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Rhemox 435,6 mg/g poudre pour administration dans l'eau de boisson pour porcins, poulets, canards, et dindes, quelle composition ? Rhemox 435,6 mg/g poudre pour administration dans l’eau de boisson pour porcins, poulets, canards, et dindes, quelle composition ? par medicament-info · 11 mars 2016
Détails techniques pour le Rhemox 435,6 mg/g poudre pour administration dans l’eau de boisson pour porcins, poulets, canards, et dindes de Industrial veterinaria
Quelles espèces sont concernées pour le Rhemox 435,6 mg/g poudre pour administration dans l’eau de boisson pour porcins, poulets, canards, et dindes ? Canard Dinde Porcins Poulet de chair Voies d’injection du nomdumericament Comment ne pas oublier certaines précautions d’emploi Le vétérinaire reste le mieux placé pour répondre.
Quelles sont les substances dans Rhemox 435,6 mg/g poudre pour administration dans l’eau de boisson pour porcins, poulets, canards, et dindes ? Poudre pour administration dans l’eau de boisson est la forme de monmedicament, pour une d’autorisation de mise sur le marché du 04/08/2015
Dénomination du médicament vétérinaire RHEMOX 435,6 MG/G POUDRE POUR ADMINISTRATION DANS L’EAU DE BOISSON POUR PORCINS, POULETS, CANARDS, ET DINDES
Composition qualitative et quantitative Un g contient : Substance(s) active(s) : Amoxicilline ………………………….…………………..435,60 mg (sous forme de trihydrate) (soit 500 mg d’amoxicilline trihydratée) Pour la liste complète des excipients, voir rubrique « Liste des excipients ».
Forme pharmaceutique Poudre pour administration dans l’eau de boisson.Poudre fine et homogène blanche ou légèrement crème.
Espèces cibles Porcins, poulets (de chair), canards (de chair) et dindes (pour la production de viande).
Indications d’utilisation, en spécifiant les espèces cibles Chez les porcins : Traitement des infections causées par des souches de Streptococcus suis sensibles à l’amoxicilline.Chez les poulets de chair, les canards de chair et les dindes pour la production de viande : Traitement de la pasteurellose et de la colibacillose causées par des souches de Pasteurella spp et d’Escherichia coli sensibles à l’amoxicilline.
Contre-indications Ne pas utiliser en cas d’hypersensibilité aux pénicillines, à d’autres bêta-lactamines ou à l’excipient.Ne pas utiliser par voie orale chez les lapins, les cobayes, les hamsters ou les autres petits herbivores, dans la mesure où l’amoxicilline, comme toutes les aminopénicillines, a des effets délétères sur les bactéries cœcales.Ne pas utiliser chez les chevaux dans la mesure où l’amoxicilline, comme toutes les aminopénicillines, a un effet important sur les bactéries cœcales.Ne pas utiliser par voie orale chez les animaux ayant un rumen fonctionnel.Ne pas utiliser chez les animaux souffrant de maladie rénale, notamment d’anurie et d’oligurie.
Mises en garde particulières à chaque espèce cible L’utilisation du produit doit être combinée avec de bonnes pratiques d’élevage, à savoir une bonne hygiène, une aération adéquate et pas de surpeuplement.
Précautions particulières d’emploi chez l’animal L’utilisation du produit doit reposer sur des tests de sensibilité aux bactéries isolées des animaux.
En cas d’impossibilité, le traitement sera établi à partir d’informations épidémiologiques locales (régionales, exploitation) sur la sensibilité des bactéries cibles.Les politiques officielles, nationales et régionales d’utilisation des antibiotiques doivent être prises en compte lors de l’utilisation du produit.L’utilisation de la spécialité en dehors des recommandations du RCP peut augmenter la prévalence des bactéries résistantes à l’amoxicilline et peut diminuer l’efficacité du traitement avec d’autres pénicillines, compte tenu de possibles résistances croisées.L’assimilation du médicament par l’animal peut être altérée par une maladie.
En cas de consommation d’eau insuffisante, les animaux doivent être traités par voie parentérale.
Précautions particulières à prendre par la personne qui administre le médicament vétérinaire aux animaux Les pénicillines et les céphalosporines peuvent provoquer des réactions d’hypersensibilité (allergie) après une injection, inhalation, ingestion ou un contact cutané. Des réactions d’hypersensibilité croisées sont observées entre les céphalosporines et les pénicillines.- Ne manipulez pas le produit si vous êtes allergique à la pénicilline ou aux céphalosporines.- Manipulez le produit avec soin afin d’éviter l’inhalation de la poudre et tout contact de celle-ci avec la peau et les yeux lorsqu’elle est ajoutée à l’eau, en prenant notamment les précautions suivantes :- Prendre les mesures nécessaires pour empêcher la poudre de se disperser au moment où le produit est ajouté à l’eau de boisson.- Porter soit un demi-masque respiratoire jetable conforme à la norme européenne EN149, soit un respirateur non-jetable selon la norme européenne EN140 avec un filtre selon la norme EN143, des gants, une combinaison et des lunettes de protection agréées.- Eviter tout contact avec la peau et les yeux.
En cas de contact, rincer abondamment à l’eau claire.- Ne pas fumer, boire ou manger en manipulant le produit.- Se laver les mains après utilisation.- Si des symptômes apparaissent après l’exposition, tels qu’une éruption cutanée, demandez conseil à un médecin et montrez-lui cette mise en garde. Un oedème du visage, des lèvres ou des yeux, ou des difficultés respiratoires, sont des symptômes plus graves qui nécessitent une consultation médicale urgente.
Autres précautions Aucune.
Effets indésirables (fréquence et gravité) Des réactions d’hypersensibilité, dont la sévérité peut aller d’une éruption cutanée à un choc anaphylactique, peuvent survenir.Symptômes gastro-intestinaux (vomissement, diarrhée).Infections secondaires dues à des micro-organismes non sensibles après une utilisation prolongée.
Utilisation en cas de gravidité, de lactation ou de ponte Les études de laboratoire sur les rats et les souris n’ont pas mis en évidence d’effets tératogènes, fœtotoxiques ou maternotoxiques.L’innocuité du médicament vétérinaire n’a pas été établie en cas de gravidité ou de lactation chez la truie.
L’utilisation ne doit se faire qu’après évaluation du rapport bénéfice/risque par le vétérinaire.
Interactions médicamenteuses et autres formes d’interactions Ne pas utiliser simultanément avec la néomycine car elle bloque l’absorption des pénicillines orales.Ne pas utiliser en combinaison avec des antibiotiques bactériostatiques car ils peuvent inhiber l’effet bactéricide des pénicillines.
Posologie et voie d’administration A administrer dans l’eau de boisson.
Liquide limpide et incolore lorsqu’il est en solution.L’eau contenant la substance médicamenteuse doit être renouvelée ou remplacée toutes les 24 heures.La consommation d’eau contenant la substance médicamenteuse dépend de l’état clinique des animaux, de l’environnement, de l’âge et du type d’aliments fournis.
Pour obtenir la posologie correcte, la concentration de substance active doit être ajustée en conséquence. Posologie et schéma thérapeutique Porcins : 20 mg d’amoxicilline trihydratée, équivalent à 17,4 mg d’amoxicilline/kg de poids vif toutes les 24 heures (correspondant à 40 mg de produit/kg de poids vif/jour) pendant 4 jours.Poulets de chair : 15 mg d’amoxicilline trihydratée, équivalent à 13,1 mg d’amoxicilline/kg de poids vif toutes les 24 heures (correspondant à 30 mg de produit/kg de poids vif/jour) pendant 5 jours.Canards de chair : 20 mg d’amoxicilline trihydratée, équivalent à 17,4 mg d’amoxicilline/kg de poids vif toutes les 24 heures (correspondant à 40 mg de produit/kg de poids vif/jour) pendant 3 jours.Dindes pour la production de viande : 15 à 20 mg d’amoxicilline trihydratée, équivalent à 13,1 à 17,4 mg d’amoxicilline/kg de poids vif toutes les 24 heures (correspondant à 30 à 40 mg de produit/kg de poids vif/jour) pendant 5 jours.Utilisez la formule suivante pour calculer la quantité de produit (mg) qui devra être incorporée au réservoir d’eau de boisson : Dose (mg de produit par kg de poids vif par jour) Xpoids vif moyen (kg) des animaux à traiter = mg de produit parlitre d’eau de boisson consommation moyenne d’eau (litre) par animal et par jour Le produit doit d’abord être dilué dans une petite quantité d’eau pour obtenir une solution mère qui est soit diluée dans le réservoir d’eau de boisson soit introduite par une pompe pour le dosage de l’eau.
La solution concentrée doit être agitée pendant au moins 15 minutes afin d’en assurer la dissolution complète.
Lors de l’utilisation d’un doseur, ajuster la pompe entre 2 et 5 % et adapter le volume de la préparation en conséquence. Compte tenu de la solubilité maximale du produit, ne pas utiliser une pompe doseuse réglée à 2 % pour administrer le produit aux dindes ou aux porcins. Pour administrer la quantité calculée de produit, il est recommandé de bien calibrer le matériel de pesage utilisé.Pour assurer une posologie correcte, le poids vif doit être déterminé aussi précisément que possible afin d’éviter tout risque de sous-dosage. Préparer la solution avec de l’eau du robinet fraîche immédiatement avant l’utilisation.La consommation d’eau doit être surveillée à intervalles rapprochés pendant le traitement.Pour garantir la consommation de l’eau contenant la substance médicamenteuse, les animaux ne doivent pas avoir accès à d’autres sources d’eau pendant le traitement.Après la fin de la période de traitement, le système d’approvisionnement en eau doit être nettoyé correctement pour éviter la prise de quantités sous-thérapeutiques de la substance active
Surdosage (symptômes, conduite d’urgence, antidotes), si nécessaire Aucun effet indésirable autre que ceux mentionnés à la rubrique « Effets indésirables (fréquence et gravité) » n’a été observé en cas de surdosage.
Temps d’attente Viande et abats : Porcins : 6 jours. Poulets : 1 jour. Dindes : 5 jours. Canards : 9 jours.Ne pas utiliser chez les oiseaux pondeurs d’œufs destinés à la consommation humaine au cours des 4 semaines précédant le début de la ponte.
Propriétés pharmacologiques Classe pharmacothérapeutique : Bêta-lactamines antibactériennes, pénicillines à large spectre.Code ATC-vet : QJ01CA04.
Propriétés pharmacodynamiques L’amoxicilline est un antibiotique à large spectre de la famille des β-lactamines appartenant au groupe des aminopénicillines. Cette substance possède une activité bactéricide et agit contre les micro-organismes Gram-positifs et Gram-négatifs. Mécanisme d’actionLe mécanisme d’action antibactérien de l’amoxicilline consiste en l’inhibition des processus biochimiques de la synthèse de la paroi cellulaire bactérienne par un blocage irréversible et sélectif de diverses enzymes impliquées dans ces processus, principalement des transpeptidases, des endopeptidases et des carboxypeptidases. Une synthèse inadéquate de la paroi bactérienne chez des espèces sensibles produit un déséquilibre osmotique qui affecte particulièrement la croissance des bactéries (lorsque les processus de synthèse de la paroi bactérienne sont tout particulièrement importants), conduisant finalement à une lyse de la cellule bactérienne. Spectre d’actionLes espèces considérées comme sensibles à l’amoxicilline comprennent :- les bactéries Gram-positives : streptocoques (Streptococcus suis) – les bactéries Gram-négatives : Pasteurella spp.Escherichia coli Toutefois, les bactéries présentant normalement une résistance à l’amoxicilline sont :- les staphylocoques producteurs de pénicillinase,- certaines entérobactéries telles que Klebsiella spp., Enterobacter spp., Proteus spp. et d’autres bactéries Gram-négatives telles que Pseudomonas aeruginosa.Le principal mécanisme de résistance bactérienne à l’amoxicilline est la production de β-lactamases, des enzymes qui inactivent le produit antibactérien par hydrolyse du cycle β-lactamines, générant ainsi un composé stable mais inactif : l’acide pénicillanique.
Les β-lactamases bactériennes peuvent être acquises à l’aide de plasmides ou bien être constitutives (chromosomiques).Ces β-lactamases sont exocellulaires dans les bactéries Gram-positives (Staphylococcus aureus) et présentes dans l’espace périplasmique de bactéries Gram-négatives.Les bactéries Gram-positives sont capables de produire et de sécréter de grandes quantités de β-lactamases. Ces enzymes sont codées dans des plasmides qui peuvent être transférés par les phages à d’autres bactéries.Les bactéries Gram-négatives telles que E. coli produisent différents types de β-lactamases qui restent dans l’espace périplasmique.
Elles sont codées aussi bien dans les plasmides que dans les chromosomes.Le mécanisme de résistance à la pénicilline de S. suis entraîne des modifications des protéines liant la pénicilline (Penicillin-Binding Proteins, PBP) sous la forme d’une surproduction ou d’une diminution, voire les deux, de l’affinité pour la pénicilline.
La résistance à la pénicilline dans S. suis est codée de manière chromosomique.La résistance aux antibiotiques dans P. multocida a été associée à de petits plasmides non conjugatifs codant les bêta-lactamases, ce qui entraîne de la résistance à l’ampicilline.Il existe une résistance croisée complète entre l’amoxicilline et d’autres pénicillines, notamment d’autres aminopénicillines (ampicilline).Concentrations critiques (valeurs limites) concernant la sensibilité (S) et la résistance (R), en µg/ml : (Source : CLSI 2008)- Streptococcus spp : ≤ 0,25 (S) >= 8 (R)
Caractéristiques pharmacocinétiques Caractéristiques généralesL’absorption de l’amoxicilline orale est indépendante de la prise d’aliments et les concentrations plasmatiques maximales sont rapidement atteintes chez la plupart des espèces animales, de 1 à 2 heures après l’administration du produit.L’amoxicilline se lie modérément aux protéines plasmatiques et diffuse rapidement dans les fluides et tissus corporels.
L’amoxicilline est largement distribuée dans le compartiment extracellulaire. Sa distribution dans les tissus est facilitée par son faible taux de liaison aux protéines plasmatiques.Le métabolisme de l’amoxicilline est limité à l’hydrolyse du cycle β-lactamines, conduisant à la libération d’acide pénicillanique inactif (20 %).
La biotransformation s’effectue dans le foie.La majeure partie de l’amoxicilline est éliminée par les reins sous forme active.
Elle est également excrétée en petite quantité dans le lait et la bile. POULETS DE CHAIRLa biodisponibilité orale est d’environ 67 %.
La concentration plasmatique maximale est atteinte au bout d’une heure environ.
L’amoxicilline est bien et rapidement distribuée dans l’organisme, avec une forte liaison aux protéines plasmatiques (17 à 20 %). PORCINS :Après administration du produit à la dose recommandée dans l’eau de boisson, les concentrations plasmatiques varient de 0,53 µg/ml (Cmax) à 0,27 µg/ml (Cmin).
L’état d’équilibre est atteint 10 heures après la première administration.
Liste des excipients Acide citrique anhydre
Incompatibilités En l’absence d’études de compatibilité, ce médicament vétérinaire ne doit pas être mélangé avec d’autres médicaments vétérinaires.
Durée de conservation Durée de conservation du médicament vétérinaire tel que conditionné pour la vente : 2 ans.Durée de conservation après première ouverture du conditionnement primaire : à utiliser immédiatement.Durée de conservation après dissolution ou reconstitution conforme aux instructions : 24 heures.
Précautions particulières de conservation À conserver dans un endroit sec.
Protéger de la lumière. À conserver à une température ne dépassant pas 25 ºC.
Nature et composition du conditionnement primaire Sachet polyester-aluminium-polyéthylène
Précautions particulières à prendre lors de l’élimination de médicaments vétérinaires non utilisés ou de déchets dérivés de l’utilisation de ces médicaments Les conditionnements vides et tout reliquat de produit doivent être éliminés suivant les pratiques en vigueur régies par la réglementation sur les déchets.
Titulaire de l’autorisation de mise sur le marché INDUSTRIAL VETERINARIA ESMERALDA, 19 08950 ESPLUGUES DE LLOBREGAT ESPAGNE
Numéro(s) d’autorisation de mise sur le marché FR/V/2974623 7/2015 Sachet de 100 g Sachet de 300 g Sachet de 400 g Sachet de 1 kg Toutes les présentations peuvent ne pas être commercialisées.
Date de première autorisation/renouvellement de l’autorisation 04/08/2015
Date de mise à jour du texte 04/08/2015 Données valables pour la France uniquement.
Étiquettes : canard dinde orale porcins Poudre pour administration dans l'eau de boisson poulet de chair
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