Procyon Dog Lepto

Procyon Dog Lepto Data Sheet

Presentation

Procyon Dog Lepto is a bivalent vaccine for injection. It comprises:
One vial of a liquid fraction containing inactivated strains of Leptospira canicola (strain 115) and Leptospira icterohaemorrhagiae (strain 117), with aluminium hydroxide adjuvant.

Uses

For the active immunisation of dogs from 6 weeks of age:

- to prevent mortality and reduce clinical signs of disease caused Leptospira interrogans serovars canicola and icterohaemorrhagiae

Immunity has been demonstrated from:

- 4 weeks after the primary vaccination course for Leptospira interrogans serovars canicola and icterohaemorrhagiae

Duration of immunity, demonstrated by challenge, is at least 12 months

Dosage and administration
The vaccine should be gently shaken and given by subcutaneous or intramuscular injection.
Dose - 1ml
Primary vaccination:
             Dogs and puppies 6 weeks of age and over:
             Administer one dose of Procyon Dog Lepto, with a second dose 3 to 4 weeks later.

Booster vaccination:
            A single dose of 1ml is recommended at 12 month intervals.

Contra-indications, warnings, etc
Contra-indications
Do not use in dogs that have been treated with immuno-suppressive drugs or hyperimmune serum within the last month.
No information is available on the use of the vaccine in pregnant bitches. Do not use in pregnant or lactating bitches.
Do not mix with any other vaccine/immunological product.

Warnings
Only healthy dogs should be vaccinated. Vaccination may not be effective in dogs incubating disease at the time of vaccination.
Following primary vaccination, dogs should remain isolated from possible sources of infection for at least 7 days.
Avoid intradermal vaccination.
Occasional hypersensitivity reactions may rarely occur. Appropriate treatment such as adrenaline or antihistamine should be administered without delay.
A mild (<1cm3), transient, local swelling may infrequently be seen at the injection site after the first intramuscular vaccination, which resolves completely without complication within a maximum of 3 weeks. Swelling commonly occurs at the injection site after the first or second subcutaneous vaccination; this swelling was up to 7.7 cm3(4 cm diameter) after the first vaccination and resolved within 2 weeks without complication. In rare cases the swelling may be severe.
In rare cases diarrhoea may be observed and after intramuscular vaccination a single case (1%) of transient (1-2 day) lameness was observed.
No systemic reactions to vaccination were seen in trials following subcutaneous administration.
In the case of accidental self-injection or ingestion, seek medical advice immediately and show the package insert or label to the physician.
Keep out of reach and sight of children.
For animal treatment only.

Withdrawal period
Not applicable.

Pharmaceutical precautions

Store and transport refrigerated between +2 °C and +8 °C. Protect from light. Do not freeze.

Any unused product or waste material should be disposed of by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

Legal category

POM-V - To be supplied only on veterinary prescription

Packaging Quantities

Pack size: 10 doses each of 1ml

Further information

With the exception of other Procyon Dog vaccines, no information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that vaccines other than those in the Procyon Dog range should not be administered within 14 days before or after vaccination.

In any animal population there may be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine together with the animal’s ability to respond. This can be influenced by factors such as genetic constitution, intercurrent infection, age, nutritional status, concurrent drug therapy and stress.

Marketing authorisation number
Vm 00201/4223.