natgillin/translations-raw huggingface dataset:
Applicant / Marketing authorisation holder
Predlagatelj/imetnik dovoljenja za promet z zdravilom
It is active mostly against Gram-positive bacteria and mycoplasmas.
Deluje predvsem proti grampozitivnim bakterijam in mikoplazmam.
Data extrapolation was done based on the excipients composition of the products concerned.
Ekstrapolacija podatkov je bila opravljena na podlagi sestave pomožnih snovi zadevnih zdravil.
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.
V skladu z veljavno zakonodajo in ustreznimi smernicami je treba karence za mejne vrednosti ostankov določiti na podlagi podatkov o izločanju ostankov, specifičnih za vrsto, za vse glavne vrste za proizvodnjo živil.
It is noted that this product can be used in adult sheep and that adult sheep would require treatment with higher injection volumes.
Opozoriti je treba, da se to zdravilo lahko uporablja pri odraslih ovcah in da bi morali odrasle ovce zdraviti z večjimi volumni injiciranja.
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.
Medtem ko ti teoretični izračuni niso znanstveno utemeljeni s podatki, je smiselno domnevati, da bi 42-dnevna karenca zagotovila, da potrošniki ne bi bili izpostavljeni zaskrbljujočim ostankom, če bi bil volumen injiciranja omejen na 2,5 ml na mesto injiciranja.
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.
Da bi zagotovili varnost potrošnikov živil in prehrambnih izdelkov, proizvedenih iz živali, zdravljenih z zdravili, ki vsebujejo tilozin, je Evropska komisija določila MRL za tilozin v tkivih ovac, namenjenih prehrani.
Tylozyna Biovet JSC Tylosin base
Tylozyna Biovet JSC tilozinova baza
Hence, the chemical form is not considered to effect residue absorption from tissues (including the injection site).
Zato velja, da kemična oblika ne vpliva na absorpcijo ostankov iz tkiv (vključno z mestom injiciranja).
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).
Dejansko so objavljeni podatki pokazali, da je hitrost absorpcije z mesta injiciranja obratno sorazmerna viskoznosti zdravila, tj. večja ko je viskoznost, počasnejša je absorpcija (Kakemi in sod., 19723).
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).
Pri teh 49 zadevnih zdravilih za uporabo v veterinarski medicini je splošno razmerje med koristmi in tveganji ob upoštevanju priporočenih sprememb informacij o zdravilu (glej Prilogo III) pozitivno.
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.
Vendar se je za odpravo nekaterih pomanjkljivosti v naboru podatkov upošteval dodaten 30-odstotni varnostni faktor, kar je privedlo do karence 28 dni.
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.
Rezultati te študije o ostankih so bili uporabljeni za določitev karenc za preostalih 49 od 50 zadevnih zdravil, tj. za vsa tista zdravila, ki se štejejo za kvalitativno primerljiva glede pomožnih snovi.
Within this group of 49 products, most products contain tylosin base as active substance, whereas only five products contain tylosin tartrate.
V okviru te skupine 49 zdravil vsebuje večina zdravil kot učinkovino tilozinovo bazo, samo pet zdravil pa kot učinkovino vsebuje tilozinijev tartrat.
In order for tylosin-derived residues to deplete below the MRLs, a sufficient time between treatment and slaughter must be allowed.
Da bi se lahko koncentracija ostankov tilozina znižala pod MRL, mora med zdravljenjem in zakolom miniti zadosten čas.
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.
Čeprav učinkovitost zadevnih zdravil pri ovcah v okviru te napotitve ni bila natančno ocenjena, se šteje, da so ocenjevana zdravila učinkovita pri zdravljenju in preprečevanju infestacij, kar vključuje okužbe dihal z grampozitivnimi mikroorganizmi in mastitis, ki ga povzročajo grampozitivni mikroorganizmi.
Regardless of the tylosin strength, the formulation of 49 of the concerned products is very similar.
Ne glede na koncentracijo tilozina je formulacija 49 zadevnih zdravil zelo podobna.
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
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, predlagateljev in imetnikov dovoljenj za promet z zdravilom v državah članicah
Two days after the last dose, tylosin could no longer be detected in sheep milk.
Dva dni po zadnjem odmerku v ovčjem mleku ni bilo več mogoče zaznati tilozina.
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).
V skladu s členom 13(1) Direktive 2001/82/ES je bila predložena vloga, tj. generična vloga za izdajo dovoljenja za promet z zdravilom v skladu z decentraliziranim postopkom za zdravilo za uporabo v veterinarski medicini Tylovectin, ki vsebuje 200 mg tilozina na ml, s Francijo kot referenčno državo članico (FR/V/0323/001/DC).
Therefore, the Netherlands considered that it is necessary to refer the matter to
Nizozemska je zato menila, da je treba zadevo zaradi varstva potrošnikov v Uniji napotiti na Odbor za zdravila za
The formulation of 49 of the concerned products is very similar.
Formulacija 49 zadevnih zdravil je zelo podobna.
Milk samples were analysed using a high-performance liquid chromatography method with solid phase extraction.
Vzorci mleka so bili analizirani s tekočinsko kromatografijo visoke ločljivosti z ekstrakcijo na trdni fazi.
A second study was conducted with Najdi ewes with 200 mg/ml tylosin (Tylan 200)7.
Druga študija je bila izvedena z ovcami pasme najdi z 200 mg/ml tilozina (Tylan 200)7.
No specific residue data were available for the target species sheep.
Za ciljno vrsto, ovce, ni bilo na voljo specifičnih podatkov o ostankih.
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).
Pomanjkanje podatkov pri odraslih ovcah bi bilo torej mogoče premostiti z omejitvijo volumna injiciranja na volumen, uporabljen v študiji ostankov, ki je na voljo za zdravilo Tylosin/Anafasis (0,6 ml).
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).
Če bi se teoretično večja injekcija absorbirala enako hitro kot pri volumnu 0,6 ml, bi bilo treba karenco podaljšati za približno 5 dni, tj. na skupno 33 dni (zaradi 21 dni plus 30-odstotnega varnostnega razpona in dodatnih 5 dni).
The residue study was performed in sheep at a dose of 10 mg/kg bodyweight (bw), administered every 12 hours for 3 consecutive days.
Študija ostankov je bila izvedena pri ovcah v odmerku 10 mg/kg telesne mase, ki so ga 3 dni zaporedoma dajali vsakih 12 ur.
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.
Odbor je menil, da za 49 zdravil, ki vsebujejo benzilalkohol in propilenglikol, razlike v koncentracijah ne bodo povzročile različnih hitrosti absorpcije z mesta injiciranja.
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.
Ker je bila karenca ugotovljena ob upoštevanju obstojnosti ostankov na mestih injiciranja in lahko večji volumen injiciranja povzroči več lokalnih ostankov na mestih injiciranja, bi bila pri odraslih ovcah, ki jih zdravijo z intramuskularnim tilozinom, potrebna daljša karenca.
For three of the products the concentration of tylosin is 50 mg/ml, whereas for the other 47 products it is 200 mg/ml.
Tri zdravila vsebujejo tilozin v koncentraciji 50 mg/ml, preostalih 47 zdravil pa v koncentraciji 200 mg/ml.
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.
Iz podatkov o referenčnem zdravilu (zdravilu Tylan 200), ki jih je predložila referenčna država članica Francija, je postalo jasno, da karenca pri ovcah temelji na ekstrapolaciji 28-dnevne karence pri govedu.
Theoretically, a withdrawal period of 42 days would accommodate for a decrease in release rate of more than 250%.
Teoretično bi 42-dnevna karenca dopuščala zmanjšanje hitrosti sproščanja
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.
Poleg tega so javno dostopni podatki pokazali, da se ostanki iz ovčjega mleka izločijo hitreje kot iz kravjega mleka in jih 48 ur po zadnjem odmerku zdravljenja ni bilo več mogoče zaznati.
It is worth noting that the withdrawal period for sheep meat for many of the products that fall within the scope of this procedure, including the generic product Tylovectin and the reference product Tylan 200 as authorised in France, is 42 days.
Treba je omeniti, da znaša karenca za meso ovac pri številnih zdravilih, ki spadajo v okvir tega postopka, vključno z generičnim zdravilom Tylovectin in referenčnim zdravilom Tylan 200, kot je odobren v Franciji, 42 dni.
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.
Vendar je hitrost absorpcije z mesta injiciranja odvisna od številnih dejavnikov in brez specifičnih podatkov o ostankih je težko izmeriti vpliv povečanja volumna injiciranja/mesta injiciranja na hitrost absorpcije.
Thus, these data indicate that a 1:1 extrapolation of the milk withdrawal period from cows to ewes is justified.
Tako ti podatki kažejo, da je ekstrapolacija karenc za mleko s krav na ovčje samice v razmerju 1 : 1 upravičena.
Overall summary of the scientific evaluation of veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo tilozin in so v obliki raztopine za injiciranje za dajanje ovcam (glejte Prilogo I)
The proposed sheep meat withdrawal period for the generic product Tylovectin was 42 days, in line with the French reference product, Tylan 200.
Predlagana karenca za meso ovac za generično zdravilo Tylovectin je bila 42 dni, v skladu s francoskim referenčnim zdravilom Tylan 200.
Residue depletion in sheep milk
Podatki o izločanju ostankov v mleko ovac
Two residue depletion studies were submitted by two of the concerned marketing authorisation holders.
Dva zadevna imetnika dovoljenja za promet z zdravilom sta predložila dve študiji izločanja ostankov.
From the residue data available, the treatment of a 50 kg sheep would require an injection volume of 2.5 ml.
Glede na razpoložljive podatke o ostankih bi bil za zdravljenje ovac s telesno maso 50 kg potreben volumen injiciranja 2,5 ml.
This study was conducted with the product Tylosin/Anafasis, containing benzyl alcohol and propylene glycol as excipients.
Ta študija je bila izvedena z zdravilom Tylosin/Anafasis, ki je kot pomožni snovi vsebovalo benzilalkohol in propilenglikol.
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.
Prepoznano je bilo tveganje v zvezi s trajanjem odobrenih karenc pri ovcah (meso, organi in mleko), ki so pri nekaterih zdravilih morda prekratke, da bi koncentracija ostankov tilozina do konca karence lahko padla pod dovoljeni MRL v vseh tkivih, namenjenih prehrani, kar pomeni tveganje za potrošnike, ki uživajo meso, organe in mleko ovac, zdravljenih s temi zdravili.
An additional risk mitigation measure of restricting the maximum injection volumes to 2.5 ml for sheep of 50 or less kg of bodyweight was considered by the CVMP.
Odbor CVMP je preučil dodatni ukrep za zmanjševanje tveganja za omejitev največjega volumna injiciranja na 2,5 ml pri ovcah s telesno maso 50 kg ali manj.
The objective of this study was to evaluate kinetics, and the residual decline of tylosin in milk and plasma of lactating ewes, following a single intramuscular injection of tylosin at the dose of 10 mg/kg bw.
Cilj te študije je bil oceniti kinetiko in upad ostankov tilozina v mleku in plazmi ovčjih samic med laktacijo po enkratni intramuskularni injekciji tilozina v odmerku 10 mg/kg telesne mase.
The first study was conducted with 50 mg/ml tylosin (Ivatyl 50 inj.
Prva je bila izvedena s 50 mg/ml tilozina (zdravilo Ivatyl 50 inj.
• from the data provided the formulation of 49 of the concerned products is very similar.
• Iz predloženih podatkov je razvidna zelo podobna formulacija 49 zadevnih zdravil.
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.
Poleg tega je odbor JECFA na svojem 66. sestanku pregledal tilozin in primerjal izločanje ostankov tilozina v kravje in ovčje mleko (JECFA, 20068).
The CVMP was requested to review all available residue depletion data for the veterinary medicinal products containing tylosin presented as a solution for injection for intramuscular use in sheep and recommend withdrawal periods for meat, offal and milk derived from treated sheep.
Odbor CVMP je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov zdravil za uporabo v veterinarski medicini, ki vsebujejo tilozin v obliki raztopine za injiciranje za intramuskularno uporabo pri ovcah, in priporoči karence za meso, organe in mleko, pridobljene iz zdravljenih ovac.
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.
Odbor CVMP je priporočil spremembo dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo tilozin v obliki raztopine za injiciranje za intramuskularno uporabo pri ovcah, in sicer je treba popraviti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
• milk from sheep is a minor food commodity and the and withdrawal periods for sheep milk can be extrapolated from those for cows' milk.
• Mleko ovac je manj pomembno živilo, karenca za ovčje mleko pa se lahko ekstrapolira s karence za kravje mleko.
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)
Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo A. Za zdravilo Tilocen, navedeno v Prilogi I (imetnik dovoljenja za promet z zdravilom: Nikolakopoulos, S.A)
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.
Odbor je menil, da bi bila uskladitev karenc za 49 zadevnih zdravil v okviru tega napotitvenega postopka na 42-dnevno karenco za meso in organe ovac konzervativen pristop za zagotavljanje varnosti potrošnikov (tj. ostanki z mesta injiciranja bi bili pod določenim MRL za tilozin v mesu (100 µg/kg)), saj bi zmanjšanje hitrosti sproščanja za več kot 250 % pokrili z 42dnevno karenco, ki bi zagotovila varnost potrošnikov, če bi bil volumen injiciranja omejen na 2,5 ml na mesto injiciranja.
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.
mesto injiciranja) so izmerili po 3, 7, 10 in 21 dneh po zdravljenju z uporabo validirane metode tekočinske kromatografije visoke ločljivosti.
There are 50 products within the scope of this referral procedure.
Ta napotitveni postopek zadeva 50 zdravil.
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.
V tej študiji je bilo sedem ovčjih samic (slovaški merino) pet dni zaporedoma intramuskularno zdravljenih s tilozinovo bazo 50 mg na ml v odmerku 100 mg na 10 kg telesne mase.
Scientific conclusions and the grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Znanstveni zaključki in podlaga za dopolnilo povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
While minor differences in concentrations of the same excipients have been considered not to have an impact on residue depletion, different solvents can have an effect on the viscosity of the formulations which can affect absorption.
Čeprav velja, da manjše razlike v koncentracijah istih pomožnih snovi ne vplivajo na izločanje ostankov, lahko različni vehikli vplivajo na viskoznost formulacij, to pa lahko vpliva na absorpcijo.
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.
V tej študiji pa so bile ugotovljene dodatne pomanjkljivosti, in sicer je bilo število zdravljenih živali (n = 3) manjše od števila, zahtevanega v smernicah VICH GL 484, živali so bile zelo mlade (povprečna telesna masa 12 kg), vzorčenje na mestu injiciranja pa ni vključevalo vzorca zunanjega obroča.
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.
Ker se lahko zdravilo uporablja tudi pri odraslih ovcah in bi bilo v tem primeru treba injicirati večje volumne, je bilo teoretično izračunano, da bi lahko za zdravljenje ovac s telesno maso do 50 kg in največjim volumnom 2,5 ml uporabili pet dni daljšo karenco (tj. skupno 33 dni).
Following this approach a withdrawal period for sheep milk can be established at 108 hours.
Na ta način se lahko za ovčje mleko določi 108-urna karenca.
For sheep milk, literature data showed that the tylosin residue depletion from sheep milk is faster than depletion from cow's milk.
Za mleko ovac so podatki iz literature pokazali, da se ostanki tilozina iz ovčjega mleka izločajo hitreje kot iz kravjega mleka.
• 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);
• Odbor CVMP je na podlagi razpoložljivih podatkov presodil, da je treba karenco za meso in organe ter mleko, pridobljeno iz zdravljenih ovac, spremeniti, da se zagotovi varnost za potrošnike za vsa zadevna zdravila za uporabo v veterinarski medicini, kot je navedeno v Prilogi I, razen za zdravilo Tilocen (imetnik dovoljenja za promet z zdravilom: A. Nikolakopoulos, S.A).
Hence, and in view of the limited data and considerations mentioned above, the Committee considered that harmonising the withdrawal periods of 49 out of 50 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., to ensure that residues at the injection site would be below the established MRL for tylosin meat (100 µg/kg)).
Zato in glede na zgoraj opisane omejene podatke in pomisleke je Odbor menil, da bi bila uskladitev karenc 49 od 50 zadevnih zdravil v okviru tega napotitvenega postopka na karenco 42 dni za meso in organe ovac konzervativen pristop za zagotovitev varnosti potrošnikov (tj. zagotovitev, da bi bili ostanki na mestu injiciranja pod določenim MRL za tilozin v mesu (100 µg/kg)).
• 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.
• Predložena ni bila nobena ustrezna študija o izločanju ostankov, rezultate katere bi lahko ekstrapolirali na zadevno zdravilo Tilocen (imetnik dovoljenja za promet z zdravilom: A. Nikolakopoulos, S.A), ki vsebuje tilozin v obliki raztopine za injiciranje za uporabo pri ciljni vrsti ovce in polietilenglikol 400 kot pomožno snov.
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).
Ker je tilozin šibka baza s pKa 7,73, lahko pričakujemo, da v fizioloških pogojih (tj. pri pH 7,4) ionizira in tvori soli.