Target Species
Chickens (breeders and layers).
Indications for use
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 avian infectious bronchitis virus (IBV), and reduce infection in primed birds.
•Prevent mortality and clinical signs and reduction of infection caused by Newcastle disease virus (NDV).
•Prevent egg production losses and egg quality defects caused by infection with egg drop syndrome ’76 virus (EDSV).
Onset of immunity: Active immunity develops within 4 weeks.
Duration of immunity: One laying period (for avian infectious bronchitis and Newcastle disease viruses, this requires birds to have been adequately primed with live vaccines against these pathogens during the growing phase).
Contraindications
None.
Special warnings for each target species
Vaccinate healthy birds only.
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.
Special precautions for use
Not applicable.
Operator warnings
To the user:
This veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal 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.
Adverse Reactions
A mild transient swelling may be observed at the injection site for 2 weeks.
Very common (>1 animal / 10 animals treated): | Injection site swelling1. |
1 Mild, may be observed at the injection site for 2 weeks.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Do not use in birds in lay and within 4 weeks before the start of the laying period.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Nobilis TRT inac, an Intervet inactivated vaccine containing TRT antigen strain But1#8544 (subgroup A).
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case-by-case basis.
Amounts to be administered and administration route
Intramuscular or subcutaneous use.
Dose: 0.5 ml per bird.
Intramuscular injection in the thigh or chest muscle, or by subcutaneous injection in the back of the neck, using a medium sized needle (20 G x ½”).
The veterinary medicinal product should be given to birds around 14 – 20 weeks of age but not less than 4 weeks before the expected start of lay.
Priming with live vaccines for avian infectious bronchitis and Newcastle disease viruses 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.
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.
Overdose
After administration of a two-fold overdose the reactions are not different from those observed after a single dose. No effects other than those described in section adverse events.
Withdrawal periods
Zero days.