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Species: Dogs Therapeutic indication: Immunological veterinary medical products: For dogs Active ingredient: Vaccine Antigens Product:Versican® Plus DHPPi/L4 lyophilisate and solvent for suspension for injection for dogs Product index: Versican Plus DHPPi/L4
Versican Plus DHPPi/L4 is a combination vaccine presented as a lyophilisate and solvent for suspension for injection. Each dose comprises of 1 ml: One vial of a lyophilisate fraction containing live attenuated canine distemper virus, strain CDV Bio 11/A (103.1 to 105.1 TCID50*); canine adenovirus type 2, strain CAV-2 Bio 13 (103.6 to 105.3 TCID50*); canine parvovirus type 2b, strain CPV-2b Bio 12/B (104.3 to 106.6 TCID50*) and canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (103.1 to 105.1 TCID50*); and one vial of liquid solvent fraction, an inactivated adjuvanted suspension of Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089 (ALR** titre ≥ 1:51), Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB 1090 (ALR** titre ≥ 1:51), Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (ALR** titre ≥ 1:40) and Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088 (ALR** titre ≥ 1:51). Adjuvants: Aluminium hydroxide 1.8-2.2 mg. *TCID50 = tissue culture 50% infectious dose. **ALR = Antibody micro agglutination-lytic reaction.
Active immunisation 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, leucopoenia 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. 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 CDV, CAV-1, CAV-2 and CPV. The duration of immunity against CAV-2 was established by serology. At least one year following the primary vaccination course for CPiV and Leptospira components.
Aseptically reconstitute the lyophilisate with the solvent. Shake well and administer immediately the entire content (1 ml) of the reconstituted product subcutaneously. The reconstituted vaccine is pinkish, or yellowish in colour with slight opalescence.
Two doses of Versican Plus DHPPi/L4 3–4 weeks apart from 6 weeks of age.
A single dose of Versican Plus DHPPi/L4 can be given every 3 years. Annual re-vaccination is required for parainfluenza and Leptospira components; therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
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. Immunological responses to the CDV, CAV 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 antibody levels are expected, the vaccination protocol should be planned accordingly. The live attenuated virus vaccine strains CAV-2, CPiV and CPV-2b may be shed by vaccinated dogs following vaccination, shedding of CPV has been shown for up to 10 days. However, due to the low pathogenicity of these strains, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs and domestic cats. The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination. 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. 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 by the veterinarian. In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 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 (i.e. anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) 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). No other adverse reactions other than those mentioned above were observed after administration of a 10-fold overdose of the vaccine. However in a minority of animals pain was observed at the injection site immediately after administration of a 10-fold overdose of the vaccine. The pain was transient and subsided without requiring any therapy.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Store and transport refrigerated (2°C – 8°C). Shelf life after reconstitution according to directions: use immediately. Do not freeze. Protect from light. Keep out of the sight and reach of children. For animal treatment only.
Legal category: POM-V
Packs with 25x 1 ml doses. Each dose is a combination of one vial of the lyophilisate fraction and one vial of solvent fraction.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
GTIN GTIN description:25x 1 dose: GTIN:05414736028125
All prices include VAT where applicable.
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