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. The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2, canine parainfluenza virus, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, and rabies virus.
Composition per 1 ml dose:
Active substances:
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;
batch potency test performed by serological testing according to Ph. Eur. monograph 0451
Pharmaceutical form:
Lyophilisate and solvent for suspension for injection.
The visual appearance is as follows:
Lyophilisate: Spongy matter, white colour.
Solvent: Pink liquid with easily shakeable sediments.
Target species:
Dogs
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 one year following the primary vaccination course for all components of Biocan Novel DHPPi/L4R. Duration of immunity for rabies was demonstrated after one vaccination at 12 weeks of age.
Contraindications:
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Special warning for each target species:
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.
Immunological responses to the CDV, CAV-2 and CPV components of the vaccine may be delayed due to maternally derived antibody interference. However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CDV, CAV and CPV at levels equal or higher to those likely to be encountered under field conditions. In situations where very high maternally derived antibodies levels are expected, the vaccination protocol should be planned accordingly.
Special precautions for use:
Special precautions for use in animals:
Only clinically healthy animals should be vaccinated.
Do not use in animals that are showing signs of rabies or that are suspected of being infected with rabies virus.
The live virus vaccine strains CAV-2, CPiV and CPV-2b may be shed by vaccinated dogs for a number of days following vaccination. Due to the low pathogenicity of the strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
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):
Following subcutaneous administration in dogs a transient swelling (up to 5 cm) may commonly be observed at the injection site, these can occasionally be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination. In rare cases gastrointestinal signs such as diarrhoea and vomiting or anorexia and decreased activity are possible.
As with any vaccine rare, occasional hypersensitivity reactions may occur. If such a reaction occurs, appropriate treatment should be administered without delay.
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:
Aseptically reconstitute the lyophilisate with the solvent. Shake well and administer immediately the entire content (1 ml) of the reconstituted product.
Reconstituted vaccine: pink-red or yellowish colour with slight opalescence.
Basic vaccination scheme:
Two doses of Biocan Novel DHPPi/L4R 3–4 weeks apart from 8–9 weeks of age. The second dose should not be given before 12 weeks of age.
Rabies
The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. Therefore, the first dose at 8-9 week of age may be given using Biocan Novel DHPPi/L4. In this case the second vaccination with Biocan Novel DHPPi/L4R should not be given before 12 weeks.
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.
In case of need, dogs younger than 8 weeks can be vaccinated as safety of this product has been demonstrated in 6 weeks old dogs.
The vaccination may be indicated as soon as 6 weeks of age with compatible product Biocan Novel DHPPi.
Revaccination scheme:
A single dose of Biocan Novel DHPPi/L4R to be given annually.
Incompatibilities:
Do not mix with any other veterinary medicinal product.
