FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP also reviewed the data submitted to gain the marketing authorisation for the pour-on combination products, focusing in particular on the target animal safety studies and toxicity events from the studies and in published literature.
Danish: CVMP gennemgik desuden de data, der blev indleveret ved ansøgningen om markedsføringstilladelse for pour-on kombinationsprodukterne, navnlig sikkerhedsundersøgelser hos måldyrearten og tilfælde af toksicitet i undersøgelserne og i den publicerede litteratur.
English: • Closivet Pour-On Solution for Cattle (Ireland);
Danish: • Closivet Pour-On Solution for Cattle (Irland)
English: In line with the requirements, all communication tools relating to pharmacovigilance should be submitted to the concerned NCAs, for information, before dissemination.
Danish: Alle kommunikationsværktøjer vedrørende lægemiddelovervågning skal forelægges de berørte nationale kompetente myndigheder til orientering før udsendelse i overensstemmelse med kravene.
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.
Danish: CVMP fandt, at de kliniske tegn ved de indberettede bivirkninger var af samme art som de, der iagttages ved toksisk overdosering med closantel, skønt dette ikke kunne bekræftes definitivt, da der ikke var foretaget obduktion ved alle dødelige udfald.
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.
Danish: Der blev fremsat den hypotese, at slikning kan have bidraget til den overeksponering, som medfører toksisk virkning af closantel hos nogle af de iagttagne dyr, som var påført den korrekte dosis, men dette er ikke endeligt bekræftet.
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.
Danish: anbefalede CVMP ophævelse af suspenderingen for markedsføringstilladelsen for CLOSAMECTIN POURON SOLUTION POUR BOVINS i Frankrig, ændring af markedsføringstilladelserne for Closamectin PourOn Solution og relaterede navne som anført i bilag I med henblik på ændring af produktresuméet og indlægssedlen i henhold til de anbefalede ændringer i produktinformationen, som fremgår af bilag III, og med de betingelser for markedsføringstilladelserne, som fremgår af bilag IV.
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.
Danish: Ændringerne af produktinformationen kunne støttes, da de ansås for at forbedre informationen om bivirkninger, styrke overvågningen i besætninger med bivirkninger på baggrund af de hidtidige erfaringer fra lægemiddelovervågning, og indføre forholdsregler til behandling af dyr med lav ernæringsstatus.
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.
Danish: CVMP gennemgik de supplerende data om bivirkningsindberetninger fremlagt af markedsføringstilladelsesindehaveren for at undersøge potentielle risikofaktorer forbundet med bivirkninger hos dyrene og finde mulige forklaringer på den højere forekomst af indberettede fatale bivirkninger Frankrig end i andre EU medlemsstater.
English: Updates to the risk management plan detailing the risk mitigation and surveillance measures should be proposed as required as soon as any issues arise, otherwise the risk management plan should be reviewed on a yearly basis at least, in conjunction with the PSUR submission.
Danish: Når der opstår problemer, bør der foreslås de nødvendige ajourføringer af risikohåndteringsplanen med beskrivelse af foranstaltningerne til risikoafbødning og overvågning, og i øvrigt bør risikohåndteringsplanen revideres mindst en gang årligt ved indsendelse af PSUR'er.
English: To investigate the potential relation between the adverse events observed and Closamectin Pour-On Solution and associated names, the CVMP considered the data provided by the MAH, Norbrook
Danish: For at undersøge den potentielle sammenhæng mellem de iagttagne bivirkninger og Closamectin PourOn Solution og relaterede navne gennemgik CVMP data fremlagt af markedsføringstilladelsesindehaveren, Norbrook Laboratories Ltd.
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.
Danish: Det blev anbefalet, at der i fremtiden indsamles supplerende data om bivirkninger for at fastlægge produkternes potentielle rolle, herunder potentiel toksicitet af closantel, samt at undersøge potentielle risikofaktorer i forbindelse med de indberettede bivirkninger efter behandling.
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.
Danish: Foruden de af markedsføringstilladelsesindehaveren forelagte lægemiddelovervågningsdata blev der også fremlagt resultater af diagnostiske undersøgelser, når disse forelå (f.eks. blodprøver og obduktionsundersøgelser osv.) til at undersøge bivirkningerne.
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.
Danish: Disse bestod i en gennemgang af videnskabelig litteratur om farmakologien og toksikologien af ivermectin og closantel, kumulative erfaringer fra lægemiddelovervågning efter brug af produkterne i EU siden 2009, en sammenligning med ivermectin-baserede produkter og med markedsføringstilladelsesindehaverens injektionspræparater med ivermectin/closantel, undersøgelser udført af indehaveren af markedsføringstilladelsen til identifikation af mulige medvirkende faktorer ved de indberettede bivirkninger, og forslag til risikoafhjælpende foranstaltninger og tiltag.
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.
Danish: Disse består i ændringer af produktinformationen (som beskrevet i bilag III til udtalelsen) for at give bedre oplysninger om bivirkninger, styrket overvågning i besætninger, hvor der forekommer bivirkninger, og indførelse af forholdsregler for behandling af dyr med lav ernæringsstatus.
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
Danish: Begrundelse for ophævelse af suspenderingen af markedsføringstilladelsen for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS i Frankrig og ændring af produktresuméet og indlægssedlen ud fra følgende betragtning:
English: It was proposed that third parties involved in pharmacovigilance activities related to these products (e.g distributors) be made aware of the risk management measures proposed.
Danish: Det blev foreslået at oplyse om de påtænkte risikohåndteringsforanstaltninger for disse produkter til tredjeparter, der er inddraget i lægemiddelovervågningsaktiviteter (f.eks. distributører).
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.
Danish: Bivirkningernes art tydede på de kliniske symptomer forbundet med overdoseringstoksicitet af closantel, skønt det bemærkedes, at de berørte dyr blev oplyst at være behandlet med den anbefalede dosis.
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.
Danish: Bivirkningerne bestod hovedsagelig i neurologiske symptomer (ataksi, tilbøjelighed til at blive liggende, parese/paralyse og blindhed) og/eller gastrointestinale lidelser (diarré, anoreksi osv.), hvoraf nogle havde fatalt udfald.
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.
Danish: Udvalget gennemgik markedsføringstilladelsesindehaverens forslag til foranstaltninger til at afbøde bivirkningerne efter brug af produktet, herunder nedenstående ændringer af produktinformationen.
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.
Danish: De indberettede kliniske symptomer blev ved deres art af ANMV anset for at være kliniske tegn på overdoseringstoksicitet af closantel.
English: Strength Pharmaceutical form Animal species
Danish: Lægemiddelform Dyrearter, som lægemidlet er beregnet til
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.
Danish: Skønt den underliggende mekanisme for bivirkningerne endnu ikke er fastlagt, blev benefit/riskforholdet for Closamectin Pour-On Solution og relaterede navne anset for gunstigt under forudsætning af indførelse af ændringer af produktinformationen og gennemførelse af supplerende foranstaltninger til risikoovervågning og risikoafbødning bestående i årlige "kombinerede" PSUR'er, yderligere undersøgelser af fremtidigt indberettede bivirkninger, og "information, oplæring vejledning" til slutbrugerne for at give bedre indsigt i risiciene ved produkterne og forholdsreglerne ved deres anvendelse.
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.
Danish: De primære risici ved produktet hænger sammen med potentialet for bivirkninger med neurologiske symptomer (ataksi, tilbøjelighed til at blive liggende, parese/paralyse og blindhed) og/eller gastrointestinale lidelser (diarré, anoreksi osv.), hvoraf nogle har haft fatalt udfald.
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.
Danish: Lægemidlet er effektivt til anvendelse hos kvæg til behandling af blandede angreb af trematoder (ikter) og nematoder eller arthropoder forårsaget af rundorm, lungeorm, øjenorm, bremselarver, mider og lus.
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.
Danish: Produkterne er effektive hos kødkvæg til behandling af blandede angreb af trematoder (ikter) og nematoder eller arthropoder forårsaget af rundorm, lungeorm, øjenorm, bremselarver, mider og lus.
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.
Danish: CVMP gennemgik desuden markedsføringstilladelsesindehaverens forslag til en risikostyringsplan, som indebærer årlig PSUR-indberetning for Closamectin Pour-On Solution og relaterede navne, yderligere detaljeret gennemgang af lægemiddelovervågningsrapporter (herunder indsamling af data om behandlede, upåvirkede dyr i samme besætning) og et forslag til "information, oplæring og vejledning") til slutbrugerne, der skal sikre, at de har fuldt indblik i risiciene ved produkterne og forholdsreglerne for anvendelse.
English: The measures detailed in the risk management plan proposed by the MAH were supported, with additional refinement described below.
Danish: Der var tilslutning til foranstaltningerne i markedsføringstilladelsesindehaverens forslag til en risikostyringsplan, med tilføjelse af nedenstående forbedring.
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.
Danish: Indehaveren af markedsføringstilladelsen foreslog derudover at gennemføre en risikostyringsplan, som indebar årlige "kombinerede" PSUR-indberetninger for produkter indeholdende Closamectin Pour-On Solution og relaterede navne (som beskrevet i bilag I til udtalelsen), detaljeret undersøgelse af fremtidige indberetninger om lægemiddelovervågning med indsamling af data om behandlede, ikke-afficerede dyr i samme besætning) (herunder kvægbrugets historie og besætningens helbredsstatus), vurdering af dyrenes helbreds- og ernæringstilstand, herunder biokemiske analyser og analyse af mikronæringsstoffer, samt "information, oplæring og vejledning") af slutbrugerne for at sikre, at de har fuldt kendskab til risiciene ved produkterne og forholdsreglerne vedrørende anvendelsen.
English: • Vermax Pour-On 5mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italy).
Danish: • Vermax Pour-On, 5mg/ml & 200 mg/ml Soluzione Pour-On per bovini (Italien).
English: Spain
Danish: Slovakiet
English: Germany Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Danish: Tyskland Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Nordirland
English: Sweden Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Danish: Sverige Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Nordirland
English: Denmark Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Danish: Danmark Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Nordirland
English: Slovenia Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Danish: Slovenien Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Nordirland
English: Romania Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Danish: Rumænien Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Nordirland
English: Belgium Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland
Danish: Grækenland Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Nordirland
English: The reactions may last longer.
Danish: Reaktionerne kan være af længere varighed.
English: SPECIAL WARNING, IF NECESSARY
Danish: SÆRLIG ADVARSEL, OM NØDVENDIGT
English: Veterinary surgeons may wish to consider two vaccinations.
Danish: Dyrlæger kan overveje to vaccinationer.
English: Date of first authorisation: 18/02/2011 Date of last renewal: 02/12/2015
Danish: Dato for første markedsføringstilladelse: 18/02/2011 Dato for seneste fornyelse af markedsføringstilladelse: 02/12/2015
English: Each dose of 1 ml contains:
Danish: 1 dosis på 1 ml indeholder:
English: After inoculation, the virus expresses the protective protein, but does not replicate in the cat.
Danish: Efter inokulering afgiver virus det beskyttende protein, men repliceres ikke hos kat.
English: Light pink to pale yellow homogeneous suspension
Danish: Lys pink til bleg gul homogen suspension.
English: The best time for a blood sample to be taken is around 28 days after vaccination.
Danish: Det bedste tidspunkt for blodprøvetagning er ca. 28 dage efter vaccination.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men færre end 10 dyr ud af 100 dyr) - Ualmindelige (mere end 1, men færre end 10 dyr ud af 1.000 dyr) - Sjældne (mere end 1, men færre end 10 dyr ud af 10.000 dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: Canarypox recombinants are known to be safe for humans.
Danish: Rekombinant canarypox er sikker for mennesker.
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.
Danish: Ved rejse til lande som kræver en bestemmelse af rabiesantistoftiter: erfaring har vist, at nogle vaccinerede dyr, skønt beskyttede, ikke kan opnå en antistoftiter på 0,5 IU/ml som påkrævet af visse lande.
English: As a consequence, the vaccine stimulates active immunity against rabies virus in cats.
Danish: Som følge heraf stimulerer vaccinen aktivt immunitet over for rabiesvirus hos kat.
English: Potassium chloride Sodium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections
Danish: Natriumchlorid Kaliumdihydrogenphosphat Dinatriumphosphatdihydrat Magnesiumchloridhexahydrat Calciumchloriddihydrat Vand til injektionsvæsker
English: Very rarely, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Danish: I meget sjældne tilfælde kan en hypersensitivitetsreaktion forekomme, som kan kræve korrekt symptomatisk behandling.
English: The vaccine strain vCP65 is a recombinant Canarypox virus expressing the glycoprotein G gene of rabies virus.
Danish: Vaccinestammen vCP65 er en rekombinant canarypox virus, der afgiver glykoprotein G-genet af rabiesvirus.
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.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan blandes og gives samtidig med MERIALs vacciner uden adjuvans, der indeholder forskellige kombinationer af felin viral rhinotracheitis, calicivirose, panleukopeni og chlamydia komponenter.
English: Special precautions for use in animals: Vaccinate healthy animals only.
Danish: Specielle forholdsregler til brug hos dyr: Vacciner kun raske dyr.
English: Administer one dose of 1 ml according to the following vaccination scheme:
Danish: Injicer 1 dosis på 1 ml i henhold til følgende vaccinationsskema:
English: Duration of immunity after revaccination: 3 years.
Danish: Varighed af immunitet efter revaccination: 3 år.
English: Efficacy data are available which demonstrate that this vaccine can be administered at least 14 days before or after the administration of MERIAL non-adjuvanted vaccine against feline leukaemia.
Danish: Der foreligger oplysninger om vaccinens virkning, der viser, at vaccinen kan gives mindst 14 dage før eller efter administration af Merials vaccine uden adjuvans mod felin leukæmi.
English: Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap.
Danish: Type I hætteglas med en butylelastomer-prop, forseglet med en aluminiumskapsel.
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 SAINT PRIEST FRANCE
Danish: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Frankrig
English: Disposal: Read package leaflet.
Danish: Bortskaffelse: Læs indlægssedlen.
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 LYON FRANCE
Danish: Laboratoire Lyon Gerland 254, rue Marcel Mérieux 69007 Lyon
English: Manufacturer responsible for batch release: MERIAL
Danish: Fremstiller ansvarlig for batchfrigivelse: Merial
English: Vaccine against rabies infection.
Danish: Vaccine mod rabiesinfektion.
English: Active immunisation of cats 12 weeks of age and older to prevent mortality due to rabies infection.
Danish: Aktiv immunisering af katte, der er 12 uger gamle eller ældre, for at forebygge dødsfald p.gr.a.
English: Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily.
Danish: Milde lokale og/eller systemiske bivirkninger i forbindelse med selvinjektion kan forbigående observeres.
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.
Danish: I meget sjældne tilfælde kan forbigående og mild apati forekomme samt let anorexi eller hyperthermi (> 39,5 oC), der sædvanligvis varer 1 eller 2 dage.
English: EU/2/10/117/001 (10 vials) EU/2/10/117/002 (50 vials) EU/2/10/117/003 (2 vials)
Danish: EU/2/10/117/001 (10 hætteglas) EU/2/10/117/002 (50 hætteglas) EU/2/10/117/003 (2 hætteglas)
English: No adverse reactions other than those already mentioned in the section “Adverse Reactions” have been observed after the administration of 10 doses.
Danish: Der er ikke iagttaget andre bivirkninger end de, der er nævnt under punktet ”Bivirkninger” efter administration af 10 doser.
English: Do not mix with any other veterinary medicinal product except those mentioned above.
Danish: Må ikke blandes med andre lægemidler til dyr undtaget dem som er nævnt ovenover.
English: DOSAGE FOR EACH SPECIES, ROUTEAND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ