Dogs.

For active immunisation of dogs to prevent mortality, clinical signs and viral excretion following canine parvovirus infection.

Onset of immunity: 1 week.

Duration of immunity: 3 years.

None.

Vaccinate healthy animals only.

The vaccine may not be effective in dogs 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. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

The immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration.

The vaccine has been proved to be of benefit against virulent challenge in the presence of maternal antibody levels to CPV that are likely to be encountered under field conditions.

Experience has shown that the maternal antibody status of pups within a litter varies greatly, and reliance should not be placed on serological examination of the bitch alone.

Animals that have received a corresponding anti-serum or immunosuppressive drugs should not be vaccinated until an interval of at least 4 weeks has elapsed.

Vaccinated dogs may excrete the parvovirus vaccine strain at very low levels for up to 8 days after vaccination. However, there is no evidence of any reversion to virulence of the vaccine strain and therefore no need to separate unvaccinated dogs from contact with recently vaccinated dogs.

In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

A diffuse swelling, up to 5 mm in diameter, may commonly be observed at the site of injection. Occasionally this swelling may be hard and painful and last for up to 3 days post injection.

A transient acute hypersensitivity reaction – with signs that may include lethargy, facial oedema, pruritus, vomiting or diarrhoea – may occur shortly after vaccination in very rare cases. Such reaction may evolve to a more severe condition (anaphylaxis), which may be life-threatening with additional signs like dyspnoea and collapse. If such reactions occur, appropriate treatment is recommended.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

Can be used in pregnant bitches which have previously been vaccinated with the CPV (strain 154) antigens included in the Nobivac vaccine range.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with the inactivated vaccines in the Nobivac range for subcutaneous administration against canine leptospirosis caused by all or some of the following serovars: L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Liangguang.

After administration with one of the leptospirosis vaccines, a mild and transient increase in body temperature (≤ 1 °C) may occur for a few days after vaccination, with some pups showing less activity and/or a reduced appetite. A small transient swelling (≤ 4 cm), which can occasionally be firm and painful on palpation, may be observed at the site of injection. Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.

After mixed administration of an overdose of Nobivac Parvo-C and an overdose of the leptospirosis vaccines in the Nobivac range, transient local reactions such as diffuse to firm swellings from 1 to 5 cm in diameter may be observed, usually these will persist no longer than 5 weeks, however some may take a little longer to completely disappear.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with the inactivated vaccine in the Nobivac range against rabies. After administration with the rabies vaccine, where this product is authorised, transient local reactions such as diffuse to firm swellings from 1 to 4 cm in diameter may be observed for up to 3 weeks after vaccination. The swellings may be painful for up to 3 days post-vaccination.

Safety and efficacy data are available which demonstrate that this vaccine can be administered at the same time but not mixed with the inactivated vaccine of the Nobivac range against Bordetella bronchiseptica.

Product information of the relevant Nobivac vaccines should be consulted before mixed product administration.

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.

Reconstitute the vaccine with 1 ml solvent or 1 ml (1 dose) of the inactivated vaccines listed in the section “Interactions".

Subcutaneous use.

Avoid contamination of vaccine with traces of chemical sterilising agents. Do not use chemicals such as disinfectant or spirit to disinfect the skin prior to inoculation.

Maternal antibodies can negatively interfere with the efficacy of a vaccine. Strict adherence to the vaccination programme is therefore recommended.

Vaccination programme:

A single injection should establish active immunity to disease caused by canine parvovirus infection in dogs of 10 weeks of age or older. Where earlier protection is required a first dose may be given to puppies from 4 weeks of age, but because maternally derived passive antibodies can interfere with the response to vaccination, a final dose at 10 weeks of age or older is generally recommended.

It is recommended that dogs be revaccinated against canine parvovirus every 3 years.

No effects other than those indicated in section "Adverse Reactions". In some dogs the swelling may be more painful or may be observed for a longer period.

Not applicable.