A freeze-dried live attenuated Salmonella enteritidis vaccine

Composition
Live attenuated Salmonella enteritidis-bacteria, strain Sm24/Rif12/Ssq, phage type 4, at least 1×108 CFU per dose.

Uses
For active immunization of healthy, susceptible, immune competent chickens to reduce mortality, colonisation, invasion and faecal excretion due to Salmonella Enteritidis.

Dosage and administration:
For administration to chickens via the drinking water from one day of age and by subcutaneous injection for the third dose only (at 16 to 20 weeks of age).

Dosage Regimen
Broilers: For birds up to 6 weeks of age, a single dose t one day of age via the drinking water.
Layers and Breeders A single dose from one day of age via the drinking water followed by a second vaccination at 6 to 8 weeks of age via the drinking water. The third vaccination is recommended at 16 to 20 weeks of age, but not later than 3 weeks before point of lay either via the drinking water or by subcutaneous injection after reconstitution in diluent Diluject sterile water E.P.

Drinking water
* Determine the number of vaccine doses and amount of water (see below) required. Do not split large vials to vaccinate more than 1 house or drinking system, as this may lead to mixing errors.
* Make sure that all conduit pipes, tubing, troughs, drinkers etc. are thoroughly clean and free of any trace of disinfectants, detergents etc.
* Use only cold and fresh water preferably non-chlorinated anf free from metal-ions. Low-fat skimmed milk powder (i.e.< 1% fat) may be added to the water (2-4 grams per litre) or skimmed milk (20-40 ml per litre of water) to improve the water quality and to increase the stability of the vaccine. This, however, has to be done 10 minutes prior to dissolution of the vaccine.
* Open the vaccine ampoule under water and dissolve contents thoroughly. Care should be taken to empty the ampoule and its top completely by rinsing them in water.
* Allow water to be consumed so that levels in drinkers are minimal before vaccine is applied. All tubing should be emptied of plain water, so that the drinkers contain only vaccine water. If water is still present, drain lines before applying vaccine.
* Apply vaccine over (up to) 2 hours, ensuring that all birds drink during this time. Birds drinking behaviour varies, it may be necessary to withhold 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.
* Ideally vaccine should be administered in the volume of water consumed by the birds in up to 2 hours. As a general rule, apply diluted vaccine to cold and fresh water at the rate of 1000 doses of vaccine to 1 litre of water per day of age for 1000 chickens, e.g. 10 litres would be needed for 1000, 10 day old chickens. Under hot climates or with heavy breeds this amount may have to be increased up to a maximum of 0 litres per 1000 birds. If in doubt, measure water intake the day before administering vaccine.
– Administer the dissolved vaccine.
– Make sure that birds do not have access to unmedicated water during vaccination.

Injection
– Reconstitute vaccine with diluent Diluject or sterile water E.P. at the rate of 1000 doses to 500 ml.
– Mix thoroughly and shake recontituted vaccine gently before and during use, avoid foaming.
– Each bird is given 0.5 ml of the vaccine by subcutaneous injection.
– Do not prerpare vaccine than needed for immediate use.

Contra-indications, warnings, etc.:
Avoid stress before, during and after vaccination.
Only healthy birds should be vaccinated. Drinking water must contain detergents or disinfectants.
The vaccine strain may spread to unvaccinated birds.
Vaccination should be completed at least 3 weeks before point of lay.
Do not administer antibacterial therapy within 3 days before or after vaccination.
When handling vaccine use gloves.
Wash hands in antibacterial soap or disinfectant after handling vaccine.
Use the dissolved vaccine within 1 hour of preparation.
Destroy the empty vials and all unused vaccine by burning or by chemical disinfectant.
Keep the vaccine and the materials used for vaccination out of the reach of children.
Day old chicken may be simultaneously vaccinated with TAD Salmonella vac E by oral route and Marek`s vaccines (both, Turkey Herpes virus and Rispens) by injection.
No other vaccine should be used within 14 days prior and post vaccination with TAD Salmonella vac E, as no supportive data is available. Care should be taken to wash and disinfectant hands after handling poultry faeces particularly in the first 7 days after vaccination of birds. Operators should not handle vaccine if known to be suffering from immunosuppressive disease.
Do not ingest. Avoid self injection. If the vaccine has been swallowed or injected, seek medical advice. The vaccine strain is sensitive to a number of antibiotics, including quinolones (ciprofloxacin).

Withdrwal period:
21 days for adible tissue.

Pharmaceutical precautions:
Store at +20C to +80C. Protectfrom light. Use before the expiry date printed on the pack. Keep out of the reach of children.

Package quantities:
Packs of 1000 and 10 x 1000 doses.
Diluent Diluject 500 ml (for reconstitition of 1000 doses).