Complete Up To Date Information about Denagard Antibiotic Premix.
NADA Number: 139-472 | |
| Proprietary Name |
Denagard® Antibiotic Premix Denagard® 5 Medicated Premix Denagard® 10 Medicated Premix |
|---|---|
| Sponsor |
Novartis Animal Health US, Inc. |
| Sponsor Address |
3200 Northline Ave, Suite 300 Greensboro, NC 27408 USA |
| Ingredients |
Tiamulin |
| Species |
Swine, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Powder |
| Drug Form |
Type A Medicated Article |
| Dispensing Status |
OTC |
| Patent Number |
3919290 3987194 4278674 |
| Exclusivity |
This over-the-counter premix supplemental application adds the label claim for treatment of swine dysentery by feeding tiamulin at a level of 200 g/ton for 14 consecutive days. Granted for use of tiamulin Type A Medicated Articles to make Type B and C medicated feeds for control of porcine proliferative enteropathies in swine. |
| Withdrawal Time |
Swine: 2 days before slaughter when fed at 35 grams per ton tiamulin; 7 days before slaughter when fed at 200 grams per ton tiamulin. |
|
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. Special considerations: Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. If signs of toxicity occur, discontinue use. . Caution: The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined. Conditions of use: Swine Amount: 10 gram per ton of feed Indications: For increased rate of weight gain and improved feed efficiency. Limitations: Feed continuously as sole ration. Amount: 35 grams of tiamulin per ton of feed Indications: For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin. Limitations: Feed continuously as sole ration on premises with a history of swine disentary but where signs of disease have not yet occurred or following approved treatment of disease. Withdraw 2 days before slaughter. Indications: For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. Limitations: Feed continuously as the sole ration for not less than 10 days. Withdraw 2 days before slaughter. 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. Amount: 200 grams of tiamulin per ton of feed. Indications: For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin. Limitations: Feed continuously as sole ration for 14 consecutive days Withdraw 7 days before slaughter.
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| Tolerances |
A tolerance of 0.6 part per million is established for 8-alpha-hydroxymutilin (marker compound) in liver (target tissue) of swine. |