FrancophonIA/ELRC3.0 huggingface dataset:
English: However, in some Member States, including the Netherlands, the reference product has not been authorised for use in sheep.
Estonian: Mõnes liikmesriigis (sh Madalmaades) ei ole võrdlusravim heaks kiidetud kasutamiseks lammastel.
English: Following this approach a withdrawal period for sheep milk can be established at 108 hours.
Estonian: Selle lähenemisviisi kohaselt võib lambapiima keeluajaks kehtestada 108 tundi.
English: However, two publically9,10 available studies were made available to CVMP.
Estonian: Veterinaarravimite komiteele edastati siiski kaks avalikult kättesaadavat uuringut9,10.
English: Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine, however tylosin is not used in human medicine.
Estonian: Makroliidid on inim- ja veterinaarmeditsiinis liigitatud kriitiliselt tähtsateks antimikroobseteks aineteks, kuid inimmeditsiinis tülosiini ei kasutata.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States
Estonian: Veterinaarravimite nimetuste, ravimvormide, tugevuste, loomaliikide, manustamisviiside, taotlejate ja müügiloa hoidjate loetelu liikmesriikides
English: Bulgaria suini
Estonian: Belgium pigs
English: However, to address certain deficiencies in the data set, an additional safety factor of 30% was considered necessary resulting in a withdrawal period of 28 days.
Estonian: Leiti siiski, et andmekogumi teatud puuduste kõrvaldamiseks on vaja kasutada täiendavat 30% ohutustegurit, mis teeb keeluaja pikkuseks 28 päeva.
English: B. For all other products listed in Annex I Summary of product characteristics
Estonian: B. Kõik ülejäänud I lisas nimetatud ravimid Ravimi omaduste kokkuvõte
English: In accordance with the current legislation and relevant guidelines, maximum residue limits withdrawal periods have to be established on the basis of species-specific residue depletion data for all major food producing species.
Estonian: Vastavalt kehtivatele õigusaktidele ja asjakohastele suunistele tuleb kõigi peamiste toiduloomaliikide ravimijääkide piirnormid kehtestada ravimijääkide ammendumise liigiomaste andmete põhjal.
English: However, the actual residue concentrations were not given, and the study was done using a single injection rather than repeated injections.
Estonian: Uuring ei maininud ravimijääkide tegelikku kontsentratsiooni ja uuringus kasutati ühekordset süstet, mitte korduvaid.
English: For these 49 concerned veterinary medicinal products, the overall benefit-risk balance remains positive subject to the recommended changes in the product information (see Annex III).
Estonian: Nende 49 asjaomase veterinaarravimi kasulikkuse ja riski üldtasakaal jääb positiivseks, kui ravimiteabes tehakse soovitatud muudatused (vt III lisa).
English: Information was received regarding the composition of the affected products (n=50).
Estonian: Saadi asjaomaste ravimite (n = 50) koostise teave.
English: Huvepharma NV Uitbreidingstraat 80
Estonian: Prantsusmaa Huvepharma NV Uitbreidingstraat 80
English: The recommended treatment and dose of Tylosin/Anafasis is 10 mg/kg bw for 3-5 days, although most products recommend only 3 days of treatment.
Estonian: Tylosini/Anafasise soovitatav annus ja ravi kestus on 10 mg/kg 35 päeva vältel, kuigi enamiku ravimite korral on soovitatav kestus ainult 3 päeva.
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e., a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product Tylovectin, containing 200 mg of tylosin per ml, with France as Reference Member State (FR/V/0323/001/DC).
Estonian: Esitati direktiivi 2001/82/EÜ artikli 13 lõike 1 kohane taotlus, st geneeriline taotlus müügiloa saamiseks detsentraliseeritud menetluse alusel veterinaarravimile Tylovectin, mis sisaldab 200 mg/ml tülosiini; viiteliikmesriik oli Prantsusmaa (FR/V/0323/001/DC).
English: However, two publically available studies were made available to CVMP.
Estonian: Veterinaarravimite komiteele esitati siiski kaks avalikult kättesaadavat uuringut.
English: Whereas these theoretical calculations are not scientifically substantiated by data, it is reasonable to assume that a withdrawal period of 42 days would ensure that consumers would not be exposed to residues of concern if the injection volume was to be restricted to 2.5 ml per injection site.
Estonian: Kuigi need teoreetilised arvutused ei ole andmetega teaduslikult põhjendatud, on mõistlik eeldada, et 42-päevane keeluaeg tagab, et tarbijad ei puutu kokku probleemsete ravimijääkidega, kui piirata süstemahuks 2,5 ml/süstekoht.
English: The chemical forms of the active substance, being tylosin base or tartrate, have been considered to have similar behaviours (FAO, 20062), and tylosin being a weak base with a pKa of 7.73, can be expected to ionize and form salts under physiological conditions (i.e. at pH 7.4).
Estonian: Toimeaine keemilised vormid - tülosiin alusena ja tülosiintartraat - on sarnase käitumisega (FAO, 20062) ning tülosiin on nõrk alus (pKa = 7,73), seega võib eeldada, et toimeaine ioniseerub füsioloogilistes tingimustes (pH 7,4) ja moodustab sooli.
English: It is ineffective against Enterobacteriaceae.
Estonian: Tülosiin ei toimi enterobakterite suhtes (Enterobacteriaceae).
English: Nevertheless, as limiting the injection volume would require adult animals having to be injected 8 to 10 times per treatment dose, this is not considered appropriate for both practical and animal welfare considerations.
Estonian: Süstemahu vähendamisel tuleb täiskasvanud lambaid ühe ravimiannuse manustamiseks süstida siiski 8-10 korda, mida ei saa pidada praktilistel ega loomaheaolu kaalutlustel asjakohaseks.
English: From these two published studies, one did not provide data that could be used within the scope of this referral procedure.
Estonian: Neist ühes ei esitatud andmeid, mida oleks saanud kasutada selles esildismenetluses.
English: It is noted that this product can be used in adult sheep and that adult sheep would require treatment with higher injection volumes.
Estonian: Tuleb märkida, et ravimit tohib kasutada üksnes täiskasvanud lammastel, kes vajavad ravi suuremate süstemahtudega.
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).
Estonian: Kui eeldada, et teoreetiliselt on suuremal süstemahul sama imendumiskiirus kui 0,6 ml süstemahu korral täheldatu, tuleb keeluaega pikendada veel ligikaudu 5 päeva, kokku 33 päevani (21 päeva, ohutustegur 30% ja veel 5 päeva).
English: Tylosin concentrations in tissues (muscle, fat, liver, kidney, and injection site) were measured at 3, 7, 10 and 21 days post-treatment using a validated high performance liquid chromatography method.
Estonian: Tülosiini kontsentratsioon kudedes (lihas, rasv, maks, neerud ja süstekoht) mõõdeti 3, 7, 10 ja 21 päeva pärast ravi valideeritud kõrgsurvevedelikkromatograafia meetodiga.
English: The first study was conducted with 50 mg/ml tylosin (Ivatyl 50 inj.
Estonian: Esimeses uuringus kasutati 50 mg/ml tülosiini (Ivatyl 50 inj ad us.vet.
English: The application of the generic product (Tylovectin) concerned cattle, pigs, sheep and goats as the target species, which is in line with the reference product as authorised in France (Tylan 200).
Estonian: Geneerilise ravimi (Tylovectin) taotluses olid sihtliikidena loetletud veised, sead, lambad ja kitsed, mis on kooskõlas võrdlusravimiga, millel on müügiluba Prantsusmaal (Tylan 200).
English: Hence, the chemical form is not considered to effect residue absorption from tissues (including the injection site).
Estonian: Sel põhjusel ei arvata, et keemiline vorm mõjutaks ravimijääkide imendumist kudedest (sh süstekohast).
English: To ensure the safety of consumers of food and food products derived from animals treated with products containing tylosin, the European Commission has set MRLs for tylosin in the edible tissues of sheep.
Estonian: Et tagada tülosiini sisaldavate ravimitega ravitud loomadest saadud toidu ja toiduainete ohutus tarbijatele, on Euroopa Komisjon kehtestanud tülosiinijääkide piirnormid lammaste söödavatele kudedele.
English: Indeed, published data has shown that the rate of absorption from the injection site is inversely proportional to the viscosity of the product, i.e. the higher the viscosity, the slower the rate of absorption (Kakemi et al.,19723).
Estonian: Avaldatud andmed tõendavad, et süstekohast imendumise kiirus on pöördvõrdeline ravimi viskoossusega: mida suurem on viskoossus, seda väiksem on imendumiskiirus (Kakemi et al., 19723).
English: Whereas, according to current standards, residue depletion studies should be conducted in animals that are representative of the target population, it has not been possible to obtain such data within the context of this referral procedure.
Estonian: Kehtivate standardite kohaselt tuleb ravimijääkide ammendumise uuringud teha loomadel, kes on sihtpopulatsiooni suhtes esinduslikud, mille tõttu ei olnud esildises võimalik selliseid andmeid leida.
English: • milk from sheep is a minor food commodity and the and withdrawal periods for sheep milk can be extrapolated from those for cows' milk.
Estonian: • Lambapiim on väheoluline toiduaine ja lambapiima keeluajad saab ekstrapoleerida lehmapiima keeluaegadest.
English: Data extrapolation was done based on the excipients composition of the products concerned.
Estonian: Andmed ekstrapoleeriti asjaomaste ravimite abiainete koostise alusel.
English: As the animals in the study were treated twice daily, as opposed to once daily as usually recommended, the study design can be considered to represent a worst-case scenario.
Estonian: Et uuringuloomi raviti kaks korda päevas ja tavaliselt soovitatav manustamissagedus on üks kord päevas, võib uuringu ülesehitust ravimijääkide ammendumise aspektist pidada halvimaks võimalikuks stsenaariumiks.
English: Sheep: Intramuscular
Estonian: Lambad:intramusk
English: Two residue depletion studies were submitted by two of the concerned marketing authorisation holders.
Estonian: Kaks asjaomaste müügilubade hoidjat esitasid kaks ravimijääkide ammendumise uuringut.
English: Within this group of 49 products, most products contain tylosin base as active substance, whereas only five products contain tylosin tartrate.
Estonian: 49 ravimist enamik sisaldab toimeainet tülosiini alusena ja ainult 5 sisaldavad tülosiintartraati.
English: No specific residue data were available for the target species sheep.
Estonian: Spetsiifilised ravimijääkide andmed sihtliigi „lammas“ kohta ei olnud kättesaadavad.
English: Consequently, for this product the Committee recommends the variation of the existing marketing authorisations in order to remove any reference to the target species sheep.
Estonian: Seepärast soovitab komitee muuta ravimi olemasolevaid müügilube, eemaldades viited sihtliigile „lammas“.
English: The residue study was performed in sheep at a dose of 10 mg/kg bodyweight (bw), administered every 12 hours for 3 consecutive days.
Estonian: Ravimijääkide uuring oli tehtud lammastel annusega 10 mg kehamassi kg kohta (mg/kg), mida manustati iga 12 tunni järel 3 järjestikusel päeval.
English: A second study was conducted with Najdi ewes with 200 mg/ml tylosin (Tylan 200)7.
Estonian: Teises uuringus kasutati Najdi uttedel 200 mg/ml tülosiini (Tylan 200)7.
English: Regarding the establishment of withdrawal periods for sheep milk, no proprietary residue depletion studies in ewes were submitted.
Estonian: Seoses lambapiima keeluaegade kehtestamisega ei esitatud ühtki ettevõttesisest ravimijääkide ammendumise uuringut uttedel.
English: Hence, an option to overcome the lack of data in adult sheep would be to limit the injection volume, to the volume used in the residue study available with Tylosin/Anafasis (of 0.6 ml).
Estonian: Seega saab täiskasvanud lammastel puuduvaid andmeid kompenseerida süstemahu piiramisega mahuni, mida kasutati Tylosini/Anafasise ravimijääkide uuringus (0,6 ml).
English: Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae.
Estonian: Tülosiin on makroliidantibiootikum, mida toodab bakter Streptomyces fradiae.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet A. For Tilocen listed in Annex I (Marketing Authorisation Holder: Nikolakopoulos S.A)
Estonian: Ravimi omaduste kokkuvõtte, märgistuse ja pakendi infolehe asjakohaste lõikude muudatused A. I lisas nimetatud ravim Tilocen (müügiloa hoidja: Nikolakopoulos S.A)
English: Scientific conclusions and the grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Estonian: Teaduslikud järeldused ning ravimi omaduste kokkuvõtete, märgistuse ja pakendi infolehtede muutmise alused
English: From the information on the reference product (Tylan 200) provided by the Reference Member State France, it became clear that the withdrawal period for sheep was based on an extrapolation from the withdrawal period for cattle of 28 days.
Estonian: Viiteliikmesriigi Prantsusmaa esitatud võrdlusravimi (Tylan 200) teabest selgus, et keeluaeg lammastel põhineb veiste keeluaja (28 päeva) ekstrapoleerimisel.
English: In order for tylosin-derived residues to deplete below the MRLs, a sufficient time between treatment and slaughter must be allowed.
Estonian: Et tülosiinijääkide kontsentratsioon väheneksid alla ravimijääkide piirnormide, peab looma ravi ja tapmise vahel olema piisav ajavahemik.
English: • from the data provided the formulation of 49 of the concerned products is very similar.
Estonian: • esitatud andmete alusel on 49 asjaomase ravimi koostis väga sarnane.
English: The reference product Tylan 200 has a sheep milk withdrawal period of 108 hours, and this is the same withdrawal period for the milk of cattle in most Member States for the same product.
Estonian: Võrdlusravimi Tylan 200 keeluaeg lambapiima korral on 108 tundi, mis on sama kui veisepiima korral enamikus liikmesriikides.
English: From the residue data available, the treatment of a 50 kg sheep would require an injection volume of 2.5 ml.
Estonian: Kättesaadavate ravimijäägiandmete järgi oleks 50 kg lammastele vaja süstida ravimit 2,5 ml.
English: The reference product is Tylan 200 solution for injection, which has been authorised in various Member States.
Estonian: Võrdlusravim on Tylan 200 süstelahus, millel on müügiluba mitmes liikmesriigis.
English: Also, as the product can be used in adult sheep, and higher injection volumes would then be required, it has been theoretically calculated that a longer withdrawal period of five days (i.e., a total of 33 days) could account for the increased volume needed to treat sheep up to 50 kg of weight, with a maximum volume of 2.5 ml.
Estonian: Et ravimit saab kasutada täiskasvanud lammastel, mil on vaja suuremaid süstemahte, on teoreetiliselt arvutatud, et 5 päeva pikem keeluaeg (kokku 33 päeva) arvestab suuremat süstemahtu, mida on vaja kuni 50 kg lammaste ravimiseks ja mille suurim maht on 2,5 ml.
English: It is active mostly against Gram-positive bacteria and mycoplasmas.
Estonian: Tülosiin toimib peamiselt grampositiivsete bakterite ja mükoplasmade suhtes.
English: the CVMP has recommended variations of the marketing authorisations for veterinary medicinal products containing tylosin presented as a solution for injection for intramuscular use in sheep in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in Annex III.
Estonian: Veterinaarravimite komitee soovitas muuta lammastele näidustatud tülosiini sisaldavate intramuskulaarsete süstelahusena manustatavate veterinaarravimite müügilube, et muuta ravimi omaduste kokkuvõtteid, märgistust ja pakendi infolehti kooskõlas ravimiteabe soovitatud muudatustega, nagu on sätestatud III lisas.
English: Tylozyna Biovet JSC Tylosin base
Estonian: Tylozyna Biovet JSC Tülosiin (alusena)
English: Regardless of the tylosin strength, the formulation of 49 of the concerned products is very similar.
Estonian: Tülosiini tugevusest olenemata oli asjaomastest ravimitest 49 koostis väga sarnane.
English: In addition, publically available data showed that residues in sheep milk deplete faster than in cow's milk, and could not be detected 48 hours after the last treatment dose.
Estonian: Ka avalikult kättesaadavad andmed tõendavad, et ravimijääkide sisaldus lambapiimas väheneb kiiremini kui lehmapiimas ja ravimijäägid olid tuvastamatud 48 tundi pärast viimase annuse manustamist.
English: Sheep (meat) is considered a major food producing species.
Estonian: Peamiste toiduloomaliikide seas on ka lambad (liha).
English: INN Strength Pharmaceutical form
Estonian: Tugevus Ravimvorm Loomaliigid Manustamisviis
English: While the efficacy of the concerned products in sheep has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and prevention of infestations, which include respiratory infections caused by Gram-positive microorganisms, and mastitis caused by Gram-positive microorganisms.
Estonian: Kuigi asjaomaste ravimite efektiivsust lammastel ei hinnatud esildise raames eraldi, võib hinnatavaid ravimeid pidada efektiivseks infestatsioonide ravis ja ennetuses, sh grampositiivsete mikroorganismide
English: Therefore the Committee used the ‘alternative' method for determining the withdrawal period, in line with CVMP note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)5.
Estonian: Sel põhjusel kasutas komitee keeluaja määramiseks alternatiivset meetodit, mis on kooskõlas veterinaarravimite komitee suunisega keeluaegade ühtlustamise kohta (EMEA/CVMP/036/95)5.
English: For three of the products the concentration of tylosin is 50 mg/ml, whereas for the other 47 products it is 200 mg/ml.
Estonian: 3 ravimis oli tülosiini kontsentratsioon 50 mg/ml ja ülejäänud 47 ravimis 200 mg/ml.
English: Milk samples were analysed using a high-performance liquid chromatography method with solid phase extraction.
Estonian: Piimaproove analüüsiti kõrgsurve-vedelikkromatograafia ja tahke faasi eraldamisega.
English: The Committee considered that for the 49 products containing benzyl alcohol and propylene glycol, the differences in concentrations will not lead to different rates of absorption from the injection site.
Estonian: Komitee oli seisukohal, et bensüülalkoholi ja propüleenglükooli sisaldava 49 ravimi korral ei muuda kontsentratsiooni erinevus süstekohast imendumise kiirust.
English: Evaluation and conclusions on the benefit-risk balance
Estonian: Kasulikkuse ja riski tasakaalu hindamine ning järeldused
English: In this study, seven ewes (Slovak merino) were treated intramuscularly with tylosin base 50 mg per ml at a dosage of 100 mg per 10 kg bw, for five consecutive days.
Estonian: Uuringus raviti seitset utte (Slovakkia meriinod) intramuskulaarselt tülosiini (alusena) 50 mg/ml süstelahusega annuses 100 mg kehamassi 10 kg kohta 5 järjestikusel päeval.
English: In absence of residue depletion data in the major species sheep, the Netherlands considered that the withdrawal period for sheep of the reference product (Tylan 200) has not been adequately justified.
Estonian: Tähtsa liigi „lammas“ kohta puudusid ravimijääkide ammendumise andmed ja seepärast leidsid Madalmaad, et võrdlusravimi (Tylan 200) keeluaeg lammastel ei ole piisavalt põhjendatud.
English: The results from this residue study have been used for establishing the withdrawal periods for the remaining 49 out of the 50 products concerned, i.e. for all those products considered to be comparable qualitatively regarding excipients.
Estonian: Selle ravimijäägiuuringu tulemuste põhjal määrati keeluajad ülejäänud 49 asjaomasele ravimile 50st (kõigile ravimitele, mida peeti abiainete osas kvalitatiivselt võrreldavateks).
English: Journal of Veterinary Research, 9(2), 138-143 8 http://www.fao.org/tempref/AG/agn/food/tylosin_2006.pdf
Estonian: Journal of Veterinary Research, 9(2), 138-143 8 http://www.fao.org/tempref/AG/agn/food/tylosin_2006.pdf ringist), tõendasid tulemused, et süstekoht on keeluaega määrav kude.
English: The Committee considered that harmonising the withdrawal periods of 49 of the products concerned within the scope of this referral procedure to a withdrawal period of 42 days for meat and offal from sheep, would be a conservative approach to ensure consumer safety (i.e., that residues from the injection site would be below the established MRL for tylosin meat (100 µg/kg)), as a withdrawal period of 42 days would accommodate for a decrease in release rate of more than 250% and ensure consumer safety if the injection volume was to be restricted to 2.5 ml per injection site.
Estonian: Komitee leidis, et esildise ravimitest 49 ravimi keeluaja ühtlustamine 42 päevale lamba liha ja söödavate kudede korral oleks konservatiivne lähenemisviis, et tagada tarbijate ohutus (st tagada, et tülosiinijäägid süstekohas oleksid alla tülosiinijääkide piirnormi lihas (100 µg/kg)), sest 42-päevane keeluaeg arvestaks imendumiskiiruse vähenemist üle 250% ja tagaks tarbijaohutuse ka siis, kui piirata süstemahuks 2,5 ml/süstekoht.
English: However, the rate of absorption from the injection site depends on a complexity of factors, and without specific residue data, the influence of increasing the injection volume/ site of injection on the absorption rate is difficult to quantify.
Estonian: Süstekohast imendumise kiirus sõltub eri tegurite keerukast koosmõjust ja ilma ravimijääkide spetsiifiliste andmeteta on raske kvantifitseerida suurema süstemahu / süstimiskohade suurema arvu mõju imendumiskiirusele.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Estonian: Tülosiini ning selle fosfaat- ja tartraatsooli kasutatakse neile ainetele tundlike organismide tekitatud seisundite ravi vetrtinaarravimites.
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.
Estonian: On tuvastatud risk, et keeluaja pikkus lammastel (liha ja söödavad koed ning piim) võib osa ravimite korral olla ebapiisav, et tülosiinijääkide kontsentratsioon väheneks keeluaja lõpuks kõigis söödavates kudedes alla lubatud ravimijääkide piirnormi, mis ohustab inimesi, kes tarvitavad nende ravimitega ravitud loomade liha, söödavaid kudesid ja piima.
English: Given that the injection site is the withdrawal period determining tissue, extrapolation of residue data from products containing propylene glycol to that containing polyethylene glycol 400 cannot be justified.
Estonian: Arvestades, et süstekoht on kude, mis määrab keeluaja kestuse, ei ole propüleenglükooli sisaldavate ravimite ravimijääkide andmete ekstrapoleerimine polüetüleenglükooli 400 sisaldavate ravimite andmeteks põhjendatud.
English: As the withdrawal period is established taking into account persistence of residues in the injection sites, and a higher injection volume may cause higher local residues in injection sites, a longer withdrawal period would be required for adult sheep treated with tylosin intramuscularly.
Estonian: Et keeluaja määramisel arvestatakse ravimijääkide püsimist süstekohtades, võib suurem süstemaht tekitada süstekohtades rohkem lokaalseid ravimijääke, mispärast on intramuskulaarse tülosiiniga ravitavatel täiskasvanud lammastel vaja pikemat keeluaega.
English: Two days after the last dose, tylosin could no longer be detected in sheep milk.
Estonian: Kaks päeva pärast viimase annuse manustamist ei olnud tülosiin lambapiimas enam tuvastatav.