Target species
Dogs and cats.
Indications for use, specifying the target species
For the active immunisation against rabies to reduce clinical signs and mortality.
Onset of immunity: an adequate serological response (≥ 0.5 I.U.) has been demonstrated 2 to 3 weeks after vaccination.
Duration of immunity: 3 years.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
The vaccine may not be effective in animals incubating the disease at the time of vaccination.
Some animals may be immunologically incompetent and fail to respond to vaccination. A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
Special precautions for use
Special precautions for safe use in the target species:
The presence of maternal antibodies can interfere with the response to vaccination.
This veterinary medicinal product should not be administered for at least one month following the administration of hyperimmune serum (anti-serum) or immunosuppressant drugs.
Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse events
Very rare (< 1 animal / 10 000 animals treated, including isolated reports): | Injection site swelling1 Hypersensitivity reaction (e.g. facial oedema, vomiting, pruritus, diarrhoea)2 Immune-mediated haemolytic anaemia, immunemediated thrombocytopenia, immune-mediated polyarthritis. Lethargy3 Anorexia3 Hyperthermia 3 |
1 Non-painful diffuse to firm swellings of approximately 1 cm in diameter may be observed for up to 3 weeks after subcutaneous vaccination.
2 Such reaction may evolve to a more severe condition (anaphylaxis), which may be life-threatening with additional signs like dyspnoea, collapse, ataxia, muscle tremor and convulsion. If such reaction occurs, appropriate treatment is recommended.
3 Mild.
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.
Use during pregnancy and lactation
Pregnancy:
Can be used during pregnancy in dogs. There are no laboratory data on use during pregnancy in other species, but on basis of field experience, such use is expected to be safe.
Interactions with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Canigen range containing one or more of the following components: live canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza or live feline viral rhinotracheitis virus, feline calicivirus and feline panleucopenia virus.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Canigen vaccines containing canine Leptospira interrogans serogroups Canicola and Icterohaemorrhagiae antigens.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.
Administration routes and dosage
Intramuscular or subcutaneous route.
Administer 1 dose (1 ml).
Sterile equipment should be used for administration. Avoid contamination of vaccine with traces of chemical sterilising agents. Do not use chemicals such as disinfectant or spirit to disinfect the skin prior to administration.
Primary vaccination and revaccination in dogs and cats
Primary vaccination age: 12* weeks or older
Revaccination: every 3 years
*The primary vaccination may be administered at an earlier age, but a second dose must then be administered at the age of 12 weeks. Minimum vaccination age in dogs and cats: 4 weeks.
Further information
Limited safety data are available for ferrets from monitoring post vaccination reactions. Ferrets can be vaccinated subcutaneously from 12 weeks of age. An adequate serological response (≥ 0.5 IU) has been demonstrated 1 month after vaccination.
Ferrets should be revaccinated every 18 months.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No clinical signs other than those in section 'Adverse events'.