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Date: Wednesday, May 22, 2024 17:12

Description: Virbac 2013
Telephone: 01359 243243
Release 2.140
Canigen Lepto 2
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Canigen Lepto 2
Product index: Canigen Lepto 2
Incorporating:
Presentation
Suspension for injection.
Colourless suspension
Active substances
Each 1ml dose contains:
Inactivated Leptospira interrogans serogroup Canicola, serovar Portland-vere, strain Ca-12-000: 990 – 1755 Units*
Inactivated Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Copenhageni, strain 820K: 699 – 1277 Units*
* Antigenic mass ELISA Units.
Uses
For active immunisation of dogs to reduce infection with Leptospira interrogans serogroup Canicola and Leptospira interrogans serogroup Icterohaemorrhagiae.
Specific claims
The duration of immunity induced by the vaccine was established as at least one year. Canigen Lepto 2 significantly reduces the number of animals which develop a urinary tract infection which can predispose to development of a carrier condition after L. Canicola and L. Icterohaemorrhagiae infection.
Dosage and administration
Subcutaneous use.
Administer 1 dose (1 ml) per animal.
Allow the vaccine to reach room temperature (15 °C – 25 °C) before use.
Sterile injection equipment should be used.
Primary vaccination course
All dogs not previously vaccinated should be vaccinated twice 2 – 4 weeks apart.
Puppies should be at least 6 weeks of age before they receive the first vaccination.
Revaccination
A single annual booster dose is recommended.
Canigen Lepto 2 may be used to reconstitute Canigen DHPPi, DHP, Pi or Parvo-C as indicated in the appropriate package leaflets.
For more detailed advice on vaccination programmes and how the product may be used in conjunction with other Canigen dog vaccines under specific circumstances, contact the company/distributor or refer to the support literature.
Contra-indications, warnings, etc
Contraindications
None
Special warnings
Vaccinate healthy animals only.
The vaccine may not be effective in dogs incubating the disease at the time of vaccination.
Animals that have received the corresponding anti-serum or immunosuppressive drugs should not be vaccinated until an interval of at least 4 weeks has elapsed.
A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration.
Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
A transient rise in body temperature post-vaccination has been observed in rare cases during the clinical safety studies.
Dogs may show local reactions after injection in very rare cases, according to spontaneous pharmacovigilance reports. A diffuse swelling, up to 5 cm in diameter, may be observed at the site of injection for up to 4 days. Occasionally this swelling may be hard and painful, but this will diminish gradually and disappear after 2 – 3 weeks.
A transient acute hypersensitivity reaction - with signs that may include lethargy, facial oedema, pruritus, vomiting or diarrhoea - may occur shortly after vaccination in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening with additional signs like dyspnoea or collapse. If such reactions occur appropriate treatment is recommended.
Mild systemic signs as lethargy and anorexia were reported very rarely.
Clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, or immune-mediated polyarthritis have been reported in very rare cases.
Use during pregnancy and lactation
Can be used during pregnancy.
The vaccine has been shown to be safe for use in pregnant bitches which have previously been vaccinated with Canigen Lepto 2.
Interactions with other medicaments and forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with live vaccines in the Canigen range containing canine distemper virus (strain Onderstepoort), canine adenovirus type 2 (strain Manhattan LPV3), canine parvovirus (strain 154) and/or canine parainfluenza virus (strain Cornell) components authorised for subcutaneous administration.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Canigen Rabies, the inactivated rabies (strain Pasteur RIV) vaccine in the Canigen range.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.
Overdose (symptoms, emergency procedures, antidotes)
No symptoms other than at single dose (see above).
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
For animal treatment only.
Pharmaceutical precautions
Major incompatibilities
Do not mix with any other veterinary medicinal product except the vaccines mentioned above where their combined use is authorised.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 21 months.
Shelf life after first opening the container: use immediately.
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package. Protect from light.
Legal category
Legal category: POM-V
Packaging quantities
Cardboard box with 1, 10 or 50 vials of 1 ml (1 dose).
Plastic box with 10 or 50 vials of 1 ml (1 dose).
Not all pack sizes may be marketed.
Further information
List of excipients
Sodium chloride
Potassium chloride
Sodium-L-lactic acid
Calcium chloride
Water for injection
Marketing Authorisation Number
Vm 01708/4493
Significant changes
GTIN
GTIN description:Canigen Lepto 2 (10 Doses)
GTIN:8713184050700
GTIN description:Canigen Lepto 2 (50 Doses)
GTIN:8713184050717