Nobilis E.coli Inac Data Sheet

Presentation
Nobilis E. Coli inac is an inactivated vaccine, containing 100 mcg F11-antigen and 100 mcg FT-antigen of Escherichia coli per dose in a water-in-oil emulsion. The vaccine contains 0.05% w/v formaldehyde as a preservative.

Uses
Nobilis E. Coli inac is indicated for partial passive immunization of broiler chickens during their first 7 weeks of life, by vaccination of the broiler breeders, as a help against postnatal colibacillosis (airsac disease and septicaemia), caused by fimbrial F11-antigen and flagellar FT-toxin-containing E. coli.

Dosage and administration
Inject 0.5 ml per bird subcutaneously into the back of the neck or intramuscularly into the breast muscle.
Course: two-fold vaccination with an interval of at least 6 weeks. First vaccination at 6 12 weeks of age, revaccination at 14 18 weeks of age.

Contra-indications, warnings, etc.
1. Only healthy birds should be vaccinated.
2. Do not mix with other vaccines or immunological products.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except the inactivated vaccines of Intervet against avian infectious bronchitis, avian infectious bursitis, avian tenosynovitis and Newcastle disease. Do not combine with other vaccines or medications, as this has not been investigated.

General precautions
No clinical reactions. Local tissue reactions of a granulomatous nature and in a number of cases necrosis or abscesses occur.
Five weeks after vaccination the local reactions are considerably decreased.
As compared to the single dose reaction, effects after administration of a double dose have the same character, but they are more severe.

Operator warning
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 insert 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 periods:
Meat and offal: 35 days
Eggs: Zero days

FOR ANIMAL TREATMENT ONLY.  KEEP OUT OF REACH OF CHILDREN.

Pharmaceutical precautions
Store in a refrigerator between +2 and +8°C.  Do not freeze.
Allow the vaccine to reach ambient temperature (15-25°C) and shake vigorously before 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 10 hours.

Any unused product or waste material should be disposed of in accordance with national requirements.

Legal category   

POM

Package quantities
Bottles of 500 ml (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 antigen 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 01708/4266

Marketing Authorisation holder
INTERVET UK Ltd
Walton Manor
Walton
Milton Keynes
MK7 7AJ

Date of preparation
March 2005

Item code: 09956 . JUL05/MP/1k