País: Reino Unido
Idioma: inglés
Fuente: VMD (Veterinary Medicines Directorate)
Salmonella enteritidis, Salmonella typhimurium
MSD Animal Health UK Limited
QI01AB01
Salmonella enteritidis, Salmonella typhimurium
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Chickens
Inactivated Bacterial Vaccine
Authorized
2000-08-17
Revised: August 2020 AN: 00299/2020 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Salenvac T Suspension for injection for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.5 ml: ACTIVE SUBSTANCES: Inactivated cells of _Salmonella _Enteritidis, strain PT 4: ≥ 1 RP* Inactivated cells of _Salmonella _Typhimurium, strain DT104: ≥ 1 RP* EXCIPIENTS: Adjuvant: aluminium hydroxide: 125 mg Preservative: thiomersal: 0.065 mg For a list of excipients, see section 6.1. * RP = relative potency = mean antibody response in rabbit potency test equal to or greater than a reference batch which was shown to be efficacious in chickens 3. PHARMACEUTICAL FORM Suspension for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (breeders and layers) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of chickens and the passive immunisation of the progeny to reduce caecum colonisation and faecal excretion with _S. _Enteritidis and _S. _Typhimurium_._ Active immunity: Onset of immunity: 4 weeks after the second administration Duration of immunity: until approximately 56-60 weeks of age for chickens vaccinated at 12 and 16 weeks. Minor indication: In exceptional circumstances chickens from one day of age may be vaccinated in order to protect them in an environment where they are likely to become infected at an early stage in the rearing phase Revised: August 2020 AN: 00299/2020 Page 2 of 6 (epidemiologically indicated by recent outbreak of Salmonella or high infection pressure on the site). Onset of immunity: 4 weeks after the second administration. Passive immunity: Onset of immunity: day one after hatching. Duration of immunity: until 14 days after hatching. Passive immunity is transferred from 4 weeks after the second vaccination up to 59 weeks of age of the parent bird. 4.3 CONTRAINDICATIONS Do not use in laying birds. 4.4 SPECIAL WARNINGS None 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals No st Leer el documento completo