DURAMUNE^® ADULT

Fort Dodge

Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus Vaccine

Modified Live Virus

For subcutaneous vaccination of healthy dogs 6 weeks of age or older as an aid in the prevention of disease caused by canine distemper, infectious canine hepatitis, canine adenovirus type 2, canine parainfluenza and canine parvovirus.

This product is particularly well suited as a booster vaccination for adult dogs when following an extended vaccination interval program.

DIRECTIONS FOR USE

·        General Directions: Aseptically rehydrate this product with Sterile Diluent supplied. Administer one 1 mL dose subcutaneously.

·        Primary Vaccination: A recommended vaccination schedule should start at or about 6 weeks of age. The presence of maternal antibody is known to interfere with the development of active immunity. Puppies should be revaccinated every 2 to 3 weeks until 12 weeks of age.

All dogs over 12 weeks of age should initially receive one dose of this product and a second dose 2 to 3 weeks later.

·        Revaccination: Dogs may be vaccinated annually with one dose. The CPV, CAV2 and CDV fractions of this product have also been studied in a longer revaccination interval program. The results of the 3 year duration of immunity studies are described in the enclosed package insert.

Gentamicin added as preservative.

EXTENDED DURATION OF IMMUNITY DATA SUMMARY:

Canine Parvovirus (CPV)*:

Ten six-week-old CPV seronegative puppies were vaccinated, five subcutaneously and five intramuscularly, with two 1 mL doses at an interval of 21 days. Approximately three years (156 weeks) after the second vaccination, ten vaccinated dogs along with the three unvaccinated seronegative controls were challenged with the virulent 2b strain of CPV and observed for post-challenge clinical signs. All the vaccinated dogs appeared healthy and active throughout the study period, including the 14-day post-challenge observation period. Transient clinical signs mostly non-specific to CPV infection were observed in some vaccinates during the post-challenge observation period. 100% of the vaccinated dogs showed seroconversion against CPV and remained seropositive through the day of challenge. All the unvaccinated controls were seronegative to CPV until the day of challenge and highly susceptible to CPV infection. There were significant differences following virulent CPV challenge between vaccinated and control groups for fecal virus shedding, weight loss/gain, and post-challenge antibody responses.

Canine Distemper Virus (CDV)*:

Ten six-week-old CDV seronegative puppies were vaccinated, five subcutaneously and five intramuscularly, with two 1 mL doses at an interval of 21 days. Three years after the second vaccination, the ten vaccinated dogs along with the three unvaccinated seronegative controls were challenged with a virulent CDV strain and observed for post-challenge clinical signs. All the vaccinated dogs appeared healthy and active throughout the study period, including the 21-day post-challenge observation period. A few of the vaccinates showed only mild and transient clinical signs mostly non-specific to CDV infection during the post-challenge observation period. 100% of the vaccinated dogs showed seroconversion against CDV and remained seropositive through the day of challenge (for 3 years). All the unvaccinated controls were seronegative to CDV on the day of challenge and highly susceptible for CDV infection. Clinical signs of severe multisystemic illness mostly related to CDV infection and high mortality (67%) were observed in the unvaccinated control group.

The results of the long-duration efficacy study strongly indicate that the modified live CDV antigen is efficacious and protective in six-weeks of age or older puppies for up to three years following second vaccination.

Canine Adenovirus (CAV)*:

The CAV fraction of Duramune^® Adult provides protection against both CAV1 strain (which causes Infectious Canine Hepatitis Virus [ICHV]) and CAV2 strain (which causes respiratory disease). Because the more severe disease form is ICHV, an ICHV challenge was selected for the long-term duration of immunity studies.

Twelve six-week-old ICHV seronegative puppies were vaccinated, nine subcutaneously (SC) and three intramuscularly (IM), with two 1 mL doses at an interval of 21 days. Over three years (36-40 months) after the second vaccination, 12 vaccinated dogs along with the 2 unvaccinated seronegative controls were challenged with the virulent strain of ICHV and observed for post-challenge clinical signs. 100% of the vaccinates showed good seroconversion against ICHV following vaccination with significantly high antibody titers on the day of challenge. All the vaccinated dogs appeared healthy and active throughout the study period, including the 21-day post-challenge observation period. None of the vaccinates had fever, severe clinical signs or loss of body weight following virulent ICHV challenge. Whereas, both unvaccinated controls remained seronegative until the day of challenge and susceptible to ICHV infection. The controls showed 100% morbidity with high fever and severe clinical signs following ICHV challenge.

The results of the long-duration efficacy study clearly demonstrate that the modified live CAV2 antigen is efficacious and protective in six-week of age or older dogs for up to three years following second vaccination.

* Data on file with USDA.

00564

17980B

For Veterinary Use Only

© 2004 Fort Dodge Animal Health.

All Rights Reserved.

Fort Dodge Animal Health

Fort Dodge, Iowa 50501 USA

U.S. Vet. License No. 112