Complete Up To Date Information about Chlortetracycline / Denagard 10 Premixes.
NADA Number: 141-011 | |
| Proprietary Name |
Chlortetracycline / Denagard® 10 Premixes |
|---|---|
| Sponsor |
Novartis Animal Health US, Inc. |
| Sponsor Address |
3200 Northline Ave, Suite 300 Greensboro, NC 27408 USA |
| Ingredients |
Chlortetracycline Hydrochloride Tiamulin Hydrogen Fumarate |
| Species |
Swine, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Medicated feed |
| Drug Form |
Type A Medicated Article |
| Dispensing Status |
OTC |
| Patent Number |
3987194 4278674 |
| Exclusivity |
New clinical or field investigations (other than bioequivalence or residue studies essential to the approval were conducted or sponsored by the applicant. |
| Withdrawal Time |
Swine: 2 days before slaughter. |
|
Dosage Amount, Indications & Limitations |
558.600 Tiamulin. Specifications: Type A article containing 5, 10, or 113.4 grams of tiamulin (as tiamulin hydrogen fumarate) per pound. Conditions of use: Swine Amount: 35 grams of tiamulin (as tiamulin hydrogen fumarate), plus the equivalent of approximately 400 grams of chlortetracycline hydrochloride varying with body weight and feed consumption to provide 10 milligrams of chlortetracycline per pound of body weight daily. Indications: Treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline, and control of swine dysentery associated with Serpulina (Treponema) hyodysenteriae susceptible to tiamulin. Limitations: Feed continuously as sole ration for 14 days as only source of chlortetracycline. As chlortetracycline calcium complex, Type A medicated articles containing the equivalent of 50 to 100 grams per pound of chlortetracycline hydrochloride.
Caution: The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined.
|
| Tolerances |
Tolerances are established for the sum of tetracycline residues in tissues of beef cattle, nonlactating dairy cows, calves, swine, sheep, chickens, turkeys, and duck or 2 parts per million in muscle, 6 parts per million in liver, and 12 parts per million in fat and kidney. A tolerance is established for residues of chlortetracycline in eggs of 0.4 part per million. A tolerance of 0.6 part per million is established for 8-alpha-hydroxymutilin (marker compound) in liver (target tissue) of swine. |