Zelnate (Canada)

See productdata.aphis.usda.gov for a summary of the studies approved by the USDA for licensing this product. The package insert may also contain additional information developed by the licensee.

DNA Immunostimulant

For Intramuscular Administration to Cattle

FOR VETERINARY USE ONLY

READ IN FULL

Description

ZELNATE is a bacterial produced plasmid DNA with a liposome carrier that stimulates the innate immune system in cattle. The innate immune system has been shown to provide a potent, rapid, nonspecific, protective response to infectious agents, such as Mannheimia haemolytica that can lead to Bovine Respiratory Disease (BRD). BRD is a serious condition that commonly causes lung lesions, reduced lung capacity, and mortality.

The freeze-dried (desiccate) product is packaged with two different diluents. The First Sterile Rehydrator (vial 1) is used to reconstitute the desiccate cake (vial 2), and then transferred to the Final Sterile Solution (vial 3) to achieve the proper concentration for administration.

INDICATION

This product has been shown to be effective for the treatment of cattle, 4 months of age or older, against bovine respiratory disease due to Mannheimia haemolytica. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

This product has also been shown to be effective at the time of, or within 24 hours after, a perceived stressful event.

IMPORTANT STORAGE CONDITIONS

Store refrigerated (2°C to 8°C).

DO NOT FREEZE.

Stability has been demonstrated for at least 8 hours after reconstitution if vial is refrigerated and sterility is maintained.

STUDY DATA

Individual Study Summary - Study #200270

Lung consolidation scores (%), in order to rank:

*death prior to Day 5

METHOD OF ADMINISTRATION

Inject 2 mL intramuscularly at the time of, or within 24 hours after, a perceived stressful event (for example: weaning, shipping, commingling, or adverse environmental conditions).

Alternatively, spray 2 mL into one nostril using a mucosal atomization device.

Use entire contents of vial once first opened. Inactivate unused contents before disposal.

PRECAUTION

Do not administer within 21 days of slaughter. Do not mix with other products, except as specified on the label. In case of human exposure, contact a physician. This product has not been tested in pregnant animals.

OTHER INFORMATION

Contains no antibiotics and no preservatives.

HOW SUPPLIED

Vials of 10 and 50 doses.

Mixing process must be completed in the appropriate order. Transfer needle must be fully inserted to prevent spillage.

MANUFACTURED BY:

Diamond Animal Health, Inc., Des Moines, IA 50327

VLN/PCN: 213/9381.D0

Made in U.S.A.

DISTRIBUTED BY:

Elanco Canada Limited, 150 Research Lane, Suite 120, Guelph, Ontario N1G 4T2

1-800-265-5475

This product is based on technology developed by Juvaris BioTherapeutics and is patent protected. Animal Health applications are being exclusively developed by Elanco and are the subject of Elanco patent applications.

87377792 LV2102

Zelnate, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

02338

CPN: 1231231.0