Target species
Dogs.
Indications for use, specifying the target species
Active immunisation of dogs from 6 weeks of age:
− to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
− to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,
− 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.
Contraindications
None.
Special warnings for each target species
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 medicinal therapy and stress.
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
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.
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.
Special precautions for the protection of the environment:
Not applicable.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
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): | Injection site lump, Injection site mass, Injection site nodule 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 the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during the second and third stages of pregnancy. Safety of the product during the early stage of pregnancy and during lactation has not been investigated.
Interaction with other medicinal products and other forms of interaction
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.
Amount(s) 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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions other than those mentioned in section 4.6 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.
Withdrawal period(s)
Not applicable.