Dogs.

Active immunisation of dogs from 3 weeks of age:

− to reduce clinical signs and bacterial excretion after infection with Bordetella bronchiseptica and

− to reduce clinical signs and viral excretion after infection with canine parainfluenza virus.

Onset of immunity: 3 days after primary vaccination for Bordetella bronchiseptica.

7 days after primary vaccination for canine parainfluenza virus.

Duration of immunity: 1 year.

None.

Vaccinate healthy animals only.

This veterinary medicinal product contains a live attenuated bacterial strain and antibiotics may interfere with the veterinary medicinal product’s efficacy. Therefore, vaccinated dogs should not receive antibiotic treatment. If antibiotics are used within one week after vaccination, vaccination against Bordetella bronchiseptica should be repeated e.g. with a Bb monovalent vaccine (if available) after completion of the antibiotic treatment.

After vaccination dogs may excrete the vaccine strain Bordetella bronchiseptica for up to 11 weeks and the vaccine strain canine parainfluenza virus for 8 days. Unvaccinated dogs can manifest mild clinical signs such as sneezing and nasal and ocular discharge after contact with vaccinated dogs.

The transmission of vaccine strains to cats, pigs and rodents could not be demonstrated. However, as the possibility of transmission to non-target species cannot be rejected, it is recommended to keep non-vaccinated animals out of close contact with vaccinated dogs for at least 4 weeks.

Safe handling and proper administration of the veterinary medicinal product and disposal of used material contribute to eliminating the risk of spreading the vaccine antigens in the veterinary workplace.

Hands and tools should be disinfected after use.

In case of accidental self-administration during dilution of the veterinary medicinal product or inhalation of the veterinary medicinal product in the form of aerosol during administration into the nostril of a dog, seek medical advice immediately and show the package leaflet or the label to the physician.

Although the risk that immunocompromised people are infected with Bordetella bronchiseptica is extremely low, it should be borne in mind that dogs can excrete the bacteria for up to several weeks after vaccination. Immunocompromised persons are advised to avoid contact with the veterinary medicinal product and vaccinated dogs during excretion.

Not applicable.

Not applicable.

Dogs:

Very common (>1 animal / 10 animals treated):	Nasal discharge1
Common (1 to 10 animals / 100 animals treated):	Ocular discharge1 Cough2 Depression1
Uncommon (1 to 10 animals / 1,000 animals treated):	Sneezing1

1Mild and generally subside without treatment within 1 to 3 days.

2Mild to moderate and observed in vaccinated dogs within 48 hours to one week after vaccination.

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.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore, the use is not recommended during pregnancy and lactation.

This veterinary medicinal product has been shown safe in dogs from 8 weeks of age when given at the same time as vaccines of the Versican Plus/Biocan Novel and Vanguard ranges containing live canine parvovirus, adenovirus, distemper virus, parainfluenza virus as well as inactivated Leptospira and rabies virus. Mild (< 1 ºC), transient increases in temperature were very commonly observed following co-administration of these vaccines.

Efficacy 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 veterinary medicinal products at the same time.

Although proven safe it should not be necessary to give a parainfluenza vaccine twice by two different routes, therefore the veterinarian should consider vaccination options based on local availability of core vaccines without parainfluenza and monovalent Bordetella vaccines.

No information is available on the safety and efficacy of this veterinary medicinal product when used with any other veterinary medicinal product except the products mentioned above. A decision to use this veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Nasal use.

Dosage and route of administration:

Aseptically reconstitute the lyophilisate with the solvent. Shake well after reconstitution. Withdraw the liquid with the syringe, remove the needle and administer directly from the tip of the syringe into one nostril. Alternatively, an intranasal applicator (available separately) can be attached to the syringe and the dose then administered into one nostril. The veterinary medicinal product should then be used immediately.

The head of the dog should be held with the nose pointing upwards. Administer one dose (0.5 ml) of the reconstituted veterinary medicinal product into one nostril.

Appearance of the reconstituted vaccine: whitish to yellowish colour with light opalescence.

Primary vaccination scheme:

A single dose from 3 weeks of age.

Re-vaccination scheme:

A single dose to be given annually.

No adverse reactions other than those mentioned in section "Adverse reactions" were observed after administration of a 10-fold overdose of the veterinary medicinal product.

Not applicable.