Complete Up To Date Information about Zilmax , Rumensin , and Tylan .
NADA Number: 141-276 | |
| Proprietary Name |
Zilmax®, Rumensin®, and Tylan® |
|---|---|
| Sponsor |
Intervet, Inc. |
| Sponsor Address |
29160 Intervet Lane P.O. Box 318 Millsboro, DE 19966 USA |
| Ingredients |
Zilpaterol Monensin Tylosin Phosphate |
| Species |
Cattle, fed in confinement for slaughter |
| Routes of Administration |
Per Os |
| Dose Form |
Type A medicated article |
| Drug Form |
Type A Medicated Article |
| Dispensing Status |
OTC |
| Patent Number |
4900735 7207289 |
| Withdrawal Time |
3 days prior to slaughter. |
|
Dosage Amount, Indications & Limitations |
558.665 Zilpaterol Specifications: Type A medicated articles containing 21.77 grams (g) zilpaterol hydrochloride per pound. To be used in the manufacture of Type B and C medicated feeds in combination with monensin USP, and tylosin phosphate. Conditions of use: Cattle (fed in confinement for slaughter) Amount: 6.8 g/ton of feed to provide 60 to 90 milligrams zilpaterol hydrochloride per head per day. In combination with: Monensin USP (Section 558.355) - 10 to 40 g/ton of feed to provide 0.14 to 0.42 mg monensin/lb of body weight (depending on severity of coccidiosis challenge) up to 480 mg/head/day; and Tylosin phosphate (Section 558.625) - 8 to 10 g/ton of feed to provide 60 to 90 mg tylosin/head/day. Indications: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. And for the 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 Arcanobacterium (Actinomyces) pyogenes. Limitations: Feed continuously as the sole ration during the last 20 to 40 days on feed. Special considerations: 1) Labeling of Type B and Type C cattle feeds shall bear the following: (i) Do not allow horses or other equines access to feed containing zilpaterol. (ii) Not for use in animals intended for breeding. (iii) Do not use in veal calves. 2) Type B Liquid Feeds can be manufactured containing 68 to 680 g zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank systems: 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. For liquid feeds stored in mechanical, air or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. |
| Tolerances |
A tolerance of 0.05 part per million is established for negligible residues of monensin in the edible tissues of cattle and goats. A tolerance for residues of monensin in chickens, turkeys and quail 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). Cattle - Liver (the target tissue). The tolerance for zilpaterol freebase (the marker residue) is 12 parts per billion (ppb). |