Biocan novel R, suspension for injection for dogs
Active immunization of dogs from 12 weeks of age to prevent mortality, clinical signs and infection caused by rabies virus.
Statement of active substances and other ingredients
Composition per 1 ml dose:
Active substances:
Inactivated rabies virus, strain SAD Vnukovo-32 > 2.0 IU*
Adjuvant:
Aluminium hydroxide (quantified as Al2O3) 1.8-2.2 mg
Excipients:
Thiomersal 0.1 mg
* International Units
The suspension for injection is pink fluid with easily shakeable sediment.
Indications
Active immunization of dogs from 12 weeks of age to prevent mortality, clinical signs and infection caused by rabies virus.
Onset of immunity:
2 weeks after a single vaccination from 12 weeks of age.
Duration of immunity:
At least three years following the basic vaccination scheme. Duration of immunity was demonstrated after one vaccination at 12 weeks of age.
Target species
Dogs
Dosage for each species, routes and methods of administration
Subcutaneous use.
Dose and route of administration:
Administer the vaccine dose (1 ml) subcutaneously.
Basic vaccination scheme:
One dose of Biocan Novel R from 12 weeks of age.
The efficacy is proven after a single dose from 12 weeks of age in laboratory studies.
However, in field studies 10% of seronegative dogs did not show seroconversion (> 0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies. Another 17% did not show the 0.5 IU/ml rabies antibody titre required by some non-EU countries to travel in. In case of travelling to risk areas or for travel outside the EU veterinary surgeons may wish to use a two dose primary course including rabies or give an additional rabies vaccination after 12 weeks.
Revaccination scheme:
A single dose of Biocan Novel R should be given every 3 years.
Although the efficacy of the rabies fraction has been demonstrated following administration at 12 weeks, in case of need, dogs younger than 12 weeks can be vaccinated. In this case the vaccine Biocan Novel R can be used to reconstitute a single dose vial of Biocan Novel DHPPi (please refer to SPC for Biocan Novel DHPPi) as the safety of this association has been demonstrated in 6-week-old dogs. The second dose of Biocan Novel R should not be administered before 12 weeks of age and not earlier than 3 weeks after the first dose.
Special warning
Special warnings for each target species:
Vaccinate healthy animals only.
A good immune response is reliant on 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 in animals:
Do not use in animals that are showing signs of rabies or that are suspected of being infected with rabies virus.
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.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore, the use is not recommended during pregnancy and lactation
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