FrancophonIA/ELRC3.0 huggingface dataset:
English: It is possible that cervical dystonia could become worse after you have had your injection.
Croatian: Moguće je da se cervikalna distonija pogorša nakon što ste primili injekciju.
English: • 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.
Croatian: • 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).
English: The safety and efficacy of NeuroBloc in children aged less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka NeuroBloc u djece mlađe od 18 godina nisu još ustanovljene.
English: In these studies, the average dosing frequency was approximately every 12 weeks.
Croatian: U tim ispitivanjima učestalost doziranja bila je približno svakih 12 tjedana.
English: If you think that the effect of NeuroBloc is too strong or too weak, talk to your doctor.
Croatian: Ako smatrate da je učinak lijeka NeuroBloc prejak ili preslab, obratite se liječniku.
English: 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.
Croatian: 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%.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Croatian: KLINIČKI PODACI 4.1 Terapijske indikacije
English: Wear waterproof gloves and soak up the liquid with an appropriate absorbent.
Croatian: Nosite vodootporne rukavice i tekućinu upijte odgovarajućim apsorbentom.
English: Seroconversion
Croatian: Serokonverzija
English: Package leaflet: Information for the user
Croatian: Uputa o lijeku: Informacija za korisnika
English: STUDY 2 (A-Responsive Patients)
Croatian: ISPITIVANJE 2 (Bolesnici s odgovorom na A)
English: Development studies in rats and rabbits have shown no evidence of foetal malformations or changes to fertility.
Croatian: Razvojna ispitivanja u štakora i kunića nisu dala dokaze fetalnih malformacija ili promjene plodnosti.
English: In the event of an overdose, general medical supportive measures should be instituted.
Croatian: U slučaju predoziranja potrebno je uvesti opće medicinske potporne mjere liječenja.
English: Use immediately if diluted (see section 4.2 and section 6.6).
Croatian: Razrijeđeni lijek upotrijebite odmah (vidjeti dio 4.2 i dio 6.6).
English: The mechanism of action of NeuroBloc in blocking neuromuscular conduction occurs by a three-step process:
Croatian: Mehanizam djelovanja NeuroBloca u blokiranju neuromuskularne provodljivosti uključuje proces od tri koraka:
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o učincima na sposobnost upravljanja vozilima i rukovanja strojevima.
English: Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults.
Croatian: Doze do 15 000 U rijetko su za posljedicu imale klinički značajnu sistemsku toksičnost u odraslih.
English: Patients treated with therapeutic doses may experience exaggerated muscle weakness.
Croatian: Bolesnici liječeni terapijskim dozama mogu iskusiti pretjeranu mišićnu slabost.
English: What NeuroBloc looks like and contents of the pack
Croatian: Kako NeuroBloc izgleda i sadržaj pakiranja
English: What NeuroBloc is and what it is used for
Croatian: Što je NeuroBloc i za što se koristi
English: 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.
Croatian: 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.
English: 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).
Croatian: NeuroBloc se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje botulinskim toksinom tipa B (vidjeti dio 5.3).
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: As with other botulinum toxins spontaneous recovery will occur over a period of time.
Croatian: Kao i s drugim botulinskim toksinima, nakon nekog vremena nastupit će spontani oporavak.
English: Vials should be visually inspected prior to use.
Croatian: Prije upotrebe bočice treba vizualno pregledati.
English: Placebo 10,000 U Placebo 5000 U 10,000 U
Croatian: Placebo 5000 U 10 000 U
English: NeuroBloc is a neuromuscular blocking agent.
Croatian: NeuroBloc je neuromuskularni blokator.
English: Patient evaluations continued for 16 weeks post injection.
Croatian: Procjena bolesnika nastavila se još 16 tjedana nakon primjene injekcije.
English: For patients with reduced muscle mass the dose should be adjusted according to individual patient need.
Croatian: U bolesnika sa smanjenom mišićnom masom dozu treba prilagoditi prema individualnim potrebama bolesnika.
English: This is because swallowing problems could make you breathe food or liquids into your lungs, which could then cause very serious pneumonia
Croatian: 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).
English: 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.
Croatian: Istraživanje posljedica serokonverzije pokazalo je da prisutnost protutijela nije značila i gubitak kliničkog odgovora te da nije utjecala na sveukupni sigurnosni profil.
English: This is because NeuroBloc can affect the way some medicines work and other medicines can also affect the way NeuroBloc works.
Croatian: 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.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you are given NeuroBloc.
Croatian: Ako niste sigurni odnosi li se nešto od gore navedenog na Vas, razgovarajte s liječnikom ili ljekarnikom prije nego što primite NeuroBloc.
English: If your doctor suspects that botulism may have occurred, you will be admitted to hospital and your breathing (respiratory function) will be monitored.
Croatian: Ako liječnik sumnja da se razvio botulizam, bit ćete primljeni u bolnicu, a Vaše će se disanje (respiratorna funkcija) nadzirati.
English: Table 1 Efficacy Results from Phase III NeuroBloc Studies STUDY 1 (A-Resistant Patients)
Croatian: Tablica 1 Rezultati djelotvornosti u fazi III ispitivanja lijeka NeuroBloc ISPITIVANJE 1 (Bolesnici bez odgovora na A)
English: 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
Croatian: 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.
English: Following NeuroBloc treatment, all patients and caregivers should be advised to seek medical attention for respiratory difficulties, choking or any new or worsening dysphagia.
Croatian: 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.
English: These include dysphagia and breathing difficulties.
Croatian: Oni uključuju disfagiju i teškoće s disanjem.
English: The systemic No Observed Effect Level (NOEL) was shown to be approximately 960 U/kg.
Croatian: Doza bez opaženih sistemskih učinka (No Observed Effect Level, NOEL) bila je približno 960 U/kg.
English: 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
Croatian: 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.
English: However, no pharmacokinetic or Absorption, Distribution, Metabolism and Excretion (ADME) studies have been performed.
Croatian: Međutim, farmakokinetička ispitivanja ili ispitivanja apsorpcije, distribucije, metabolizma i izlučivanja nisu provedena.
English: The safety of NeuroBloc when used to treat other conditions is not known: some side effects may be fatal.
Croatian: Sigurnost lijeka NeuroBloc kada se primjenjuje za liječenje drugih stanja nije poznata: neke nuspojave mogu imati smrtni ishod.
English: Pharmacotherapeutic group: muscle relaxant, peripherally acting agents, ATC code: M03AX 01.
Croatian: Farmakoterapijska skupina: mišićni relaksans, lijekovi s perifernim djelovanjem, ATK oznaka: M03AX 01
English: Because of the nature of the product, no animal studies have been carried out to establish the carcinogenic effects of NeuroBloc.
Croatian: Zbog naravi lijeka nisu provedena ispitivanja na životinjama kako bi se ustanovili kancerogeni učinci NeuroBloca.
English: 5 years, as packaged for sale.
Croatian: U originalnom pakiranju 5 godina.
English: 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).
Croatian: 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).
English: This is because NeuroBloc can affect the medicines you may be given before a general anaesthetic.
Croatian: To je zbog toga što NeuroBloc može utjecati na lijekove koje biste mogli primiti prije opće anestezije.
English: 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.
Croatian: 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.
English: No fertility studies have been performed and it is not known whether NeuroBloc can affect reproduction capacity.
Croatian: Nisu provedena ispitivanja plodnosti i nije poznato može li NeuroBloc utjecati na sposobnost reprodukcije.
English: NeuroBloc is not to be used in children aged less than18 years.
Croatian: NeuroBloc nije za primjenu u djece mlađe od 18 godina.
English: 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.
Croatian: Ozbiljno stanje zvano "botulizam" koje uzrokuje paralizu mišića i zatajenje disanja može nastupiti ako je previše djelatnog sastojka (botulinskog toksina) ubrizgano u tijelo.
English: Other medicines and NeuroBloc
Croatian: Drugi lijekovi i NeuroBloc
English: What you need to know before you use NeuroBloc Do not use NeuroBloc:
Croatian: Što morate znati prije nego počnete primjenjivati NeuroBloc Nemojte primjenjivati NeuroBloc:
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}> Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}.>
English: At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Croatian: Na kraju ovoga razdoblja lijek ne smije biti vraćen u hladnjak nego ga treba baciti.
English: However, in clinical studies, NeuroBloc was administered 16 weeks after the injection of Botulinum Toxin Type A.
Croatian: Međutim, u kliničkim ispitivanjima NeuroBloc je bio primijenjen 16 tjedana nakon injekcije botulinskog toksina tipa A.
English: Assessments
Croatian: Procjene
English: 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.
Croatian: Daljnja klinička ispitivanja i praćenja otvorenog tipa pokazala su da se odgovor ispitanika na NeuroBloc može nastaviti kroz dulja razdoblja s tim da su neki ispitanici imali više od 14 ciklusa liječenja u razdoblju duljem od 3,5 godina.
English: If you are going to have an operation, please tell your doctor that you have been given NeuroBloc.
Croatian: Ako se morate podvrgnuti operativnom zahvatu, obavijestite liječnika da ste primili NeuroBloc.
English: The effect of administering different botulinum neurotoxin serotypes concurrently is unknown.
Croatian: Učinak primjene različitih serotipova botulinskih neurotoksina trenutačno nisu poznati.
English: The total dose was divided between the selected muscles and 1 to 5 injections per muscle were administered.
Croatian: Ukupna doza raspodijeljena je na te odabrane mišiće i primijenjeno je od 1 do 5 injekcija po mišiću.
English: If botulism is clinically suspected, hospitalisation for the monitoring of respiratory function (incipient respiratory failure) may be required.
Croatian: Ako se klinički sumnja na botulizam, može biti potrebna hospitalizacija kako bi se nadzirala respiratorna funkcija (početak respiratornog zatajenja).
English: 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.
Croatian: U slučaju predoziranja ili injekcije primijenjene u mišić koji obično kompenzira cervikalnu distoniju, moguće je da se distonija pogorša.
English: The immunogenicity of NeuroBloc has been evaluated in two clinical studies and an open-label extension study.
Croatian: Imunogenost NeuroBloca procijenjena je u dva klinička ispitivanja i jednom otvorenom produžetku ispitivanja.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Dysphagia has been reported following injection to sites other than the cervical musculature.
Croatian: Disfagija je zabilježena nakon injekcije i u druga mjesta osim cervikalne muskulature.
English: 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.
Croatian: Lijek je ubrizgan u istom navratu u 2 do 4 sljedeća mišića: splenius capitis, sternocleidomastoideus, levator scapulae, trapezius, semispinalis capitis i scalenus.
English: Marketing Authorisation Holder: Sloan Pharma S.à.r.l.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet: Sloan Pharma S.à.r.l.
English: NeuroBloc contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc.
Croatian: NeuroBloc sadrži manje od 1 mmol natrija (23 mg) na 10 000 U lijeka.
English: A series of clinical studies have been conducted to evaluate the efficacy and safety of NeuroBloc in the treatment of cervical dystonia.
Croatian: Niz kliničkih ispitivanja provedeno je kako bi se procijenila djelotvornost i sigurnost NeuroBloca u liječenju cervikalne distonije.
English: The frequency of these side effects is not known.
Croatian: Učestalost ovih nuspojava nije poznata.
English: When injected directly into a muscle, NeuroBloc causes a localised paralysis that gradually reverses over time.
Croatian: Ubrizgan izravno u mišić, NeuroBloc uzrokuje lokaliziranu paralizu koja se s vremenom postupno povlači.
English: 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.
Croatian: U bolesnika s neuromuskularnim poremećajima ili disfagijom i aspiracijom u anamnezi, botulinski toksini smiju se primjenjivati samo u eksperimentalnim uvjetima pod strogim liječničkim nadzorom.
English: Particular caution should be paid to ensure that it is not injected into a blood vessel.
Croatian: Posebnu pozornost treba posvetiti da se lijek ne primijeni u krvnu žilu.
English: In long term clinical studies, the average dosing frequency was approximately every 12 weeks, however this may vary between subjects, and a proportion of patients maintained a significant improvement relative to baseline for 16 weeks or longer.
Croatian: U dugotrajnim kliničkim ispitivanjima prosječna učestalost doziranja bila je otprilike svakih 12 tjedana, no to može varirati među ispitanicima i određeni je udio bolesnika održao značajno poboljšanje u odnosu na početno stanje 16 tjedana ili dulje.
English: Pre-Existing neuromuscular disorders
Croatian: Postojeći neuromuskularni poremećaji
English: NeuroBloc injection works by reducing or stopping muscle contractions.
Croatian: Injekcija lijeka NeuroBloc djeluje tako da smanjuje ili zaustavlja mišićne kontrakcije.
English: These units are not interchangeable with the units used to express the potency of other botulinum toxin preparations (see section 4.4).
Croatian: Ove se jedinice ne smiju međusobno zamijeniti s jedinicama koje se upotrebljavaju za izražavanje jačine drugih pripravaka botulinskog toksina (vidjeti dio 4.4).
English: NeuroBloc has been approved for the treatment of cervical dystonia only and should not be used to treat anything else.
Croatian: NeuroBloc je odobren samo za liječenje cervikalne distonije i ne smije se upotrebljavati za neko drugo liječenje.
English: In common with Botulinum Toxin Type A, electrophysiological jitter, which is not associated with clinical weakness or other electrophysiological abnormalities, may be experienced in some distant muscles.
Croatian: Slično kao i za botulinski toksin tipa A, elektrofiziološko podrhtavanje koje nije povezano s kliničkom slabošću ili drugim elektrofiziološkim abnormalnostima može se pojaviti u nekim udaljenim mišićima.
English: Caution should be used in patients with bleeding disorders or receiving anticoagulant therapy.
Croatian: Potreban je oprez u bolesnika s poremećajima hemostaze ili u onih koji primaju antikoagulantnu terapiju.
English: The excretion of Botulinum Toxin Type B in milk has not been studied in animals.
Croatian: Izlučivanje botulinskog toksina tipa B u mlijeko nije ispitano u životinja.
English: Common (may affect up to 1 in 10 people) blurred vision or drooping of your upper eyelid indigestion or being sick (vomiting) constipation neck pain feeling weak, pain or stiff muscles around your body loss of strength or energy changes in the taste of your food and drink changes in the sound of your voice flu-like symptoms
Croatian: Česte (mogu se pojaviti u do 1 na 10 osoba) zamagljen vid ili spuštanje gornje vjeđe probavne smetnje ili povraćanje zatvor bol u vratu osjećaj slabosti, boli ili ukočeni mišići posvuda u tijelu gubitak snage ili energije promjene okusa hrane i pića promjene glasa simptomi nalik gripi.
English: Talk to your doctor or pharmacist before using NeuroBloc: if you have a bleeding problem such as haemophilia if you have lung problems if you have difficulty swallowing.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što primite NeuroBloc: ako imate teškoća s krvarenjem poput hemofilije ako imate tegoba s plućima ako otežano gutate.
English: Intramuscular use.
Croatian: Intramuskularna primjena.
English: The presence of antibodies in these studies was assessed using the mouse protection assay (also known as the Mouse Neutralization Assay, MNA).
Croatian: Prisutnost protutijela u tim ispitivanjima procijenjena je testom zaštite miševa (poznatom također kao test neutralizacije u miševa, Mouse Neutralization Assay - MNA).
English: 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).
Croatian: NeuroBloc je otopina za injekciju u bočici koja sadrži 0,5 ml (2500 U), 1,0 ml (5000 U) ili 2,0 ml (10 000 U).
English: Once diluted, the medicinal product must be used immediately as the formulation does not contain a preservative.
Croatian: Kad je razrijeđen, lijek treba upotrijebiti odmah jer pripravak ne sadrži konzervans.
English: NeuroBloc injected intramuscularly produces localised muscle weakness by chemical denervation.
Croatian: NeuroBloc primijenjen intramuskularno izaziva lokaliziranu mišićnu slabost kemijskom denervacijom.
English: If your swallowing difficulty gets worse or you have choking or breathing problems, see a doctor immediately.
Croatian: Ako Vam se teškoće s gutanjem pogoršaju ili se pojavi gušenje ili teškoće s disanjem, otiđite liječniku bez odlaganja.
English: 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
Croatian: izvanstanično vezanje toksina na specifična vezna mjesta (akceptore) na završecima motornih živaca internalizacija i oslobađanje toksina u citosol živčanih završetaka inhibicija oslobađanja acetilkolina iz živčanih završetaka na neuromuskularnoj sinapsi.
English: Justification for not including Braille accepted.
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.