Contra-indications
None.
Special warnings for target species
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 CDV, CAV2, CPV and CPi 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.
Special precautions for use
Special precautions for use in animals
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 up to 8 days following 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.
Special precautions to be taken by the person administering the product
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse events
Dogs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site swelling. 1 Elevated temperature. 2 Hypersensitivity reaction (e.g. lethargy, facial oedema, pruritus, vomiting or diarrhoea).3 |
1 Small and transient (≤ 5 cm), which can occasionally be firm and painful on palpation. Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.
2 Transient.
3 Such reaction may evolve to a more severe condition (anaphylaxis), which may be life-threatening with additional signs like ataxia, dyspnoea, tremor and collapse. If such reactions occur, appropriate treatment is recommended.
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.
Overdose (symptoms, emergency procedures, antidotes) (if necessary)
No clinical signs other than those indicated under 'Adverse events'. In some dogs the swelling may be more painful or may be observed for a longer period.
Use during pregnancy and lactation
Can be used in pregnant bitches which have previously been vaccinated with the CDV (strain Onderstepoort), CAV2 (strain Manhattan LPV3), CPV (strain 154) and CPi (strain Cornell) antigens included in the Canigen vaccine range.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data (viral excretion) are available which demonstrate that this vaccine can be mixed and administered with the inactivated vaccines in the Canigen range 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.
The product information of the relevant Canigen vaccines should be consulted before administration of the mixed product. When mixed with Canigen leptospirosis vaccines at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
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 this vaccine and an overdose of the leptospirosis vaccines in the Canigen 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 data and efficacy data for the canine distemper virus, canine adenovirus and canine parvovirus components of this vaccine are available which demonstrate that this vaccine can be administered at the same time but not mixed with the inactivated vaccine in the Canigen range against Bordetella bronchiseptica.
When this vaccine is administered in association with the inactivated vaccine in the Canigen range against Bordetella bronchiseptica, the demonstrated antibody response data for the live canine parainfluenza component of this vaccine are the same as when this vaccine is administered alone.
When this vaccine is used with any of the other Canigen vaccines referred to above, the minimum vaccination age for each vaccine must be taken into account such that at the time of vaccination, the dogs are at or older than the oldest minimum vaccination age for the individual vaccines.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day with solvent or the vaccine in the Canigen range containing inactivated rabies virus strain Pasteur RIV. This can be used to reconstitute this freeze-dried vaccine.
No information is available on the compatibility 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.
Withdrawal Period
Not applicable
For animal treatment only. Keep out of reach and sight of children.