natgillin/translations-raw huggingface dataset:
Keep pipettes in the original packaging until ready to use.
Držati pipete u originalnom pakovanju do primjene.
NAME OF THE MARKETING AUTHORISATION HOLDER
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET
Special precautions for use in animals
Posebne mjere predostrožnost za primjenu na životinjama:
Local and/or systemic reactions have been observed in some people after exposure to the product such as: local skin reactions; nasal or throat/mouth irritation; neurological signs; respiratory signs; gastrointestinal signs or other systemic signs.
kožne reakcije, nazalne ili iritacije grla/usta, neurološki znakovi, respiratorni znakovi,
SPECIAL STORAGE PRECAUTIONS
11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE
1.2 - 5 Very small dogs
Jako mali psi
If clinical signs of poisoning occur, seek veterinary advice immediately and show this package leaflet to your veterinarian.
Kod slučajnog izlaganja na mačkama: Ukoliko se pojave znakovi trovanja, odmah potražiti veterinarsku pomoć te pokazati uputu.
− rare (more than 1 but less than 10 animals in 10,000 animals treated)
Učestalost nuspojava je određena prema sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojave) - česte (više od jedne ali manje od 10 tretiranih životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 tretiranih životinja na 1000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10 000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10 000 tretiranih životinja, uključujući izolirane slučajeve).
Permethrin (mg/kg)
Permetrin (mg/kg)
METHOD AND ROUTE(S) OF ADMINISTRATION For spot-on use.
NAČIN I PUT(EVI) PRIMJENE
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
Pyrethroids affect the voltage-gated sodium channels in vertebrates and non- vertebrates.
Piretroidi djeluju na naponski regulirane natrijeve kanale kralježnjaka i beskralježnjaka.
Weight of dog (kg) Pipette size to be used
Veličina pipeta za korištenje
QUANTITY OF THE ACTIVE SUBSTANCE(S)
KOLIČINA DJELATNE(IH) TVARI
VIRBAC Österreich GmbH, Hildebrandgasse 27, A-1180 Wien, Tel: + 43 (0) 1 21 834 260
A-1180 Wien, Tel: + 43 (0) 1 21 834 260
Excipients:
Predoziranje:
A dry white residue may be also observed.
Suho-bijeli ostatak proizvoda može biti vidljiv.
- BP 27, FR-06517 Carros, service-conso@virbac.fr
- BP 27, FR-06517 Carros,
4.5 Special precautions for use
4.5 Posebne mjere predostrožnost za primjenu Posebne mjere predostrožnost za primjenu na životinjama
Ticks
Buhe
Snap the tip open by bending it and folding it back on itself.
Korak 1: Držite pipetu u uspravnom položaju dalje od lica i otvorite ju savijajući vrh te ga vratite u početni položaj.
Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs (1.2 - 5 kg) Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs (5.1 - 10 kg) Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs (10.1 - 20 kg) Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs (20.1 - 40 kg) Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs (40.1 - 60 kg)
Activyl Tick Plus 75 mg + 240 mg spot-on otopina za jako male pse (1,2 - 5 kg) Activyl Tick Plus 150 mg + 480 mg spot-on otopina za male pse (5,1 - 10 kg) Activyl Tick Plus 300 mg + 960 mg spot-on otopina za srednje velike pse ( 10,1 - 20 kg) Activyl Tick Plus 600 mg + 1920 mg spot-on otopina za velike pse ( 20,1 - 40 kg) Activyl Tick Plus 900 mg + 2880 mg spot-on otopina za jako velike pse (40,1 - 60 kg)
Indoxacarb 75 mg + permethrin 240 mg Indoxacarb 150 mg + permethrin 480 mg Indoxacarb 300 mg + permethrin 960 mg Indoxacarb 600 mg + permethrin 1920 mg Indoxacarb 900 mg + permethrin 2880 mg
Indoksakarb 75 mg + permetrin 240 mg Indoksakarb 150 mg + permetrin 480 mg Indoksakarb 300 mg + permetrin 960 mg Indoksakarb 600 mg + permetrin 1920 mg Indoksakarb 900 mg + permetrin 2880 mg
6.4 Special precautions for storage
4.4 Posebna upozorenja
One unit-dose pipette holds 0.5 ml, 1 ml, 2 ml, 4 ml, or 6 ml spot-on solution.
Jedna pipeta s jediničnom dozom sadrži 0,5 ml, 1 ml, 2 ml, 4 ml ili 6 ml otopine za nakapavanje.
Intravenous infusion of electrolytes should be provided to stabilize vital functions if clinical signs of poisoning occur (e.g. hypersalivation, tremor, muscle cramp).
ukoliko se pojave klinički znakovi trovanja (npr. pretjerano slinjenje, tremor, grčenje mišića).
Fleas
Krpelji
Sand flies
Rue de Lyons
Τηλ: + 30 210 6219520, info@virbac.gr
Τηλ: + 30 210 6219520,
Fertility: Do not use in breeding dogs.
Ne koristiti kod pasa za rasplod.
Cardboard box of 1 pipette of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Kartonska kutija s 1 pipetom od 0,5 ml, 1 ml, 2 ml, 4 ml ili 6 ml.
Cardboard box of 4 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Kartonska kutija s 4 pipete od 0,5 ml, 1 ml, 2 ml, 4 ml ili 6 ml.
Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs
Activyl Tick Plus 75 mg + 240 mg spot-on otopina za jako male pse Activyl Tick Plus 150 mg + 480 mg spot-on otopina za male pse Activyl Tick Plus 300 mg + 960 mg spot-on otopina za srednje velike pse Activyl Tick Plus 600 mg + 1920 mg spot-on otopina za velike pse Activyl Tick Plus 900 mg + 2880 mg spot-on otopina za jako velike pse
Cardboard box of 6 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Kartonska kutija s 6 pipeta od 05 ml, 1 ml, 2 ml, 4 ml ili 6 ml.
10.1 - 20 Medium dogs 20.1 - 40 Large dogs
5,1 -10 Mali psi 10,1 -20 Srednje veliki psi 20,1 - 40 Veliki psi 40,1 -60 Jako veliki psi treba upotrijebiti odgovarajuću kombinaciju pipeta
Indoxacarb + permethrin
info@virbac.gr
Ергон-Миланова ЕООД, Р България, гр.София,
Luxembourg/Luxemburg: VIRBAC BELGIUM NV,
MARKETING AUTHORISATION NUMBER(S)
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET
4.11 Withdrawal period(s)
4.11 Karencija
Permethrin (mg)
Permetrin (mg)
Batch {number}
(mg)
BATCH NUMBER
BROJ PROIZVODNE SERIJE
Before having an operation
Prije operacije
If he/she is unavailable seek emergency assistance.
Ako on/ona nije dostupan/na, potražite hitnu medicinsku pomoć.
Recovery usually takes place over a period of time.
Oporavak obično nastupa nakon nekog vremena.
You may need urgent medical treatment.
Može Vam biti potrebno hitno medicinsko liječenje.
This can be due to the high dosages usually used in this population.
Razlog tomu mogu biti visoke doze obično primjenjivane u toj populaciji.
Injections should be repeated as required to maintain good function and minimise pain.
Injekcije treba ponavljati prema potrebi da bi se održala dobra funkcija i smanjila bol.
n = 38 n = 39 n = 36 n = 36 n = 37
n = 36 n = 36 n = 37
Restricted to hospital use only.
Ograničeno samo na bolničku upotrebu.
The risks, which can include death, may outweigh the potential benefits.
Rizici, uključujući i smrt, mogu prevagnuti nad potencijalnim koristima.
The risk of spreading of effect is greater than in adults, and more frequently severe.
Rizik od širenja učinka veći je nego u odraslih, a češće je i težeg oblika.
The dose resulting in death was 2400 U/kg.
Doza koja je rezultirala smrću bila je 2400 U/kg.
TWSTRS-Total
TWSTRS - ukupno
You may feel pain at the place where you had the injection, but this should wear off after a few minutes.
Možda ćete osjetiti bol na mjestu uboda injekcije, ali to bi trebalo proći nakon nekoliko minuta.
They may happen days to weeks after you have had the injection.
Mogu se dogoditi danima ili tjednima nakon što ste primili injekciju.
On these scales, scores of 50 indicate no change, 0 much worse, and 100 much better.
Na tim ljestvicama 50 bodova pokazuje da nema promjene, 0 veliko pogoršanje, a 100 veliko poboljšanje.
If this happens, do not drive or use any tools or machines.
Ako se to dogodi, nemojte voziti niti rukovati alatima ili strojevima.
However, the pharmacological characteristics do not indicate any need to adjust the dose.
Međutim, farmakološke značajke ne pokazuju potrebu za prilagodbom doze.
Store in a refrigerator at 2oC-8oC.
Čuvati u hladnjaku na 2oC-8oC.
The safety of NeuroBloc outside the approved indication has not been established.
Sigurnost NeuroBloca izvan odobrenih indikacija nije ustanovljena.
Do not shake.
Nemojte tresti.
Very common (may affect more than 1 in 10 people) dry mouth difficulty swallowing headache
Vrlo česte (mogu se pojaviti u više od 1 na 10 osoba) suha usta otežano gutanje glavobolja
The following information is intended for healthcare professionals only: INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Sljedeće informacije namijenjene su samo zdravstvenim radnicima: UPUTE ZA PRIMJENU, RUKOVANJE I ZBRINJAVANJE
Animal reproduction studies are insufficient with respect to effects on pregnancy and embryonal/foetal development.
Ispitivanja provedena na životinjama nedostatna su s obzirom na učinke na trudnoću i embrionalni/fetalni razvoj.
Spread of toxin effect
Širenje učinka toksina
Cases of overdose (some with signs of systemic toxicity) have been reported.
Zabilježeni su slučajevi predoziranja (neki uz znakove sistemske toksičnosti).
This is where you have contractions of your neck or shoulder muscles that you cannot control.
To je stanje u kojem imate stezanja (kontrakcije) mišića vrata ili ramena koja ne možete kontrolirati.
There were 77 subjects enrolled into the first study and 109 subjects into the second.
U prvo ispitivanje bilo je uključeno 77 ispitanika, u drugo 109 ispitanika.
The available reports indicate that the product has been used in the paediatric population.
Dostupna izvješća pokazuju da se ovaj lijek primjenjivao u pedijatrijskoj populaciji.
General precaution:
Opće mjere opreza:
Date of first authorisation: 22 January 2001 Date of latest renewal: 29 November 2010
Datum posljednje obnove odobrenja: 29. studeni 2010.
You may get a dry mouth and it might become difficult to swallow.
Možda ćete osjetiti da su Vam suha usta i može Vam postati teško gutati.
In rare cases difficulty in swallowing may be severe and choking is possible.
U rijetkim slučajevima teškoće s gutanjem mogu postati teške pa je moguće gušenje.
You must not be given NeuroBloc if any of the above applies to you.
Ne smijete primiti NeuroBloc ako se bilo što od gore navedenog odnosi na Vas.
Elderly No dose adjustment is required in older people ≥ 65 years of age.
Nije potrebna prilagodba doze u starije populacije u dobi od 65 ili više godina.
The medicinal product is ready to use and no reconstitution is required.
Lijek je spreman za upotrebu i rekonstitucija nije potrebna.
This warning includes use in children and in any other indication besides cervical dystonia.
Ovo upozorenje uključuje primjenu u djece i svaku drugu indikaciju osim cervikalne distonije.
Contents of the pack and other information What NeuroBloc contains
Sadržaj pakiranja i druge informacije Što NeuroBloc sadrži
The dosing frequency should therefore be adapted based on the clinical assessment/response of an individual patient.
Stoga učestalost doziranja treba prilagoditi na temelju kliničke procjene/odgovora svakog pojedinog bolesnika.
It is possible that cervical dystonia could become worse after you have had your injection.
Moguće je da se cervikalna distonija pogorša nakon što ste primili injekciju.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• prilikom svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
The safety and efficacy of NeuroBloc in children aged less than 18 years have not yet been established.
Sigurnost i djelotvornost lijeka NeuroBloc u djece mlađe od 18 godina nisu još ustanovljene.
In these studies, the average dosing frequency was approximately every 12 weeks.
U tim ispitivanjima učestalost doziranja bila je približno svakih 12 tjedana.
If you think that the effect of NeuroBloc is too strong or too weak, talk to your doctor.
Ako smatrate da je učinak lijeka NeuroBloc prejak ili preslab, obratite se liječniku.
Specifically, these studies showed approximately 19-25% seroconverted within 18 months of initiation of treatment, increasing to approximately 33-44% with up to 45 months of treatment.
Posebice su ta ispitivanja pokazala da je bilo 19-25% slučajeva serokonverzije u roku od 18 mjeseci nakon započetog liječenja što se do 45. mjeseca liječenja povećalo na približno 33-44%.
CLINICAL PARTICULARS 4.1 Therapeutic indications
KLINIČKI PODACI 4.1 Terapijske indikacije
Wear waterproof gloves and soak up the liquid with an appropriate absorbent.
Nosite vodootporne rukavice i tekućinu upijte odgovarajućim apsorbentom.
Seroconversion
Serokonverzija
Package leaflet: Information for the user
Uputa o lijeku: Informacija za korisnika
STUDY 2 (A-Responsive Patients)
ISPITIVANJE 2 (Bolesnici s odgovorom na A)
Development studies in rats and rabbits have shown no evidence of foetal malformations or changes to fertility.
Razvojna ispitivanja u štakora i kunića nisu dala dokaze fetalnih malformacija ili promjene plodnosti.
In the event of an overdose, general medical supportive measures should be instituted.
U slučaju predoziranja potrebno je uvesti opće medicinske potporne mjere liječenja.
Use immediately if diluted (see section 4.2 and section 6.6).
Razrijeđeni lijek upotrijebite odmah (vidjeti dio 4.2 i dio 6.6).
The mechanism of action of NeuroBloc in blocking neuromuscular conduction occurs by a three-step process:
Mehanizam djelovanja NeuroBloca u blokiranju neuromuskularne provodljivosti uključuje proces od tri koraka:
No studies on the effects on the ability to drive and use machines have been performed.
Nisu provedena ispitivanja o učincima na sposobnost upravljanja vozilima i rukovanja strojevima.
Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults.
Doze do 15 000 U rijetko su za posljedicu imale klinički značajnu sistemsku toksičnost u odraslih.
Patients treated with therapeutic doses may experience exaggerated muscle weakness.
Bolesnici liječeni terapijskim dozama mogu iskusiti pretjeranu mišićnu slabost.
What NeuroBloc looks like and contents of the pack
Kako NeuroBloc izgleda i sadržaj pakiranja
What NeuroBloc is and what it is used for
Što je NeuroBloc i za što se koristi
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.
Potrebno je odlučiti treba li nastaviti/prekinuti dojenje ili nastaviti/prekinuti liječenje NeuroBlocom uzimajući u obzir korist dojenja za dijete i korist liječenja NeuroBlocom za ženu.
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).
NeuroBloc se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje botulinskim toksinom tipa B (vidjeti dio 5.3).
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.
Te su nuspojave katkad imale za posljedicu smrt i moguće je da su povezane sa širenjem botulinskog toksina u dijelove tijela podalje od mjesta u koje je primijenjena injekcija.
Case reports are more likely to be serious in children (40%) compared to those in adults and older people (12%), possibly as a result of using an inappropriately high dosage for the child (see section 4.9).
Prema prikazima pojedinačnih slučajeva više su vjerojatne ozbiljne nuspojave u djece (40%) nego u odraslih i starijih osoba (12%), vjerojatno kao posljedica primjene neprimjereno visokih doza za djecu (vidjeti dio 4.9).
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
As with other botulinum toxins spontaneous recovery will occur over a period of time.
Kao i s drugim botulinskim toksinima, nakon nekog vremena nastupit će spontani oporavak.
Vials should be visually inspected prior to use.
Prije upotrebe bočice treba vizualno pregledati.
Placebo 10,000 U Placebo 5000 U 10,000 U
Placebo 5000 U 10 000 U
NeuroBloc is a neuromuscular blocking agent.
NeuroBloc je neuromuskularni blokator.
Patient evaluations continued for 16 weeks post injection.
Procjena bolesnika nastavila se još 16 tjedana nakon primjene injekcije.
For patients with reduced muscle mass the dose should be adjusted according to individual patient need.
U bolesnika sa smanjenom mišićnom masom dozu treba prilagoditi prema individualnim potrebama bolesnika.
This is because swallowing problems could make you breathe food or liquids into your lungs, which could then cause very serious pneumonia
To je zbog toga što teškoće s gutanjem mogu prouzročiti da udahnete hranu ili tekućinu u pluća, a to bi moglo prouzročiti vrlo tešku upalu pluća (pneumoniju).
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.
Istraživanje posljedica serokonverzije pokazalo je da prisutnost protutijela nije značila i gubitak kliničkog odgovora te da nije utjecala na sveukupni sigurnosni profil.
This is because NeuroBloc can affect the way some medicines work and other medicines can also affect the way NeuroBloc works.
To je zbog toga što NeuroBloc može utjecati na način na koji neki lijekovi djeluju, a drugi lijekovi također mogu utjecati na način na koji djeluje 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.
Ako niste sigurni odnosi li se nešto od gore navedenog na Vas, razgovarajte s liječnikom ili ljekarnikom prije nego što primite NeuroBloc.
If your doctor suspects that botulism may have occurred, you will be admitted to hospital and your breathing (respiratory function) will be monitored.
Ako liječnik sumnja da se razvio botulizam, bit ćete primljeni u bolnicu, a Vaše će se disanje (respiratorna funkcija) nadzirati.
Table 1 Efficacy Results from Phase III NeuroBloc Studies STUDY 1 (A-Resistant Patients)
Tablica 1 Rezultati djelotvornosti u fazi III ispitivanja lijeka NeuroBloc ISPITIVANJE 1 (Bolesnici bez odgovora na A)
How much will be given your doctor will decide how much NeuroBloc to give you the usual dose is 10,000 units, however, it can be higher or lower if you have had NeuroBloc injections before, your doctor will take into account how well it worked the other times
Koliko ćete primiti liječnik će odlučiti koliko Vam lijeka NeuroBloc treba dati uobičajena je doza 10 000 U, no doza može biti viša ili niža ako ste prije primali injekcije lijeka NeuroBloc, liječnik će uzeti u obzir koliko je dobro lijek djelovao u prethodnim slučajevima.
Following NeuroBloc treatment, all patients and caregivers should be advised to seek medical attention for respiratory difficulties, choking or any new or worsening dysphagia.
Nakon liječenja NeuroBlocom sve bolesnike i njihove njegovatelje treba upozoriti da potraže liječničku pomoć u slučaju respiratornih teškoća, gušenja ili bilo koje nove ili pogoršane disfagije.
These include dysphagia and breathing difficulties.
Oni uključuju disfagiju i teškoće s disanjem.
The systemic No Observed Effect Level (NOEL) was shown to be approximately 960 U/kg.
Doza bez opaženih sistemskih učinka (No Observed Effect Level, NOEL) bila je približno 960 U/kg.
NeuroBloc will be injected into your neck or shoulder muscles, depending on which ones are causing the problem your doctor may inject part of the dose into different places in your muscles
NeuroBloc će Vam se ubrizgati u mišiće vrata ili ramena, ovisno o tome koji mišići Vam stvaraju tegobe liječnik Vam može ubrizgati po dio doze na nekoliko različitih mjesta u mišiću.
However, no pharmacokinetic or Absorption, Distribution, Metabolism and Excretion (ADME) studies have been performed.
Međutim, farmakokinetička ispitivanja ili ispitivanja apsorpcije, distribucije, metabolizma i izlučivanja nisu provedena.
The safety of NeuroBloc when used to treat other conditions is not known: some side effects may be fatal.
Sigurnost lijeka NeuroBloc kada se primjenjuje za liječenje drugih stanja nije poznata: neke nuspojave mogu imati smrtni ishod.
Pharmacotherapeutic group: muscle relaxant, peripherally acting agents, ATC code: M03AX 01.
Farmakoterapijska skupina: mišićni relaksans, lijekovi s perifernim djelovanjem, ATK oznaka: M03AX 01
Because of the nature of the product, no animal studies have been carried out to establish the carcinogenic effects of NeuroBloc.
Zbog naravi lijeka nisu provedena ispitivanja na životinjama kako bi se ustanovili kancerogeni učinci NeuroBloca.
5 years, as packaged for sale.
U originalnom pakiranju 5 godina.
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).
Nuspojave opažene u svim kliničkim ispitivanjima navedene su niže prema klasifikaciji organskih sustava MedDRA te redoslijedom prema sve manjoj učestalosti definiranoj kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100).
This is because NeuroBloc can affect the medicines you may be given before a general anaesthetic.
To je zbog toga što NeuroBloc može utjecati na lijekove koje biste mogli primiti prije opće anestezije.
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.
Mehanizam kojim se paraliza mišića s vremenom povlači nije poznat, ali može biti povezan s intraneuronalnom pretvorbom (turnover) zahvaćenog proteina i/ili rastom živčanog završetka.
No fertility studies have been performed and it is not known whether NeuroBloc can affect reproduction capacity.
Nisu provedena ispitivanja plodnosti i nije poznato može li NeuroBloc utjecati na sposobnost reprodukcije.
NeuroBloc is not to be used in children aged less than18 years.
NeuroBloc nije za primjenu u djece mlađe od 18 godina.
A serious condition called “botulism” which causes paralysis of muscles and respiratory failure could occur if too much of the active ingredient (botulinum toxin) is injected into the body.
Ozbiljno stanje zvano "botulizam" koje uzrokuje paralizu mišića i zatajenje disanja može nastupiti ako je previše djelatnog sastojka (botulinskog toksina) ubrizgano u tijelo.
Other medicines and NeuroBloc
Drugi lijekovi i NeuroBloc
What you need to know before you use NeuroBloc Do not use NeuroBloc:
Što morate znati prije nego počnete primjenjivati NeuroBloc Nemojte primjenjivati NeuroBloc:
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}> Other sources of information
Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}.>
At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Na kraju ovoga razdoblja lijek ne smije biti vraćen u hladnjak nego ga treba baciti.
However, in clinical studies, NeuroBloc was administered 16 weeks after the injection of Botulinum Toxin Type A.
Međutim, u kliničkim ispitivanjima NeuroBloc je bio primijenjen 16 tjedana nakon injekcije botulinskog toksina tipa A.