Target species
Dogs.
Indications for use for each target species
For active immunisation of dogs of 8 weeks of age or older to reduce clinical signs following infection with Bordetella bronchiseptica.
Onset of immunity: 7 days.
Duration of immunity: 1 year.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
The veterinary medicinal product contains live bacteria and must be administered by the oral route only. Parenteral administration can generate abscesses and cellulitis.
Vaccinated dogs may excrete the vaccine strain of Bordetella bronchiseptica for up to 35 days oronasally and for at least 70 days in faeces following vaccination.
Due to the attenuated nature of the vaccine strain it is not necessary to keep unvaccinated dogs separate from vaccinated dogs. However during this time, it is advised that immunocompromised dogs avoid contact with vaccinated dogs.
The Bordetella bronchiseptica in the veterinary medicinal product has been shown to be safe in pigs exposed to the vaccine strain (e.g. from contact with vaccinated dogs). Cats exposed to the vaccine strain (e.g. from contact with vaccinated dogs) may show moderate clinical signs such as sneezing, nasal and ocular discharge.
Safety of the bacteria in the veterinary medicinal product shed by vaccinated dogs has not been studied in other animal species.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Disinfect hands and equipment after use.
In case of accidental self-injection during reconstitution of the veterinary medicinal product, seek medical advice immediately and show the package leaflet or the label to the physician.
Persons administering the veterinary medicinal product to the dog should be aware that repeated exposure to the veterinary medicinal product may lead to rare hypersensitivity reactions.
Immunocompromised persons are advised to avoid contact with the veterinary medicinal product and vaccinated dogs during the oronasal shedding period.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs:
Rare (1 to 10 animals / 10,000 animals treated): | Ocular discharge1 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Diarrhoea2, Vomiting2 Hypersensitivity reaction (e.g. anaphylaxis, dyspnoea and/or tachypnoea, facial oedema, urticaria)3 Nasal discharge2, Cough2 Lethargy2 |
1Mild.
2Mild, for up to 14 days after vaccination.
3If a hypersensitivity reaction occurs, appropriate treatment should be administered without delay.
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore, use is not recommended in pregnant or lactating bitches.
Interaction with other medicinal products and other forms of interaction
Do not use immunosuppressive agents within 1 month of vaccination with the veterinary medicinal product.
Do not administer antibiotics for 14 days following vaccination.
The veterinary medicinal product has been shown safe when given at the same time as vaccines of the Versican Plus and Vanguard ranges containing live canine parvovirus, adenovirus, distemper virus, parainfluenza virus as well as inactivated Leptospira and rabies. Efficacy after concurrent use has not been tested.
No information is available on the safety and efficacy of this veterinary medicinal product when used with any other veterinary medicinal product. 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.
Administration routes and dosage
Oral use.
Method and route of administration:
Grip the lyophilisate vial with your fingers and position your thumb directly under the embossed triangle on the vial cap. | |
Using your thumb, push the vial cap upwards from underneath the embossed triangle to allow access to the rubber stopper. Do not remove the vial cap or aluminium collar as they are not designed to be removed for use with a syringe and needle. Aseptically reconstitute the lyophilisate with the solvent. The reconstituted veterinary medicinal product should be an orange to yellow turbid liquid which might contain a loose resuspendable sediment. Shake the veterinary medicinal product well after reconstitution. | |
Withdraw the liquid with the syringe and remove the needle. The veterinary medicinal product should then be used immediately. | |
The head of the dog should be held with the nose pointing upwards and mouth open. Administer the entire 1 ml dose into the buccal pouch (between the teeth and the buccal mucosa). | |
Primary vaccination scheme:
Vaccination with 1 dose of 1 ml per dog from the age of 8 weeks.
Re-vaccination scheme:
One dose annually.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse events other than those mentioned in section "Adverse events", were observed after a ten-fold overdose of the veterinary medicinal product.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.