FrancophonIA/ELRC3.0 huggingface dataset:
English: It was recommended that additional data be collected for the adverse events occurring in future to determine the potential role of the products, including potential closantel toxicity, and also investigate potential risk factors associated with the adverse events reported following treatment.
Bulgarian: Insamling av ytterligare data rekommenderades för de oönskade händelser som inträffar i framtiden för att bestämma produkternas potentiella roll, däribland potentiell klosanteltoxicitet, liksom för att undersöka potentiella riskfaktorer förknippade med de oönskade händelser
English: Special precautions for use in animals:
Bulgarian: Särskilda försiktighetsåtgärder för djur
English: • Closivet Solución Pour-On (Spain); and
Bulgarian: Closivet Solución Pour-On (Spanien)
English: − intensified data collection relating to pharmacovigilance reports; and
Bulgarian: − Intensifierad datainsamling gällande säkerhetsövervakningsrapporter.
English: Whereas:
Bulgarian: Skälen är som följer:
English: It was also noted that the overall adverse reaction incidence was slightly higher for the injectable combination product when compared to the pour-on products; with, on average, a higher number of animals involved in each report although the reported mortality incidence was lower.
Bulgarian: injicerbara kombinationsläkemedlet jämfört med pour-on läkemedel, med ett i genomsnitt större antal djur i varje rapport, även om den rapporterade mortaliteten var lägre.
English: In addition to the pharmacovigilance data provided by the MAH, where available, results of the diagnostic tests (e.g. blood tests and post-mortem examinations etc.) to investigate the adverse events were also provided.
Bulgarian: Utöver säkerhetsövervakningsuppgifterna från innehavaren av godkännande för försäljning tillhandahölls även, i förekommande fall, resultat av de diagnostiska undersökningarna (t.ex. blodprov och besiktning efter slakt osv.) för att granska de oönskade händelserna.
English: Measures to mitigate the risk of adverse events following use of the product have been proposed.
Bulgarian: Åtgärder har föreslagits för att minska risken för oönskade händelser efter läkemedlets användning.
English: The detailed results of investigations of adverse events and their analysis should be included in each PSUR.
Bulgarian: De utförliga resultaten av undersökningarna av oönskade händelser och deras analys ska ingå
English: A single risk management plan should be presented covering all products included within the scope of this procedure.
Bulgarian: ska läggas fram som tar upp alla ingående läkemedel inom tillämpningsområdet för detta förfarande.
English: It was also proposed to provide ‘education, training and guidance' to end-users to improve understanding related to the risks of the products and the precautions for use.
Bulgarian: Man föreslog även att slutanvändare tillhandahålls ”utbildning och vägledning” för att förbättra förståelsen av läkemedlens risker och försiktighetsåtgärderna vid användning.
English: However further investigations were considered necessary to confirm or refute nutritional status and specific micro-nutrient deficiencies as risk factors for the adverse effects observed in animals following use of Closamectin Pour-on Solution and associated names.
Bulgarian: tillbakavisa att näringsstatus och brist på specifika mikronäringsämnen är riskfaktorer för de oönskade händelser som setts hos djur efter användning av Closamectin Pour-On lösning och associerade namn.
English: Strength Pharmaceutical form Animal species
Bulgarian: Läkemedelsform Djurslag Administreringsväg
English: Marketing authorisation holder
Bulgarian: Innehavare av godkännande för försäljning
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.
Bulgarian: De främsta riskerna förknippade med läkemedlet gäller potentialen för oönskade händelser, däribland neurologiska tecken (ataxi, att djuret ligger ned, pares/paralys och blindhet) och/eller magtarmproblem (diarré, anorexi osv.) hos behandlade djur av vilka somliga har varit fatala.
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.
Bulgarian: Ytterligare diagnostiska analyser, däribland blodprov (inräknat biokemisk analys och analys av mikronäringsämnen) samt avföringsanalys, bör utföras på de påverkade djuren
English: • Closivet Pour-On Solution for Cattle (Ireland);
Bulgarian: Closivet Pour-On Solution for Cattle (Irland)
English: Additionally, observations made on the consequences of licking/grooming behaviour suggested that the maximal dose administered orally did not seem to produce any adverse effect.
Bulgarian: Observationer av följderna av slickning/ansning (grooming) visade dessutom att den högsta dosen som tillfördes oralt
English: Closantel is an alternative flukicide to triclabendazole to which resistance is emerging.
Bulgarian: Klosantel är en alternativ flukicid till triklabendazol
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.
Bulgarian: Läkemedlet har effekt vid användning till nötkreatur för behandling av blandade angrepp med trematod (sugmask) och nematod eller artropod på grund av rundmaskar, lungmaskar, ögonmaskar, nötstyng, kvalster och lus.
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.
Bulgarian: De oönskade händelserna gällde främst neurologiska tecken (ataxi, att djuret ligger ned, pares/paralys och blindhet) och/eller magtarmproblem (diarré, anorexi osv.) av vilka somliga var fatala.
English: France
Bulgarian: Frankrike
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.
Bulgarian: CVMP fann att de kliniska tecknen i de rapporterade oönskade händelserna liknade de som setts vid överdoseringstoxicitet för klosantel, även om detta inte kunde bekräftas definitivt eftersom besiktning efter slakt inte utfördes för alla fatala händelser. Man noterade att läkemedlet i allmänhet rapporterades ha tillförts vid den rekommenderade dosen.
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.
Bulgarian: ANMV ansåg att de rapporterade kliniska tecknen var av en sort som var typisk för kliniska tecken förknippade med överdoseringstoxicitet av klosantel.
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.
Bulgarian: som föreslogs av innehavaren av godkännande för försäljning för att minimera risken för oönskade händelser efter läkemedlets användning, däribland ändringar av produktinformationen enligt nedanstående beskrivning.
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.
Bulgarian: till klosanteltoxicitet hos vissa av de observerade djuren där korrekt dos hade applicerats, även om detta inte definitivt bekräftats.
English: Closamectin Pour-On Solution and associated names is authorised in several EU Member States.
Bulgarian: Closamectin Pour-On lösning och associerade namn är godkänt
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.
Bulgarian: Även om den bakomliggande mekanismen för de oönskade händelserna ännu inte är fastställd, ansågs nytta-riskförhållandet för Closamectin Pour-On lösning och associerade namn vara gynnsamt förutsatt att ändringar införs i produktinformationen och att kompletterande riskreducerande och övervakande åtgärder utförs för att
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.
Bulgarian: i EU sedan 2009, en jämförelse med ivermektin-baserade läkemedel och med injicerbara formuleringar av ivermektin/klosantel som tillhör innehavaren av godkännande för försäljning, undersökningar utförda av innehavaren av godkännande för försäljning för att fastställa eventuella ingående faktorer i rapporterade oönskade händelser samt förslag om riskreducerande åtgärder och insatser.
English: Package leaflet:
Bulgarian: Bipacksedel:
English: Although the pharmacovigilance reports indicated potential closantel toxicity as an underlying cause, it was noted that reports of neurological events (including a case of blindness) and diarrhoea occurred with the ivermectin-only formulations.
Bulgarian: som bakomliggande orsak, konstaterades det att neurologiska händelser (inräknat ett fall av blindhet) och diarré rapporterades med de beredningar
English: Additional investigations were initiated in animals affected in 2015, involving monitoring vitamins A, E and selenium blood levels in samples from both affected and unaffected animals.
Bulgarian: inga bevis som stödjer denna hypotes. Ytterligare undersökningar inleddes på djur som påverkats under 2015, med övervakning av halterna av vitamin A, E och selen i blodprov från både påverkade och opåverkade djur. CVMP ansåg att dessa brister och en allmän låg näringsstatus var potentiella faktorer förknippade med de oönskade händelser
English: The detailed results of these analyses should be reported at regular intervals with every PSUR submission and immediately in case of any significant finding or upon request.
Bulgarian: Information bör även samlas in om den påverkade besättningen och djurhållningssystemet i stort, inräknat besättningens hälsostatus. De utförliga resultaten av dessa analyser bör regelbundet rapporteras vid varje inlämning av PSUR-rapporter och omedelbart vid fall av signifikanta fynd eller på begäran.
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.
Bulgarian: som avser Closamectin Pour-On lösning och associerade namn (såsom anges i bilaga I i meddelandet), utförlig undersökning av framtida säkerhetsövervakningsrapporter med datainsamling från behandlade opåverkade djur inom samma besättning (inräknat gårdshistoria, besättningens hälsostatus samt bedömning av djurhälsa och näringsstatus, däribland biokemisk analys och analys av mikronäringsämnen).
English: This may suggest that risk factors exist in the field, leading to either overexposure of some animals to closantel or enhanced intrinsic sensitivity of these animals to the toxic effects of closantel.
Bulgarian: till att djuren får ökad inneboende känslighet för de toxiska effekterna av klosantel.
English: • on the basis of the pharmacovigilance and additional data reviewed, including risk minimisation measures, the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see Annex I) subject to amendments in the product information;
Bulgarian: totala nytta-riskförhållandet är positivt för de veterinärmedicinska läkemedlen (se bilaga I) förutsatt att ändringar införs i produktinformationen.
English: However, there is no evidence to date to support this hypothesis.
Bulgarian: inte gav upphov till någon biverkning.
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.
Bulgarian: CVMP övervägde även en riskhanteringsplan från innehavaren av godkännande för försäljning med en utförlig beskrivning av den årliga PSUR-rapporteringen för Closamectin Pour-On lösning och associerade namn, kompletterande ingående undersökningar av säkerhetsövervakningsrapporter (däribland insamling av data om behandlade opåverkade djur inom samma besättning) samt ett förslag om
English: The proposal for annual PSUR submissions, covering all products related to Closamectin Pour-On Solution and associated names was supported.
Bulgarian: Förslaget om årliga inlämningar av PSUR-rapporter, som täcker alla läkemedel relaterade till Closamectin Pour-On lösning och associerade namn, godkändes. Det betonades att analys och incidensberäkningar bör utföras på de samlade uppgifterna, men samtidigt
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).
Bulgarian: syn (rapporterades bara med pour-on läkemedel) och applikationsställe samt respiratoriska tecken (rapporterades bara med det injicerbara läkemedlet).
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.
Bulgarian: Ändringarna av produktinformationen godkändes eftersom dessa ansågs förbättra informationen om oönskade händelser, förstärka övervakningen i besättningar där oönskade händelser
English: These deficiencies and poor nutritional status in general were considered potential factors associated with the adverse events observed following treatment and considered possible explanations for the higher frequency of reported adverse events in France.
Bulgarian: som setts efter behandling, och övervägde möjliga förklaringar av den högre frekvensen av rapporterade oönskade händelser i Frankrike.
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.
Bulgarian: CVMP beaktade de kompletterande uppgifterna till rapporten om oönskade händelser från innehavaren av godkännandet för försäljning i syfte att undersöka potentiella riskfaktorer förknippade med de oönskade händelserna hos djur och möjliga förklaringar
English: Product name
Bulgarian: Produktresumé
English: • Vermax Pour-On 5mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italy).
Bulgarian: Vermax Pour-On 5 mg/ml och 200 mg/ml Soluzione Pour-On per bovini (Italien).
English: It was emphasised that analysis and incidence calculations should be performed on the overall data however also ensuring precise identification of the concerned product for individual adverse event reports.
Bulgarian: ska en precis identifiering av den berörda produkten säkerställas för rapporter om enskilda oönskade händelser.
English: Closamectin 5mg/ml + 200mg/ml roztok pro nalévání na hřbet - pour-on
Bulgarian: Closamectin 5mg/ml + 200mg/ml roztok pro nalévání na hřbet - pouron
English: Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt
Bulgarian: Closamectin vet 5 mg/ml+200 mg/ml Pouron lösning till nöt
English: Vermax Pour-On 5mg/ml + 200mg/ml Soluzione PourOn per bovini
Bulgarian: Vermax Pour-On 5mg/ml + 200mg/ml Soluzione Pour-On per bovini
English: Route of administration
Bulgarian: Riskhanteringsplanen
English: Romania Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Bulgarian: Rumänien Norbrook Laboratories Ltd Station Works,
English: These included changes to the product information (as detailed in Annex III of the Opinion) to improve the information on adverse events, reinforce surveillance in herds where adverse events occur and introduce precautions for treatment of animals with low nutritional status.
Bulgarian: till meddelandet) för att förbättra informationen om oönskade händelser, förstärka övervakningen i besättningar där oönskade händelser
English: Slovenia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Bulgarian: Slovenien Norbrook Laboratories Ltd Station Works,
English: Slovakia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Bulgarian: Slovakien Norbrook Laboratories Ltd Station Works,
English: Germany Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Bulgarian: Storbritannien Norbrook Laboratories Ltd Station Works,
English: The reactions may last longer.
Bulgarian: Реакциите могат да бъдат по-продължителни.
English: 10 x1 ml 50 x1 ml 2 x 1 ml
Bulgarian: 10 х 1 ml 50 х 1 ml 2 х 1 ml
English: Do not freeze.
Bulgarian: Да не се замрaзява.
English: Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections
Bulgarian: Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate
English: Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Bulgarian: Много рядко е възможна поява на реакция на свръхчувствителност, при което може да наложи подходящо симптоматично лечение.
English: EXP (month/year)
Bulgarian: Годен до: (месец/година)
English: After inoculation, the virus expresses the protective protein, but does not replicate in the cat.
Bulgarian: След инокулиране, вирусът изразява протективния протеин, но не се реплицира в котката.
English: Canarypox recombinants are known to be safe for humans.
Bulgarian: Знае се, че рекомбинантите на сanarypox са безопасни за хората.
English: As a consequence, the vaccine stimulates active immunity against rabies virus in cats.
Bulgarian: Като резултат ваксината стимулира активен имунитет срещу вируса на бяс при котките.
English: The best time for a blood sample to be taken is around 28 days after vaccination.
Bulgarian: Най-доброто време за вземане на кръвна проба е около 28 дни след ваксинация.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Bulgarian: В случай на инцидентно самоинжектиране, незабавно да се потърси медицински съвет, като на лекаря се предостави листовката за употреба или етикета на продукта.
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.
Bulgarian: Пътуване до страни, които изискват серологичен тест за бяс: опитът е показал, че някои ваксинирани животни, докато са защитени, може да не покажат 0.5 IU/ml титри на антителата които се изисква от някои страни.
English: SPECIAL WARNING, IF NECESSARY
Bulgarian: СПЕЦИАЛНИ ПРЕДУПРЕЖДЕНИЯ, АКО
English: ATC vet code:QI06AD08.
Bulgarian: Ветеринарномедицински Анатомо-Терапевтичен Код: QI06AD08.
English: EU/2/10/117/001 (10 vials) EU/2/10/117/002 (50 vials) EU/2/10/117/003 (2 vials)
Bulgarian: EU/2/10/117/001 (10 флакона) EU/2/10/117/002 (50 флакона) EU/2/10/117/003 (2 флакона)
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Bulgarian: УСЛОВИЯ ИЛИ ОГРАНИЧЕНИЯ, ОТНАСЯЩИ СЕ ДО ПРЕДЛАГАНЕТО
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 LYON FRANCE
Bulgarian: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
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.
Bulgarian: Много рядко може да се появи преходна локална реакция (болезненост при палпация, ограничен оток, който може да стане възловиден, затопляне в мястото на инжектиране, а в някои случаи еритема), които обикновено изчезват до 1-2 седмици най-много.
English: Do not mix with any other veterinary medicinal product, except those mentioned in section 4.8.
Bulgarian: Не смесвайте с друг ветеринарномедицински продукт, с изключение на тези посочени в т. 4.8. 6.3
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.
Bulgarian: Наличните данни за безопасност и ефикасност сочат, че тази ваксина може да бъде смесвана и с ваксини на MERIAL без аджувант съдържаща различни комбинации от котешки вирусен ринотрахеит, калицивироза, панлевкопения и хламидиоза.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after “EXP”.
Bulgarian: Да не се използва този ветеринарномедицински продукт след изтичанe срока на годност, посочен върху етикета след „Годен до“.
English: Veterinary surgeons may wish to consider two vaccinations.
Bulgarian: Ветеринарните лекари могат да обмислят възможността за двувкратна ваксинация.
English: Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap.
Bulgarian: Стъклен флакон тип I със запушалка от бутилов еластомер, покрита с алуминиева капсула.
English: The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of rabies virus.
Bulgarian: Ваксиналния щам vCP65 е рекомбинантен Canarypox вирус, изразяващ ген гликопротеин G на вируса на бяс.
English: Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
Bulgarian: Активна имунизация на котки на 12 седмична възраст и по-големи за предпазване от смъртност поради заразяване с бяс.
English: No adverse reactions other than those already mentioned in section 4.6 have been observed after the administration of 10 doses.
Bulgarian: Не са наблюдавани странични реакции различни от тези описани в т. 4.6 след прилагане на 10 дози от ваксината.