Canigen Lepto 2
Revised: December 2015
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Canigen Lepto 2
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient per dose of 1 ml
Inactivated Leptospira interrogansserogroup
- Canicola; strain Ca-12-000 957 - 1676 ELISA Units*
- Icterohaemorrhagiae; strain 820K 625 - 1335 ELISA Units
* Antigen mass ELISA Units, in vitro potency test according to Ph.Eur. monograph 0477.
Preservative: Thiomersal 0.1 mg
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Aqueous suspension for injection.
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
For active immunisation of dogs to reduce infection with Leptospira interrogans serogroup canicolaand Leptospira interrogans serogroup icterohaemorrhagiae.
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. icterohaemorrhagiaeinfection.
Only healthy dogs should be vaccinated.
4.4 Specific warnings for target species
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.
4.5 Special precautions for use
Special precautions for use in animals
Special precautions to be taken by the person administering the product to animals
4.6 Adverse reactions (frequency and seriousness)
A local reaction of limited size may occur during the first few days after vaccination.
After subcutaneous administration with the DHPPi, Pi, Parvo-C and/or rabies vaccines of the Canigen series a diffuse swelling may be observed at the injection site in most puppies. Occasionally this swelling may be hard and painful but this will diminish gradually and will disappear after 2 - 3 weeks.
In the rare event of a hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline, without delay and by the most immediate route.
4.7 Use during pregnancy and lactation
The vaccine has been shown to be safe for use in pregnant bitches which have previously been vaccinated with Canigen Lepto 2.
4.8 Interactions with other medicaments and forms of interaction
Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed with live vaccines from 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).
Safety and/or efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with the inactivated rabies (strain Pasteur RIV) vaccine for the Canigen range.
4.9 Amounts to be administered and administration route
The contents of one vial (1 ml) should be administered by subcutaneous injection.
Allow the vaccine to reach room temperature (15 C - 25 C) before use. Sterile injection equipment should be used.
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.
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 in specific circumstances contact the company direct or refer to the support literature.
4.10 Overdose (symptoms, emergency procedures, antidotes)
No particular symptoms at double dose (see section 4.6).
4.11 Withdrawal period
5. IMMUNOLOGICAL PROPERTIES
Strains of Leptospira interrogansserogroups Canicola and Icterohaemorrhagiae are responsible for leptospirosis in dogs. The active ingredients of the vaccine Leptospira interrogansCanicola; strain Ca-12-000 and Leptospira interrogansIcterohaemorrhagiae; strain 820K stimulate active immunity against these serogroups.
6. PHARMACEUTICAL PRECAUTIONS
6.1 List of excipients
Stabiliser solution, thiomersal
Do not mix with any other medicinal product except with the vaccines indicated in 4.8.
Shelf life of the veterinary medicinal product as packaged for sale: 21 months
Shelf life after first opening of the immediate packaging: 10 hours
6.4 Special precautions for storage
Store at 2 C - 8 C. Protect from light. Do not freeze.
6.5 Nature and composition of immediate packaging
Carton box with 1, 10 or 50 vials of glass type I (Ph.Eur.) containing 1 ml or 10 ml
or Plastic box with 10 or 50 vials of glass type I (Ph.Eur.) containing 1 ml
closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Not all presentations may be marketed.
6.6 Special precautions for the disposal of unused product or waste material derived from the use of such product
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet UK Ltd.
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
27 August 2003
10. DATE OF REVISION OF THE TEXT
23 December 2015
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