Target species
Dogs.
Indications for use
For active immunisation of dogs from 12 weeks of age, to induce an anti-OspA response against Borrelia spp. (B. burgdorferi sensu stricto, B. garinii and B. afzelii). Reduction of Borrelia transmission was only investigated under laboratory conditions, following a challenge with field ticks (collected from a region known to be affected by Borrelia). Under these conditions, it was shown that no Borrelia could be isolated from the skin of vaccinated dogs, while Borrelia were isolated from the skin of non vaccinated dogs.
Reduction of transmission of Borrelia from the tick to the host has not been quantified, and no correlation has been established between a specific level of antibodies and reduction of Borrelia transmission. The efficacy of the vaccine against an infection that leads to the development of clinical disease has not been studied.
Onset of immunity: 1 month after primary vaccination.
Duration of immunity: 1 year after primary vaccination.
Contra-indications
Do not use in cases of general febrile illness. Do not use in sick animals that have intercurrent disease, heavy parasitic infestation and/or are in poor general condition.
Do not use in cases of suspected or confirmed clinical Lyme borreliosis.
Do not use in cases of hypersensitivity to the active substances, to the adjuvant or to any of the excipients.
Special warnings for each target species
Vaccinate healthy animals only
No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Special precautions for use
None.
Adverse reactions
Dogs:
Rare
(1 to 10 animals / 10 000 animals treated):
Injection site swelling.1
Anorexia, lethargy.
Very rare
(<1 animal / 10 000 animals treated, including isolated reports):
Injection site swelling.2
Elevated temperature.3
Hypersensitivity reaction.4
1 Up to 7 cm in diameter, for up to 5 days.
2 Up to 15 cm in diameter.
3 Transient, up to 1.5°C.
4 Which may require appropriate symptomatic treatment.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medical 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. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medical product has not been established during pregnancy or lactation.
Interactions with other medical products and other forms of interaction
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.
Amounts to be administered and administration route
Dose: 1 ml from 12 weeks of age.
Method of administration: Subcutaneous use. Shake the vial well before use.
Primary vaccination: Administer two doses separated by an interval of 3 weeks.
Revaccination: Annual revaccination with a single dose is recommended to maintain immunity although this schedule has not been investigated.
Vaccination should be carried out prior to periods of increased tick activity, allowing sufficient time for the immune response to vaccination to develop fully (see Indications for use) prior to expected tick exposure.
Overdose (symptoms, emergency prodecures, antidotes), if necessary
No other adverse reactions than those described above were observed after administration of a double dose.