FrancophonIA/ELRC3.0 huggingface dataset:
English: With regard to pour-on products the information received from Member States indicates that the withdrawal period for cattle meat and offal is 35 days in all Member States (EU/EEA), where the products are authorised or pending authorisations.
Slovenian: Kar zadeva zdravila za poliv informacije, ki so jih predložile države članice, navajajo, da znaša obdobje karence za goveje meso in organe 35 dni v vseh državah članicah (EU/EGP), kjer so zdravila odobrena ali čakajo na odobritev.
English: Meat and offal: 70 days
Slovenian: Meso in organi: 70 dni.
English: Environmental safety
Slovenian: Varnost za okolje
English: Environmental risk assessment
Slovenian: Ocena tveganja za okolje
English: However, study results were highly variable (the studies predate the current CVMP and VICH guidelines recommending injection site sampling procedures and consequently did not incorporate quality control measures to ensure that the injection site was appropriately sampled).
Slovenian: Vendar so rezultati študij močno variirali (študije so bile izvedene pred trenutnimi navodili CVMP in VICH glede priporočenih postopkov vzorčenja na mestu injiciranja, zato niso vključevale ukrepov za nadzor kakovosti, s katerimi bi zagotovili ustrezno vzorčenje na mestu injiciranja).
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.
Slovenian: Nizozemska je menila, da je v interesu potrošnikov EU in okolja, da se uskladijo obdobja karence in ukrepi za zmanjšanje tveganja za okolje, zato je 22. marca 2012 Evropski agenciji za zdravila predstavila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini za injiciranje ali kožni poliv, ki vsebujejo doramektin in so namenjena uporabi pri vrstah sesalcev, ki proizvajajo prehrano za ljudi.
English: It should be noted that due to the absence of a maximum residue limit (MRL) in milk the veterinary medicinal products containing doramectin are not authorised for use in lactating animals.
Slovenian: Opozoriti je treba, da zaradi odsotnosti mejne vrednosti ostankov v mleku zdravila za uporabo v veterinarski medicini, ki vsebujejo doramektin, niso dovoljena za uporabo pri živalih v laktaciji.
English: However, these products have been used during the dry period with different precautionary measures in place to limit residues in milk, in particular instructions are given on the time that must be allowed to elapse between treatment and calving or lambing.
Slovenian: Vendar so se ta zdravila uporabljala v presušitvi z različnimi previdnostnimi ukrepi za omejitev ostankov v mleku; podana so predvsem navodila o času, ki mora preteči med zdravljenjem in otelitvijo oziroma jagnjitvijo.
English: 4.5 Special precaution for use
Slovenian: 4.5 Posebni previdnostni ukrepi
English: Therefore, risk mitigation measures are considered necessary to be included in the product information as specified above.
Slovenian: Iz tega razloga je bilo ocenjeno, da je v informacije o zdravilu nujno vključiti ukrepe za zmanjševanje tveganja, kot je navedeno zgoraj.
English: As no harmonised guidance on how to conduct Tier B assessment studies for dung insects is currently available, risk mitigation measures to reduce exposure are considered to overcome the identified risk.
Slovenian: Ker usklajena navodila za izvedbo ocenjevanja tveganja v stopnji B za insekte, prisotne v gnoju, trenutno niso na voljo, so potrebni ukrepi za zmanjševanje tveganja, da bi bilo mogoče preseči ugotovljeno tveganje.
English: For the dung fauna, the results of the Tier A assessment showed a very high RQ indicating an unacceptable acute risk.
Slovenian: Za organizme, prisotne v gnoju, so rezultati ocene v stopnji A pokazali zelo visok količnik tveganja, ki kaže na nesprejemljivo akutno tveganje.
English: This would yield a withdrawal period of 105 days for reindeer.
Slovenian: To bi pomenilo karenco 105 dni za jelenjad.
English: For the run-off scenario, as the highest PECcattle (0.84 µg/kg) is higher than the highest PECsheep (0.48 µg/kg), the conclusion from the cattle can be extrapolated to sheep.
Slovenian: Ker je najvišji PKOgoveda (0,84 µg/kg) višji od najvišjega PKOovce (0,48 µg/kg), je mogoče sklep z goveda za scenarij površinskega odtekanja ekstrapolirati na ovce.
English: This conclusion applies to both the pour-on and to the injectable products.
Slovenian: Ta sklep velja za zdravila za kožni poliv in za zdravila za injiciranje.
English: The following text should be included in SPC section 5.3 Environmental properties:
Slovenian: Naslednje besedilo je treba vključiti v poglavje 5.3 povzetka glavnih značilnosti zdravila (okoljski podatki):
English: As part of the CVMP evaluation the Committee considered whether further recommendations are necessary in order to ensure that use during the non-lactating period would not lead to residues in milk that, combined with residues from other foodstuffs, would result in consumer exposure exceeding the acceptable daily intake (ADI) (60 μg/person per day).
Slovenian: Odbor je kot del ocene CVMP obravnaval, ali so potrebna nadaljnja priporočila, s katerimi bi zagotovili, da med obdobjem izven časa laktacije ne bi prišlo do ostankov v mleku, ki bi lahko skupaj z ostanki iz drugih živil povzročili izpostavljenost potrošnika, ki je večja od največjega dovoljenega dnevnega vnosa (60 μg/osebo na dan).
English: Three residue depletion studies were evaluated by the CVMP.
Slovenian: CVMP je ocenil tri študije izločanja ostankov.
English: However, in view of the variability seen across the studies, in view of the fact that none of the studies were performed in line with standards in place today and considering that in a number of studies residue levels remained above the MRL at the last timepoint, it was considered appropriate to add a safety margin of 30% to compensate for the uncertainties associated with the overall data package.
Slovenian: Vendar je bilo ocenjeno, da je zaradi variabilnosti med študijami in dejstva, da nobena od študij ni bila izvedena v skladu z današnjimi standardi, in ker so bile na zadnji časovni točki stopnje ostanka v številnih študijah nad mejno vrednostjo ostankov, primerno dodati varnostno mejo 30 %, ki bo nadomestila negotovosti glede celotnega nabora podatkov.
English: Based on the data available it was considered that the existing warning sentence in the product information (Do not use in dry dairy ewes including pregnant dairy ewes within 70 days prior to lambing) is conservative and gives sufficient assurance in terms of consumer safety following administration at the highest recommended dose of 300 μg/kg bw.
Slovenian: Na podlagi razpoložljivih podatkov je bilo ocenjeno, da je trenutni opozorilni stavek v informacijah o zdravilu (Ne uporabljajte pri ovcah molznicah v presušitvi, vključno z brejimi ovcami v času 70 dni pred jagnjitvijo) konzervativen in daje zadostno zagotovilo glede varnosti za potrošnika po dajanju pri najvišjem priporočenem odmerku 300 μg/kg telesne mase.
English: Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Slovenian: Podobno kot drugi makrociklični laktoni lahko tudi doramektin negativno vpliva na neciljne organizme.
English: LABORATÓRIOS PFIZER, LDA.
Slovenian: Portugalska LABORATÓRIOS PFIZER, LDA.
English: Considering the highest residue levels seen at 10 days and taking account of the estimated half it was calculated that by 66 days after product administration doramectin levels at the injection site would be present at levels below half the MRL.
Slovenian: Ob upoštevanju najvišjih ravni ostankov, ki so jih opazili pri 10 dneh, in ocenjene razpolovne dobe je bilo izračunano, da bodo do 66 dni po dajanju zdravila ravni doramektina na mestu injiciranja prisotne pri ravneh, ki so pod polovico mejne vrednosti ostankov.
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.
Slovenian: je CVMP priporočil spremembe dovoljenj za promet z zdravili za vsa zdravila za uporabo za injiciranje in kožni poliv v veterinarski medicini, ki vsebujejo doramektin in so namenjena uporabi pri vrstah, ki proizvajajo prehrano za ljudi (glejte Prilogo I), s katerimi se bo dopolnilo povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo skladno s priporočenimi spremembami v informacijah o zdravilu, kot so navedena v Prilogi III.
English: This withdrawal period (70 days) is recommended for both doses in sheep (i.e. 200 µg/kg bw and 300 µg/kg bw) approved for intramuscular administration.
Slovenian: Ta karenca (70 dni) je priporočena za oba odmerka pri ovcah (tj. 200 µg/kg telesne mase in 300 µg/kg telesne mase) in je odobrena za intramuskularno dajanje.
English: The available study in reindeer provided residue data at the injection site at 10 days after product administration.
Slovenian: V razpoložljivi študiji pri jelenjadi so bili navedeni podatki o ostankih na mestu injiciranja 10 dni po dajanju zdravila.
English: One GLP residue study (1998) in reindeer was available for evaluation by the CVMP but could not be used to determine the withdrawal period as there were only two slaughter time points, the number of animals/group was relatively small and at the last time point one of the injection site samples contained residues above the MRL for muscle (40 μg/kg).
Slovenian: CVMP je imel na voljo za vrednotenje eno študijo dobre laboratorijske prakse o ostankih (1998) pri jelenjadi, vendar študije ni bilo mogoče uporabiti za določitev karence, ker je imela samo dve časovni točki zakola, ker je bilo število živali/skupina relativno majhna in ker so bili na zadnji časovni točki pri enem vzorčenje na mestu injiciranja ostanki nad mejno vrednostjo ostankov za mišice (40 μg/kg).
English: Using the data from the most appropriate study a calculated withdrawal period of 54 days could be derived.
Slovenian: S pomočjo podatkov iz najustreznejše študije je mogoče izračunati obdobje karence 54 dni.
English: In terms of bioaccumulation the log Pow value is not considered to be robust given the method employed (shake flask), but nevertheless indicates doramectin being potentially bioaccumulative.
Slovenian: Kar zadeva biološko kopičenje vrednost log Pow zaradi uporabljene metode (stresanje bučke) ni bila ocenjena za zanesljivo, vendar kljub temu kaže na potencialno biološko kopičenje doramektina.
English: Aquatic organisms were considered not at risk from doramectin entering surface water bodies via run-off from use in sheep.
Slovenian: Vodni organizmi naj ne bi bili izpostavljeni tveganju doramektina, ki v površinska vodna telesa vstopa preko površinskega odtekanja pri uporabi na ovcah.
English: Pour-on solution topical - on the back of the animal
Slovenian: Kožni poliv, raztopina topikalno - na hrbet živali
English: CZECH REPUBLIC
Slovenian: Češka Republika
English: A Daphnia magna reproduction study for conducting a Tier B assessment was not submitted in the ERA.
Slovenian: Študija vpliva na sposobnost razmnoževanja vodne bolhe (Daphnia magna) za izvedbo ocene v stopnji B v okviru ocene tveganja za okolje ni bila predložena.
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)
Slovenian: Splošni povzetek znanstvenega vrednotenja vseh zdravil za uporabo v veterinarski medicini za injiciranje ali poliv, ki vsebujejo doramektin in so namenjena uporabi pri vrstah sesalcev, ki proizvajajo prehrano za ljudi (glejte Prilogo I)
English: In addition to the fact that the available data do not allow to rule out bioaccumulation of doramectin, a risk to aquatic organisms has been identified based on available toxicity data (acute toxicity for Daphnia magna) as well as a risk to dung fauna exposed to residue-containing dung when the products are used in accordance with the recommended posology.
Slovenian: Poleg dejstva, da na osnovi razpoložljivih podatkov ni mogoče izključiti biološkega kopičenja doramektina, je bilo na osnovi razpoložljivih podatkov o toksičnosti ugotovljeno tveganje za vodne organizme (akutna toksičnost za vrsto Daphnia magna) ter tveganje za organizme, prisotne v gnoju, ki so pri uporabi zdravila v skladu s priporočenim načinom odmerjanja izpostavljeni gnoju, ki vsebuje ostanke.
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;
Slovenian: • CVMP je menil, da je celokupno razmerje med tveganji in koristmi za zdravila za uporabo za injiciranje in kožni poliv v veterinarski medicini, ki vsebujejo doramektin, pozitivno, če se upoštevajo spremembe v informacijah o zdravilu;
English: The risk to aquatic ecosystems will be reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Slovenian: Tveganje za vodne ekosisteme je mogoče zmanjšati tako, da se govedu prepreči približevanje vodnim telesom dva do pet tednov po zdravljenju.
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.
Slovenian: Na osnovi teh podatkov je bilo ocenjeno, da časovni razpon 2 mesecev med zdravljenjem in otelitvijo goveda izven časa laktacije zagotavlja varne ravni ostankov v mleku po dajanju zdravil za injiciranje, ki vsebujejo doramektin, v priporočenem odmerku.
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.
Slovenian: Ker vzorčenje na mestu injiciranja ni bilo v skladu z današnjimi standardi in ker je bila ekstrapolacija z zadnje časovne točke zakola (35 dni) do izračunane karence relativno velika, pa je bilo ocenjeno, da je za izračunano karenco 60 dni primerno uporabiti 30-odstotni varnosti razpon.
English: Conclusion on the benefit-risk balance
Slovenian: Zaključki o razmerju med tveganji in koristmi
English: intramuscular Pigs
Slovenian: intramuskularno Prašiči
English: Lagoas Park - Edifício 10 2740-244 Porto Salvo PORTUGAL
Slovenian: 2740-244 Porto Salvo
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.
Slovenian: Vendar je bilo ocenjeno, da je trenutni opozorilni stavek v informacijah o zdravilu (Ne uporabljajte pri kravah molznicah v presušitvi, vključno z brejimi telicami v času 60 dni pred otelitvijo) konzervativen.
English: Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIUM
Slovenian: Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIJA
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.
Slovenian: 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)
English: Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM
Slovenian: Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIJA
English: Injektionslösung für Schweine intramuscular Pigs
Slovenian: Injektionslösung für Schweine intramuskularno Prašiči
English: No studies in lactating or non-lactating doe were provided.
Slovenian: Predložene niso bile nobene študije pri srnah molznicah ali srnah izven časa laktacije.
English: Using the data from a pivotal study with Dectomax Incjectable a withdrawal period of 65 days could be derived.
Slovenian: S pomočjo podatkov iz ključne študije z zdravilom Dectomax za injiciranje je mogoče izračunati karenco 65 dni.
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.
Slovenian: Blato z doramektinom, ki ga na pašniku izločijo zdravljene živali, lahko zmanjša količino organizmov, prisotnih v gnoju, kar lahko vpliva na razgradnjo gnoja.
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.
Slovenian: V navodilih CVMP o zahtevah za varnost in podatkih o ostankih za zdravila za uporabo v veterinarski medicini, ki so namenjena manjši uporabi ali uporabi pri manj pomembnih vrstah (EMEA/CVMP/SWP/66781/2005)3 je predlagano, da se lahko v primeru odsotnosti vsakršnih podatkov pri manj pomembnih vrstah upošteva karenca, ki je 1,5-kratnik odobrene karence za pomembnejše vrste.
English: The outcome of the ERA indicates that RQ are higher than 1 in the Tier A assessment in two cases, namely aquatic invertebrates (following direct excretion scenario) and dung fauna.
Slovenian: Izid ocene tveganja za okolje kaže, da je količnik tveganja (RQ) pri ocenjevanju v stopnji A večji od 1 v dveh primerih, v glavnem pri vodnih nevretenčarjih (pri scenariju neposrednega izločanja) in pri organizmih, prisotnih v gnoju.
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.
Slovenian: Mesto injiciranja je bilo tkivo z najpočasnejšo stopnjo izločanja ostankov v vseh študijah, zato podatki z mesta injiciranja predstavljajo osnovo za izračun karence.
English: Pigs:
Slovenian: Prašiči:
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.
Slovenian: Na podlagi podatkov pri govedu je bila za ostanke doramektina na mestu injiciranja pri jelenjadi konzervativno ocenjena končna razpolovna doba 7 dni.
English: The Netherlands noted that identical or similar injectable veterinary medicinal products containing doramectin intended for food producing species have different withdrawal periods established by the Member States (EU/EEA).
Slovenian: Nizozemska je opozorila, da imajo identična ali podobna zdravila za injiciranje za uporabo v veterinarski medicini, ki vsebujejo doramektin in so namenjena uporabi pri vrstah, namenjenih za človeško prehrano, drugačna obdobja karence v posameznih državah članicah (EU/EGP).
English: However, as reindeer is considered to be a minor species (with cattle being the corresponding major species) the possibility of extrapolating a withdrawal period from cattle was considered appropriate.
Slovenian: Ker je jelenjad manj pomembna vrsta (govedo pa pomembnejša vrsta), pa je bilo ocenjeno, da je mogoče izvesti ekstrapolacijo karence z goveda.
English: Therefore an evaluation of the withdrawal periods in meat and offal for pour-on products was not necessary.
Slovenian: Zato ocena obdobij karence pri mesu in organih za zdravila za kožni poliv ni bila potrebna.
English: Milk - Time span between treatment of non-lactating animals and parturition:
Slovenian: Mleko − časovni razpon med zdravljenjem živali izven časa laktacije in kotitvijo:
English: From the pivotal study representative of the worst case a withdrawal period of 60 days could be calculated.
Slovenian: Iz ključne študije, ki predstavlja najslabši primer, je mogoče izračunati karenco 60 dni.
English: ZEARL PORCS Doramectin 10 mg/ml intramuscular Pigs
Slovenian: ZEARL PORCS Doramectin 10 mg/ml intramuskularno Prašiči
English: Cattle, pigs
Slovenian: Govedo, prašiči
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.
Slovenian: Ocena razmerja med tveganji in koristmi za zadevna zdravila velja za pozitivno pod pogojem, (i) da se za zdravila za injiciranje določijo karence za meso in drobovino, in sicer 70 dni za govedo, 70 dni za ovce, 77 dni za prašiče in 70 dni za jelenjad, (ii) da se za zdravila za injiciranje in kožni poliv določijo naslednja obdobja glede mleka, ki predstavljajo minimalni časovni razpon, ki mora preteči med zdravljenjem in otelitvijo/jagnjitvijo: 2 meseca za govedo in jelenjad ter 70 dni za ovce in (iii) da se za zdravila za injiciranje in kožni poliv v informacije o zdravilu vključijo ukrepi za zmanjševanje tveganja v zvezi s tveganjem za vodne organizme in organizme, prisotne v gnoju.
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.
Slovenian: Nadalje je bilo v okviru ocene zaključeno, da lahko uporaba zdravil za injiciranje in kožni poliv za uporabo v veterinarski medicini, ki vsebujejo doramektin, med obdobjem izven laktacije vodi do ravni ostankov v mleku, ki povzročajo izpostavljenost potrošnika, ki je večja od največjega dovoljenega dnevnega vnosa.
English: Animal species
Slovenian: Pot uporabe Živalska vrsta
English: Sheep:
Slovenian: Ovce:
English: The MRLs currently established for doramectin in tissues use 90% (60 μg/person per day) of the ADI, leaving 10% (6 μg) available to cover exposure to residues resulting from other sources, such as via milk.
Slovenian: Mleko − časovni razpon med zdravljenjem živali izven časa laktacije in otelitvijo: Trenutno sprejeta mejna vrednost ostankov za doramektin v tkivih predstavlja 90 % (60 μg/osebo na dan) največjega dovoljenega dnevnega vnosa, kar pomeni, da ostane 10 % (6 μg) za izpostavljenost ostankom iz drugih virov, na primer prek mleka.
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Slovenian: Znanstveni zaključki in podlaga za dopolnilo povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo