Biocan Novel DHPPI/L4R, Lyophilisate and solvent for suspension for injection for dogs
Canine live vaccine against parvovirosis, distemper,inf. hepatitis, inf. laryngotracheitis and parainfluenza and inactivated liquid vaccine against four serovars of leptospirosis and rabies. Vaccine for active immunization of dogs from 8-9 weeks of age.
Composition per 1 ml dose:
Lyophilisate (live attenuated):
Canine Distemper virus, strain CDV Bio 11/A- min.103.1 TCID50*, max. 105.1 TCID50*
Canine Adenovirus Type 2, strain CAV-2 Bio 13 - min. 103.6 TCID50* , max. 105.3 TCID50*
Canine Parvovirus Type 2b, strain CPV-2b Bio 12/B - min. 104.3 TCID50* , max. 106.6 TCID50*
Canine Parainfluenza Type 2 virus, strain CPiV-2 Bio 15 - min. 103.1 TCID50*, max. 105.1 TCID50*
Solvent (inactivated):
Leptospira interrogans serogroup icterohaemorrhagiae serovar icterohaemorrhagiae, strain MSLB 1089 GMT** ≥ 1:51 ALR***
Leptospira interrogans serogroup canicola serovar canicola, strain MSLB 1090 GMT** ≥ 1:51 ALR***
Leptospira kirschneri serogroup grippotyphosa serovar grippotyphosa, strain MSLB 1091 GMT** ≥ 1:40 ALR***
Leptospira interrogans serogroup australis serovar bratislava, strain MSLB 1088 GMT** ≥ 1:51 ALR***
Inactivated rabies virus, strain SAD Vnukovo-32 > 2.0 IU****
Adjuvant: aluminium hydroxide (quantified as Al2O3) 1.8-2.2 mg
* Tissue culture infectious dose – 50%
** Antibody micro agglutination-lytic reaction (serology in rabbits)
*** Geometric mean titre
**** International Units;
Pharmaceutical form:
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Spongy matter, white colour.
Solvent: Pink liquid with easily shakeable sediments.
Target species:
Dogs
Indications for use, specifying the target species:
Active immunization of dogs from 8-9 weeks of age.
- to prevent mortality and clinical signs caused by canine distemper virus
- to prevent mortality and clinical signs caused by canine adenovirus type 1
- to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2
- to prevent clinical signs, leukopenia and viral excretion caused by canine parvovirus
- to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus
- to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava
- to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae
- to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa
- 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 for rabies,
- 3 weeks after the first vaccination for CDV, CAV, CPV,
- 3 weeks after completion of the primary course for CPiV and
- 4 weeks after completion of the primary course for Leptospira components.
Duration of immunity:
At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2, canine parvovirus and rabies. At least one year following the primary vaccination course for canine parainfluenza virus, Leptospira components. Duration of immunity for rabies was demonstrated after one vaccination at 12 weeks of age.
The duration of immunity against CAV-2 was not established by challenge. It was shown that 3 years after the vaccination CAV-2 antibodies are still present. Protective immune response against CAV-2 associated respiratory disease is considered to last at least 3 years.
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.
Bioveta