Nobilis Salenvac ETC
Active substance
ATC code
Species
Chickens (breeders and layers).
Indications
For the active immunisation of chickens from 6 weeks of age to reduce colonisation and faecal excretion of S. Enteritidis (serogroup D), S. Typhimurium and S. Heidelberg (serogroup B), S. Infantis, S. Hadar and S. Virchow (serogroup C).
Onset of immunity after the second vaccination
| S. Enteritidis, S. Typhimurium, S. Infantis, S. Hadar and S. Virchow: | 4 weeks |
| S. Heidelberg: | 9 weeks* |
*Earliest timepoint investigated
Duration of immunity after the second vaccination
| S. Enteritidis: | 48 weeks (evidenced by challenge) and 90 weeks (evidenced by serology) |
| S. Typhimurium: | 57 weeks (evidenced by challenge) and 90 weeks (evidenced by serology) |
| S. Infantis: | 51 weeks (evidenced by challenge) |
| S. Hadar: | 51 weeks (evidenced by challenge) |
| S. Virchow: | 51 weeks (drawn from scientific reasoning) |
| S. Heidelberg: | 57 weeks (drawn from scientific reasoning) |
Dose to be administered and administration route
For intramuscular use.
Shake well before use. Syringes and needles must be sterile before use. Follow standard aseptic procedures.
Intramuscular injection of one dose of 0.5 ml from 6 weeks of age followed by a second vaccination with one dose of 0.5 ml at least 4 weeks later. The second vaccination should be administered no later than 3 weeks before the onset of lay.
Hygiene measures and good husbandry practices should also play an important part of a control programme to reduce the incidence of Salmonella infection.
Adverse reactions
Chickens:
|
Very common (>1 animal / 10 animals treated): |
Decreased activity1; Reduced food intake1; Injection site nodule2 |
1 May last up to 2 days after the first vaccination
2 ≤ 8 mm in size; may be present up to 2 weeks after the second vaccination
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, toeither the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See section “Contact details” of the package leaflet.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Salenvac ETC suspension for injection for chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.5 ml contains:
Active substances:
Inactivated Salmonella Enteritidis, strain PT4: 1 – 6.6 RP*
InactivatedSalmonella Typhimurium, strain DT104: 1 – 16.1 RP
Inactivated Salmonella Infantis, strain A, S03499-06: 1 – 26.6 RP
*RP (relative potency): Ratio of antigenic mass (in Units) as compared to the antigenic mass (in Units) of a reference batch which was shown to be efficacious in chickens.
Adjuvant:
Aluminium hydroxide: 125 mg
Excipients:
Thiomersal: 0.065 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
A homogeneous, cream to mid-brown suspension.
4. CLINICAL PARTICULARS
4.1 Target species
Chickens (breeders and layers).
4.2 Indications for use, specifying the target species
For the active immunisation of chickens from 6 weeks of age to reduce colonisation and faecal excretion of S. Enteritidis (serogroup D), S. Typhimurium and S.
Heidelberg (serogroup B), S. Infantis, S. Hadar and S. Virchow (serogroup C).
Onset of immunity after the second vaccination
S. Enteritidis, S. Typhimurium, S. Infantis, S. Hadar and S. Virchow: 4 weeks
S. Heidelberg: 9 weeks*
*Earliest timepoint investigated
Duration of immunity after the second vaccination
S. Enteritidis: 48 weeks (evidenced by challenge) and 90 weeks (evidenced by serology)
S. Typhimurium: 57 weeks (evidenced by challenge) and 90 weeks (evidenced by serology)
S. Infantis: 51 weeks (evidenced by challenge) S. Hadar: 51 weeks (evidenced by challenge)
S. Virchow: 51 weeks (drawn from scientific reasoning) S. Heidelberg: 57 weeks (drawn from scientific reasoning)
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
4.5 Special precautions for use Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
4.6 Adverse reactions (frequency and seriousness) Chickens:
|
Very common (>1 animal / 10 animals treated): |
Decreased activity[1]; Reduced food intake1; Injection site nodule[2] |
either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See section “Contact details” of the package leaflet.
4.7 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.
4.8 Interaction with other medicinal products and other forms of interaction
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.
4.9 Amount(s) to be administered and administration route
For intramuscular use.
Shake well before use. Syringes and needles must be sterile before use. Follow standard aseptic procedures.
Intramuscular injection of one dose of 0.5 ml from 6 weeks of age followed by a second vaccination with one dose of 0.5 ml at least 4 weeks later. The second vaccination should be administered no later than 3 weeks before the onset of lay.
Hygiene measures and good husbandry practices should also play an important part of a control programme to reduce the incidence of Salmonella infection.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No data available.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunological for Aves, inactivated bacterial vaccine (salmonella) for domestic fowls, Salmonella.
ATCvet code: QI01AB01
To stimulate active immunity to S. Enteritidis (serogroup D), S. Typhimurium and S.
Heidelberg (serogroup B), S. Infantis, S. Hadar and S. Virchow (serogroup C).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Aluminium hydroxide
Tris (trometamol)
Maleic acid
Sodium chloride
Thiomersal
Water for injections
6.2 Major 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: 3 years. Shelf life after first opening the immediate packaging: 10 hours.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Protect from light.
Keep the bottle in the outer box.
6.5 Nature and composition of immediate packaging
Low density polyethylene bottle containing 1000 doses of vaccine. The bottle is closed with a halogenobutyl stopper and sealed with an aluminium cap.
Pack sizes:
Cardboard box with one bottle of 500 ml (1000 doses).
6.6 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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
MSD Animal Health UK Limited
Walton Manor, Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 01708/5073
9. DATE OF FIRST AUTHORISATION
18 May 2020
10. DATE OF REVISION OF THE TEXT
May 2023
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Approved: 11 May 2023
[1] May last up to 2 days after the first vaccination
[2] ≤ 8 mm in size; may be present up to 2 weeks after the second vaccination
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
