natgillin/translations-raw huggingface dataset:
Neupro 2 mg/24 h Each patch releases 2 mg of rotigotine per 24 hours.
Neupro 2 mg/ 24 h Vsak obliž sprosti 2 mg rotigotina v 24 urah.
Neupro 4 mg/24 h Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 4 mg/ 24 h Vsak obliž sprosti 4 mg rotigotina v 24 urah.
Neupro 6 mg/24 h Each patch releases 6 mg of rotigotine per 24 hours.
Neupro 6 mg/ 24 h Vsak obliž sprosti 6 mg rotigotina v 24 urah.
Neupro 8 mg/24 h Each patch releases 8 mg of rotigotine per 24 hours.
Neupro 8 mg/ 24 h Vsak obliž sprosti 8 mg rotigotina v 24 urah.
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Zunanja stran je rumenorjave barve, z natisnjenim napisom Neupro 2 mg/ 24 h, 4 mg/ 24 h, 6 mg/ 24 h ali 8 mg/ 24 h.
Shannon, Industrial Estate, Co.Clare, Ireland
Shannon, Industrial Estate,
Sverige UCB Nordic A/S Tel: + 46 / (0) 40 29 49 00
201 Sverige Κύπρος UCB Nordic A/ S Lifepharma (Z. A. M.) Ltd Tel: + 46 / (0) 40 29 49 00 Τηλ: + 357 22 34 74 40
Tel: +44 / (0)1753 534 655
UCB Pharma Oy Finland Tel: +44 / (0) 1753 534 655 Tel: + 358 9 229 0100
199
202
NeuroBloc is a solution for injection containing the active substance botulinum toxin type B (5000 units [U] per millilitre).
Zdravilo NeuroBloc je raztopina za injiciranje, ki vsebuje zdravilno učinkovino botulinski toksin vrste B (5. 000 enot [e] na mililiter).
Cervical dystonia, which is also known as torticollis, is a disorder when the neck muscles contract, causing abnormal movement and twisting of the neck and unusual positioning of the head.
Cervikalna distonija, ki je znana tudi kot tortikolis, je motnja, ki se pojavi pri krčenju vratnih mišic, kar povzroči nenormalno premikanje in upogibanje vratu ter nenavadne položaje glave.
NeuroBloc should only be given by injection into a muscle by a specialist who has experience in the treatment of cervical dystonia and in the use of botulinum toxins.
Zdravilo NeuroBloc sme dati z injiciranjem v mišico le zdravnik specialist z izkušnjami v zdravljenju cervikalne distonije in uporabi botulinskih toksinov.
The starting dose of NeuroBloc is 10,000 U, divided into equal injections directly into the two to four muscles in the neck and shoulders that are most affected.
Začetni odmerek zdravila NeuroBloc je 10. 000 enot in ga je treba razdeliti v enake injekcije, ki se vbrizgajo neposredno v dve do štiri najbolj prizadete mišice vratu in ramen.
The dose and number of injections depend on the patient’ s response.
Odmerek in število injekcij so odvisni od odziva bolnika.
The active substance in NeuroBloc, botulinum toxin type B, is a muscle relaxant.
Zdravilna učinkovina v zdravilu NeuroBloc, botulinski toksin vrste B, je mišični relaksant.
Botulinum toxin type B is a toxic substance produced by the bacterium Clostridium botulinum.
Botulinski toksin vrste B je strupena snov, ki jo tvori bakterija Clostridium botulinum.
The bacterium causes botulism, a type of food poisoning that causes muscle weakness and paralysis.
Bakterija povzroča botulizem, vrsto zastrupitve krvi, ki povzroča šibkost mišičja in paralizo.
The toxin reduces the release of acetylcholine, a chemical messenger that causes muscle contraction.
Strup zmanjša sproščanje acetilholina, sporočilne molekule, ki povzroči krčenje mišic.
When NeuroBloc is injected directly into a muscle it reduces or prevents muscle contraction at the site of injection, which helps to relieve the symptoms of cervical dystonia.
Če se zdravilo NeuroBloc injicira neposredno v mišico, zmanjša ali prepreči krčenje mišic na mestu injiciranja, kar pomaga sprostiti simptome cervikalne distonije.
Three of the studies included patients who had stopped responding to type A botulinum toxin (another type of botulinum toxin that may also be used to treat cervical dystonia), and the fourth only included patients who did respond to type A toxin.
V tri študije so bili vključeni bolniki, ki so se prenehali odzivati na botulinski toksin vrste A (druga vrsta botulinskega toksina, ki se prav tako lahko uporablja za zdravljenje cervikalne distonije), v četrto študijo pa so bili vključeni le bolniki, ki so se odzivali na toksin vrste A.
Effectiveness was measured by looking at the change in symptoms (severity, pain and disability) after four weeks, measured using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).
Učinkovitost so merili z opazovanjem sprememb simptomov (resnost, bolečina in nezmožnost) po štirih tednih, ki so jih zabeležili z uporabo lestvice za oceno spazmičnega tortikolisa Toronto Western (TWSTRS).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has NeuroBloc shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Diacomit izkazalo med raziskavami?
Most patients who had a response to NeuroBloc by the fourth week had returned to their original condition 12 to 16 weeks after the injection.
Večina bolnikov, ki so se odzvali na NeuroBloc do četrtega tedna, je doživela povratek v začetno stanje 12 do 16 tednov po prejeti injekciji.
The most common side effects with NeuroBloc (seen in more than 1 patient in 10) are dry mouth, headache (in patients new to treatment with botulinum toxins), dysphagia (difficulty swallowing) and reactions at the site of the injection (in patients previously treated with botulinum toxins).
Najpogostejši neželeni učinki zdravila NeuroBloc (opaženi pri več kot 1 bolniku od 10) so suha usta, glavobol (pri bolnikih, ki zdravljenje z botulinskimi toksini šele začenjajo), disfagija (težave s požiranjem) in reakcije na mestu vbrizganja (pri bolnikih, ki so se predhodno zdravili z botulinskimi toksini).
For the full list of all side effects reported with NeuroBloc, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila NeuroBloc, glejte Navodilo za uporabo.
NeuroBloc should not be used in people who may be hypersensitive (allergic) to botulinum toxin or any of the other ingredients.
Zdravila NeuroBloc ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) botulinski toksin ali katerokoli drugo sestavino zdravila.
NeuroBloc should not be used in patients with other neuromuscular (nerve and muscle) disorders.
Zdravila NeuroBloc ne bi smeli uporabljati bolniki z drugimi živčnimi in mišičnimi motnjami.
The Committee for Medicinal Products for Human Use (CHMP) decided that NeuroBloc’ s benefits are greater than its risks for the treatment of cervical dystonia (torticollis).
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristni učinki zdravila NeuroBloc pri zdravljenju cervikalne distonije (tortikolisa) večji od z njim povezanih tveganj.
The Committee recommended that NeuroBloc be given marketing authorisation.
Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom NeuroBloc.
NeuroBloc was originally authorised under ‘ Exceptional Circumstances ’ because limited information was available at the time of approval.
Zdravilo NeuroBloc je bilo prvotno odobreno „ v izjemnih okoliščinah “, ker so bili v času odobritve na voljo le omejeni podatki.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 8 July 2005.
Ko je družba predložila dodatne zahtevane podatke, je bila odobritev „ v izjemnih okoliščinah “ dne 8. julija 2005 preklicana.
Other information about NeuroBloc:
Druge informacije o zdravilu NeuroBloc:
The European Commission granted a marketing authorisation valid throughout the European Union for NeuroBloc on 22 January 2001.
Evropska komisija je dovoljenje za promet z zdravilom NeuroBloc, veljavno po vsej Evropski uniji, odobrila dne 22. januarja 2001.
The marketing authorisation was renewed on 22 January 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 22. januarja 2006.
The marketing authorisation holder is Eisai Ltd.
Imetnik dovoljenja za promet je družba Eisai Ltd.
The full EPAR for NeuroBloc is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NeuroBloc je na voljo tukaj.
NeuroBloc 5000 U/ ml solution for injection.
NeuroBloc 5. 000 e/ ml raztopina za injiciranje
One ml contains 5000 U Botulinum Toxin Type B.
En ml vsebuje 5. 000 e botulinskega toksina vrste B.
NeuroBloc 5000U/ ml contains less than 1 mmol sodium per ml.
Zdravilo NeuroBloc 5. 000 e/ ml vsebuje manj kot 1 mmol natrija na ml.
Clear and colourless to light yellow solution.
Raztopina za injiciranje Bistra in brezbarvna do svetlo rumena raztopina.
NeuroBloc is indicated for the treatment of cervical dystonia (torticollis).
NeuroBloc je indiciran za zdravljenje cervikalne distonije (tortikolisa).
See Section 5.1 for data on efficacy in patients responsive / resistant to Botulinum Toxin Type A.
Za podatke o učinkovitosti pri bolnikih, ki se odzivajo ali so rezistentni na botulinski toksin vrste A, glejte poglavje 5. 1.
NeuroBloc should only be administered by intramuscular injection by a medical specialist with experience in the treatment of cervical dystonia and in the use of botulinum toxins.
Dati ga sme le zdravnik specialist z izkušnjami pri zdravljenju cervikalne distonije in uporabi botulinskih toksinov.
The dosage units are specific to NeuroBloc and are not interchangeable with those used to quantify the dose of other botulinum toxin products.
Enote odmerkov so specifične za NeuroBloc in jih ne smete zamenjati s količinami enot odmerkov za druga zdravila, ki vsebujejo botulinski toksin.
The dose and frequency of administration should be adjusted for each patient depending on the clinical response.
Začetni odmerek je 10. 000 e in ga je treba razdeliti med dve do štiri najbolj prizadete mišice.
Data from clinical trials 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.
Podatki iz kliničnih preskušanj 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.
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.
Zato lahko pretehtate uporabo začetnega odmerka s 5. 000 e, čeprav lahko odmerek z 10. 000 e poveča verjetnost ugodnega kliničnega učinka.
Care should be taken to ensure that NeuroBloc is not injected into a blood vessel.
Paziti morate, da zagotovo NeuroBloca ne injicirate v krvno žilo.
NeuroBloc may be diluted with sodium chloride 9 mg/ ml (0.9%) solution for injection.
NeuroBloc lahko razredčite z 9mg/ ml (0. 9%) raztopino natrijevega klorida za injiciranje.
In clinical studies the duration of effect was variable.
V kliničnih študijah je bilo trajanje učinka spremenljivo.
In the patients who responded to treatment (those who experienced an improvement in TWSTRS greater than 20% over baseline) the following duration of effect was observed: at least 4 weeks (40% of patients); at least 8 weeks (30%), at least 12 weeks (16%); 16 weeks or longer (14%).
Pri bolnikih, ki so se odzvali na zdravljenje (tistih, pri katerih se je pokazalo izboljšanje vrednosti TWSTRS (lestvica za oceno spazmičnega tortikolisa Toronto Western - Toronto Western Spasmodic Torticollis Rating Scale), za več kot 20% nad izhodiščno vrednostjo) so opazili naslednje trajanje učinka: najmanj 4 tedne (40% bolnikov), najmanj 8 tednov (30%), najmanj 12 tednov (16%); 16 tednov ali več (14%).
Adults (including the elderly ≥ 65 years old) The dose recommended for cervical dystonia is applicable to adults of all ages, including the elderly.
Odrasli bolniki (vključno z bolniki, starimi 65 let ali več) Priporočen odmerek za cervikalno distonijo velja za bolnike vseh starosti, tudi za starejše.
2 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.
Children and Adolescents The safety and efficacy of NeuroBloc have not been demonstrated in children.
2 Otroci in mladostniki Varnost in učinkovitost NeuroBloca pri otrocih še nista dokazani.
NeuroBloc is not recommended in children and adolescents until further data become available.
Zdravilo NeuroBloc se ne priporoča pri otrocih in mladoletnikih, dokler ne bo na voljo več podatkov.
Hepatic and renal impairment Studies have not been carried out in patients with hepatic or renal impairment.
Okvarjeno delovanje jeter in ledvic Študije pri bolnikih z okvarjenim delovanjem jeter ali ledvic niso bile opravljene.
ALS or peripheral neuropathy) or known neuromuscular junctional disorders (e. g. myasthenia gravis or Lambert-Eaton syndrome) should not be given NeuroBloc.
Osebam z drugo znano nevromuskularno boleznijo (npr. amiotrofično lateralno sklerozo ali periferno nevropatijo) ali znano boleznijo nevromuskularnega stika (npr. miastenijo gravis ali Eaton - Lambertovim sindromom) NeuroBloca ne smete dajati.
NeuroBloc is recommended for intramuscular administration only.
NeuroBloc je namenjen le za intramuskularno uporabo.
Particular caution should be paid to ensure that it is not injected into a blood vessel.
Zagotoviti je treba, da se ga ne injicira v krvno žilo.
Following repeated administration of NeuroBloc, development of an immune response can occur due to production of neutralising antibodies to Botulinum Toxin Type B.
Po večkratni uporabi NeuroBloca se lahko razvije imunski odziv zaradi proizvajanja nevtralizirajočih protiteles proti botulinskem toksinu vrste B.
Tolerance, thought to be due to the development of an immune response, may occur uncommonly.
Občasno se lahko pojavi toleranca, za katero menijo, da nastane zaradi razvoja imunskega odziva.
As with all injected medicines, caution should be used in patients with bleeding disorders or receiving anticoagulant therapy.
Kot pri vseh zdravilih, ki jih moramo injicirati, morate biti previdni pri bolnikih, ki imajo motnje krvavitve ali se zdravijo z antikoagulanti.
Neuromuscular effects related to spread of toxin, distant from the site of administration have been reported (see section 4.8).
Poročajo o učinkih na nevromuskulaturo v zvezi s širjenjem toksina na mestih, ki so oddaljena od mesta odmerjanja (glejte poglavje 4. 8) Bolniki, zdravljeni s terapevtskim odmerkom, lahko čutijo pretirano oslabelost mišic.
There have been spontaneous reports of dysphagia, aspiration pneumonia and/ or potentially fatal respiratory disease, after treatment with botulinum toxin type A/ B.
Po zdravljenju z botulinskim toksinom vrste A/ B spontano poročajo o disfagiji, aspiracijski pljučnici in/ ali potencialno usodnih obolenjih dihal.
Patients with underlying neuromuscular disorders including swallowing disorders are at increased risk of these undesirable effects.
Pri bolnikih z nevromuskulaturnimi motnjami, vključno z motnjami požiranja, je tveganje neželenih učinkov še večje.
In patients with neuromuscular disorders or history of dysphagia and aspiration, botulinum toxins should be used under close medical supervision and only if the benefit clearly outweighs the risk.
Koristi morajo znatno presegati tveganja.
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, dušenju ali pojavu nove disfagije ali njenem poslabšanju poiskati zdravniško pomoč.
The initial starting dose of 10,000 U (or 5000 U) is relevant only to NeuroBloc (Botulinum Toxin Type B).
Začetni odmerek 10. 000 e (ali 5. 000 e) velja le za NeuroBloc (botulinski toksin vrste B).
These dosage units are specific to NeuroBloc only and are not relevant to preparations of Botulinum Toxin Type A.
Ti odmerki so specifični le za NeuroBloc, ne pa tudi za pripravke botulinskega toksina vrste A.
The unit dose recommendations for Botulinum Toxin Type A are significantly lower than those for NeuroBloc and administration of Botulinum Toxin Type A at the unit dose recommended for NeuroBloc may result in systemic toxicity and life-threatening clinical sequelae.
Uporaba botulinskega toksina vrste A v odmerkih, priporočenih za NeuroBloc, lahko povzroči sistemsko toksičnost in smrtno nevarne klinične posledice.
3 4.5 Interactions with other medicinal products and other forms of interaction
3 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
However, in clinical trials, NeuroBloc was administered 16 weeks after the injection of Botulinum Toxin Type A.
Vendar so v kliničnih raziskavah dajali NeuroBloc 16 tednov po injiciranju botulinskega toksina vrste A.
Co-administration of NeuroBloc and aminoglycosides or agents interfering with neuromuscular transmission (e. g. curare-like compounds) should be considered with caution.
Pri sočasni uporabi NeuroBloca in aminoglikozidov ali učinkovin, ki ovirajo nevromuskularni prenos (npr. spojine, podobne kurareju), morate biti previdni.
Animal studies are insufficient with respect to effects on pregnancy and embryonal/ foetal development.
Študije na živalih ne zadoščajo za ocenitev učinkov na nasečnost in razvoj embrija/ ploda.
NeuroBloc should not be used during pregnancy unless clearly necessary.
NeuroBloca ne uporabljati med nosečnostjo, razen kadar je to nujno potrebno
It is unknown whether Botulinum Toxin Type B is excreted in human breast milk.
Ni znano, ali se botulinski toksin vrste B izloča v človeško mleko.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with NeuroBloc should be made taking into account the benefit of breast-feeding to the child and the benefit of NeuroBloc therapy to the women.
Ob odločitvi o nadaljevanju ali prekinitvi dojenja oz. o nadaljevanju ali prekinitvi zdravljenja z NeuroBlocom je treba upoštevati prednosti dojenja za otroka in prednosti zdravljenja z NeuroBlocom pri ženskah.
However, the pharmacological characteristics do not indicate that they would be affected.
Vendar farmakološke značilnosti ne kažejo, da bi obstajal tak vpliv.
Undesirable effects, typically dry mouth, dysphagia and blurred vision, may occur following NeuroBloc injection.
Po injiciranju zdravila NeuroBloc se lahko pojavijo neželeni učinki, ki so običajno suha usta, disfagija in zamegljen vid.
The two most commonly reported undesirable effects in clinical studies among patients with prior Botulinum Toxin Type A exposure were dry mouth and dysphagia, which were reported at a frequency of 41% and 29%, respectively.
V kliničnih študijah pri bolnikih, ki so bili pred tem izpostavljeni botulinskemu toksinu vrste A, sta bila najpogostejša neželena učinka suha usta, o katerih so poročali v 41% primerov, in disfagija v 29%.
Data from clinical studies indicate that there is a tendency for the proportion of treatments associated with dysphagia to increase with higher doses injected into the sternocleidomastoid muscle.
Podatki iz kliničnih študij kažejo, da se tendenca deleža zdravljenj, povezanih z disfagijo, povečuje z višjimi odmerki, injiciranimi v sternokleidomastoidno mišico.
Injection site pain was also reported.
Poročali so tudi o bolečinah na mestu injiciranja.
The two most commonly reported undesirable effects in a Phase IV comparative clinical study among toxin naïve patients treated with NeuroBloc 10,000 U to 15,000 U were dry mouth and dysphagia, which were reported at a frequency of 44% and 35%, respectively.
35%.
Very Common (> 1/ 10); Common (> 1/ 100 to < 1/10); Uncommon (> 1/1000 to < 1/100).
Neželeni učinki iz vseh raziskav 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).
Patients with Prior Botulinum Toxin Type A Exposure
Bolniki, ki so že bili izpostavljeni botulinskemu toksinu vrste A
4 System Organ Class Nervous system disorders
Organski sistem Bolezni živčevja
Very Common dry mouth
Zelo pogosti suha usta
Common torticollis (worsening from baseline), taste perversion
Pogosti tortikolis (poslabšanje od izhodiščne vrednosti), popačeno okušanje
voice alteration
sprememba glasu
Gastrointestinal disorders Musculoskeletal connective tissue and bone disorders
Bolezni prebavil Bolezni mišično- skeletnega sistema in vezivnega tkiva
dysphagia
disfagija
General disorders and administration site conditions
dispepsija miastenija bolečine v vratu
injection site pain
Splošne težave in spremembe na mestu aplikacije
neck pain
bolečine na mestu injiciranja
Patients Naïve to Botulinum Toxins
4 Bolniki, ki še niso bili izpostavljeni botulinskemu toksinu
Respiratory thoracic and mediastinal disorders
Organski sistem Bolezni živčevja Očesne bolezni Bolezni dihal, prsnega koša in mediastinalnega prostora
Very Common dry mouth, headache
Zelo pogosti suha usta, glavobol
Common torticollis blurred vision dysphonia
Pogosti tortikolis zamegljen vid disfonija
Gastrointestinal disorders General disorders and administration site conditions
Bolezni prebavil Splošne težave in spremembe na mestu aplikacije
dyspepsia injection site pain
dispepsija bolečine na mestu injiciranja
Post marketing experience Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases) (see section 4.4).
Postmarketinške izkušnje Poročajo o neželenih učnikih, povezanih s širjenjem toksina proč od mesta injiciranja (pretirana oslabelost mišic, disfagija, dispneja, in v nekaterih primerih usodna aspiracijska pljučnica) (glejte poglavje 4. 4)
The following effects have also been reported during post marketing use: abnormal accommodation, ptosis, vomiting, constipation, flu-like symptoms, and asthenia.
V času postmarketinške uporabe poročajo tudi o naslednjih učinkih: abnormalna akomodacija, ptoza, bruhanje, zaprtost, gripi podobni simptomi in astenija.
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.
However, in children (non-approved use) clinically significant systemic toxicity has occurred at doses approved for the treatment of adult patients.
Vendar se je pri otrocih (pri katerih uporaba ni odobrena) klinično značilna sistemska toksičnost pojavila pri odmerkih, ki so odobreni za zdravljenje odraslih bolnikov.
1.
5. 1 Farmakodinamične lastnosti
Extracellular binding of the toxin to specific acceptors on motor nerve terminals 2.
M03AX01
Internalisation and release of the toxin into the cytosol of the nerve terminals 3.
NeuroBloc je nevromuskularni blokator.
Inhibition of acetylcholine release from nerve terminals at the neuromuscular junction
Način delovanja NeuroBloca pri blokiranju nevromuskularne prevodnosti poteka v treh stopnjah:
When injected directly into a muscle, NeuroBloc causes a localised paralysis that gradually reverses over time.
Po neposrednem injiciranju v mišico NeuroBloc povzroči lokalizirano paralizo, ki se čez čas postopoma povrne v normalno stanje.
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.
Both studies enrolled adult patients (≥ 18 years) who had a history of receiving Botulinum Toxin Type A.
Obe študiji sta vključevali odrasle bolnike (stari 18 let in več), ki so v