Merilym 3 Suspension for Injection for Dogs

Merilym 3 Suspension for Injection for Dogs

Uses
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).
Onset of immunity: 1 month after primary vaccination.
Duration of immunity: one year after primary vaccination.
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.
Presentation
Suspension for injection.
Pinkish up to white fluid containing white sediment that disperses easily when the content is shaken.
Composition of one dose (1ml): Active substances:
Inactivated Borrelia burgdorferi sensu lato:
Borrelia garinii RP ≥ 1*
Borrelia afzelii RP ≥ 1*
Borrelia burgdorferi sensu stricto RP ≥ 1*
*RP = Relative potency (ELISA test) compared with the reference serum obtained after vaccination of mice with a vaccine batch that has successfully passed the challenge test in the target species.
Adjuvant:
Aluminium (as hydroxide) 2 mg
Excipients:
Formaldehyde max. 0.5 mg/ml

The vaccine induces specific anti-OspA antibodies against Borrelia burgdorferi sensu lato. Scientific literature are available which indicate that during a tick blood feeding, vaccine-induced antibodies present in the blood are ingested by the tick and are expected to bind to OspA proteins expressed by the bacteria in the tick gut; this is expected to reduce their migration to the salivary glands and transmission to the host.
Contra-indications, warnings, etc
Do not use in case of general febrile illness.
Do not use in case of suspected or confirmed clinical Lyme borreliosis.
No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Undesirable effects
Vaccination may induce a transient increase in body temperature (not more than 1.5°C). Transitory swelling may be observed through palpation at the injection site (maximum diameter of 7 mm for a minimum of 5 days). No other adverse reactions other than these were observed after administration of a double dose.
In rare circumstances, a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Special precautions for use in animals
none.
Interaction with other veterinary medicinal 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.
http://www.noahcompendium.co.uk/Merial_Animal_Health_Ltd/Merilym_3_Suspension_for_Injection_for_Dogs/-62020.html