Oncept (Canada)

Canine Melanoma Vaccine, DNA

Oncept Indications

The vaccine aids in extending survival times of dogs with stage II or stage Ill oral melanoma and for which local disease control has been achieved (negative local lymph nodes or positive lymph nodes that were surgically removed or irradiated).

Dosage

- The vaccine is packaged in a box containing four single-dose vials. This package of four vials is sufficient for the initial series of vaccinations required to treat one dog.

- The vaccine is administered in a 0.4 mL dose volume using the VET JET^® transdermal vaccination system. Refer to the device package insert for instructions on vaccinating with the device.

- The site of injection for all size dogs is into the muscle of the medial thigh just caudal to the femur.

- Initial treatment requires administration of four doses of vaccine at two week intervals.

- A booster dose should be administered at six month intervals.

Safety

- A transient, low-grade fever may be observed in some dogs.

- Transdermal injection has been associated with injection site pain, swelling, and bruising. Please see device label for complete information.

Mode Of Action

- Each dose contains plasmid DNA that expresses the gene coding for human tyrosinase.

- Tyrosinase protein is over expressed on melanoma cells.

- Upon injection, the DNA is taken up by muscle cells which then express the human tyrosinase protein.

- The human tyrosinase protein is different enough from the canine tyrosinase protein that it will stimulate an immune response, yet similar enough to the canine tyrosinase that the immune response is effective against canine melanoma cells which express tyrosinase.

Precautions And Contraindications

- There are no known contraindications for the use of this product in dogs with oral melanoma.

- Store at 2-7°C (35-45°F). Do not freeze. Use entire contents when first opened.

- In rare instances, administration of vaccines may cause lethargy, fever, and inflammatory or hypersensitivity types of reactions. Treatment may include antihistamines, anti-inflammatories, and/or epinephrine.

For Veterinary Use Only.

For use with the VET JET^® transdermal vaccination system.

Manufactured By: MERIAL, INC., Athens, GA 30601 USA, U.S. Vet. Lic. No. 298.

1-888-Merial-1 (1-888-637-4251)

©2011 Merial. All rights reserved.

^®VET JET is a registered trademark of Merial. ™ONCEPT is a trademark of Merial.

CPN: 11821430