Target species
Dogs.
Indications for use for each target species
Active immunisation of dogs from 6 weeks of age:
− to prevent mortality and clinical signs caused by canine distemper virus,
− to prevent mortality and clinical signs caused by canine adenovirus type 1,
− to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2,
− to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus,
− 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 the first vaccination for CDV, CAV, CPV,
− 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 three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus. The duration of immunity against CAV-2 was not established by challenge. It was shown that 3 years after the vaccination CAV-2 antibodies are still present. Protective immune response against CAV-2 associated respiratory disease is considered to last at least 3 years. At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
Contraindications
None.
Special warnings
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.
Immunological responses to the CDV, CAV and CPV components of the vaccine may be delayed due to maternally derived antibody interference. However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CDV, CAV and CPV at levels equal or higher to those likely to be encountered under field conditions. In situations where very high maternally derived antibody levels are expected, the vaccination protocol should be planned accordingly.
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
The live attenuated virus vaccine strains CAV-2, CPiV and CPV-2b may be shed by vaccinated dogs following vaccination, shedding of CPV has been shown for up to 10 days. However, due to the low pathogenicity of these strains, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs and domestic cats. The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination.
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.
Adverse events
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 the package leaflet for respective 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.
Rabies:
If protection against Rabies is required:
First dose: Versican Plus DHPPi/L4 from 8–9 weeks of age.
Second dose: Versican Plus DHPPi/L4R 3–4 weeks later but not before 12 weeks of age.
The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. However, in field studies 10% of sero-negative dogs did not show seroconversion (>0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies. Some animals may also not show titres > 0.5 IU/ml after the primary vaccination. Antibody titres drop over the course of the 3-year duration of immunity, although dogs are protected when challenged. In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥ 0.5 IU/ml).
In case of need, dogs younger than 8 weeks can be vaccinated as safety of Versican Plus DHPPi/L4R has been demonstrated in 6-week old dogs.
Administration routes and dosage
Subcutaneous use.
Dosage and route of administration:
Aseptically reconstitute the lyophilisate with the suspension. Shake well and administer immediately the entire content (1 ml) of the reconstituted product.
Appearance of the reconstituted vaccine: pinkish or yellowish colour with light opalescence.
Primary vaccination scheme:
Two doses of Versican Plus DHPPi/L4 3–4 weeks apart from 6 weeks of age.
Re-vaccination scheme:
A single dose of Versican Plus DHPPi/L4 should be given every 3 years. Annual re-vaccination is required for Parainfluenza and Leptospira components. Therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse events other than those mentioned in section "Adverse events" 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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.