for Bordetella bronchiseptica: 72 hours after vaccination;

for canine parainfluenza virus: 3 weeks after vaccination.

1 year.

Vaccinate healthy animals only.

Vaccinated dogs may excrete the Bordetella bronchiseptica vaccine strain up to six 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.

Immunocompromised individuals should avoid any contact with the vaccine and vaccinated dogs up to six weeks after vaccination.

Disinfect hands and equipment after use.

Immunocompromised persons are advised to avoid contact with the vaccine and vaccinated animals up to 6 weeks after vaccination.

Mild discharges from the eyes and nose have been observed very commonly from the day after vaccination, sometimes accompanied by wheezing, sneezing and/or coughing, particularly in very young susceptible puppies. Signs are generally 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.

Lethargy and vomiting may occur after vaccination in very rare cases.

Hypersensitivity reactions may occur in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. If such reactions occur appropriate treatment is recommended.

Clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia or immune-mediated polyarthritis have been reported in very rare cases.

Dogs:

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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 of the Nobivac series against canine distemper, canine contagious hepatitis caused by canine adenovirus type 1, canine parvovirus disease (based on strain 154) and respiratory disease caused by canine adenovirus type 2, where authorised, and inactivated vaccines of the Nobivac series 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.

Safety data are available which demonstrate that Nobivac KC can be administered on the same day but not mixed with the bivalent puppy vaccine of the Nobivac series that contains canine parvovirus strain 630a. Efficacy of Nobivac KC after concurrent use has not been tested. Therefore, while safety of concurrent use has been demonstrated, the veterinarian should take this into account when deciding to administer the products at the same time.

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.

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.

The reconstituted vaccine is an off-white or yellowish coloured suspension.

Dogs should be at least 3 weeks of age. When Nobivac KC is concurrently administered (i.e. not mixed) with another vaccine of the Nobivac series as indicated in section "Interactions", dogs should not be younger than the minimum age recommended for the other Nobivac 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 (see also section "Special precautions for use").

Revaccinate annually.

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.