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Date: Saturday, May 18, 2024 14:42

Description: MSD-AH
Telephone: 01908 685685 (Customer Support Centre)
Release 3.28
Nobilis® Salenvac T
 
Species: Chickens, Poultry
Therapeutic indication: Immunological veterinary medical products: For poultry, For chickens
Active ingredient: Vaccine Antigens
Product:Nobilis® Salenvac T
Product index: Nobilis® Salenvac T
Poultry - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Per dose of 0.5 ml:
Active substances:
Inactivated cells of Salmonella Enteritidis, strain PT 4: ≥ 1 RP*
Inactivated cells of Salmonella Typhimurium, strain DT104: ≥ 1 RP*
* RP = relative potency = mean antibody response in rabbit potency test equal to or greater than a reference batch which was shown to be efficacious in chickens.
Excipients:
Adjuvant: aluminium hydroxide: 125 mg.
Preservative: thiomersal: 0.065 mg.
For a list of excipients, see section “Pharmaceutical Particulars”.
Pharmaceutical form
Suspension for injection.
Clinical particulars
Target species
Chickens (breeders and layers).
Indications for use
For the active immunisation of chickens and the passive immunisation of the progeny to reduce caecum colonisation and faecal excretion with S. Enteritidis and S. Typhimurium.
Active immunity:
Onset of immunity: 4 weeks after the second administration
Duration of immunity: until approximately 56-60 weeks of age for chickens vaccinated at 12 and 16 weeks.
Minor indication: In exceptional circumstances chickens from one day of age may be vaccinated in order to protect them in an environment where they are likely to become infected at an early stage in the rearing phase (epidemiologically indicated by recent outbreak of Salmonella or high infection pressure on the site).
Onset of immunity: 4 weeks after the second administration.
Passive immunity:
Onset of immunity: day one after hatching.
Duration of immunity: until 14 days after hatching.
Passive immunity is transferred from 4 weeks after the second vaccination up to 59 weeks of age of the parent bird.
Contraindications
Do not use in laying birds.
Special warnings for each target species
None.
Special precautions for use
No studies have been performed to evaluate the effect of maternally derived antibodies on the response to vaccination. Therefore, for use in 1 day old chicks, where epidemiologically indicated, only birds from non-vaccinated and non-infected parent flocks should be vaccinated with Nobilis Salenvac T.
Operator warnings
In the case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
Adverse reactions
The vaccine contains an adjuvant and vaccination may result in temporary swellings at the injection site.
In chickens of 4 weeks of age and above (receiving a dose of 0.5 ml), vaccination may rarely result in transient small palpable nodules at the injection site (reaching a maximum size of 1 cm2), evident immediately after vaccination and generally lasting only 1-2 days. Vaccination may also be associated with transient dullness, lethargy and lameness, lasting up to 2 days.
In one-day-old chicks (receiving 0.1 ml) the reactions are more noticeable.
It should be taken into account that post-vaccination injection site swellings are generally more evident than when administering 0.5 ml to birds of 4 weeks of age or older, and occasionally, the whole thigh may become swollen. These reactions are temporary and in the majority of cases resolved by 7 days. Exceptionally, a swelling may still be detectable 15 days after inoculation. In addition, after vaccination a significant proportion of the birds may show signs of lethargy, dullness and lameness, and a reduction of weight gain.
Use during pregnancy or lactation
Do not vaccinate birds in lay.
Interactions
Vaccination causes a serological response in the chickens which may interfere with a surveillance programme based solely on serological screening without confirmatory bacteriology. The vaccine should therefore not be used when serological detection alone is used to assess flocks for infection with S. Enteritidis and/or S. Typhimurium. Vaccination also may cause cross reactions in the plate agglutination test for S. Pullorum/Gallinarum. Specific serological methods or bacteriology should be used for the differential diagnosis.
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
Standard vaccination:
Intramuscular injection of one dose of 0.5 ml.
For active immunization of layers and breeders:
Two vaccinations, with an interval of four weeks should be given.
The recommended age for vaccination is 12 and 16 weeks of age.
Emergency vaccination (when epidemiologically indicated in high-risk environments):
Intramuscular injection of one dose of 0.1 ml in one-day-old chicks.
After an interval of 4 weeks a repeat vaccination with a dose of 0.5 ml should be given.
For passive immunization of progeny of breeders:
Two vaccinations, with an interval of at least four weeks should be given.
The recommended age for first vaccination is at 6-12 weeks of age and for the second vaccination at 13-16 weeks of age.
In case the induction of active- and passive immunity is intended in breeders and their offspring, the vaccination scheme for active immunization should be followed.
Hygiene measures and good husbandry practices should also play an important part of a control programme to reduce the incidence of Salmonella infection.
Overdose
Similar reactions to those seen after a single dose (see Section "Adverse Reactions"), but more pronounced after double dose.
Withdrawal period
Zero days.
Pharmacological particulars
ATC vet code: QI01AB01.
Pharmacotherapeutic group
To stimulate active immunity and passive immunity of the progeny against S. Enteritidis and S. Typhimurium. For the passive immunisation scheme upon challenge with S. Enteritidis or S. Typhimurium, no significant reduction of Salmonella positive samples of liver and spleen was demonstrated.
Pharmaceutical particulars
Excipients
Aluminium hydroxide gel
Tris
Maleic acid
Sodium chloride
Formaldehyde
Thiomersal
Water for injection.
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Unopenend: 3 years.
Use broached containers immediately.
Special precautions for storage
Store and transport refrigerated (2 - 8°C). Do not freeze. Protect from light.
Immediate packaging
Carton box with a multidose low density polyethylene bottle of 250 ml or 500 ml sealed with an aluminium cap over a rubber stopper. Containers and closures conform to Ph.Eur.
Disposal
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 Number
UK: Vm 01708/4472
Significant changes
Date of the first authorisation or date of renewal
17 August 2000.
Date of revision of the text
August 2020.
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 T 1x500ml:
GTIN:08713184028242