Complete Up To Date Information about Otpaflexx™ / Rumensin / Tylan .
NADA Number: 141-224 | |
| Proprietary Name |
Otpaflexx™ / 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 |
Ractopamine Hydrochloride 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 |
4690951 5631298 5643967 |
| Withdrawal Time |
Cattle: zero days. |
|
Dosage Amount, Indications & Limitations |
558.500 Ractopmaine Special considerations: Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. Conditions of use: Cattle fed in confinement for slaughter Amount: 8.2 to 24.6 grams, monensin, 10 to 30 grams and tylosin 8 to 10 grams per ton of feed. Indications: For increased rate of weight gain, improved feed efficiency, for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes during the last 28 to 42 days on feed. Limitations: Feed continuously as sole ration for the last 28 to 42 days on ration. Not for animals intended for breeding. Amount: 9.8 to 24.6 grams per ton and monensin, 10 to 30 grams per ton of feed. Indications: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes during the last 28 to 42 days on feed. Limitations: Feed continuously as sole ration for the last 28 to 42 days on ration. Not for animals intended for breeding. |
| 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.
The tolerance for ractopamine hydrochloride (the marker residue) in swine is 0.15 part per million) in liver (target tissue).
The tolerance for ractopamine hydrochloride (the marker residue) in cattle is 0.03 part per million in muscle and 0.09 part per million in liver.
The tolerance for ractopamine hydrochloride (the marker residue) in turkeys is 0.45 ppm in liver(target tissue) and 0.1 ppm in muscle.
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). |