FrancophonIA/ELRC3.0 huggingface dataset:
English: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP guideline on injection site residues (EMEA/CVMP/542/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004429.pdf withdrawal period of 70 days for cattle meat and offal is therefore recommended for injectable veterinary medicinal products containing doramectin.
Danish: 1 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: Injektionslösung für Schweine intramuscular Pigs
Danish: Injektionslösung für Schweine intramuskulær Svin
English: intramuscular Pigs
Danish: intramuskulær Svin
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.
Danish: Injektionsstedet var det væv, hvor depletionshastigheden af restkoncentrationer var lavest i alle undersøgelserne, hvorfor data fra injektionsstedet er grundlag for beregning af tilbageholdelsestiden.
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.
Danish: På grundlag af data hos kvæg blev den terminale halveringstid forsigtigt anslået til 7 dage for restkoncentrationer af doramectin på injektionsstedet hos rensdyr.
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;
Danish: • CVMP anså det overordnede benefit/risk-forhold for at være positivt for doramectinholdige injektionspræparater og pour-on-præparater under forudsætning af ændringer i produktinformationen,
English: The following text should be included in SPC section 4.5 Special precautions for use:
Danish: Følgende tekst indsættes i punkt 4.5 af produktresuméet (Særlige forsigtighedsregler vedrørende brugen):
English: Meat and offal: 70 days
Danish: Slagtning: 70 døgn.
English: A withdrawal period of 77 days is therefore recommended for pig meat and offal.
Danish: Der anbefales derfor en tilbageholdelsestid på 77 dage for kød og indmad fra svin.
English: Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIUM
Danish: Pfizer Animal Health S.A., Rue Laid Burniat, 1, 1348 Louvain-la-Neuve, BELGIEN
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Indgivelsesvej Dyrearter
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.
Danish: På grundlag af den højeste iagttagne restkoncentration ved 10 dage og den skønnede halveringstid beregnedes koncentrationen af doramectin på injektionsstedet til at være under det halve af maksimalgrænseværdien 66 dage efter administration af produktet.
English: Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM
Danish: Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIEN
English: Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Danish: Videnskabelige konklusioner og begrundelse for ændringen af produktresuméerne, etiketteringen og indlægssedlerne
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.
Danish: Benefit/risk-forholdet for de omhandlede produkter anses for at være positivt, forudsat at (i) tilbageholdelsestiden for kød og indmad ved anvendelse af injektionspræparaterne sættes til 70 dage for kvæg, 70 dage for får, 77 dage for svin og 70 dage for rensdyr, (ii), at der for injektionspræparaterne og pour-on vedrørende mælk fastsættes følgende perioder som det mindste tidsrum mellem behandling og kælvning/læmning: 2 måneder for kvæg og rensdyr og 70 dage for får, og (iii), at der i produktinformationen for injektionspræparater og pour-on tilføjes foranstaltninger til afhjælpning af risikoen for akvatiske organismer og gødningsorganismer.
English: ZEARL PORCS Doramectin 10 mg/ml intramuscular Pigs
Danish: ZEARL PORCS Doramectin 10 mg/ml intramuskulær Svin
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.
Danish: Miljørisikovurderingen viser et risikoforhold større end 1 i niveau A-bestemmelsen i to tilfælde, nemlig for hvirvelløse akvatiske dyr (ved scenariet med direkte udskillelse) og for organismer i gødning.
English: • On the basis of the environmental risk assessment data submitted by the applicants/marketing authorisation holders for the injectable and pour-on veterinary medicinal products containing doramectin, the CVMP considered that in order to address the identified risks for aquatic organisms and dung fauna, as well as any remaining uncertainty regarding bioaccumulation, risk mitigation measure should be applied;
Danish: • på grundlag af de data til miljørisikovurdering, der var forelagt af ansøgerne/markedsføringstilladelsesindehaverne for doramectinholdige injektionspræparater og pour-on-præparater, anså CVMP det for nødvendigt at anvende foranstaltninger til afhjælpning af de fundne risici over for akvatiske organismer og organismer i gødning og af enhver tilbageværende usikkerhed om bioakkumulering,
English: Injectable veterinary medicinal product containing doramectin
Danish: Injektionspræparater indeholdende doramectin Kvæg
English: Sheep:
Danish: FÅR:
English: 109 37401 Amboise Cedex, FRANCE
Danish: De Poce-sur-Cisse, B.P. 109 37401 Amboise Cedex, FRANKRIG
English: Not permitted for use in lactating animals producing milk for human consumption.
Danish: Må ikke anvendes til lakterende dyr, hvis mælk er bestemt til menneskeføde.
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.
Danish: Fæces indeholdende doramectin, som af de behandlede dyr udskilles på græsarealer, kan nedsætte mængden af organismer i gødning, hvilket kan påvirke gødningens nedbrydning.
English: In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended for the pour-on veterinary medicinal products containing doramectin:
Danish: Til imødegåelse af de fundne risici for akvatiske organismer og organismer i gødning og af eventuel tilbageværende usikkerhed om bioakkumulering anbefales følgende risikoafhjælpende foranstaltninger for pour-on-produkter indeholdende doramectin:
English: Amendments in the relevant sections of the product information for injectable veterinary medicinal products containing doramectin:
Danish: Ændringer i de relevante afsnit af produktresuméer for injicerbare veterinærlægemidler indeholdende doramectin.
English: Germany
Danish: TYSKLAND
English: The risk to aquatic ecosystems will be reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Danish: Risikoen for akvatiske økosystemer reduceres ved at holde behandlet kvæg borte fra vandområder i to til fem uger efter behandling.
English: The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Danish: Risikoen for akvatiske økosystemer kan reduceres yderligere ved at holde behandlet kvæg væk fra vandområder i to til fem uger efter behandling.
English: Cattle, pigs
Danish: Kvæg, svin
English: A Daphnia magna reproduction study for conducting a Tier B assessment was not submitted in the ERA.
Danish: Den forelagte miljørisikovurdering omfattede ikke en reproduktionsundersøgelse med Daphnia magna med henblik på niveau B-vurdering.
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.
Danish: Der er desuden fundet risiko over for akvatiske organismer på grundlag af de foreliggende toksicitetsdata (akut toksicitet for Daphnia magna) samt risiko over for gødningsorganismer ved eksponering for restkoncentrationer i gødning, når produktet anvendes i den anbefalede dosering.
English: • On the basis of the residue depletion data in cattle and sheep submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, and in the absence of maximum residue limits for doramectin in milk, the CVMP considered the minimum time spans of 2 months for cattle and reindeer and 70 days for sheep must elapse between administration of these doramectin containing products and calving or lambing;
Danish: • på grundlag af de restkoncentrationsdata hos kvæg og får, der er forelagt af ansøgerne/markedsføringstilladelsesindehaverne for injektionspræparater indeholdende doramectin, og i mangel af maksimalgrænseværdier for restkoncentrationer af doramectin i mælk fastsatte CVMP en minimumsperiode på 2 måneder for kvæg og rensdyr og 70 dage for får mellem administration af disse doramectinholdige produkter og kælvning eller læmning,
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 akvatiske økosystemer 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 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.
Danish: Den 22. marts 2012 anmeldte Nederlandene derfor til Det Europæiske Lægemiddelagentur en indbringelse i medfør af artikel 35 i direktiv 2001/82/EF for alle doramectinholdige injektionspræparater og pour-on-præparater, der er bestemt til anvendelse hos fødevareproducerende pattedyr.
English: A withdrawal period of 70 days is therefore recommended for reindeer meat and offal.
Danish: Der anbefales derfor en tilbageholdelsestid på 70 dage for kød og indmad fra rensdyr.
English: The current data package does not allow the assessment of bioaccumulation and therefore, bioaccumulation of doramectin cannot be ruled out.
Danish: Den foreliggende dokumentation giver ikke mulighed for vurdering af bioakkumulering.
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.
Danish: Risikoen over for akvatiske økosystemer og organismer i gødning kan mindskes ved undgåelse af for hyppig og gentagen brug af doramectin (og produkter i samme klasse af anthelmintika) hos kvæg.
English: United Kingdom
Danish: STORBRITANNIEN
English: Labelling:
Danish: Etikettering
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.
Danish: Endvidere konkluderes det i vurderingen, at anvendelse i goldperioden af doramectinholdige injektionspræparater og pour-onformuleringer kan medføre restkoncentrationer i mælk, der eksponerer forbrugeren for mængder over ADI-værdien.
English: Pigs:
Danish: Svin:
English: Bulgaria
Danish: BULGARIEN
English: 3 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf
Danish: 3 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)
English: Cattle, reindeer, pigs
Danish: Kvæg, rensdyr, svin
English: The injection site was consistently the tissue in which the marker residue persisted for longest and was consequently the key tissue for the withdrawal period derivation.
Danish: Injektionsstedet var til stadighed det væv, hvor markørstoffet persisterede længstog var derfor det vigtigste væv til beregning af tilbageholdelsestiden.
English: Add, to all products: WITHDRAWAL PERIOD
Danish: Tilføj for alle produkter Tilbageholdelsestid
English: Belgium Eli Lilly Benelux S.A. Division Elanco Animal Health Stoofstraat 52
Danish: Division Elanco Animal Health Stoofstraat 52
English: BIOVET AD 39 Petar Rakov str. Peshtera 4550
Danish: Bulgarien BIOVET AD 39 Petar Rakov str.
English: One GLP residue depletion study in non-lactating sheep was available for evaluation by the CVMP, as well as two published studies in lactating sheep.
Danish: Der forelå én GLP-restkoncentrationsundersøgelse hos ikke-lakterende får og to publicerede undersøgelser hos lakterende får.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflets
Danish: Ændringer til relevante afsnit i produktresumé, etikettering og indlægsseddel
English: Doramectin is very toxic to aquatic organisms and may accumulate in sediments.
Danish: Doramectin er meget toksisk for akvatiske organismer og kan akkumuleres i sedimenter.
English: No milk residue data following treatment of dairy animals in the dry period were available to the CVMP.
Danish: CVMP havde ikke rådighed over restkoncentrationsdata for mælkeproducerende dyr i goldperioden.
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).
Danish: Undersøgelsernes resultater var imidlertid stærkt varierende (i undersøgelserne blev der ikke anvendt kvalitetskontrolforanstaltninger til at sikre korrekt prøvetagning fra injektionsstedet, da de er af ældre dato end de nuværende CVMP- og VICHretningslinjer, som indeholder anbefalinger for fremgangsmåden ved prøvetagning fra
English: Milk - Time span between treatment of non-lactating animals and parturition:
Danish: Mælk - tidsrum mellem behandling af ikke-lakterende dyr og læmning:
English: BELGIUM
Danish: BELGIEN
English: Amendments in the relevant sections of the product information for pour-on veterinary medicinal products containing doramectin:
Danish: Ændringer i de relevante afsnit af produktresuméer for pouron veterinærlægemidler indeholdende doramectin.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflets
Danish: Begrundelse for ændringen af produktresuméet, etiketteringen og indlægssedlerne
English: However, two non-GLP residue depletion studies performed in lactating cattle were available and provided data on residues in milk.
Danish: For lakterende kvæg forelå der imidlertid to ikke-GLP-restkoncentrationsundersøgelser med restkoncentrationsdata for mælk.
English: Do not use in pregnant ewes, which are intended to produce milk for human consumption, within 70 days of expected parturition.
Danish: Må ikke anvendes til drægtige moderfår, hvis mælk er bestemt til menneskeføde, inden for 70 dage forud for den forventede læmningsdato.
English: (EMA/CVMP/VICH/463199/2009)1 which indicates that quality control measures should be introduced to ensure that the injection site is appropriately sampled, for example by collection of separate core and surrounding samples, which is the methodology recommended in the CVMP guideline on injection site residues (EMEA/CVMP/542/03)2.
Danish: Det bemærkes, at størstedelen af de restkoncentrationsundersøgelser, der blev forelagt for CVMP, var udført før indførelsen af de gældende retningslinjer for prøvetagning fra injektionsstedet: VICH GL48 om undersøgelser af depletionen af restmarkører til fastsættelse af tilbageholdelsestider (EMA/CVMP/VICH/463199/2009)1, som foreskriver, at der skal anvendes kvalitetskontrolforanstaltninger, der sikrer korrekt prøvetagning fra injektionsstedet f.eks. gennem separat udtagning af prøver fra kernen og omgivende områder, hvilket er den metode, der anbefales i CVMP's retningslinjer for restkoncentrationer på injektionsstedet (EMEA/CVMP/542/03)2.
English: Cattle, sheep
Danish: Kvæg, får
English: Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Danish: Må ikke anvendes til drægtige køer eller kvier, hvis mælk er bestemt til menneskeføde, inden for 2 måneder forud for den forventede kælvningsdato.
English: In reindeer doramectin is administered as a single subcutaneous injection at a dose of 200 μg/kg bw for treatment of nematodes and throat bot.
Danish: Til rensdyr administreres doramectin som en enkelt subkutan injektion i en dosis på 200 µg/kg kropsvægt til behandling af nematoder og halsbremselarver.
English: The injection site was the tissue in which the marker residue persisted for longest and was consequently the tissue for the withdrawal period derivation.
Danish: Injektionsstedet var det væv, hvor markørstoffet persisterede længst, og var derfor grundlag for beregningen af tilbageholdelsestiden.
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).
Danish: Nederlandene bemærkede, at medlemsstaterne i EU/EØS har fastsat forskellige tilbageholdelsestider for doramectinholdige produkter bestemt til fødevareproducerende dyr, skønt produkterne er identiske eller svarer til hinanden.
English: Cattle, sheep, reindeer
Danish: Kvæg, får, rensdyr
English: Milk - Time span between treatment of non-lactating animals and lambing:
Danish: Mælk - tidsrum mellem behandling af ikke-lakterende dyr og kælvning:
English: In addition, the Netherlands noted that injectable and pour-on veterinary medicinal products containing doramectin intended for food producing species contain different risk mitigation measures in the product information in relation to the risks for the environment.
Danish: Desuden bemærkede Nederlandene, at der er forskel mellem foranstaltningerne til afhjælpning af miljørisici i produktinformationen for doramectinholdige injektionspræparater og pour-on-formuleringer, der er bestemt til fødevareproducerende arter.
English: Prontax subcutaneous Cattle
Danish: Prontax subkutan
English: Zearl 10 mg/ml Solution for Injection for Pigs intramuscular Pigs
Danish: Zearl 10 mg/ml Solution for Injection for Pigs intramuskulær Svin
English: Dectomax-S Injektionslösung intramuscular Pigs
Danish: Dectomax-S Injektionslösung intramuskulær Svin
English: Pour-on veterinary medicinal product containing doramectin (cattle)
Danish: Pour-on produkter indeholdende doramectin (kvæg) Kød og indmad:
English: In addition, in cattle doramectin is administered topically on the back of the animal at a dose of 500 μg/kg bw for treatment of infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly.
Danish: Til kvæg administreres doramectin desuden topikalt på dyrets ryg i en dosis af 500 µg/kg kropsvægt til behandling af angreb af gastrointestinale rundorm, lungeorm, øjenorm, bremselarver, sugende og bidende lus, skabmider og stikfluer.
English: Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.
Danish: Doramectin er meget toksisk for organismer i gødning og for akvatiske organismer og kan akkumuleres i sedimenter.
English: One non-GLP residue depletion study in lactating dairy cattle and two GLP residue depletion studies in non-lactating cattle were available for evaluation by the CVMP.
Danish: Som grundlag for CVMP's vurdering forelå der én ikke-GLP-estkoncentrationsundersøgelse hos lakterende malkekvæg og to GLP-overensstemmende restkoncentrationsundersøgelser hos ikkelakterende kvæg.
English: Having considered the residue depletion data submitted by the applicants/marketing authorisation holders for the injectable veterinary medicinal products containing doramectin, withdrawal periods of 70 days for cattle meat and offal, 70 days for sheep meat and offal, 77 days for pig meat and offal and 70 days for reindeer meat and offal were considered safe.
Danish: Efter gennemgang af de restkoncentrationsdata, der er forelagt af ansøgerne/markedsføringstilladelsesindehaverne for injektionspræparater indeholdende doramectin, anses en tilbageholdelsestid på 70 dage for kød og indmad fra kvæg, 70 dage for kød og indmad fra får, 77 dage for kød og indmad fra svin og 70 dage for kød og indmad fra rensdyr for at være sikker.
English: Pour-on solution topical - on the back of the animal
Danish: Pour-on, opløsning på hudenlangs ryggen
English: Doramectin is administered by subcutaneous injection to cattle at a dose of 200 μg/kg body weight (bw) for the treatment and control of gastrointestinal nematodes, lungworms, eyeworms, warbles, lice, mange mites and ticks.
Danish: Doramectin administreres ved subkutan injektion til kvæg i en dosis af 200 µg/kg kropsvægt til behandling og bekæmpelse af gastrointestinale nematoder, lungeorm, øjenorm, bremselarver, lus, skabmider og flåter.
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.
Danish: Det bemærkes, at doramectin ikke at godkendt til anvendelse hos lakterende dyr på grund af de manglende maksimalgrænseværdier for restkoncentrationer i mælk.