FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Den totale restkoncentration af doramectin, der blev udskilt i fæces fra kvæg, var maksimal på dag 5 efter administrationen (562 µg/kg) og var aftaget til 239 µg/kg på dag 14.
English: Cattle and sheep - 1 ml per 50 kg bodyweight
Danish: Kvæg og får1 ml pr. 50 kg legemsvægt
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Danish: Ændringer til relevante afsnit i produktresumé, etikettering og indlægsseddel.
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.
Danish: CVMP blev anmodet om at fremsætte en udtalelse om de betænkeligheder, der var rejst af de berørte medlemsstater, og om benefit/risk-forholdet for Prontax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin.
English: • During this referral procedure in Ireland the marketing authorisations of the two reference products Dectomax 1% w/v solution for injection for cattle and sheep and Dectomax 10 mg/ml solution for injection for pigs were transferred from Pfizer Healthcare Ireland to Elanco Animal Health, Eli Lilly and Company Limited and the names of the reference products in Ireland were changed to Zearl 10 mg/ml solution for injection for cattle and sheep and Zearl 10 mg/ml solution for injection for pigs).
Danish: • Under denne henvisningsprocedure er markedsføringstilladelserne i Irland for de to referenceprodukter Dectomax, injektionsvæske, opløsning, 1 % w/v, til kvæg og får, og Dectomax, injektionsvæske, opløsning, 10 mg/ml, til svin, overgået fra Pfizer Healthcare Ireland til Elanco Animal Health, Eli Lilly and Company Limited, og navnene på referenceprodukterne i Irland er ændret til Zearl, injektionsvæske, opløsning, 10 mg/ml, til kvæg og får, og Zearl, injektionsvæske, opløsning, 10 mg/ml, til svin.
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.
Danish: Undersøgelsen var veludført, men ikke helt i overensstemmelse med retningslinjerne for restkoncentrationer på injektionsstedet (EMEA/CVMP/542/03-FINAL), da der ikke blev taget ringprøver af omgivende væv.
English: 4.11 Withdrawal Period(s)
Danish: 4.11 Tilbageholdelsestid
English: The applicant Pfizer Limited has submitted an application for a decentralised procedure for Dectomax 10 mg/ml solution for cattle, sheep, and pigs.
Danish: Ansøgeren, Pfizer Limited, har indgivet en ansøgning ved den decentrale procedure for Dectomax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin.
English: Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing.
Danish: Må ikke anvendes til golde malkefår, herunder drægtige malkefår, inden for 70 dage forud for den forventede fødselsdato.
English: Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.
Danish: Må ikke anvendes til golde malkekøer, herunder drægtige malkekvier, inden for 60 dage forud for den forventede fødselsdato.
English: In sheep, the product is intended for the treatment and control of Psoroptes ovis (sheep scab mite) and for the treatment and control of gastrointestinal roundworms and nasal bots.
Danish: Hos får er produktet bestemt til behandling og kontrol af Psoroptes ovis (fåreskabmider) og til behandling og kontrol af gastrointestinale rundorm samt bremselarver.
English: Conclusions on the benefit-risk balance
Danish: Konklusioner vedrørende benefit/risk-forholdet
English: The study is not in accordance with the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95/final) and the guideline on injection site residues (EMEA/CVMP/542/03-FINAL) as the injection site was not sampled as recommended in the current guideline (i.e. with a separate core plus its surrounding tissue).
Danish: Undersøgelsen er ikke i overensstemmelse med CVMP's ”Note for guidance on the approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95/final) eller vejledningen for restkoncentrationsundersøgelser på injektionsstedet (EMEA/CVMP/542/03-FINAL), da der ikke blev taget prøver på injektionsstedet som anbefalet i de nuværende retningslinjer (dvs. med en separat kerne plus det omgivende væv).
English: Based on the Predicted No Effect Concentrations (PNECs) derived from the LC50 of 1.34 µg/kg soil for horn flies (Haematobia irritans) and the NOEC of 4.0 µg/kg soil for dung beetles (Ontophagus gazelle) the resulting risk quotients (RQs) for both species were high (41940 and 1405, respectively, based on the amount of total residues in dung at day 5 after administration), indicating a high acute risk to dung insects in Tier A. Consequently a Tier B assessment should be performed.
Danish: På grundlag af de beregnede nuleffektkoncentrationer (PNEC-værdier), der var afledt dels af LC50værdien på 1,34 µg/kg jord for stikfluer (Haematobia irritans), dels af NOEC-værdien på 4,0 µg/kg jord for gødningsbiller (Ontophagus gazelle) blev risikoforholdet for de to arter beregnet til henholdsvis 41 940 og 1 405 på grundlag af de totale restkoncentrationer i gødning på dag 5 efter administrationen).
English: Muscle: 40 μg/kg
Danish: Muskel: 40 μg/kg
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.
Danish: • På grundlag af ansøgningens restkoncentrationsdata for kvæg fandt udvalget, at der bør sættes en tilbageholdelsestid på 70 dage for kød og indmad fra kvæg konkluderede CVMP, at de indvendinger, der er rejst af Nederlandene og Frankrig, ikke bør være til hinder for udstedelse af markedsføringstilladelse for Prontax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin, og relaterede navne (se bilag I), da det overordnede benefit/risk-forhold for produktet er positivt, forudsat at der foretages de anbefalede ændringer i produktinformationen, som fremgår af bilag III.
English: Pigs - 1 ml per 33 kg bodyweight
Danish: Svin - 1 ml pr. 33 kg legemsvægt
English: Sheep and pigs - intramuscular
Danish: Kvægsubkutan Får og svinintramuskulær
English: • During the decentralised procedure the proposed product name was changed from Dectomax 10 mg/ml solution for injection for cattle, sheep and pigs to Prontax 10 mg/ml solution for injection for cattle, sheep and pigs
Danish: • Under den decentrale procedure blev det påtænkte særnavn ændret fra Dectomax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin, til Prontax, injektionsvæske, opløsning, 10 mg/ml, til kvæg og får og svin
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.
Danish: Derudover er der påpeget risiko over for det akvatiske delmiljø 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: 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:
Danish: Følgende foranstaltninger anbefales til imødegåelse af de påpegede risici over for vandorganismer og organismer i gødning og af eventuel tilbageværende usikkerhed om bioakkumulering:
English: The outcome of the ERA for cattle indicates that the RQs are higher than 1 in the Tier A assessment in two cases, namely daphnids (following direct excretion scenario) and dung fauna.
Danish: Miljørisikovurderingen for kvæg viser et risikoforhold > 1 i niveau A-bestemmelsen i to tilfælde, nemlig over for dafnier (ved scenariet med direkte udskillelse) og over for organismer i gødning.
English: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs contains doramectin as active ingredient.
Danish: Prontax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin, indeholder doramectin som det aktive indholdsstof.
English: Individual doramectin residues were still above the muscle MRL at the injection site 49 days after administration, which is the last timepoint for which there is data.
Danish: Enkeltværdier af restkoncentrationen af doramectin var stadig over maksimalgrænseværdierne for muskel på injektionsstedet på dag 49 efter administrationen, som var det sidste prøvetagningstidspunkt.
English: PIGS: Meat and offal:withdrawal period 56 days.
Danish: SVIN: Slagtning:tilbageholdelsestid 56 døgn.
English: Prontax 10 mg/ml solution for injection for cattle, sheep, and pigs and associated names is a sterile solution for injection containing doramectin 10 mg per ml.
Danish: Prontax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin, og relaterede navne er en steril injektionsvæske, opløsning, der indeholder doramectin, 10 mg/ml.
English: In cattle, the product is intended for the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, warbles, lice and mange mites.
Danish: Hos kvæg er produktet indiceret til behandling og kontrol af gastrointestinale rundorm, lungeorm, øjenorm, bremselarver, lus og skabmider.
English: The study is not in accordance with the Note for guidance on injection site residues (EMEA/CVMP/542/03-FINAL) as the injection site was not sampled as recommended in the current guideline (i.e. with a separate core plus surrounding tissue) and the sample weight was low, only between 201-359 g.
Danish: Undersøgelsen er ikke i overensstemmelse med CVMP's ”Note for guidance on the approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95/final) (EMEA/CVMP/542/03-FINAL), da der ikke blev taget prøver på injektionsstedet som anbefalet i de nuværende retningslinjer (dvs. med en separat kerne plus det omgivende væv), og da prøvernes vægt var lav, kun 201-359 g.
English: The reference products for this generic application were Dectomax 1% w/v solution for injection for cattle and sheep and Dectomax 10 mg/ml solution for injection for pigs.
Danish: Referenceprodukterne for denne generiske ansøgning var Dectomax, injektionsvæske, opløsning, 1 % w/v, til kvæg og får, og Dectomax, injektionsvæske, opløsning, 10 mg/ml, til svin.
English: Doramectin residues were above the muscle MRL at the injection site in all animals at 35 days after administration, which is the last timepoint for which there is data.
Danish: Restkoncentrationerne af doramectin i muskel var over maksimalgrænseværdierne på injektionsstedet hos alle dyr på dag 35 efter administrationen, som var det sidste prøvetagningstidspunkt.
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.
Danish: Dette begrundedes med forskellene mellem undersøgelserne, det forhold, at ingen af undersøgelserne var fuldstændig i overensstemmelse med de aktuelle retningslinjer, og at restkoncentrationerne i nogle af undersøgelserne lå over maksimalgrænseværdierne ved det seneste prøvetagningstidspunkt.
English: Overall summary of the scientific evaluation of Prontax 10 mg/ml solution for injection for cattle, sheep, and pigs and associated names
Danish: Samlet resumé af den videnskabelige vurdering af Prontax, injektionsvæske, opløsning, 10 mg/ml, til kvæg, får og svin, og relaterede navne
English: Based on Predicted Environmental Concentrations for surface water PECsw of 0.0005 g doramectin/l surface water (run-off scenario) and PECsw of 0.209 g doramectin/l surface water (direct excretion) an acute risk for Daphnia was identified in Tier A for both exposure scenarios with risk quotients (RQ) of 5 and 2090, respectively.
Danish: De forventede eksponeringskoncentrationer (PEC-værdier) for overfladevand, PECsw, var henholdsvis 0,0005 µg doramectin/l overfladevand ved spildscenariet og 0,209 µg doramectin/l overfladevand ved scenariet direkte udskillelse.
English: Doramectin is very toxic to aquatic organisms and may accumulate in sediments.
Danish: Doramectin er meget toksisk for vandorganismer og kan akkumuleres i sedimenter.
English: The individual doramectin residues were below the MRL at the injection sites at 35 days after treatment.
Danish: De individuelle restkoncentrationer af doramectin var under maksimalgrænseværdien på injektionsstederne på dag 35 efter behandlingen.
English: In pigs, the product is intended for the treatment of mange mites, gastrointestinal roundworms, lungworms, kidney worms and sucking lice.
Danish: Hos svin er produktet indiceret til behandling af skabmider, gastrointestinale rundorm, lungeorm, nyreorm og sugende lus.
English: Fat: 150 μg/kg
Danish: Fedt: 150 μg/kg
English: Liver: 100 μg/kg
Danish: Lever: 100 μg/kg
English: INN/Strength Animal species
Danish: Lægemiddelform INN/Styrker
English: Several studies and published literature on the toxicity to dung fauna were available.
Danish: For toksiciteten over for organismer i gødning forelå der flere undersøgelser samt publiceret litteratur.
English: A Daphnia magna reproduction study for conducting a Tier B assessment was not submitted in the ERA.
Danish: Miljørisikovurderingen indeholdt ikke en reproduktionsundersøgelse med Daphnia magna med henblik på niveau B-vurdering.
English: Solution for injection
Danish: Injektionsvæsk e, opløsning
English: Doramectin residues were below muscle MRL at the injection site 35 days after treatment.
Danish: Restkoncentrationerne af doramectin lå under maksimalgrænseværdien for muskel på injektionsstedet 35 dage efter behandlingen.
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.
Danish: Ved en af restkoncentrationsundersøgelserne blev der ikke taget prøver fra injektionsstedet.
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.
Danish: Resultaterne fra injektionsstedet danner derfor grundlag for fastsættelse af tilbageholdelsestiden.
English: SHEEP: Meat and offal:withdrawal period: 63 days.
Danish: FÅR: Slagtning:tilbageholdelsestid: 70 days.
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 vandorganismer og kan akkumuleres i sedimenter.
English: A GLP tissue depletion study from 2002 performed in cattle (34 animals) following two subcutaneous administrations of doramectin at the recommended dose of 200 µg/kg bw with an interval of 7 days between doses.
Danish: Der forelå en GLP-restkoncentrationsundersøgelse fra 2002 i kalve (34 dyr) efter to subkutane injektioner af doramectin i den anbefalede dosis på 200 µg/kg kropsvægt med syv dages mellemrum.
English: Kidney: 60 μg/kg
Danish: Nyre: 60 μg/kg
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.
Danish: Der blev foretaget en yderligere forbedret bestemmelse af PEC-værdien ved scenariet med direkte udskillelse, hvor der blev taget hensyn til, at den maksimale udskillelse af samlede restmængder optrådte på dag 5 efter administrationen og udgjorde 7,8 % af den administrerede dosis, og hvor beregningen var baseret på sedimentfordeling.
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.
Danish: Denne anses for ret kort på baggrund af de restkoncentrationer på injektionsstedet, der er påvist i andre undersøgelser end den, der blev anvendt som hovedundersøgelse.
English: CATTLE: Meat and offal:withdrawal period: 54 days.
Danish: KVÆG: Slagtning:tilbageholdelsestid: 70 days.
English: A GLP tissue depletion study from 1989 was performed in calves (3 groups of 4 animals) following a single subcutaneous administration of doramectin at the recommended dose of 200 µg/kg bw.
Danish: Der forelå en GLP-restkoncentrationsundersøgelse fra 1989 i kalve (tre grupper med fire dyr) efter en enkelt subkutan injektion af doramectin i den anbefalede dosis på 200 µg/kg kropsvægt.
English: A non-GLP tissue depletion study from 2003 was performed in cattle (24 animals) following a single subcutaneous administration of doramectin at the recommended dose of 200 µg/kg bw.
Danish: Der forelå en restkoncentrationsundersøgelse (ikke-GLP) fra 2003 i kalve (24 dyr) efter en enkelt subkutan injektion af doramectin i den anbefalede dosis på 200 µg/kg kropsvægt.
English: The current data package does not allow the assessment of bioaccumulation and therefore, bioaccumulation of doramectin cannot be ruled out.
Danish: Den nuværende dokumentationspakke giver ikke mulighed for vurdering af bioakkumulering.
English: A GLP tissue depletion study from 1991 was performed in calves (18 animals) following a single subcutaneous administration of doramectin at the recommended dose of 200 µg/kg bw.
Danish: Der forelå en GLP-restkoncentrationsundersøgelse fra 1991 i kalve (18 dyr) efter en enkelt subkutan injektion af doramectin i den anbefalede dosis på 200 µg/kg kropsvægt.
English: Route of administration
Danish: Dyrearter Indgivelsesvej
English: Pharmaceutical form
Danish: Indlægsseddel
English: 1 Mean toxin neutralising titre obtained after repeated vaccination of a half dose in rabbits.
Danish: ¹ Middel titer for neutralisering af toxin opnået efter gentagen vaccination med halv dosis i kaniner ² Middel agglutinations titer opnået efter en enkel vaccination med halv dosis i kaniner.
English: This summary was last updated in 11-2006.
Danish: Dette sammendrag blev sidst ajourført i 11-2006.
English: This side effect usually disappears within one week.
Danish: Denne bivirkning svinder sædvanligvis inden for en uge.
English: The first laboratory study tested the dose needed to provide protection.
Danish: I den første laboratorieundersøgelse blev det testet, hvilken dosis der er nødvendig for at give beskyttelse.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den faglige drøftelse (der ligeledes er en del af EPAR).
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Danish: Vedvarer smerten længere end 12 timer efter lægeundersøgelsen, skal lægen kontaktes igen.
English: Rarely, hypersensitivity (allergic) reactions may occur, which require treatment.
Danish: I sjældne tilfælde kan der opstå overfølsomhedsreaktioner (allergi), som kræver behandling.
English: In one field trial the serological response (antibody production) was measured.
Danish: I den ene feltundersøgelse måltes den serologiske respons (antistofproduktionen).
English: The bitch should be revaccinated in the same way during each pregnancy.
Danish: Tæven bør vaccineres igen på samme måde ved hver drægtighed.
English: The second injection is given 1 to 2 weeks before the expected date of whelping.
Danish: Den anden injektion gives 1 til 2 uger før den forventede fødsel.
English: The Package Leaflet should be taken to the doctor.
Danish: Indlægssedlen skal da vises til lægen.
English: If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Danish: Kommer man til at sprøjte produktet i sig, skal man straks søge lægehjælp, selv om den indsprøjtede mængde er meget lille.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - rarely causing the loss of a finger.
Danish: Uforvarende selvinjektion kan give stærk smerte og hævelse, navnlig ved injektion i led eller fingre - i sjældne tilfælde med tab af fingeren til følge.
English: Information on the prescription status of this product may be found on the labelling.
Danish: Oplysningerne om udleveringsbestemmelserne for dette lægemiddel findes på etiketten.
English: The benefitrisk balance may be found in module 6 of this EPAR.
Danish: Benefit/risk-forholdet fremgår af afsnit 6 i denne EPAR.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Eurican Herpes 205 to Merial on 26 March 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eurican Herpes 205 til Merial den 26. marts 2001.
English: In the study to show the protection of puppies (from vaccinated bitches) from canine herpes virus, over 80% of the pups from the vaccinated bitches survived..
Danish: I den undersøgelse, der skulle påvise beskyttelsen af hvalpe (fra vaccinerede tæver) mod hundeherpesvirus, overlevede over 80 % af hvalpene fra de vaccinerede tæver.
English: When exposed to canine herpes virus later in life, the puppies will either not become infected or have a much less serious infection.
Danish: Når hvalpene senere udsættes for hundeherpesvirus, vil de enten ikke blive inficeret, eller også bliver infektionen ikke nær så alvorlig.
English: Here Eurican Herpes 205 was compared with no vaccination (controls).
Danish: Her blev Eurican Herpes 205 sammenlignet med ingen vaccination (kontroldyr).
English: Eurican Herpes 205 has been studied in three laboratory studies and two field trials.
Danish: Eurican Herpes 205 blev undersøgt i tre laboratoriundersøgelser og to feltundersøgelser.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EURICAN HERPES 205 EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) EURICAN HERPES 205 EPAR - sammendrag for offentligheden
English: The first injection is given either when the bitch is on heat or 7 -10 days after the date of mating.
Danish: Den første injektion gives enten når tæven er i løbetid eller 7-10 dage efter parringen.
English: In the other, a study was made of the effect of vaccination on the ability of bitches to breed in an infected kennel.
Danish: I den anden undersøgtes vaccinationens virkning på tævernes evne til at yngle i en inficeret kennel.
English: Eurican Herpes 205 contains the active substance canine herpes virus (F205 strain) antigens in a dose of 0.3 to 1.75 µg.
Danish: Eurican Herpes 205 indeholder det aktive stof antigener fra hundeherpesvirus (stamme F205) i en mængde af 0,3 til 1,75 µg.
English: Eurican Herpes 205 contains mineral oil.
Danish: Eurican Herpes 205 indeholder mineralsk olie.
English: Eurican Herpes 205 is given as two 1 ml subcutaneous (under the skin) doses.
Danish: Eurican Herpes 205 gives som to doser a 1 ml subkutant (ved indsprøjtning under huden).