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Date: Sunday, June 22, 2025 3:06

Release 4.160
Versican Plus Pi/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 Pi/L4 lyophilisate and suspension for suspension for injection for dogs
Product index: Versican Plus Pi/L4
Incorporating:
Presentation
Each dose of 1 ml contains:
Active substances:
Lyophilisate (live attenuated):
Minimum
Maximum
Canine parainfluenza Type 2 virus, strain CPiV-2
Bio 15
103.1 TCID50*
105.1 TCID50*
Suspension (inactivated):
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
ALR ** titre ≥ 1:51
* Tissue culture infectious dose 50%.
** Antibody micro agglutination-lytic reaction.
Adjuvant:
Aluminium hydroxide 1.8–2.2 mg.
Uses
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 completion of the 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.
Dosage and administration
Subcutaneous use.
Dose and route of administration:
Aseptically reconstitute the lyophilisate with the suspension. Shake well and administer immediately the entire contents (1 ml) of the reconstituted product.
Appearance of the reconstituted vaccine: whitish to yellowish colour with light opalescence.
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.
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 medical therapy and stress.
The live attenuated virus vaccine strain CPiV may be shed by vaccinated dogs following vaccination. However, due to the low pathogenicity of the strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
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.
Dogs:
Common
(1 to 10 animals / 100 animals treated):
injection site swelling1
Rare
(1 to 10 animals / 10,000 animals treated):
hypersensitivity reaction2(anaphylaxis, angioedema, circulatory shock, collapse, diarrhoea, dyspnoea, vomiting)
anorexia, decreased activity
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
hyperthermia, lethargy, malaise immune mediated haemolytic anaemia, immune mediated haemolytic thrombocytopenia, immune mediated polyarthritis
1A transient swelling (up to 5 cm) which can be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination.
2If a hypersensitivity reaction occurs, appropriate treatment should be administered without delay. Such reactions may evolve to a more severe condition which may be life-threatening.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
No 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
Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Type I glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Pack sizes:
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.
Further information
Medicines should not be disposed of via wastewater.
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 42058/5086
UK(NI): EU/2/14/172/001-002
Significant changes
GTIN
GTIN description:25x 1 dose:
GTIN:05414736028149