Nobivac Lepto 2 Data Sheet

Presentation

Inactivated, bacterial vaccine a liquid suspension of Leptospira interrogans serogroups
- Canicola; strain Ca-12-000: 900 - 1750 Units*
- Icterohaemorrhagiae; strain 820K :750 - 1400 Units
*Antigen mass ELISA Units, in vitropotency test according to Ph.Eur. monograph 0477.
Also contains 0.1 mg/ml Thiomersal as a preservative. 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.

Specific claims
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. icterohaemorrhagiae infection.
The duration of immunity induced by the vaccine was established as at least one year. Nobivac Lepto 2 can be used alone or as a diluent for other freeze dried Nobivac 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.
Nobivac Lepto 2 may be used to reconstitute Nobivac DHPPi, Nobivac DHP, Nobivac Pi and Nobivac Parvo-C as indicated in the appropriate package leaflet.

The product may be used in pregnant bitches which have previously been vaccinated with Nobivac Lepto.

 

Contra-indications, warnings, etc.

Only healthy dogs should be vaccinated.

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.
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 Nobivac Rabies 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.
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. 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.
Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed with Nobivac DHPPi, DHP, Pi and/or Parvo-C.

Safety and/or efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Nobivac Rabies.


Do not mix with any other medicinal product except with the vaccines listed above.
For animal treatment only. Keep out of reach and sight of children.


Pharmaceutical precautions

Store at 2 to 8ÂșC. Do not freeze. Protect from light.

In-use shelf life : 10 hours.

Disposal advice

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

 

Legal category

POM-V


Package quantities

Cartons of 10 and 50 single dose vials or carton with one 10ml vial.
Not all pack sizes may be marketed.


Further information

Nil.

 

Marketing Authorisation number

Vm 01708/4360.