Target species
Dogs.
Indications for use, specifying the target species
Active immunisation of dogs from 6 weeks of age:
− 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:
4 weeks after completion of the primary course.
Duration of immunity:
At least one year following the primary vaccination course for all components of Versican Plus 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
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.
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 other than Versican Plus DHPPi and Versican Plus Pi. 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.
Vaccination against distemper, adeno, parvo and parainfluenza virus (DHPPi):
If protection against DHPPi or Pi is required, dogs can be vaccinated with two doses of Versican Plus DHPPi or Versican Plus Pi mixed with Versican Plus L4 3–4 weeks apart from 6 weeks of age:
The contents of a single vial of Versican Plus DHPPi or Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent). Once mixed, the contents of the vial should appear a whitish to yellowish colour with light opalescence (Pi/L4) or pinkish or yellowish colour with light opalescence (DHPPi/L4). The mixed vaccines should be injected immediately via the subcutaneous route.
Amount(s) to be administered and administration route
Subcutaneous use.
Dosage and route of administration:
Shake well and administer immediately the entire contents (1 ml) of the product.
Primary vaccination scheme:
Two doses of Versican Plus L4 3–4 weeks apart from 6 weeks of age.
Re-vaccination scheme:
A single dose of Versican Plus L4 to be given annually.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No data are available on the safety of an overdose.
Withdrawal period(s)
Not applicable.