SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cevac Salmovac lyophilisate for use in drinking water for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose contains:

Active substance:

Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 441/014 (adenine and histidine auxotrophic), live 1 - 8 x 10⁸ CFU*

* CFU = Colony Forming Unit Excipient:

Qualitative composition of excipients and other constituents

Sucrose

Light beige to brownish light grey lyophilisate.

3. CLINICAL INFORMATION

3.1 Target species

Chickens (future breeders and layers).

3.2 Indications for use for each target species

Active immunisation of chickens to reduce colonisation, persistence and invasion of the intestinal tract and internal organs by Salmonella Enteritidis and Salmonella Typhimurium.

Onset of immunity within 6 days after first vaccination.

Duration of immunity for Salmonella Enteritidis is 35 weeks after second vaccination and 63 weeks after third vaccination when used according to the recommended vaccination schedule.

Duration of immunity for Salmonella Typhimurium is 60 weeks after the third vaccination when used according to the recommended vaccination schedule.

3.3 Contraindications

Do not use in broilers.

3.4 Special warnings

Vaccinate healthy animals only.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Vaccinated chickens may excrete the vaccine strain up to six weeks following vaccination. During this time, the contact of immunosuppressed and unvaccinated chickens with vaccinated chickens should be avoided.

The vaccine can spread to susceptible birds. Special precautions should be taken to avoid spreading of the vaccine strain to susceptible birds. Contact chickens may also excrete the vaccine strain.

The vaccine strain has been isolated from chicken litter up to 13 days after vaccination.

In studies, the vaccine strain can be found in the environment for up to 8 weeks after the 2^nd vaccination and 5 weeks after the 3^rd vaccination.

On very rare occasions, the vaccine strain may be isolated from the environment beyond the above-mentioned period.

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.

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

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 trimethoprim in combination.

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 such as the Ceva S-check test.

A clear vaccine strain wild type strain differentiation is also possible on special chromogenic selective media (e.g. ASAP media, Biomérieux) due to a different colour of the vaccine colonies versus wild SE strains.

The vaccine strain can also be distinguished from the field strain by molecular biology methods, such as real time Polymerase Chain Reaction (PCR) and Restriction Fragment Polymorphism (RFLP) in Pulse Gel Electrophoresis (PFGE).

Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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 antibiotics with the exception of sulfamerazine.

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.

Immunocompromised persons are advised to avoid contact with the vaccine and vaccinated animals during the excretion of the vaccine strain.

Personnel involved in attending vaccinated chickens 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 chickens.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

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 local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Laying birds:

Do not use in birds in lay and within 3 weeks before the start of laying period.

Unvaccinated birds intended for lay should not come into contact with vaccinated birds.

3.8 Interaction with other medicinal products and other forms of interaction

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 of this vaccine when used with any other veterinary medical 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.

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

3.9 Administration routes and dosage

Immunisation against Salmonella Enteritidis

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

One dose from first 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.

Recommended vaccination scheme for birds on farms with a known history and absence of Salmonella Enteritidis according to routine bacteriological monitoring: One dose from first day of age followed by a second dose two weeks later (but not later than 6 weeks before the onset of lay). A greater level of protection, with regards to the duration of immunity, is observed with the 3-dose regime.

Immunisation against Salmonella Enteritidis and Salmonella Typhimurium (whatever the salmonella status)

One dose from first day of age, a second dose six weeks later and a third dose around 13 weeks of age.

Administration in drinking water (oral route).

- Apply the 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 the complete dissolution of the lyophilisate. Then add the reconstituted vaccine to sufficient water to be consumed within 4 hours and mix thoroughly.

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.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Administration of a 10-fold overdose can occasionally result in loose faeces and in a transient weight loss without any consequences on the final performances.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Meat: 6 weeks from last vaccination.

Eggs: 3 weeks after third vaccination.

Do not use within 3 weeks before the start of the laying period.

4. IMMUNOLOGICAL INFORMATION

4.1 ATCvet code: QI01AE01

For active immunisation of chickens against Salmonella Enteritidis and Salmonella Typhimurium.

The live vaccine strain stimulates cell-mediated immunological mechanisms (as demonstrated in mice) and antibody formation in chickens against Salmonella Enteritidis and Salmonella Typhimurium. 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.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

Do not mix with any other veterinary medicinal product.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf life after reconstitution according to directions: 4 hours.

5.3 Special precautions for storage

Store in a refrigerator (2 °C – 8 °C). Protect from light.

5.4 Nature and composition of immediate packaging

Nature of primary packaging elements:

Injection vial, 10 ml or 25 ml, glass type I (1,000 or 2,500 vaccine doses).

Injection vial, 100 ml, glass type II (5,000 vaccine doses).

Closure for freeze-dried products and caps in compliance with Ph. Eur.

Packaging:

- 1,000-dose vial of lyophilisate: box of 1 vial

- 1,000-dose vial of lyophilisate: box of 10 vials. - 2,500-dose vial of lyophilisate: box of 1 vial.

- 2,500-dose vial of lyophilisate: box of 10 vials. - 5,000-dose vial of lyophilisate: box of 1 vial.

- 5,000-dose vial of lyophilisate: box of 12 vials.

Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Ceva Sante Animale

7. MARKETING AUTHORISATION NUMBER

Vm 14966/5004

8. DATE OF FIRST AUTHORISATION

20 October 2003

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 24 July 2026