Rabies Vaccine Product Insert
Nobivac Rabies
Nobivac® Rabies Data Sheet
Presentation
Inactivated vaccine containing > 2 I.U. Rabies virus strain Pasteur RIV per dose. Also contains Aluminium phosphate as an adjuvant. 0.1 mg/ml Thiomersal are added as a preservative.
Uses
For the active immunization against rabies to reduce clinical signs and mortality.
Onset of immunity: an adequate serological response (> 0.5 I.U.) has been demonstrated 2 to 3 weeks after vaccination.
Duration of immunity: 3 years.
Dosage and administration
A single dose inoculation of 1 ml is sufficient irrespective of size, species or breed of animal. Sterile equipment should be used for administration. Avoid contamination of vaccine with traces of chemical sterilizing agents. Do not use chemicals such as disinfectant or spirit to disinfect the skin prior to inoculation.
Primary vaccination age* 3 months or older
Booster vaccination every 3 years
Route of administration intramuscularly or subcutaneously
* Primary vaccination may be administered at an earlier age (minimum in dogs and cats of 4 weeks of age), but then a repeat vaccination must be given at the age of 3 months.
Can be used during pregnancy in dogs.
Further information:
Limited safety data for ferrets are available from monitoring post vaccination reactions. Ferrets can be vaccinated subcutaneously from 3 months of age. An adequate serological response (> 0.5 I.U.) has been demonstrated 1 month after vaccination and they should receive a booster vaccination every 18 months. Health regulations and requirements in certain countries specify that dogs must be revaccinated annually against rabies.
Pet Travel Scheme (PETS):
Animals intended for vaccination under the Pet Travel Scheme (PETS) must be identified by a permanent numbered microchip. This microchip number must be recorded on the record of the dog, cat and ferret vaccination at the time of rabies vaccination.
Contra-indications, warnings, etc
Do not use in unhealthy animals.
The vaccine may not be effective in animals incubating the disease at the time of vaccination. 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.
Some animals may be immunologically incompetent and fail to respond to vaccination. Animals that have received the corresponding anti-serum or immunosuppressive drugs should not be vaccinated until an interval of at least 4 weeks has elapsed.
Transient local reactions such as non-painful diffuse to firm swellings of approximately 1 cm in diameter may be observed for up to 3 weeks after subcutaneous vaccination. In the rare event of a hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline, without delay and by the most immediate route.
After administration of an overdose no effects other than those described above occurred. The presence of maternal antibodies can interfere with the response to vaccination.
Can be used during pregnancy in dogs. There are no laboratory data on use during pregnancy in other species, but on the basis of field experience, such use is expected to be safe.
Safety and efficacy data are available which demonstrate that this vaccine can be used to reconstitute the freeze dried Intervet vaccines of the Nobivac range containing one or more of the following: live canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza and inactivated canine leptospirosis antigens or live feline viral rhinotracheitis virus, feline calicivirus and feline panleucopenia virus.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
This product should not be given for at least one month following the administration of hyperimmune serum or immunosuppressant drugs.
Do not mix with any other veterinary medicinal products apart from those listed above.
Withdrawal period:
Not applicable.
For animal treatment only. Keep out of reach and sight of children.
Legal category
POM-V
Packaging Quantities
Cartons with 1, 10 or 50 glass type I vials with 1 ml, and carton with 1 vial of type I with 10 ml, with a rubber stopper and aluminum cap. Not all presentations may be marketed.
Pharmaceutical precautions
Store in a refrigerator (2°C to 8°C). Do not freeze.
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.
Significant Changes
Further information
Nil.
Marketing authorization number
Vm 01708/4325.
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