natgillin/translations-raw huggingface dataset:
In rare cases difficulty in swallowing may be severe and choking is possible.
V redkih primerih so lahko težave s požiranjem hude in možno je dušenje.
The safety and efficacy of NeuroBloc in children aged less than 18 years have not yet been established.
Varnost in učinkovitost zdravila NeuroBloc pri otrocih, mlajših od 18 let, še nista dokazani.
Spread of toxin effect
Širjenje delovanja toksina
An investigation into the consequence of seroconversion showed that the presence of antibodies was not synonymous with a loss of clinical response, and did not have an impact on the overall safety profile.
Raziskava posledic serokonverzije je pokazala, da prisotnost protiteles ni obvezno pomenila izgube kliničnega odziva in ni vplivala na celoviti varnostni profil.
Animal reproduction studies are insufficient with respect to effects on pregnancy and embryonal/foetal development.
Študije o vplivu na razmnoževanje pri živalih ne zadoščajo za oceno učinkov na nosečnost in razvoj embrija/ploda.
The safety of NeuroBloc outside the approved indication has not been established.
Varnost zdravila NeuroBloc zunaj odobrene indikacije ni bila dokazana.
CLINICAL PARTICULARS 4.1 Therapeutic indications
KLINIČNI PODATKI 4.1 Terapevtske indikacije
TWSTRS-Total
TWSTRS - Skupno
If you are going to have an operation, please tell your doctor that you have been given NeuroBloc.
Če boste imeli operacijo, povejte svojemu zdravniku, da ste prejeli zdravilo NeuroBloc.
If you think that the effect of NeuroBloc is too strong or too weak, talk to your doctor.
Če menite, da je učinek zdravila NeuroBloc premočan ali prešibak, se posvetujte z zdravnikom.
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2 °C-8 °C).
However, no pharmacokinetic or Absorption, Distribution, Metabolism and Excretion (ADME) studies have been performed.
Vendar niso bile opravljene nikakršne farmakokinetične študije ali študije absorpcije, porazdelitve, presnove in izločanja (ADME - Absorption, Distribution, Metabolism and Excretion).
Restricted to hospital use only.
Dovoljeno samo za uporabo v bolnišnici.
The systemic No Observed Effect Level (NOEL) was shown to be approximately 960 U/kg.
Sistemska raven brez vidnega učinka (NOEL - No Observed Effect Level) je bila približno 960 E/kg.
SPECIAL WARNINGS THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Pharmacotherapeutic group: muscle relaxant, peripherally acting agents, ATC code: M03AX 01.
Farmakoterapevtska skupina: mišični relaksanti s perifernim delovanjem, oznaka ATC: M03AX 01.
Data from clinical studies suggest that efficacy is dose dependent, but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U. Therefore an initial dose of 5000 U may also be considered, but a dose of 10,000 U may increase the likelihood of clinical benefit.
Podatki iz kliničnih študij kažejo, da je učinkovitost odvisna od odmerka, vendar ta preskušanja, ker niso bila primerjalna, ne kažejo signifikantne razlike med odmerkoma s 5.000 E in 10.000 E. Zato lahko pretehtate uporabo začetnega odmerka s 5.000 E, čeprav lahko odmerek z 10.000 E poveča verjetnost ugodnega kliničnega učinka.
Patient evaluations continued for 16 weeks post injection.
Bolnike so ocenjevali še 16 tednov po injiciranju.
Recovery usually takes place over a period of time.
Stanje se navadno sčasoma izboljša.
Placebo 10,000 U Placebo 5000 U 10,000 U
ocene placebo 10.000 E placebo 5.000 E 10.000 E
Paediatric use (non approved): in children, clinically significant systemic toxicity has occurred at doses approved for the treatment of adult patients.
Pediatrična uporaba (neodobrena uporaba): pri otrocih se je pri odmerkih, odobrenih za zdravljenje odraslih bolnikov, pojavila klinično pomembna sistemska toksičnost.
If he/she is unavailable seek emergency assistance.
Če ni dosegljiv, poiščite nujno medicinsko pomoč.
At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Po koncu tega obdobja zdravila ne smete spraviti nazaj v hladilnik, ampak ga morate zavreči.
The immunogenicity of NeuroBloc has been evaluated in two clinical studies and an open-label extension study.
Imunogenost zdravila NeuroBloc so ocenili v dveh kliničnih študijah in odprti podaljšani študiji.
This is because swallowing problems could make you breathe food or liquids into your lungs, which could then cause very serious pneumonia
Zaradi težav s požiranjem bi namreč lahko vdihnili hrano ali tekočine v pljuča, kar bi lahko potem povzročilo zelo resno pljučnico.
Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults.
Odmerki do 15.000 E so pri odraslih redko povzročili klinično značilno sistemsko toksičnost.
Further clinical studies and open label follow-up have shown that subjects can continue to respond to NeuroBloc for prolonged periods of time, with some subjects receiving more than 14 treatment sessions over a period of more than 3.5 years.
Nadaljnje klinične študije in odprte nadaljevalne študije so pokazale, da se bolniki lahko še naprej za dolga časovna obdobja odzivajo na zdravilo NeuroBloc, pri čemer so nekateri bolniki prejeli več kot 14 sej zdravljenja v obdobju več kot 3,5 leta.
The solution is clear and colourless to pale yellow.
Raztopina je bistra in brezbarvna do bledo rumena.
Adverse reactions seen in all clinical studies are listed below according to MedDRA system organ class and in decreasing frequency which is defined as follows: Very Common (>1/10); Common (>1/100 to <1/10); Uncommon (>1/1000 to <1/100).
Neželeni učinki iz vseh kliničnih študij so navedeni spodaj in so razdeljeni po organskih sistemih po MedDRA in pogostosti na naslednji način: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1000 do < 1/100).
Development studies in rats and rabbits have shown no evidence of foetal malformations or changes to fertility.
Študije razvoja pri podganah in kuncih niso pokazale deformacij ploda ali spremembe plodnosti.
Analysis of the TWSTRS sub scales revealed significant effects on the severity of cervical dystonia and its associated pain and disability.
Analiza podlestvic lestvice TWSTRS je pokazala signifikantne učinke na hudost cervikalne distonije ter z njo povezane bolečine in invalidnosti.
If your doctor suspects that botulism may have occurred, you will be admitted to hospital and your breathing (respiratory function) will be monitored.
Če vaš zdravnik posumi, da gre za botulizem, boste sprejeti v bolnišnico, kjer bodo spremljali vaše dihanje (respiratorno funkcijo).
NeuroBloc should not be used during pregnancy unless the clinical condition of the woman requires treatment with Botulinum Toxin Type B (see section 5.3).
Zdravila NeuroBloc ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje z botulinskim toksinom vrste B (glejte poglavje 5.3).
Use immediately if diluted (see section 4.2 and section 6.6).
Razredčeno zdravilo porabite takoj (glejte poglavje 4.2 in poglavje 6.6).
Caution should be used in patients with bleeding disorders or receiving anticoagulant therapy.
Previdni morate biti pri bolnikih, ki imajo motnje krvavitve ali se zdravijo z antikoagulanti.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
This is because NeuroBloc can affect the medicines you may be given before a general anaesthetic.
Zdravilo NeuroBloc namreč lahko vpliva na zdravila, ki vam jih bodo mogoče dali pred splošno anestezijo.
The primary efficacy outcome variable for both studies was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score (range of possible scores is 0-87) at Week 4.
Primarna spremenljivka izida učinkovitosti je bila pri obeh študijah skupni rezultat vrednosti Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (možne vrednosti so v intervalu 0-87) v četrtem tednu.
The excretion of Botulinum Toxin Type B in milk has not been studied in animals.
Izločanje botulinskega toksina vrste B v mleko ni bilo preučeno na živalih.
Particular caution should be paid to ensure that it is not injected into a blood vessel.
Potrebna je posebna pozornost, da se zdravilo ne injicira v krvno žilo.
If your swallowing difficulty gets worse or you have choking or breathing problems, see a doctor immediately.
Če se težave s požiranjem poslabšajo ali če se začnete dušiti ali je dihanje oteženo, pojdite nemudoma k zdravniku.
A decision must be made on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NeuroBloc taking into account the benefit of breast-feeding to the child and the benefit of NeuroBloc therapy to the woman.
Odločiti se je treba med nadaljevanjem/prenehanjem dojenja in nadaljevanjem/prekinitvijo zdravljenja z zdravilom zdravila NeuroBloc, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z zdravilom NeuroBloc za mater.
Children (non approved use) and patients with underlying neuromuscular disorders including swallowing disorders are at increased risk of these adverse reactions.
Pri otrocih (neodobrena uporaba) in bolnikih z nevromuskulaturnimi motnjami, vključno z motnjami požiranja, je tveganje neželenih učinkov še večje.
What you need to know before you use NeuroBloc Do not use NeuroBloc:
Kaj morate vedeti, preden boste uporabili zdravilo Neurobloc Ne uporabljajte zdravila NeuroBloc:
NeuroBloc contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc.
Zdravilo NeuroBloc vsebuje manj kot 1 mmol natrija (23 mg) na 10.000 enot zdravila NeuroBloc.
The presence of antibodies in these studies was assessed using the mouse protection assay (also known as the Mouse Neutralization Assay, MNA).
Prisotnost protiteles v teh študijah so ocenjevali s testom zaščite miši (ki je znan tudi kot test nevtralizacije pri miših (MNA- Mouse Neutralization Assay).
The total dose was divided between the selected muscles and 1 to 5 injections per muscle were administered.
Skupni odmerek so razdelili med izbrane mišice in v posamezno dali eno do pet injekcij.
These side effects have sometimes resulted in death and are possibly related to the spread of botulinum toxin to body parts away from the place where the injection is given.
Ti neželeni učinki se včasih končajo s smrtjo in so mogoče povezani s širjenjem botulinskega toksina v druge telesne dele z mesta, kamor je bila dana injekcija.
The medicinal product was injected on a single occasion into 2 to 4 of the following muscles: splenius capitus, sternocleidomastoid, levator scapulae, trapezius, semispinalis capitus and scalene.
Zdravilo so ob enem obisku injicirali v dve do štiri od naslednjih mišic: splenius capitis, sternocleidomastoideus, levator scapulae, trapezius, semispinalis capitis in scalenus.
Because of the nature of the product, no animal studies have been carried out to establish the carcinogenic effects of NeuroBloc.
Zaradi narave zdravila niso bile izvedene študije na živalih, ki bi pokazale karcinogene učinke zdravila NeuroBloc.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you are given NeuroBloc.
Če niste gotovi, ali kaj od zgoraj navedenega velja za vas, se pogovorite s svojim zdravnikom ali farmacevtom, preden vam dajo zdravilo NeuroBloc.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines: aminoglycoside antibiotics for an infection medicines to stop blood clotting, such as warfarin
Še posebno povejte svojemu zdravniku ali farmacevtu, če jemljete ali ste jemali kateri od naslednjih zdravil: aminoglikozidne antibiotike zaradi okužbe, zdravila za preprečevanje strjevanja krvi, na primer varfarin.
Very common (may affect more than 1 in 10 people) dry mouth difficulty swallowing headache
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): suha usta, oteženo požiranje, glavobol.
Standard tests to investigate the mutagenicity of NeuroBloc have not been performed.
Standardni testi za raziskovanje mutagenosti zdravila NeuroBloc niso bili opravljeni.
No fertility studies have been performed and it is not known whether NeuroBloc can affect reproduction capacity.
Študije plodnosti niso bile opravljene in ni znano, ali zdravilo NeuroBloc lahko vpliva na sposobnost razmnoževanja.
NeuroBloc is presented as a solution for injection in a vial that contains 0.5 ml (2500 Units), 1.0 ml (5000 Units) or 2.0 ml (10,000 Units).
Zdravilo NeuroBloc je na voljo kot raztopina za injiciranje v viali, ki vsebuje 0,5 ml (2.500 enot), 1,0 ml (5.000 enot) ali 2,0 ml (10.000 enot).
A series of clinical studies have been conducted to evaluate the efficacy and safety of NeuroBloc in the treatment of cervical dystonia.
Opravili so vrsto kliničnih študij, da bi ovrednotili učinkovitost in varnost zdravila NeuroBloc za zdravljenje cervikalne distonije.
However, in clinical studies, NeuroBloc was administered 16 weeks after the injection of Botulinum Toxin Type A.
Vendar so v kliničnih študijah dajali zdravilo NeuroBloc 16 tednov po injiciranju botulinskega toksina vrste A.
10,000 U
10.000 E
Patients treated with therapeutic doses may experience exaggerated muscle weakness.
Bolniki, zdravljeni s terapevtskim odmerkom, lahko čutijo pretirano oslabelost mišic.
Vials should be visually inspected prior to use.
Pred uporabo viale vizualno preglejte.
For patients with reduced muscle mass the dose should be adjusted according to individual patient need.
Pri bolnikih z zmanjšano maso mišic morate odmerek prilagoditi njihovim osebnim potrebam.
Solution for injection 1 vial
raztopina za injiciranje 1 viala
What NeuroBloc is and what it is used for
Kaj je zdravilo Neurobloc in za kaj ga uporabljamo
In patients with neuromuscular disorders or history of dysphagia and aspiration, botulinum toxins should only be used in an experimental setting under strict medical supervision.
Pri bolnikih z nevromuskulaturnimi motnjami ali anamnezo disfagije in aspiracije je dovoljeno botulinski toksin uporabljati le v raziskovalnem okolju pod strogim zdravstvenim nadzorom.
Contents of the pack and other information What NeuroBloc contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo NeuroBloc
Elderly No dose adjustment is required in older people ≥ 65 years of age.
Starejši ljudje V skupini starejših ljudi, starih ≥ 65 let, ni potrebno prilagajanje odmerka.
5000 U
5.000 E
In the event of an overdose or injection into a muscle that normally compensates for the cervical dystonia, it is conceivable that the dystonia may worsen.
V primeru prevelikega odmerjanja ali injiciranja v mišico, ki ponavadi kompenzira cervikalno distonijo, se lahko distonija poslabša.
NeuroBloc injection works by reducing or stopping muscle contractions.
Injekcija zdravila NeuroBloc deluje tako, da zmanjša ali zaustavi krčenje mišic.
The initial dose is 10,000 U and should be divided between the two to four most affected muscles.
Začetni odmerek je 10.000 E in ga je treba razdeliti med dve do štiri najbolj prizadete mišice.
The primary efficacy assessment was the TWSTRS Total score, and secondary efficacy assessments included VAS assessment of change evaluated by patient and investigator, conducted at 4, 8 and 12 weeks after treatment.
Primarno učinkovitost so ocenjevali z lestvico celotne TWSTRS, ocenjevanje sekundarne učinkovitosti pa je vključevalo oceno spremembe lestvice VAS, ovrednoteno tako s strani bolnika kot tudi raziskovalca, opravljeno po 4, 8 in 12 tednih zdravljenja.
EU/1/00/166/001 - 2500 U EU/1/00/166/002 - 5000 U EU/1/00/166/003 - 10,000 U
EU/1/00/166/001 - 2.500 E EU/1/00/166/002 - 5.000 E EU/1/00/166/003 - 10.000 E
NeuroBloc has been approved for the treatment of cervical dystonia only and should not be used to treat anything else.
Zdravilo NeuroBloc je odobreno samo za zdravljenje cervikalne distonije in ga ne smete uporabiti za zdravljenje ničesar drugega.
The units expressed are Type B Units, which are not interchangeable with the units used to express the potency of other Botulinum toxin preparations.
Enote, v katerih je izražena jakost, so enote vrste B, ki niso zamenljive z enotami, ki se uporabljajo za izražanje jakosti drugih pripravkov botulinskega toksina.
These units are not interchangeable with the units used to express the potency of other botulinum toxin preparations (see section 4.4).
Teh enot ne smete zamenjati z enotami, ki se uporabljajo za izražanje jakosti drugih pripravkov botulinskega toksina (glejte poglavje 4.4).
Pre-Existing neuromuscular disorders
Obstoječe živčnomišične bolezni
The initial dose of 10,000 U should be divided between the two to four most affected muscles.
Začetni odmerek 10.000 E je treba razdeliti med dve do štiri najbolj prizadete mišice.
The study met the pre-defined criteria for non-inferiority of NeuroBloc compared to Botulinum Toxin Type A, both in terms of mean TWSTRS total score at week 4 after first and second treatment sessions, and in terms of duration of effect.
Študija je izpolnjevala vnaprej definirana merila za neinferiornost zdravila NeuroBloc v primerjavi z botulinskim toksinom vrste A, tako glede rezultata povprečne celotne TWSTRS v 4. tednu po prvem in drugem ciklu zdravljenju, kot glede trajanja učinka.
P-Value* * Analysis of covariance, two-tailed tests, a = 0.05
Srednja vrednost - 4. teden 47,9 Vrednost P* * analiza kovariance, dvostranski testi, a = 0,05
2500 U
2.500 E
Following NeuroBloc treatment, all patients and caregivers should be advised to seek medical attention for respiratory difficulties, choking or any new or worsening dysphagia.
Po zdravljenju z zdravilom NeuroBloc je treba vse bolnike in skrbnike obvestiti, da naj v primeru težav pri dihanju, v primeru dušenja ali pojava nove disfagije ali njenega poslabšanja poiščejo zdravniško pomoč.
The second study enrolled patients who continued to respond to type A toxin (A-responders).
V drugi študiji so vključili bolnike, ki so se še vedno odzivali na toksin vrste A (A-dovzetni).
The non-inferiority of NeuroBloc compared to Botulinum Toxin Type A was further supported by a responder analysis where similar percentages of subjects showed improvement in the TWSTRS score at Week 4 of Session 1 (86% NeuroBloc and 85% Botox), and a similar proportion of subjects experienced at least a 20% decrease from baseline in the TWSTRS score at Week 4 of Session 1 (51% NeuroBloc, 47% Botox).
Enakovrednost zdravila NeuroBloc glede na butulinski toksin vrste A je nadalje podprla analiza responderjev, v kateri so različni odstotni deleži bolnikov pokazali izboljšanje rezultata TWSTRS v 4. tednu 1. cikla (86 % NeuroBloc in 85 % Botox), podoben delež bolnikov pa je pokazal vsaj 20odstotno zmanjšanje rezultata TWSTRS od izhodišča v 4. tednu 1. seje (51 % NeuroBloc, 47 % Botox).
Immunogenicity data from three long-term clinical studies indicate that approximately one third of patients develop antibodies, as determined by the mouse neutralisation/ mouse protection assay dependent on duration of exposure.
Podatki o imunogenosti iz treh dolgoročnih kliničnih študij kažejo, da se pri približno eni tretjini bolnikov razvijejo protitelesa, kot je bilo ugotovljeno s testom nevtralizacije pri miših/zaščite miši, odvisno od trajanja izpostavljenosti.
The mechanism by which muscle paralysis is reversed over time remains unknown, but may be associated with the intraneuronal turnover of the affected protein and/or sprouting of the nerve ending.
Mehanizem, zaradi katerega se mišična paraliza čez čas povrne v normalno stanje, ni znan, vendar je lahko povezan z intranevralno pretvorbo (turnover - nastajanjem in razkrojem) prizadete beljakovine in/ali rastjo živčnega končiča.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE in IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Produced in Clostridium botulinum Serotype B (Bean Strain) cells.
Izdelano v celicah Clostridium botulinum serotipa B (sev, izoliran iz fižola).
Nervous system disorders dry mouth, headache torticollis (worsening from baseline), taste perversion
Bolezni živčevja suha usta, glavobol tortikolis (poslabšanje od izhodišča), popačeno okušanje
Other medicines and NeuroBloc
Druga zdravila in zdravilo NeuroBloc
From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination the product should be used immediately.
Z mikrobiološkega vidika je treba zdravilo uporabiti takoj, razen kadar način odpiranja/redčenja preprečuje tveganje onesnaženja zdravila z mikrobi.
STUDY 2 (A-Responsive Patients)
ŠTUDIJA (bolniki, dovzetni za A)
This is because NeuroBloc can affect the way some medicines work and other medicines can also affect the way NeuroBloc works.
Zdravilo NeuroBloc namreč vpliva na delovanje nekaterih drugih zdravil, nekatera druga zdravila pa lahko vplivajo na delovanje zdravila NeuroBloc.
Single dose pharmacology studies in cynomolgus monkeys have shown no effects other than the anticipated dose-dependent paralysis of injected muscles, together with some diffusion of toxin at high doses producing similar effects in neighbouring non-injected muscles.
Farmakološke raziskave enkratnih odmerkov na opicah vrste Macaca fascicularis niso pokazale učinkov, razen od odmerka odvisne pričakovane paralize mišic, v katere so injicirali zdravilo, ter nekaj difuzije toksina pri visokih odmerkih, kar je povzročilo podobne učinke v bližnjih mišicah, v katere zdravila niso injicirali.
Extracellular binding of the toxin to specific acceptors on motor nerve terminals Internalisation and release of the toxin into the cytosol of the nerve terminals Inhibition of acetylcholine release from nerve terminals at the neuromuscular junction
zunajcelična vezava toksina na specifične akceptorje na končičih motoričnih nevronov; vstop in sproščanje toksina v citosol živčnih končičev; inhibicija sproščanja acetilholina iz živčnih končičev v nevromuskularno špranjo.
NeuroBloc is a neuromuscular blocking agent.
Zdravilo NeuroBloc je nevromuskularni blokator.
When injected directly into a muscle, NeuroBloc causes a localised paralysis that gradually reverses over time.
Po neposrednem injiciranju v mišico zdravilo NeuroBloc povzroči lokalizirano paralizo, ki se čez čas postopoma povrne v normalno stanje.
Once diluted, the medicinal product must be used immediately as the formulation does not contain a preservative.
Razredčeno zdravilo morate uporabiti takoj, ker pripravek ne vsebuje konzervansa.
The safety of NeuroBloc when used to treat other conditions is not known: some side effects may be fatal.
Varnost zdravila NeuroBloc za zdravljenje drugih bolezni ni znana; nekateri neželeni učinki so lahko za bolnika smrtni.
Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of NeuroBloc (see section 4.3).
Bolnike z živčnomišičnimi boleznimi lahko ogrožajo klinično pomembni učinki, med drugim težka disfagija in prizadetost dihanja pri običajnih odmerkih zdravila NeuroBloc (glejte poglavje 4.3).
It is unknown whether Botulinum Toxin Type B is excreted in human breast milk.
Ni znano, ali se botulinski toksin vrste B izloča v materino mleko.
Studies have not been carried out in patients with hepatic or renal impairment.
Študije pri bolnikih z okvarjenim delovanjem jeter ali ledvic niso bile opravljene.
Following local intramuscular injection of NeuroBloc serious adverse events that may have been due to systemic effects of Botulinum Toxin Type B, were observed in 12% of adverse reaction cases reported during the post-marketing experience (including the following adverse reactions: dry mouth, dysphagia and blurred vision).
Po lokalnem intramuskularnem injiciranju zdravila NeuroBloc so opazili resne neželene učinke, ki bi lahko bili posledica sistemskih učinkov botulinskega toksina vrste B, pri 12 % primerov neželenih učinkov, o katerih so poročali po uvedbi zdravila na trg (vključno z naslednjimi neželenimi učinki: suha usta, disfagija in zamegljen vid).