Suspension for injection.

Aqueous, white to nearly white suspension, mild creaming.

Each dose (1 ml) contains:

Bordetella bronchiseptica fimbriae1 : 88 - 399 U2

1Purified from strain Bb7 92932

2Antigenic mass ELISA units

Adjuvant: dl-α-tocopheryl acetate: 74.7 mg

dl-α-tocopheryl acetate

Thiomersal

Sodium chloride

Disodium hydrogen phosphate dihydrate

Sodium dihydrogen phosphate dihydrate

Polysorbate 80

Water for injections

Dogs.

For active immunisation of dogs against Bordetella bronchiseptica to reduce clinical signs of upper respiratory tract disease and bacterial shedding post infection.

Onset of immunity: 2 weeks.

Duration of immunity: 7 months after primary vaccination. 1 year after re-vaccination.

Subcutaneous use, 1 ml dose per vaccination.

Dogs can be vaccinated from the age of 6 weeks onwards.

Allow the vaccine to reach room temperature (15 °C – 25 °C) before use.

Shake well before each administered dose. Avoid introduction of contamination by using a clean needle for each administered dose.

Two vaccinations with an interval of 4 weeks.

A single vaccination, administered 7 months after primary vaccination with this vaccine, is sufficient to maintain protection against Bordetella bronchiseptica for a further year. Thereafter, a single vaccination should be administered, annually. In case re-vaccination at 7 months is missed, a single vaccination within 12 months after primary vaccination is sufficient to extend protection against Bordetella bronchiseptica for a further year.

This vaccine can also be used for re-vaccination in a schedule where Canigen KC has been used for primary vaccination. A single vaccination, administered one year after primary vaccination with Canigen KC, is sufficient to prolong immunity against Bordetella bronchiseptica for another year.

One vaccination, annually.

When this vaccine is administered in associated use (i.e. not mixed) with another vaccine of the Canigen series as indicated, the vaccines should be given subcutaneously at the same time, at a different site. Dogs should not be younger than the minimum age recommended for the other Canigen vaccine, as stated in the respective product information.

None.

Vaccinate healthy animals only.

Not applicable.

Not applicable.

Dogs:

1The swelling may uncommonly last for up to 35 days post-vaccination.

2If hypersensitivity reaction occurs, appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition which may be life-threatening.

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.

Can be used during pregnancy. The safety of this vaccine has not been investigated during the first 20 days of gestation.

Safety and efficacy data are available which demonstrate that this Canigen Bb vaccine can be administered at the same time but not mixed with the live vaccines of the Canigen series 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.

Safety data are available which demonstrate that this Canigen Bb vaccine can be administered at the same time but not mixed with the Canigen series of vaccines mentioned above together with the live Canigen parainfluenza vaccine and the inactivated vaccines of the Canigen series against leptospirosis caused by 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/Lianguang.

In addition, for the live canine parainfluenza vaccine antibody response data, and for the inactivated canine leptospirosis vaccines antibody response data and other immunity data support the use of the Canigen Bb vaccine at the same time but not mixed with the mentioned Canigen series of vaccines.

When this vaccine is administered in association with the relevant Canigen vaccines, the demonstrated safety and efficacy claims of Canigen Bb are the same as when this vaccine is administered alone.

The product information of the relevant Canigen vaccines used in association with this vaccine should be consulted before administration.

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.

Not applicable.

Pharmacotherapeutic group:Immunologicals for Canidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

ATCvet code: QI07AB03.

The subunit vaccine stimulates active immunity against Bordetella bronchiseptica infection in dogs.

Do not mix with any other veterinary medicinal product.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 4 weeks.

Store in a refrigerator (2°C – 8°C). Do not freeze.

Once broached store between 2°C – 25°C. Do not freeze.

Store in the original package in order to protect from light.

Polyethylene terephthalate (PET) vial closed with a halogenobutyl rubber stopper and aluminium cap.

Cardboard box with 1 multidose vial containing 10 doses (10 ml) of vaccine.

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

Vm 01708/5063