Presentation

Inactivated vaccine containing per dose of 0.5 ml:

Infectious Bronchitis M41 antigen                      > 6.0 log₂ HI units

Egg Drop Syndrome antigen                               > 6.5 log₂ HI units

Newcastle Disease antigen                                > 4 log₂ HI units per

1/50 dose (or > 50 PD₅₀ units per dose as per Ph.Eur.)

Also contains liquid paraffin as adjuvant.  The vaccine also contains formaldehyde remaining from the inactivation procedure.

Uses

The vaccine is recommended for the vaccination of laying and breeding birds to:

-        Prevent egg production losses caused by infection with the Massachusetts serotype of IBV, and reduce infection in primed   birds.

-        Prevent mortality and clinical signs and to reduce infection caused by Newcastle Disease.

-        Prevent egg production losses and egg quality defects caused by infection with Egg Drop Syndrome Virus.

Active immunity develops within 4 weeks and is maintained for one laying period (for Infectious Bronchitis and Newcastle Disease this requires birds to have been adequately primed with live vaccines against these pathogens during the growing phase).

Dosage and administration

Nobilis IB+ND+EDS should be given to birds around 14-20 weeks of age but not less than 4 weeks before the expected onset of lay.

Priming with live vaccines for Infectious Bronchitis and Newcastle Disease is necessary unless serological tests indicate otherwise.  The interval between priming and booster should not be less than 4 weeks and preferably more than 6 weeks.

Dose: 0.5 ml vaccine per bird by intramuscular injection in the thigh or chest muscle or by subcutaneous injection in the back of the neck, using a medium-sized needle (20g x ½”).

Allow the vaccine to reach ambient temperature (15 – 25°C) before use.

The vaccine may occasionally separate into two layers on storage. This in no way affects its potency.

Shake the bottle vigorously before and periodically during use.

An automatic injection system, incorporating a means to prevent back-flushing and hence possible contamination of the vaccine, should be used for administration.

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.

Contra-indications, warnings, etc.

A mild transient swelling may be observed at the injection site for 2 weeks.

No particular symptoms are observed after administration of a double dose.

Do not vaccinate unhealthy birds.

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

Safety and/or efficacy data are available which demonstrate that this vaccine can be administered on the same day as (but not mixed with) Nobilis TRT inac, an Intervet inactivated vaccine containing TRT antigen strain But1#8544(subgroup A).

Do not mix with any other medicinal products.

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.  Immuno-competence 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, fully immune birds may succumb to disease.  Therefore successful vaccination may not be synonymous with full protection in the face of a disease challenge.

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 THE REACH AND SIGHT OF CHILDREN

Pharmaceutical precautions

Store between +2^oC and + 8^oC (in a refrigerator). Do not freeze. Protect from light

Shelf life after opening: 3 hours.

Disposal advice:

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Legal category

POM-VPS

Package quantities

PET bottles containing 500 ml (1000 doses). The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.

Further information

Nil.

Marketing Authorisation number

Vm 01708/4275

Marketing Authorisation holder

Intervet UK Ltd

Walton Manor

Walton,

Milton Keynes

Bucks. MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation:

February 2008. 

                                                                                                                        010011^.Feb 2008.