Versican Plus BbPi IN is a combination vaccine presented as a lyophilisate and solvent for suspension.

Each dose comprises of 0.5 ml:

One vial of a lyophilisate fraction containing live attenuated Bordetella bronchiseptica, strain MSLB 3096 (108.0 to 109.8 CFU*) and live attenuated Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 (103.5 to 105.8 CCID50**) and one vial of liquid solvent fraction containing water for injections.

*CFU = Colony forming unit.

** CCID50 = Cell culture infectious dose 50%

Active immunisation of dogs from 3 weeks of age:

3 days after primary vaccination for Bordetella bronchiseptica.

7 days after primary vaccination for canine parainfluenza virus.

12 months.

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 vaccine should 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 vaccine into one nostril.

Reconstituted vaccine: Whitish to yellowish colour with a slight opalescence.

A single dose from 3 weeks of age.

A single dose to be given annually.

Vaccinate healthy animals only.

This product contains a live attenuated bacterial strain and antibiotics may interfere with the vaccine’s efficacy. Therefore, vaccinated animals 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 vaccine and disposal of used material contribute to eliminating the risk of spreading the vaccine antigens in the veterinary workplace.

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 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 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 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.

Do not mix with any veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.

Transient mild nasal discharge is very commonly, mild ocular discharge and mild depression are commonly and mild sneezing is uncommonly observed in animals after vaccination. These signs generally subside without treatment within one to three days. Mild to moderate coughing was commonly observed in vaccinated kenneled dogs from nine days after vaccination when housed together with non-vaccinated dogs.

The frequency of adverse reactions is defined using the following convention:

No adverse reactions other than those mentioned above were observed after administration of a 10-fold overdose of the vaccine.

Hands and tools should be disinfected after use.

In case of accidental self-administration during dilution of the product or inhalation of the product in the form of aerosol during administration into the nostril of a dog, seek medical advice immediately and show the package leaflet or 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 vaccine and vaccinated dogs during excretion.

Store and transport refrigerated (2°C – 8°C).

Do not freeze.

Protect from light.

Shelf life after reconstitution according to directions: use immediately.

Keep out of the sight and reach of children.

For animal treatment only.

Packs with 5 x 0.5 ml doses or 10 x 0.5 ml doses. Each dose is a combination of one vial of the lyophilisate fraction and one vial of solvent fraction.

Not all pack sizes may be marketed.

Applicators are packed separately and can be distributed together with the vaccine on request.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Vm 42058/4210