Target species
Chickens.
Indications for use
For active immunisation of healthy susceptible, immune competent chickens to reduce mortality, colonisation, invasion and faecal excretion due to Salmonella Enteritidis, phage type 4.
Onset of immunity: 15 days
Duration of immunity: 6 to 8 weeks following a single dose and 60 weeks following the 3 dose programme.
Contra-indications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
i) Special precautions for safe use in the target species:
The vaccine strain is highly sensitive to quinolone antibiotics and has increased sensitivity to erythromycin, chloramphenicol, doxycycline, detergents and environmental noxae.
The vaccine strain can spread to susceptible birds in contact with vaccinated chickens. vaccinated birds may excrete the vaccine strain for up to 16 days following vaccination.
The differentiation between vaccine and field strains is done by means of an antibiogram. In contrast to field strains, vaccine strains are sensitive to erythromycin (recommended concentration 15-30 µg/ml) and resistant to streptomycin and rifampicin (recommended concentration 200 µg/ml).
The presence of maternal antibodies to Salmonella Enteritidis may reduce the effect of vaccination over the first 4 days of life.
The vaccine strain can also be distinguished from field strains by molecular biology methods, such as a real-time polymerase chain reaction (PCR) method. For detailed information, please contact the marketing authorization holder.
Depending on the test system used, oral vaccination may result in low seropositive reactions of individual birds in a flock. Since serological Salmonella monitoring is a flock test only, positive findings have to be confirmed, e.g. by bacteriology.
ii)Special precautions to be taken by the person administering the veterinary medicinal product to animals
Use gloves when reconstituting the vaccine. Open vial under water to avoid aerosols. Disinfect and wash hands after handling vaccine. Do not ingest. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician. The vaccine strain is sensitive to a number of antibiotics including quinolones (ciprofloxacin).
Care should be taken to wash and disinfect hands after handling poultry faeces, particularly in the first 7 days after vaccination of birds.
Immunocompromised persons are advised to avoid contact with the vaccine and recently vaccinated animal.
Adverse reactions
None known.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Laying birds:
Do not use in birds in lay and within 3 weeks before the start of the laying period.
Interactions
Antibacterials shall not be administered 3 days before and after immunization.
If antibiotic treatment is inevitable, the respective animals must be re-immunized, however, not earlier than three days after this treatment.
The vaccine may be administered on the same day as AviPro Salmonella vac T, but not simultaneously.
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
Dosage and use:
One dose should be administered per animal.
The vaccine may be used from the 1st day of life.
Recommended vaccination scheme:
Broiler: For birds up to 6 weeks of age, a single dose from one day of age.
Layers and Breeders: A single dose from one day of age followed by a second vaccination at 6 to 8 weeks of age and a third vaccination at 16-18 weeks at least 3 weeks before onset of lay.
Drinking water:
1. Make sure that all conduit pipes, tubing, troughs, drinkers etc. are thoroughly clean and free of any trace of disinfectants, detergents, soap etc.
2. Open the vaccine ampoule under water and dissolve thoroughly. As the concentrated vaccine is slightly viscous, care should be taken to empty the ampoule completely by rinsing it in water.
3. Then thoroughly dissolve in a 1 litre jug and stir well before mixing with more water in a 10 litre bucket before application. The vaccine must be stirred thoroughly for several minutes at each stage. Do not split large vials to vaccinate more than 1 house or drinking system, as this leads to mixing errors.
4. As a guide, apply the diluted vaccine to cold and fresh water at the rate of 1 liter of water per 1,000 birds per day of age e.g. 10 litres would be needed for 1,000 10-day old chickens. Use water meter recordings for the previous day to accurately determine the correct quantity of water in each case. Low-fat skimmed milk powder (i.e.<1 % fat) should be added to the water (2-4 g per liter) or skimmed milk (20-40 ml per litre of water) to increase the stability of the vaccine. All tubing should be emptied of plain water, so that the drinkers contain only vaccine water.
5. Allow water in the drinkers to be consumed so that levels prior to vaccine applications are minimal. If water is still present the lines must be drained before applying the vaccine. The vaccine treated water should be used within 4 hours. It should be ensured that all birds drink during this period. Birds drinking behavior varies. It may be necessary to withhold drinking water on some sites prior to vaccination in order to ensure that all birds drink during the vaccination period. The aim is to give every bird one dose of vaccine. A period of thirst of up to 2-3 hours before vaccination may be necessary to achieve this.
Overdose
There were no undesired effects after application of the 10-fold dose.
Withdrawal periods
Meat and offal: 21 days.