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NADA Number: 006-084

Proprietary Name Sulmet® Drinking Water Solution
Sponsor Fort Dodge Animal Health, Division of Wyeth Holdings Corp.
Sponsor Address P. O. Box 1339
Fort Dodge, IA    50501
USA
Ingredients Sulfamethazine
Species Cattle, dairy, not lactating
Cattle, beef
Turkey, not laying eggs for human consumption
Chicken, not laying eggs for human consumption
Swine, no use class stated or implied
Routes of Administration Per Os
Dose Form Liquid (solution)
Drug Form Liquid (solution)
Dispensing Status OTC
Withdrawal Time Swine: 15 days before slaughter. Cattle: 10 days before slaughter. Chicken and Turkey: 10 days before slaughter.
Dosage Amount,
Indications
& Limitations

520.2261a Sulfamethazine sodium drinking water solution.

Specifications: 12.5-percent sulfamethazine sodium solution.

Conditions of use:

Cattle (beef and nonlactating dairy)

Amount: 112.5 milligrams of sulfamethazine sodium per pound body weight in drinking water per day on the first day and 56.25 milligrams of sulfamethazine sodium per pound of body weight in drinking water on subsequent days.

Indications: For treatment and control of diseases caused by organisms sensitive to sulfamethazine. Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella species), colibacillosis (bacterial scours) (Escherichia coli), necrotic pododermatitis (foot rot) (Fusobacterium necrophorum), calf diphtheria (Fusobacterium necrophorum), acute mastitis (Streptococcus species), and acute metritis (Streptococcus species).

Limitations: Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication from cattle 10 days prior to slaughter for food. Not for use in lactating dairy cattle. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days in cattle. Medicated cattle must actually consume enough medicated water which provides the recommended dosages.

Swine

Amount: 112.5 milligrams of sulfamethazine sodium per pound body weight in drinking water per day on the first day and 56.25 milligrams of sulfamethazine sodium per pound of body weight in drinking water on subsequent days.

Indications: For treatment and control of diseases caused by organisms to sulfamethazine. Treatment of porcine colibacillosis (bacterial scours) (Escherichia coli), and bacterial pneumonia (Pasteurella species).

Limitations: Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication from swine 15 days prior to slaughter for food. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed a total of 5 consecutive days in swine. Medicated swine must actually consume enough medicated water which provides the recommended dosages.

Chickens

Amount: 61 to 89 milligrams of sulfamethazine sodium per pound of body weight in drinking water per day.

Indications: For treatment and control of diseases caused by organisms to sulfamethazine. In chickens for control of infectious coryza (Avibacterium paragallinarum), coccidiosis (Eimeria tenella, Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella var. Pullorum). Medicate as follows: Infectious coryza in chickens, medicate for 2 consecutive days; acute fowl cholera and pullorum disease in chickens, medicate for 6 consecutive days; coccidiosis in chickens, medicate as stated above for chickens, then reduce amount of medication to one-half for 4 additional days.

Limitations: Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication from chickens 10 days prior to slaughter for food. Do not medicate chickens producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated chickens must actually consume enough medicated water which provides the recommended dosages.

Turkeys

Amount: 53 to 130 milligrams of sulfamethazine sodium per pound of body weight in drinking water per day, depending upon the dosage, age, and class of chickens or turkeys, ambient temperature, and other factors.

Indications: For treatment and control of diseases caused by organisms to sulfamethazine. In chickens for control of infectious coryza (Haemophilus gallinarum), coccidiosis (Eimeria tenella, Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella pullorum). In turkeys for control of coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides). Medicate as follows: Infectious coryza in chickens, medicate for 2 consecutive days; acute fowl cholera and pullorum disease in chickens, medicate for 6 consecutive days; coccidiosis in chickens and turkeys, medicate as stated above for chickens and turkeys, then reduce amount of medication to one-half for 4 additional days.

Limitations: Add the required dose to that amount of water that will be consumed in 1 day. Consumption should be carefully checked. Have only medicated water available during treatment. Withdraw medication from turkeys 10 days prior to slaughter for food. Do not medicate turkeys producing eggs for human consumption. Treatment of all diseases should be instituted early. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms. Medicated turkeys must actually consume enough medicated water which provides the recommended dosages.

NAS/NRC status: The conditions of use specified in this section have been reviewed by NAS/NRC and are found effective. Applications for these uses need not include effectiveness data as specified by 514.111 of this chapter, but may require bioequivalency and safety information.

Tolerances

A tolerance of 0.1 part per million is established for negligible residues of sulfamethazine in the uncooked edible tissues of chickens, turkeys, cattle, and swine.