Target species
Dog
Indications for use, specifying the target species
For active immunisation of dogs from 8 weeks of age to:
- prevent mortality and clinical signs caused by canine distemper virus;
- prevent mortality and clinical signs caused by canine adenovirus type 1;
- prevent clinical signs and mortality and reduce excretion caused by canine parvovirus in challenge studies performed with a CPV-2b strain;
- prevent clinical signs and reduce excretion caused by canine parvovirus in a challenge study performed with a CPV-2c strain;
- reduce respiratory clinical signs and viral excretion caused by canine parainfluenza virus and canine adenovirus type 2;
- prevent mortality and reduce infection, clinical signs, kidney colonisation, renal lesions and urine shedding of L. canicola;
- reduce infection, clinical signs, kidney colonisation and urine shedding of L. icterohaemorrhagiae;
Onset of immunity
The onset of immunity has been demonstrated from 3 weeks after the primary vaccination for CDV, CAV-2 and CPV, 4 weeks for CAV-1 and CPiV, 5 weeks for L. Canicola and 2 weeks for L. Icterohaemorrhagiae.
Duration of immunity
After the primary vaccination course, the duration of immunity lasts for one year for all components.
In the duration of immunity studies one year after the basic vaccination scheme there was no significant difference between vaccinated and control dogs in viral excretion for CPiV and CAV-2, in reduction of kidney colonisation for L. Canicola and L. Icterohaemorrhagiae, nor in renal lesions and urine shedding for L. Canicola.
After the annual booster, the duration of immunity lasts for 3 years for CDV, CAV-1, CAV-2 and CPV.
For CAV-2, the duration of immunity after the annual booster was not established by challenge, and is based on the presence of CAV-2 antibodies 3 years after the booster vaccination.
Contra-indications
None
Special warnings for each target species
Vaccinate healthy animals only.
The presence of maternally derived antibodies (puppies from vaccinated females) may in some cases interfere with the vaccination. Therefore the vaccination scheme should be adapted accordingly (see below).
Special precautions for use
Special precautions for use in animals
After vaccination the live viral vaccinal strains (CAV-2, CPV) can be spread to unvaccinated animals without any pathological effect for these in-contact animals.
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.
Adverse reactions (frequency and seriousness)
Dogs:
Common (1 to 10 animals / 100 animals treated): | Injection site swelling1,2,3, Injection site oedema2,3,4 Lethargy2 |
Rare (1 to 10 animals / 10,000 animals treated): | Injection site pain2,3, Injection site pruritus2,3 Hyperthermia2 , Anorexia2 Digestive tract disorders2 (e.g. Diarrhoea2 , Vomiting2 ) |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction (e.g. Anaphylaxis, Allergic skin reaction such as Allergic oedema, Urticarial erythema, Allergic pruritus)5 |
1 (≤ 4 cm)
2 Transient
3 Resolves spontaneously within 1 to 2 weeks.
4 Slight diffuse
5 Appropriate symptomatic treatment should be administered without delay.
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
Do not use during pregnancy and lactation.
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 decided on a case by case basis.
Amounts to be administered and administration route
After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule:
Primary vaccination course
First injection from 8 weeks of age
Second injection 3 or 4 weeks later.
Maternally derived antibodies may in some cases influence the immune response to vaccination. In such cases, a third injection is recommended from 15 weeks of age.
Re-vaccinations
One booster injection of a single dose should be given one year after the primary vaccination course.
Subsequent vaccinations are carried out at intervals of up to three years.
Annual revaccination is required for CPiV and Leptospira components, therefore a single dose of the Virbac vaccine against Canine Parainfluenza virus and Leptospira can be used annually.
The appearance of the reconstituted product is slightly pinkish beige.
Overdose
The administration of a 10 fold overdose at a single injection site did not cause any reactions other than those mentioned above except for the duration of the local reactions (up to 26 days).
Withdrawal period(s)
Not applicable