SULMET- sulfamethazine solution

Sulmet by

Drug Labeling and Warnings

Sulmet by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc., Huvepharma EOOD, Huvepharma, Inc. - St. Louis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NDC: 23243-3500-#

Sulmet®

(sulfamethazine sodium)

Drinking Water Solution, 12.5%

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian

Antibacterial
For Animal Use Only

Net Contents: 16 fl oz (473 mL)/1 Gallon (3.7 L)
NADA 006-084, Approved by FDA

Huvepharma

Rev. 04-2016

Indications:

For control and treatment of the following diseases when caused by one or more of the following pathogenic organisms susceptible to sulfamethazine.

For the treatment of:

Cattle: Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping Fever Complex) (Pasteurella spp.)

Colibacillosis (Bacterial Scours) (Escherichia coli)

Necrotic Pododermatitis (Foot Rot) (Fusobacterium necrophorum)

Calf Diphtheria (Fusobacterium necrophorum)

Acute Metritis (Streptococcus spp.)

Beef Cattle: Acute Mastitis (Streptococcus spp.)

Swine: Porcine Colibacillosis (Bacterial Scours) (Escherichia coli)

Bacterial Pneumonia (Pasteurella spp.)

For the control of:

Chickens: Infectious Coryza (Avibacterium paragallinarum)

Coccidiosis (Eimeria tenella, Eimeria necatrix)

Acute Fowl Cholera (Pasteurella multocida)

Pullorum Disease (Salmonella Pullorum)

Turkeys: Coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides)

Dosage and Administration:

Dosage: Cattle, Calves and Swine:

1st day: 6 tablespoons (3 fl oz) for each 100 lb body weight providing approximately 112.5 mg/lb (247.5 mg/kg) body weight.

2nd, 3rd and 4th days: 3 tablespoons (1 1/2 fl oz) for each 100 lb body weight, providing approximately 56.25 mg/lb (123.75 mg/kg) body weight.

Dosage: Poultry: Add 2 tablespoons (1 fl oz) to each gallon of drinking water, or the contents of 1 gal (3.7 L) container to 128 gallons, or contents of 16 fl oz (473 mL) container to 16 gallons. Following administration directions below, this will provide a recommended dose of approximately 61 to 89 mg/lb/day (134 to 196 mg/kg/day) body weight in chickens and 53 to 130 mg/lb/day (117 to 286 mg/kg/day) body weight in turkeys, depending upon the dosage, age and class of chickens or turkeys, ambient temperature, and other factors.

Administration: Cattle, Calves and Swine: Add the required dose given above to that amount of water that will be consumed in 1 day; consumption should be carefully checked. Factors such as temperature, humidity and disease will cause variable fluid intake. As a generalization, the above animals will consume approximately 1 gallon per 100 lb body weight per day.

Administration: Chickens and Turkeys: Add the required dose given above to that amount of water that will be consumed in 1 day. Water consumption should be carefully checked to insure adequate drug intake. As a generalization, 100 turkeys will drink 1 gallon of water per day for each week of age; chickens will consume one-half this amount.

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 above for 2 days, then reduce amount of Sulmet Drinking Water Solution to one-half above for 4 additional days.

Residue Warnings

Do not medicate chickens or turkeys producing eggs for human consumption. To avoid drug residues in edible flesh, withdraw medication from chickens and turkeys ten (10) days prior to slaughter for food.

Treated cattle must not be slaughtered for at least ten (10) days after the last dose. Exceeding five (5) consecutive days of treatment may cause violative tissue residue to remain beyond the withdrawal time. Do not use in calves under one (1) month of age or calves being fed an all-milk diet. Use in these classes of calves may cause violative residues to remain beyond the withdrawal time. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues.

Withdraw medication from swine fifteen (15) days prior to slaughter for food.

Precaution

For best advice in control and treatment of animal disease, consult a veterinarian. Have only medicated water available during treatment, and check carefully to insure adequate Sulmet dosage and water intake. Cattle and calves not drinking or eating must be dosed by drench or with Sulmet Oblets. For best results, treat sick animals individually.

In poultry, consult a veterinarian or poultry pathologist for diagnosis. For control of outbreaks of disease, medication should be initiated as soon as the diagnosis is determined.

Medicated cattle, swine, chickens and turkeys must actually consume enough medicated water which provides the recommended dosages.

Sulmet works fast. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Excessive dosage may cause toxic reactions. Follow above dosage and administration instructions carefully. Hatchability of eggs laid during medication with sulfas and for short periods thereafter, may be adversely affected.

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 or swine.

STORAGE AND HANDLING

Store at or below 25°C (77°F). Protect from freezing.

SPL UNCLASSIFIED SECTION

Not for Human Use

Restricted Drug (California) - Use Only as Directed

HUVEPHARMA and Sulmet are registered trademarks of Huvepharma EOOD

Manufactured for:

Huvepharma, Inc.
525 Westpark Dr., Suite 230Peachtree City, GA 30269 U.S.A

473 mL Label Image

 473 mL Label Image

3700 mL Label Image

3700 mL Label Image

INGREDIENTS AND APPEARANCE

SULMET 
sulfamethazine solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 23243-3500
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFAMETHAZINE SODIUM (UNII: 7Z13P9Q95C) (SULFAMETHAZINE - UNII:48U51W007F)	SULFAMETHAZINE SODIUM	125 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-3500-1	473 mL in 1 BOTTLE, PLASTIC
2	NDC: 23243-3500-2	3700 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA006084	08/23/2010

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma EOOD (552691651)

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc. - St. Louis		883128204	manufacture, analysis, pack, label