Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

Oral lyophilisate for reconstitution in drinking water for oral suspension.

One dose of vaccine contains:

Active substances:

1 to 8 × 108 CFU* of a double-attenuated (adenine-histidine auxotrophic) Salmonella Enteritidis mutant, strain 441/014.

Excipient(s): q.s. 1 dose

Sucrose (max 0.6 mg/dose) is added as stabilizer.

* CFU = Colony Forming Unit

Uses

Chickens from one day old (breeders and layers).

Active immunization of chickens to reduce colonization, persistence and invasion of the intestinal tract and internal organs by Salmonella Enteritidis. Onset of immunity within 6 days after first vaccination. The duration of immunity after two step vaccination is demonstrated 35 weeks after second vaccination according to the recommended programme. The duration of immunity after the three step vaccination is demonstrated 63 weeks after third vaccination according to the recommended programme.

Dosage and administration

Under the direction of the veterinarian responsible for the farm where vaccinated birds will be housed and with due consideration for the historical salmonella monitoring results for the farm, one of the following vaccination programme should be implemented:

Recommended vaccination scheme for birds on farms with a known history and absence of Salmonella Enteritidis according to routine bacteriological monitoring:

One dose from one day of age followed by a second dose two weeks later.

Recommended vaccination scheme for birds on farms of unknown salmonella status or positive Salmonella Enteritidis detection:

One dose from one day of age, a second dose two weeks later and a third dose not later than three weeks before the laying period. There should be more than two weeks between the second and third administration.

A greater level of protection, with regards to the duration of immunity, is observed with the 3-dose regime.

-Apply usual aseptic precautions to all administration procedures.

-Calculate the number of vials of vaccine required to vaccinate all the birds.

-Use only clean, antiseptic and disinfectant free drinking water.

-Reconstitute the vaccine using a small volume of drinking water in the vaccine vial. Ensure complete dissolution of the lyophilisate. Then add the reconstituted vaccine to sufficient water to be consumed within 4 hours and mix thoroughly.

Administration in drinking water (oral route):

The required number of doses of reconstituted vaccine is added to sufficient water that will be consumed within 4 hours.

Birds may have drinking water withdrawn for 1-2 hours before administering vaccine.

As a guide administer the vaccine in a volume of at least 2 litres of drinking water per 1,000 chickens at first vaccination and at least 5 litres of drinking water per 1,000 chickens at second vaccination two weeks later.

If a third dose is administered, use at least 10 – 20 litres of drinking water per 1,000 chickens. This third dose should be administered not later than three weeks before the laying period.

Contra-indications, warnings, etc

For animal treatment only.

Do not vaccinate unhealthy chickens or chickens under heavy stress conditions. Do not use in broilers.

The use of the vaccine in fancy breeds has not been studied.

Due to the adenine-histidine auxotrophy of the vaccine strain, a differentiation between vaccine and field strains is possible by means of an appropriate growth test.

The vaccine strain is among others sensitive to ampicillin, cefotaxime, chloramphenicol, ciprofloxacin, gentamycin, kanamycin, oxytetracycline, streptomycin.

The vaccine strain is resistant to sulfamerazine alone but sensitive to sulfamerazine and trimethoprime in combination.

The vaccine strain can also be distinguished from the field strain by molecular biology methods, such as restriction fragment polymorphism (RFLP) in pulse gel electrophoresis (PFGE).

The vaccine strain has been shown to spread to non-target species such as calves and pigs. It persisted in these animals and was excreted over a period of 9 days in calves and 22 days in pigs and has been shown to cause a transient increase in body temperature.

Not to be used within 3 weeks (after the third vaccination) or 6 weeks (after the second vaccination) before the onset of lay and during the laying period.

Birds intended for lay should not come into contact with vaccinated birds for 3 weeks following vaccination.

No anti-infective substances should be used within 3 days before and after immunisation with the vaccine. In case of essential administration, the vaccination of the concerned birds has to be repeated.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.

No competitive microflora preparations should be administered concurrently with the product.

Administration of an overdose (10 doses) can occasionally result in loose faeces and in a transient weight loss without any effects on the final performances.

Vaccinated chickens excrete the vaccine strain up to six weeks post vaccination. The vaccine may thus spread to susceptible birds in contact with vaccinated chickens.

Operator warnings

Use disposable gloves when reconstituting the vaccine. Wash and disinfect hands after handling vaccine.

Do not ingest. If the vaccine has been swallowed seek medical advice. The vaccine strain is sensitive to antibiotics with the exception of sulfamerazine.

Immunocompromised personnel should not handle the vaccine or come into contact with vaccinated chickens during the period of excretion of the vaccine strain.

The vaccine strain has been isolated from chicken litter up to 13 days after vaccination and is excreted from vaccinated chickens up to 19 days post vaccination. The vaccine strain can be found in the environment for up to 8 weeks after the 2nd vaccination and 5 weeks after the 3rd vaccination.

Personnel involved in attending vaccinated flocks should follow general hygiene principles (changing clothes, wearing gloves, cleaning and disinfection of boots) and take particular care in handling litter from recently vaccinated chickens. Hands should be washed and disinfected after attending vaccinated flocks.

Appropriate veterinary and husbandry measures should be taken to avoid spread to susceptible species.

Withdrawal period

Meat: 6 weeks from last vaccination.

Eggs: After the two first vaccinations: 6 weeks

After the third vaccination: 3 weeks

Pharmaceutical precautions

Keep out of reach of children.

Do not mix with any other vaccine/immunological products.

Use within 4 hours after reconstitution.

Store between 2 °C and 8 °C and protected from light.

Original vaccine containers (opened as well as emptied) and all equipment used for the vaccination procedure have to be disinfected after use (use disinfectants - except quaternary ammonium bases - at usual working concentration) and disposed of in accordance with national and local requirements.

Legal category

POM-V

Packaging Quantities

1000-dose bottle of lyophilisate: box of 10 bottles.

5000-dose bottle of lyophilisate: box of 1 bottle.

Further information

For active immunisation of chickens against Salmonella Enteritidis.

The live vaccine strain stimulates cell-mediated immunological mechanisms (as demonstrated in mice) and antibody formation in chickens against Salmonella Enteritidis. The antibody formation does not affect serological testing for Salmonella Gallinarum (rapid serum agglutination).

The vaccine strain is resistant to sulfamerazine. The strain has been demonstrated as genetically stable.

Marketing authorisation number

Vm 08327/4208.