Versican Plus Pi/L4
canine parainfluenza virus and Leptospira
Marke ting authorisation holde r:
Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM
Manufacturer responsible for batch release:
Bioveta, a.s., Komenského 212,
683 23 Ivanovice na Hané, CZECH REPUBLIC
Versican Plus Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Each dose of 1 ml contains:
Lyophilis ate (live atte nuate d): Minimum Maximum
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50*
Sus pe ns ion (inactivate d):
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
Leptospira interrogans serogroup Australis
serovar Bratislava, strain MSLB 1088 ALR ** titre ≥ 1:51
Aluminium hydroxide 1.8–2.2 mg.
* Tissue culture infectious dose 50%.
** Antibody micro agglutination-lytic reaction.
Lyophilisate: spongy matter of white colour. Suspension: whitish colour with fine sediment.
Active immunisation of dogs from 6 weeks of age:
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, and
to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri
serogroup Grippotyphosa serovar Grippotyphosa.
Onset of immunity:
3 weeks after completion of the primary course for CPiV and
4 weeks after the completion of primary course for Leptospira components.
Duration of immunity:
At least one year following the primary vaccination course for all components of Versican Plus Pi/L4.
None.
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 treated displaying 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).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Dogs.
Subcutaneous use.
Primary vaccination scheme:
Two doses of Versican Plus Pi/L4 3–4 weeks apart from 6 weeks of age.
Re-vaccination scheme:
A single dose of Versican Plus Pi/L4 to be given annually.
Aseptically reconstitute the lyophilisate with the suspension. Shake well and administer immediately the entire contents (1 ml) of the reconstituted product.
Reconstituted vaccine: pinkish or yellowish colour with a slight opalescence.
Not applicable.
Keep out of the sight and reach of children.
Store and transport refrigerated (2C–8C). Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Use immediately after reconstitution.
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.
Vaccinate healthy animals only.
Spe cial precautions for use in animals:
The live attenuated virus vaccine strain CPiV may be shed by vaccinated animals following vaccination. However, due to the low pathogenicity of the strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
Spe cial precautions to be take n by the pe rson administering the ve terina ry medicina l produc t to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregna nc y and lactation:
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.
Interaction with othe r medicina l produc ts and othe r 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.
Ove rdose (symptoms, emerge nc y proc edures, antidotes):
No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been 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.
Incompatibilit ie s:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of suspension. Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of suspension.
Not all pack sizes may be marketed.