U.S. FDA approves Pulmotil and Rumensin feeding combination

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GREENFIELD, Ind. ― The U.S. Food and Drug Administration (FDA) has approved the combination feeding of Pulmotil®, an in-feed bovine respiratory disease (BRD) treatment, with Rumensin®, an efficiency-enhancing feed additive. This means producers can now combine the only 14-day sustained, in-feed BRD treatment with one of the most proven, widely used feed additives in the industry.

“Implementing these products together will give producers more options and allow them to feed one ration that contains both Rumensin and Pulmotil,” said Carl Guthrie, DVM and Elanco beef technical director. “This approval provides producers the combined benefits of two innovative, value-enhancing products ― the control of BRD that Pulmotil provides with the prevention and control of coccidiosis and feed efficiency improvements Rumensin delivers.”

Approved by the FDA in late 2011, Pulmotil is an innovative BRD treatment for groups of cattle in the early stages of an outbreak that provides 14 days of sustained in-feed therapy, a practice that reduces stress associated with cattle handling. Pulmotil expands BRD control beyond the chute by providing another option for groups of cattle not requiring a metaphylaxis treatment on arrival and/or when labor resources are limited. By feeding Pulmotil, producers can reduce pulls, while requiring less individual animal management.

Similar to the prescription requirement for injectable products, the FDA requires a veterinarian to issue a Veterinary Feed Directive (VFD) for the use of Pulmotil to help ensure veterinarian oversight and judicious use of Pulmotil according to the label use and feeding directions. The VFD process requires a coordinated effort by the veterinarian, producer, feed advisor and feed supplier. Elanco has developed a number of tools to help producers and their veterinarians implement a VFD. Step-by-step directions on how to fill a VFD form, including the combination approval section, can be found on this checklist.

“Since the initial approval of Pulmotil, we have been working with veterinarians and nutritionists to provide training on the VFD process and conducting further Pulmotil research trials,” said Guthrie. “Now we are making Pulmotil widely available to commercial operations, many of which will value the convenience of using Rumensin and Pulmotil together.”

Learn more about Pulmotil.

About Elanco
Elanco is a global innovation-driven company that develops and markets products to improve animal health and food animal production in more than 75 countries. Elanco employs more than 2,500 people worldwide, with offices in more than 40 countries, and is a division of Eli Lilly and Company, a leading global pharmaceutical corporation. Additional information about Elanco is available at www.elanco.com.

For all products: The label contains complete use information, including cautions and warnings. Always read, understand and follow the label and use directions.

For Rumensin: Consumption by unapproved species or feeding undiluted may be toxic or fatal. Do not feed to veal calves.

For Pulmotil: Feeds containing tilmicosin must be withdrawn 28 days prior to slaughter.
CAUTION: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian’s professional practice.



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