natgillin/translations-raw huggingface dataset:
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.
Ker povezava med klozantelom v plazmi in toksičnimi učinki še ni bila vzpostavljena, je bilo prav tako priporočeno, da se predložijo rezultati vzorčenja krvne plazme, skupaj z informacijami o času zdravljenja, pojavu kliničnih znakov in vzorčenju.
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.
Vendar je bila podana domneva, da bi lizanje oziroma čiščenje, ki je morda povezano s sistemom vzreje v Franciji, v katerem prevladuje vzreja za meso, lahko deloma pojasnilo primerjalno večje število dogodkov, o katerih so poročali v tej državi.
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.
O podrobnih rezultatih teh analiz bi morali redno poročati ob predložitvi vsakega redno posodobljenega poročila o varnosti zdravila oziroma nemudoma v primeru pomembnih ugotovitev ali na zahtevo.
Closantel is an alternative flukicide to triclabendazole to which resistance is emerging.
Klozantel je zdravilna učinkovina proti metljajem, ki je alternativa zdravilni učinkovini triklabendazol, v zvezi s katero se pojavlja odpornost.
In line with the requirements, all communication tools relating to pharmacovigilance should be submitted to the concerned NCAs, for information, before dissemination.
V skladu z zahtevami se vsa komunikacijska orodja, povezana s farmakovigilanco, pred razširjanjem predložijo v vednost pristojnim nacionalnim organom.
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.
Dne 19. junija 2015 je francoska agencija za zdravila za uporabo v veterinarski medicini (ANMV) izdala nujno opozorilo, v katerem je države članice, Evropsko komisijo in Evropsko agencijo za zdravila obvestila, da namerava po oceni farmakovigilančnih podatkov začasno umakniti dovoljenje za promet z zdravilom CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS v Franciji.
Therefore, should neurological signs be observed in one animal, it is recommended to reinforce surveillance, at the herd level, of all treated animals.
Če se opazijo nevrološke motnje pri eni živali, se zato priporoča okrepitev nadzora vseh zdravljenih živali na ravni črede.
The product was also recalled at veterinary clinic and wholesale level.
Zdravilo je bilo umaknjeno tudi na ravni veterinarskih klinik in veleprodaje.
Special precautions for use in animals:
Posebni previdnostni ukrepi za uporabo pri živalih
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.
Agencija ANMV je od 25. maja 2011 do 31. maja 2015 prejela skupaj 123 poročil o neželenih dogodkih v zvezi z zdravilom CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS, ki so zadevali 401 žival, od katerih jih je 121 poginilo.
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.
Vendar je prevladalo mnenje, da so potrebne dodatne preiskave, da bi potrdili ali ovrgli stanje prehranjenosti in pomanjkanje posebnih mikrohranil kot dejavnika tveganja za neželene učinke, opažene pri živalih po uporabi zdravila Closamectin Pour-on Solution in povezanih imen.
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.
Kljub temu ni bilo pojasnjeno, zakaj je bila pojavnost neželenih dogodkov, o katerih so poročali, v Franciji večja kot v drugih državah članicah, zato je imetnik dovoljenja za promet z zdravilom o tem sprožil nadaljnje preiskave.
− annual PSUR submissions covering all concerned veterinary medicinal products (see Annex I);
− predložitev letnih redno posodobljenih poročil o varnosti zdravila (PSUR), ki zajemajo vsa zadevna zdravila za uporabo v veterinarski medicini (glejte Prilogo I);
The measures detailed in the risk management plan proposed by the MAH were supported, with additional refinement described below.
Ukrepi, podrobno opisani v načrtu obvladovanja tveganj, ki ga je predložil imetnik dovoljenja za promet z zdravilom, so bili odobreni, pri čemer so bile podane dodatne izboljšave, opisane spodaj.
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.
Odbor za zdravila za uporabo v veterinarski medicini je prav tako pregledal podatke, predložene za pridobitev dovoljenja za promet z zdravilom, pri čemer se je osredotočil zlasti na študije o varnosti ciljne živalske vrste ter pojave toksičnih učinkov v študijah in objavljeni literaturi.
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.
Poleg tega so opažanja o posledicah lizanja in čiščenja kazala, da največji odmerek, vzet peroralno, ni povzročil nobenih neželenih učinkov.
• 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;
• na podlagi pregleda farmakovigilančnih in dodatnih podatkov, vključno z ukrepi za zmanjšanje tveganja, je odbor CVMP menil, da je splošno razmerje med tveganji in koristmi za zdravila za uporabo v veterinarski medicini (glejte Prilogo I) pozitivno, če se upoštevajo dopolnila v informacijah o zdravilu,
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.
Prav tako je bilo predlagano, da se končnim uporabnikom zagotovi izobraževanje, usposabljanje in usmerjanje, s čimer bi ti bolje razumeli tveganja, povezana z zdravili, in previdnostne ukrepe za uporabo zdravila.
The proposal for annual PSUR submissions, covering all products related to Closamectin Pour-On Solution and associated names was supported.
Predlog za letna redno posodobljena poročila o varnosti zdravila, ki bi zajemala vsa zdravila, povezana z zdravilom Closamectin Pour-On Solution in povezanimi imeni, je bil odobren.
It was noted that in general the product was reported to have been administered at the recommended dose.
Ugotovljeno je bilo, da je bilo zdravilo po poročilih sodeč na splošno dano v priporočenih odmerkih.
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.
Čeprav so farmakovigilančna poročila kot osnovni vzrok nakazovala morebitno toksičnost klozantela, je bilo ugotovljeno, da so o nevroloških dogodkih (vključno s primerom slepote) in diareji poročali pri formulacijah, ki so vsebovale zgolj ivermektin.
• Closivet Solución Pour-On (Spain); and
• Closivet Solución Pour-On (Španija) in
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.
Posodobitve načrta za obvladovanje tveganj, ki podrobno opredeljuje ukrepe za zmanjšanje tveganja in nadzor, bi morali v skladu z zahtevami predložiti nemudoma ob pojavu morebitnih težav, sicer pa bi morali načrt za obvladovanje tveganj pregledati vsaj enkrat letno, in sicer ob predložitvi redno posodobljenih poročil o varnosti zdravila.
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).
Zdravilo Closamectin Pour-On Solution se daje topikalno v odmerku 500 mg ivermektina na kg telesne mase in 20 mg klozantela na kg telesne mase (1 ml na 10 kg telesne mase).
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.
Priporočeno je bilo zbiranje dodatnih podatkov o neželenih dogodkih, ki se bodo zgodili v prihodnje, da bi opredelili možno vlogo zdravil, vključno z morebitno toksičnostjo klozantela, in raziskali možne dejavnike tveganja, povezane z neželenimi dogodki, o katerih so poročali po zdravljenju.
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.
Poleg farmakovigilančnih podatkov, ki jih je zagotovil imetnik dovoljenja za promet z zdravilom, kadar so bili na voljo, so bili zagotovljeni tudi rezultati diagnostičnih testov (npr. preiskave krvi in obdukcije itd.), opravljenih med preiskavami neželenih dogodkov.
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.
Kot nujna je bila opredeljena analiza post mortem v primerih pogina, da bi opredelili možno vlogo toksičnosti klozantela ter diagnosticirali morebitne druge bolezenske procese.
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.
Ti primeri so lahko povezani tudi s prebavnimi znaki, kot so anoreksija, diareja in v izjemnih primerih so lahko znaki trdovratni in povzroči smrt živali.
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.
V zelo redkih primerih (pri manj kot 1 žival od 10.000 živali, vključujoč posamezne primere), se lahko po dajanju zdravila pojavijo nevrološki znaki, kot so slepota, ataksija in mirovanje.
Care should be taken when treating animals which may be of low nutritional status as this may increase susceptibility of adverse events occurring.
Potrebna je previdnost pri zdravljenju živali s slabim stanjem prehranjenosti, saj lahko to poveča dovzetnost za pojav neželenih dogodkov.
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.
Nizke ravni teh mikrohranil in splošno slabo stanje prehranjenosti so bili ocenjeni kot možni dejavniki, povezani z neželenimi dogodki, opaženimi po zdravljenju, in kot možen vzrok za večjo pogostnost poročil o neželenih dogodkih v Franciji.
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.
Pri govedu je bil opravljen primerjalni pregled varnostnega profila drugih zdravil, ki vsebujejo ivermektin in/ali klozantel in ki jih proizvaja imetnik dovoljenja za promet z zdravilom (vključno z zdravilom za injiciranje, ki vsebuje kombinacijo obeh učinkovin).
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.
Poudarjeno je bilo, da bi morali analizo in izračun pojavnosti neželenih dogodkov opraviti na podlagi vseh podatkov, vendar obenem paziti, da se v posameznih poročilih o neželenih dogodkih točno navede ime zadevnega zdravila.
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.
Ti so zajemali spremembe informacij o zdravilu (kot je podrobno opisano v Prilogi III mnenja), katerih namen je izboljšati informacije o neželenih dogodkih, okrepiti nadzor v čredah, v katerih prihaja do neželenih dogodkov, in uvesti previdnostne ukrepe za zdravljenje živali s slabim stanjem prehranjenosti.
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.
Prav tako je bilo ugotovljeno, da je bila skupna pojavnost neželenih učinkov nekoliko višja pri zdravilu za injiciranje, ki vsebuje obe učinkovini, kot pri zdravilu za kožni poliv; v vsakem od poročil je bilo prizadeto večje število živali, čeprav je bilo število primerov, v katerih so poročali o poginu, manjše.
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.
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.
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.
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.
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.
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.
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.
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.
As an indirect benefit, it is noted that pour-on products are often preferred over injectable products due to the ease of administration.
Ugotovljena posredna korist je, da se zaradi lažjega dajanja zdravilom v obliki kožnega poliva pogosto daje prednost pred zdravili za injiciranje.
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.
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.
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.
Čeprav je skupna pojavnost neželenih dogodkov zelo redka, je bilo ugotovljeno, da je lahko ob pojavu neželenega dogodka v čredi prizadetih več živali.
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.
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.
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
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
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.
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.
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:
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:
SPC section 4.5 Special precautions for use: Special precautions for use in animals:
Povzetek glavnih značilnosti zdravila, poglavje 4.5 - Posebni previdnostni ukrepi: Posebni previdnostni ukrepi za uporabo pri živalih:
SPC section 4.6 Adverse reactions (Frequency and Seriousness)
Povzetek glavnih značilnosti zdravila, poglavje 4.6 - Neželeni učinki (pogostnost in resnost)
Summary of Product Characteristics
Povzetek glavnih znaèilnosti zdravila
Measures to mitigate the risk of adverse events following use of the product have been proposed.
Predlagani so bili ukrepi za zmanjševanje tveganja pojava neželenih dogodkov po uporabi zdravila.
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).
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).
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.
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.
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.
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.
The nature of the reported clinical signs was considered by ANMV to be indicative of the clinical signs associated with overdose toxicity of closantel.
Agencija ANMV je menila, da narava kliničnih znakov, o katerih so poročali, kaže na klinične znake, povezane s toksičnim učinkom prevelikega odmerka klozantela.
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.
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.
Amendments in the relevant sections of the summary of product characteristics and package leaflet
Popravki zadevnih poglavij povzetka glavnih znaèilnosti zdravila in navodila za uporabo
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.
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.