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NADA Number: 040-209

Proprietary Name Rofenaid® 40
Sponsor Zoetis Inc.
Sponsor Address 333 Portage St.
Kalamazoo, MI    49007
Ingredients Sulfadimethoxine
Ormetoprim
Species (Class) CHICKENS (Chicken, under 16 weeks)
CHICKENS (Chicken, replacements)
CHICKENS (Chicken, broilers)
CHUKAR PARTRIDGES (Chukar partridges, up to 8 weeks of age)
DUCKS (Duck, excluding layers)
TURKEYS (Turkey, not laying eggs for human consumption)
Routes of Administration Per Os
Dosage Form Medicated feed
Dispensing Status OTC
Withdrawal Time Turkey and Chicken (broilers): 5 days before slaughter. Ducks: 5 days before slaughter. Chukar: Not released into wild before 18 weeks and can only be used up to 8 weeks of age.
Dosage Amount,
Indications
& Limitations

558.575 Sulfadimethoxine, ormetoprim.

Specifications: Type A medicated articles 25 percent sulfadimethoxine and 15 percent ormetoprim.

Conditions of use:

Chickens (broilers)

Amount: Sulfadimethoxine, 113.5 grams (0.0125 percent) per ton of feed, plus ormetoprim, 68.1 grams (0.0075 percent) per ton of feed.

Indications: As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely, E. tenella, E. necatrix E. acervulina, E. brunetti, E. mivati, and E. maxima and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).

Limitations: Feed as sole ration.

Chickens (replacements)

Amount: Sulfadimethoxine, 113.5 grams (0.0125 percent) per ton of feed plus ormetoprim, 68.1 grams (0.0075 percent) per ton of feed.

Indications: As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to chickens, namely E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati and E. maxima, and bacterial infections due to H galmaxima and bacterial infections due to H. gallinarum (infectious coryza), E. coli (colibacillosis) and P. multocida (fowl cholera).

Limitations: Feed as a sole ration. Do not feed to chickens over 16 weeks (112 days) of age.

Turkeys

Amount: Sulfadimethoxine, 56.75 grams (0.00625 percent) per ton of feed plus ormetoprim, 34.05 grams (0.00375 percent) per ton of feed.

Indications: As an aid in the prevention of coccidiosis caused by all Eimeria species known to be pathogenic to turkeys, namely, E. adenoeides, E. gallopavonis, and E. meleagrimitis and bacterial infection due to P. multocida (fowl cholera).

Limitations: Do not feed to turkeys producing eggs for food.

Chukar partridges

Amount Sulfadimethoxine 113.5 grams (0.0125 percent) per ton plus ormetoprim 68.1 grams (0.0075 percent) per ton.

Indications: For prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis.

Limitations: Feed continuously to young birds up to 8 weeks of age as sole ration.

Ducks

Amount: Sulfadimethoxine, 454 grams (0.05 percent) per ton plus ormetoprim, 272.4 grams (0.03 percent)grams per ton.

Indications: As an aid in the control of bacterial infections due to E. coli, Riemerella anatipestifer, and severe challenge of P. multocida (fowl cholera) in ducks.

Limitations: Feed as a sole ration for 7 days; withdraw 5 days before slaughter; medication should be started at the first signs of infection; not for breeding ducks; do not feed to ducks producing eggs for food.

Tolerances

Sulfadimethoxine: Tolerances are established for residues of sulfadimethoxine in edible products of animals as follows: a. Chickens, turkeys, cattle, ducks, salmonids, catfish and chukar partridges: 0.1 part per million (negligible residue) in uncooked edible tissues b. Milk: 0.01 part per million (negligible residue).Tolerances are established for residues of sulfadimethoxine in edible products of animals as follows: a. Chickens, turkeys, cattle, ducks, salmonids, catfish and chukar partridges: 0.1 part per million (negligible residue) in uncooked edible tissues b. Milk: 0.01 part per million (negligible residue).

Ormetoprim: A tolerance of 0.1 part per million is established for negligible residues of ormetoprim in the edible tissues of chickens, turkeys, ducks, salmonids, and catfish.