Target species
Dogs.
Indications for use, specifying the target species
Active immunisation of dogs against Bordetella bronchiseptica and canine parainfluenza virus for periods of increased risk to reduce clinical signs induced by B. bronchiseptica and canine parainfluenza virus and to reduce shedding of canine parainfluenza virus.
Onset of immunity:
Bordetella bronchiseptica: 72 hours after vaccination;
Canine parainfluenza virus: 3 weeks after vaccination.
Duration of immunity: 1 year
Contraindications
None.
Special warnings
Vaccinate healthy animals only..
Special precautions for use
Special precautions for safe use in the target species:
Vaccinated dogs may excrete the Bordetella bronchiseptica vaccine strain up to 6 weeks and the canine parainfluenza vaccine strain up to a few days following vaccination. During this time, the contact of immunosuppressed and unvaccinated dogs with vaccinated dogs should be avoided.
Immunosuppressive medication may impair the development of active immunity and may increase the chance of adverse effects caused by the live vaccine strains. Cats, pigs and unvaccinated dogs may react to the vaccine strains with mild and transient respiratory signs. Other animals, like rabbits and small rodents have not been tested.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Immunocompromised persons are advised to avoid contact with the vaccine and vaccinated animals up to 6 weeks after vaccination.
Disinfect hands and equipment after use.
Adverse events
Dogs:
Very common (>1 animal / 10 animals treated): | Nasal discharge1. Ocular discharge1. |
Common (1 to 10 animals / 100 animals reacted) | Sneezing1, cough1. |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Wheezing1. Lethargy. Vomiting. Hypersensitivity reaction, anaphylactic-type reaction2. Immune mediated haemolytic anaemia, immune mediated thrombocytopenia, immune mediated polyarthritis. |
1 Particularly observed in very young susceptible puppies. Signs are generally mild and transient, but in occasional cases may persist for up to four weeks. In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.
2 Such reaction may evolve to a more severe condition, which may be life-threatening. If such reaction occurs appropriate 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
Pregnancy:
Can be used during pregnancy.
Interaction with other medicinal products and other forms of interaction
Do not administer in conjunction with other intranasal treatments or during antibiotic treatment.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day, but not mixed, with the live vaccines in the Canigen range against canine distemper, canine contagious hepatitis caused by canine adenovirus type 1, canine parvovirus disease and respiratory disease caused by canine adenovirus type 2, where authorised, and inactivated vaccines in the Canigen range against canine leptospirosis caused by all or some of the following serovars: L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Liangguang. In very rare cases a transient acute hypersensitivity reaction may occur when this product is used with other vaccines.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.
In case antibiotics are administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment is finished.
Administration routes and dosage
Nasal use.
Allow the sterile solvent provided to reach room temperature (15 °C – 25 °C). Aseptically reconstitute the lyophilisate with the solvent. Shake the vial well after addition of the solvent. Withdraw the vaccine into the syringe, remove the needle and administer 0.4 ml directly from the tip of the syringe into one nostril.
Vaccination scheme:
Dogs should be at least 3 weeks of age. When this vaccine is concurrently administered (i.e. not mixed) with another vaccine in the Canigen range as indicated, dogs should not be younger than the minimum age recommended for the other Canigen vaccine.
Unvaccinated dogs should receive one dose at least 3 weeks prior to the period of anticipated risk, e.g. temporary kennelling, in order to get protection for both vaccine agents. In order to get protection for Bordetella bronchiseptica unvaccinated dogs should receive one dose at least 72 hours prior to the period of anticipated risk.
Revaccinate annually.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Particularly in very young puppies, signs of upper respiratory tract disease have been observed after a 10-fold overdose of the vaccine, including ocular and nasal discharges, pharyngitis, sneezing and coughing. The signs started the day after vaccination and have been seen for up to 4 weeks after vaccination.