Biocan Novel DHPPi/L4, 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
|type of preparative:||Vaccines|
|target species animals:||Dog|
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*, min. 106.6 TCID50*
Canine Parainfluenza Type 2virus, strain CPiV-2 Bio 15 - min. 103.1 TCID50*, max. 105.1 TCID50*
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***
Adjuvant: aluminium hydroxide (quantified as Al2O3) 1.8-2.2 mg
* Tissue culture infectious dose – 50%
** Geometric mean titre
*** Antibody micro agglutination-lytic reaction
Active immunization of dogs from 6 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 Icterhaemorrhagiae serovar Icterohaemorrhagiae
- to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa
Onset of immunity:
- 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 and canine parvovirus. At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
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.
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients..
Following subcutaneous administration in dogs, a small 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.
If you notice any serious or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
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)
Dosage for each species, route(s) and method of administration
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: pinkish or yellowish colour with slight opalescence.
Primary vaccination scheme:
Two doses of Biocan Novel DHPPi/L4 3-4 weeks apart from 6 weeks of age.
If protection against Rabies is required:
First dose: Biocan Novel DHPPi/L4 from 8–9 weeks of age.
Second dose: Biocan Novel DHPPi/L4R 3–4 weeks later, but not before 12 weeks of age.
The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. However, in field studies, 10 % of sero-negative 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 Biocan Novel DHPPi/L4R has been demonstrated in 6 weeks old dogs.
A single dose of Biocan Novel DHPPi/L4 should be given every 3 years. Annual re-vaccination is required for Parainfluenza and Leptospira components, therefore a single dose of compatible vaccine Biocan Novel Pi/L4 can be used annually as required.
Advice on correct administration:
Reconstitute one vial of the lyophilisate aseptically using the contents of one vial of the solvent. Shake well and immediately inject the entire content of the reconstituted vial (1 ml) subcutaneously. Do not use chemically sterilised syringes or needles, as these may interfere with the effectiveness of the vaccine.
Reconstituted vaccine: pinkish or yellowish colour with slight opalescence.
Special storage precautions:
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze. Protect from light.
Do not use after the expiry date which is stated on the label after EXP.
Use immediately after reconstitution.
Special precautions for use in animals:
Only clinically healthy animals should be vaccinated.
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 this 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, i tis recommended vaccinated dogs to be separated from other canine and feline species after vaccination.
Special warnings 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 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
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.
Do not mix with any other veterinary medicinal product.
10 x 1 dose
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