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Date: Friday, March 29, 2024 13:32

Release 5.123
Versican Plus L4 suspension for injection for dogs
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Versican® Plus L4 suspension for injection for dogs
Product index: Versican Plus L4
Incorporating:
Presentation
Versican Plus L4 is presented as a suspension for injection. Each dose comprises of 1 ml:
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.
**ALR = Antibody micro agglutination-lytic reaction.
Uses
Active immunisation of dogs from 6 weeks of age:
- 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
4 weeks after completion of the primary course.
Duration of immunity
At least one year following the primary vaccination course for all components of Versican Plus L4.
Dosage and administration
Dose and route of administration
Shake well and administer immediately the entire content (1 ml) of the product subcutaneously.
Primary vaccination scheme
Two doses of Versican Plus L4 3–4 weeks apart from 6 weeks of age.
Re-vaccination scheme
A single dose of Versican Plus 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 drug therapy and stress.
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 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).
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 first opening the immediate packaging: 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.
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 42058/5084
UK(NI): EU/2/14/171/001-002
Significant changes
GTIN
GTIN description:25x 1 dose:
GTIN:05414736028132