FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the studies showed high variability of residues in injection site samples and none fully comply with current guidelines.
Slovenian: Poleg tega so študije pokazale veliko raznolikost ostankov pri vzorcih, vzetih na mestu injiciranja, nobena pa ni povsem skladna z veljavnimi smernicami.
English: The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Slovenian: Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku usklajevalne skupine z naslednjimi dopolnili:
English: During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the data presented to support the environmental risk assessment and the proposed withdrawal period for cattle.
Slovenian: Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede podatkov, predloženih v podporo oceni tveganja za okolje, in predlagane karence za govedo.
English: This was not part of this referral and therefore not considered by the CVMP.
Slovenian: To ni bil del tega napotitvenega postopka, zato tega CVMP tudi ni obravnaval.
English: The CVMP considered that the test method for the determination of the n-octanol/water partition coefficient was not appropriate.
Slovenian: CVMP je zato menil, da testna metoda za določitev porazdelitvenega koeficienta n-oktanol/voda ni bila ustrezna.
English: Significant differences between studies were observed (range from 5 to 68-fold) which cannot be explained by different sample weights of injection sites.
Slovenian: Opažene so bile pomembne razlike med študijami (v razponu od 5- do 68-kratnika), ki jih ni mogoče razložiti z različnimi masami vzorcev, odvzetih na mestu injiciranja.
English: Residues were found to be highly variable between animals.
Slovenian: Ostanki so se med živalmi zelo razlikovali.
English: The study report provided is very brief and the animal weights were not provided.
Slovenian: Predloženo poročilo o študiji je zelo kratko in ne vsebuje telesnih mas živali.
English: The internal and external parasites indicated for this product are recognised as causing significant loss of production and negatively impact on animal welfare.
Slovenian: Notranji in zunanji zajedavci, za katere je to zdravilo indicirano, povzročajo veliko izgubo proizvodnje in negativno vplivajo na zdravje živali.
English: Based on the data from the last study a withdrawal period of 54 days could be calculated.
Slovenian: Na osnovi podatkov iz zadnje študije je bilo mogoče izračunati karenco 54 dni.
English: The groups included more animals than the minimum number recommended in the withdrawal period guideline (EMEA/CVMP/036/95/final): 6 animals per groups instead of 4.
Slovenian: Skupine so vključevale več živali, kot jih je najmanj priporočenih v smernici o karenci (EMEA/CVMP/036/95/final): 6 živali v skupini namesto 4.
English: Therefore, appropriate risk mitigation measures are considered necessary, as specified in the product information.
Slovenian: Iz tega razloga je bilo ocenjeno, da so nujni ustrezni ukrepi za zmanjševanje tveganja, kot so navedeni v informacijah o zdravilu.
English: However, in view of the variability seen across the studies, the fact that none of the studies were in full compliance with the current guideline, and 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 pa je bil ob upoštevanju razhajanj med študijami, dejstva, da nobena od študij ni bila povsem skladna z veljavno smernico, in dejstva, da so bili pri številnih študijah ob zadnji časovni točki vzorčenja ostanki še vedno nad mejno vrednostjo ostankov za mišičje, sprejet zaključek, da se doda varnostna rezerva 30 % za izravnavo negotovosti, povezanih s celotnim naborom podatkov.
English: CATTLE:
Slovenian: GOVEDO:
English: This study was considered the most appropriate study on which to base a withdrawal period for meat and offal in cattle, although all relevant data should be taken into account in the assessment.
Slovenian: Ta študija je bila ocenjena kot najustreznejša študija, ki bi služila kot osnova za določitev karence za meso in drobovino pri govedu, vendar pa je treba pri vrednotenju upoštevati vse zadevne podatke.
English: As for the benefits, quality of the product was not discussed by CVMP as part of this referral.
Slovenian: Kar zadeva koristi, CVMP v okviru tega napotitvenega postopka ni razpravljal o kakovosti zdravila.
English: The application was submitted in accordance with the Article 13(1) of the Directive 2001/82/EC (i.e. an application for a generic product).
Slovenian: Vloga je bila predložena v skladu s členom 13(1) Direktive 2001/82/ES (tj. vloga za generično zdravilo).
English: Several studies and published literature on the toxicity to dung fauna were available.
Slovenian: Na razpolago je bilo več študij in objavljena literatura o strupenosti za organizme, prisotne v gnoju.
English: The product has dual action against endo- and ecto-parasites and may reduce the number of treatments with different pharmaceutical products.
Slovenian: Zdravilo ima dvojni učinek proti notranjim in zunanjim parazitom in lahko zmanjša število zdravljenj z drugimi farmacevtskimi zdravili.
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 pri scenariju odtekanja najvišja vrednost PKOgovedo (0,84 µg/kg) višja od najvišje vrednosti PKOovce (0,48 µg/kg), je zaključke pri govedu mogoče ekstrapolirati na ovce.
English: After refinement of PECsw using the FOCUS model as recommended by CVMP guideline CVMP/ERA/418282/2005, it was concluded that aquatic organisms were not at risk from doramectin entering surface water bodies via run-off.
Slovenian: Po izboljšavi PKOpovršinske vode z modelom FOCUS, kot priporoča smernica CVMP/ERA/418282/2005, je bilo ugotovljeno, da vodni organizmi niso izpostavljeni tveganju, da bi doramektin vstopil v vodna telesa površinske vode z odtekanjem.
English: Two of the residue studies were carried out using a different route of administration than the intended use of the product and were therefore not considered relevant for the evaluation.
Slovenian: Dve študiji ostankov sta bili izvedeni z drugačno potjo uporabe, kot je predvidena za uporabo zdravila, zato je bilo ocenjeno, da nista ustrezni za vrednotenje.
English: Doramectin is an antiparasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Slovenian: Doramektin je antiparazitik, izoliran pri fermentaciji izbranih sevov, ki izvirajo iz talnega organizma Streptomyces avermitilis.
English: An ERA was performed by the applicant in accordance with the VICH guidelines for Phase I and Phase II assessment adopted by the CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) as well as the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH Guidelines GL6 and GL38 (CVMP/ERA/418282/2005-corr).
Slovenian: Oceno tveganja za okolje je predlagatelj izvedel v skladu s smernicami VICH za oceno faze I in faze II, ki jih je sprejel CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final), in smernico CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernic VICH GL6 in GL38 (CVMP/ERA/418282/2005-corr).
English: In respect to the environmental impact for the use of Prontax 10 mg/ml 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”.
Slovenian: Kar zadeva vpliv uporabe zdravila Prontax 10 mg/ml, raztopina za injiciranje pri ovcah, na okolje je CVMP menil, da v skladu z navodilom CVMP scenarij „neposrednega izločanja v površinske vode“ zadeva le govedo.
English: Two subcutaneous administrations were performed instead of one leading to more injection sites.
Slovenian: Namesto enega sta bili izvedeni dve subkutani dajanji zdravila, kar je privedlo do več mest injiciranja.
English: Therefore no PEC refinement based on metabolism is possible, the risk assessment is based on total residues.
Slovenian: Iz tega razloga izboljšava PKO na osnovi presnove ni mogoča, ocena tveganj pa temelji na celotnih ostankih.
English: As a result of a log Pow ≥ 4 the assessment of bioaccumulation is required.
Slovenian: Ker je log Pow ≥ 4, je zahtevana izvedba ocene biološkega kopičenja.
English: Sheep and pigs - intramuscular
Slovenian: Ovce in prašiči intramuskularn
English: Aquatic organisms were considered not at risk from doramectin entering surface water bodies via run-off from use in sheep.
Slovenian: Ocenjeno je bilo, da kar zadeva vodne organizme, ni prisotno tveganje, da bi doramektin vstopil v vodna telesa površinske vode z odtekanjem pri uporabi pri ovcah.
English: For the dung fauna, 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: As the risk for daphnids could not be ruled out by PEC refinements Tier B assessment should be performed according VICH Guideline 38 for which a Daphnia magna reproduction study is required.
Slovenian: Ker tveganja za dafnide z izboljšanjem PKO ni bilo mogoče izključiti, bi bilo treba izvesti ocenjevanje tveganja stopnje B v skladu s smernico VICH 38, za katero je potrebna študija vpliva na sposobnost razmnoževanja Daphnia magna.
English: The product has the same indications as the reference product.
Slovenian: Zdravilo ima enake indikacije kot referenčno zdravilo.
English: There are no specific studies available on dung fauna in sheep.
Slovenian: Specifične študije z organizmi, prisotnimi v gnoju, za ovce niso na voljo.
English: In particular the Committee considered that findings in other studies showing residues above the MRLs for muscle at the last measured timepoints of 35 and 49 days could not be ignored.
Slovenian: Odbor je zlasti menil, da ni mogoče zanemariti izsledkov drugih študij, v katerih so bili ostanki ob zadnjih časovnih točkah vzorčenja 35. in 49. dan po dajanju zdravila nad mejno vrednostjo ostankov za mišičje.
English: The following text should be included in section 5.3 of the SPC (environmental properties):
Slovenian: Naslednje besedilo je treba vključiti v oddelek 5.3 povzetka glavnih značilnosti zdravila (okoljski podatki):
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 necessary 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: In general terms, as for the benefits, that except for the risks identified in particular by the referral (ERA and withdrawal period in cattle) all other risks are expected to be the same as for the reference product and have not been discussed in any detail by CVMP.
Slovenian: Na splošno velja, tako kot pri koristih, da so z izjemo tveganj, ki so bila posebej opredeljena v napotitvenem postopku (ocena tveganja za okolje in karenca pri govedu), vsa druga tveganja po pričakovanjih enaka kot pri referenčnem zdravilu, CVMP pa o njih ni podrobno razpravljal.
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:
Slovenian: Za obravnavo opredeljenih tveganj za vodne organizme in organizme, prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem, se priporočajo naslednji ukrepi za zmanjševanje tveganja:
English: The application has been presented in accordance with Article 13(1) of Directive 2001/82/EC as amended, i.e. it is a generic application.
Slovenian: Vloga je bila predložena v skladu s členom 13(1) Direktive 2001/82/ES, kakor je bila spremenjena, gre torej za vlogo za generično zdravilo.
English: The potential serious risk regarding the withdrawal period identified by the Netherlands relates to the proposed withdrawal period of 54 days for slaughter in cattle, which is considered rather short taking into account the residue levels at injection site demonstrated in other studies than the one used as pivotal study, and that none of the residue depletion studies was performed according to existing guidelines for injection site residues.
Slovenian: Možno resno tveganje glede karence, ki ga je izpostavila Nizozemska, zadeva predlagano karenco 54 dni za zakol govedi, ki je dokaj kratka, če upoštevamo ravni ostankov na mestu injiciranja, ki so bile dokazane v drugih študijah, ne pa v študiji, ki je bila uporabljena kot osrednja študija, in dejstvo, da nobena od študij izločanja ostankov ni bila izvedena v skladu z veljavnimi smernicami za ostanke na mestu injiciranja.
English: The benefit-risk evaluation is deemed to be positive provided that (1) the recommended risk mitigation measures are added to the product literature regarding risk to aquatic organisms and dung fauna and (2) the withdrawal period for meat and offal in cattle should be set at 70 days.
Slovenian: Ocena razmerja med tveganji in koristmi velja za pozitivno pod pogojem, da se (1) v dokumentacijo izdelka vključijo priporočeni ukrepi za zmanjševanje tveganja v zvezi s tveganjem za vodne organizme in organizme, prisotne v gnoju, ter da se (2) za meso in drobovino pri govedu določi karenca 70 dni.
English: In absence of data, it is proposed that the risk to dung fauna from sheep dung should be viewed as similar to the risk arising from treatment of cattle.
Slovenian: Glede na pomanjkanje podatkov se predlaga, da je treba šteti, da je tveganje za organizme, prisotne v gnoju, pri ovcah podobno tveganju pri zdravljenju goveda.
English: In terms of environmental safety, in addition to the fact that the current data package does not allow to rule out bioaccumulation of doramectin, a risk to the aquatic compartment 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 product is used in accordance with the recommended posology.
Slovenian: V zvezi z varnostjo za okolje je bilo poleg dejstva, da na osnovi trenutnega nabora podatkov ni mogoče izključiti biološkega kopičenja doramektina, na osnovi razpoložljivih podatkov o toksičnosti ugotovljeno tveganje za vodno okolje (akutna toksičnost za 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: It is a macrocyclic lactone and is closely related to ivermectin.
Slovenian: Je makrociklični lakton, ki je soroden ivermektinu.
English: Consequently the matter was referred to the CVMP.
Slovenian: Zato je bila zadeva napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
English: Cattle and sheep - 1 ml per 50 kg bodyweight
Slovenian: Govedo in ovce - 1 ml na 50 kg telesne mase
English: Two Concerned Member States (the Netherlands and France) considered that the authorisation of Prontax 10 mg/ml solution for injection for cattle, sheep, and pigs may present a potential serious risk to the environment and risk to the consumer.
Slovenian: Dve zadevni državi članici (Nizozemska in Francija) sta menili, da utegne odobritev zdravila Prontax 10 mg/ml, raztopina za injiciranje za govedo, ovce in prašiče, predstavljati možno resno tveganje za okolje in tveganje za potrošnika.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, withdrawal periods, applicant in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, živalskihvrst, poti uporabe, karence, imetnikov dovoljenja za promet v državah članicah.
English: Injection site residues were highly variable between animals.
Slovenian: Ostanki na mestu injiciranja so se med živalmi zelo razlikovali.
English: One of the residue studies did not include sampling at the injection site and was therefore not considered for the establishment of the withdrawal period.
Slovenian: Ena od študij ostankov ni vključevala vzorčenja na mestu injiciranja, zato ni bila upoštevana pri določanju karence.
English: In terms of consumer safety, a withdrawal period for meat and offal in cattle of 70 days is recommended.
Slovenian: Kar zadeva varnost potrošnikov, se priporoča karenca za meso in drobovino pri govedu 70 dni.
English: the CVMP concluded that the objections raised by the Netherlands and France should not prevent the granting of a marketing authorisation for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names (see annex I) as the overall benefit-risk balance for the product is positive subject to the recommended changes in the product information set out in annex III.
Slovenian: je CVMP zaključil, da ugovori Nizozemske in Francije ne smejo preprečiti odobritve dovoljenja za promet z zdravilom Prontax 10 mg/ml, raztopina za injiciranje za govedo, ovce in prašiče, in povezanimi imeni (glejte prilogo I), saj je celokupno razmerje med tveganji in koristmi za zdravilo, ob upoštevanju priporočenih sprememb informacij o zdravilu, ki so navedene v prilogi III, pozitivno.
English: The CVMP considered that the available data package does not allow the assessment of bioaccumulation and therefore, bioaccumulation of doramectin cannot be ruled out.
Slovenian: CVMP je menil, da razpoložljivi nabor podatkov ne omogoča ocene biološkega kopičenja, zato biološkega kopičenja doramektina ni mogoče izključiti.
English: The potential serious risks regarding the environment identified by France and the Netherlands are risks to dung fauna and Daphnia magna in accordance with the proposed instructions for use and a risk identified by the Netherlands due to the bioaccumulation potential linked to the determination of the log KOW by using a test method, which was not considered appropriate for the active ingredient.
Slovenian: Možna resna tveganja za okolje, ki sta jih izpostavili Francija in Nizozemska, so tveganja za organizme, prisotne v gnoju, in organizem Daphnia magna glede na predlagano navodilo za uporabo ter tveganje, ki ga je izpostavila Nizozemska, glede možnosti biološkega kopičenja v povezavi z določitvijo log KOW s testno metodo, ki je bila ocenjena za neustrezno za to zdravilno učinkovino.
English: Since the authorisation of the reference product the MRLs for the active substance, doramectin, were increased (to the levels shown above) and residue data were submitted to support a shorter withdrawal period for cattle.
Slovenian: Po odobritvi referenčnega zdravila so bile mejne vrednosti ostankov za zdravilno učinkovino doramektin zvišane (na ravni, ki so prikazane zgoraj), predloženi pa so bili tudi podatki o ostankih v podporo krajši karenci za govedo.
English: The risk characterisation for the aquatic environment was conducted based on an EC50 of 0.1 µg/l and a NOEC of 0.025 derived from an acute toxicity study of doramectin in Daphnia (D. magna).
Slovenian: Opredelitev tveganj za vodno okolje je bila izvedena na osnovi vrednosti EC50 0,1 µg/l in koncentracije brez opaznega učinka (KBOU) 0,025 µg/l, ki sta izvirali iz študije akutne toksičnosti doramektina za vodno bolho (Daphnia magna).
English: The concentration of total doramectin residues excreted in cattle faeces peaked at 5 days after administration (562 µg/kg) and declined thereafter, accounting for 239 µg/kg at 14 days.
Slovenian: Koncentracija celotnih ostankov doramektina, izločenih z blatom goveda, je dosegla najvišjo vrednost 5. dan po dajanju zdravila (562 µg/kg) ter se nato zmanjševala in 14. dan znašala 239 µg/kg.
English: • On the basis of environmental risk assessment data submitted with the application it was 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 measures should be applied;
Slovenian: • na osnovi podatkov za oceno tveganja za okolje, ki so bili predloženi z vlogo, je bilo sprejeto stališče, da je treba za obravnavanje opredeljenih tveganj za vodne organizme in organizme, prisotne v gnoju, ter morebitnih preostalih negotovosti v zvezi z biološkim kopičenjem uporabiti ukrepe za zmanjševanje tveganja;
English: Further PEC refinement for the direct excretion scenario considering that peak excretion of total residues occurred on day 5 after administration and accounted for 7.8% of the administered dose, as well as based on sediment partitioning lead to a PECsw-refined-direct of 0.00049 µg/l, resulting in a RQ for Daphnia (4.9) still higher than 1.
Slovenian: Nadaljnje izboljšanje PKO za scenarij neposrednega izločanja ob upoštevanju, da je bilo izločanje celotnih ostankov največje 5. dan po dajanju zdravila in je ustrezalo 7,8 % uporabljenega odmerka, ter na podlagi porazdelitve sedimenta je privedlo do izboljšane PKOpovršinske vode za neposredno izločanje 0,00049 µg/l, kar pomeni, da je količnik tveganja za organizem Daphnia (4,9) še vedno večji od 1.
English: • On the basis of the residue depletion data in cattle submitted with the application is was considered that a 70-day withdrawal period should be established in cattle meat and offal;
Slovenian: • na osnovi podatkov o izločanju ostankov pri govedu, ki so bili predloženi z vlogo, je bilo sprejeto stališče, da je treba za meso in drobovino pri govedu določiti karenco 70 dni;
English: A Daphnia magna reproduction study for conducting a Tier B assessment was not submitted in the ERA.
Slovenian: Študija vpliva na sposobnost razmnoževanja Daphnia magna za izvedbo ocene v stopnji B v okviru ocene tveganja za okolje ni bila predložena.
English: Pigs - 1 ml per 33 kg bodyweight
Slovenian: Prašiči - 1 ml na 33 kg telesne mase
English: The sample sizes of injection sites were not reported and surrounding ring samples were not collected.
Slovenian: O velikosti vzorcev z mest injiciranja niso poročali, prav tako niso bili zbrani vzorci sosednjega tkiva.
English: Injection site was the tissue with the slowest rate of residue depletion and therefore results from the injection site are the basis from which derive the withdrawal period.
Slovenian: Mesto injiciranja je bilo tkivo z najnižjo hitrostjo izločanja ostankov, zato so rezultati z mesta injiciranja osnova za določitev karence.
English: The CVMP was asked to give its opinion on the concerns raised by the Concerned Member States and to conclude on the benefit/risk balance for Prontax 10 mg/ml solution for injection for cattle, sheep, and pigs.
Slovenian: CVMP je bil naprošen, da poda mnenje v zvezi z zadržki, ki so jih je izrazile zadevne države članice, in sprejme sklep glede razmerja med tveganji in koristmi za zdravilo Prontax 10 mg/ml, raztopina za injiciranje za govedo, ovce in prašiče.
English: The study was well conducted but not fully in accordance with the guideline on injection site residues (EMEA/CVMP/542/03-FINAL) since a surrounding ring sample was not collected.
Slovenian: Študija je bila izvedena dobro, vendar ne povsem v skladu s smernico o ostankih na mestu injiciranja (EMEA/CVMP/542/03-FINAL), saj vzorci sosednjega tkiva niso bili zbrani.
English: Meat and offal: 70 days
Slovenian: Meso in organi: 70 dni
English: The applicant Pfizer Limited has submitted an application for a decentralised procedure for Dectomax 10 mg/ml solution for cattle, sheep, and pigs.
Slovenian: Predlagatelj družba Pfizer Limited je predložil vlogo za decentralizirani postopek za zdravilo Dectomax 10 mg/ml, raztopina za govedo, ovce in prašiče.