FrancophonIA/ELRC3.0 huggingface dataset:
English: • on the basis of the available data, the CVMP considered the withdrawal periods for meat and offal, and milk derived from treated sheep should be amended to provide assurance for consumer safety for all concerned veterinary medicinal products, as referred in Annex I, except for Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A);
Danish: • På baggrund af de tilgængelige data vurderer CVMP, at tilbageholdelsestiden for kød, indmad og mælk fra behandlede får bør ændres for at sikre forbrugersikkerheden, hvad angår alle de omhandlede veterinærlægemidler, jf. bilag I, bortset fra Tilocen (indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A).
English: Having considered the grounds for referral and the data available, the CVMP concluded that for 49 out of 50 products, these being all those containing benzyl alcohol and propylene glycol as excipients, the withdrawal periods for meat and offal derived from treated sheep should be amended to 42 days, and the withdrawal periods for milk derived from treated sheep should be amended to 108 hours to provide assurance for consumer safety.
Danish: Efter at have gennemgået begrundelserne for indbringelse og de tilgængelige data vurderer CVMP, at for 49 af de 50 produkter, nemlig dem, der indeholder benzylalcohol og propylenglycol som hjælpestoffer, bør tilbageholdelsestiden for kød og indmad fra behandlede får ændres til 42 dage, og tilbageholdelsestiden for mælk fra behandlede får bør ændres til 108 timer for at sikre forbrugersikkerheden.
English: For only one concerned product (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), the solvent polyethylene glycol 400 is used instead of propylene glycol.
Danish: I kun ét af de omhandlede produkter (Tilocen, indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A) anvendes solvenset polyethylenglycol 400 i stedet for propylenglycol.
English: It has been noted that there are different approved withdrawal periods for sheep (milk, meat and offal) for veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep across the EU, e.g. sheep meat and offal from 8 days to 42 days; sheep milk from 4 days to 7 days.
Danish: Det er blevet bemærket, at der er forskellige godkendte tilbageholdelsestider for får (mælk, kød og indmad), hvad angår veterinærlægemidler, som indeholder tylosin, formuleret som injektionsvæske, opløsning, til behandling af får i hele EU, f.eks. for fårekød og -indmad fra 8 dage til 42 dage, og for
English: The remaining product contains polyethylene glycol 400 instead of propylene glycol.
Danish: Det sidste produkt indeholder polyethylenglycol 400 i stedet for propylenglycol.
English: Tylozyna Biovet JSC Tylosin base
Danish: Tylozyna Biovet JSC
English: In this study, however, additional shortcomings were identified, these being that the number of treated animals (n=3) was below the number required in VICH GL 484, animals were very young (12 kg mean bw), and also the sampling of the injection site did not include an outer ring sample.
Danish: Der blev imidlertid fundet yderligere mangler ved dette studie: Antallet af behandlede dyr (n = 3) var mindre end det påkrævede antal i henhold til VICH GL 48-retningslinjen4, dyrene var meget unge (gennemsnitlig kropsvægt på 12 kg), og prøvetagningen fra injektionsstedet omfattede ikke en ringprøve.
English: A second study was conducted with Najdi ewes with 200 mg/ml tylosin (Tylan 200)7.
Danish: I et andet studie blev der anvendt 200 mg/ml tylosin (Tylan 200) hos Najdi-hunfår7.
English: While minor differences on concentrations of the same excipients have been considered not to have an impact on residue depletion from the injection site, different solvents can have an effect on the viscosity of the formulations, and consequently affect absorption of residues from the injection site.
Danish: Mens mindre forskelle i indholdet af de samme hjælpestoffer ikke vurderes at have nogen betydning for nedbrydningen af restkoncentrationer ved injektionsstedet, kan forskellige solvenser have betydning for formuleringens viskositet, hvilket derfor kan påvirke absorptionen af restkoncentrationer fra injektionsstedet.
English: For one product (Tilocen), the solvent polyethylene glycol 400 was used instead of propylene glycol.
Danish: I ét produkt (Tilocen) anvendes solvenset polyethylenglycol 400 i stedet for propylenglycol.
English: For these 49 products, excipients listed are benzyl alcohol and propylene glycol (in concentrations that differ slightly between products), as well as small concentrations of different pH adjustors.
Danish: For disse 49 produkter er de anførte hjælpestoffer benzylalkohol og propylenglycol (i koncentrationer, der er en smule forskellige fra produkt til produkt) samt små koncentrationer af forskellige pH-regulatorer.
English: Hence, data from this study could not be extrapolated to the only product containing the excipient polyethylene glycol 400 (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), for the reason mentioned above.
Danish: Dataene fra dette studie vil derfor ikke kunne ekstrapoleres til det eneste produkt, der indeholder hjælpestoffet polyethylenglycol 400 (Tilocen, indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A), jf. ovennævnte begrundelse.
English: Bulgaria suini
Danish: PORCINO
English: Regardless of the tylosin strength, the formulation of 49 of the concerned products is very similar.
Danish: Formuleringen af 49 af de omhandlede produkter er meget ensartet, uanset tylosin-styrke.
English: • no suitable residue depletion study was made available the results from which could be extrapolated to the concerned product Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A) containing tylosin presented as solution for injection for use in the target species sheep, and containing polyethylene glycol 400 as excipient.
Danish: • Der blev ikke fremlagt resultater fra noget restkoncentrationsstudie, der kunne ekstrapoleres til det berørte produkt Tilocen (indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A), som indeholder tylosin, formuleret som injektionsvæske, opløsning, til anvendelse hos måldyrearten får, og som indeholder polyethylenglycol 400 som hjælpestof.
English: • on the basis of the available data, the CVMP considered the withdrawal periods for meat and offal, and milk derived from treated sheep cannot be established for Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A), as referred in Annex I.
Danish: • På baggrund af de foreliggende data vurderer CVMP, at tilbageholdelsestiderne for kød, indmad og mælk fra behandlede får ikke kan fastsættes for Tilocen (indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A), jf. bilag I.
English: • a GLP compliant residue study conducted with tylosin solution for injection, used intramuscularly in sheep was provided, and from which withdrawal periods could be established for meat and offal of treated sheep for 49 concerned products, i.e., those with excipients benzyl alcohol and propylene glycol.
Danish: • Der blev fremlagt et GLP-studie af nedbrydningen af restkoncentrationer efter intramuskulær anvendelse af tylosin-holdig injektionsvæske hos får, hvor der kunne fastsættes en tilbageholdelsestid for kød og indmad fra behandlede får for 49 af de omhandlede produkter, dvs. dem med hjælpestofferne benzylalkohol og propylenglycol.
English: Data from the literature indicated that the residue depletion from milk from sheep is faster than from milk from cows.
Danish: Data fra litteraturen viser, at nedbrydningen af restkoncentrationer sker hurtigere i fåremælk end i komælk.
English: At day 21 after the last dose was administered, the residue concentrations in all samples of the injection site were below the established maximum residue limit (MRL) for tylosin in sheep meat of 100 µg/kg.
Danish: 21 dage efter administration af den sidste dosis lå restkoncentrationen i alle prøver fra injektionsstedet under den fastsatte maksimalgrænseværdi (MRL) for tylosin i fårekød (100 µg/kg).
English: Milk samples were analysed using a high-performance liquid chromatography method with solid phase extraction.
Danish: Mælkeprøver blev analyseret ved højtryksvæskekromatografi (HPLC) med fastfase-ekstraktion.
English: A GLP-compliant residue study with tylosin solution for injection, conducted in sheep via intramuscular administration was made available to CVMP.
Danish: Data fra et GLP-studie med får, der fik tylosin-holdig injektionsvæske, opløsning, ved intramuskulær administration, blev fremlagt for CVMP.
English: For the product containing the excipient polyethylene glycol 400 (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), no suitable residue depletion data are available for establishing a withdrawal period for sheep meat, offal, and milk.
Danish: Hvad angår det produkt, der indeholder hjælpestoffet polyethylenglycol 400 (Tilocen, indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A), foreligger der ingen relevante restkoncentrationsdata til fastsættelse af en tilbageholdelsestid for kød, indmad og mælk fra får.
English: Given that the viscosities of propylene glycol and polyethylene glycol 400 are different, a significant impact on the absorption and residue depletion, and consequently on the withdrawal periods needed for tylosin solutions for injections with these different excipients cannot be excluded.
Danish: Da propylenglycol og polyethylenglycol 400 har forskellig viskositet, kan det ikke udelukkes, at dette har stor betydning for absorptionen og nedbrydningen af restkoncentrationer og dermed for de tilbageholdelsestider, der bør gælde for tylosin-holdige injektionsvæsker med disse forskellige hjælpestoffer.
English: At day 21 after the last dose was administered, the residue concentrations in the injection site were all below the established MRL for tylosin in sheep meat, of 100 µg/kg.
Danish: 21 dage efter administration af den sidste dosis var alle restkoncentrationer ved injektionsstedet under den fastsatte MRL-værdi for tylosin i fårekød (100 µg/kg).
English: In addition, JECFA at their 66th meeting reviewed tylosin and compared the residue depletion of tylosin in milk from cows and sheep (JECFA, 20068).The results show that tylosin residues deplete faster in milk from ewes, than in milk from cows.
Danish: møde gennemgik JECFA desuden tylosin og sammenlignede nedbrydningen af tylosinrester i komælk og fåremælk (JECFA, 20068).
English: The differences in concentrations of benzyl alcohol and propylene glycol, and in pH adjustors, have also been considered not to have an impact on residue absorption from tissues and the injection site.
Danish: Forskellene i koncentrationen af benzylalkohol, propylenglycol og pHregulatorer vurderes heller ikke at have nogen betydning for restkoncentrationabsorptionen fra væv og injektionssted.
English: A risk has been identified regarding the length of the authorised withdrawal periods for sheep (meat and offal, and milk), which, for some products, may be insufficient to allow residues of tylosin to fall below the authorised MRLs in all edible tissues by the end of the withdrawal period, thereby posing a risk to consumers of meat, offal and milk from sheep treated with these products.
Danish: For nogle produkters vedkommende kan tilbageholdelsestiden være utilstrækkelig til, at restkoncentrationer af tylosin kan falde til under de godkendte MRL-værdier i alle spiselige væv inden udgangen af tilbageholdelsestiden, hvilket udgør en risiko for forbrugere af kød, indmad og mælk fra får, der er behandlet med disse produkter.
English: Given that the viscosities of propylene glycol and polyethylene glycol 400 are different, a significant impact on the absorption and residue depletion from the injections site, and consequently on the withdrawal periods cannot be excluded.
Danish: Da propylenglycol og polyethylenglycol 400 har forskellig viskositet, kan det ikke udelukkes, at dette har stor betydning for absorptionen og nedbrydningen af restkoncentrationer fra injektionsstedet og dermed for tilbageholdelsestiderne.
English: Therefore, the Committee considers that the benefit-risk balance for the veterinary medicinal product Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A) containing tylosin presented as solution for injection for use in target species sheep, and containing polyethylene glycol 400 is not favourable in the absence of adequate residue depletion data in sheep to justify a withdrawal period of 42 days for sheep meat and offal, and 108 hours for sheep milk.
Danish: Derfor vurderer udvalget, at benefit/risk-forholdet for veterinærlægemidlet Tilocen (indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A), der indeholder tylosin, formuleret som injektionsvæske, opløsning, til anvendelse hos måldyrearten får, og som indeholder polyethylenglycol 400, ikke er positivt, da der ikke foreligger relevante restkoncentrationsdata for får til at begrunde en tilbageholdelsestid på 42 dage for fårekød og -indmad og 108 timer for fåremælk.
English: INN Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Dyrearter Administrationsvej
English: However, as the injection site is the withdrawal period determining tissue, for the product containing polyethylene glycol 400 (Tilocen, marketing authorisation holder: A. Nikolakopoulos S.A), and in view of the effect of this excipient on product viscosity, a different rate of absorption of residues from the injection site cannot be ruled out.
Danish: Injektionsstedet er imidlertid det væv, der er bestemmende for tilbageholdelsestiden, og hvad angår det produkt, som indeholder polyethylenglycol 400 (Tilocen, indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A), kan det ikke udelukkes, at absorptionshastigheden fra injektionsstedet er en anden i betragtning af dette hjælpestofs indvirkning på produktets viskositet.
English: For the product Tilocen (marketing authorisation holder: A. Nikolakopoulos S.A) containing tylosin presented as solution for injection for use in target species sheep, and containing polyethylene glycol 400, there was no data available that could be used to determine adequate withdrawal periods that could assure that after 42 days after treatment, the residues are below the established MRLs for tylosin in sheep.
Danish: For produktet Tilocen (indehaver af markedsføringstilladelse: A. Nikolakopoulos S.A), der indeholder tylosin, formuleret som injektionsvæske, opløsning, til anvendelse hos måldyrearten får, og som indeholder polyethylenglycol 400, forelå der ingen relevante data til fastsættelse af en hensigtsmæssig tilbageholdelsestid, der kunne sikre restkoncentrationer under den fastsatte MRL-værdi for tylosin hos får 42 dage efter behandling.
English: Anafasis LTD Santorinis 3 Pallouriotissa 1048 Nicosia Cyprus
Danish: Grækenland Anafasis LTD Santorinis 3
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION For sheep over 50 kg of bodyweight, the injection should be divided over two injection sites (maximum 2.5 ml injection volume per injection site).
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ For får med en kropsvægt på over 50 kg bør dosen fordeles på to injektionssteder (med et maksimalt injektionsvolumen pr. injektionssted på 2,5 ml).
English: Nevertheless, it has been reported that the rate of absorption from the injection site depends on a number of factors (e.g. injection volume, excipients, lipophilicity of the active substance), and without specific residue data,
Danish: Ikke desto mindre fremgår det af rapporterne, at absorptionshastigheden fra injektionsstedet afhænger af en række faktorer (f.eks. injektionsvolumen, hjælpestoffer, det aktive stofs lipofilicitet), og uden specifikke restkoncentrationsdata er det vanskeligt at kvantificere, hvilken betydning det har for absorptionshastigheden at øge injektionsvolumenet/injektionssted.
English: No proprietary residue depletion studies in ewes were submitted.
Danish: Der er ikke fremlagt data fra interne restkoncentrationsstudier hos hunfår.
English: The differences on concentrations of benzyl alcohol and propylene glycol, and on pH adjustors have been considered not to have an impact on residue absorption from the injection site.
Danish: Forskellene i koncentrationen af benzylalkohol, propylenglycol og pH-regulatorer vurderes ikke at have nogen betydning for restkoncentrationabsorptionen fra injektionsstedet.
English: For sheep over 50 kg of bodyweight, the CVMP recommends that the dose is divided over two injection sites.
Danish: For får med en kropsvægt på over 50 kg anbefaler CVMP, at dosen fordeles på to injektionssteder.
English: For sheep over 50 kg, however, the CVMP recommends that the dose is divided over two injection sites (maximum injection volume per site of 2.5 ml).
Danish: For får over 50 kg anbefaler CVMP imidlertid, at dosen fordeles på to injektionssteder (med et maksimalt injektionsvolumen pr. injektionssted på 2,5 ml).
English: The CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1)1 allows extrapolation of the withdrawal period between animal species, but only from a major species to a minor species.
Danish: CVMP's retningslinje om sikkerhed og krav til restkoncentrationsdata for veterinærlægemidler til mindre udbredt anvendelse eller til mindre benyttede dyrearter (MUMS)/begrænset marked (EMA/CVMP/SWP/66781/2005-Rev.1)1 tillader ekstrapolering af tilbageholdelsestiden mellem dyrearter, men kun fra en meget benyttet dyreart til en mindre benyttet dyreart.
English: For sheep over 50 kg, the CVMP recommends that the dose is divided over two injection sites.
Danish: For får over 50 kg anbefaler CVMP, at dosen fordeles på to injektionssteder.
English: Tylosin 200
Danish: BILOVET 200
English: Although a number of shortcoming were identified from this study (more specifically that the number of treated animals (n=3) was below the number required in VICH GL 48, animals were very young (12 kg mean bw), and also the sampling of the injection site did not include an outer ring sample), the results showed that the injection site is the withdrawal period determining tissue and results from this residue study have been used for establishing the withdrawal periods for 49 out of the 50 products concerned.
Danish: VICH GL 48-retningslinjen, dyrene var meget unge (gennemsnitlig kropsvægt på 12 kg), og prøverne fra injektionsstedet omfattede ikke en ringprøve), fremgik det af resultaterne, at injektionsstedet er det væv, der er bestemmende for tilbageholdelsestiden, og resultaterne fra dette restkoncentrationsstudie er blevet anvendt til at fastsætte tilbageholdelsestiden for 49 af de 50 omhandlede produkter.
English: For sheep milk, literature data showed that the tylosin residue depletion from sheep milk is faster than depletion from cow's milk.
Danish: Data fra litteraturen viser, at nedbrydningen af tylosinrester sker hurtigere i fåremælk end i komælk.
English: 5 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link the influence of increasing the injection volume/site of injection on the absorption rate is difficult to quantify.
Danish: 5 CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95) - link dvs. i alt 33 dage (svarende til 21 dage plus en sikkerhedsmargen på 30 % plus yderligere 5 dage).
English: Tylosin residues were detected in milk during the treatment, and were below the established MRL for tylosin in cattle milk (50 µg/kg) 36 hours after the last administration, and were not detected 48 hours after the last treatment dose.
Danish: 36 timer efter sidste indgift var restkoncentrationen under den fastsatte MRL-værdi for tylosin i komælk (50 µg/kg), og 48 timer efter sidste behandlingsdosis kunne der ikke spores nogen restkoncentration.
English: In accordance with CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1), the milk withdrawal period for cattle milk of 108 hours has been also established as the withdrawal period for sheep milk.
Danish: I overensstemmelse med CVMP's retningslinje om sikkerhed og krav til restkoncentrationsdata for veterinærlægemidler til mindre udbredt anvendelse eller til mindre benyttede dyrearter (MUMS)/begrænset marked (EMA/CVMP/SWP/66781/2005-Rev.1) er tilbageholdelsestiden for fåremælk fastsat til den samme som for komælk (108 timer).
English: below the MRLs for tylosin in cattle milk (50 µg/kg), 36 hours after the last administration, and were not detected 48 hours after the last treatment dose.
Danish: Det andet offentliggjorte studie viste, at restkoncentrationen i fåremælk var under MRL-værdien for tylosin i komælk (50 µg/kg) 36 timer efter sidste indgift, og at der ikke kunne spores nogen restkoncentration 48 timer efter sidste behandlingsdosis.
English: The other submitted study was a GLP-compliant residue study with tylosin solution for injection, conducted in sheep via intramuscular administration.
Danish: Det andet studie var et GLP-studie af nedbrydningen af restkoncentrationer hos får efter intramuskulær indgivelse af tylosin-holdig injektionsvæske, opløsning.
English: Cattle, sheep, pigs, dogs, cats
Danish: Kvæg, får, svin, hunde, katte
English: If, theoretically, a larger injection would have the same absorption rate as established for a volume of 0.6 ml, then the withdrawal period would need to be extended by approximately 5 days, i.e., a total of 33 days (resulting from 21 days, plus a 30% safety span, and the additional 5 days).
Danish: Hvis en større injektion i teorien har samme absorptionshastighed som et volumen på 0,6 ml, skal tilbageholdelsestiden forlænges med ca. 5 dage,
English: While the residue studies mentioned above were made available, milk from sheep is considered a minor food commodity, and withdrawal periods for sheep milk can be extrapolated from those for cows' milk in accordance with the CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1).
Danish: Der er fremlagt data fra ovennævnte restkoncentrationsstudier, men fåremælk anses for at være en mindre benyttet fødevare, og tilbageholdelsestiden for fåremælk kan ekstrapoleres fra tilbageholdelsestiden for komælk, jf. CVMP's retningslinje om sikkerhed og krav til restkoncentrationsdata for veterinærlægemidler til mindre udbredt anvendelse eller til mindre benyttede dyrearter (MUMS)/begrænset marked (EMA/CVMP/SWP/66781/2005-Rev.1).
English: Biovet JSC 39 Petar Rakov Str. 4550 Peshtera
Danish: Rumænien Biovet JSC 39 Petar Rakov Str.
English: Milk from sheep is, however, considered a minor food commodity, and withdrawal periods for sheep milk can be extrapolated from those for cows' milk, in accordance with the CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1).
Danish: Fåremælk anses imidlertid for at være en mindre benyttet fødevare, og tilbageholdelsestiden for fåremælk kan ekstrapoleres fra tilbageholdelsestiden for komælk, jf. CVMP's retningslinje om sikkerhed og krav til restkoncentrationsdata for veterinærlægemidler til mindre udbredt anvendelse eller til mindre benyttede dyrearter (MUMS)/begrænset marked (EMA/CVMP/SWP/66781/2005-Rev.1).
English: Cats, cattle, dogs, goats, pigs, sheep
Danish: Katte, kvæg, hunde, geder, svin, får
English: PHARMASIN 200 mg/ml SOLUCION INYECTABLE PARA BOVINO OVINO CAPRINO Y PORCINO
Danish: PHARMASIN 200 mg/ml SOLUCION INYECTABLE PARA BOVINO OVINO CAPRINO Y
English: Cattle, dogs, goats, pigs, sheep
Danish: Kvæg, hunde, geder, svin, får
English: Therefore, the Netherlands considered that it is necessary to refer the matter to
Danish: Anbefalingen fremsættes ud fra følgende betragtninger: