Composition - 1 ml:
Borrelia burgdorferi sensu lato inactivata
Borrelia garinii - RP ³ 1 *
Borrelia afzelii - RP ³ 1 *
Borrelia burgdorferi sensu stricto - RP ³ 1 *
* relative potency (RP) in comparison with the reference serum collected from animals vaccinated with the batch that complied in the challenge test on target animal species
Adjuvant: Hydrated aluminium hydroxide 2%, 0.2 ml
Pinkish up to white fluid containing white sediment that disperses easily when the content is shaken
Indication:
For active immunisation of dogs against Lyme disease from the 12th week of age for the purpose of prevention of infection. Onset of immunity: immunity is fully developed 1 month after revaccination
Duration of immunity: 12 months after prime immunization
Contraindication:
Not to be used in cases of general pyrexial condition and suspicion of Lyme disease.
Adverse reactions:
No undesirable side effects have been detected during the testing of the Borrelym 3 vaccine.After the vaccination with Borrelym 3 it is possible to expect appropriate local reactions sized of a pea with a diameter of 5 - 10 mm (especially after subcutaneous application), which are self limited and absorbed within two weeks after vaccination.
An individual hypersensitivity treatable with general conservative therapy cannot be excluded in a limited number of vaccinated individuals.If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Target species:
Dog
Dosage for each species, rote(s) and method of administration:
Dosage - 1 ml regardless of age, weight and breed of the individual; but at the earliest in the 12th week of animal age. Administration method: dog - subcutaneously, best in the region behind the shoulder blade.
Revaccination within a period of 14 - 21 days should be performed in the case of primovaccination. Annual revaccination is recommended in order to maintain permanent immunity. The best period for immunisation is before the occurrence of ticks, i.e. in November to March.
Advice on corret administration:
The content of the vial has to be shaken prior to use.
Withdrawal period:
No withdrawal period.
Storage precautions:
Keep out of the reach and sight of children.
Store in a refrigerator (2 °C – 8 °C).
Special warning(s):
Special precautions for use in animals. Animals with antibodies against Lyme disease may be vaccinated and thereby protected against possible infection and clinical manifestation of Lyme disease.
The risk groups for vaccination include animals with demonstrated clinical manifestation of Lyme disease verified e.g. by cultivation of borrelias in the infected individual, in which case vaccination doesn't improve the condition of the vaccinated animal (the germs of B. burgdorferi persist in well-protected sites for the whole life of the dog regardless of therapy and/or vaccination - e.g. in joint synovia) and therefore such vaccination is useless because despite the performed vaccination, the disease caused by borrelias may develop (stress, other infectious diseases, etc.).Special precautions to be taken by the person administering the veterinary medicinal product to animals.
Not applicable. The safety of the veterinary medicinal product has not been established during pregnancy and lactation.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. After the administration of a double vaccine dose to target species any other adverse reactions than those described in chapter 6 were not observed. Do not mix with any other veterinary medicinal product.
Shelf-life:
Shelf life of the veterinary medicinal product in intact package: 2 years.
Package:
2 x 1 ml, 10 x 1 ml
