Immunological veterinary medical products: For dogs
Nobivac® Lepto 2
Nobivac Lepto 2
Active ingredient per dose of 1 ml Inactivated Leptospira interrogans serogroup - 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 "Pharmaceutical particulars".
Aqueous suspension for injection.
For active immunisation of dogs to reduce infection with Leptospira interrogans serogroup canicola and 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. icterohaemorrhagiae infection.
Only healthy dogs should be vaccinated.
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.
None. Operator warnings: None.
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.
The vaccine has been shown to be safe for use in pregnant bitches which have previously been vaccinated with Nobivac Lepto 2.
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.
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.
No particular symptoms at double dose (see section “ Adverse reactions”).
Immunological properties: ATC Vet code: QI07AB01 Strains of Leptospira interrogans serogroups Canicola and Icterohaemorrhagiae are responsible for leptospirosis in dogs. The active ingredients of the vaccine Leptospira interrogans Canicola; strain Ca-12-000 and Leptospira interrogans Icterohaemorrhagiae; strain 820K stimulate active immunity against these serogroups.
Stabiliser solution and thiomersal.
Do not mix with any other medicinal product except with the vaccines indicated in section “ Interactions”.
Shelf life of the veterinary medicinal product as packaged for sale: 21 months. Shelf life after first opening of the immediate packaging: 10 hours.
Store at 2 °C - 8 °C. Protect from light. Do not freeze.
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.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
31 May 2002.
20 January 2016.
For animal treatment only. Keep out of the sight and reach of children.
Legal category: POM-V
GTIN description:Nobivac Lepto 2 10x1ds: GTIN:08713184144133, GTIN description:Nobivac Lepto 2 50x1ds: GTIN:08713184027665
All prices include VAT where applicable.
Each dose of 1 ml contains:
Live canine distemper virus (CDV), strain Onderstepoort ≥ 104.0 TCID50*
Live canine adenovirus type 2 (CAV2), strain Manhattan LPV3 ≥ 104.0 TCID50*
Live canine parvovirus (CPV), strain 154 ≥ 107.0 TCID50*
Live canine parainfluenza virus (CPi), strain Cornell ≥ 105.5 TCID50*
* TCID50 = median Tissue Culture Infective Dose
For the full list of excipients, see the Pharmaceutical Particulars section.
Lyophilisate for suspension for injection. Off-white or cream-coloured pellet.
Indications for use:
For active immunisation of dogs to prevent mortality and clinical signs caused by canine distemper virus infection. To reduce clinical signs of infectious hepatitis and viral excretion due to canine adenovirus type 1 infection. To prevent mortality, clinical signs and viral excretion following canine parvovirus infection. To reduce clinical signs and viral excretion caused by canine parainfluenza virus infection and to reduce clinical signs of respiratory disease and viral excretion following adenovirus type 2 infection.
Onset of immunity
1 week for canine distemper virus, canine adenovirus and canine parvovirus vaccine components
4 weeks for canine parainfluenza virus vaccine component
Duration of immunity
At least three years for the canine distemper virus, canine adenovirus and canine parvovirus vaccine components.
The duration of immunity for the canine parainfluenza virus component has not been demonstrated, but an anamnestic response is produced in dogs given a revaccination one year after basic vaccination. Annual revaccination with the canine parainfluenza virus vaccine component is recommended.
Only healthy dogs should be vaccinated. 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.
Special warnings for each target species:
The efficacy of the CDV, CAV2, CPV and CPi components of the vaccine may be reduced due to maternal antibody interference. However, the vaccine has been proved to be of benefit against virulent challenge in the presence of maternal antibody levels to CDV, CAV2, CPV and CPi that are likely to be encountered under field conditions.
Special precautions for use:
Only healthy dogs should be vaccinated.
The canine parvovirus vaccine strain may be shed at very low levels for up to 8 days after inoculation. However there is no evidence of any reversion to virulence of the vaccine strain and therefore no need to separate unvaccinated dogs from contact with recently vaccinated individuals.
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
In very rare cases, a diffuse swelling, up to 5 mm in diameter, may be observed at the site of injection. Occasionally this swelling may be hard and painful and last for up to 3 days post injection.
In the very rare event of a hypersensitivity reaction occurring following vaccination, administer an antihistamine, corticosteroid or adrenaline, without delay and by the most immediate route.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy or lactation:
Can be used in pregnant bitches which have previously been vaccinated with the CDV (strain Onderstepoort), CAV2 (strain Manhattan LPV3), CPV (strain 154) and CPi (strain Cornell) antigens included in the Nobivac vaccine series.
Safety and efficacy data (viral excretion) are available which demonstrate that this vaccine can be mixed and administered with the inactivated vaccines of the Nobivac series against canine leptospirosis caused by all or some of the following serovars: 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/Liangguang.
The product information of the relevant Nobivac vaccines should be consulted before administration of the mixed product. When mixed with Nobivac leptospirosis vaccines at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
After administration with one of the leptospirosis vaccines, 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.
After mixed administration of an overdose of Nobivac DHPPi and an overdose of the leptospirosis vaccines of the Nobivac series, transient local reactions such as diffuse to firm swellings from 1 to 5 cm in diameter may be observed, usually these will persist no longer than 5 weeks, however some may take a little longer to completely disappear.
When Nobivac DHPPi is used with any of the other Nobivac vaccines referred to above, the minimum vaccination age for each vaccine must be taken into account such that at the time of vaccination, the dogs are at or older than the oldest minimum vaccination age for the individual vaccines.
Safety and efficacy data are available which demonstrate that this vaccine can also be administered on the same day with Nobivac Solvent or Nobivac Rabies. These can be used to reconstitute the freeze-dried Nobivac DHPPi.
No information is available on the compatibility 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.
Amounts to be administered and administration route:
One ml solvent or 1 ml (1 dose) of inactivated vaccine (as specified in the section on ‘Interactions’) must be used to reconstitute the freeze-dried Nobivac DHPPi vaccine.
The contents of one vial of reconstituted vaccine should be injected subcutaneously.
Avoid contamination of vaccine with traces of chemical sterilising agents. Do not use chemicals such as disinfectant or spirit to disinfect the skin prior to inoculation.
Primary course vaccination:
A single injection should establish active immunity to canine distemper, infectious canine hepatitis and disease caused by canine parvovirus infection in dogs of 10 weeks of age or older. Where earlier protection is required a first dose may be given to puppies from 6 weeks of age, but because maternally derived passive antibody can interfere with the response to vaccination a final dose at 10 weeks of age or older is generally recommended. For an optimal response to the parainfluenza component, animals should be vaccinated twice, 2-4 weeks apart with the final vaccination at 10 weeks of age or more.
The event that the initial primary course dose of Nobivac DHPPi is delayed to 10 weeks of age or older, a single dose of Nobivac Pi at 12 weeks of age or older should suffice to establish immunity for this component.
It is recommended that dogs be revaccinated with canine distemper virus, canine adenovirus and canine parvovirus every 3 years and against canine parainfluenzavirus every year.
It was not possible to produce clinical signs of kennel cough by parainfluenza challenge in adult dogs and duration of immunity could not therefore be demonstrated, but an anamnestic response was seen in dogs given a booster one year after primary vaccination. Revaccination against parainfluenza is recommended prior to exposure to high risk environments (such as kennelling, showing or mixing with dogs of unknown vaccination history).
Experience has shown that the maternal antibody status of pups within a litter varies greatly and reliance should not be placed on serological examination of the bitch alone.
A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. The 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.
Similar in nature to that from a single dose (see section on 'Adverse Reactions'). In some dogs the swelling may be more painful or may be observed for a longer period.
ATC Vet Code: QI07AD04
Pharmacotherapeutic group: live viral vaccine for dogs.
The vaccine contains attenuated antigens to stimulate active immunity against canine distemper, canine parvovirus disease, canine infectious hepatitis caused by canine adenovirus type 1 and respiratory disease caused by canine adenovirus type 2 and canine parainfluenza virus.
Sorbitol, Hydrolised Gelatine, Pancreatic digest of casein, Di-Sodium phosphate 12 H2O, Water for injections.
Do not mix with any other veterinary medicinal products, except with Nobivac Solvent, or other Nobivac dog vaccines mentioned in the Interactions section.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after reconstitution according to directions: 30 minutes
Special precautions for storage:
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Protect from light.
Care should be taken to avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use - in hot summer conditions vaccine potency can be severely reduced within a few hours.
Clear, Glass Type I (Ph.Eur.) single vials with halogenobutyl rubber stopper, closed with a colour coded aluminium cap. Cardboard or plastic boxes containing 10 or 50 vials
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
20 October 2005
09 February 2017
For animal treatment only. Keep out of the sight and reach of children.
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Below are some recent questions we've received regarding Nobivac Lepto 2, including answers from our team.
Will I get card to prove dosage and batch for proof of cover for kennels
If you ask separately for a vaccine card we can send one with your order at no extra charge. You have to do this or you will not get one. The vaccine itself comes in small bottles with a peel-off label which you can stick on the vaccine card. It states the name of the vaccine, the batch number and the expiry date (= use-by date for giving the vaccine, not how long the immunity lasts for). There is a place on the card for the person who gave the vaccine to sign. Normally your vet would sign here, but a vet should not sign if they did not give the vaccine. You can sign it yourself and as long as you do not put any false qualifications there, then the vaccine record card is correct, genuine and can be used. You must not pretend to be a vet, or that is actually against the law. It would be up to the kennels to decide if they wanted to accept a record card signed by you, though they might well not notice who signed it in fact.
does lepto4 have to be given 4weeks apart. what time scale is there between injections
Ideally it should be 4 weeks between injections which is on the data sheet. Some vets still use the same protocol as for Lepto 2, ie a minimum of 2 weeks and a maximum of 4 weeks between the two injections for an initial course. My guess is that this would be effective but it is not on the data sheet. early completion of the course to facilitate early socialisation and habituation is a factor to consider.