COMPOSITION
One vaccination dose (1 ml) contains:
Active substances:
Lyophilisate Minimum Maximum
Canine Distemper virus, strain CDV Bio 11/A, live att. 104,1 TCID50 105,5 TCID50
Canine Parvovirus type 2b, strain CPV-2b Bio 12/B, live att. 105,5 TCID50 107,0 TCID50
* Tissue culture infectious dose – 50%
Lyophilised vaccine is spongy matter, white colour. Solvent is clear colourless liquid.
Target species
Dogs.
Indications for use, specifying the target species
Active immunization of dogs from 6 weeks of age:
- to prevent mortality and clinical signs caused by canine distemper virus
- to prevent clinical signs, leukopenia and viral excretion caused by canine parvovirus type 2a, 2b and 2c
Onset of immunity:
Immunity against CDV and CPV is developed within 14 days after a single dose in puppies free of maternally derived antibodies.
Duration of immunity:
The duration of immunity against CDV and CPV in puppies without maternally derived antibodies was after a single dose of Biocan Novel Puppy vaccine determined for 12 months. The duration of immunity against CDV and CPV type 2b was demonstrated serologically and by challenge, duration of immunity against CPV types 2a and 2c was demonstrated serologically.
Special warnings for each target species
Immunological responses to the CDV and CPV components may be delayed due to maternally derived antibody interference. In situations where very high maternally derived antibodies levels against CDV and CPV are expected, the vaccination with further doses of polyvalent Biocan Novel vaccines that also contain CDV and CPV should follow.
Special precautions for use
Special precautions for use in animals
Only clinically healthy animals should be vaccinated. The live virus vaccine strain CPV-2b can be spread to non-vaccinated animals but does not cause disease. Since the vaccine virus strain CPV-2b has not been tested in domestic cats and other carnivores (except dogs) that are known to be susceptible to canine parvoviruses, it is recommended vaccinated dogs to be separated from other canine and feline species after vaccination.
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 reactions (frequency and seriousness)
Not observed.As with other vaccines, hypersensitivity reactions may occur very rarely. If such a reaction, it is necessary to immediately provide appropriate treatment.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
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.
Interaction with other 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.
Amounts to be administered and administration route
Subcutaneous use.
Dose and route of administration:
Each dose is prepared by reconstituting the vial with lyophilisate (component CDV and CPV) by vial of solvent (water for injection). The reconstituted vaccine should be gently shaken and is intended for immediate subcutaneous administration. Apply 1 ml regardless of the weight and breed of individual from 6 weeks of age.
Reconstituted vaccine: Clear colourless to yellowish liquid with light opalescence.
The recommended vaccination schedule
Basic vaccination scheme:
A single dose of Biocan Novel Puppy vaccine from 6 weeks of age.In case where the presence of maternally derived antibodies against CDV and CPV is expected and if protection against other antigens is required a single dose of Biocan Novel Puppy vaccine should be followed by vaccination with polyvalent Biocan Novel vaccines that also contain CDV and CPV in accordance with the relevant SPC three weeks after vaccination with Biocan Novel Puppy.
Revaccination:
Annual revaccination with single dose of Biocan Novel Puppy vaccine should be given in cases that immunization against CDV and CPV is only required.It is recommended that dogs, who received one dose of Biocan Novel Puppy followed by vaccination with polyvalent Biocan Novel vaccines that also contain CDV and CPV in accordance with the relevant SPC three weeks after vaccination with Biocan Novel Puppy, should be revaccinated with canine distemper virus and canine parvovirus by polyvalent Biocan Novel vaccines every 3 years in accordance with the relevant SPC.
Withdrawal period(s)
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.Shelf life after reconstitution according to directions: use immediately.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C). Protect from light. Do not freeze.
Package
10 x 1 ml, 25 x 1 ml
