FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Priporočeni minimalni odmerek je 15 mg indoksakarba/kg telesne mase in 48 mg/kg permetrina, kar ustreza 0,1 ml kožnega nanosa na kg telesne mase.
English: Indoxacarb (mg)
Slovenian: Indoksakarb (mg)
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.
Slovenian: V zelo redkih primerih se pojavijo gastrointestinalni znaki (npr. bruhanje, diareja ali anoreksija (izguba apetita)), reverzibilni nevrološki znaki (npr. tremor (tresenje) ali ataksija (nestabilno gibanje) ali letargija (zaspanost) .
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).
Slovenian: Nasvet za veterinarje: Če se pojavijo klinični znaki zastrupitve (npr. preveliko izločanje sline, tremor, mišični krč) je za stabilizacijo vitalnih funkcij treba zagotoviti intravensko infuzijo elektrolitov.
English: Treatment of flea infestations (Ctenocephalides felis); the product has persistent insecticidal efficacy for up to 4 weeks against Ctenocephalides felis.
Slovenian: INDIKACIJA(E) Zdravljenje infestacije z bolhami (Ctenocephalides felis); zdravilo deluje insekticidno do 4 tedne na
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Slovenian: KOLIČINA UČINKOVIN(E)
English: VIRBAC BELGIUM NV, Esperantolaan 4, BE-3001 Leuven, Tél/Tel: + 32 (0) 16 38 72 60
Slovenian: België/Belgique/Belgien: VIRBAC BELGIUM NV, Esperantolaan 4, BE-3001 Leuven, Tél/Tel: + 32 (0) 16 38 72 60
English: The sachet is child-resistant.
Slovenian: Vrečka je varna za otroke.
English: Intervet International BV
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Intervet International BV
English: Volume of unit dose (ml)
Slovenian: Enkratni odmerek (ml)
English: METHOD AND ROUTE(S) OF ADMINISTRATION For spot-on use.
Slovenian: NAČIN IN POT(I) UPORABE Kožni nanos.
English: Indoxacarb + permethrin
Slovenian: Indoksakarb + permetrin
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)
Slovenian: Zelo majhni psi (1,2 - 5 kg) Majhni psi (5,1 - 10 kg) Srednje veliki psi (10,1 - 20 kg) Veliki psi (20,1 - 40 kg) Zelo veliki psi (40,1 - 60 kg)
English: Stored pipettes must be kept in the child-resistant sachet.
Slovenian: Merilne kapalke morate hraniti v vrečkah, ki so varne za otroke.
English: Sand flies
Slovenian: bolhe klopi peščene muhe
English: Ticks
Slovenian: Brejost
English: PHARMACOLOGICAL PROPERTIES
Slovenian: FARMAKOLOŠKE LASTNOSTI
English: One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) for up to 3 weeks.
Slovenian: Repelentno delovanje (preprečevanje hranjenja) proti peščenim muham traja do 3 tedne.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: 40.1 - 60 Extra large dogs
Slovenian: 20,1 - 40 veliki psi
English: One pipette delivers:
Slovenian: En enkratni odmerek v kapalki vsebuje:
English: For very small dogs (1.2 - 5 kg) For small dogs (5.1 - 10 kg) For medium dogs (10.1 - 20 kg) For large dogs (20.1 - 40 kg) For extra large dogs (40.1 - 60 kg)
Slovenian: Za zelo majhne pse (1,2 - 5 kg) Za majhne pse (5.1 - 10 kg) Za srednje velike pse (10,1 - 20 kg) Za velike pse (20,1 - 40 kg) Za zelo velike pse (40,1 - 60 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.
Slovenian: V zelo redkih primerih se pojavijo gastrointestinalni znaki (npr. bruhanje, diareja ali anoreksija), reverzibilni nevrološki znaki (npr. tremor ali ataksija) ali letargija.
English: Keep the used pipette out of sight and reach of children.
Slovenian: Uporabljena merilna kapalka naj ne bo v dosegu otrok.
English: Pyrethroids affect the voltage-gated sodium channels in vertebrates and non- vertebrates.
Slovenian: Piretroidi delujejo na napetostno občutljive natrijeve kanale pri vretenčarjih in nevretenčarjih.
English: Fertility: Do not use in breeding dogs.
Slovenian: Plodnost: Ne uporabljajte pri vzrejnih psih.
English: 1 pipette 4 pipettes 6 pipettes
Slovenian: VELIKOST PAKIRANJA 1 merilna kapalka 4 merilne kapalke 6 merilnih kapalk
English: Overdose
Slovenian: ZDRAVILA
English: Cardboard box of 1 pipette of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Slovenian: Kartonska škatla z 1 merilno kapalko po 0,5 ml, 1 ml, 2 ml, 4 ml ali 6 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Permethrin (mg/kg)
Slovenian: Permetrin (mg/kg)
English: Apply the product only to the skin surface and on intact skin.
Slovenian: Zdravilo je potrebno nanesti na suho in nepoškodovano kožo.
English: Lactation: Do not use in lactating dogs.
Slovenian: Laktacija: Ne uporabite pri psicah v obdobju laktacije.
English: Do not apply an excessive amount of solution at any one spot in order to prevent run-off. Should run-off occur, re-application is not necessary.
Slovenian: Ne nanašajte prevelike količine raztopine na eno mesto, de ne bi zdravilo teklo po dlaki živali.
English: 10.1 - 20 Medium dogs 20.1 - 40 Large dogs
Slovenian: 5,1 - 10 majhni psi 10,1 - 20 srednje veliki psi
English: EXP {month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP (mesec/leto)
English: SPECIAL WARNING(S), IF NECESSARY
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite navodilo za uporabo.
English: Pharmacotherapeutic group: Ectoparasiticides for topical use, incl.
Slovenian: Farmakoterapevtska skupina: Učinkovine proti ektoparazitom za lokalno zdravljenje, vključno z insekticidi; permetrin, kombinacije.
English: The major route of excretion is in faeces for indoxacarb and both in urine and faeces for permethrin.
Slovenian: V glavnem se metaboliti indoksakarba izločajo z blatom, metaboliti permetrina pa z urinom in s fecesom.
English: PACKAGE SIZE
Slovenian: Uporabljena velikost kapalk
English: 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
Slovenian: 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
English: Pregnancy:
Slovenian: Odmerjanje:
English: BATCH NUMBER
Slovenian: ŠTEVILKA SERIJE Serija {številka}
English: Keep pipettes in the original packaging until ready to use.
Slovenian: Merilne kapalke do uporabe shranjujte v originalni ovojnini.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Merilne kapalke shranjujte v originalni ovojnini do uporabe.
English: Activyl Tick Plus 75 mg + 240 mg for dogs 1.2 - 5 kg Activyl Tick Plus 150 mg + 480 mg for dogs 5.1 - 10 kg Activyl Tick Plus 300 mg + 960 mg for dogs 10.1 - 20 kg Activyl Tick Plus 600 mg + 1920 mg for dogs 20.1 - 40 kg Activyl Tick Plus 900 mg + 2880 mg for dogs 40.1 - 60 kg
Slovenian: Activyl Tick Plus 150 mg + 480 mg za pse 5,1 - 10 kg Activyl Tick Plus 300 mg + 960 mg,za pse 10,1 - 20 kg Activyl Tick Plus 600 mg + 1920 mg za pse 20,1 - 40 kg
English: Intravenous infusion of electrolytes should be provided to stabilize vital functions if clinical signs of poisoning occur (e.g. hypersalivation, tremor, muscle cramp).
Slovenian: Če se pojavijo klinični znaki zastrupitve (npr. povečano izločanje sline, tremor, mišični krč) je za stabilizacijo vitalnih funkcij treba zagotoviti intravensko infuzijo elektrolitov.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (pipette label)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
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)
Slovenian: Activyl Tick Plus 75 mg + 240 mg, kožni nanos, raztopina za zelo majhne pse (1,2 - 5 kg) Activyl Tick Plus 150 mg + 480 mg, kožni nanos, raztopina za majhne pse (5,1 - 10 kg) Activyl Tick Plus 300 mg + 960 mg, kožni nanos, raztopina za srednje velike pse (10,1 -20 kg) Activyl Tick Plus 600 mg + 1920 mg, kožni nanos, raztopina za velike pse (20,1 - 40 kg) Activyl Tick Plus 900 mg + 2880 mg, kožni nanos, raztopina za zelo velike pse (40,1 do 60 kg)
English: One unit-dose pipette holds 0.5 ml, 1 ml, 2 ml, 4 ml, or 6 ml spot-on solution.
Slovenian: Vsaka merilna kapalka z enim odmerkom vsebuje 0,5 ml, 1 ml, 2 ml, 4 ml ali 6 ml raztopine kožnega nanosa.
English: Cardboard box of 4 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Slovenian: Kartonska škatla s 4 merilnimi kapalkami po 0,5 ml, 1 ml, 2 ml, 4 ml ali 6 ml Kartonska škatla s 6 merilnimi kapalkami po 0,5 ml, 1 ml, 2 ml, 4 ml ali 6 ml
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
Slovenian: Activyl Tick Plus 75 mg + 240 mg kožni nanos, raztopina za zelo majhne pse Activyl Tick Plus 150 mg + 480 mg kožni nanos, raztopina za majhne pse Activyl Tick Plus 300 mg + 960 mg kožni nanos, raztopina za srednje velike pse Activyl Tick Plus 600 mg + 1920 mg kožni nanos, raztopina za velike pse Activyl Tick Plus 900 mg + 2880 mg kožni nanos, raztopina za zelo velike pse
English: PHARMACEUTICAL FORM
Slovenian: FARMACEVTSKI PODATKI
English: Do not use in pregnant dogs.
Slovenian: Ne uporabite pri psicah v obdobju brejosti.
English: For application to the dog's skin only.
Slovenian: Nanos na kožo.
English: Spot-on use.
Slovenian: Pot uporabe:
English: insecticides; permethrin, combinations.
Slovenian: FARMACEVTSKA OBLIKA Kožni nanos, raztopina.
English: It is important to ensure that the product is applied to an area where the dog cannot lick it off, and to ensure that other animals do not lick the treatment sites following application.
Slovenian: Zdravljeno žival je Dokler se mesto nanosa ne posuši je potrebno zdravljeno žival ločiti od preostalih živali.
English: Permethrin (mg)
Slovenian: Permetrin (mg)
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
English: Date of first authorisation: 22 January 2001 Date of latest renewal: 29 November 2010
Slovenian: Datum prve odobritve: 22. januar 2001 Datum zadnjega podaljšanja: 29. november 2010
English: The potential risk for humans is unknown.
Slovenian: Potencialno tveganje za ljudi ni znano.
English: n = 38 n = 39 n = 36 n = 36 n = 37
Slovenian: n = 38 n = 39 n = 36 n = 36
English: This can be due to the high dosages usually used in this population.
Slovenian: To je lahko posledica visokih odmerkov, ki se običajno uporabijo pri tej populaciji.
English: If this happens, do not drive or use any tools or machines.
Slovenian: Če se to zgodi, ne upravljajte vozil, orodja ali strojev.
English: Before having an operation
Slovenian: Pred operacijo
English: There were 77 subjects enrolled into the first study and 109 subjects into the second.
Slovenian: V prvi študiji je bilo vključenih 77 oseb, v drugi pa 109 oseb.
English: This means it is essentially “sodium free”.
Slovenian: To pomeni, da je v bistvu »brez natrija«.
English: You may need urgent medical treatment.
Slovenian: Mogoče boste potrebovali nujno medicinsko zdravljenje.
English: The risk of spreading of effect is greater than in adults, and more frequently severe.
Slovenian: Tveganje za širjenje učinka je večje in pogosto bolj resno kot pri odraslih.
English: Results of comparisons of the primary and secondary efficacy variables are summarised in Table 1.
Slovenian: Rezultati primerjanja primarnih in sekundarnih variabel učinkovitosti so povzeti v preglednici 1.
English: Other side effects include:
Slovenian: Med drugimi neželenimi učinki so:
English: The available reports indicate that the product has been used in the paediatric population.
Slovenian: Razpoložljiva poročila kažejo, da je bilo zdravilo uporabljeno pri pediatrični populaciji.
English: On these scales, scores of 50 indicate no change, 0 much worse, and 100 much better.
Slovenian: Na teh lestvicah je vrednost 50 pomenila, da ni bilo spremembe, 0 je bilo hudo poslabšanje, 100 pa veliko izboljšanje.
English: The dosing frequency should therefore be adapted based on the clinical assessment/response of an individual patient.
Slovenian: Zato je treba pogostnost odmerjanja prilagoditi na podlagi klinične ocene/odziva posameznega bolnika.
English: The risks, which can include death, may outweigh the potential benefits.
Slovenian: Tveganje, ki lahko vključuje smrt bolnika, je lahko večje od možnih koristi.
English: In these studies, the average dosing frequency was approximately every 12 weeks.
Slovenian: V teh študijah je bila povprečna pogostnost odmerjanja približno vsakih 12 tednov.
English: In the event of an overdose, general medical supportive measures should be instituted.
Slovenian: V primeru prevelikega odmerjanja morate uporabiti splošne zdravstvene podporne ukrepe.
English: This warning includes use in children and in any other indication besides cervical dystonia.
Slovenian: To opozorilo vključuje uporabo pri otrocih in vsako drugo indikacijo, razen cervikalne distonije.
English: Wear waterproof gloves and soak up the liquid with an appropriate absorbent.
Slovenian: Nosite nepremočljive rokavice in popivnajte tekočino z ustreznim absorbentom.
English: The frequency of these side effects is not known.
Slovenian: Pogostnost teh neželenih učinkov ni znana.
English: Intramuscular use.
Slovenian: Intramuskularna uporaba.
English: Injections should be repeated as required to maintain good function and minimise pain.
Slovenian: Injiciranje morate po potrebi tudi ponavljati, da bi zagotovili dobro delovanje in čim bolj zmanjšali bolečine.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: The following information is intended for healthcare professionals only: INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju: NAVODILA ZA PRIPRAVO IN RAVNANJE Z ZDRAVILOM IN ODLAGANJE
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.
Slovenian: Natančneje rečeno so te študije pokazale, da je približno 19-25 % bolnikov serokonvertiralo v 18 mesecih po uvedbi zdravljenja, ta delež pa se je do 45. meseca zdravljenja zvečal na približno 33-44 %.
English: General precaution:
Slovenian: Splošni previdnostni ukrepi:
English: Very Common
Slovenian: Zelo pogosti
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}> Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}> Drugi viri informacij
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).
Slovenian: Večja verjetnost je, da so poročila o primerih resnejša pri otrocih (40 %) v primerjavi z odraslimi in starejšimi ljudmi (12 %), kar je morda posledica uporabe neprimerno/neustrezno visokega odmerka pri otrocih (glejte poglavje 4.9).
English: You may feel pain at the place where you had the injection, but this should wear off after a few minutes.
Slovenian: Morda boste čutili bolečino na mestu injiciranja, vendar bi ta po nekaj minutah morala prenehati.
English: These include dysphagia and breathing difficulties.
Slovenian: To vključuje disfagijo in težave z dihanjem.
English: They may happen days to weeks after you have had the injection.
Slovenian: Lahko se pojavijo več dni do več tednov po injekciji.
English: Cases of overdose (some with signs of systemic toxicity) have been reported.
Slovenian: Poročali so o primerih prevelikega odmerjanja (nekaterih z znaki sistemske toksičnosti).
English: However, the pharmacological characteristics do not indicate any need to adjust the dose.
Slovenian: Vendar farmakološke lastnosti ne kažejo na to, da bi morali odmerek prilagajati.
English: The dose resulting in death was 2400 U/kg.
Slovenian: Smrtni odmerek je bil 2400 E/kg.
English: The medicinal product is ready to use and no reconstitution is required.
Slovenian: Zdravilo je pripravljeno za uporabo in rekonstitucija ni potrebna.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: As with other botulinum toxins spontaneous recovery will occur over a period of time.
Slovenian: Kot pri drugih botulinskih toksinih čez čas pride do spontanega okrevanja.
English: In rare cases difficulty in swallowing may be severe and choking is possible.
Slovenian: V redkih primerih so lahko težave s požiranjem hude in možno je dušenje.
English: The safety and efficacy of NeuroBloc in children aged less than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila NeuroBloc pri otrocih, mlajših od 18 let, še nista dokazani.
English: Spread of toxin effect
Slovenian: Širjenje delovanja toksina
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.
Slovenian: Raziskava posledic serokonverzije je pokazala, da prisotnost protiteles ni obvezno pomenila izgube kliničnega odziva in ni vplivala na celoviti varnostni profil.
English: Animal reproduction studies are insufficient with respect to effects on pregnancy and embryonal/foetal development.
Slovenian: Študije o vplivu na razmnoževanje pri živalih ne zadoščajo za oceno učinkov na nosečnost in razvoj embrija/ploda.
English: The safety of NeuroBloc outside the approved indication has not been established.
Slovenian: Varnost zdravila NeuroBloc zunaj odobrene indikacije ni bila dokazana.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Slovenian: KLINIČNI PODATKI 4.1 Terapevtske indikacije
English: TWSTRS-Total
Slovenian: TWSTRS - Skupno
English: If you are going to have an operation, please tell your doctor that you have been given NeuroBloc.
Slovenian: Če boste imeli operacijo, povejte svojemu zdravniku, da ste prejeli zdravilo NeuroBloc.
English: Seroconversion
Slovenian: Serokonverzija
English: If you think that the effect of NeuroBloc is too strong or too weak, talk to your doctor.
Slovenian: Če menite, da je učinek zdravila NeuroBloc premočan ali prešibak, se posvetujte z zdravnikom.
English: Store in a refrigerator (2°C-8°C).
Slovenian: Shranjujte v hladilniku (2 °C-8 °C).
English: However, no pharmacokinetic or Absorption, Distribution, Metabolism and Excretion (ADME) studies have been performed.
Slovenian: Vendar niso bile opravljene nikakršne farmakokinetične študije ali študije absorpcije, porazdelitve, presnove in izločanja (ADME - Absorption, Distribution, Metabolism and Excretion).
English: Restricted to hospital use only.
Slovenian: Dovoljeno samo za uporabo v bolnišnici.
English: The systemic No Observed Effect Level (NOEL) was shown to be approximately 960 U/kg.
Slovenian: Sistemska raven brez vidnega učinka (NOEL - No Observed Effect Level) je bila približno 960 E/kg.
English: SPECIAL WARNINGS THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: Pharmacotherapeutic group: muscle relaxant, peripherally acting agents, ATC code: M03AX 01.
Slovenian: Farmakoterapevtska skupina: mišični relaksanti s perifernim delovanjem, oznaka ATC: M03AX 01.
English: Data from clinical studies suggest that efficacy is dose dependent, but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U. Therefore an initial dose of 5000 U may also be considered, but a dose of 10,000 U may increase the likelihood of clinical benefit.
Slovenian: Podatki iz kliničnih študij kažejo, da je učinkovitost odvisna od odmerka, vendar ta preskušanja, ker niso bila primerjalna, ne kažejo signifikantne razlike med odmerkoma s 5.000 E in 10.000 E. Zato lahko pretehtate uporabo začetnega odmerka s 5.000 E, čeprav lahko odmerek z 10.000 E poveča verjetnost ugodnega kliničnega učinka.
English: Patient evaluations continued for 16 weeks post injection.
Slovenian: Bolnike so ocenjevali še 16 tednov po injiciranju.
English: Recovery usually takes place over a period of time.
Slovenian: Stanje se navadno sčasoma izboljša.
English: Placebo 10,000 U Placebo 5000 U 10,000 U
Slovenian: ocene placebo 10.000 E placebo 5.000 E 10.000 E
English: Paediatric use (non approved): in children, clinically significant systemic toxicity has occurred at doses approved for the treatment of adult patients.
Slovenian: Pediatrična uporaba (neodobrena uporaba): pri otrocih se je pri odmerkih, odobrenih za zdravljenje odraslih bolnikov, pojavila klinično pomembna sistemska toksičnost.
English: If he/she is unavailable seek emergency assistance.
Slovenian: Če ni dosegljiv, poiščite nujno medicinsko pomoč.
English: At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Slovenian: Po koncu tega obdobja zdravila ne smete spraviti nazaj v hladilnik, ampak ga morate zavreči.
English: The immunogenicity of NeuroBloc has been evaluated in two clinical studies and an open-label extension study.
Slovenian: Imunogenost zdravila NeuroBloc so ocenili v dveh kliničnih študijah in odprti podaljšani študiji.
English: This is because swallowing problems could make you breathe food or liquids into your lungs, which could then cause very serious pneumonia
Slovenian: Zaradi težav s požiranjem bi namreč lahko vdihnili hrano ali tekočine v pljuča, kar bi lahko potem povzročilo zelo resno pljučnico.
English: Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults.
Slovenian: Odmerki do 15.000 E so pri odraslih redko povzročili klinično značilno sistemsko toksičnost.