FrancophonIA/ELRC3.0 huggingface dataset:
English: The internal and external parasites indicated for this product are recognised as causing significant loss of production and negatively impact on animal welfare.
Danish: De interne og eksterne parasitter, som produktet er indiceret til, er kendt for at medføre et betydeligt produktionstab og for at have negativ indflydelse på dyrevelfærden.
English: The study report provided is very brief and the animal weights were not provided.
Danish: Undersøgelsesrapporten er meget kortfattet, og dyrenes vægt blev ikke angivet.
English: This results in a withdrawal period of 70 days.
Danish: Derved fås en tilbageholdelsestid på 70 dage.
English: Withdrawal period for cattle
Danish: Tilbageholdelsestid for kvæg
English: 4.5 Special precaution for use
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen
English: Consequently the matter was referred to the CVMP.
Danish: Sagen blev derfor indbragt for CVMP.
English: Therefore, appropriate risk mitigation measures are considered necessary, as specified in the product information.
Danish: Det anses derfor for nødvendigt med foranstaltninger til risikonedsættelse som angivet i produktinformationen.
English: Cattle, sheep and pigs
Danish: Kvæg, får og svin
English: It protects pigs against infection or reinfection with Sarcoptes scabiei for 18 days.
Danish: Det giver beskyttelse af svin mod infektion og reinfektion med Sarcoptes scabiei i 18 dage.
English: As for the benefits, quality of the product was not discussed by CVMP as part of this referral.
Danish: Ligesom fordelene blev produktets kvalitet ikke drøftet af CVMP som led i denne henvisning.
English: The weights of animals were below 250 kg. Only injection sites (500-600 g) were sampled.
Danish: Dyrenes vægt var under 250 kg. Der blev kun taget prøver fra injektionsstedet (500-600 g).
English: However, this study is not available and cannot be requested in this referral.
Danish: Denne undersøgelse foreligger imidlertid ikke, og der kan ikke stilles krav herom i forbindelse med denne henvisning.
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.
Danish: To af restkoncentrationsundersøgelserne blev udført for en anden administrationsvej end den, produktet er bestemt til, og anses derfor ikke for relevante for vurderingen.
English: The log Pow of 4.4 can therefore only be considered as an indicator of the actual value.
Danish: Værdien 4,4 for log Pow kan derfor kun anses for vejledende i forhold til den faktiske værdi.
English: The following MRLs have been established in the EU for the active substance doramectin (Table 1 of the Annex to Regulation (EU) No 37/2010 for all mammalian food producing species:
Danish: Følgende maksimalgrænseværdier for restkoncentrationer af fastsat i EU for det aktive indholdsstof doramectin (tabel 1 i bilaget til forordning (EU) nr. 37/2010 for alle pattedyrarter bestemt til konsum):
English: Injection sites at 35 and 56 days were not assayed.
Danish: Der blev ikke foretaget bestemmelser for injektionsstedet ved 35 og 56 dage.
English: All except one were GLP studies and were carried out with the same formulation (plus or minus radioactive tracer).
Danish: Alle undersøgelserne undtagen én var i overensstemmelse med GLP og blev udført med samme formulering (med eller uden radioaktivt sporstof).
English: A withdrawal period of 63 days has been established for cattle for the reference product.
Danish: For kvæg er fastsat en tilbageholdelsestid på 63 dage for referenceproduktet.
English: Residues were found to be highly variable between animals.
Danish: Restkoncentrationerne blev fundet at variere stærkt mellem de enkelte dyr.
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.
Danish: Denne undersøgelse blev anset for at være den mest velegnede til fastsættelse af tilbageholdelsestider for kød og indmad fra kvæg, dog bør alle relevante data tages i betragtning ved vurderingen.
English: Conclusions regarding the environmental impact
Danish: Konklusioner vedrørende miljøvirkningen
English: Benefits have not been subject of this referral; they were considered in the preceding decentralised procedure.
Danish: Vurdering af fordele er ikke indgået i behandlingen af denne henvisning, men blev behandlet i den foregående decentrale procedure.
English: No data on the nature and rates of metabolites are available.
Danish: Der foreligger ingen data om art eller andel af metabolitter.
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
Danish: Liste over det veterinærlægemidlets navn, lægemiddelform, styrke, dyrearter, indgivelsesvej, tilbageholdelsestider, ansøger i medlemsstaterne
English: This was not part of this referral and therefore not considered by the CVMP.
Danish: Dette var ikke omfattet af henvisningen og blev derfor ikke behandlet af CVMP.
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).
Danish: Ansøgningen blev indgivet i overensstemmelse med artikel 13, stk. 1, i direktiv 2001/82/EF (dvs. en ansøgning for et generisk lægemiddel).
English: The following text is proposed in section 4.5 (special precautions for use):
Danish: Følgende tekst foreslås indsat i punkt 4.5 (Særlige advarsler og forsigtighedsregler vedrørende brugen):
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.
Danish: Under denne procedure var der uenighed mellem referencemedlemsstaten og de berørte medlemsstater vedrørende de forelagte oplysninger til støtte for miljørisikovurderingen og den ansøgte tilbageholdelsestid for kvæg.
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.
Danish: Ligesom for fordelene gælder det generelt, at bortset fra de risici, der særligt er påpeget ved henvisningen (ERA og tilbageholdelsestiden for kvæg), forventes alle øvrige risici at svare til referenceproduktets og har ikke været drøftet i detaljer af CVMP.
English: The ERA for pigs can stop at Phase I in accordance with the VICH guideline.
Danish: Miljørisikovurdering for svin kan standse i fase 1 i overensstemmelse med VICH-retningslinjerne.
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.
Danish: Ansøgningen blev indgivet i overensstemmelse med artikel 13, stk. 1, i direktiv 2001/82/EF som ændret, dvs. som en generisk ansøgning.
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:
Danish: De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppe med følgende tilføjelser:
English: In terms of bioaccumulation the log Pow value is not considered to be robust given the method employed (shake flask).
Danish: Hvad angår bioakkumulering anses log Pow-værdien ikke for fyldestgørende på grund af den anvendte metode (shake flask).
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.
Danish: Navnlig fandt udvalget, at der ikke kunne ses bort fra resultaterne af andre undersøgelser, der viste restkoncentrationer over maksimalgrænseværdier for muskel ved de seneste prøvetagningspunkter dag 35 og dag 49.
English: Grounds for amendments of the product information
Danish: Begrundelse for ændring af produktoplysningerne
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.
Danish: Grupperne omfattede flere dyr end det anbefalede mindste antal i retningslinjerne for tilbageholdelsestid (EMEA/CVMP/036/95/final): 6 dyr i hver gruppe i stedet for 4.
English: The need for repeat treatments is reduced relative to other anthelmintic products.
Danish: Der kræves færre gentagne behandlinger end med andre anthelmintika.
English: The n-octanol/water coefficient (log Pow) was determined as 4.4 using the shake flask method.
Danish: Fordelingskoefficienten n-oktanol/vand (log Pow) blev bestemt til 4,4 ved hjælp af shake flaskmetoden.
English: Two subcutaneous administrations were performed instead of one leading to more injection sites.
Danish: Anvendelse af to subkutane injektioner i stedet for en enkelt medførte flere injektionssteder.
English: There are no specific studies available on dung fauna in sheep.
Danish: Der foreligger ingen specifikke undersøgelser vedrørende organismer i gødning for får.
English: However, no bioaccumulation study was provided; also no assessment of secondary poisoning was performed.
Danish: Der er imidlertid ikke udført en bioakkumuleringsundersøgelse eller en undersøgelse af sekundær forgiftning.
English: Significant differences between studies were observed (range from 5 to 68-fold) which cannot be explained by different sample weights of injection sites.
Danish: Der ses betydelige afvigelser mellem undersøgelserne (med en faktor 5 til 68), som ikke kan forklares ved forskelle i vægt mellem prøverne fra injektionsstedet.
English: The CVMP considered that the test method for the determination of the n-octanol/water partition coefficient was not appropriate.
Danish: CVMP anså den anvendte metode til bestemmelse af fordelingskoefficienten n-oktanol/vand for uhensigtsmæssig.
English: Additional benefits of this product are the same as the reference product.
Danish: Dette produkt har de samme yderligere fordele som referenceproduktet.
English: Seven residue studies were made available and assessed by the CVMP for the evaluation of the withdrawal period for cattle.
Danish: Der blev forelagt syv restkoncentrationsundersøgelser, som blev vurderet af CVMP med henblik på tilbageholdelsestiden for kvæg.
English: In the first case, the risk to daphnids could not be ruled out by performing several PEC refinements for the direct excretion scenario.
Danish: I det første tilfælde kunne risiko over for dafnier ikke udelukkes gennem udførelse af flere forbedrede PEC-bestemmelser for scenariet med direkte udskillelse.
English: In terms of consumer safety, a withdrawal period for meat and offal in cattle of 70 days is recommended.
Danish: Hvad angår forbrugernes sikkerhed anbefales en tilbageholdelsestid på 70 dage for kød og indmad fra kvæg.
English: Before addressing the issues of disagreement the following two changes to the initial application that were made during the decentralised procedure and the CVMP referral procedure should be noted:
Danish: Det bemærkes, at der blev foretaget følgende to ændringer i den oprindelige ansøgning under den decentrale procedure og henvisningsproceduren:
English: In addition, the studies showed high variability of residues in injection site samples and none fully comply with current guidelines.
Danish: Desuden udviser undersøgelserne stor spredning i restkoncentrationerne på injektionsstedet, og ingen af dem opfylder fuldt ud de nuværende retningslinjer.
English: Therefore no PEC refinement based on metabolism is possible, the risk assessment is based on total residues.
Danish: Der kan derfor ikke foretages en forbedret bestemmelse af PEC-værdier på grundlag af metabolisering, hvorfor risikovurderingen er baseret på totale restkoncentrationer.
English: The supplementary data provided did not allow ruling out a medium to long-term risk to dung insects.
Danish: På grundlag af de forelagte supplerende data kunne det ikke udelukkes, at der er mellemlangsigtet til langsigtet risiko over for insekter i gødning.
English: As a result of a log Pow ≥ 4 the assessment of bioaccumulation is required.
Danish: En log Pow ≥ 4 udløser et krav om en vurdering af bioakkumulering.
English: The product has dual action against endo- and ecto-parasites and may reduce the number of treatments with different pharmaceutical products.
Danish: Produktet virker mod både endo- og ektoparasitter og kan mindske det nødvendige antal behandlinger med en række andre produkter.
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.
Danish: Benefit/risk-vurderingen anses for at være positiv, forudsat (1) at der i produktoplysningerne tilføjes de anbefalede foranstaltninger til nedsættelse af risikoen over for vandorganismer og organismer i gødning, og (2) at tilbageholdelsestiden for kød og indmad fra kvæg sættes til 70 dage.
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.
Danish: I mangel af data skønnes det, at risikoen over for gødningsorganismer forårsaget af gødning fra får kan anses for at svare til risikoen ved behandling af kvæg.
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).
Danish: Risikokarakteriseringen for vandmiljøet blev foretaget på grundlag af en EC50-værdi på 0,1 µg/l og en NOEC-værdi på 0,025, der var afledt af en akut toksicitetsundersøgelse af doramectin i dafnier (D. magna).
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).
Danish: Ansøgeren foretog en miljørisikovurdering i overensstemmelse med VICH-retningslinjerne for fase Iog fase II-vurdering, der er vedtaget af CVMP (CVMP/VICH/592/98-FINAL, CVMP/VICH/790/03-final) samt CVMP's retningslinjer for miljørisikovurdering for veterinærmedicinske produkter til støtte for VICH-retningslinjerne GL6 og GL38 (CVMP/ERA/418282/2005-corr).
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.
Danish: Siden godkendelsen af referenceproduktet er maksimalgrænseværdierne for restkoncentrationer af det aktive indholdsstof doramectin forhøjet (til ovennævnte værdier), og der er forelagt restkoncentrationsundersøgelser til støtte for en kortere tilbageholdelsestid for kvæg.
English: Injection site residues were highly variable between animals.
Danish: Restkoncentrationerne på injektionsstedet varierede stærkt mellem de enkelte dyr.
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.
Danish: Risikoen over for vandøkosystemer og organismer i gødning kan mindskes ved at undgå for hyppig og gentagen brug af doramectin (og produkter i samme klasse af anthelmintika) hos kvæg og får.
English: The sample sizes of injection sites were not reported and surrounding ring samples were not collected.
Danish: Størrelsen af prøverne fra injektionsstedet blev ikke angivet, og der blev ikke udtaget omgivende ringprøver.
English: Aquatic organisms were considered not at risk from doramectin entering surface water bodies via run-off from use in sheep.
Danish: Vandorganismer blev ikke anset for at være udsat for risiko for tilførsel af doramectin til overfladevand ved spild under anvendelse hos får.
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.
Danish: Eftersom forbedrede PEC-bestemmelser ikke kunne udelukke risiko over for dafnier, skal der foretages niveau B-vurdering i henhold til VICH-Guideline 38, hvilket kræver en reproduktionsundersøgelse for Daphnia magna.
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.
Danish: Efter forbedret bestemmelse af PECsw ved hjælp af FOCUS-modellen som anbefalet i CVMP's retningslinjer CVMP/ERA/418282/2005 konkluderedes det, at vandorganismer ikke er udsat for risiko fra overfladevand, der indeholder doramectin som følge af spild.
English: For the dung fauna, results of the Tier A assessment showed a very high RQ indicating an unacceptable acute risk.
Danish: For organismer i gødning viste niveau A-vurderingen et meget højt risikoforhold som tegn på en uacceptabel akut risiko.
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”.
Danish: Hvad angår miljøvirkningen af anvendelse af Prontax, injektionsvæske, opløsning, 10 mg/ml, til får, fastslog CVMP', at det i henhold til CVMP's vejledning kun er kvæg, der er omfattet af scenariet ”direkte udskillelse i overfladevand”.
English: Doramectin is an antiparasitic agent, isolated from the fermentation of selected strains derived from the soil organism Streptomyces avermitilis.
Danish: Doramectin er et antiparasitikum, der udvindes ved fermentering af udvalgte stammer af den jordlevende organisme Streptomyces avermitilis.
English: The Committee noted that the final version of the product information achieved during the Coordination Group procedure at day 210 includes specific warnings concerning conditions of use in dairy cattle.
Danish: Udvalget bemærkede, at der findes specifikke advarsler vedrørende betingelser for anvendelse hos malkekvæg i den endelige version af produktinformationen, der er fastlagt ved forhandlinger i koordinationsgruppen på dag 210.
English: A Phase II, Tier A assessment was required for cattle and sheep.
Danish: Der krævedes en fase II-vurdering, niveau A, for kvæg og får.
English: However, it is recognised that no harmonised guidance on how to conduct Tier B assessment studies for dung insects is currently available.
Danish: Det bemærkes dog, at der på nuværende tidspunkt ikke foreligger en harmoniseret vejledning for undersøgelser til brug for niveau B-vurdering for insekter i gødning.
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.
Danish: CVMP fandt, at den foreliggende dokumentationspakke ikke giver mulighed for en vurdering af bioakkumulering, og at bioakkumulering af doramectin derfor ikke kan udelukkes.
English: The following text should be included in section 5.3 of the SPC (environmental properties):
Danish: Følgende tekst skal indsættes i punkt 5.3 af produktresuméet (Miljøoplysninger):
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.
Danish: For spildscenariet gælder, at den højeste PEC-værdi for kvæg (0,84 µg/kg) er højere end den højeste PECværdi for får (0,48 µg/kg).
English: The referral for Prontax 10 mg/ml solution for injection for injection for cattle, sheep and pigs relates to the potential serious risks raised by France and the Netherlands regarding the environmental risk assessment (ERA) and by the Netherlands regarding the proposed withdrawal period for cattle.
Danish: Henvisningen for Prontax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin, vedrører de potentielle alvorlige risici, der blev påpeget af Frankrig og Nederlandene vedrørende miljørisikovurderingen (ERA), og af Nederlandene vedrørende den ansøgte tilbageholdelsestid for kvæg.
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.
Danish: Da der på nuværende tidspunkt ikke foreligger en harmoniseret vejledning for undersøgelser med henblik på niveau B-vurdering for insekter i gødning, vurderedes det, at den påpegede risiko bør imødegås med foranstaltninger til mindskelse af eksponeringen.
English: The risk characterisation for dung fauna was performed using Predicted Environmental Concentrations (PECs) for dung, which were derived using the metabolism study provided.
Danish: Der blev udført risikokarakterisering for organismer i gødning ved hjælp af forventede eksponeringskoncentrationer (PEC-værdier) for gødning, der var udledt af den forelagte metaboliseringsundersøgelse.
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.
Danish: To at de berørte medlemsstater (Nederlandene og Frankrig) fandt, at godkendelsen af Prontax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin kan udgøre en potentiel alvorlig risiko for miljøet og en risiko for forbrugerne.
English: Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption.
Danish: Mælk: - Må ikke anvendes til diegivende dyr, hvis mælk er bestemt til menneskeføde.
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.
Danish: De potentielle alvorlige risici for miljøet, der blev påpeget af Frankrig og Nederlandene, er dels risici over for organismer i gødning og over for Daphnia magna i henhold til den påtænkte brugsanvisning, dels en af Nederlandene påpeget risiko betinget af potentialet for bioakkumulering som følge af, at log KOW er bestemt ved en metode, der blev anset for uegnet til det aktive indholdsstof.
English: The concentration of parent drug in faeces peaked at 3 days after administration (319 μg/kg) with a concentration of 133 µg/kg at 14 days (last sampling point).
Danish: Koncentrationen af moderstof i fæces var maksimal på dag 3 efter administrationen (319 μg/kg) og var faldet til 133 µg/kg på dag 14 (sidste prøvetagningspunkt).
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;
Danish: • På grundlag af miljørisikovurderingen i ansøgningen blev det anset for nødvendigt at indføre foranstaltninger til imødegåelse af de påpegede risici over for vandorganismer og organismer i gødning og af eventuel tilbageværende usikkerhed om bioakkumulering.