natgillin/translations-raw huggingface dataset:
13 Rue Pages 92158 Suresnes Cedex FRANCE
13 Rue Pages 92158 Suresnes Cedex FRANCIJA
Consumer safety
Varnost za potrošnika
The marketing authorisation holders provided a Phase II environmental risk assessment.
Imetniki dovoljenj za promet z zdravili so predložili oceno tveganja za okolje faze II.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskih vrst, poti uporabe, predlagateljev/imetnikov dovoljenja za promet v državah članicah.
Two studies in sheep were provided.
Predloženi sta bili dve študiji pri ovcah.
Amend where applicable:
Dopolniti, kjer je primerno:
By applying this ratio to milk and using 6 µg as the total amount of doramectin residues that can be considered safe in 1.5 litres of milk (i.e. the amount of milk considered to be consumed on a daily basis), one can calculate the concentration of doramectin in milk that can be considered safe to be 3.44 µg/l (6 µg x 0.86/1.5 l).
Z uporabo tega razmerja za mleko in z uporabo količine 6 µg kot celotne količine ostankov doramektina, ki se jih lahko varno zaužije v 1,5 litra mleka (tj. količina mleka, ki naj bi jo zaužili vsakodnevno), se lahko izračuna koncentracija doramektina v mleku, ki se lahko oceni kot varna in znaša 3,44 µg/l (6 µg x 0,86/1,5 l).
Residue data
Podatki o ostankih
The value of 3.44 µg/l was rounded down to 3 µg/l, which was considered to represent a safe doramectin level in milk.
Vrednost 3,44 µg/l je bila zaokrožena navzdol na 3 µg/l, kar naj bi predstavljalo varno raven doramektina v mleku.
The current data package does not allow the assessment of bioaccumulation and therefore, bioaccumulation of doramectin cannot be ruled out.
Trenutni nabor podatkov ne omogoča izvedbe ocene biološkega kopičenja, zato biološkega kopičenja doramektina ni mogoče izključiti.
PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GREECE
PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GRČIJA
As some data in reindeer were available it was considered appropriate to refine this estimate.
Ker so določeni podatki pri jelenjadi bili na voljo, so ocenili, da je primerno prilagoditi ta približek.
While no data were available that would allow the establishment of the ratio of marker to total residues for milk, it was considered that the ratio established by CVMP for fat (0.86) could be applied to milk.
Čeprav ni bilo na voljo podatkov, ki bi omogočali določitev razmerja med označevalcem in celokupnimi ostanki za mleko, je bilo ocenjeno, da se lahko razmerje, ki ga je CVMP določil za maščobo (0,86), uporabi tudi za mleko.
It is a macrocyclic lactone closely related to ivermectin.
Je makrociklični lakton, ki je soroden ivermektinu.
Several studies in cattle were provided.
Predloženih je bilo več študij pri govedu.
Meat and offal: 77 days
Meso in organi: 77 dni.
Following treatment, excretion of potentially toxic levels of doramectin may take place over a period of several weeks.
Po zdravljenju lahko izločanje potencialno toksičnih ravni doramektina traja še več tednov.
In respect to the environmental impact for the use of the solution for injection in sheep the CVMP considered that according to the CVMP guidance, only cattle are concerned with the scenario “direct excretion into surface water”.
V zvezi z vplivom na okolje pri uporabi raztopine za injiciranje pri ovcah je CVMP menil, da v skladu z navodili CVMP „scenarij neposrednega izločanja v površinske vode‟ velja samo za govedo.
The supplementary data provided did not allow ruling out a medium to long-term risk to dung insects.
Na podlagi predloženih dodatnih podatkov ni bilo mogoče izključiti srednje- do dolgoročnega tveganja za insekte, prisotne v gnoju.
However, in view of the fact that the study was not performed in line with standards in place today, it was considered that the withdrawal period of 70 days recommended in the 2005 referral procedure under Article 34 of Directive 2001/82/EC for Dectomax 1% injectable solution for cattle and sheep (EMEA/V/A/009) should be maintained.
Ker študija ni bila izvedena v skladu z današnjimi standardi, pa je bilo ocenjeno, da bi bilo treba ohraniti karenco 70 dni, kot je priporočeno v napotitvenem postopku iz leta 2005 v skladu s členom 34 Direktive 2001/82/ES za zdravilo Dectomax 1 % raztopina za injiciranje za govedo in ovce (EMEA/V/A/009).
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.
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.
Meat and offal: 70 days
Meso in organi: 70 dni.
Environmental safety
Varnost za okolje
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).
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).
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.
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.
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.
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.
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.
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.
4.5 Special precaution for use
4.5 Posebni previdnostni ukrepi
Therefore, risk mitigation measures are considered necessary to be included in the product information as specified above.
Iz tega razloga je bilo ocenjeno, da je v informacije o zdravilu nujno vključiti ukrepe za zmanjševanje tveganja, kot je navedeno zgoraj.
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.
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.
For the dung fauna, the results of the Tier A assessment showed a very high RQ indicating an unacceptable acute risk.
Za organizme, prisotne v gnoju, so rezultati ocene v stopnji A pokazali zelo visok količnik tveganja, ki kaže na nesprejemljivo akutno tveganje.
This would yield a withdrawal period of 105 days for reindeer.
To bi pomenilo karenco 105 dni za jelenjad.
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.
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.
This conclusion applies to both the pour-on and to the injectable products.
Ta sklep velja za zdravila za kožni poliv in za zdravila za injiciranje.
The following text should be included in SPC section 5.3 Environmental properties:
Naslednje besedilo je treba vključiti v poglavje 5.3 povzetka glavnih značilnosti zdravila (okoljski podatki):
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).
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).
Three residue depletion studies were evaluated by the CVMP.
CVMP je ocenil tri študije izločanja ostankov.
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.
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.
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.
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.
Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Podobno kot drugi makrociklični laktoni lahko tudi doramektin negativno vpliva na neciljne organizme.
LABORATÓRIOS PFIZER, LDA.
Portugalska LABORATÓRIOS PFIZER, LDA.
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.
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.
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.
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.
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.
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.
The available study in reindeer provided residue data at the injection site at 10 days after product administration.
V razpoložljivi študiji pri jelenjadi so bili navedeni podatki o ostankih na mestu injiciranja 10 dni po dajanju zdravila.
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).
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).
Using the data from the most appropriate study a calculated withdrawal period of 54 days could be derived.
S pomočjo podatkov iz najustreznejše študije je mogoče izračunati obdobje karence 54 dni.
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.
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.
Aquatic organisms were considered not at risk from doramectin entering surface water bodies via run-off from use in sheep.
Vodni organizmi naj ne bi bili izpostavljeni tveganju doramektina, ki v površinska vodna telesa vstopa preko površinskega odtekanja pri uporabi na ovcah.
Pour-on solution topical - on the back of the animal
Kožni poliv, raztopina topikalno - na hrbet živali
A Daphnia magna reproduction study for conducting a Tier B assessment was not submitted in the ERA.
Študija vpliva na sposobnost razmnoževanja vodne bolhe (Daphnia magna) za izvedbo ocene v stopnji B v okviru ocene tveganja za okolje ni bila predložena.
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)
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)
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.
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.
• 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;
• 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;
The risk to aquatic ecosystems will be reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Tveganje za vodne ekosisteme je mogoče zmanjšati tako, da se govedu prepreči približevanje vodnim telesom dva do pet tednov po zdravljenju.
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.
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.
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.
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.
Conclusion on the benefit-risk balance
Zaključki o razmerju med tveganji in koristmi
intramuscular Pigs
intramuskularno Prašiči
Lagoas Park - Edifício 10 2740-244 Porto Salvo PORTUGAL
2740-244 Porto Salvo
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.
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.
Injektionslösung für Schweine intramuscular Pigs
Injektionslösung für Schweine intramuskularno Prašiči
No studies in lactating or non-lactating doe were provided.
Predložene niso bile nobene študije pri srnah molznicah ali srnah izven časa laktacije.
Using the data from a pivotal study with Dectomax Incjectable a withdrawal period of 65 days could be derived.
S pomočjo podatkov iz ključne študije z zdravilom Dectomax za injiciranje je mogoče izračunati karenco 65 dni.
Faeces containing doramectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Blato z doramektinom, ki ga na pašniku izločijo zdravljene živali, lahko zmanjša količino organizmov, prisotnih v gnoju, kar lahko vpliva na razgradnjo gnoja.
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.
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.
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.
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.
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.
Mesto injiciranja je bilo tkivo z najpočasnejšo stopnjo izločanja ostankov v vseh študijah, zato podatki z mesta injiciranja predstavljajo osnovo za izračun karence.
Based on data in cattle a terminal half-life of 7 days was conservatively estimated for doramectin residues at the injection site in reindeer.
Na podlagi podatkov pri govedu je bila za ostanke doramektina na mestu injiciranja pri jelenjadi konzervativno ocenjena končna razpolovna doba 7 dni.
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).
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).
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.
Ker je jelenjad manj pomembna vrsta (govedo pa pomembnejša vrsta), pa je bilo ocenjeno, da je mogoče izvesti ekstrapolacijo karence z goveda.
Therefore an evaluation of the withdrawal periods in meat and offal for pour-on products was not necessary.
Zato ocena obdobij karence pri mesu in organih za zdravila za kožni poliv ni bila potrebna.
Milk - Time span between treatment of non-lactating animals and parturition:
Mleko − časovni razpon med zdravljenjem živali izven časa laktacije in kotitvijo:
From the pivotal study representative of the worst case a withdrawal period of 60 days could be calculated.
Iz ključne študije, ki predstavlja najslabši primer, je mogoče izračunati karenco 60 dni.
ZEARL PORCS Doramectin 10 mg/ml intramuscular Pigs
ZEARL PORCS Doramectin 10 mg/ml intramuskularno Prašiči
Cattle, pigs
Govedo, prašiči