Nobilis RT+IBmulti+G+ND

Nobilis RT+IBmulti+G+ND Data Sheet

Presentation
Nobilis RT+IBmulti+G+ND contains immunogenic strains of Infectious Bronchitis, Turkey Rhinotracheitis, Infectious Bursal Disease and Newcastle Disease viruses inactivated with formalin or b-propiolactone and suspended in the aqueous phase of an oil adjuvant emulsion.  
 
Per dose of 0.5 ml: 

  IBV strain M41(Massachusetts):

  inducing ≥ 5.5 log2 VN units

  IBV strain 249g (D274/D207):

  inducing ≥ 4.0 log2 VN units

  TRT strain But1#8544 (subgroup A):

  inducing ≥ 9.5 log2 ELISA units

  IBDV strain D78:

  inducing ≥ 14.5 log2 VN units

  NDV strain Clone 30:

  inducing ≥ 4.0 log2 HI units per 1/50th dose or containing ≥ 50 PD50 units



Uses
The vaccine is recommended for the vaccination of breeder chickens for:

- reduction of infection and prevention of egg drop caused by the Massachusetts serotype, and reduction of egg drop and egg shell defects caused by the D274/D207 serotype of Infectious Bronchitis virus

- reduction of infection caused by Newcastle Disease virus

- prevention of respiratory signs and reduction of egg drop and egg shell defects related to Avian Rhinotracheitis virus (Avian Pneumovirus) and to induce

- passive immunisation of the progeny of the vaccinated birds against Infectious Bursal Disease for at least the first four weeks of life.

Dosage and administration
Each bird should be given 0.5 ml of vaccine intramuscularly in the thigh or chest muscle using a medium-sized needle.

Recommended vaccination programme
Nobilis RT+IBmulti+G+ND should be given to birds around 14 20 weeks of age but not later than 4 weeks before the expected onset of lay.

An optimal booster effect will be obtained if birds are primed with live vaccines against the inactivated vaccine components.  In this case, Nobilis RT+IBmulti+G+ND should be given at least 4 weeks after the administration of the live vaccines.

Contra-indications, warnings, etc
Birds to be vaccinated should be in good health and not suffering from any disease.

Not to be used for birds in lay or within 4 weeks before the onset of the laying period.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after administration of this product.

Vaccination reaction
A slight, transient, swelling may be felt at the site of vaccination. 

In some cases these swellings may be observed for 2 weeks.  This does not constitute permanent tissue damage provided that the vaccination has been carried out aseptically.

Vaccination with inactivated vaccine will not completely prevent shedding of wild type virus after infection.  Therefore this vaccine is only meant to reduce the clinical signs and not as a tool for eradication of the disease.

Operator warnings:
To the user
This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, 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.

Withdrawal period
Zero days.

For animal treatment only. Keep out of reach of children.

Pharmaceutical precautions
Store in a refrigerator at between +2°C and + 8°C, in the original carton.  Do not freeze.
Allow vaccine to reach ambient temperature (15° - 25°C) before use.
Shake the bottle vigorously before use and periodically during use.
Ensure that vaccination equipment is clean and sterile before use.
Do not use vaccination equipment with rubber parts as the excipient may attack certain types of rubber.
Opened bottles should be used within 3 hours.  Avoid the introduction of contamination during use.
Do not mix with other vaccines.
Unused product should be disposed of in accordance with local requirements.

Legal category
POM.

Package quantities
Bottles containing 250 or 500 ml (500 or 1000 doses).

Further information
A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigens will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress. Under certain conditions, for example extreme disease pressure and variant challenge, fully immune birds may succumb to disease. Therefore successful vaccination may not be synonymous with full protection in the face of a disease challenge.

Marketing authorisation number
VM 06376/4030