NADA Number: 140-533

Proprietary Name 3-Nitro® / BMD® / Stenorol®
Sponsor Huvepharma AD
Sponsor Address 33 James Boucher Blvd.
Sophia 1407,   
Bulgaria
Ingredients Halofuginone Hydrobromide
Bacitracin Methylene Disalicylate
Roxarsone
Species Chicken, broilers excluding layers
Routes of Administration Per Os
Dose Form Medicated feed
Drug Form Type A Medicated Article
Dispensing Status OTC
Withdrawal Time Chicken (broilers): 5 days before slaughter.
Dosage Amount,
Indications
& Limitations

558.265 Halofuginone hydrobromide.

Specifications: Type A Medicated article: 6 grams per kilogram (2.72 grams per pound).

Conditions of use:

Chickens (broilers)

Amount: Halofuginone hydrobromide 2.72 grams (0.003 percent) plus bacitracin methylene dislaicylate 10 to 50 grams and roxarsone 22.7 to 45.4 grams.

Indications: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of gain; and improved feed efficiency.

Limitations: Feed continuously as sole ration. Withdraw 5 days before slaughter. Use as sole source of organic arsenic do not feed to layers. Avoid contact with skin, eyes, or clothing. Keep out of lakes, ponds, or streams.

Tolerances

The marker residue selected to monitor for total residues of halofuginone hydrobromide in broilers and turkeys is parent halofuginone hydrobromide and the target tissue selected is liver. A tolerance is established in broilers of 0.16 part per million and in turkeys of 0.13 part per million for parent halofuginone hydrobromide in liver. These marker residue concentrations in liver correspond to total residue concentrations of 0.3 part per million in liver.

Tolerances for total residues of combined arsenic (calculated as Arsenic) in food are established as follows:

a. Chickens and turkeys (edible tissues): (1) 0.5 part per million in uncooked muscle tissue. (2) 2 parts per million in uncooked edible by-products.

b. Chicken and turkey eggs: 0.5 part per million

c. Swine (edible tissues): (1) 2 parts per million in uncooked liver and kidney. (2) 0.5 part per million in uncooked muscle tissue and by-products other than liver and kidney.

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