Pulmotil 18

tilmicosin

Type B Medicated Feed

Pulmotil 18 Caution

Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

For Use in swine and cattle feeds only.

Do Not Feed Undiluted

ACTIVE DRUG INGREDIENT:

INGREDIENTS: Rice Hulls, Calcium Carbonate, Distillers Dried Grains with Solubles, and Mineral Oil

GUARANTEED ANALYSIS:

This product has been formulated to contain at least 25% nutrient content.

Pulmotil 18 Indications

Swine: Pulmotil is indicated for the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

Cattle: For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

MIXING DIRECTIONS:

For Incorporation into Swine Feeds: Thoroughly mix Pulmotil 18 with feed to provide a complete Type C medicated feed containing 181 to 363 g tilmicosin phosphate per ton. Do not use in any feeds containing bentonite. Bentonite in feeds may affect the efficacy of tilmicosin.

For Incorporation into Cattle Feeds: Thoroughly mix Pulmotil 18 with feed to provide a complete Type C medicated feed containing 568 to 757 g tilmicosin phosphate per ton on a 100% dry matter basis. Complete Type C medicated feeds should not be pelleted. Do not use in any feeds containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, cottonseed meal, or cottonseed hulls in feeds may affect the efficacy of tilmicosin.

^A100% dry matter basis

Pulmotil 18 Caution

Do not allow horses or other equines access to feeds containing tilmicosin. The safety of tilmicosin has not been established in cattle or male swine intended for breeding purposes.

Swine: Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for re-evaluation of antimicrobial use by a licensed veterinarian before re-initiating a further course of therapy with an appropriate antimicrobial. Veterinary Feed Directive (VFD) expiration date must not exceed ninety (90) days from the time of issuance. VFDs for tilmicosin phosphate shall not be refilled.

Cattle: Use only in cattle fed in confinement for slaughter. To assure both food safety and responsible use in cattle, the treatment of cattle with this medicated feed is required to be initiated within the first 45 days of the production period. The treatment should not occur concurrent with or following administration of an injectable macrolide, or within 3 days following administration of a non-macrolide injectable BRD therapy. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical illness should be evaluated for individual treatment with an alternative non-macrolide therapy. The expiration date for a tilmicosin Veterinary Feed Directive (VFD) for cattle must not exceed 45 days from the time of issuance. VFDs for tilmicosin phosphate shall not be refilled.

WARNING: Swine: Feeds containing Pulmotil must be withdrawn 7 days prior to slaughter.

WARNING: Cattle: Feeds containing Pulmotil must be withdrawn 28 days prior to slaughter. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves.

User Safety Warnings: Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators mixing and handling Pulmotil should use protective clothing, impervious gloves, goggles, and a NIOSH-approved dust mask. Wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water. If irritation persists, seek medical attention. Not for human consumption. Keep out of reach of children. The Material Safety Data Sheet contains more detailed occupational safety information. To report adverse effects in users, to obtain more information, or to obtain a material safety data sheet, call 1-800-428-4441.

To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

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

CPN: 1131068.0