For animal treatment only
Vaccinate healthy animals only.
The use is not recommended during pregnancy and lactation due to the lack of supportive studies and possible spread of the vaccine strain.
Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment.
In rare cases, transient coughing (1 or 2 days) may occur, during the first days following vaccination.
In rare cases, transient nasal or ocular discharge may be observed. In animals, which show more severe signs, appropriate antibiotic treatment may be indicated. However, veterinarians should be aware that antibiotic treatment given less than 14 days after vaccination may impair vaccine efficacy.
Hypersensitivity reactions may occur in very rare cases. In case of anaphylactic reactions, administer adrenaline.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
In addition to the adverse reactions mentioned above, ten-fold overdose vaccinated puppies may sneeze one or more times following vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
The product contains live bacteria and must be administered by the intranasal route only. Parenteral administration can generate abscesses and cellulitis. Do not use immunodepressing agents within 1 month of vaccination with the product. Do not administer antibiotics during 14 days following vaccination. If any antibiotic is used within 2 weeks after vaccination, vaccination should be repeated after competition of the antibiotic treatment.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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 other veterinary medicinal product, except the solvent supplied for use with the product.
Special precautions for use in animals
Vaccinated dogs may excrete the vaccine strain of Bordetella bronchiseptica up to 7 weeks following vaccination. During this time, immunodepressed persons are advised to avoid contact with vaccinated dogs. Similar precautions are also applicable to unvaccinated in-contact or immunodepressed animals. The vaccine has been shown safe in pigs. Cats and unvaccinated dogs in contact with vaccinated dogs may react to the vaccine strain, presenting moderate clinical signs such as sneezing, nasal and ocular discharge. Other animals, such as rabbits and small rodents, have not been tested.
Special precautions should be taken to avoid spreading of the vaccine strain in the clinic.
Operator warnings
Disinfect hands and equipment after use. In case of accidental self-injection during reconstitution of the product or inhalation of the aerosolized product at the time of application in the dog nostrils, seek medical advice immediately and show the package leaflet or the label to the physician.
Persons administering the product to the dog should be aware that repeated exposure to the product by inhalation of aerosolized product may lead to rare hypersensitivity reactions.
Although the risk that immunocompromised humans become infected with Bordetella bronchiseptica is extremely low, such individuals should be aware that dogs can shed the organism for up to 7 weeks after vaccination. Immunocompromised persons are advised to avoid contact with the vaccine and vaccinated dogs during the shedding period.