Sécurité sanitaire et qualité des aliments
 

Edition en ligne: "Résidus pour les médicaments vétérinaires"

Aide en ligne   Terminology

Cette base de données contient l'information la plus récente sur les niveaux de résidus maximum pour les médicaments vétérinaires recommandés par JECFA. Toute la documentation publiée dans l'étude FAO Alimentation et Nutrition No. 41 est disponible en ligne en format numérique. Cette documentation existe seulement en Anglais, tandis que les pages d'information générale et une partie de la base de données sont traduites en Anglais, Français, Espagnol, Arabe et Chinois.

Médicament vétérinaire Doramectin
Classe fonctionnelle Antiparasitic
Dernière évaluation 2004
Réunion de JECFA 62
DJA 0-1 µg/kg bw
Statut de la DJA Full
Monographies des résidus  
Définition du résidu Parent drug
Limites maximales de résidu
(LMR) recommandés
CattleFat150 µg/kgF
CattleKidney30 µg/kgF
CattleLiver100 µg/kgF
CattleMilk15 µg/kgF
CattleMuscle10 µg/kgF
PigFat150 µg/kgF
PigKidney30 µg/kgF
PigLiver100 µg/kgF
PigMuscle5 µg/kgF
Autres remarques The Committee noted that on the basis of an MRL of 15mg/kg fordoramectin in whole milk in cattle, the milk discard times would be approximately 240 h according to the studies using the pour-on treatment. Milk discard times would be approximately 480 h after treatment using the dose formulated for injection. The Committee noted that the discard time necessary to accommodate the recommended MRL in milk was unlikely to be consistent with good veterinary practice.
Résumé de l'évaluation In recommending MRLs for doramectin in milk, the Committee considered the following factors:
- The ADI for doramectin was 0-1 mg/kg bw, equivalent to an intake of up to 60 mg per day for a 60 kg person
- Based on MRLs for tissues in cattle and pigs, and the theoretical maximum daily intake of residues in tissue of 33 mg per day, approximately 27mg per day are available for milk.
- Based on its limited metabolism and the known large partitioning ratio for residues between milk fat and aqueous milk, the Committee considered that the ratio for marker residue to total residue for doramectin in milk would be equivalent to the ratio of doramectin residues in fat (0.80).
- The residue studies provided used a pour-on formulation at 0.58 mg/kg bw and the injectable formulation at 0.23 mg/kg, somewhat in excess of the recommended doses of 0.5mg/kg bw and 0.2 mg/kg bw, respectively.
- The marker residue is doramectin.
- A suitable analytical method is available for determining residuesin milk.
Based on the factors noted above, the Committee considered recommending an MRL on the basis of the available portion of doramectin residues permitted by the ADI. The Committee recommended an MRL of 15mg/kg, determined as doramectin. Taking into account the marker residue to total residue ratio in fat (0.8) and 1.5 kg of milk in the model food diet, this would be equivalent to 28mg. Total residues of doramectin for muscle, liver, kidney and fat tissues and cow's milk, estimated from the model food diet, would be 61mg/kg.
TRS 925