Contra-indications and warnings for Lepto vaccines 

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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 drug therapy and stress.

The live attenuated virus vaccine strain CPiV may be shed by vaccinated animals 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.

A transient swelling (up to 5 cm) may commonly be observed at the injection site following subcutaneous administration in dogs. This can be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination.

Anorexia and decreased activity are rarely observed.

Hypersensitivity reactions (e.g. gastrointestinal signs such as diarrhoea and vomiting, anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur rarely. If such a reaction occurs appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition, which may be life-threatening.

Systemic reactions such as lethargy, hyperthermia and general malaise may occur very rarely.

Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases.

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)

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

No other 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.