Complete Up To Date Information about Rumensin / Tylan .
NADA Number: 104-646 | |
| Proprietary Name |
Rumensin® / Tylan® |
|---|---|
| Sponsor |
Elanco Animal Health, A Division of Eli Lilly & Co. |
| Sponsor Address |
Lilly Corporate Center Room 1-23, 12420 Parklawn Drive Indianapolis, IN 46285 USA |
| Ingredients |
Monensin Sodium Tylosin Phosphate |
| Species |
Cattle, fed in confinement for slaughter |
| Routes of Administration |
Per Os |
| Dose Form |
Medicated feed |
| Drug Form |
Type A Medicated Article |
| Dispensing Status |
OTC |
| Patent Number |
3839557 3995027 4048268 4061755 4075323 4083962 4218438 4283388 4333919 4366168 4405609 4468380 |
| Withdrawal Time |
Cattle: zero days before slaughter. |
|
Dosage Amount, Indications & Limitations |
558.355 Monensin. Specifications: Monensin as the base or the sodium salt, contains a minimum of 90 percent monensin activity derived from monensin A and a minimum of 95 percent derived from monensin A plus B. Approvals for Type A medicated articles containing 45 and 60 grams per pound, as monensin sodium. Conditions of use: Cattle fed in confinement for slaughter Amount: Monensin, 5 to 40 grams per ton of feed, plus tylosin 8 to 10 grams per ton of feed. Indications: Improved feed efficiency; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorus and Arcanobacterium (Actinomyces) pyogenes. Limitations. Feed only to cattle being fed in confinement for slaughter. Feed continuously as sole ration at the rate of 50 to 400 milligrams of monensin and 60 to 90 milligrams of tylosin per head per day; as monensin sodium; as tylosin phosphate. Amount: Monensin, 10 to 40 grams per ton plus tylosin, 8 to 10 grams per ton of feed. Indications: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. Limitations: Feed only to cattle being fed in confinement for slaughter. Feed at a rate of 0.14 to 0.42 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 400 milligrams per head per day; and 60 to 90 milligram of tylosin per head per day. Labeling: The labeling of all Type A articles and Type B feeds (liquid and dry) containing monensin intended for use in cattle shall bear the following caution statements: Do not allow horses or other equines access to formulations containing monensin. Ingestion of monensin by equines has been fatal. Monensin medicated cattle feed is safe for use in cattle only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle. Must be thoroughly mixed in feeds before use. Do not feed undiluted. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average gains may result. Do not feed to lactating dairy cows. Type C cattle feeds containing 30 grams or less monensin sodium per ton shall bear an expiration date of 30 days after its date of manufacture. |
| Tolerances |
A tolerance of 0.10 part per million (ppm) in cattle liver, 0.05 ppm in muscle, kidney, and fate. A tolerance of 0.05 ppm in goats edible tissue.
A tolerance for residue of monensin in chickens, turkeys and quail is not needed. A tolerance for residues of monensin in milk is not needed.
Tolerances are established for residues of tylosin in edible products of animals as follows: a. Chickens and turkeys: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney. b. Cattle: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney. c. Swine: 0.2 part per million (negligible residue) in uncooked fat, muscle, liver, and kidney. d. Milk: 0.05 part per million (negligible residue). e. Eggs: 0.2 part per million (negligible residue). |