Introduction

Company name: Virbac Limited

Address: Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk

IP30 9UP

Telephone: 01359 243243

Fax: 01359 243200

Website: www.virbac.co.uk

Presentation

Inactivated, bacterial vaccine containing a liquid suspension of Leptospira interrogans serogroups Canicola (strain Ca-12-000) and Icterohaemorrhagiae (strain 820K), each ≥ 40 PD80 per dose.

Each vial contains a single dose.

Uses

For active immunisation of dogs to reduce infection with Leptospira interrogans serovar canicola and

Leptospira interrogans serovar icterohaemorrhagiae.

Canigen Lepto2 significantly reduces the number of animals which develop a carrier condition after

L. canicola and L. icterohaemorrhagiae infection.

The duration of immunity induced by the vaccine was established as at least one year.

Canigen Lepto2 can be used alone or as a diluent for other freeze dried Canigen dog vaccines.

Dosage and administration

The contents of one vial (1 ml) should be administered by subcutaneous injection. Sterile equipment should be used for administration.

Primary course vaccination: 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.

Booster vaccination: A single annual booster dose is recommended.

Canigen Lepto 2 may be used to reconstitute Canigen DHPPi ,PPi and Pi and as indicated in the

appropriate package inserts.

The product may be used in pregnant bitches which have previously been vaccinated with Canigen L.

For more detailed advice on vaccination programmes and how Canigen Lepto 2 may be used in conjunction with other Canigen dog vaccines in specific circumstances contact the company direct.

Contra-indications, warnings, etc

Only healthy dogs should be vaccinated.

In the rare event of a hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline, without delay and by the most immediate route.

A local reaction of limited size may occur during the first few days after vaccination.

The vaccine may not be effective in dogs incubating the disease at the time of vaccination.

Some animals may be immunologically incompetent and fail to respond to vaccination (see further information).

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.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except Canigen DHPPi, PPi and Pi. It is therefore recommended that no other vaccines than these should be administered within 14 days before or after vaccination with the product.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

For animal treatment only.

Pharmaceutical precautions

Store between +2°C and + 8°C. Do not freeze. Protect from light.

Unused product and containers should be disposed of in accordance with any guidance from an appropriate waste regulation authority.

Legal category

POM-V

Packaging Quantities

Cartons of 10 and 50 single dose vials.

Further information

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.

Marketing authorisation number

Vm 1708/4493.