Target Species:
Chickens (for reproduction and layer hen)
Indications for use:
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 (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.
Contraindications:
None.
Special warnings for each target species:
Vaccinate healthy animals only.
No studies have been performed to evaluate the effect of maternally derived antibodies on the response to vaccination. Therefore, for use in 1-day old chicks, where epidemiologically indicated, only chickens from non-vaccinated and non-infected parent flocks should be vaccinated with the veterinary medicinal product.
Special precautions for use:
Not applicable.
Operator warnings:
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse Reactions:
Chickens:
Very common (>1 animal / 10 animals treated): | Injection site swelling1; Lameness2; Low weight gain3; Lethargy4 , dull4 |
Common (1 to 10 animals / 100 animals treated): | Injection site nodule5 |
1 In one-day-old chickens (receiving a dose of 0.1 ml), the reactions are more evident than in chickens of 4 weeks of age or older (receiving a dose of 0.5 ml), and occasionally, the whole thigh may become swollen. These reactions are temporary and in the majority of cases resolved by 7 days. Exceptionally, a swelling may still be detectable 15 days after inoculation.
2 Observed in chickens of 4 weeks of age or older (receiving a dose of 0.5 ml), lameness can last up to 2 days.
3 Observed after use in one-day-old chicks (receiving a dose of 0.1 ml).
4 Observed in chickens of 4 weeks of age or older (receiving a dose of 0.5 ml), lethargy can last up to 2 days.
5 In chickens of 4 weeks of age and above (receiving a dose of 0.5 ml), transient small palpable injection site nodules are (reaching a maximum size of 1 cm2) evident immediately after vaccination and generally last only 1-2 days.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.
Use during pregnancy or lactation:
Do not use in birds in lay.
Interactions:
Vaccination causes a serological response in the chickens which may interfere with a surveillance programme based solely on serological screening without confirmatory bacteriology. The vaccine should therefore not be used when serological detection alone is used to assess flocks for infection with S. Enteritidis and/or S. Typhimurium. Vaccination also may cause cross reactions in the plate agglutination test for S. Pullorum/Gallinarum. Specific serological methods or bacteriology should be used for the differential diagnosis.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route:
Standard vaccination:
Intramuscular injection of one dose of 0.5 ml.
Shake well before use. Observe aseptic precautions.
For active immunisation of layers and breeders:
Two vaccinations, with an interval of four weeks should be given.
The recommended age for vaccination is 12 and 16 weeks of age.
Emergency vaccination (when epidemiologically indicated in high-risk environments):
Intramuscular injection of one dose of 0.1 ml in one-day-old chicks.
After an interval of 4 weeks a repeat vaccination with a dose of 0.5 ml should be given.
For passive immunisation of progeny of breeders:
Two vaccinations, with an interval of at least four weeks should be given.
The recommended age for first vaccination is at 6-12 weeks of age and for the second vaccination at 13-16 weeks of age.
In case the induction of active- and passive immunity is intended in breeders and their offspring, the vaccination scheme for active immunisation should be followed.
Hygiene measures and good husbandry practices should also play an important part of a control programme to reduce the incidence of Salmonella infection.
Overdose:
Similar reactions to those seen after a single dose (see 4.6), but more pronounced after double dose.
Withdrawal periods:
Zero days.