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Nobivac Lepto 4 is a liquid vaccine supplied in single dose bottles to protect dogs against Leptospirosis infection. It can be used as the diluent for Nobivac DHPPi in order to provide protection against additional diseases (Canine Distemper, Hepatitis, Parvo virus and Paranifluenza). Two injections given 4 weeks apart are needed for the first vaccination, which can start from 6 weeks of age. After that, a single booster vaccination needs to be given annually. (It is not necessary to boost for Distemper, Parvo and Hepatitis every year. These can be done on alternate years, or such longer period as advised by your veterinary surgeon.)
Inactivated, bacterial vaccine a liquid suspension of Leptospira interrogans serogroups
-Canicola (strain Ca-12-000) ≥ 40 PD80 /dose
-Icterohaemorrhagiae (strain 820K) ≥ 40 PD80 /dose
Also contains 0.1 mg/ml Thiomersal as a preservative. Each vial contains a single dose.
For active immunisation of dogs to reduce infection with Leptospira interrogans serovar canicola and Leptospira interrogans serovar icterohaemorrhagiae.
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.
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.
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.
Store at 2 to 8°C. Do not freeze. Protect from light.
In-use shelf life : 10 hours.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Cartons of 10 and 50 single dose vials or carton with one 10 ml vial.
Not all pack sizes may be marketed.
Each dose of 1 ml contains:
Inactivated Leptospira strains:
L. interrogans serogroup Canicola
serovar Portland-vere (strain Ca-12-000)
L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni
L. interrogans serogroup Australis
serovar Bratislava (strain As-05-073)
L. kirschneri serogroup Grippotyphosa serovar Dadas strain
* Antigenic mass ELISA units.
Excipient: Thiomersal 0.1 mg.
For a full list of excipients, see section "Pharmaceutical particulars".
Suspension for injection. Colourless suspension.
For active immunisation of dogs against:
- L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion.
- L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion.
- L. interrogans serogroup Australis serovar Bratislava to reduce infection.
- L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion.
Onset of immunity: 3 weeks.
Duration of immunity: 1 year.
Vaccinate only healthy animals.
A mild and transient increase in body temperature (≤ 1°C) may occur for a few days after vaccination, with some pups showing less activity and/or a reduced appetite. A small transient swelling (≤ 4 cm), which can occasionally be firm and painful on palpation, may be observed at the site of injection. Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination. An occasional transient acute hypersensitivity (anaphylaxis) reaction may occur.
Can be used during pregnancy.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with vaccines of the Nobivac series containing distemper, canine adenovirus type 2 and/or parvovirus components 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 vaccines of the Nobivac series containing Bordetella bronchiseptica and/or parainfluenza virus components for intranasal administration.
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.
Before use, allow the vaccine to reach room temperature.
Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.
Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.
Revaccination: Dogs should be re-vaccinated annually with one dose (1 ml) of vaccine.
(*) In case of high level of MDA, first vaccination is recommended at 9 weeks of age.
For simultaneous use, 1 dose of a Nobivac vaccine containing distemper, canine adenovirus type 2 and/or parvovirus components should be reconstituted with 1 dose (1 ml) of Nobivac L4. The mixed vaccines will be administered by subcutaneous injection.
No adverse reactions other than those mentioned in section "Adverse Reactions" were observed after the administration of a double dose of vaccine. However, these reactions may be more severe and/or last longer. For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
Pharmacotherapeutic group: Inactivated bacterial vaccine.
ATC vet code QI07AB01.
To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.
In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of cross-protection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
Do not mix with any other veterinary medicinal products except those mentioned in section "Interactions".
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 10 hours.
Shelf life after reconstitution of Nobivac vaccines: 45 min.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.
Glass type I vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Box with 5, 10, 25 or 50 vials of 1 ml (1 dose).
Box with 1 vial of 10 ml (10 doses).
Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Intervet International B.V, The Netherlands.
16 July 2012.
16 July 2012.
For animal treatment only. Keep out of the sight and reach of children.
Nobivac L4 10x1ds:
Nobivac L4 50x1ds:
All prices include VAT where applicable.
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