natgillin/translations-raw huggingface dataset:
The first study enrolled patients who were clinically resistant to type A toxin (A-non responders), confirmed by a Frontalis Type A test.
V prvi študiji so vključili bolnike, ki so bili klinično rezistentni na toksin vrste A (A- nedovzetni), kar je bilo potrjeno s testom vrste A Frontalis.
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).
On enrolment all patients had Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total scores of 20 or greater with at least two muscles involved, no neck contractures or other causes of decreased neck range of motion, and no history of any other neuromuscular disorder.
Ob vključitvi so imeli vsi bolniki skupni rezultat na lestvici TWSTRS (lestvica za oceno spazmičnega tortikolisa Toronto Western - Toronto Western Spasmodic Torticollis Rating Scale) 20 ali več, z udeležbo najmanj dveh mišic, brez skrčenj vratu ali drugih vzrokov zmanjšane gibljivosti vratu in brez nevromuskularnih obolenj v preteklosti.
The TWSTRS is comprised of three sub-scales which examine severity, pain and disability.
Lestvica TWSTRS je sestavljena iz treh podlestvic, ki ocenjujejo hudost, bolečino in invalidnost.
In the first study, type A resistant patients (A-non responders) were randomised to receive placebo or 10,000 U of NeuroBloc and in the second, type A toxin responsive patients (A-responders) were randomised to receive placebo, 5000 U or 10,000 U of toxin.
V drugi so bili bolniki, ki so se še vedno odzivali na toksin vrste A (A- dovzetni), naključno razporejeni v skupine, ki so prejemale placebo, 5. 000 e ali 10. 000 e toksina.
Study drug 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, uporabljeno v študiji, so ob enem obisku injicirali v dve do štiri od naslednjih mišic: splenius capitus, sternocleidomastoideus, levator scapulae, trapezius, semispinalis capitus in scalenus.
There were 77 subjects enrolled into the first study and 109 into the second.
V prvi raziskavi je bilo vključenih 77 oseb, v drugi pa 109.
The primary efficacy outcome variable for both studies was the 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 TWSTRS (možne vrednosti so v intervalu 0- 87) v četrtem tednu.
Exploratory analyses of these studies suggested that the majority of patients who showed a beneficial response by the fourth week had returned to their baseline status between 12 to 16 weeks after their injection.
Raziskovalne analize teh študij so napovedovale, da se bo večina bolnikov, ki so pokazali ugoden odziv v četrtem tednu, med 12. in 16. tednom po injiciranju vrnila v izhodiščno stanje.
Efficacy Results from Phase III NeuroBloc Studies
Preglednica 1 Rezultati učinkovitosti NeuroBloca v študijah III faze
STUDY 1
ŠTUDIJA
STUDY 2
ŠTUDIJA
(A-Resistant Patients)
(bolniki, rezistentni na A)
(A-Responsive Patients)
(bolniki, dovzetni za A)
Assessments TWSTRS-Total
ocene TWSTRS - Skupno
Placebo n = 38
placebo n = 38
10,000 U Placebo n = 39 n = 36
10. 000 e placebo n = 39 n = 36
5000 U n = 36
5. 000 e n = 36
10,000 U n = 37
10. 000 e n = 37
51.2 49.2 -2.0
Sprememba od
52.8 43.6 41.8 39.3 -11.1 -4.3 0.0001
izhodiščne vrednosti Vrednost P * Splošna ocena bolnika
Mean at Week 4 P-Value* Physician Global
Srednja vrednost 4. teden
39.5
64, 6
60.2 43.6 0.0001
0, 0001
60.6 0.0010
0, 0010
64.6 0.0001
0, 0001
Mean at Week 4 P-Value*
Srednja vrednost 4. teden
47.9
64, 2
60.6 52.0 0.0001
Vrednost P *
65.3 0.0011
0, 0011
64.2 0.0038
0, 0038
* Analysis of covariance, two-tailed tests, α = 0.05
* analiza kovariance, dvostranski testi, α = 0, 05
A further exploratory analysis of duration of effect employed data from a Phase II study in addition to the Phase III data described.
6 V nadaljnjih raziskovalnih analizah trajanja učinka so poleg podatkov iz raziskave III faze uporabili tudi podatke iz raziskave II faze.
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 doses of 5000 and 10,000 U.
Pri bolnikih, ki so se odzvali na zdravljenje (tistih, ki so pokazali izboljšanje vrednosti TWSTRS (lestvica za oceno spazmičnega tortikolisa Toronto Western - Toronto Western Spasmodic Torticollis Rating Scale), za več kot 20% nad izhodiščno vrednostjo), so pri odmerkih 5. 000 in 10. 000 e opazili naslednje trajanje učinka:
Duration of Effect in Responders
Preglednica 2 Trajanje učinka pri bolnikih, ki so se odzvali
Duration Of Effect (% Responders)
trajanje učinka (odstotek bolnikov v%, ki so se odzvali)
4 Weeks
4 tedne
8 Weeks 12 Weeks
12 tednov
5000 U
5. 000 e
10,000 U Overall
10. 000 e skupno
In open-label studies, doses up to 15,000 U were given to patients at intervals of not less than 12 weeks.
V odprtih študijah so v presledkih po 12 tednov ali več bolnikom dajali odmerke do 15. 000 e.
The proportion of patients who responded to these injections was similar to that in the key controlled studies.
Delež bolnikov, ki so se odzvali na te injekcije, je bil podoben kot v ključnih nadzorovanih študijah
A Phase IV randomised, multicentre, double-blind study was conducted to compare the efficacy of NeuroBloc (10,000 U) to Botulinum Toxin Type A (150 U) in patients with cervical dystonia who have never previously received a botulinum toxin product.
Izvedena je bila randomizirana, multicentrična, dvojno slepa študija IV. faze zaradi primerjave učinkovitosti zdravila NeuroBloc (10. 000 e) z botulinskim toksinom vrste A (150 e) pri bolnikih s cervikalno distonijo, ki nikoli prej niso uporabljali zdravil z botulinskim toksinom.
Final analysis was carried out on a total of 93 enrolled botulinum naive patients (46 in the NeuroBloc group) following a single injection, into 2 of 4 predetermined muscles.
Opravljena je bila končna analiza pri skupno 93 vključenih bolnikih, ki niso še nikoli jemali botulina (46 v skupini, ki je jemala NeuroBloc), po eni injekciji v 2 od 4 predhodno določenih mišic.
Baseline assessments, including TWSTRS and VAS pain evaluation by patient and investigator, were repeated at 4, 8 and 12 weeks after treatment.
Izhodiščna ocenjevanja vključno z oceno bolečine po lestvicah TWSTRS in VAS, tako s strani bolnika kot tudi raziskovalca, so se ponovila po 4, 8 in 12 tednih zdravljenja.
The primary efficacy analysis demonstrates the noninferiority of NeuroBloc to Type A toxin as shown by the TWSTRS total score at session 1, week 4, for the PP population.
Analiza primarne učinkovitosti kaže neinferiornost zdravila NeuroBloc glede na toksin vrste A, kot pokaže skupni seštevek TWSTRS v 1. seji, 4. tednu, za populacijo PP.
Excluding site 121, the mean scores for NeuroBloc and Type A toxin were 32.7 (SD 11.61) and 36.0 (SD 11.71) respectively with a 95% CI of 29.3, 36.2 and 32.6, 39.4 respectively.
Z izključitvijo mesta 121 je srednja vrednost za zdravilo NeuroBloc in toksin vrste A 32, 7 (SD 11, 61) in 36, 0 (SD 11, 71) oziroma 95% CI od 29, 3; 36. 2 oziroma 32. 6; 39, 4.
The upper limit of the 1-sided CI in the LS mean difference (NeuroBloc - type A toxin) in the TWSTRS total score at week 4 of session 1 for the PP population (excluding site 121) was 0.6 which is well within the predefined criterion for noninferiority of 4 points in the mean difference between groups adjusted for baseline for the TWSTRS.
Zgornja meja enostranske CI v povprečni razliki LS (NeuroBloc – toksin vrste A) v skupnem seštevku TWSTRS 4. teden 1. seje za populacijo PP (z izključitvijo mesta 121) je bila 0. 6, kar je v okviru predhodno opredeljenih kriterijev za neinferiornost 4 točk v srednji razliki med skupinama, prilagojenima na izhodiščno vrednost za TWSTRS.
These findings led to an identical conclusion when site 121 was included.
Sklepanje iz teh izsledkov je bilo po vključitvi mesta 121 identično.
7 The robustness of this analysis was confirmed by additional analyses that calculated the 1-sided 97.5% CI, analyses using the unadjusted scores, and analyses using the ITT and interim CSR PP populations.
Trdnost te analize so potrdile dodatne analize, v katerih so izračunali 1- stranski 97, 5% CI, analize, kjer so uporabljali neprilagojeno točkovanje in analize, kjer so uporabljali ITT in vmesne CSR PP populacije.
In this regard the noninferiority of NeuroBloc compared to Botulinum Toxin Type A is also supported by a responder analysis using the ITT population, which showed that a similar percentages of subjects showed any improvement in the TWSTRS score at Week 4 of Session 1 (86% NeuroBloc and 85% Botox), as did subjects who experienced at least a 20% decrease from baseline in the TWSTRS score at Week 4 of Session 1 (51% NeuroBloc, 47% Botox).
V tem smislu podpira neinferiornost zdravila NeuroBloc v primerjavi z botulinskim toksinom vrste A tudi analiza odziva, kjer je sodelovala populacija ITT, ki je pokazala, da je podoben odstotek udeležencev kazal izboljšanje po točkah TWSTRS 4. teden 1. seje (86% NeuroBloc in 85% Botox), kot je bolnikov, ki so izkusili vsaj 20% upad seštevka TWSTRS od izhodiščne točke 4. teden 1. seje (51% NeuroBloc, 47% Botox).
A Phase IV open label study has been conducted to evaluate the safety, immunogenicity and effect of repeated doses of NeuroBloc in subjects with cervical dystonia (CD) who were previously treated with Botulinum Toxin Type A.
Opravljena je bila odprta študija IV faze, da bi ocenili varnost, imunogenost in učinek večkratnih odmerkov zdravila NeuroBloc pri osebah s cervilano distonijo (CD), ki so bile predhodno zdravljene z botulinskim toksinom tipa vrste A.
The primary objectives of the open label study were to evaluate the safety, immunogenicity and effect of repeat doses of NeuroBloc in subjects with CD who were already resistant to Botulinum Toxin Type A compared to subjects who were responsive to Botulinum Toxin Type A..
Osnovni nameni odprte študije so bili oceniti varnost, imunogenost in učinek večkratnih odmerkov zdravila NeuroBloc pri osebah s CD, ki so že bile odporne na botulinski toksin tipa vrste A, v primerjavi z osebami, ki so se odzvale na botulinski toksin tipa A.
A total of 130 subjects were enrolled, comprising 67 Type A resistant and 63 type A responsive.
Vključenih je bilo skupno 130 bolnikov, in sicer 67 odpornih na tip vrsto A, in 63, ki so se odzvali na tip A.
Subjects were given a starting dose of 10,000 Units of NeuroBloc at their first treatment, then subsequent doses modified at increments of 2,500 or 5,000 units to a maximum of 25,000 units with a dosage interval of at least 12 weeks.
Osebe so ob prvem zdravljenju prejele začetni odmerek 10. 000 enot zdravila NeuroBloc, nadaljnji odmerki pa so se zviševali po 2. 500 ali 5. 000 enot do maksimalnega odmerka 25. 000 enot, z najmanj 12- tedenskim intervalom med posameznimi odmerki.
Eight of the 67 Type A resistant subjects (11.9%) had developed neutralising antibodies to Botulinum Toxin Type B within completion of 4 treatment cycles of NeuroBloc and 15 out of 67 subjects (22.4%) had developed neutralising antibodies at the time of interim study analysis.
Pri 8 od 67 oseb, odpornih na vrstotip A, so se po zaključenih 4 ciklusih terapije z zdravilom NeuroBloc (11. 9%) pojavila nevtralizirajoča protitelesa za botulinski toksin tipa vrste B, pri 15 od
The earliest development of neutralising antibodies was seen in 2 out of 67 subjects (3%) 6-9 months after the start of NeuroBloc treatment.
Najbolj zgodaj so se nevtralizirajoča protitelesa pojavila pri 2 od 67 oseb (3%) 6- 9 mesecev po začetku terapije z zdravilom NeuroBloc.
NeuroBloc treatment was associated with a low incidence of development of neutralising antibodies to Botulinum Toxin Type B during the first year of treatment.
V prvem letu terapije z zdravilom NeuroBloc je bila incidenca razvoja nevtralizacijskih protiteles za botulinski toksin tipa vrste B nizka.
The presence of antibodies does not necessarily mean resistance to treatment as the number of patients truly resistant is likely to be much lower than the results indicate.
Prisotnost protiteles nujno ne pomeni tudi rezistence na terapijo, saj je število bolnikov, ki so resnično rezistentni, verjetno veliko manjše kot kažejo dobljeni rezultati.
Therefore patients resistant to Botulinum Toxin Type A may benefit from treatment with NeuroBloc and continue to experience this benefit over a long time period.
Zato je lahko terapija z zdravilom NeuroBloc za bolnike, odporne na botulinski toksin tipa vrste A koristna, ugodni učinek pa lahko traja tudi skozi daljše časovno obdobje.
NeuroBloc injected intramuscularly produces localised muscle weakness by chemical denervation.
Intramuskularno injiciran NeuroBloc s kemično denervacijo povzroča lokalizirano šibkost mišic.
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 drug reaction cases reported during the post-marketing experience (including the following adverse events: dry mouth, dysphagia and blurred vision).
Po lokalnem intramuskularnem injiciranju NeuroBloca v odmerkih do 15. 000 e so redko opazili klinično značilne sistemske učinke.
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.
The dose resulting in death was 2400 U/ kg.
Smrtni odmerek je bil 2400 e/ kg.
8 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 NeuroBloca.
Standard tests to investigate the mutagenicity of NeuroBloc have not been performed.
Standardni testi za raziskovanje mutagenosti NeuroBloca niso bili opravljeni.
In the development studies, the No Observed Adverse Effect Dose Level (NOAEL) in rats was 1000 U/ kg/ day for maternal effects and 3000 U/ kg/ day for foetal effects.
V študijah razvoja je bila raven brez vidnega neželenega učinka (NOAEL - No Observed Adverse Effect Dose Level) pri podganah 1000 e/ kg/ dan za učinke na brejo mater in 3000 e/ kg/ dan za učinke na plod.
In rabbits, the NOAEL was 0.1 U/ kg/ day for maternal effects and 0.3 U/ kg/ day for foetal effects.
Pri kuncih je bila vrednost NOAEL 0, 1 e/ kg/ dan za učinke na brejo mater in 0, 3 e/ kg/ dan za učinke na plod.
In the fertility studies the NOAEL was 300 U/ kg/ day for general toxicity in both males and females and 1000 U/ kg/ day for fertility and reproductive performance.
Pri študijah plodnosti je bila vrednost NOAEL 300 e/ kg/ dan za splošno toksičnost tako pri samcih kot samicah ter 1000 e/ kg/ dan za plodnost in sposobnost razmnoževanja.
Disodium succinate Sodium chloride Human serum albumin (containing sodium caprylate andsodium acetyltryptophanate as excipients) Hydrochloric acid for pH adjustment) Water for injections
Dinatrijev sukcinat Natrijev klorid Humani serumski albumin (vsebuje natrijev kaprilat in natrijev acetiltriptofanat kot vehikla) Klorovodikova kislina za uravnavanje pH Voda za injekcije
In the absence of incompatibility studies, NeuroBloc must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila NeuroBloc ne smemo mešati z drugimi zdravili.
From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination the product should be used immediately.
8 Iz mikrobiološkega vidika je treba proizvod uporabiti takoj, razen kadar način odpiranja/ redčenja preprečuje tveganje onesnaženja proizvoda z mikrobi.
Store in a refrigerator (2oC - 8oC).
Shranjujte v hladilniku (2o C - 8o C).
Keep the container in the outer carton in order to protect from light.
Za zagotovitev zaščite pred svetlobo, vsebnik shranjujte v zunanji ovojnini.
Within its shelf-life, the product may be stored below 25oC for up to 3 months, without being refrigerated again during this period, and must be withdrawn if not used after this.
Če ga v tem času ne porabite, ga morate zavreči.
NeuroBloc is supplied in 3.5 ml Type I glass vials, with siliconised grey butyl rubber stoppers oversealed by aluminium crimped caps.
NeuroBloc je na voljo v 3, 5 ml velikih steklenih vialah vrste I, s sivimi zamaški iz butilne gume, prevlečenimi s silikonom, zaprtimi z aluminijastimi nagubanimi zaporkami.
Carton containing a single vial containing 0.5 ml, 1.0 ml or 2.0 ml of solution.
Škatla vsebuje po eno vialo s 0, 5 ml, 1, 0 ml ali 2, 0 ml raztopine.
6.6 Special precautions for disposal and other handling
Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom 6. 6
9 NeuroBloc is provided as a clear and colourless to light yellow sterile injectable solution in vials for single use only.
NeuroBloc je na voljo kot bistra in brezbarvna ali svetlo rumena sterilna raztopina, pripravljena za injiciranje, v vialah za enkratno uporabo.
Any unused solution should be discarded (see instructions below).
Neuporabljeno raztopino zavrzite (glejte navodila spodaj).
If the NeuroBloc solution is not clear and colourless/ light yellow or if the vial appears damaged the product should be discarded as Medical Biohazardous Waste in accordance with local requirements.
Če raztopina NeuroBloc ni bistra in brezbarvna/ svetlo rumena ali če izgleda poškodovana, proizvod zavrzite kot medicinsko biološko nevarni odpadek v skladu z lokalnimi predpisi.
The solution in the vials is ready for use.
Raztopina v vialah je pripravljena za uporabo.
NeuroBloc may be diluted with sodium chloride 9 mg/ ml (0.9%) solution for injection.
NeuroBloc lahko razredčite z natrijevim kloridom 9 mg/ ml (0, 9%) raztopine za injiciranje.
Decontaminate any spill with 10% caustic solution, or sodium hypochlorite (household chlorine bleach – 2 ml (0.5%):
Sleherno izlitje dekontaminirajte z 10- odstotno kavstično raztopino ali raztopino natrijevega klorata (gospodinjsko klorovo belilo - 2 ml (0, 5%):
1 litre water) solution.
1 liter vode).
Place the absorbed toxin in an autoclave bag, seal it and process as Medical Biohazardous Waste in accordance with local requirements.
Absorbirani toksin dajte v vrečko za avtoklav, zaprite in obdelajte kot medicinsko biološko nevaren odpadek v skladu z lokalnimi predpisi.
Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN Velika Britanija
EU/ 1/ 00/ 166/ 001 – 2500 U EU/ 1/ 00/ 166/ 002 – 5000 U EU/ 1/ 00/ 166/ 003 – 10,000 U
9 EU/ 1/ 00/ 166/ 002 – 5000 U EU/ 1/ 00/ 166/ 003 – 10. 000 U
22 January 2001 Date of latest renewal:
22. januar 2001 Datum zadnjega podaljšanja:
22 January 2006
22. januar 2006
Solstice Neurosciences Inc 701 Gateway Blvd, South San Francisco California 94080 USA
Solstice Neurosciences Inc 701 Gateway Blvd, South San Francisco California 94080 ZDA
Eisai Manufacturing Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
Eisai Manufacturing Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN Velika Britanija
14 PARTICULARS TO APPEAR ON OUTER PACKAGING Outer carton 0.5 ml vial
14 PODATKI NA ZUNANJI OVOJNINI
NeuroBloc 5000 U/ ml solution for injection Botulinum Toxin Type B
NeuroBloc 5. 000 e/ ml raztopina za injiciranje botulinski toksin vrste B
One ml contains 5000 U Botulinum Toxin Type B (2500 U per vial)
En ml vsebuje 5. 000 e botulinskega toksina vrste B (2. 500 e na vialo)
Disodium succinate, sodium chloride, human serum albumin, sodium caprylate, sodium acetyltryptophanate, hydrochloric acid and water for injections.
Dinatrijev sukcinat, natrijev klorid, humani serumski albumin, natrijev kaprilat, natrijev acetiltriptofanat, klorovodikova kislina in voda za injekcije.
1 x 0.5 ml vial, 2500 U
1 x viala 0, 5 ml, 2. 500 e
SPECIAL WARNINGS THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2° C - 8° C).
For the purpose of ambulatory use, the product may be removed from the refrigerator for one single period of up to 3 months at a temperature not above 25oC without exceeding the expiry date.
Za ambulantno uporabo smete vzeti zdravilo iz hladilnika le enkrat za obdobje, ki ne sme biti daljše od 3 mesecev, temperatura ne sme presegati 25 ºC, rok uporabnosti pa ne sme preteči.
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.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIAL DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Read package leaflet for special precautions for handling and disposal.
Za posebne varnostne ukrepe pri ravnanju in odstranjevanju preberite navodilo za uporabo.
Eisai Limited Mosquito Way Hatfield Herts AL10 9SN United Kingdom
Eisai Limited Mosquito Way Hatfield Herts AL10 9SN Velika Britanija
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 0.5 ml vial
16 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
NeuroBloc 5000 U/ ml solution for injection IM
NeuroBloc 5. 000 e/ ml raztopina za injiciranje IM
BATCH NUMBER
ŠTEVILKA SERIJE:
CONTENTS BY WEIGHT, VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
2500 U
2. 500 e
17 PARTICULARS TO APPEAR ON OUTER PACKAGING Outer carton 1.0 ml vial
17 PODATKI NA ZUNANJI OVOJNINI Zunanja škatla 1, 0 ml
NeuroBloc 5000 U/ ml Solution for injection Botulinum Toxin Type B
NeuroBloc 5. 000 e/ ml raztopina za injiciranje botulinski toksin vrste B
One ml contains 5000 U Botulinum Toxin Type B (5000 U per vial)
En ml vsebuje 5. 000 e botulinskega toksina vrste B (5. 000 e na vialo)
Disodium succinate, sodium chloride, human serum albumin, sodium caprylate, sodium acetyltryptophanate, hydrochloric acid and water for injections.
Dinatrijev sukcinat, natrijev klorid, humani serumski albumin, natrijev kaprilat, natrijev acetiltriptofanat, klorovodikova kislina in voda za injekcije
1 x 1.0 ml vial, 5000 U
1 x viala 1, 0 ml, 5. 000 e
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2° C- 8° C).
19 Justification for not including Braille accepted
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 1.0 ml vial
Oznaka viale 1, 0 ml
21 PARTICULARS TO APPEAR ON OUTER PACKAGING Outer carton 2.0 ml vial
20 PODATKI NA ZUNANJI OVOJNINI
One ml contains 5000 U of Botulinum Toxin Type B (10,000 U per vial)
En ml vsebuje 5. 000 e botulinskega toksina vrste B (10. 000 e na vialo)
1 x 2.0 ml vial, 10,000 U
1 x viala 2, 0 ml, 10. 000 e
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2° C- 8°C).
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 2.0 ml vial
22 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
10,000 U
10. 000 e
INFORMATION FOR THE USER NeuroBloc 5000 U/ ml Solution for Injection Botulinum Toxin Type B
NeuroBloc 5. 000 e/ ml raztopina za injiciranje botulinski toksin vrste B
Read all of this leaflet carefully before you are given this medicine.
Pred uporabo natančno preberite navodilo!
What NeuroBloc is and what it is used for 2.
Kaj je zdravilo NeuroBloc in za kaj ga uporabljamo 2.
Before you are given NeuroBloc 3.
Kaj morate vedeti, preden boste uporabili zdravilo NeuroBloc 3.
How you will be given NeuroBloc 4.
Kako uporabljati zdravilo NeuroBloc 4.
How to store NeuroBloc 6.
Shranjevanje zdravila NeuroBloc 6.
WHAT NEUROBLOC IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO NEUROBLOC IN ZA KAJ GA UPORABLJAMO
NeuroBloc is a toxin produced by bacteria called Clostridium botulinum.
NeuroBloc je toksin, ki ga proizvaja bakterija, imenovana Clostridium botulinum.