FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, it was considered difficult to ascertain whether the clinical signs observed indicative of toxicity may be due to the ivermectin and/or the closantel components of the combination product Closamectin Pour-On.
Slovenian: Zato je bilo ocenjeno, da je težko ugotoviti, ali so opaženi klinični znaki, ki nakazujejo toksičnost, pri kombiniranem zdravilu Closamectin Pour-On posledica ivermektina in/ali klozantela.
English: Additional diagnostic analyses, including blood samples (including biochemistry and micronutrient analyses) and faecal analysis, should be conducted in the affected animals ensuring that all samples are handled appropriately to avoid the introduction of any bias into analyses.
Slovenian: Pri prizadetih živalih bi morali opraviti dodatne diagnostične analize, vključno z analizami vzorcev krvi (vključno z biokemičnimi analizami in analizami vsebnosti mikrohranil) in blata, in pri tem zagotoviti ustrezno ravnanje z vzorci, da bi preprečili izkrivljanje rezultatov analiz.
English: The nature of the adverse events were indicative of the clinical signs associated with overdose toxicity of closantel although it was noted that in general affected animals were reported to have been treated according to the recommended dose.
Slovenian: Narava neželenih dogodkov je kazala na klinične znake, povezane toksičnimi učinki prekomernega odmerka klozantela, čeprav je bilo ugotovljeno, da naj bi bile živali v splošnem zdravljene v skladu s priporočenimi odmerki.
English: Pre-marketing studies tended to suggest that both combined ivermectin/closantel and closantel only formulations were well tolerated in cattle at doses up to 3 times the recommended posology, even in case of repeated administration.
Slovenian: Študije pred dajanjem na trg so nakazovale, da je govedo dobro prenašalo formulacije, ki so vsebovale ivermektin in klozantel, in tudi formulacije, ki so vsebovale zgolj klozantel, in sicer v odmerkih, ki so bili do trikrat večji od priporočenih, tudi kadar je šlo za ponavljajoče se odmerke.
English: As an indirect benefit, it is noted that pour-on products are often preferred over injectable products due to the ease of administration.
Slovenian: Ugotovljena posredna korist je, da se zaradi lažjega dajanja zdravilom v obliki kožnega poliva pogosto daje prednost pred zdravili za injiciranje.
English: The CVMP considered the additional data relating to the adverse event reports provided by the MAH to investigate potential risk factors associated with the adverse events in animals and possible explanations for the higher incidence of fatal adverse events reported in France compared with other EU Member States.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je pretehtal dodatne podatke v zvezi s poročili o neželenih dogodkih, ki jih je predložil imetnik dovoljenja za promet z zdravilom, da bi preučil možne dejavnike tveganja, povezane z neželenimi dogodki pri živalih, ter možna pojasnila za večjo pojavnost neželenih dogodkov, ki so se končali s poginom, v Franciji v primerjavi z drugimi državami članicami EU.
English: Even though the overall incidence of adverse events is very rare, it has been noted that, when there is an adverse event in a herd, several animals may be affected.
Slovenian: Čeprav je skupna pojavnost neželenih dogodkov zelo redka, je bilo ugotovljeno, da je lahko ob pojavu neželenega dogodka v čredi prizadetih več živali.
English: the CVMP has recommended lifting of the suspension of the marketing authorisation for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS in France; variations of the marketing authorisations for Closamectin Pour-On Solution and associated names as referred in Annex I in order to amend the summary of product characteristics and package leaflet in line with recommended changes in the product information as set out in Annex III; and conditions of the marketing authorisations as set out in Annex IV.
Slovenian: je odbor CVMP priporočil preklic začasnega umika dovoljenja za promet z zdravilom CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS v Franciji, spremembo dovoljenja za promet z zdravilom za zdravilo Closamectin Pour-On Solution in povezana imena, ki so navedena v Prilogi I, da bi tako dopolnili povzetek glavnih značilnosti zdravila in navodil za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, navedenimi v Prilogi III, ter pogoje dovoljenj za promet z zdravilom, kot so navedeni v Prilogi IV.
English: Grounds for lifting of the suspension of the marketing authorisation for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS in France and amendment of the summary of product characteristics and package leaflet
Slovenian: Razlogi za preklic začasnega umika dovoljenja za promet z zdravilom CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS v Franciji in dopolnilo povzetka glavnih značilnosti zdravila in navodila za uporabo
English: The amendments to the product information were supported as these were considered to improve the information on adverse events, reinforce surveillance in herds where adverse events occur, in light of the pharmacovigilance experience to date, and introduce precautions for treatment of animals with low nutritional status.
Slovenian: Dopolnila informacij o zdravilu so bila odobrena, saj je bilo ocenjeno, da se bodo s tem izboljšale informacije o neželenih dogodkih, okrepil nadzor v čredah, v katerih prihaja do neželenih dogodkov, ob upoštevanju dosedanjih farmakovigilančnih izkušenj, in uvedli previdnostni ukrepi za zdravljenje živali s slabim stanjem prehranjenosti.
English: Other veterinary medicinal products with the same qualitative and quantitative composition which belong to the same marketing authorisation holder (MAH), Norbrook Laboratories Ltd, are also authorised under two other DCP and three national procedures, as follows:
Slovenian: Na podlagi dveh drugih decentraliziranih postopkov in treh nacionalnih postopkov so za uporabo odobrena so tudi druga zdravila za uporabo v veterinarski medicini z isto kakovostno in količinsko sestavo istega imetnika dovoljenja za promet z zdravilom, družbe Norbrook Laboratories Ltd, in sicer:
English: SPC section 4.5 Special precautions for use: Special precautions for use in animals:
Slovenian: Povzetek glavnih značilnosti zdravila, poglavje 4.5 - Posebni previdnostni ukrepi: Posebni previdnostni ukrepi za uporabo pri živalih:
English: SPC section 4.6 Adverse reactions (Frequency and Seriousness)
Slovenian: Povzetek glavnih značilnosti zdravila, poglavje 4.6 - Neželeni učinki (pogostnost in resnost)
English: Summary of Product Characteristics
Slovenian: Povzetek glavnih znaèilnosti zdravila
English: Measures to mitigate the risk of adverse events following use of the product have been proposed.
Slovenian: Predlagani so bili ukrepi za zmanjševanje tveganja pojava neželenih dogodkov po uporabi zdravila.
English: The CVMP considered the clinical profile of injectable and pour-on combined formulations to be comparable, except for signs of blindness/impaired vision (reported only with the pour-on products) and application site and respiratory signs (reported only with the injectable product).
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je menil, da sta klinična profila formulacij za injiciranje in za kožni poliv primerljiva, razen za znake slepote/okvare vida (o njih so poročali le pri zdravilih za kožni poliv) ter za znake reakcij na mestu injiciranja in respiratorne znake (o teh so poročali le pri zdravilu za injiciranje).
English: The adverse events principally related to neurological signs (ataxia, recumbency, paresis/paralysis and blindness) and/or gastrointestinal disorders (diarrhoea, anorexia etc.) some of which had a fatal outcome.
Slovenian: Neželeni dogodki so se v glavnem nanašali na nevrološke znake (ataksijo, nezmožnost vstajanja, parezo/paralizo in slepoto) in/ali bolezni prebavil (diarejo, anoreksijo itd.); nekateri so se končali s poginom.
English: The principal risks associated with the product relate to the potential for adverse events involving neurological signs (ataxia, recumbency, paresis/paralysis and blindness) and/or gastrointestinal disorders (diarrhoea, anorexia etc.) in treated animals some of which have been fatal.
Slovenian: Glavna tveganja, povezana z zdravilom, zadevajo možnost neželenih dogodkov, ki vključujejo nevrološke znake (ataksijo, nezmožnost vstajanja, parezo/paralizo in slepoto) in/ali bolezni prebavil (diarejo, anoreksijo itd.) pri zdravljenih živalih, pri čemer so se nekateri primeri končali s poginom.
English: The nature of the reported clinical signs was considered by ANMV to be indicative of the clinical signs associated with overdose toxicity of closantel.
Slovenian: Agencija ANMV je menila, da narava kliničnih znakov, o katerih so poročali, kaže na klinične znake, povezane s toksičnim učinkom prevelikega odmerka klozantela.
English: The Committee considered the measures proposed by the MAH to mitigate the risk of adverse events following use of the product, which included changes to the product information detailed below.
Slovenian: Odbor je preučil ukrepe, ki jih je za zmanjšanje tveganja neželenih dogodkov po uporabi zdravila predlagal imetnik dovoljenja za promet z zdravilom in ki so vsebovali spremembe informacij o zdravilu, navedene spodaj.
English: Amendments in the relevant sections of the summary of product characteristics and package leaflet
Slovenian: Popravki zadevnih poglavij povzetka glavnih znaèilnosti zdravila in navodila za uporabo
English: The CVMP considered the clinical signs in the reported adverse events were similar to those observed with closantel overdose toxicity, although this could not be confirmed definitively as post-mortems were not conducted for all fatal events.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je menil, da so bili klinični znaki, opaženi pri neželenih dogodkih, o katerih so poročali, podobni kliničnim znakom, ugotovljenim pri toksičnosti zaradi prevelikega odmerka klozantela, čeprav tega ni bilo mogoče potrditi, saj obdukcije niso bile opravljene pri vseh poginih.
English: Additionally the MAH proposed to implement a risk management plan comprising submission of annual ‘combined' PSUR reports for the products concerning Closamectin Pour-On Solution and associated names (as detailed in Annex I of the Opinion); detailed investigation of future pharmacovigilance reports which should include data collection from treated un-affected animals within the same herd (including farm history and herd health status, assessment of animal health and nutritional status involving biochemistry and micronutrient analysis; investigation of potential closantel toxicity (via blood plasma sampling and post-mortem examinations); and ‘education, training and guidance' for end-users to ensure that the risks of the products and the precautions for use are fully understood.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom predlagal izvajanje načrta za zmanjšanje tveganj, ki zajema predložitev letnega skupnega redno posodobljenega poročila o varnosti zdravila v zvezi z zdravilom Closamectin Pour-On Solution in povezanimi imeni (kot je navedeno v Prilogi I mnenja), podrobno proučitev prihodnjih farmakovigilančnih poročil, ki bi morala vključevati zbiranje podatkov o zdravljenih neprizadetih živalih iz iste črede (vključno s preteklimi dogodki na kmetiji in zdravstvenim stanjem črede ter oceno zdravja živali in njihovega stanja prehranjenosti, ki bi vključevala biokemične analize in analize vsebnosti mikrohranil), preiskavo morebitne toksičnosti klozantela (z vzorčenjem krvne plazme in obdukcijami) ter izobraževanje, usposabljanje in usmerjanje končnih uporabnikov, da bi ti povsem razumeli tveganja, povezana z zdravili, in previdnostne ukrepe za uporabo zdravila.
English: The product is effective for use in cattle for the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice.
Slovenian: Zdravilo je učinkovito pri uporabi pri govedu za zdravljenje mešanih infestacij, ki jih povzročajo metljaji in nematodi ali artropodi, z glistami, pljučnimi črvi, očesnimi črvi, ličinkami zolja, garjami in ušmi.
English: Strength Pharmaceutical form Animal species
Slovenian: Farmacevtska oblika
English: Although the underlying mechanism for the adverse events has not yet been determined, the benefitrisk balance of Closamectin Pour-On Solution and associated names was considered favourable subject to amendments to product information and implementation of additional risk mitigation and surveillance measures to provide annual ‘combined' PSURs, further investigate adverse events reported in future and provide ‘education, training and guidance' to end-users to improve understanding related to the risks of the products and the precautions for use.
Slovenian: Čeprav osnovni mehanizem za pojav neželenih dogodkov še ni bil opredeljen, je bilo razmerje med tveganji in koristmi za zdravilo Closamectin Pour-On Solution in povezana imena ocenjeno kot ugodno, če se upoštevajo dopolnila informacij o zdravilu in izvajanje dodatnih ukrepov za zmanjševanje tveganja in nadzor, katerih namen je zagotoviti letna skupna redno posodobljena poročila, nadalje raziskati neželene dogodke, ki bodo predmet poročil v prihodnosti, ter zagotoviti izobraževanje, usposabljanje in usmerjanje končnih uporabnikov, da bi izboljšali njihovo razumevanje tveganj, povezanih z zdravilom, in previdnostnih ukrepov za uporabo zdravila.
English: It was hypothesised that licking behaviour may contribute to the overexposure leading to closantel toxicity in some of the animals observed where the correct dose had been applied although this has not been confirmed definitively.
Slovenian: Domneva se, da bi k prekomerni izpostavljenosti, ki je vodila k toksičnim učinkom klozantela pri nekaterih živalih, ki so sicer prejele pravilen odmerek, lahko prispevalo lizanje, čeprav tega ni bilo mogoče dokončno potrditi.
English: The products are effective for use in beef cattle for the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice.
Slovenian: Ta zdravila so učinkovita pri uporabi pri govedu, ki se vzreja za meso, in sicer za zdravljenje mešanih infestacij, ki jih povzročajo metljaji in nematodi ali artropodi, z glistami, pljučnimi črvi, očesnimi črvi, ličinkami zolja, garjami in ušmi.
English: • Vermax Pour-On 5mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italy).
Slovenian: • Vermax Pour-On 5 mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italija).
English: The CVMP also considered a risk management plan proposed by the MAH detailing annual PSUR reporting for Closamectin Pour-On Solution and associated names, further detailed investigation of pharmacovigilance reports (including collection of data on treated un-affected animals within the same herd) and a proposal for ‘education, training and guidance' of end users to ensure that the risks of the products and the precautions for use are fully understood.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini je prav tako preučil načrt obvladovanja tveganj, ki ga je predložil imetnik dovoljenja za promet z zdravilom, v katerem so bili opredeljeni letno redno posodobljeno poročilo o varnosti zdravila Closamectin Pour-On Solution in povezanih imen, nadaljnje podrobne preiskave farmakovigilančnih poročil (vključno z zbiranjem podatkov o zdravljenih neprizadetih živalih v isti čredi) ter predlog za izobraževanje, usposabljanje in usmerjanje končnih uporabnikov, da bi ti povsem razumeli tveganja, povezana z zdravilom, in previdnostne ukrepe za uporabo.
English: This included a review of scientific literature regarding the pharmacology and toxicology of ivermectin and closantel, cumulative pharmacovigilance experience following use of the products in the European Union (EU) since 2009, a comparison with ivermectin-based products and with ivermectin/closantel injectable formulations held by the MAH, investigations carried out by the MAH to identify possible factors involved in reported adverse events and proposals for risk mitigation measures and actions.
Slovenian: Da bi Odbor za zdravila za uporabo v veterinarski medicini (CVMP) raziskal morebitno povezavo med opaženimi neželenimi dogodki ter zdravilom Closamectin Pour-On Solution in povezanimi imeni, je preučil podatke, ki jih je zagotovil imetnik dovoljenja za promet z zdravilom, družba Norbrook Laboratories Ltd. Ti so vključevali pregled znanstvene literature glede farmakoloških in toksikoloških značilnosti ivermektina in klozantela, skupne farmakovigilančne izkušnje, ki izhajajo iz uporabe teh zdravil v Evropski uniji od leta 2009, primerjavo z zdravili, ki temeljijo na ivermektinu, in s formulacijami ivermektina/klozantela za injiciranje, ki jih proizvaja imetnik dovoljenja za promet z zdravilom, preiskave, ki jih je izvedel imetnik dovoljenja za promet z zdravilom, da bi opredelil morebitne dejavnike, ki so vplivali na neželene dogodke, o katerih so poročali, ter predloge za ukrepe za zmanjšanje tveganja.
English: ADVERSE REACTIONS
Slovenian: 6 Neželeni učinki
English: Sweden Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Slovenian: Švedska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
English: Germany Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Slovenian: Nemčija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
English: Romania Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Slovenian: Romunija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
English: Slovakia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Slovenian: Slovaška Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
English: Slovenia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Slovenian: Slovenija Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
English: Belgium Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Slovenian: Portugalska Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska
English: The detailed results of investigations of adverse events and their analysis should be included in each PSUR.
Slovenian: Vsako redno posodobljeno poročilo o varnosti zdravila bi moralo zajemati podrobne rezultate preiskav neželenih dogodkov.
English: The reactions may last longer.
Slovenian: Neželeni učinki lahko vztrajajo dlje časa.
English: Date of first authorisation: 18/02/2011 Date of last renewal: 02/12/2015
Slovenian: Datum pridobitve dovoljenja za promet: 18/02/2011 Datum podaljšanja dovoljenja za promet: 02/12/2015
English: ATC vet code:QI06AD08.
Slovenian: Oznaka ATC vet: QI06AD08
English: Apply usual aseptic procedures.
Slovenian: Držite se običajnih načel asepse.
English: Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Slovenian: Zelo redko se lahko pojavi preobčutljivostna reakcija, ki jo je treba ustrezno simptomatično zdraviti.
English: Pharmacotherapeutic group: Other immunologicals for cats.
Slovenian: Farmakoterapevtska skupina: Druga imunološka zdravila za mačke.
English: EXP (month/year)
Slovenian: EXP {mesec/leto}
English: Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections
Slovenian: Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dihidrat Magnezijev klorid heksahidrat Kalcijev klorid dihidrat Voda za injiciranje
English: Travel to countries requiring a rabies serology test: experience has shown that some vaccinated animals, while protected, may not show the 0.5 IU/ml antibody titre required by some countries.
Slovenian: Potovanje v države, ki zahtevajo serološko testiranje: Izkušnje so pokazale, da nekatere cepljene živali, čeprav so zaščitene, nimajo titra protiteles večjega od 0,5 IE/ml, kakršna je zahteva nekaterih držav.
English: Special precautions for use in animals: Vaccinate healthy animals only.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Cepite le zdrave živali.
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 LYON FRANCE
Slovenian: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
English: Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap.
Slovenian: Viala iz stekla tipa I z butil elastomerno zaporko, zapečateno z aluminijastim pokrovčkom.
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCE
Slovenian: Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCIJA
English: In very rare cases, transient and slight apathy may occur, as well as mild anorexia or hyperthermia (above 39.5 °C), usually lasting 1 or 2 days.
Slovenian: V zelo redkih primerih se lahko pojavi blaga in prehodna apatija, pa tudi blaga anoreksija in povišana temperatura (nad 39,5 °C), ki običajno trajajo 1 do 2 dni.
English: Light pink to pale yellow homogeneous suspension
Slovenian: Svetlo rožnata do bledo rumena homogena suspenzija
English: Canarypox recombinants are known to be safe for humans.
Slovenian: Rekombinantni poxvirus kanarčkov je varen za ljudi.
English: Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily.
Slovenian: Občasno se lahko pojavijo blage prehodne lokalne in/ali sistemske reakcije povezane z injekcijo.
English: Manufacturer responsible for batch release: MERIAL
Slovenian: Izdelovalec, odgovoren za sprostitev serije: MERIAL
English: The best time for a blood sample to be taken is around 28 days after vaccination.
Slovenian: Najprimernejši čas odvzema krvi za določanje titra protiteles je 28 dni po cepljenju.
English: Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
Slovenian: Aktivna imunizacija mačk, starih 12 tednov ali več, proti steklini za zaščito pred smrtnostjo zaradi okužbe z virusom stekline.
English: Do not mix with any other veterinary medicinal product, except those mentioned in section 4.8.
Slovenian: Ne mešajte z nobenim drugim zdravilom razen s cepivi, navedenimi v poglavju 4.8.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, po EXP, navedenega na ovojnini.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with MERIAL non-adjuvanted vaccines containing various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da je cepivo varno mešati in dajati z MERIALovimi neadjuviranimi cepivi za mačke (več kombinacij mačjih cepiv s komponentami proti virusnemu rinotraheitisu, kalicivirozi, panlevkopenji in klamidiozi).
English: A transient local reaction may very rarely occur (pain at palpation, limited swelling that may become nodular, heat at the injection site, and in some cases erythema), that usually disappears within 1 or 2 weeks at most.
Slovenian: Na mestu injiciranja se lahko v zelo redkih primerih pojavi prehodna lokalna reakcija (bolečina ob palpaciji, omejena oteklina, lahko kot manjši vozlič, toplota na mestu vboda in v nekaterih primerih eritem), ki običajno izgine v enem do dveh tednih.
English: After inoculation, the virus expresses the protective protein, but does not replicate in the cat.
Slovenian: Po inokulaciji virus izloča zaščitne proteine, a se v mački ne množi.
English: Disposal: Read package leaflet.
Slovenian: Odstranjevanje: Preberite navodilo za uporabo.
English: The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of rabies virus.
Slovenian: Cepni sev vCP65 je rekombinantni poxvirus kanarčkov, ki izraža glikoprotein G gen virusa stekline.