Zelnate (Canada)

This treatment applies to the following species:

Company: Elanco

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

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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

Study Type			Efficacy
Pertaining to			Mannheimia haemolytica
Study Purpose			Efficacy against bovine respiratory disease
Product Administration			One dose administered by IM route at the time of challenge. Control group administered diluent only.
Study Animals			64 Hoistein steers of 3-4 months of age; randomized into 2 groups of 32 calves each.
Challenge Description			Live M. haemolytica inoculum
Interval observed after challenge			Observed daily for 5 days. Lungs were evaluated 5 days after challenge.
Results			The percent of lung mass that was abnormal (consolidated) was calculated/scored for every animal. For animals that died prior to Day 5, the necropsy lung score was not included in the analysis.
5 number summary for lung consolidation
Treatment	Minimum	01	Median	03	Maximum
Controls	0%	6%	10%	15%	33%
Treated	0%	1%	4%	10%	22%
			Raw data shown on the table below. The animals that died prior to Day 5 are marked with an asterisk (*). The deaths prior to Day 5 were: 1/32 in Treated group: 1/32 in Control group. Diagnosis was severe bovine respiratory disease for calf in Control group.
USDA Approval Date			28-Feb-2013

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

Treated	0%	0%	1%	1%	1%	1%	1%	1%
Control	0%	0%	3%	3%	3%	4%	6%	6%
Treated (Cont.)	4%	5%	5%	6%	8%	9%	10%	10%
Control (Cont.)	10%	10%	10%	11%	13%	14%	15%	15%

Treated	2%	2%	3%	3%	3%	4%	4%	4%
Control	6%	7%	7%	7%	8%	8%	10%	10%
Treated (Cont.)	10%	11%	12%	13%	13%	15%	18%	22%
Control (Cont.)	18%	18%	21%	23%	27%	29%	33%	34%*

*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

ELANCO CANADA LIMITED
1919 MINNESOTA COURT, SUITE 401, MISSISSAUGA, ON, L5N 0C9

Customer Service:		800-265-5475
Fax:		519-821-7831
Website:		www.elanco.ca
Email:		elancocanadacustomerservice@elancoah.com

THIS SERVICE AND DATA ARE PROVIDED "AS IS". Animalytix assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the Animalytix service and data. See the Terms of Use for further details.