FOR ANIMAL USE ONLY
Reg. No. G3558 (Act 36/1947)
Namibia Reg. No. V05/24.3/49 NS0
For the active immunisation of future breeder and layer chickens and as an aid to reduce faecal excretion and infection of birds by Salmonella Enteritidis and Salmonella Typhimurium.
As an aid in the control of Salmonella Enteritidis and Salmonella Typhimurium infections in poultry.
Vaccination will provide the above protection from S. Enteritidis and S. 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.
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.
|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.
- Store between 2 °C and 8 °C
- Protect from light.
- Withdrawal period: 21 days.
- DO NOT USE IN CHICKENS IN LAY.
- DO NOT USE IN BROILERS.
- Do not market chickens for slaughter purposes until at least 6 weeks after vaccination.
- Vaccinate healthy chickens only.
- Administer during rearing only, prior to point of lay.
- The vaccine contains aluminium hydroxide as an adjuvant and therefore, inoculation may result in temporary swelling at the injection site.
- When administered at dose volume of 0,5 mℓ to chickens of 4 weeks of age and above, 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.
- Do not mix 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.
- Partially used containers, empty packs, syringes and needles must be disposed of in accordance with local waste disposal requirements of clinical waste at the end of each day’s operations.
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
DOSAGE AND METHOD OF ADMINISTRATION
- Inject all the chickens in the flock.
- Shake the bottle before use.
- 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.
The vaccine has been shown to be efficacious in chicks from non-infected parent flocks at 1 day-old, dosage of 0,1mℓ with a repeat dose of 0,5mℓ 4 weeks later. In exceptional circumstances it may be considered necessary to vaccinate chickens from day 1 of age because of risk of infection. 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 inoculation. 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 program to reduce the incidence of Salmonella spp. infection.
Nobilis® Salenvac T is packed in low density multi-dose polyethylene bags or 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 MANUFACTURER
Intervet South Africa (Pty) Ltd. Intervet International B.V.
20 Spartan Road 35 Wim de Körver Straat
Spartan, 1619, RSA Boxmeer, The Netherlands
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
DATE OF PUBLICATION OF PACKAGE INSERT
18 March 2016