SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

AviPro SALMONELLA DUO lyophilisate for use in drinking water

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose contains:

Active substances:

• Live attenuated Salmonella Enteritidis bacteria, strain Sm24/Rif12/Ssq, min. 1 x 10⁸ CFU* and max. 6 x 10⁸ CFU*

• Live attenuated Salmonella Typhimurium bacteria, strain Nal2/Rif9/Rtt, min. 1 x 10⁸ CFU* and max. 6 x 10⁸ CFU*

*CFU – colony forming units.

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate for use in drinking water.

Appearance: White grey to white brown pellet.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens (future breeders and future layer hens), turkey breeders and turkeys for meat production and ducks for meat production.

4.2 Indications for use, specifying the target species

Chickens (future breeders and future layer hens):

For active immunisation of healthy and susceptible chickens to reduce faecal excretion and colonisation of internal organs with Salmonella Enteritidis and Salmonella Typhimurium field strains and to reduce colonisation of eggs with Salmonella Enteritidis field strains.

Onset of immunity: 15 days.

Duration of immunity: 52 weeks against virulent S. Enteritidis and 46 weeks against virulent S. Typhimurium from the time of the last vaccination when used according to the recommended vaccination schedule.

Turkey breeders and turkeys for meat production:

For active immunisation of healthy and susceptible turkeys to reduce colonisation of internal organs with SalmonellaEnteritidis and SalmonellaTyphimurium field strains.

In general, the colonisation of internal organs of vaccinated turkeys with challenge bacteria is reduced compared to unvaccinated turkeys; a statistically significant reduction could not be shown in all instances.

Onset of immunity: 21 days after first vaccination.

Duration of immunity: for future breeders: 30 weeks against virulent SalmonellaEnteritidis and 28 weeks against virulent SalmonellaTyphimurium from the time of the last vaccination when used according to the recommended vaccination schedule.

for turkeys for meat production: 10 weeks against virulent SalmonellaEnteritidis and against virulent SalmonellaTyphimurium from the time of the last vaccination when used according to the recommended vaccination schedule.

Ducks for meat production:

For active immunisation of healthy and susceptible ducks to reduce colonisation of internal organs with Salmonella Typhimurium field strains.

Onset of immunity: 22 days.

Duration of immunity: 43 days.

4.3 Contraindications

None.

4.4 Special warnings for each target species

In chickens, protection in the presence of maternally derived antibodies has been shown with a vaccine containing SalmonellaEnteriditis but no information is available on the SalmonellaTyphimurium component.

In turkeys, the influence of maternally derived antibodies was not studied.

The prevalence of SalmonellaEnteritidis and SalmonellaTyphimurium in commercial turkey holdings can vary widely amongst the European Union Member States. The vaccine should only be used on turkey farms with known occurrence of SalmonellaEnteritidis or SalmonellaTyphimurium unless national Salmonellacontrol programs in European Union Member States promote control measures such as vaccination.

In ducks, the maternally derived antibodies may have an impact on the development of the immune response.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate healthy animals only.

Vaccinated chickens may excrete the Salmonella Enteritidis vaccine strain up to 21 days and the Salmonella Typhimurium vaccine strain up to 35 days following vaccination.

Vaccinated ducks may excrete the SalmonellaEnteritidis vaccine strain up to 14 days and the SalmonellaTyphimurium vaccine strain up to 28 days following vaccination.

Shedding of Salmonellavaccine strains in turkeys is intermittent. After vaccinated once at the first day of life, duration of excretion was observed for the SalmonellaEnteritidis vaccine strain up to day 49 and for the SalmonellaTyphimurium vaccine strain up to day 63. After repeated vaccinations duration of excretion is shortened. Due to limited data the eggs of vaccinated turkey breeders are not intended for human consumption.

Not tested on ornamental and pure-bred poultry.

The vaccine can spread to susceptible birds in contact with vaccinated birds.

On very rare occasions, the vaccine strains may be isolated from the environment beyond the above mentioned period when using very sensitive detection methods.

Ensure that the drinking water is free of detergents, disinfectants and acids.

The vaccine strains are highly sensitive to fluoroquinolone antibiotics and have increased sensitivity to erythromycin, chloramphenicol, doxycycline, detergents and environmental noxae.

The differentiation between the vaccine and field strains is achieved by means of an antibiogram:

In contrast to field strains, the vaccine strain is sensitiveto erythromycin (recommended concentration 15–30 µg/ml) and resistantto streptomycin (recommended concentration 200 µg/ml) and rifampicin (recommended concentration 200 µg/ml).

In contrast to field strains, the vaccine strain is sensitiveto erythromycin (recommended concentration 15–30 µg/ml) and resistantto nalidixic acid (recommended concentration 20 µg/ml) and rifampicin (recommended concentration 200 µg/ml).

Depending on the test system used, oral vaccination may result in low seropositive reactions of individual birds in a flock. Since the serological monitoring of Salmonellais only a flock test, positive findings have to be confirmed, e.g. by bacteriology.

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

Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.

Open the vial only under water to avoid aerosols.

Wash and disinfect hands after handling the 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 strains are sensitive to a number of antibiotics including quinolones (ciprofloxacin).

Since the vaccine has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.

Vaccinated animals may excrete the vaccine strains. Immunocompromised persons are advised to avoid contact with the vaccine and recently vaccinated animals.

The veterinary medicinal product should not be administered by pregnant women.

Personnel involved in attending vaccinated animals should follow general hygiene principals (changing clothes, wearing gloves, cleaning and disinfection of boots) and take particular care in handling litter from vaccinated chickens until 35 days after vaccination, from vaccinated ducks until 28 days after vaccination and from vaccinated turkeys until 63 days after vaccination.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Do not use in chickens in lay and within 3 weeks before the onset of the laying period.

Do not use in ducks intended for lay.

Do not use in turkeys in lay and within 5 weeks before the onset of the laying period.

4.8 Interaction with other medicinal products and other forms of interaction

Since the vaccine strains are live bacteria, simultaneous use of chemotherapeutics which are effective against Salmonellashould be avoided. However, if this is inevitable, the flock must be re-immunised. A decision to use this vaccine before or after any chemotherapeutic treatment needs to be taken on a case-by-case basis.

No information is available on the safety and efficacy of this vaccine when used with other veterinary medical product. A decision to use this vaccine before or after any other veterinary medicinal product therefor needs to be made on a case-by-case basis.

4.9 Amounts to be administered and administration route

For oral use after resuspension in drinking water.

Advice on correct administration:

The contents of opened bottles should be used completely.

Prepare only the amounts of the vaccine that will be used within 4 hours.

Protect the reconstituted vaccine from direct sunlight, frost and temperatures above 25 °C.

Follow these instructions for correct administration, so that all birds receive the appropriate dose.

Vaccination scheme:

AviPro SALMONELLA DUO may be used from the 1^stday of life.

Ducks for meat production:A single dose from first day of life.

Chickens (future breeders and future layer hens):A single dose from first day of life followed by a second vaccination at an age of 6 to 8 weeks and a third vaccination around the 16^thweek of life at least 3 weeks before onset of lay.

Turkeys for meat production:A single dose from the first day of life followed by a second vaccination at an age of 6 weeks.

Turkey breeders:A single dose from the first day of life followed by a second vaccination at an age of 6 weeks, a third vaccination at an age of 16 weeks and a fourth vaccination at an age of 23-24 weeks.

Administration via the drinking water:

• Ideally the vaccine should be administered in the volume of water consumed by the birds within 3 hours. Use water meter recording for the previous day to accurately determine the correct quantity of water in each case. Alternatively, the amount of water needed can be calculated out of the number and age of birds combined with the information given in the water consumption tables from the breeding companies.

• Under hot climatic conditions and in heavy breeds or species other than chickens, especially in the case of older turkeys, this amount might need to be increased to ensure sufficient water uptake of each bird.

• The whole content of a vial should be used for one house or drinking system as splitting may lead to dosing errors.

• All equipment used for the vaccination (pipes, hoses, tubes, etc.) should be thoroughly cleaned and free of detergent and disinfectant residues.

• Use only cool, clean and fresh water, preferably free of chlorine and metal ions. Skimmed milk powder (<1% fat) (2–4 grams per litre of water) or skimmed milk (20–40 ml per litre of water) can improve the quality of tap water and thus the stability of the vaccine. However, this has to be done at least 10 minutes prior to adding the vaccine.

• Open the vaccine vial under water and dissolve thoroughly. As the concentrated vaccine is slightly viscous, care should be taken to empty the ampoule and its top completely by rinsing them in water. Vaccine solution must be stirred thoroughly for several minutes before administration.

• 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.

• Apply vaccine over (up to) 3 hours, ensuring that all birds drink during this time. Due to the varying drinking behaviour of chickens, it might be necessary to withhold water on some sites prior to vaccination in order to ensure that all birds drink during the vaccination period.

• A period of thirst of up to 2–3 hours before vaccination might be necessary to ensure that every bird receives a vaccine dose.

• Make sure that birds do not have access to plain (vaccine free) water during vaccination.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse reactions are known after an overdose.

4.11 Withdrawal period(s)

For chicken and ducks: meat, offal and eggs: 21 days.

For turkeys: meat and offal: 70 days after the first vaccination,

49 days after repeated vaccination.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for Aves, live bacterial vaccines for domestic fowl, turkeys and ducks.

ATCvet code: QI01AE01, QI01BE01, QI01CE01.

AviPro SALMONELLA DUO stimulates active immunity against Salmonella Enteritidis and against Salmonella Typhimurium.

The vaccine strains are natural metabolic drift mutants, i.e. they lack or do not express certain metabolic pathways which result in attenuation.

The genetic basis results in defective ribosomal protein S12 affecting polypeptide synthesis (streptomycin resistance), defective gyrase affecting DNA replication (nalidixic acid resistance) and defective RNA polymerase affecting transcription of DNA to RNA (rifampicin resistance).

The vaccine strains also have attenuations that increase the permeability of the cell membrane for harmful agents such as detergents and antibiotics. This means that the strains have poor survival in the environment and are highly sensitive to fluoroquinolones and unlike field strains are sensitive to erythromycin.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Soy peptone

Sucrose

Gelatine

HEPES buffer

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after reconstitution according to directions: 4 hours.

6.4 Special precautions for storage

Store and transport refrigerated (2 C – 8 C).

Do not freeze.

Protect from direct sunlight.

6.5 Nature and composition of immediate packaging

Type I (Ph. Eur.) 20 ml glass vials with welt edge and rubber stopper. The vials are sealed with aluminium tear-off caps.

The vaccine is available in the following pack sizes:

Cardboard box with 1 vial containing 1,000 vaccine doses.

Cardboard box with 1 vial containing 2,000 vaccine doses.

Bundle packs:

Cardboard box with 10 vials containing of 1,000 vaccine doses.

Cardboard box with 10 vials containing of 2,000 vaccine doses.

Not all pack sizes may be marketed.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Lohmann Animal Health GmbH

Heinz – Lohmann Str. 4

27472 Cuxhaven

Germany

8. MARKETING AUTHORISATION NUMBER

Vm 16894/4009

9. DATE OF FIRST AUTHORISATION

22 July 2011

10. DATE OF REVISION OF THE TEXT

July 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 28 July 2016