Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable.
Adverse reactions (frequency and seriousness)
Dogs:
Very common (> 1 animal / 10 animals treated): | Injection site swelling (≤ 2 cm, occasionally firm, may be present up to 25 days post-vaccination). |
Common (1 to 10 animals / 100 animals treated): | Injection site swelling (≤ 3.5 cm may be present up to 25 days post-vaccination1 and can be painful). |
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction.2 |
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.
Use during pregnancy, lactation or lay
Can be used during pregnancy. The safety of this vaccine has not been investigated during the first 20 days of gestation.
Interaction with other medicinal products and other forms of interaction
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.