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Date: Saturday, May 18, 2024 22:50

Release 4.179
Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Versican® Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs
Product index: Versican Plus DHPPi/L4
Incorporating:
Presentation
Versican Plus DHPPi/L4 is a combination vaccine presented as a lyophilisate and suspension 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 suspension 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.
Uses
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.
Dosage and administration
Dose and route of administration
Aseptically reconstitute the lyophilisate with the suspension. 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.
Primary vaccination scheme
Two doses of Versican Plus DHPPi/L4 3–4 weeks apart from 6 weeks of age.
Re-vaccination scheme
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.
Contra-indications, warnings, etc
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.
Can be used during the second and third stages of pregnancy. Safety of the product during the early stage of pregnancy and during lactation have not been investigated.
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.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
A transient swelling (up to 5 cm) may commonly be observed at the injection site following subcutaneous administration in dogs. This can be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination.
Anorexia and decreased activity are rarely observed.
Hypersensitivity reactions ( e.g. gastrointestinal signs such as diarrhoea and vomiting, anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur rarely. If such a reaction occurs appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition, which may be life-threatening.
Systemic reactions such as lethargy, hyperthermia and general malaise may occur very rarely.
Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treateddisplaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, 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.
User warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pharmaceutical precautions
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
Legal category: POM-V
Packaging quantities
Packs with 25x 1 ml doses. Each dose is a combination of one vial of the lyophilisate fraction and one vial of suspension fraction.
Further information
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK(GB): Vm 42058/5083
UK(NI): EU/2/14/164/001-002
Significant changes
GTIN
GTIN description:25x 1 dose:
GTIN:05414736028125