- to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and

- to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.

Onset of immunity:

- 3 weeks after completion of the primary course for CPiV and

- 4 weeks after completion of the primary course for Leptospira components.

Duration of immunity:

At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.

Dose to be administered and administration route

Subcutaneous use.

Dosage and route of administration:

Aseptically reconstitute the lyophilisate with the suspension. Shake well and administer immediately the entire contents (1 ml) of the reconstituted product.

Appearance of the reconstituted vaccine: whitish to yellowish colour with light opalescence.

Primary vaccination scheme:

Two doses of Versican Plus Pi/L4 3–4 weeks apart from 6 weeks of age.

Re-vaccination scheme:

A single dose of Versican Plus Pi/L4 to be given annually.

Adverse reactions

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.