NADA Number: 140-992

Proprietary Name Revalor®-IH
Revalor®-H
Revalor®-200
Sponsor Intervet, Inc.
Sponsor Address 29160 Intervet Lane
P.O. Box 318
Millsboro, DE    19966
USA
Ingredients Estradiol
Trenbolone Acetate
Species Cattle, beef, heifers fed in confinement for slaughter excluding veal
Cattle, beef, steers fed in confinement for slaughter, excluding veal
Routes of Administration Subcutaneous
Dose Form Implant (pellet)
Drug Form Implant (pellet)
Intervet, Inc. Has Pioneered:                   Component® TE-200
    Ivy Laboratories, Division of Ivy Animal Health, Inc.
                  Component® TE-200 with Tylan®
    Ivy Laboratories, Division of Ivy Animal Health, Inc.
                  Component® TE-H
    Ivy Laboratories, Division of Ivy Animal Health, Inc.
                  Component® TE-H with Tylan®
    Ivy Laboratories, Division of Ivy Animal Health, Inc.
                  Component® TE-IH
    Ivy Laboratories, Division of Ivy Animal Health, Inc.
Dispensing Status OTC
Exclusivity Granted for increased rate of weight gain and improved feed efficiency in heifers fed in confinement for slaughter.
Granted for increased rate of weight gain and improved feed efficiency in steers fed in confinement for slaughter.
Granted for an additional dose form of ear implant in heifers, fed in confinement kept for slaughter; to improve rate of weight gain and feed efficiency.
Granted for an additional dose form of ear implant (containing 200 mg trenbolone acetate and 20 mg estradiol) used in heifers fed in confinement kept for slaughter; to improve rate of weight gain and feed efficiency. Each implant is made up of ten pellets with each pellet containing 20 mg trenbolone acetate and 2 mg estradiol.
Withdrawal Time Cattle: zero days before slaughter.
Dosage Amount,
Indications
& Limitations

522.2477 Trenbolone acetate and estradiol.

Specifications: No specifications are included in the CFR for this product.

Conditions of use:

Cattle (steers fed in confinement for slaughter)

Amount: 120 milligrams (mg) trenbolone acetate and 24 mg estradiol (one implant consisting of 6 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose.

Indications: For increased rate of weight gain and improved feed efficiency.

Limitations: Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Amount: 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of 4 pellets), or 120 mg trenbolone acetate and 24 mg estradiol (one implant consisting of 6 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose.

Indications: For increased rate of weight gain and improved feed efficiency.

Limitations: Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Cattle (slaughter, stocker, feeder steers, and heifers)

Amount: 40 mg trenbolone acetate and 8 mg estradiol (one implant consisting of 2 pellets, each pellet containing 20 mg trenbolone acetate and 4 mg estradiol) per implant dose.

Indications: For increased rate of weight gain.

Limitations: Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Cattle (heifers fed in confinement for slaughter)

Amount: 140 mg trenbolone acetate and 14 mg estradiol (one implant consisting of 7 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol).

Indications: For increased rate of weight gain and improved feed efficiency.

Limitations: Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Amount: 80 mg trenbolone acetate and 8 mg estradiol (one implant consisting of 4 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose.

Indications: For increased rate of weight gain.

Limitations: Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Amount: 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose.

Indications: For increased rate of weight gain and improved feed efficiency.

Limitations: Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

Tolerances

A tolerance for total trenbolone residues in uncooked edible tissues of cattle is not needed.

No residues of estradiol, resulting from the use of estradiol or any of the related esters, are permitted in excess of the following increments above the concentrations of estradiol naturally present in untreated animals:

a. In uncooked edible tissues of heifers, steers, and calves: (1) 120 parts per trillion for muscle (2) 480 parts per trillion for fat (3) 360 parts per trillion for kidney (4) 240 parts per trillion for liver

b. In uncooked edible tissues of lambs: (1) 120 parts per trillion for muscle (2) 600 parts per trillion for fat, kidney, and liver