Nobilis REO inac Data Sheet

Presentation

Inactivated avian reovirus vaccine containing two immunogenic strains (1733 & 2408) of reo virus grown in cell-line tissue culture inducing > 7.4 log₂ ELISA units.  The vaccine is inactivated with formalin and suspended in the aqueous phase of an oil adjuvant emulsion.

Uses

For the active immunisation of parent birds for the passive immunisation of their progeny, to reduce mortality and clinical signs of disease caused by avian reoviruses.

Active immunity develops in the parent within 4 weeks, and offspring born at any stage of the subsequent laying period will have passive immunity against reovirus infections for protection during the susceptible period in the early phase of life.

Dosage and administration

0.5 ml for intramuscular injection into the thigh or chest muscle or subcutaneous injection into the back of the neck, using a medium sized needle (20g x ½”).  For an optimal response in birds not primed by field virus, two vaccinations should be given approximately 6 weeks apart.

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

Ensure that vaccination equipment is clean and sterile before use.  Do not use vaccination equipment with rubber parts as the excipient may damage certain types of rubber.

Nobilis Reo inac should be given to birds around 10-20 weeks of age but not less than 4 weeks before the expected onset of lay.

Contra-indications, warnings, etc

Only healthy birds should be vaccinated.

Not to be used in birds in lay.  Not to be used within 4 weeks before the onset of lay.

Do not mix with any other vaccines or immunological products.

No information is available from the concurrent use of this vaccine with any other except for other Intervet inactivated oil emulsion vaccines, containing the IB, G, ND, TRT or EDS antigens, administered at the same time but at separate sites. It is therefore recommended that no other vaccines other than these vaccines should be administered within 14 days before or after vaccination with Nobilis Reo inac.

A slight transient swelling (resolved within 3 weeks) may be felt in 50% of the vaccinated birds at the site of vaccination.

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 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 period

Zero days.

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

Pharmaceutical precautions

Store between +2° and +8°C. Do not freeze.

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

Shake vigorously before and during use.

Opened bottles should be used within 3 hours.

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant, in accordance with the national requirements.

Legal category

POM

Package quantities

Glass or PET bottles containing 500 ml (1000 doses) vaccine.

Further information

The vaccine may occasionally separate into two layers on storage. This in no way affects its potency, but the vaccine should be shaken vigorously before and during use to ensure a good emulsification.

After field priming and subsequent correct vaccination the offspring born at any stage of the laying period will, under normal field situations, have sufficient maternal antibodies to protect them against disease caused by reo infections during the first weeks of life.

Marketing authorisation number

Vm 01708/4329