FrancophonIA/ELRC3.0 huggingface dataset:
English: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP guideline on injection site residues (EMEA/CVMP/542/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004429.pdf withdrawal period of 70 days for cattle meat and offal is therefore recommended for injectable veterinary medicinal products containing doramectin.
Croatian: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 2 CVMP guideline on injection site residues (EMEA/CVMP/542/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004429.pdf
English: Conclusion on the benefit-risk balance
Croatian: Zaključak o omjeru koristi i rizika
English: However, in view of the fact that sampling of the injection site was not in line with standards in place today and in view of the relatively large extrapolation from the last time point of slaughter (35 days) to the calculated withdrawal period, it was considered appropriate to apply a 30% safety span to the calculated withdrawal period of 60 days.
Croatian: No, s obzirom na činjenicu da uzorkovanje u mjestu injekcije nije provedeno u skladu sa standardima primjenjivima danas te s obzirom na relativno veliku ekstrapolaciju od posljednjeg klanja (35 dana) do izračunate karencije, zaključeno je da je primjereno dodati sigurnosnu marginu od 30% na izračunatu karenciju u trajanju od 60 dana.
English: The CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)3 suggests that, in the absence of any data in the minor species a withdrawal period of 1.5 times that approved for the major species can be considered.
Croatian: U smjernici CVMP za zahtjeve za sigurnost i podatke rezidua za veterinarsko-medicinske proizvode namijenjene za manje uporabe ili manje vrste (EMEA/CVMP/SWP/66781/2005)3 navedeno je da se u slučaju izostanka bilo kakvih podataka za manje vrste može razmotriti mogućnost karencije koja je 1,5 puta dulja od karancije odobrene za veće vrste.
English: 3 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf
Croatian: 3 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf na injekcijske VMP.
English: Three residue depletion studies were evaluated by the CVMP.
Croatian: CVMP je ocijenio tri ispitivanja deplecije rezidua.
English: Via Isonzo, 71 04100 Latina ITALY
Croatian: Pfizer Italia S.r.l. Via Isonzo, 71 04100 Latina ITALIJA
English: From the pivotal study representative of the worst case a withdrawal period of 60 days could be calculated.
Croatian: Na temelju pivotalnog ispitivanja reprezentativnog za najgori scenarij izračunata je karencija u trajanju od 60 dana.
English: Cattle, reindeer, pigs
Croatian: Goveda, reindeer, svinje
English: However, the existing warning sentence in the product information (Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving) is considered to be conservative.
Croatian: Smatra se da je postojeće upozorenje u informaciji o VMP (Ne koristite u mliječnih krava u suhostaju, uključujući i u gravidnih mliječnih junica, tijekom 60 dana prije teljenja) konzervativno.
English: A withdrawal period of 77 days is therefore recommended for pig meat and offal.
Croatian: Stoga se preporuča karencija od 77 dana za svinjsko meso i iznutrice.
English: Cattle, sheep, reindeer
Croatian: Goveda, ovce, reindeer
English: Cattle, pigs
Croatian: Goveda, svinje
English: Injektionslösung für Schweine intramuscular Pigs
Croatian: Injektionslösung für Schweine intramuskularno Svinje
English: Sheep:
Croatian: Ovce:
English: The Netherlands considered that it is in the interest of EU consumers and the environment to harmonise the withdrawal periods and the environmental risk mitigation measures and therefore, on 22 March 2012, the Netherlands presented to the European Medicines Agency a referral notification under Article 35 of Directive 2001/82/EC for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species.
Croatian: Nizozemska smatra da je usklađivanje razdoblja karencije i mjera za smanjenje rizika za okoliš u interesu potrošača Europske unije i okoliša, te je stoga dana 22. ožujka 2012. godine Nizozemska uputila Europskoj agenciji za lijekove obavijest o upućivanju sukladno članku 35.
English: Injectable veterinary medicinal product containing doramectin
Croatian: Injekcijski veterinarsko-medicinski proizvod koji sadrži doramektin Goveda
English: Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIUM
Croatian: Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIJA
English: Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM
Croatian: Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIJA
English: The available study in reindeer provided residue data at the injection site at 10 days after product administration.
Croatian: Dostupno ispitivanje provedeno u jelena navelo je podatke za rezidue u mjestu injekcije 10. dana nakon primjene VMP.
English: Environmental safety
Croatian: Sigurnost okoliša
English: In the first case, the risk to aquatic invertebrates could not be ruled out by performing several PEC refinements for the direct excretion scenario.
Croatian: U prvom se slučaju nije mogao isključiti rizik za vodene beskralježnjake na temelju provođenja nekoliko poboljšanja predviđenih koncentracija u okolišu (PKO) za scenarij izravne ekskrecije.
English: ZEARL PORCS Doramectin 10 mg/ml intramuscular Pigs
Croatian: ZEARL PORCS Doramectin 10 mg/ml intramuskularno Svinje
English: Animal species
Croatian: Put primjene Vrste životinja
English: The injection site was the tissue with the slowest rate of residue depletion in all studies and therefore data from the injection site provide the basis from which the withdrawal period is derived.
Croatian: Mjesto injekcije bilo je tkivo s najsporijom stopom deplecije rezidua u svim ispitivanjima, te stoga podaci prikupljeni za ovo mjesto injekcije čine osnovu za izračun karencije.
English: Faeces containing doramectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Croatian: Izmet, koji sadrži doramektin, a kojeg su liječene životinje izlučile na pašnjak, može smanjiti količinu organizama koji se hrane gnojem, što može imati učinak na razgradnju gnoja.
English: Based on data in cattle a terminal half-life of 7 days was conservatively estimated for doramectin residues at the injection site in reindeer.
Croatian: Na temelju podataka prikupljenih za goveda, procijenjen je terminalan poluvijek u trajanju od 7 dana za rezidue doramektina u mjestu injekcije u jelena.
English: The risk to aquatic ecosystems will be reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Croatian: Rizičnost za vodene ekosustave će se smanjiti ako se tretirane životinje drže podalje od vodenih ekosustava dva do pet tjedana nakon primjene.
English: For the dung fauna, the results of the Tier A assessment showed a very high RQ indicating an unacceptable acute risk.
Croatian: A pokazali su vrlo visoki RQ što ukazuje na neprihvatljiv akutan rizik.
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Croatian: Znanstveni zaključci i razlozi za izmjenu sažetaka opisa svojstava VMP, označavanja i upute o VMP
English: Pigs:
Croatian: Svinje:
English: 109 37401 Amboise Cedex, FRANCE
Croatian: De Poce-sur-Cisse, B.P. 109 37401 Amboise Cedex, FRANCUSKA
English: The information in some of these products is considered insufficient to mitigate the risk to the environment.
Croatian: Informacije u slučaju pojedinih VMP smatraju se nedostatnima za smanjenje rizika za okoliš.
English: Based on these data it was considered that a time span of 2 months between treatment and calving in non-lactating cattle would ensure safe residue levels in milk following administration of injectable products containing doramectin at the recommended dose.
Croatian: Na temelju ovih podataka zaključeno je da je vremenski razmak od 2 mjeseca od liječenja do teljenja goveda u suhostaju dovoljan kako bi se osigurale sigurne razine rezidua u mlijeku nakon primjene injekcijskih VMP, koji sadrže doramektin u preporučenoj dozi.
English: This would yield a withdrawal period of 105 days for reindeer.
Croatian: Na ovaj se način dolazi do karencije za jelene u trajanju od 105 dana.
English: • On the basis of the environmental risk assessment data submitted by the applicants/marketing authorisation holders for the injectable and pour-on veterinary medicinal products containing doramectin, the CVMP considered that in order to address the identified risks for aquatic organisms and dung fauna, as well as any remaining uncertainty regarding bioaccumulation, risk mitigation measure should be applied;
Croatian: • na temelju podataka procjene rizika za okoliš dostavljenih od strane podnositelja zahtjeva za odobrenje za stavljanje VMP u promet/nositelja odobrenja za injekcijske VMP i VMP za polijevanje po koži koji sadrže doramektin, CVMP smatra da se moraju primijeniti mjere za smanjenje rizika u cilju rješavanja identificiranih rizika za vodene organizme i faunu prisutnu u gnoju, kao i svih preostalih neizvjesnosti u vezi s bioakumulacijom;
English: the CVMP has recommended variations of the marketing authorisations for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species (see annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in annex III.
Croatian: je CVMP preporučio izmjene odobrenja za stavljanje VMP u promet za injekcijske VMP i VMP za polijevanje po koži koji sadrže doramektin, a koji su namijenjeni za uporabu u vrstama sisavaca koji se koriste za proizvodnju hrane (vidjeti Dodatak I) sa ciljem dopune sažetaka opisa svojstava VMP, označavanja i uputa o VMP u skladu s preporučenim izmjenama u informacijama o VMP, koje su navedene u Dodatku III.
English: • the CVMP considered that the overall benefit-risk balance is positive for the injectable and pour-on veterinary medicinal products containing doramectin, subject to amendments in the product information;
Croatian: • CVMP smatra da je ukupan omjer koristi i rizika pozitivan za injekcijske VMP i VMP za polijevanje po koži koji sadrže doramektin, koji je predmetom dopuna informacija o VMP;
English: The benefit-risk evaluation for the products concerned is deemed to be positive provided that (i) for the injectable products the withdrawal periods for meat and offal are set for cattle at 70 days, for sheep at 70 days, for pigs at 77 days and for reindeer at 70 days, (ii) for the injectable and pour-on products the following periods with regard to milk are set as the minimum time spans that must elapse between treatment and calving/lambing: 2 months for cattle and reindeer and 70 days for sheep and (iii) for the injectable and pour-on products risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
Croatian: Ocjena omjera koristi i rizika za predmetne VMP pokazala se pozitivnom pod uvjetom da (i) za injekcijske VMP vrijeme karencije za meso i iznutrice iznosi 70 dana za goveda, 70 dana za ovce, 77 dana za svinje i 70 dana za jelene, (ii) se za injekcijske VMP i VMP za polijevanje po koži sljedeća razdoblja s obzirom na mlijeko odrede kao minimalni vremenski razmaci, koji moraju proći između liječenja i teljenja/janjenja: 2 mjeseca za stoku i jelene te 70 dana za ovce, (iii) se za injekcijske VMP i VMP za polijevanje po koži u informacije o lijeku dodaju mjere za smanjenje rizika povezane s rizikom za vodene organizme i faunu prisutnu u gnoju.
English: Belgium Eli Lilly Benelux S.A. Division Elanco Animal Health Stoofstraat 52
Croatian: Division Elanco Animal Health Stoofstraat 52
English: No milk residue data following treatment of dairy animals in the dry period were available to the CVMP.
Croatian: CVMP nije imao pristupa podacima o reziduima u mlijeku nakon liječenja mliječnih životinja u razdoblju suhostaja.
English: Furthermore the evaluation concludes that use of injectable and pour-on veterinary medicinal products containing doramectin during the nonlactating period could lead to residue levels in milk resulting in consumer exposure over the acceptable daily intake.
Croatian: Nadalje, na temelju ocjene zaključeno je da primjena injekcijskih VMP i VMP za polijevanje po koži koji sadrže doramektin tijekom razdoblja suhostaja može uzrokovati razine rezidua u mlijeku, što rezultira izlaganjem potrošača razinama koje premašuju prihvatljivi dnevni unos.
English: Amendments in the relevant sections of the product information for injectable veterinary medicinal products containing doramectin:
Croatian: Dodatci u relevantnim dijelovima informacija o proizvodu za injekcijske veterinarsko medicinske proizvode koji sadrže doramektin:
English: Overall summary of the scientific evaluation of all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene svih injekcijskih veterinarsko-medicinskih proizvoda i veterinarskomedicinskih proizvoda za polijevanje po koži koji sadrže doramektin, a koji su predviđeni za uporabu u vrstama sisavaca koje se koriste za proizvodnju hrane (vidjeti Dodatak I)
English: Cattle, sheep
Croatian: Goveda, ovce
English: In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended for the pour-on veterinary medicinal products containing doramectin:
Croatian: U cilju rješavanja identificiranih rizika za vodene organizme i faunu u gnoj, kao i ostalih neizvjesnosti u vezi s bioakumulacijom, preporučaju se sljedeće mjere za smanjenje rizika za VMP za polijevanje po koži koji sadrže doramektin:
English: In addition, the Netherlands noted that injectable and pour-on veterinary medicinal products containing doramectin intended for food producing species contain different risk mitigation measures in the product information in relation to the risks for the environment.
Croatian: Nadalje, Nizozemska je upozorila da injekcijski VMP i VMP za polijevanje po koži, koji sadrže doramektin i predviđeni su za uporabu u vrsta koje se koriste za proizvodnju hrane, sadrže različite mjere za smanjenje rizika u informacijama o VMP u vezi s rizicima za okoliš.
English: The injection site was consistently the tissue in which the marker residue persisted for longest and was consequently the key tissue for the withdrawal period derivation.
Croatian: Mjesto injekcije je konzistentno tkivo u kojem se marker rezidua najdulje zadrži, te je to stoga ključno tkivo za izvođenje razdoblja karencije.
English: Do not use in pregnant ewes, which are intended to produce milk for human consumption, within 70 days of expected parturition.
Croatian: Ne primjenjivati na gravidnim životinjama koje su namijenjene za proizvodnju mlijeka za ljudsku upotrebu u roku od 70 dana od očekivanog poroda.
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle and sheep.
Croatian: Rizik za vodene organizme i faunu prisutnu u gnoju može se smanjiti izbjegavanje prečeste i ponovljene uporabe doramektina (i lijekova istog antiemetičkog razreda) u goveda i ovaca.
English: Dectomax-S Injektionslösung intramuscular Pigs
Croatian: Dectomax-S Injektionslösung intramuskularno Svinje
English: A withdrawal period of 70 days is therefore recommended for reindeer meat and offal.
Croatian: Stoga se preporuča karencija od 70 dana za jelenje meso i iznutrice.
English: PRONTAX 5 mg/ml Pour On Solution for Cattle
Croatian: PRONTAX 5 mg/ml Pour On Solution for Goveda
English: However, two non-GLP residue depletion studies performed in lactating cattle were available and provided data on residues in milk.
Croatian: No, dostupna su dva ispitivanja deplecije rezidua, koja ne podliježu DLP, koja su provedena u goveda u laktaciji, te se u ovim ispitivanjima navode podaci o reziduima u mlijeku.
English: Milk - Time span between treatment of non-lactating animals and parturition:
Croatian: Mlijeko - vremenski razmak između liječenja životinja u suhostaju i teljenja:
English: Doramectin is very toxic to aquatic organisms and may accumulate in sediments.
Croatian: Doramektin je vrlo toksičan za organizme vodenih sustava i može se akumulirati u sedimentima.
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle.
Croatian: Rizik za vodene organizme i faunu prisutnu u gnoju može se smanjiti izbjegavanje prečeste i ponovljene uporabe doramektina (i lijekova istog antiemetičkog razreda) u goveda.
English: Do not use in pregnant does, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Croatian: Ne primjenjivati na gravidnim životinjama koje su namijenjene za proizvodnju mlijeka za ljudsku upotrebu u roku od 2 mjeseca od očekivanog poroda.
English: BELGIUM
Croatian: BELGIJA
English: The injection site was the tissue in which the marker residue persisted for longest and was consequently the tissue for the withdrawal period derivation.
Croatian: Mjesto injekcije VMP bilo je tkivo u kojem se marker rezidua zadrži najdulje, te je to stoga ključno tkivo za izvođenje razdoblja karencije.
English: Doramectin is administered by subcutaneous injection to cattle at a dose of 200 μg/kg body weight (bw) for the treatment and control of gastrointestinal nematodes, lungworms, eyeworms, warbles, lice, mange mites and ticks.
Croatian: Doramektin se primjenjuje potkožnom injekcijom u goveda u dozi od 200 μg/kg tjelesne mase (tm) za potrebe liječenja i kontrole gastrointestinalnih nematoda, plućnih crva, očnih crva, štrkova, uši, grinja šugarca i krpelja.
English: • On the basis of the residue depletion data in cattle and sheep submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, and in the absence of maximum residue limits for doramectin in milk, the CVMP considered the minimum time spans of 2 months for cattle and reindeer and 70 days for sheep must elapse between administration of these doramectin containing products and calving or lambing;
Croatian: • na temelju podataka o deplecije rezidua u goveda, ovaca, svinja i jelena dostavljenih od strane podnositelja zahtjeva za odobrenje za stavljanje VMP u promet/nositelja odobrenja za injekcijske VMP koji sadrže doramektin te u nedostatku maksimalnih razina rezidua za doramektin u mlijeku, CVMP smatra da minimalni vremenski odmaci od 2 mjeseca za goveda i jelene te 70 dana za ovce moraju proći od primjene ovih VMP, koji sadrže doramektin, i teljenja ili janjenja;
English: UNITED KINGDOM
Croatian: Velika Britanija
English: United Kingdom
Croatian: VELIKA BRITANIJA
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflets
Croatian: Dodatci u relevantnim dijelovima sažetka opisa svojstava, označavanju i uputi
English: • On the basis of the residue depletion data in cattle, sheep, pigs and reindeer submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, the CVMP considered that withdrawal periods of 70 days for cattle meat and offal, 70 days for sheep meat and offal, 77 days for pig meat and offal and 70 days for reindeer meat and offal were safe;
Croatian: • na temelju podataka o deplecije rezidua u goveda, ovaca, svinja i jelena dostavljenih od strane podnositelja zahtjeva za odobrenje za stavljanje VMP u promet/nositelja odobrenja za injekcijske VMP koji sadrže doramektin, CVMP smatra da je karencija od 70 dana za goveđe meso i iznutrice, 70 dana za ovčje meso i iznutrice, 77 dana za svinjsko meso i iznutrice i 70 dana za jelenje meso i iznutrice sigurna;
English: In addition, in cattle doramectin is administered topically on the back of the animal at a dose of 500 μg/kg bw for treatment of infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly.
Croatian: Nadalje, doramektin se u goveda primjenjuje topikalno u leđa životinje u dozi od 500 μg/kg tm za liječenja zaraza gastrointestinalnim nematodima, plućnim crvima, očnim crvima, štrkovima, pravim ušima i tekutima (Mellophaga), grinjama šugavaca te muhama Haematobia irritans.
English: Amendments in the relevant sections of the product information for pour-on veterinary medicinal products containing doramectin:
Croatian: Dodatci u relevantnim dijelovima informacija o proizvodu za veterinarsko medicinske proizvode u obliku poliva koji sadrže doramektin:
English: In reindeer doramectin is administered as a single subcutaneous injection at a dose of 200 μg/kg bw for treatment of nematodes and throat bot.
Croatian: Doramektin se primjenjuje u jelena u obliku jedne potkožne injekcije u dozi od 200 μg/kg tm za potrebe liječenja nematoda i kukca Cephenemyia trompe.
English: Sheep
Croatian: Ovce
English: Austria
Croatian: AUSTRIJA
English: AUSTRIA
Croatian: Austrija
English: Pour-on veterinary medicinal product containing doramectin (cattle)
Croatian: Veterinarsko-medicinski proizvod za polijevanje po koži koji sadrži doramektin (goveda) Meso i iznutrice:
English: This conclusion applies to both the pour-on and to the injectable products.
Croatian: Ovaj se zaključak primjenjuje na VMP za polijevanje po koži i na injekcijske VMP.
English: Having considered the residue depletion data submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, withdrawal periods of 70 days for cattle meat and offal, 70 days for sheep meat and offal, 77 days for pig meat and offal and 70 days for reindeer meat and offal were considered safe.
Croatian: Po razmatranju podataka o depleciji rezidua koje su dostavili podnositelji zahtjeva za odobrenje za stavljanje VMP u promet/nositelji odobrenja za VMP koji sadrže doramektin, zaključeno je da je karencija u trajanju od 70 dana za goveđe meso i iznutrice, 70 dana za ovčje meso i iznutrice, 77 dana za svinjsko meso i iznutrice i 70 dana za jelenje meso i iznutrice sigurna.