FrancophonIA/ELRC3.0 huggingface dataset:
English: Higher incidence values were reported in Sweden (0.011%) and France (0.007%).
Danish: Den indberettede incidens var højere i Sverige (0,011 %) og Frankrig (0,007 %).
English: Sales volumes should also be reported separately for specific products for each Member State.
Danish: Der skulle endvidere angives separate salgstal for specifikke produkter for hver medlemsstat.
English: A single risk management plan should be presented covering all products included within the scope of this procedure.
Danish: Der skal forelægges en enkelt risikohåndteringsplan for alle produkter omfattet af denne procedure.
English: • implementation of a risk management plan addressing the following risk mitigation and surveillance measures:
Danish: • gennemførelse af en risikostyringsplan med følgende foranstaltninger til risikoafbødning og overvågning:
English: Overall summary of the scientific evaluation of Closamectin Pour-On Solution and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Closamectin Pour-On Solution og relaterede navne (se bilag I)
English: It was noted that these events often involved more than one animal within affected herds.
Danish: Det blev bemærket, at disse hændelser ofte omfattede flere end ét dyr i de berørte besætninger.
English: • UK/V/0325/001 - Closamectin Pour-On (UK, Ireland);
Danish: • UK/V/0325/001 - Closamectin Pour-On (Det Forenede Kongerige, Irland)
English: Other treatment options have limited activity against immature fluke.
Danish: Andre behandlingsmuligheder har begrænset aktivitet mod umodne ikter.
English: Closamectin Pour-On Solution and associated names is authorised in several EU Member States.
Danish: Closamectin Pour-On Solution og relaterede navne er godkendt i flere i EU medlemsstater.
English: CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS is a veterinary medicinal product which has been authorised in France since 25 May 2011 following a decentralised procedure (DCP) (UK/V/0369/001) with the United Kingdom (UK) as reference Member State.
Danish: CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS er et veterinærlægemiddel, der har været godkendt i Frankrig siden 25. maj 2011 efter en decentral procedure (UK/V/0369/001) med Det Forenede Kongerige som referencemedlemsstat.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holder in the Member States
Danish: Liste over veterinærlægemidlets navne, lægemiddelformer, styrker, dyrearter, administrationsvej, og indehaver af markedsføringstilladelsen i medlemsstaterne
English: These measures were considered to be appropriate to mitigate the risks observed following treatment.
Danish: Disse foranstaltninger blev anset for hensigtsmæssige til at afbøde de iagttagne risici efter behandling.
English: The aforementioned products have the same qualitative and quantitative composition and consequently it was considered that the animal health issues described were applicable to these products as well.
Danish: Ovennævnte lægemidler har samme kvalitative og kvantitative sammensætning, hvorfor de beskrevne dyrehelbredsproblemer ligeledes fandtes at kunne tilskrives disse lægemidler.
English: The national competent authorities of Member State(s) or the reference Member State, as applicable, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Danish: De nationale kompetente myndigheder i medlemsstaten (-staterne) eller i givet fald i referencemedlemsstaten sikrer, at indehaverne af markedsføringstilladelse opfylder følgende vilkår:
English: The overall EU incidence of adverse events, in relation to sales volumes was classified as ‘very rare' (0.003%) and considered within acceptable limits.
Danish: Den samlede bivirkningsforekomst i EU i forhold til salgsvolumen blev klassificeret som "meget sjælden" (0,003 %), hvilket blev anset for at ligge inden for grænserne for det acceptable.
English: It was noted that in general the product was reported to have been administered at the recommended dose.
Danish: Det bemærkedes, at produktet sædvanligvis blev angivet at være administreret i den anbefalede dosis.
English: It was also recommended to ensure data collection on a representative sample of unaffected treated animals within the same herd.
Danish: Det blev ligeledes anbefalet at indsamle data fra en repræsentativ stikprøve af ikke berørte dyr i samme besætning.
English: As an indirect benefit, it is noted that pour-on products are often preferred over injectable products due to the ease of administration.
Danish: Som en indirekte fordel bemærkes det, at pour-on-præparater ofte foretrækkes for injektionspræparater pga. den lette administration.
English: • UK/V/0368/001 - Closiver 5mg/ml & 200 mg/ml Pour-On (UK); Closamectin 5mg/ml & 200 mg/ml Pour-On (Austria, Belgium, Czech Republic, Denmark, Germany, Greece, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden);
Danish: • UK/V/0368/001 - Closiver Pour-On, 5 mg/ml & 200 mg/ml (Det Forenede Kongerige), Closamectin Pour-On, 5 mg/ml & 200 mg/ml (Østrig, Belgien, Tjekkiet, Danmark, Tyskland, Grækenland, Italien, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien og Sverige)
English: The data reviewed did not indicate age, sex, breed or geographical distribution as potential risk factors for the adverse events observed.
Danish: De gennemgåede data tydede ikke på, at alder, køn, race eller geografisk fordeling var potentielle risikofaktorer for de iagttagne bivirkninger.
English: − intensified data collection relating to pharmacovigilance reports; and
Danish: − intensiveret dataindsamling vedrørende lægemiddelovervågningsrapporter
English: On 19 June 2015, ANMV circulated a rapid alert notifying Member States, the European Commission and the European Medicines Agency of the intention to suspend the marketing authorisation for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS in France, following the evaluation of pharmacovigilance data.
Danish: Den 19. juni 2015 udsendte ANMV en hastemeddelelse til medlemsstaterne, Europa-Kommissionen og Det Europæiske Lægemiddelagentur om, at det havde til hensigt at suspendere markedsføringstilladelsen for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS i Frankrig efter vurdering af lægemiddelovervågningsdata.
English: − annual PSUR submissions covering all concerned veterinary medicinal products (see Annex I);
Danish: − årlig indsendelse af PSUR'er for alle de berørte veterinærlægemidler (se bilag I)
English: Add, to all products (if not already present): 4.5 Special precautions for use Special precautions for use in animals
Danish: Følgende skal tilføjes alle produkter (hvis de ikke allerede findes): 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr
English: Although the overall incidence of adverse events was considered to be within acceptable limits (0.006% in the last annual periodic safety update report (PSUR)) the continued occurrence of serious adverse events and the severity of subsequent losses on farms in France were considered significant, which led to the suspension of the marketing authorisation in France on 6 July 2015.
Danish: Skønt den samlede forekomst af bivirkninger blev anset for at være inden for det acceptable (0,006 % i den seneste årlige periodiske sikkerhedsopdateringsrapport (PSUR), blev den fortsatte forekomst af alvorlige bivirkninger med efterfølgende alvorlige tab på brug i Frankrig anset for at være betydningsfuld, hvilket førte til suspendering af markedsføringstilladelsen i Frankrig den 6. juli 2015.
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.
Danish: Detaljerede resultater af disse analyser bør indsamles med regelmæssige intervaller ved hver indsendelse af en PSUR samt straks i tilfælde af betydningsfulde fund eller på anmodning.
English: Closivet Solución Pour- On Ivermectin Closantel
Danish: Closivet Solución Pour- On Closantel og Ivermectin
English: The risk management plan should be submitted to the national competent authorities within 3 months of the Commission Decision and maintained until such time as the concerned national competent authorities consider that the risk profile of the product has been sufficiently characterised and all appropriate risk mitigation and surveillance measures have been implemented.
Danish: Risikohåndteringsplanen forelægges for de nationale kompetente myndigheder senest 3 måneder efter Kommissionens beslutning og skal forblive i kraft, indtil de berørte nationale kompetente myndigheder finder, at produktets risikoprofil er tilstrækkeligt karakteriseret, og at alle hensigtsmæssige foranstaltninger til risikoafbødning og overvågning er gennemført.
English: The proposal for annual PSUR submissions, covering all products related to Closamectin Pour-On Solution and associated names was supported.
Danish: Forslaget om årlig indsendelse af PSUR'er for alle produkter knyttet til Closamectin Pour-On Solution og relaterede navne fik tilslutning.
English: From 2000 until 30 June 2015, a total of 371 adverse events reports were reported in the EU, 65% of which, according to the MAH, concerned animal toxicity, mainly in France (120 reports) and the UK (91 reports).
Danish: Fra 2000 indtil 13. juni 2015 blev der i alt indberettet 371 bivirkninger i EU, af hvilke 65 % ifølge indehaveren af markedsføringstilladelsen vedrørte toksisk virkning, hovedsagelig i Frankrig (120 indberetninger) og Det Forenede Kongerige (91 indberetninger).
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.
Danish: Det blev understreget, at analyse og incidensberegning skulle foretages på de samlede data, dog med præcis identifikation af det pågældende produkt i de enkelte bivirkningsindberetninger.
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.
Danish: Der blev indledt supplerende undersøgelser af berørte dyr i 2015, herunder overvågning af vitamin A og E samt selen i blodprøver fra både berørte og ikke berørte dyr.
English: From the literature review reported it appeared that variability existed between animals in terms of their clinical response to a same level of overdose.
Danish: Af den forelagte litteratur fremgik det, at der var variabilitet mellem dyrene hvad angår den kliniske respons ved samme grad af overdosering.
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:
Danish: Følgende andre veterinærlægemidler er godkendt med samme kvalitative og kvantitative sammensætning og med samme markedsføringstilladelsesindehaver, Norbrook Laboratories Ltd., dels ved to andre decentrale procedurer, dels ved tre nationale procedurer:
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.
Danish: Observation af konsekvenserne af slikning/soignering tydede desuden på, at den maksimale dosis administreret oralt ikke syntes at frembringe bivirkninger.
English: It was however, suggested that licking/grooming, possibly associated with the predominantly beef cattle breeding systems in France could explain, in part, the comparatively higher number of events reported there.
Danish: Det blev dog foreslået, at slikning/soignering, muligvis forbundet med det overvejende kødkvægbrug i Frankrig, delvis kunne forklare det relativt højere antal indberettede hændelser der.
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.
Danish: Dette kan tyde på, at der er risikofaktorer i felten, som enten fører til overeksponering af nogle dyr for closantel eller øget iboende følsomhed af disse dyr for de toksiske virkninger af closantel.
English: Therefore, should neurological signs be observed in one animal, it is recommended to reinforce surveillance, at the herd level, of all treated animals.
Danish: Skulle neurologiske symptomer derfor observeres i ét dyr, tilrådes det at øge kontrollen, på besætningsniveau, med alle behandlede dyr.
English: It remained unclear, however, why the frequency of adverse events reported in France was higher than for other Member States and further investigations into this were initiated by the MAH.
Danish: Det var imidlertid fortsat uklart, hvorfor frekvensen af indberettede bivirkninger i Frankrig var højere end i de andre medlemsstater, og indehaveren af markedsføringstilladelse påbegyndte yderligere undersøgelser heraf.
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.
Danish: Desuden blev det foreslået at give "information, oplæring og vejledning" til slutbrugerne, så de får bedre indsigt i risiciene ved produkterne og forholdsreglerne ved deres anvendelse.
English: This follow-up should also continue to investigate other potential risk factors which may also play a role in the adverse events observed, including, for example, aspects related to animal husbandry.
Danish: Denne opfølgning bør desuden fortsætte med undersøgelser af andre potentielle risikofaktorer, som ligeledes kan spille en rolle ved de iagttagne bivirkninger, herunder f.eks. aspekter vedrørende avlspraksis.
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.
Danish: Det blev dog fundet nødvendigt med yderligere undersøgelser til at be- eller afkræfte ernæringsstatus og mangel på specifikke mikronæringsstoffer som risikofaktorer for de bivirkninger, der er iagttaget hos dyrene efter anvendelse af Closamectin Pour-On Solution og relaterede navne.
English: The detailed results of investigations of adverse events and their analysis should be included in each PSUR.
Danish: Detaljerede undersøgelsesresultater og analyse af bivirkningerne skulle indgå i hver PSUR.
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.
Danish: Undersøgelserne inden markedsføring tydede på, at både kombinationsprodukter af ivermectin/closantel og produkter med closantel alene var veltolereret hos kvæg i doser op til 3 gange den anbefalede dosering, selv ved gentagen administration.
English: Post-mortem analysis of fatal cases was considered necessary to determine the potential role of closantel toxicity, as well as diagnosing any other disease processes.
Danish: Post mortem-analyse af fatale tilfælde blev anset for nødvendigt for at bestemme den potentielle rolle af toksicitet af closantel og for at diagnosticere eventuelle andre sygdomsprocesser.
English: SPC section 4.5 Special precautions for use: Special precautions for use in animals:
Danish: Produktresuméets punkt 4.5 Særlige forsigtighedsregler vedrørende brugen: Særlige forsigtighedsregler vedrørende brug til dyr:
English: Information should also be collected on the affected herd and husbandry system in general, including herd health status.
Danish: Der bør indsamles oplysninger om den berørte besætning og avlspraksis generelt, herunder besætningens helbredsstatus.
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;
Danish: • CVMP ud fra de gennemgåede lægemiddelovervågningsdata og supplerende data, herunder risikominimeringsforanstaltninger, anså det overordnede benefit/risk-forhold for positivt for veterinærlægemidlerne (se bilag I) under forudsætning af, at der indføres ændringer i produktinformationen,
English: Closamectin Pour-On Solution should be administered topically at a dose of 500 mg ivermectin per kg body weight and 20 mg closantel per kg body weight (1 mL per 10 kg body weight).
Danish: Closamectin Pour-On Solution administreres topikalt i en dosis på 500 mg ivermectin/kg kropsvægt og 20 mg closantel/kg kropsvægt (1 ml/10 kg kropsvægt).
English: In very rare cases (less than 1 animal in 10,000 animals, including isolated reports), neurological signs such as blindness, ataxia, and recumbency may occur after administration of the product.
Danish: I meget sjældne tilfælde (hos færre end 1 ud af 10.000 dyr, herunder isolerede rapporter) kan neurologiske symptomer som f.eks. blindhed, ataksi og tendens til at ligge ned forekomme efter administration af lægemidlet.
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.
Danish: Der bør foretages supplerende diagnostiske analyser, herunder blodprøver (med biokemiske analyser og analyse af mikronæringsstoffer) og fæcesanalyse for berørte dyr, idet det sikres, at alle prøver håndteres korrekt for at undgå at indføre skævhed i analyserne.
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.
Danish: Mangel på disse næringsstoffer og generelt dårlig ernæringstilstand blev anset for potentielle faktorer med sammenhæng med de iagttagne bivirkninger efter behandling og blev anset for muligvis at kunne forklare den større hyppighed af indberettede bivirkninger i Frankrig.
English: • Closivet Solución Pour-On (Spain); and
Danish: • Closivet Solución Pour-On (Spanien)
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.
Danish: Det blev desuden bemærket, at den samlede forekomst af bivirkninger var en smule højere for de kombinerede injektionspræparat end for pour-on-præparaterne, idet der gennemsnitligt var et større antal inddragne dyr i hver indberetning, skønt den indberettede mortalitet var lavere.
English: The ANMV received a total of 123 adverse event reports involving CLOSAMECTIN POUR-ON POUR BOVINS between 25 May 2011 and 31 May 2015 in which 401 animals were affected and 121 died.
Danish: ANMV modtog i alt 123 indberetninger om bivirkninger med inddragelse af CLOSAMECTIN POUR-ON POUR BOVINS mellem den 25. maj 2011 og den 31. maj 2015.
English: The product was also recalled at veterinary clinic and wholesale level.
Danish: Lægemidlet blev desuden kaldt tilbage fra veterinærklinikker og grossister.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics and package leaflet
Danish: Videnskabelige konklusioner og begrundelse for ændringen af produktresuméet og indlægssedlen
English: Care should be taken when treating animals which may be of low nutritional status as this may increase susceptibility of adverse events occurring.
Danish: Forsigtighed bør udvises ved behandling af dyr med mulig lav ernæringsstatus, da dette kan øge tilbøjeligheden til forekomst af bivirkninger.
English: A comparative review of the safety profile in cattle of other products containing ivermectin and/or closantel held by the MAH (including the injectable combination product) was conducted.
Danish: Der blev udført en sammenlignende gennemgang af sikkerhedsprofilen hos kvæg af andre af markedsføringstilladelsesindehaverens produkter indeholdende ivermectin og/eller closantel (herunder det kombinerede injektionspræparat).
English: In addition, as the link between plasma closantel and toxicity has yet to be established it was also recommended to provide results of blood plasma sampling, together with information on the time of treatment, onset of clinical signs and sampling.
Danish: Da sammenhængen mellem plasmaclosantel og toksisk virkning ikke er fastlagt, blev det desuden anbefalet, at resultaterne af blodplasmaprøver angives sammen med tidspunkt for behandling, indsætten af kliniske symptomer og prøvetagning.
English: SPC section 4.6 Adverse reactions (Frequency and Seriousness)
Danish: Produktresuméets punkt 4.6 Bivirkninger (hyppighed og sværhed)
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.
Danish: Skønt lægemiddelovervågningsrapporterne tydede på potentiel toksicitet af closantel som underliggende årsag, bemærkedes det, at der med rene ivermectin-formuleringer var indberetninger om neurologiske hændelser (herunder et tilfælde af blindhed) og diarré.
English: These cases may also be associated with gastrointestinal signs such as anorexia, diarrhoea and in extreme cases signs may persist and may result in death of the animal.
Danish: Disse tilfælde kan desuden være forbundet med gastrointestinale symptomer såsom anoreksi og diarré og kan i ekstreme tilfælde persistere og medføre dyrets død.
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.
Danish: Selv om den generelle forekomst af bivirkninger er meget sjælden, er det blevet bemærket, at når der opstår en bivirkning i en besætning, kan flere dyr være påvirket.
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.
Danish: Det blev derfor anset for vanskeligt at fastslå, om de iagttagne kliniske symptomer på toksicitet skyldes ivermectinog/eller closantel-komponenten i kombinationsproduktet Closamectin Pour-On.
English: Measures to mitigate the risk of adverse events following use of the product have been proposed.
Danish: Der er foreslået foranstaltninger til afbødning af risikoen for bivirkninger efter brug af produktet.
English: Closantel is an alternative flukicide to triclabendazole to which resistance is emerging.
Danish: Closantel er som iktemiddel et alternativ til triclabendazol, da dette i stigende grad bevirker resistens.
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).
Danish: CVMP fandt den kliniske profil af injektionspræparater og kombinerede pour-on-præparater sammenlignelig, bortset fra blindhed/synsnedsættelse (kun indberettet med pour-on-præparaterne) og symptomer fra påføringsstedet og respirationssymptomer (kun indberettet med injektionspræparatet).
English: Amendments in the relevant sections of the summary of product characteristics and package leaflet
Danish: Ændringer til relevante afsnit i produktresuméet og indlægssedlen