Pulmotil 90

Dosage Form: FOR ANIMAL USE ONLY
Pulmotil® 90

tilmicosin

For Use in Swine Feeds Only *

ELANCO* AF0472

Net Weight:

10 kg (22.0 lb)

Type A Medicated Article

Do not feed undiluted.

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.

Active Drug Ingredient: tilmicosin (as tilmicosin phosphate) 90.7 g per lb (200 g per kg)

Inert ingredients: ground corncobs.

Description: Pulmotil is a formulation of the antibiotic tilmicosin. Tilmicosin is produced semi-synthetically and is in the macrolide class of antibiotics. Each kilogram of Type A Medicated Article contains 200 grams (0.44 lbs) of tilmicosin adsorbed onto ground corncobs.

Indications: For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

Feeding Directions: Tilmicosin is to be fed continuously at 181 grams to 363 grams per ton (200 ppm to 400 ppm) of Type C medicated feed as the sole ration for a 21-day period, beginning approximately 7 days before an anticipated disease outbreak.

IMPORTANT: Must be thoroughly mixed in feeds before use.

Mixing Directions: Thoroughly mix Pulmotil Type A medicated article with feed to provide a Type B medicated feed containing up to 36,300 grams tilmicosin per ton or to provide a complete Type C medicated feed containing 181 to 363 g tilmicosin per ton. Do not use in any feeds containing bentonite. Bentonite in feeds may affect the efficacy of tilmicosin.

Starting concentration of Pulmotil Type A Medicated Article	Amount of Type A Medicated Article to add per ton	Resulting concentration in Type B Medicated Feed
grams per pound	pounds	grams per ton	grams per pound
90.7	400	36,300	18.1
	300	27,200	13.6
	200	18,100	9.05

Starting concentration of Pulmotil Type A Medicated Article	Amount of Type A Medicated Article to add per ton	Resulting concentration in Type C Medicated Feed
grams per pound	pounds	grams per ton
90.7	4	363
	3	272
	2	181

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

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 90 days from the time of issuance. VFDs for tilmicosin phosphate shall not be refilled.

RESIDUE WARNING: Feeds containing tilmicosin must be withdrawn 7 days prior to slaughter.

NOT FOR HUMAN USE

Human Safety Warning: Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators mixing and handling Pulmotil 90 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.

Pharmacology: Oral dosing of tilmicosin phosphate at 181 to 363 g/ton of feed results in serum tilmicosin levels, which do not correlate with efficacy. Lung concentrations of tilmicosin are significantly higher than serum. Following seven consecutive days of administering tilmicosin-medicated feeds to swine, the concentration of tilmicosin in respiratory tissues, phagocytic cells, and nasal secretions was significantly higher than that of plasma or serum. Lung levels are achieved within 2 days after beginning feeding and plateau by 4 days. Using in-vitro incubation techniques, the ratio of intracellular to extracellular concentrations of tilmicosin for neutrophils, monocyte-macrophages, and alveolar macrophages were 69, 19, and 17, respectively, after four hours of incubation. Although lower levels of accumulation were observed in-vivo, swine alveolar macrophages have been shown in-vitro and in-vivo to concentrate large amounts of tilmicosin; these cells may be important for in-vivo distribution of the drug and may serve as an important reservoir for tilmicosin in lung tissue.

Toxicology: The cardiovascular system is the target of toxicity in laboratory and domestic animals given tilmicosin by oral or parenteral routes. Primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotropy). Given orally, the median lethal dose is 800 mg/kg in fasted rats and 2250 mg/kg in non-fasted rats. No compound-related lesions were found at necropsy. Results of genetic toxicology studies were all negative. Results of teratology and reproduction studies in rats were all negative. The no effect level in dogs after daily oral doses for up to one year is 4 mg/kg of body weight. Tilmicosin was included in the diet of 18 adult horses for a period of 14 days at dose levels of 400, 1200, and 2000 ppm. Some horses at both the low and high dose levels demonstrated gastrointestinal disturbance with more severe colic evident at the higher levels. One horse died after consuming the 2000 ppm diet.

Adverse Drug Reactions: No adverse toxicological effects were observed in swine given rations containing 2000 ppm tilmicosin for 42 days and 4000 ppm for 21 days.

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

Storage Information: Avoid moisture and excessive heat (40°C).

Not to be used after the date printed on the bag.

Restricted Drug (California) - Use Only as Directed

NADA # 141-064, Approved by FDA

Manufactured For:

Elanco Animal Health, A Division of Eli Lilly and Company, Indianapolis, IN 46285, USA

*Elanco®, Pulmotil® and the diagonal color bar are registered trademarks of Eli Lilly and Company.

(Lot number and expiry date are printed on the bag.)

Do not feed undiluted.

BG7601DEAML (V06-06-2007)

Principal Display Panel

Principal Display Panel – 22 lb Bag Label

ELANCO* AF0472

Pulmotil® 90

tilmicosin

For Use in Swine Feeds Only *

Net Weight:

10 kg (22.0 lb)

Pulmotil 90  tilmicosin phosphate  granule

Product Information Product Type VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 0986-0472 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TILMICOSIN PHOSPHATE (TILMICOSIN) TILMICOSIN PHOSPHATE 200 g  in 1 kg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0986-0472-09 10 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141064	05/26/2010

Labeler - Elanco Animal Health Co (807447169)

Establishment
Name	Address	ID/FEI	Operations
Eli Lilly and Company Limited, Speke Operations		230761368	API MANUFACTURE, MANUFACTURE

Revised: 05/2010Elanco Animal Health Co