Merilym 3

10 x 1 dose

Suspension for injection

Active substance

Borrelia afzelii (attenuated)

Borrelia burgdorferi sensu stricto (attenuated)

Borrelia garinii (attenuated)

ATC code

QI07AB04 Borrelia

QI07AB Inactivated bacterial vaccines (including Mycoplasma, Toxoid and Chlamydia)

QI07A Immunologicals for dog

QI07 Immunologicals for canidae

QI Immunologicals

Species

Dogs.

Indications

For active immunization of dogs from 12 weeks of age, to induce an anti-OspA response against Borrelia spp. (B. burgdorferi, 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.

Dose to be administered and administration route

Dose:
1 ml from 12 weeks of age.

Method of administration:
Subcutaneously.

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 section 4.2) prior to expected tick exposure.

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 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. See the package leaflet for respective contact details.