Nobilis Erysipelas
Active substance
ATC code
Species
Turkeys
Indications
For active immunisation of turkeys to reduce mortality caused by Erysipelothrix rhusiopathiae
The onset of immunity is 6 weeks post second vaccination and the duration of immunity is 23 weeks post second vaccination.
Dose to be administered and administration route
Dose: 0.5 ml
Administration: by subcutaneous injection
Turkeys are to be vaccinated twice. Subcutaneous injection of 0.5 ml (one dose) of vaccine can take place from six weeks of age onwards. Vaccination is repeated after 4 weeks. The second vaccination for breeder turkeys has to be given not later than two weeks before the onset of the laying period.
Before using the vaccine allow it to reach room temperature (15-25°C) and shake before and intermittently during use. Use sterile syringes and needles. Avoid introduction of contamination by multiple broaching.
Adverse reactions
None
Dispensing
POM-VPS - Prescription Only Medicine – Veterinarian, Pharmacist, SQP
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Erysipelas
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF PRODUCT
Active substance
|
Erysipelothrix rhusiopathiae, strain M2 (serotype 2) Adjuvant |
¼ RPU[1]/ 0.5 ml dose |
|
dl α-tocopheryl acetate Excipient |
37.5 mg/dose |
|
Preservative: Formaldehyde |
0.05% |
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Suspension for injection
4. CLINICAL PARTICULARS
4.1 Target Species
Turkeys
4.2 Indications for use specifying the target species
For active immunisation of turkeys to reduce mortality caused by Erysipelothrix rhusiopathiae
The onset of immunity is 6 weeks post second vaccination and the duration of immunity is 23 weeks post second vaccination.
4.3 Contra-indications
None.
4.4 Special warnings for each target species
Do not vaccinate unhealthy birds.
A good immune response is reliant on the reaction of an immunogenic agent
and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
4.5 Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the product to animals
None.
4.6 Adverse reactions (frequency and seriousness)
None
4.7 Use during pregnancy, lactation or lay
Do not vaccinate laying birds or within 2 weeks before onset of the laying period.
4.8 Interaction with other medicinal products and other forms of interactions
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 decided on a case by case basis.
4.9 Amounts to be administered and administration route
Dose: 0.5 ml
Administration: by subcutaneous injection
Before using the vaccine allow it to reach room temperature (15-25°C) and shake before and intermittently during use. Use sterile syringes and needles.
Turkeys are to be vaccinated twice. Subcutaneous injection of 0.5 ml (one dose) of vaccine can take place from six weeks of age onwards. Vaccination is repeated after 4 weeks. The second vaccination for breeder turkeys has to be given not later than two weeks before the onset of the laying period.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No particular signs after administration of a double dose.
4.11 Withdrawal period
Zero days.
5. IMMUNOLOGICAL PROPERTIES
ATC Vet QI01CB02: Inactivated bacterial vaccines for Turkeys, Erysipelothrix vaccine
The active ingredient is a cell lysate of E. rhusiopathiae strain M2 (serotype 2), which induces protection against turkey erysipelas.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Formaldehyde
dl α-tocopheryl acetate
Polysorbate 80
Simethicone
Sodium chloride
Trometamol (Tris)
Water for injections
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: 2 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
6.5 Nature and composition of immediate packaging
Carton with 1 glass bottle (type I Ph.Eur.) or PET bottle containing 250 ml (= 500 doses) or 500ml (= 1000 doses), closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap.
Not all presentations may be marketed.
6.6 Special precautions for disposal of unused veterinary medicinal product or waste material derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with the local requirements.
7. MARKETING AUTHORISATION HOLDER
MSD Animal Health UK Limited
Walton Manor
Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 01708/4546
9. DATE OF FIRST AUTHORISATION
26 September 2009
10. DATE OF REVISION OF THE TEXT
June 2020
Approved: 02 June 2020
[1] 1 RPU = 1 Relative Potency Unit, is the calculated potency compared to a reference serum obtained by means of a reference vaccine which has been tested and found to be satisfactory in pigs.
