A combined inactivated vaccine for chickens and is recommended for the booster vaccination of breeding stock for protection against Infectious Bronchitis and Newcastle Disease and for the immunisation against Reo Virus Infection and Infectious Bursal Disease virus so as to protect the offspring against Reo virus Infections and Gumboro Disease by maternal antibodies for at least the first week of life.
Reg. No. G2564 (Act 36/1947)
Namibia Reg. No. V05/24.3/47 [NS0]
Newcastle disease is a controlled disease in terms of the Animal Diseases Act (Act35/1984). The occurrence of suspicion of this disease has to be reported to the responsible state Veterinarian.
Nobilis® Reo+IB+G+ND is a combined inactivated vaccine for chickens and is recommended for the booster vaccination of breeding stock for protection against Infectious Bronchitis and Newcastle Disease and for the immunisation against Reo Virus Infection and Infectious Bursal Disease virus so as to protect the offspring against Reo virus Infections and Gumboro Disease by maternal antibodies for at least the first week of life.
Each dose of Nobilis® Reo+IB+G+ND contains inactivated Infectious Bronchitis virus Massachusetts serotype strain 41 inducing ≥ 6,0 log2 HI units, Newcastle Disease virus Clone 30 ≥ 50 PD50 units, Gumboro virus strain D78 inducing ≥ 14,5 log2 VN units and Reo virus strains 1733 and 2408 inducing ≥ 5,0 log2 VN units. The viruses were grown in embryonated eggs or on CEF or Vero Cell cultures, inactivated with formalin and subsequently suspended in the aqueous phase of an oil adjuvant emulsion.
- Store in the dark between 2 °C and 8 °C.
- Do not freeze.
- Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
- Protect from exposure to direct sunlight.
- Opened bottles, not used within 3 hours.
- Withdrawal period: Do not market chickens for slaughter purposes for at least 6 weeks after vaccination.
- Avoid intravenous injection.
- Ensure that chickens marketed do not have swellings at the site of vaccine administration, as this may result in the condemnation of the chickens.
- Do not mix Nobilis® Reo+IB+G+ND with other vaccines.
- Vaccination of chickens in production may lead to a slight decrease in egg production.
- Accidental self-vaccination may lead to severe local allergic reaction. Consult a physician informing him/her that the vaccine contains a mineral oil.
- Do not store partially used vaccine containers for future use and use the entire contents once opened.
- 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.
- Vaccinate healthy chickens only.
- Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes, etc.) is clean and sterile prior to and during use.
- It is essential to adhere to the vaccination programme to maintain a satisfactory immune status.
- It is good vaccination practice to avoid contact with the eyes, hands and clothing when handling the vaccine.
- 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).
Special precautions to be taken by the person administering Nobilis® Reo+IB+G+ND to animals
To the user
Nobilis® Reo+IB+G+ND contains mineral oil. If you are accidentally injected with this vaccine, seek prompt medical advice even if only a very small amount is injected and take the package insert with you to show to the physician. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician
Nobilis® Reo+IB+G+ND contains mineral oil. Even if small amounts have been injected, this vaccine can cause intense vascular spasm which may, for example result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon sheaths.
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Shake well before use and at regular intervals during the vaccination process.
RECOMMENDED VACCINATION PROGRAMME
Nobilis® Reo+IB+G+ND should be given to chickens around 16 to 20 weeks of age, but not less than 4 weeks before the expected onset of lay.
For an optimal booster effect, the chickens must be primed with a live vaccine against Infectious Bronchitis, Newcastle Disease, Avian Reo virus infection and Infectious Bursal Disease.
The best results will be obtained if vaccination with inactivated vaccine takes place 6 or more weeks after administration of the live primer, but under no circumstances should it be done earlier than 4 weeks after priming.
DOSAGE AND ADMINISTRATION
- Each chicken should be given 0,5 mℓ of the vaccine intramuscularly into the thigh or breast muscle or subcutaneously into the lower part of the neck. (Administration via intramuscular injection into the breast muscle, the needle should be pointed in the direction of the chicken’s head, to prevent the needle from entering the body cavity.)
- Shake well before use and at regular intervals during the vaccination process.
- Remove the aluminium over seal and the vaccine is ready for use.
- Inject all the chickens in the flock.
If priming and subsequent vaccination have been carried out correctly, the chickens will develop antibodies at a level which provides protection against Newcastle Disease and production losses caused by the Massachusetts serotype of Infectious Bronchitis.
Under normal field situations, the offspring hatched at any stage of the laying period will have sufficient maternal antibodies to protect them against disease caused by Gumboro infections and Reo infections during the first weeks of life.
In healthy chickens, no clinical reaction to the vaccination will be observed. For some weeks after vaccination a slight swelling may be felt at the site of the vaccination. Local tissue reactions may occur.
Bottles containing 500 mℓ sufficient for 1 000 doses packed in an outer cardboard carton.
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
Tel: +27 (0) 11 923 9300
DATE OF PUBLICATION OF THIS PACKAGE INSERT
20 January 2015
|Zimbabwe Reg. No. E96/80.23.17/9437 |
Pharmacological classification: 802310
Distribution category: VMGD