Zelnate

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

DNA Immunostimulant

For Intramuscular or Intranasal Administration to Cattle

FOR VETERINARY USE ONLY

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Description

The innate immune system in cattle 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.

ZELNATE^® is a bacterial-produced plasmid DNA with a liposome carrier that stimulates the innate immune system and has been shown to be effective against bovine respiratory disease due to Mannheimia haemolytica.

The freeze-dried (desiccate) product is packaged with two different sterile 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 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 (35°F to 46°F)

DO NOT FREEZE.

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

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 an atomization tip attached to the syringe; the atomizer should produce a fine mist of particles 30-100 microns in size for delivery to the mucosal membranes. Use entire contents of vial once first opened.

Zelnate Caution

In case of human exposure, contact a physician.

PRECAUTION

Do not administer within 21 days of slaughter. Do not mix with other products, except as specified on this label. 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.

ZELNATE^® is ready for use.

MANUFACTURED BY:

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

U.S. Veterinary License No. 213

PCN 9381.D0.

Made in U.S.A.

DISTRIBUTED BY:

Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 U.S.A.

1-800-633-3796

This product is based on technology developed by Juvaris BioTherapeutics and is patent protected. Animal health applications are being exclusively developed by Bayer HealthCare, Animal Health Division and are the subject of Bayer patent applications.

©2019 Bayer

Bayer, the Bayer Cross and Zelnate are registered trademarks of Bayer.

LV1907

Regulations for product use are established by country. Information contained on this site pertains only to the United States of America, and is not intended to provide adequate information for product use. Before using or dispensing any product, read and carefully observe the label directions.