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NADA Number: 046-592

Proprietary Name BMD® 60
BMD 50 Granular A
BMD 30 Granular A
BMD® 30
BMD® 50
Sponsor Zoetis Inc.
Sponsor Address 333 Portage St.
Kalamazoo, MI    49007
Ingredients Bacitracin Methylene Disalicylate
Species (Class) CATTLE (Cattle, beef, feedlot)
CHICKENS (Chicken, no use class stated or implied)
CHICKENS (Chicken, broilers)
CHICKENS (Chicken, layers, first 7 months of production)
CHICKENS (Chicken, replacements)
PHEASANTS (Pheasant, no use class stated or implied)
QUAIL (Quail, not over 5 weeks)
SWINE (Swine, finishing)
SWINE (Swine, feeder pigs, under 250 lbs)
SWINE (Swine, growing)
SWINE (Swine, sows that are pregnant)
TURKEYS (Turkey, no use class stated or implied)
Routes of Administration Per Os
Dosage Form Medicated feed
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 (broiler and replacement)

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: 50 grams per ton of feed.

Indications: As an aid in the prevention of necrotic enteritis caused by or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylene disalicylate.

Limitations: Feed as the sole ration.

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 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).

Chickens (laying)

Amount: 10 to 25 grams per ton of feed.

Indications: Increased egg production and improved feed efficiency during the first seven months of production.

Limitations: Feed continuously as the sole ration for the first seven months of egg production.

Turkeys (Growing)

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: For increased rate of weight gain and improved feed efficiency in quail not over 5 weeks of age.

Limitations: No limitations are included in the CFR for this species when using this product in this amount.

Quail (growing)

Amount: 200 grams per ton of feed.

Indications: For prevention of ulcerative enteritis in growing quail caused by Clostridium colinum susceptible to bacitracin methylene disalicylate.

Limitations: From Type A medicated articles containing 25, 40 or 50 grams of bacitracin methylene disalicylate. Feed continuously as the sole ration.

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.

Swine (pregnant sows)

Amount: 250 grams per ton of feed.

Indications: For control of clostridial enteritis caused by Clostridium perfringens in suckling piglets when fed to sows from 14 days through 21 days after farrowing on premises with a history of clostridial scours.

Limitations: Feed as the sole ration to sows from 14 days before through 21 days after farrowing. 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: For reduction in the number of liver condemnations due to abscesses.

Limitations: Administer continuously throughout the feeding period.

Amount: 250 milligrams per head per day used as bacitracin methylene disalicylate in feed.

Indications: For reduction in the number of liver condemnations due to abscesses.

Limitations: Administer continuously for 5 days to provide 250 mg bacitracin methylene per head per day, then discontinue for subsequent 25 days; repeat the pattern during the feeding period.

 

Tolerances

Bacitracin Methylene Disalicylate: 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