Complete Up To Date Information about Zilmax and Rumensin .
NADA Number: 141-278 | |
| Proprietary Name |
Zilmax® and Rumensin® |
|---|---|
| Sponsor |
Intervet, Inc. |
| Sponsor Address |
29160 Intervet Lane P.O. Box 318 Millsboro, DE 19966 USA |
| Ingredients |
Zilpaterol Monensin |
| 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 |
| Withdrawal Time |
Cattle: 3 days |
|
Dosage Amount, Indications & Limitations |
558.665 Zilpaterol. Specifications: Type A medicated articles containing 21.77 grams (g) zilpaterol hydrochloride per pound in combination with monensin USP 80 grams (g) per pound for the manufacture of Type B and C medicated feeds. 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 at 10 to 40 g/ton to provide 0.14 to 0.42 milligrams monensin/lb of body weight, depending on severity of coccidia challenge, to a maximum of 480 mg monensin/head/day. Indications: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle and to prevent and control coccidiosis due to Eimeria bovis and E. zuernii during the last 20 to 40 days on feed. 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. Cattle - Liver (the target tissue). The tolerance for zilpaterol freebase (the marker residue) is 12 parts per billion (ppb). |