Complete Up To Date Information about Synovex -C.
NADA Number: 009-576 | |
| Proprietary Name |
Synovex®-C Synovex®-S |
|---|---|
| Sponsor |
Fort Dodge Animal Health, Division of Wyeth |
| Sponsor Address |
800 Fifth Street NW Fort Dodge, IA 50501 USA |
| Ingredients |
Progesterone Estradiol Benzoate |
| Species |
Cattle, beef, calves, under 400 pounds weight, not weaned Cattle, beef, steers over 400 pounds Cattle, beef, steers fed in confinement for slaughter |
| Routes of Administration |
Subcutaneous |
| Dose Form |
Implant (pellet) |
| Drug Form |
Implant (pellet) |
| Dispensing Status |
OTC |
| Exclusivity |
The supplemental approval for this over-the-counter ear implant provides for re-implantation of Synovex-S? at approximately day 70 in steers fed in confinement for slaughter for additional improvement in rate of weight gain. |
|
Dosage Amount, Indications & Limitations |
522.1940 Progesterone and estradiol benzoate in combination. Specifications: No specifications are included in the CFR for this product. Conditions of use: Cattle (suckling beef calves) Amount: 100 milligrams progesterone and 10 milligrams estradiol benzoate (one implant consisting of 4 pellets, each pellet containing 25 milligrams progesterone and 2.5 milligrams estradiol benzoate) per implant dose. Indications: Increased rate of weight gain. Limitations: For use in suckling beef calves (at least 45 days of age) up to 400 pounds of body weight. For subcutaneous ear implantation, one dose per animal. Do not use in bull calves intended for reproduction. 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 (steers) Amount: 200 milligrams of progesterone and 20 milligrams estradiol benzoate (one implant consisting of 8 pellets, each pellet containing 25 milligrams progesterone and 2.5 milligrams estradiol benzoate) per implant dose. Indications: For additional improvement in rate of weight gain and improved feed efficiency. Limitations: For animals weighing 400 pounds or more; for subcutaneous ear implantation; one dose per anumal. 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 (steers in confinement for slaughter) Amount: 200 milligrams of progesterone and 20 milligrams estradiol benzoate in eight pellets per implant dose followed by re-implant at day 70 with 200 milligrams of progesterone and 20 milligrams estradiol benzoate. Indications: For additional improvement in rate of weight gain and improved feed efficiency. Limitations: For subcutaneous ear implantation. Cattle (steers in confinement for slaughter) Amount: Re-implant 200 milligrams of progesterone and 20 milligrams of estradiol benzoate on approximately day 70 following an initial implant of 100 milligrams of progesterone and 10 milligrams of estradiol benzoate or 200 milligrams of progesterone and 20 milligrams of estradiol benzoate. Indications: For additional improvement in rate of weight gain. Limitations. For subcutaneous ear implantation. 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 |
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 No residues of progesterone are permitted in excess of the following increments above the concentrations of progesterone naturally present in untreated animals: a. Steers and calves (uncooked edible tissues): (1) 3 parts per billion for muscle. (2) 12 parts per billion for fat. (3) 9 parts per billion for kidney. (4) 6 parts per billion for liver. b. Lambs (uncooked edible tissues): (1) 3 parts per billion for muscle. (2) 15 parts per billion for fat, kidney, and liver. |