i AUC izloženosti plazme u in vivo testovima više (više nego 10-erostruke doze temeljem AUC-a) nego kod onih primijećenih u ljudskoj plazmi pri terapijskim dozama.
English: Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is recognised as a risk factor for impairment of human fertility.
Croatian: Tiokolhikozid i njegovi metaboliti pokazuju aneugeničnu aktivnost pri različitim koncentracijama, što je prepoznato kao rizični faktor za poremećaj plodnosti u ljudi.
English: Aneuploidy is considered as a risk factor for teratogenicity, embryo/foeto-toxicity, spontaneous abortion, and impaired male fertility and a potential risk factor for cancer.
Croatian: Aneuploidija se smatra faktorom rizika za teratogenost, embriofetalnu toksičnost, spontani abortus i poremećaj plodnosti kod muškarca i potencijalno rizičnim faktorom za rak.
English: Biotransformation After oral administration, thiocolchicoside is first metabolized in the aglycon 3demethyltiocolchicine or SL59.0955.
Croatian: Biotransformacija Nakon peroralne primjene, tiokolhikozid se prvo metabolizira u aglikon 3-demetiltiokolhicin ili SL59.0955.
English: After oral administration of thiocolchicoside, the SL18.0740 metabolite is eliminated with an apparent t1/2 ranging from 3.2 to 7 hours and the metabolite SL59.0955 has a t1/2 averaging 0.8h.
Croatian: Nakon peroralne primjene tiokolhikozida, metabolit SL18.0740 se eliminira s prividnim t1/2 u rasponu od 3,2 do 7 sati dok metabolit SL59.0955 ima prosječni t1/2 od 0,8 sati.
English: SL18.0740 and SL59.0955 are found in urine and feces while the didemethyl-thiocolchicine is only recovered in feces.
Croatian: SL18.0740 i SL59.0955 su pronađeni u mokraći i stolici dok je didemetil-tiokolhicin pronađen samo u stolici.
English: The recommended and maximal dose is 4 mg every 12 hours (i.e. 8 mg per day).
Croatian: Preporučena i maksimalna doza je 4 mg svakih 12 sati (tj. 8 mg na dan).
English: See section 4.8 for how to report adverse reactions.
Croatian: Za postupak prijavljivanja nuspojava vidjeti dio 4.8
English: At high doses, thiocolchicoside induced emesis in dog, diarrhoea in rat and convulsions in both rodents and non-rodents after acute administration by oral route.
Croatian: Pri visokim dozama, tiokolhikozid je izazivao emezu kod pasa, dijareju kod štakora i konvulzije i kod glodavaca i neglodavaca nakon akutne primjene peroralnim putem.
English: Absorption - After IM administration, thiocolchicoside Cmax occur in 30 min and .reach values of 113 ng/mL after a 4 mg dose and 175 ng/mL after a 8 mg dose.
Croatian: Apsorpcija - Nakon intramuskularne primjene, Cmax tiokolhikozida postiže se za 30 minuta i doseže vrijednosti od 113 ng/mL nakon doze od 4 mg i 175 ng/mL nakon doze od 8 mg.
English: Contents of the pack and other information [the currently approved wording should be deleted and replaced by the following] 30 tablets/capsules for the 4mg dose and 14 tablets/capsules for the 8mg dose.
Croatian: Sadržaj pakiranja i druge informacije [trenutno odobreni tekst mora se obrisati i zamijeniti sljedećim] 30 tableta/kapsula za dozu od 4 mg i 14 tableta/kapsula za dozu od 8 mg. 10 bočica/ampula za dozu od 4 mg / 2 ml.
English: The pharmacologically active metabolite SL18.0740 is also observed at lower concentrations with a Cmax of 11.7 ng/mL occurring 5 h post dose and an AUC of 83 ng.h/mL.
Croatian: Farmakološki aktivni metabolit SL18.0740 također je opažen pri nižim koncentracijama uz Cmax od 11,7 ng/mL koji se postiže 5 h nakon doze i AUC od 83 ng.h/mL.
English: Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is a risk factor for impairment of human fertility (see section 5.3).
Croatian: Tiokolhikozid i njegovi metaboliti imaju aneugenični učinak pri različitim koncentracijama, što je prepoznato kao rizični faktor za poremećaj plodnosti u ljudi (vidjeti dio 5.3).
English: Elimination - After IM administration the apparent t1/2 of thiocolchicoside is 1.5h and the plasma clearance 19.2 L/h.
Croatian: Eliminacija - Nakon intramuskularne primjene prividni t1/2 tiokolhikozida je 1,5 sati dok je klirens plazme 19,2 L/h.
English: After a single oral dose of 8 mg of thiocolchicoside the Cmax and AUC of SL18.0740 are about 60 ng/mL and 130 ng.h/mL respectively.
Croatian: Nakon jednokratne peroralne doze od 8 mg tiokolhikozida, Cmax i AUC metabolita SL18.0740 iznose oko 60 ng/mL odnosno 130 ng.h/mL.
English: This is because this medicine may harm your unborn child. Do not take this medicine if you are breast-feeding.
Croatian: To je zato što ovaj lijek može naškoditi vašem nerođenom djetetu.
English: In a fertility study performed in rats, no impairment of fertility was seen at doses up to 12 mg/kg, i.e. at dose levels inducing no clinical effect.
Croatian: U ispitivanjima plodnosti provedenim na štakorima, nije opažen utjecaj na plodnost pri dozama do 12 mg/kg, tj. pri dozama koje ne induciraju klinički učinak.
English: In a fertility study performed in rats, no impairment of fertility was seen at doses up to 12 mg/kg/day, i.e. at dose levels inducing no clinical effect.
Croatian: U ispitivanjima plodnosti provedenim na štakorima, nije opažen utjecaj na plodnost pri dozama do 12 mg/kg/dan, tj. pri dozama koje ne induciraju klinički učinak.
English: The micronuclei predominantly resulted from chromosome loss (centromere positive micronuclei after FISH centromere staining), suggesting aneugenic properties.
Croatian: Mikronukleusi su predominantno rezultirali iz gubitka kromosoma (mikronukleusi pozitivni na centromere nakon bojenja centromera metodom FISH), što upućuje na aneugenična svojstva.
English: Distribution The apparent volume of distribution of thiocolchicoside is estimated around 42.7 L after an IM administration of 8 mg. No data are available for both metabolites.
Croatian: Distribucija Prividni volumen raspodjele tiokolhikozida se procjenjuje na oko 42,7 L nakon i.m. primjene doze od 8 mg.
English: The micronuclei predominantly resulted from chromosome loss (centromere positive micronuclei after FISH or CREST centromere staining), suggesting aneugenic properties.
Croatian: Mikronukleusi su uglavnom rezultirali iz gubitka kromosoma (mikronukleusi pozitivni na centromere nakon bojenja centromera metodama FISH ili CREST), što upućuje na aneugenična svojstva.
English: The major glucuro-conjugated metabolite SL18.0740 did not induce gene mutation in bacteria (Ames test); however it induced in vitro chromosomal damage (in vitro micronucleus test on human lymphocytes) and in vivo chromosomal damage (in vivo micronucleus test in mouse bone marrow administered orally).
Croatian: Glavni glukurokonjugirani metabolit SL18.0740 nije izazvao mutaciju gena kod bakterija (Ames test); međutim, izazvao je in vitro oštećenje kromosoma (in vitro mikronukleus test na ljudskim limfocitima) i in vivo oštećenje kromosoma (in vivo mikronukleus test u koštanoj srži miševa kod peroralne primjene).
English: The aneugenic effect of SL59.0955 was observed at concentrations in the in vitro test and at exposures in the in vivo test close to those observed in human plasma at therapeutic doses of 8 mg twice daily per os. Aneugenic effect in dividing cells may result in aneuploid cells.
Croatian: Aneugenični učinak SL59.0955 opažen je u in vitro testu te kod koncentracija i u in vivo testu pri izloženostima blizu onima opaženim u ljudskoj plazmi pri terapijskim dozama od 8 mg dvaput na dan per os.
English: No unchanged thiocolchicoside is excreted either in urine or feces.
Croatian: Neizmijenjeni tiokolhikozid ne izlučuje se ni putem mokraće ni putem stolice.
English: Thiocolchicoside itself did not induce gene mutation in bacteria (Ames test), in vitro chromosomal damage (chromosome aberration test in human lymphocytes) and in vivo chromosomal damage (in vivo micronucleus in mouse bone marrow administered intraperitoneally).
Croatian: Tiokolhikozid sam po sebi nije izazvao mutaciju gena kod bakterija (Ames test), in vitro oštećenje kromosoma (test aberacije kromosoma na ljudskim limfocitima) i in vivo oštećenje kromosoma (in vivo mikronukleus u koštanoj srži miševa kod intraperitonealne primjene).
English: The aglycon metabolite (3-demethylthiocolchicine-SL59.0955) formed mainly after oral administration induced in vitro chromosomal damage (in vitro micronucleus test on human lymphocytes) and in vivo chromosomal damage (in vivo oral micronucleus test in rat bone marrow administred orally).
Croatian: Metabolit aglikon (3-demetiltiokolhicin-SL59.0955) koji nastaje uglavnom nakon peroralne primjene izazvao je in vitro oštećenje kromosoma (in vitro mikronukleus test na ljudskim limfocitima) i in vivo oštećenje kromosoma (in vivo oralni test mikronukleusa na koštanoj srži miševa kod peroralne primjene).
English: unequal number of chromosomes in dividing cells) at concentrations close to human exposure observed at doses 8 mg twice daily per os (see section 5.3).
Croatian: Pretklinička ispitivanja pokazala su da jedan o metabolita tiokolhozida (SL59.0955) izaziva aneuploidiju (tj. nejednak broj kromosoma u stanicama u diobi) pri koncentracijama bliskim izloženosti kod ljudi primijećenoj pri dozama od 8 mg peroralno dvaput na dan (vidjeti dio 5.3).
English: o Both for oral and for intramuscular forms:
Croatian: o Za oblike koji se primjenjuju kroz usta i u mišić:
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Croatian: Izmjene i dopune odgovarajućih dijelova sažetka opisa svojstava lijeka, označavanja i upute o lijeku
English: o For IM form:
Croatian: o Za oblike koji se primjenjuju u mišić:
English: Reporting of side effects
Croatian: Izvješćivanje o nuspojavama
English: Please tell your doctor if:
Croatian: Obavijestite svojeg liječnika ako:
English: Absolute Difference
Croatian: Apsolutna razlika
English: Store in a refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2° C - 8° C).
English: September 2020
Croatian: rujan 2020.
English: Chemical and physical in-use stability has been demonstrated for 72 hours at 2 - 8°C.
Croatian: Kemijska i fizička stabilnost lijeka u primjeni dokazana je za razdoblje od 72 sata pri 2 - 8° C.
English: In order to reduce the complication of eyelid ptosis the following steps should be taken:
Croatian: Kako bi se ublažile komplikacije ptoze (spuštanja) vjeđe, potrebno je poduzeti sljedeće korake:
English: This leaflet was last revised in{month YYYY}.
Croatian: Ova uputa je zadnji put revidirana u {mjesec GGGG}.
English: The interval between treatments will be decided by your doctor.
Croatian: O vremenskom razmaku između primjena lijeka odlučuje Vaš liječnik.
English: The central part of the rubber cap should be cleaned with alcohol.
Croatian: Središnji dio gumenog čepa mora se očistiti alkoholom.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta lijek je potrebno upotrijebiti odmah.
English: The usual dose of NUCEIVA is 20 Units.
Croatian: Uobičajena doza lijeka NUCEIVA je 20 jedinica.
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.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Uncommon events occurred in between 2 and 7 subjects.
Croatian: Manje česti događaji pojavili su se kod dva do sedam ispitanika.
English: 4 Units
Croatian: 4 jedinice
English: Do not drive or use machinery until such effects have cleared.
Croatian: Nemojte upravljati vozilima i strojevima sve dok ovi učinci lijeka ne prođu.
English: Co. Meath, K32YD60
Croatian: Meath, K32YD60
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.
Croatian: Ukupno 922 bolesnika sudjelovalo je u dvama jednogodišnjim otvorenim nekontroliranim ispitivanjima, a tijekom tih ispitivanja prosječni je bolesnik primio tri liječenja.
English: Duration of response in the phase 3 study was 139 days, based on a 1 point GLS improvement.
Croatian: Trajanje odgovora u ispitivanju faze 3. iznosilo je 139 dana, na temelju poboljšanja GLS rezultata za 1 bod.
English: Swallowing and breathing difficulties are serious and can result in death.
Croatian: Teškoće s gutanjem i disanjem ozbiljne su i mogu imati smrtni ishod.
English: Excessive doses may produce local or distant generalised and profound neuromuscular paralysis.
Croatian: Pretjerane doze mogu dovesti do nastanka lokalne ili udaljene generalizirane i duboke neuromuskularne paralize.
English: What NUCEIVA is and what it is used for
Croatian: Što je NUCEIVA i za što se koristi
English: Note: Of the 1659 subjects treated with NUCEIVA, rare events occurred in 1 subject only.
Croatian: Napomena: Od 1659 osoba liječenih lijekom NUCEIVA, rijetki su se događaji pojavili samo u jednog ispitanika.
English: - Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
Croatian: - Ubrizgani volumen/doza mora biti točna i, ako je to moguće, najmanja moguća.
English: The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown.
Croatian: Učinak primjene različitih serotipova botulinskog neurotoksina istodobno ili u međusobnom razmaku od nekoliko mjeseci nije poznat.
English: Signs of overdose may not be apparent immediately post-injection.
Croatian: Znakovi predoziranja možda neće biti vidljivi odmah nakon injiciranja.
English: Only clear, colorless solution without particles should be used.
Croatian: Smije se upotrijebiti samo bistra, bezbojna otopina bez čestica.
English: Other medicines and NUCEIVA
Croatian: Drugi lijekovi i NUCEIVA
English: Symptomatic treatment should be instigated if necessary.
Croatian: Ako je to potrebno, valja pokrenuti simptomatsko liječenje.
English: It works by blocking the nerve impulses to the muscles in which it has been injected.
Croatian: Djeluje na način da blokira prijenos živčanih impulsa u mišiće u koje je injiciran.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of acute and repeat dose toxicity.
Croatian: Neklinički podatci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja akutne toksičnosti i toksičnosti ponovljenih doza.
English: - if you have an infection or inflammation at the proposed injection sites.
Croatian: - ako imate infekciju ili upalu na planiranim mjestima primjene injekcije.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama u pogledu reproduktivne toksičnosti nedostatna su (vidjeti dio 5.3).
English: Daewoong Pharmaceutical Co. Limited 35-14 Jeyakgongdan 4-gil Hyangnam-eup
Croatian: Limited 35-14 Jeyakgongdan 4-gil Hyangnam-eup
English: It is used in adults less than 65 years of age in whom those facial lines have an important psychological impact.
Croatian: Koristi se u odraslih bolesnika mlađih od 65 godina kod kojih te bore na licu imaju važan psihološki utjecaj.
English: What NUCEIVA looks like and contents of the pack
Croatian: Kako NUCEIVA izgleda i sadržaj pakiranja
English: Injection into vulnerable anatomical structures, such as nerves and blood vessels, must be avoided.
Croatian: Nužno je izbjegavati injiciranje u vulnerabilne anatomske strukture, kao što su živci i krvne žile.
English: For any information about this medicine, please contact the the Marketing Authorisation Holder
Croatian: Za sve informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje lijeka u promet
English: Effects on peri-/postnatal development have not been evaluated.
Croatian: Nisu procijenjeni učinci na perinatalni i postnatalni razvoj.
English: - you see no significant improvement of your lines one month after your first course of treatment; - you suffer from certain diseases affecting your nervous system (such as amyotrophic lateral sclerosis or motor neuropathy); - you have inflammation at the proposed injection site(s);
Croatian: - ne vidite značajno poboljšanje bora mjesec dana nakon prvog ciklusa liječenja, - bolujete od određene bolesti živčanog sustava (poput amiotrofične lateralne skleroze ili motorne neuropatije), - imate upalu na planiranom(im) mjestu(ima) primjene injekcije;
English: NUCEIVA (N=245) GLS=0 at Day 30 at Maximum Contraction
Croatian: NUCEIVA (N=245) GLS=0 na 30. dan pri najjačoj kontrakciji
English: There is a risk of eyelid ptosis following treatment (see section 4.2).
Croatian: Postoji rizik od ptoze vjeđe nakon liječenja (vidjeti dio 4.2.).
English: - The toxin is very sensitive to heat and certain chemical agents.
Croatian: • Toksin je jako osjetljiv na toplinu i na određene kemijske agense.
English: GLS=1 at Day 30 at Maximum Contraction
Croatian: GLS=1 na 30. dan pri najjačoj kontrakciji
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.
Croatian: Psihološki učinak glabelarnih bora potvrđen je na početku ispitivanja, a iako nije mogao biti dokazan pozitivan učinak na psihološku dobrobit, dokazani su značajni učinci na ishode koje su prijavili bolesnici u usporedbi s placebom.
English: Toxin spread
Croatian: Širenje toksina
English: To prevent this, there must be a gap of at least three months between doses.
Croatian: Kako bi se to spriječilo, razmak između dvije primjene ne smije biti manji od tri mjeseca.
English: No specific dose adjustment is required for use in the elderly.
Croatian: Nije potrebna prilagodba doze u starijih osoba.
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.
Croatian: Nadalje, učinci lijeka NUCEIVA na psihološku dobrobit i ishode koje su prijavili bolesnici bili su usporedivi s Botoxom, aktivnom kontrolom koja je primijenjena u pivotalnom ispitivanju.
English: It prevents muscles from contracting, leading to a temporary paralysis.
Croatian: Sprječava stezanje mišića, što dovodi do privremene paralize.