Nobilis™ RT+IBMULti+ND+EDS Data Sheet

Inactivated vaccine for Chickens (breeders and layers) against Avian Rhinotracheitis, Infectious Bronchitis, Newcastle disease and Egg Drop Syndrome

Presentation

White to nearly white oily emulsion containing inactivated viral antigens of: IBV strain M41(inducing 5.5 log2 VN units*), IBV strain 249g (inducing ≥ 4.0 log2 VN units*), ART strain But1#8544 (inducing 9.5 log2 ELISA units*), EDS’76 strain BC14 (inducing ≥ 6.5 log2 HI units*), NDV strain Clone 30 (inducing ≥ 4.0 log2 HI units per 1/50th of a dose*, or containing ≥ 50 PD50 units). 215 mg liquid

Uses

Active immunisation of breeder and layer chickens for:

Reduction of infection and prevention of egg drop caused by the Massachusetts serotype of Infectious Bronchitis Virus;

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);

Reduction of egg drop and egg shell defects related to EDS’76 virus.

Onset of immunity: 4 weeks after vaccination.

Duration of immunity: one laying period.

Dosage and administration

Nobilis RT+IBmulti+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.

Each bird should be given 0.5 ml of vaccine intramuscularly in the thigh or chest muscle.

Before using the vaccine allow it to reach ambient temperature (15-25ºC).

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 damage certain types of

rubber.

In the event that live vaccines were used to prime birds against Infectious Bronchitis, Rhinotracheitis and Newcastle disease, Nobilis RT+IBmulti+ND+EDS should be given at least 4 weeks after the administration of the live vaccines.

Contra-indications, warnings etc.
A mild transient swelling may be observed at the injection site for up to 2 weeks.
Vaccinate only healthy animals.
Not to be used during 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 products. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product.

No particular symptoms are observed after administration of a double dose. A mild transient swelling may be observed at the injection site for 2 up to weeks.

Do not mix with any other vaccine/immunological product.

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 at + 2º and + 8ºC. Protect from light. Do not freeze.
Once broached, use within 3 hours.

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

Legal category
POM

Package quantities
500 ml (1000 doses) of vaccine in PET bottles.

Further information
Nil

Marketing authorisation number
Vm 06376/4039

Marketing Authorisation Holder
Intervet International BV
Represented by:
Intervet UK Ltd
Walton Manor, Walton
Milton Keynes   Bucks  
MK7 7AJ

Manufacturer

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Date of preparation
June 2004