Complete Up To Date Information about Zilmax .
NADA Number: 141-258 | |
| Proprietary Name |
Zilmax® |
|---|---|
| Sponsor |
Intervet, Inc. |
| Sponsor Address |
29160 Intervet Lane P.O. Box 318 Millsboro, DE 19966 USA |
| Ingredients |
Zilpaterol |
| 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 5731028 7207289 |
| Exclusivity |
Exclusivity granted on the basis that this approval is for a new animal drug, no active ingredient of which has been previously approved. |
| 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. 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. 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. 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 |
Cattle - Liver (the target tissue). The tolerance for zilpaterol freebase (the marker residue) is 12 parts per billion (ppb). |