Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobivac 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.

Excipients

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

Dogs.

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.

Specific claims:

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

Nobivac 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.

4.3 Contraindications

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

None.

None.

None.

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 Nobivac 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 Nobivac 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 Nobivac 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 Nobivac 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.

Booster vaccination

A single annual booster dose is recommended.

Nobivac Lepto 2 may be used to reconstitute Nobivac 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 Nobivac 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

Not applicable.

5. Immunological properties

QI07AB01

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

6.2 Incompatibilities

Do not mix with any other medicinal product except with the vaccines indicated in 4.8.

6.3 Shelf-life

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 2-8 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.

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. Marketing Authorisation number

Vm 01708/4360

9. Date of first authorisation

31 May 2002

10. Date of revision of the text

January 2016

Approved: 20 January 2016