NOBILIS® SALENVAC T
Nobilis® Salenvac T is indicated for the active immunisation of future breeder and layer chickens as an aid to reduce faecal excretion and infection by Salmonella enteritidis and Salmonella typhimurium.
FOR ANIMAL USE ONLY
NOBILIS® SALENVAC T
Reg. No. G3558 (Act 36/1947)
Namibia Reg. No. V05/24.3/49 [NS0]
INDICATIONS
Nobilis® Salenvac T is indicated for the active immunisation of future breeder and layer chickens as an aid to reduce faecal excretion and infection of birds by Salmonella Enteritidis and Salmonella Typhimurium and as an aid in the control of Salmonella Enteritidis and Salmonella Typhimurium infections in poultry.
COMPOSITION
Active Constituents per dose (0,5 mℓ)
Formalin killed cells of Salmonella Enteritidis PT 4 ≥ 1 RP*
Formalin killed cells of Salmonella Typhimurium 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
Aluminium hydroxide gel.
Preservative: Thiomersal 0,065 mg per 0,5 mℓ.
IMMUNITY
Active immunity:
Vaccination will provide the above protection from Salmonella Enteritidis and Salmonella Typhimurium from 4 weeks after the second administration until approximately 57 to 60 weeks of age. Protection has been demonstrated against other Salmonellas of the serogroup B namely S. Agona and S. Heidelberg.
Passive immunity:
Onset of immunity: day 1 after hatching.
Duration of immunity: until at least 14 days after hatching.
Passive immunity is transferred from at least 4 weeks after the second vaccination up to at least 59 weeks of age of the parent bird.
STORAGE INSTRUCTIONS
- Store between 2 °C and 8 °C in a refrigerator.
- Do not freeze.
- Protect from light.
- Once opened, the vaccine must be used within 10 hours.
WARNINGS
- Withdrawal period: Do not market chickens for slaughter purposes until at least 6 weeks after vaccination.
- DO NOT USE IN CHICKENS IN LAY.
- DO NOT USE IN BROILERS.
- Vaccinate healthy chickens only.
- Administer during rearing only, prior to point of lay.
- Nobilis® Salenvac T contains aluminium hydroxide as an adjuvant and therefore, vaccination may result in temporary swelling at the injection site.
- When administered at the dose volume of 0,5 mℓ to chickens of 4 weeks of age and older, 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 to 2 days.
- Vaccination may also be associated with transient dullness, lethargy and lameness, lasting up to 2 days.
- In case of accidental self-injection, seek medical advice immediately and show the package insert to the doctor.
- KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
- Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.
PRECAUTIONS
- Do not mix Nobilis® Salenvac T with any other vaccine.
- Do not use after the expiry date stated on the label.
- Avoid contact with the eyes, hands and clothing when handling or administering the vaccine.
- 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.
- It is recommended that no other vaccine should be administered simultaneously with or within 14 days after use of Nobilis® Salenvac T.
- Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
The vaccine bottle must be shaken before use.
DOSAGE AND METHOD OF ADMINISTRATION
- Inject all the chickens in the flock.
- Administration is done by intramuscular injection in the thigh muscle.
- Inject 0,5 mℓ in birds of 4 weeks of age and older.
- Observe aseptic precautions.
- Two vaccinations, with an interval of at least 4 weeks should be given.
- The first vaccination can be given from 6 weeks of age, and the second vaccination not later than 16 weeks of age.
- Once opened, use of the vaccine must be completed within 10 hours.
Note
The vaccine has been shown to be efficacious at 1-day-old, a dosage of 0,1 mℓ with a repeat dose of 0,5 mℓ, 4 weeks later, in chicks from non-vaccinated and non-infected parent flocks.
In exceptional circumstances, it may be considered necessary to vaccinate chicks from day 1 of age, because of infection risk.
In this situation, it should be taken into account that post-vaccination injection site swellings are generally more evident than when administering 0,5 mℓ to chicks 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 within 7 days. Exceptionally, a swelling may still be detectable 15 days after vaccination.
In addition, after vaccination, a significant proportion of the chickens may show signs of lethargy, dullness and lameness, and a reduction of weight gain.
Hygiene measures and good husbandry practices should also play an important part of a control programme to reduce the incidence of Salmonella spp. infection.
PRESENTATION
Nobilis® Salenvac T is packed in low density multi-dose polyethylene (LDPE) bags or polyethylene terephthalate (PET) vials of 250 mℓ and 500 mℓ capacity sealed with aluminium caps over rubber stopper.
Not all pack sizes may necessarily be marketed.
REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road
Spartan, 1619, RSA
Tel: +27 (0) 11 923 9300
E-mail: msdahza@msd.com
DATE OF PUBLICATION OF PACKAGE INSERT
18 March 2016