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Date: Saturday, May 18, 2024 12:46

Release 2.59
Nobilis® Salenvac ETC suspension for injection for chickens
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:Nobilis® Salenvac ETC suspension for injection for chickens
Product index: Nobilis® Salenvac ETC
Poultry - meat: Zero days
Poultry - eggs: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose of 0.5 ml contains:
Active substances:
Inactivated Salmonella Enteritidis, strain PT4: 1 – 6.6 RP*
Inactivated Salmonella 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 “Pharmaceutical particulars”.
Pharmaceutical form
Suspension for injection.
A homogeneous, cream to mid-brown suspension.
Clinical particulars
Target Species
Chickens (breeders and layers).
Indications for use
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)
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Not applicable.
Operator warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
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, to 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.
Use during pregnancy or lactation
Laying birds:
Do not use in birds in lay and within 3 weeks before the start of the laying period.
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 made on a case by case basis.
Amounts 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.
Overdose
No data available.
Withdrawal period
Zero days.
Pharmacological particulars
ATC Vet Code: QI01AB01
Pharmacotherapeutic group
Immunological for Aves, inactivated bacterial vaccine (salmonella) for domestic fowls, Salmonella.
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).
Pharmaceutical particulars
Excipients
Aluminium hydroxide
Tris (trometamol)
Maleic acid
Sodium chloride
Thiomersal
Water for injection
Major incompatibilities
Do not mix with any other veterinary medicinal product.
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.
Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Protect from light.
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 a bottle of 500 ml (1000 doses).
Disposal
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
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK(GB):Vm 01708/5073
UK(NI): Vm 01708/3007
Significant changes
Date of the first authorisation or date of renewal
18th May 2020.
Date of revision of the text
May 2023.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Nobilis® Salenvac ETC: 1x500ml
GTIN:8713184205643