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Contra-indications, warnings, etc
Vaccinate healthy animals only.
A good immune response is reliant on 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 medical therapy and stress.
The live attenuated virus vaccine strain CPiV may be shed by vaccinated dogs following vaccination. However, due to the low pathogenicity of the strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
Can be used during the second and third stages of pregnancy. Safety of the product during the early stage of pregnancy and during lactation have not been investigated.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Dogs:
Common
(1 to 10 animals / 100 animals treated):
injection site swelling1
Rare
(1 to 10 animals / 10,000 animals treated):
hypersensitivity reaction2(anaphylaxis, angioedema, circulatory shock, collapse, diarrhoea, dyspnoea, vomiting)
anorexia, decreased activity
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
hyperthermia, lethargy, malaise immune mediated haemolytic anaemia, immune mediated haemolytic thrombocytopenia, immune mediated polyarthritis
1A transient swelling (up to 5 cm) which can be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination.
2If a hypersensitivity reaction occurs, appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition which may be life-threatening.
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 also section 16 of the package leaflet for contact details.
No adverse reactions other than those mentioned above were observed after administration of a 10-fold overdose of the vaccine. However, in a minority of animals pain was observed at the injection site immediately after administration of a 10-fold overdose of the vaccine.
User warnings:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.