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Contra-indications, warnings, etc
Special warnings
Vaccinate healthy animals only.
The vaccine may not be effective in dogs incubating the disease at the time of 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.
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.
Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
A transient rise in body temperature post-vaccination has been observed in rare cases during the clinical safety studies.
Dogs may show local reactions after injection in very rare cases, according to spontaneous pharmacovigilance reports. A diffuse swelling, up to 5 cm in diameter, may be observed at the site of injection for up to 4 days. Occasionally this swelling may be hard and painful, but this will diminish gradually and disappear after 2 – 3 weeks.
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 reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening with additional signs like dyspnoea or collapse. If such reactions occur appropriate treatment is recommended.
Mild systemic signs as lethargy and anorexia were reported very rarely.
Clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, or immune-mediated polyarthritis have been reported in very rare cases.
Use during pregnancy and lactation
Can be used during pregnancy.
The vaccine has been shown to be safe for use in pregnant bitches which have previously been vaccinated with Canigen Lepto 2.
Interactions with other medicaments and forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with live vaccines in the Canigen range containing canine distemper virus (strain Onderstepoort), canine adenovirus type 2 (strain Manhattan LPV3), canine parvovirus (strain 154) and/or canine parainfluenza virus (strain Cornell) components authorised for subcutaneous administration.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Canigen Rabies, the inactivated rabies (strain Pasteur RIV) vaccine in the Canigen range.
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.
Overdose (symptoms, emergency procedures, antidotes)
No symptoms other than at single dose (see above).
For animal treatment only.