NADA Number: 046-592 | |
| Proprietary Name |
BMD® 40 Type A Medicated Article BMD® 70 Type A Medicated Article BMD® 50 Type A Medicated Article BMD® 25 Type A Medicated Article BMD® 60 Type A Medicated Article BMD® 30 Type A Medicated Article BMD® 45 Type A Medicated Article BMD® 10 Type A Medicated Article |
|---|---|
| Sponsor |
Alpharma, Inc. |
| Sponsor Address |
440 Rte. 22 Bridgewater, NJ 08807 USA |
| Ingredients |
Bacitracin Methylene Disalicylate |
| Species |
Cattle, beef, feedlot Pheasant, no use class stated or implied Chicken, layers, first 7 months of production Chicken, no use class stated or implied Quail, not over 5 weeks Swine, feeder pigs, under 250 lbs Swine, sows that are pregnant Turkey, no use class stated or implied Chicken, replacements Swine, growing Swine, finishing Chicken, broilers |
| Routes of Administration |
Per Os |
| Dose Form |
Medicated feed |
| Drug Form |
Type A Medicated Article |
| Dispensing Status |
OTC |
| Exclusivity |
This supplemental NADA provides for the use of Type A medicated articles containing 25, 30, 40, 50, 60 and 75 grams of bacitracin (as bacitracin
methylene disalicylate) per pound to manufacture Type C medicated swine
feeds containing 250 grams of bacitracin per ton. The Type C feed is used
for the control of clostridial enteritis caused by Clostridium perfringens in
suckling pigs by feeding the medicated feed to sows 14 days before through
21 days after farrowing. The product is approved for OTC use. |
|
Dosage Amount, Indications & Limitations |
558.76 Bacitracin methylene disalicylate. Specifications: Type A medicated articles: 10, 25, 30, 40, 50, 60, or 75 grams per pound. Conditions of use: Chickens Amount: 4 to 50 grams per ton of feed. Indications: Increased rate of weight gain and improved feed efficiency. Limitations: No limitations are included in the CFR for this species when using this product in this amount. Turkeys Amount: 4 to 50 grams per ton of feed. Indications: Increased rate of weight gain and improved feed efficiency. Limitations: No limitations are included in the CFR for this species when using this product in this amount. Amount: 200 grams per ton of feed. Indications: As an aid in the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylene disalcylate. Limitations: No limitations are included in the CFR for this species when using this product in this amount. Pheasants Amount: 4 to 50 grams per ton of feed. Indications: Increased rate of weight gain and improved feed efficiency. Limitations: No limitations are included in the CFR for this species when using this product in this amount. Quail Amount: 5 to 20 grams per ton of feed. Indications: Not over 5 weeks of age; increased rate of weight gain and improved feed efficiency. Limitations: No limitations are included in the CFR for this species when using this product in this amount. Swine (growing-finishing) Amount: 10 to 30 grams per ton of feed. Indications: For increased rate of weight gain and improved feed efficiency. Limitations: For growing and finishing swine. Amount: 250 grams per ton of feed. Indications: For control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease condition. Limitations: As the sole ration. Not for use in swine weighing more than 250 pounds. Diagnosis should be confirmed by a veterinarian when results are not satisfactory. Chickens (broilers) Amount: 100 to 200 grams per ton of feed. Indications: As an aid in the control of necrotic enteritis caused or complicated by Clostridium species or other organisms susceptible to bacitracin. Limitations: No limitations are included in the CFR for this species when using this product in this amount. Swine (pregnant sows) Amount: 250 grams per ton of feed. Indications: For control of clostridial enteritis caused by C. perfringens in suckling piglets. Limitations: As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory. Cattle (feedlot beef) Amount: 70 milligrams per head per day used as bacitracin methylene disalicylate in feed. Indications: Reduction in the number of liver condemnations due to abscesses. Limitations: Administer continuously throughout the feeding period. NAS/NRC status: These conditions are reviewed and found effective. Applications for these uses may not require effectiveness data as specified by 514.111 of this chapter, but may require bioequivalency and safety information. Chickens Amount: 100 to 200 grams per ton Indications: As an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium species or other organisms susceptible to bacitracin methylene disalicylate. Limitations: Feed continuously as sole ration. Start at first clinical signs of disease, vary dosage based on severity of infection, administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 grams per ton). |
| Tolerances |
The tolerance for residues of bacitracin from zinc bacitracin or bacitracin methylene disalicylate in uncooked edible tissues of cattle, swine, chickens, turkeys, pheasants, and quail, and in milk and eggs is 0.5 part per million |