FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: Reazzjonijiet lokali u/jew sistemiċi ġew osservati f' xi persuni wara espożizzjoni għall-prodott bħal: irritazzjonijiet lokali fil-ġilda; irritazzjonijiet fl-imnieħer u griżmejn/ħalq; sinjali newroloġiċi; sinjali respiratorji; sinjali gastrointestinali u sinjali sistemiċi oħra.
English: insecticides; permethrin, combinations.
Maltese: Ektoparasitiċida għall-użu topiku, inkl. insettiċidi: permethrin, kombinazzjonijiet
English: Ticks
Maltese: Klieb
English: Dosage schedule:
Maltese: Data tal-aħħar tiġdid:
English: Following a single administration, the veterinary medicinal product will prevent further flea infestation for 4 weeks and prevent tick re-infestation (through an acaricidal effect) with I. ricinus and R. sanguineus for 5 and 3 weeks, respectively; repellent (anti-feeding) activity against sand flies will last for 3 weeks.
Maltese: Wara applikazzjoni waħda, il-prodott veterinarju mediċinali jipprevjeni infestazzjonijiet oħra talqurdien għal 4 ġimgħat u jipprevjeni ri-infestazzjoni mill-qurdien (minn effett arakiċidali) I. ricinus u R.sanguineus għal 5 u 3 ġimgħat, rispettivament;
English: Pentobarbital, phenobarbital or propofol might be indicated if repeated occasions of cramp/tremors occur.
Maltese: Pentobarbital, phenobarbital jew propofol jistgħu jkunu indikati jekk iseħħu episodji ta` bugħawwieġ/rodgħa repetuti.
English: After treatment, ticks will generally be killed and fall off the host within 48 hours after infestation without having had a blood meal but an attachment of single ticks after treatment cannot be excluded.
Maltese: Wara t-trattament, il-qurdien ġeneralment imutu u jaqgħu minn fuq l-ospitanti fi żmien 48 siegħa wara l-infestazzjoni mingħajr ma jerdgħu d-demm iżda ma jistax jiġi eskluż li qurdiena waħda tista' tibqa' mwaħħla wara t-trattament.
English: The recommended dose for dogs is 15 mg indoxacarb and 48 mg permethrin per kg bodyweight, equivalent to 0.1 ml/kg bodyweight.
Maltese: Id-doża rakkomandata hija ta' 15 mg indoxacarb u 48 mg permethrin għal kull kg piż, ekwivalenti għal 0.1 ml/kg piż.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substances:
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: SPECIAL STORAGE CONDITIONS
Maltese: KOMPOŻIZZJONI KWALITATTIVA
English: This results in a rapid cessation of feeding within 0 to 4 hours after treatment followed by cessation of egg laying (oviposition), paralysis and death occurring within 4 to 48 hours.
Maltese: Dan iwassal f'waqfien mill-ikel minn 0 sa 4 sigħat wara t-trattament segwit minn twaqqif fi tqegħid ta' bajd (oviposition), paraliżi u mewt li sseħħ bejn 4 u 48 siegħa wara.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For spot-on use.
Maltese: U METODU TA' AMMINISTRAZZJONI Użu spot-on.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott veterinarju mediċinali tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Fleas
Maltese: Biss
English: The recommended minimum dose is 15 mg indoxacarb/kg bodyweight and 48 mg/kg permethrin, equivalent to 0.1 ml spot-on solution per kg bodyweight.
Maltese: Id-doża rakkomandata hija ta' 15 mg indoxacarb/kg piż, u 48 mg/kg permethrin ekwivalenti għal 0.1
English: Very small dogs (1.2 - 5 kg) Small dogs (5.1 - 10 kg) Medium dogs (10.1 - 20 kg) Large dogs (20.1 - 40 kg) Extra large dogs (40.1 - 60 kg)
Maltese: Klieb żgħar ħafna (1.2 sa 5 kg) Klieb żgħar (5.1 to 10 kg)
English: Gastrointestinal signs (e.g. emesis, diarrhoea or anorexia), reversible neurological signs (e.g. tremor or ataxia) or lethargy have been observed in very rare cases.
Maltese: Ġew osservati sinjali gastro-intestinali (e.g. remettar, dijarea jew anoressija), sinjali newroloġiċi riversibbli (e.g. rogħda jew atassja) jew telqa, f`każijiet rari ħafna.
English: Cardboard box of 1 pipette of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Maltese: Kaxxa tal-kartun b'pipetta waħda ta' 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml Kaxxa tal-kartun b'erba' pipetti ta' 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml Kaxxa tal-kartun b'sitt pipetti ta' 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml
English: 10.1 - 20 Medium dogs 20.1 - 40 Large dogs
Maltese: Klieb medji 20.1 - 40 Klieb kbar
English: CONTRAINDICATIONS
Maltese: KARATTERISTIĊI
English: Pulawska 314, PL-02 819 Warszawa, Tel.: + 48 22 855 40 46
Maltese: Pulawska 314, PL-02 819 Warszawa,
English: C. STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TAL-MRLs
English: 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)
Maltese: Activyl Tick Plus 75 mg + 240 mg soluzzjoni spot-on għal klieb żgħar ħafna (1.2 - 5 kg) Activyl Tick Plus 150 mg + 480 mg soluzzjoni spot-on għal-klieb żgħar (5.1 - 10 kg) Activyl Tick Plus 300 mg + 960 mg soluzzjoni spot-on għal-klieb medji (10.1 - 20 kg) Activyl Tick Plus 600 mg + 1920 mg soluzzjoni spot-on għal-klieb kbar (20.1 - 40 kg) Activyl Tick Plus 900 mg + 2880 mg soluzzjoni spot-on għal-klieb kbar ħafna (40.1 - 60kg)
English: Pyrethroids are so-called “open channel blockers” affecting the sodium channel by slowing both the activation and the inactivation properties, thus leading to hyper-excitability and death of the parasite.
Maltese: Pyrethroids huma dawk li jissejħu “open channel blockers” li jaffettwaw il-kanali tas-sodju billi jnaqqsu l-attivazzjoni kif ukoll l-inattivazzjoni, li jwasslu għal hyper-excitability u mewt tal-parassita.
English: EXPIRY DATE
Maltese: Doża eċċessiva
English: The veterinary medicinal product is extremely poisonous to cats and can induce potentially fatal convulsions in cats, due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin.
Maltese: Il-prodott mediċinali veterinarju huwa valenuż ħafna għal qtates u jista' jwassal għal konvulżjonijiet potenzjalment fatali fil-qtates billi din l-ispeċi għandha fisjoloġija unika fejn ċerti sustanzi inkluż ilpermethrin, ma jistgħux jiġu mmetabolizzati.
English: Excipients:
Maltese: Tqala:
English: Store the pipettes in the original package in order to protect from moisture and light.
Maltese: Żomm il-pipetti fil-pakett oriġinali sakem lest biex tuża.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Maltese: Sustanza Attiva:
English: 5.2 Pharmacokinetic particulars
Maltese: .2 Tagħrif Farmakokinetiċi
English: The absorbed indoxacarb and permethrin are extensively metabolised by the liver to a variety of metabolites.
Maltese: L-indoxacarb u lpermethrin li jiġu assorbiti jiġu metabolizzati b'mod estensiv fil-fwied f'numru ta' metaboliti.
English: One unit dose pipette delivers:
Maltese: Pipetta waħda tagħti:
English: Overdose
Maltese: FARMAĊEWTIKU
English: Gastrointestinal signs (e.g. emesis (vomiting), diarrhoea or anorexia (loss of appetite), reversible neurological signs (e.g. tremor (shakiness) or ataxia (unsteady movement)) or lethargy (drowsiness) have been observed in very rare cases.
Maltese: Ġew osservati sinjali gastro-intestinali (e.g. remettar, dijareja jew anoressija (nuqqas ta`aptit), sinjali newroloġiċi riversibbli (eż. rogħda jew atassja (movimenti mhux kordinati) jew telqa f`każijiet rari ħafna.
English: Indoxacarb (mg)
Maltese: Indoxacarb
English: 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
Maltese: Activyl Tick Plus 75 mg + 240 mg soluzzjoni spot-on għal klieb żgħar ħafna Activyl Tick Plus 150 mg + 480 mg soluzzjoni spot-on għal klieb żgħar Activyl Tick Plus 300 mg + 960 mg soluzzjoni spot-on għal klieb medji Activyl Tick Plus 600 mg + 1920 mg soluzzjoni spot-on għal klieb kbar Activyl Tick Plus 900 mg + 2880 mg soluzzjoni spot-on għal klieb kbar ħafna
English: Manufacturer responsible for batch release: Intervet Productions SA Rue de Lyons
Maltese: Intervet Productions S.A.
English: Advice for the veterinarian: Intravenous infusion of electrolytes should be provided to stabilize vital functions if clinical signs of poisoning occur (e.g. hypersalivation, tremor, muscle cramp).
Maltese: Infużjoni fil-vina ta` elektroliti għandha tingħata sabiex tistabbilizza l-funzjonijiet vitali jekk isseħħu s-sinjali kliniċi ta` avvenelament (e.g. ipersalivazzjni, rodgħa, bugħawwieġ fil-muskoli).
English: Indoxacarb is a pro- drug that requires bioactivation by enzymes in susceptible insects to exert its pharmacodynamic effects.
Maltese: Indoxacarb huwa prodrug li għandu bżonn ta' bijoattivazzjoni b'enżimi ta' l-insett biex jeżerċita l-effetti farmakodinamiċi tiegħu.
English: Pregnancy:
Maltese: Fertilità:
English: Disposal: read package leaflet.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: Transitory erythema (redness of skin), hair loss or itching at the application site were commonly (13 of 359 dogs) observed in clinical studies.
Maltese: Ħakk li jgħaddi eritema (ħmura tal-ġilda), u telf ta' pil fiż-żona tal-applikazzjoni kienu osservati frekwentament.
English: However, a reproductive toxicity study conducted in the dog at three times the recommended therapeutic dose did reveal a significant reduction in the live pup ratio; the clinical significance of this latter finding is unknown as no studies were carried out in dogs using the recommended therapeutic dose.
Maltese: Madanakollu, studju dwar it-tossiċità fuq ir-riproduzzjoni fuq il-klieb b'doża tliet darbiet aktar minn dik rakkomandata, wera tnaqqis sinifikanti fir-ratio ta' ġriewi ħajjin; is-sinifikat kliniku ta' dan laħħar studju mhux magħruf billi ma sar l-ebda studju fuq il-klieb bid-doża ta' kura rakkomandata.
English: Pharmacotherapeutic group: Ectoparasiticides for topical use, incl.
Maltese: Jekk is-sintomi jseħħu, fittex parir mediku u uri l-fuljett tal-informazzjoni lit-tabib.
English: Following a single spot-on application of the product, indoxacarb and permethrin can still be detected in both skin and hair coat after 4 weeks post-treatment.
Maltese: Wara applikazzjoni spot-on waħda tal-prodott, indoxacarb u permethrin jistgħu jinstabu kemm filġilda kif ukoll fil-pil 4 ġimgħat wara t-trattament.
English: Cardboard box of 6 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Maltese: In-natura u l-għamla tal-ewwel ippakkjar Kaxxa tal-kartun b'pipetta spot-on waħda, erbgħa jew sitta, li jikkonsistu f'pipetti ta' 0.5 ml, 1 ml, 2 ml, 4 ml u 6 ml.
English: Ергон-Миланова ЕООД, Р България, гр.София,
Maltese: 4.7 Użu fit-tqala, fit-treddigħ u fi żmien il-bidien
English: No adverse reactions were observed in dogs aged 8 weeks and older, treated 8 times at 4 week intervals or 6 times at 2 week intervals, with 5 times the recommended dose.
Maltese: Ma dehrux effetti mhux mixtieqa fi klieb ta' età ta' 8 ġimgħat jew aktar li ġew amministrati doża ħames darbiet ogħla minn dik rakkomandata għal 8 darbiet f'intervalli ta' 4 ġimgħat jew 6 darbiet f'intervalli ta' ġimagħtejn.
English: PACKAGE SIZE
Maltese: FIL-PAKETT
English: Spot-on use
Maltese: Mhux applikabbli
English: Luxembourg
Maltese: Lussemburgu
English: P-Value* * Analysis of covariance, two-tailed tests, a = 0.05
Maltese: Valur P* * Analażi ta' kovarjanza, testijiet two-tailed, a = 0.05
English: Seroconversion
Maltese: Serokonverżjoni
English: TWSTRS-Total
Maltese: Totali TWSTRS
English: Date of first authorisation: 22 January 2001 Date of latest renewal: 29 November 2010
Maltese: Data tal-aħħar tiġdid: 29 ta' Novembru 2010
English: Disodium succinate Sodium chloride
Maltese: Sodium chloride
English: Pack size of 1.
Maltese: Daqs tal-pakkett ta' 1.
English: Physician Global
Maltese: Tabib Globali
English: 33, Rue du Puits Romain 8070 Bertrange Luxembourg
Maltese: Sloan Pharma S.à.r.l. 33, Rue du Puits Romain 8070 Bertrange Lussemburgu
English: Produced in Clostridium botulinum Serotype B (Bean Strain) cells.
Maltese: Magħmul f'ċelluli ta' Clostridium botulinum Serotip B (Razza Bean).
English: Disodium succinate, sodium chloride, human serum albumin solution, hydrochloric acid and water for injections.
Maltese: Disodium succinate, sodium chloride, soluzzjoni ta' human serum albumin, hydrochloric acid u ilma għall-injezzjonijiet.
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).
Maltese: Reazzjonijiet avversi li ġraw fl-studji kliniċi kollha huma elenkati taħt skond is-sistema tal-klassifika tal-organi MedDRA u b'frekwenza li tonqos li hija mfissra kif ġej: Komuni Ħafna (³1/10); Komuni (³1/100 sa <1/10); Mhux Komuni (³1/1,000 sa <1/100).
English: The active substance is Botulinum Toxin Type B. One millilitre (ml) contains 5000 U.
Maltese: Is-sustanza attiva hija Tossina Botulinum ta' Tip B. Millilitru wieħed (1 ml) fih 5000 U.
English: Mean at Week 4 P-Value*
Maltese: Ġimgħa Valur P*
English: NeuroBloc injected intramuscularly produces localised muscle weakness by chemical denervation.
Maltese: NeuroBloc injettat ġol-muskoli jipproduċi dgħjufija lokalizzata fil-muskoli permezz ta' denervazzjoni kimika.
English: Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults.
Maltese: Dożi sa 15,000 U b'mod mhux frekwenti rriżultaw f'tossiċità sistemika klinikament sinifikanti f'adulti.
English: Table 1 Efficacy Results from Phase III NeuroBloc Studies STUDY 1 (A-Resistant Patients)
Maltese: III dwar NeuroBloc STUDJU 1 (Pazjenti Reżistenti għal A)
English: The non-inferiority of NeuroBloc compared to Botulinum Toxin Type A was further supported by a responder analysis where similar percentages of subjects showed improvement in the TWSTRS score at Week 4 of Session 1 (86% NeuroBloc and 85% Botox), and a similar proportion of subjects experienced at least a 20% decrease from baseline in the TWSTRS score at Week 4 of Session 1 (51% NeuroBloc, 47% Botox).
Maltese: In-non-inferjorità ta' NeuroBloc meta mqabbel ma' Tossina Botulinum ta' Tip A kien appoġġjat b'mod ulterjuri minn analiżi ta' dawk li rrispondew fejn persentaġġi simili ta' pazjenti wrew titjib filpunteġġ TWSTRS f'Ġimgħa 4 ta' l-Ewwel Sessjoni (86% NeuroBloc u 85% Botox) u proporzjon simili ta' individwi esperjenzaw tnaqqis ta' mill-inqas 20% mil-linja bażi fil-punteġġ TWSTRS f'Ġimgħa 4 ta' l-Ewwel Sezzjoni (51% NeuroBloc, 47% Botox).
English: Two Phase III randomised, multicentre, double-blind, placebo-controlled studies were conducted in patients with cervical dystonia.
Maltese: III ikkontrollati bi plaċebo, randomised, double-blind, multiċentrali, f'pazjenti b'distonja ċervikali.
English: Placebo 10,000 U Placebo 5000 U 10,000 U
Maltese: Plaċebo 10,000
English: Decontaminate any spill with 10% caustic solution, or sodium hypochlorite (household chlorine bleach -2 ml (0.5%): 1 litre water) solution.
Maltese: Iddekontamina kwalunkwe tixrid b'10% ta' soluzzjoni korrożiva, jew soluzzjoni ta' sodium hypochlorite (chlorine bleach domestiku -2 ml (0.5%): 1 litru ta' ilma).
English: Gastrointestinal disorders dysphagia dyspepsia
Maltese: Disturbi gastro-intestinali disfaġja dispepsja
English: Co. Louth
Maltese: Louth
English: Human serum albumin Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Human serum albumin Hydrochloric acid għal (aġġustament tal-pH) Ilma għall-injezzjonijiet
English: NeuroBloc contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc.
Maltese: NeuroBloc fih anqas minn 1 mmol sodium (23 mg) f'kull 10,000 unità ta' NeuroBloc, jiġifieri essenzjalment huwa ‘ħieles mis-sodium'.
English: Use immediately if diluted (see section 4.2 and section 6.6).
Maltese: Użah immedjatament jekk ikun dilwit (ara sezzjoni 4.2 u sezzjoni 6.6).
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.
Maltese: Il-prodott mediċinali ġie injettat f'okkażjoni waħda fi tnejn jew f'erbgħa mill-muskoli li ġejjin: splenius capitus, sternocleidomastoid, levator scapulae, trapezius, semispinalis capitus u scalene.
English: 33, Rue du Puits Romain 8070 Bertrange
Maltese: 33, Rue du Puits Romain
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.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikata fuq il-portal elettroniku Ewropew tal-mediċini.
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).
Maltese: NeuroBloc hu ppreżentat bħala soluzzjoni għall-injezzjoni f'kunjett tal-ħġieġ li fih 0.5 ml (2500 Unità), 1.0 ml (5000 Unità) jew 2.0 ml (10,000 Unità).
English: Other side effects include:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: NeuroBloc is indicated for the treatment of cervical dystonia (torticollis) in adults.
Maltese: NeuroBloc huwa indikat għall-kura ta' distonja ċervikali (torticollis) fl-adulti.
English: General precaution:
Maltese: Prekawzjoni ġenerali:
English: Respiratory thoracic and mediastinal disorders dysphonia
Maltese: Disturbi respiratorji, toraċiċi u medjastinali disfonija
English: Patient Global
Maltese: Pazjent Globali
English: Pharmacotherapeutic group: muscle relaxant, peripherally acting agents, ATC code: M03AX 01.
Maltese: Kategorija farmakoterapewtika: rilassant tal-muskoli, sustanzi li jaħdmu fuq il-periferiji, Kodiċi ATC:
English: In rabbits, the NOAEL was 0.1 U/kg/day for maternal effects and 0.3 U/kg/day for foetal effects.
Maltese: Fil-fniek, in-NOAEL kien ta' 0.1 U/kg/ġurnata għal effetti fuq l-omm u 0.3 U/kg/ġurnata għal effetti fuq il-fetu.
English: Contents of the pack and other information What NeuroBloc contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih NeuroBloc
English: However, no pharmacokinetic or Absorption, Distribution, Metabolism and Excretion (ADME) studies have been performed.
Maltese: Madankollu, ma saru l-ebda studji farmakokinetiċi jew studji ta' Assorbiment, Distribuzzjoni, Metaboliżmu u ta' Eliminazzjoni (ADME).
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: You may get a dry mouth and it might become difficult to swallow.
Maltese: tkun severa u huwa possibli li tifga.
English: Following local intramuscular injection of NeuroBloc serious adverse events that may have been due to systemic effects of Botulinum Toxin Type B, were observed in 12% of adverse reaction cases reported during the post-marketing experience (including the following adverse reactions: dry mouth, dysphagia and blurred vision).
Maltese: Wara injezzjoni lokali ġol-muskoli ta' NeuroBloc episodji avversi serji li setgħu kienu minħabba l-effetti sistemiċi ta' Tossina Botulinum ta' Tip B, kienu osservati fi 12% tal-każijiet ta' reazzjoni avversa tal-mediċina rrappurtati waqt l-esperjenza ta' wara t-tqegħid fis-suq (inkluż rreazzjonijiet avversi li ġejjin : ħalq xott, disfaġja u vista mċajpra).
English: Cases of overdose (some with signs of systemic toxicity) have been reported.
Maltese: Ġew irrapportati każi ta' doża eċċessiva (wħud b'sinjali ta' tossiċità sistemika).
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
Maltese: Tgħaqqid ekstraċellulari tat-tossina ma' aċċettaturi speċifiċi fuq it-terminali tan-nervi motorji Internalizzazzjoni u rilaxx tat-tossina fis-cytosol tat-terminali tan-nervaturi Inibizzjoni tar-rilaxx ta' acetylcholine minn terminali tan-nervaturi fil-junctions newromuskolari
English: There have been spontaneous reports of dysphagia, aspiration pneumonia and/or potentially fatal respiratory disease, after treatment with Botulinum Toxin Type A/B.
Maltese: Kien hemm rapporti spontanji ta' problemi biex tibla', pnewmonja tal-aspirazzjoni u/jew mard respiratorju potenzjalment fatali, wara l-kura b'Tossina Botulinum ta' Tip A/B.
English: Lack of interchangeability between botulinum toxin products The initial starting dose of 10,000 U (or 5000 U) is relevant only to NeuroBloc (Botulinum Toxin Type B).
Maltese: Nuqqas ta' interkambjabbiltà bejn prodotti ta' tossina ta' botulinum Id-doża tal-bidu ta' 10,000 U (jew 5000 U) hija relevanti biss għal NeuroBloc (Tossina Botulinum ta' Tip B).
English: It contains the active ingredient ‘Botulinum Toxin Type B'.
Maltese: Fih is-sustanza attiva ‘Tossina Botulinum ta' Tip B'.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkatafitsezzjoni 6.1.
English: Paediatric use (non approved): in children, clinically significant systemic toxicity has occurred at doses approved for the treatment of adult patients.
Maltese: L-użu pedjatriku (mhux approvat): fit-tfal, tossiċità sistemika klinikament sinifikanti seħħet f'dożi approvati għall-kura ta' pazjenti adulti.
English: NeuroBloc 5000 U/ml Solution for Injection Botulinum Toxin Type B
Maltese: NeuroBloc 5000 U/ml Soluzzjoni għall-injezzjoni Tossina Botulinum ta' Tip B
English: Individuals with known neuromuscular diseases (e.g. amyotrophic lateral sclerosis or peripheral neuropathy) or known neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome) must not be given NeuroBloc.
Maltese: Individwi b'mard newromuskolari magħruf (eż. sklerosi laterali amitrofika jew newropatija periferali) jew problemi magħrufa newromuskolari tal-ġogi (eż. myasthenia gravis jew sindromu Lambert-Eaton) m'għandhomx jingħataw NeuroBloc.
English: Keep this leaflet.
Maltese: Iċċaqlaqx bis-saħħa.
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).
Maltese: Rapporti dwar każijiet x'aktarx li se jkunu iktar serji fit-tfal (40%) meta mqabbla ma' dawk fl-adulti u anzjani (12%), possibbilment bħala riżultat li jintuża dożaġġ għoli mhux adattat għat-tifel/tifla.
English: The immunogenicity of NeuroBloc has been evaluated in two clinical studies and an open-label extension study.
Maltese: L-immunoġeniċità ta' NeuroBloc kienet evalwata f'żewġ studji kliniċi u studju open-label ta' estensjoni.
English: A further 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.
Maltese: Studju addizzjonali randomised, multicentre, u double-blind twettaq biex iqabbel l-effikaċja ta' NeuroBloc (10,000 U) ma' Tossina Botulinum ta' Tip A (150 U) f'pazjenti b'distonija ċervikali li qatt ma kienu rċevew minn qabel prodott b'botulinum toxin.