sulfadimethoxine

Cattle (dairy calves, dairy heifers, and beef)

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Concentrated Solution 12.5%

Cattle (dairy calves, dairy heifers, and beef)

The oral solution is administered as a cattle drench or diluted as directed to prepare drinking water for treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulforal®

Cattle (dairy calves, dairy heifers, and beef)

Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfasol Soluble Powder

For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus), sensitive to sulfadimethoxine.

Di-Methox Injection 40%

For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine.

Albon® or Agribon®

For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot.

Tissue damage may result from perivascular infiltration. Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Sulfadimethoxine Injection 40%

Cattle (dairy calves, dairy heifers, and beef cattle)

Treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Albon®

Cattle (dairy calves, dairy heifers, and beef cattle)

Treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. Federal law prohibits the extralabel use of this product in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfamed-G®

Cattle (beef and nonlactating dairy)

Treatment of shipping fever complex and bacterial pneumonia associated with organisms such as Pasteurella species sensitive to sulfadimethoxine; calf diphtheria and foot rot associated with Sphaerophorus necrophorus.

Do not repeat treatment for 7 days. Do not use in lactating dairy cattle. Do not administer within 12 days of slaughter. During treatment make certain that animals maintain adequate water intake. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Albon® S.R. (Sustained Release)

Chickens (broiler and replacements)

For treatment of outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Concentrated Solution 12.5%

Chickens (broilers and replacements)

As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; as an aid in the prevention of bacterial infections caused by Haemophilus gallinarum (infectious coryza), Escherichia coli (colibacillosis) and P. multocida (fowl cholera).

Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

Rofenaid® 40

Chickens (broilers and replacements)

For treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine 12.5% Oral Solution

Chickens (broilers)

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. gallinarium (infectious coryza), E. coli (colibacillosis), and P. multocida (fowl cholera); growth promotion and feed efficiency; improving pigmentation.

Withdraw 5 days before slaughter. Feed as sole source of organic arsenic.

Rofenaid® Plus Roxarsone

Chickens (broiler and replacement)

For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Do not administer to chickens over 16 weeks (112 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Sulfadimethoxine Soluble Powder

Turkeys (growing)

For growing turkeys: For treatment of disease outbreaks of coccidiosis and fowl cholera.

Do not administer to turkeys over 24 weeks of age.Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Concentrated Solution 12.5%

Turkeys (growing)

For treatment of disease outbreaks of coccidiosis and fowl cholera.

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication.Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine 12.5% Oral Solution

Turkeys (meat)

Treatment of disease outbreaks of coccidiosis and fowl cholera.

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfamed-G®

Turkeys (meat-producing)

For the treatment of disease outbreaks of coccidiosis and fowl cholera.

Do not administer to turkeys over 24 weeks (168 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Sulfadimethoxine Soluble Powder

As an aid in the prevention of coccidiosis caused by E. adenoeides, E. gallopavonis, and E. meleagrimitis and for the prevention of bacterial infections caused by P. multocida (fowl cholera).

Do not feed to turkeys producing eggs for food. Withdraw 5 days before slaughter.

Rofenaid® 40

For the treatment of respiratory genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in the treatment of canine bacterial enteritis associated with coccidiosis and canine Salmonellosis.

Federal law restricts this drug to use by or on the order of a veterinarian.

Albon®

Treatment of skin and soft tissue infections (wounds and abscesses) in dogs caused by strains of Staphylococcus aureus and Escherichia coli and urinary tract infections caused by Escherichia coli, Staphylococcus species, and Proteus mirabilis susceptible to ormetoprim-potentiated sulfadimethoxine.

Continue treatment until patient is asymptomatic for 48 hours, but do not exceed a total of 21 consecutive days. Maintain adequate water intake during the treatment period. Safety in breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Primor® Tablets

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs and enteritis associated with coccidiosis in dogs.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Albon Oral Suspension 5%

It is used or intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs.

For use by or on the order of a licensed veterinarian.

Medacide-SDM Injection 10%

Treatment of sulfadimethoxine-susceptible bacterial infections.

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.

Bactrovet Tablets 250 mg

For the treatment of respiratory genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine.

Federal law restricts this drug to use by or on the order of a veterinarian.

Albon®

It is intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in cats.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Albon Oral Suspension 5%

It is intended for use in the treatment of sulfonamide susceptible bacterial infections.

For use only by or on the order of a licensed veterinarian.

Bactrovet Oral Suspension 12.5%

Treatment of sulfadimethoxine-susceptible bacterial infections.

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.

Bactrovet Tablets 250 mg

Fresh-water reared salmonids

For the control of furunculosis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination.

Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter.

Romet®-30

Catfish

For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim combination.

Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish.

Romet®-30

Ducks (including breeding ducks)

As an aid in the control of bacterial infections due to P. multocida (fowl cholera) in ducks including breeding ducks.

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

Rofenaid® 40

As an aid in the control of bacterial infections due to Escherichia coli, Riemerella anatipestifer (strains 2, 3, and 4), and severe challenge of P. multocida (fowl cholera).

Feed as 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.

Rofenaid® 40

Chukar partridges

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

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

Rofenaid® 40

For the treatment of respiratory disease caused by Streptococcus equi (strangles).

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Albon®

Albon is indicated for the treatment of respiratory, genitourinary tract, enteric, and soft tissue infections in dogs and cats: tonsillitis pharyngitis bronchitis pneumonia cystitis nephritis metritis pyometra pustular dermatitis anal gland infections abscesses wound infections bacterial enteritis canine salmonellosis bacterial enteritis associated with coccidiosis in dogs when caused by streptococci, staphylococci, escherichia, salmonella, klebsiella, proteus or shigella organisms sensitive to sulfadimethoxine. Limitations: Sulfadimethoxine is not effective in viral or rickettsial infections, and as with any antibacterial agent, occasional failures in therapy may occur due to resistant microorganisms. The usual precautions in sulfonamide therapy should be observed.

ALBON® (sulfadimethoxine)

INDICATIONS: Sulfadimethoxine Injection 40% is indicated for the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus), sensitive to sulfadimethoxine. LIMITATIONS: Sulfadimethoxine is not effective in viral or rickettsial infections, and as with any anti-bacterial agent, occasional failures in therapy may occur due to resistant microorganisms. The usual precautions in sulfonamide therapy should be observed.

FDA application 200-038

INDICATIONS FOR USE: For Broiler and Replacement Chickens Only - Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. For Meat-producing Turkeys Only - Use for the treatment of disease outbreaks of coccidiosis, and fowl cholera. For Dairy Calves, Dairy Heifers, and Beef Cattle - Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.

SULFASOL SOLUBLE POWDER

INDICATIONS: CATTLE – For the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus), sensitive to sulfadimethoxine.

FDA application 200-038

For Dairy Calves, Dairy Heifers, and Beef Cattle - Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.

Sulfadimethoxine Soluble Powder

Albon is effective in the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum sensitive to sulfadimethoxine in cattle.

ALBON® Boluses

For control of furunculosis in freshwater-reared salmonids (trout and salmon) caused by Aeromonas salmonicida and of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to the sulfadimethoxine and ormetoprim combination.

ROMET 30 Sulfadimethoxine & OrmetoprimType A Medicated ArticleFor freshwater-reared salmonids (trout and salmon) and catfish

For the treatment of sulfadimethoxine-sensitive bacterial infections in dogs and cats and bacterial enteritis associated with coccidiosis in dogs.

ALBON® (sulfadimethoxine)

Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

Sulfadimethoxine Soluble Powder

Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

Sulfadimethoxine Soluble Powder

Sulfadimethoxine has been demonstrated clinically or in the laboratory to be effective against a variety of organisms, such as streptococci, klebsiella, proteus, shigella, staphylococci, escherichia, and salmonella.1,2 These organisms have been demonstrated in respiratory, genitourinary, enteric, and soft tissue infections of dogs and cats. The systemic sulfonamides which include sulfadimethoxine are bacteriostatic agents. Sulfonamides competitively inhibit bacterial synthesis of folic acid (pteroylglutamic acid) from para-aminobenzoic acid. Mammalian cells are capable of utilizing folic acid in the presence of sulfonamides. The tissue distribution of sulfadimethoxine, as with all sulfonamides, is a function of plasma levels, degree of plasma protein binding, and subsequent passive distribution in the tissues of the lipid-soluble un-ionized form. The relative amounts are determined by both its pKa and by the pH of each tissue. Therefore, levels tend to be higher in less acid tissue and body fluids or those diseased tissues having high concentrations of leucocytes.2 In the dog, sulfadimethoxine is not acetylated as in most other animals, and it is excreted predominantly as the unchanged drug.3 Sulfadimethoxine has a relatively high solubility at the pH normally occurring in the kidney, precluding the possibility of precipitation and crystalluria. Slow renal excretion results from a high degree of tubular reabsorption,4 and plasma protein binding is very high, providing a blood reservoir of the drug. Thus, sulfadimethoxine maintains higher blood levels than most other long-acting sulfonamides. Single, comparatively low doses of Albon give rapid and sustained therapeutic blood levels.1 To assure successful sulfonamide therapy (1) the drug must be given early in the course of the disease, and it must produce a high sulfonamide level in the body rapidly after administration, (2) therapeutically effective sulfonamide levels must be maintained in the body throughout the treatment period, (3) treatment should continue for a short period of time after the clinical signs have disappeared, and (4) the causative organisms must be sensitive to this class of drugs.

ALBON® (sulfadimethoxine)

ACTIONS: Sulfadimethoxine has been demonstrated clinically or in the laboratory to be effective against a variety of organisms, such as streptococci, klebsiella, proteus, shigella, staphylococci, escherichia, and salmonella.1,2 The systemic sulfonamides which include sulfadimethoxine are bacteriostatic agents. Sulfonamides competitively inhibit bacterial synthesis of folic acid (pteroylglutamic acid) from para-aminobenzoic acid. Mammalian cells are capable of utilizing folic acid in the presence of sulfonamides. The tissue distribution of sulfadimethoxine, as with all sulfonamides, is a function of plasma levels, degree of plasma protein binding, and subsequent passive distribution in the tissues of the lipid-soluble un-ionized form. The relative amounts are determined by both its pKa and by the pH of each tissue. Therefore, levels tend to be higher in less acid tissue and body fluids or those diseased tissues having high concentrations of leucocytes.2 Slow renal excretion results from a high degree of tubular reabsorption,3 and plasmaprotein binding is very high, providing a blood reservoir of the drug. Thus, sulfadimethoxine maintains higher blood levels than most other long-acting sulfonamides. Single, comparatively low doses of sulfadimethoxine give rapid and sustained therapeutic blood levels.1 To assure successful sulfonamide therapy (1) the drug must be given early in the course of the disease, and it must produce a high sulfonamide level in the body rapidly after administration, (2) therapeutically effective sulfonamide levels must be maintained in the body throughout the treatment period, (3) treatment should continue for a short period of time after the clinical signs have disappeared, and (4) the causative organisms must be sensitive to this class of drugs.

FDA application 200-038

Sulfadimethoxine has been demonstrated in laboratory studies to be effective against a wide variety of organisms, such as streptococci, staphylococci, and members of the E. coli-salmonella group of bacteria. Comparatively low doses of Albon give rapid, sustained blood levels required for effective disease therapy.

ALBON® Boluses

CAUTION: Store at room temperature; if freezing occurs, thaw before using. Protect from light; direct sunlight may cause discoloration. Freezing or discoloration does not affect potency. Prepare a fresh stock solution daily. Chickens and Turkeys - If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Handle the recommended dilutions (chickens 0.05% and turkeys 0.0.25%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Cattle - During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, reevaluate diagnosis. Treatment should not be continued beyond 5 days. Restricted Drug (California) - Use Only as Directed. Not for Human Use. CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Dechra at (866) 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae WARNINGS: Chickens and Turkeys-Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age. Cattle - Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in preruminating calves. Do Not Use in Calves to be Processed For Veal DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT

Sulforal (sulfadimethoxine)

CAUTION: Chickens and Turkeys - If animals show no improvement within 5 days, discontinue treatment and reevaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Cattle - During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, reevaluate diagnosis. Treatment should not be continued beyond 5 days. WARNINGS: Chickens and Turkeys - Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age. Cattle - Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in pre-ruminating calves. Do Not Use in Calves to be Processed For Veal

SULFASOL SOLUBLE POWDER

PRECAUTION: Store at room temperature; if freezing occurs, thaw before using. Protect from light; direct sunlight may cause discoloration. Freezing or discoloration does not affect potency. Prepare a fresh stock solution daily. CHICKENS AND TURKEYS– If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilutions (chickens 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. CATTLE– During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.

FDA application 200-030

Chickens and Turkeys - If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Cattle - During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.

Sulfadimethoxine Soluble Powder

Chickens and Turkeys – Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age. Cattle – Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in pre-ruminating calves. Do Not Use in Calves to be Processed for Veal Restricted Drug (California) – Use Only as Directed DO NOT SLAUGHTER COW FOR 7 DAYS AFTER LAST TREATMENT

Sulfadimethoxine Concentrated Solution 12.5%

NOT FOR USE IN HUMANS KEEP OUT OF REACH OF CHILDREN Restricted Drug (California) – Use Only as Directed To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

FDA application 200-030

RESIDUE WARNINGS: CHICKENS AND TURKEYS– Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age. CATTLE– Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA application 200-030

Not for Human Use Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not slaughter animals for food purposes within 7 days following the last treatment. A withdrawal period has not been established for this product in preruminating calves. Do Not Use in Calves to be Processed for Veal

ALBON® Boluses

RESIDUE WARNINGS: Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. LOT NO.: EXP. DATE:

FDA application 200-038

Do not feed to turkeys and ducks producing eggs for food. Withdraw 5 days prior to slaughter of broiler and replacement chickens, turkeys and ducks.

RofenAid 40

Withdraw 42 days in freshwater-reared salmonids (trout and salmon) and 3 days in catfish before slaughter or release as stocker fish.

ROMET 30 Sulfadimethoxine & OrmetoprimType A Medicated ArticleFor freshwater-reared salmonids (trout and salmon) and catfish

NOT FOR USE IN HUMANS KEEP OUT OF REACH OF CHILDREN Restricted Drug (California) – Use Only as Directed.

FDA application 200-030

RESTRICTED DRUG (California), USE ONLY AS DIRECTED NOT FOR USE IN HUMANS KEEP OUT OF REACH OF CHILDREN

FDA application 200-038

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

FDA application 200-030

Not for Use in Humans • Keep Out of Reach of Children

Sulfadimethoxine Soluble Powder

Antibacterial Soluble Powder

Sulfadimethoxine Soluble Powder

Not for human use.

ALBON® (sulfadimethoxine)

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae. NOTE: Store at room temperature. Should crystallization occur at cold temperatures, crystals will dissolve either by storing at room temperature for several days or by heating the vial in warm water. Crystallization and redissolution do not impair the efficacy of the product.

FDA application 200-038

To report adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), please contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

Sulfadimethoxine Soluble Powder

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

FDA application 200-030

Cattle (dairy calves, dairy heifers, and beef)

The oral solution is administered as a drench or diluted as directed to prepare drinking water. Administer 1.18 to 2.36 (0.031 percent to 0.062 percent) grams per gallon of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Oral

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. During treatment period, make certain that animals maintain adequate water intake. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

DI-METHOX®

Cattle (dairy calves, dairy heifers, and beef)

1.18 to 2.36 (0.031 to 0.062 percent) grams per gallon. The powder is used to prepare a drench or drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).

Oral

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfasol Soluble Powder

Cattle (dairy calves, dairy heifers, and beef)

Administer 1.18 to 2.36 (0.031 percent to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. The oral solution is administered as a drench or diluted as directed to prepare drinking water.

Oral

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. During treatment period, make certain that animals maintain adequate water intake. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

DI-METHOX®

Cattle (dairy calves, dairy heifers, and beef)

1.18 to 2.36 grams per gallon (0.031 to 0.062 percent) of drinking water. As a drench, administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days.

Oral

Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine 12.5% Oral Solution

Cattle (dairy calves, dairy heifers, and beef)

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench.

Oral

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Soluble Powder

Cattle (dairy calves, dairy heifers, and beef)

Administer 25 mg/lb the first day followed by 12.5 mg/lb/day for 4 consecutive days.

Oral

During treatment period, make certain that animals maintain adequate water Intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Sulfadimethoxine Soluble Powder

To be administered in amounts to provide 25 mg/lb (55 mg/kg) for the initial dose, followed by 12.5 mg/lb (27.5 mg/kg) for maintenance doses every 24 hours. Must be administered only by the intravenous route in cattle. Length of treatment depends on the clinical response. In most cases treatment for 3-5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

Intravenous

Di-Methox Injection 40%

It is administered by intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.

Intravenous

Tissue damage may result from perivascular infiltration. Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Sulfadimethoxine Injection 40%

1.25 to 2.5 grams per 100 pounds body weight. Administer 2.5 grams per 100 pounds body weight for 1 day followed by 1.25 grams per 100 pounds body weight per day.

Oral

Albon® or Agribon®

Cattle (dairy calves, dairy heifers, and beef cattle)

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon to prepare a drench or drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench. Available as a sulfadimethoxine soluble powder or a 12.5 percent sulfadimethoxine sodium solution (3.75 grams sulfadimethoxine per fluid ounce).

Oral

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. Federal law prohibits the extralabel use of this product in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfamed-G®

Cattle (dairy calves, dairy heifers, and beef cattle)

1.18 to 2.36 (0.031 to 0.062 percent) grams of powder per gallon of drinking water. Administer 2.5 grams per 100 pounds of body weight for first day, then 1.25 grams per 100 pounds of body weight per day for the next 4 consecutive days. In drinking water or drench.

Oral

If no improvement within 2 to 3 days, reevaluate diagnosis. Do not treat beyond 5 days. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

Albon®

Cattle (beef and nonlactating dairy)

Administer one bolus for the nearest 200 pounds of body weight, i.e., 62.5 milligrams per pound of body weight.

Oral

Do not repeat treatment for 7 days. Do not use in lactating dairy cattle. Do not administer within 12 days of slaughter. During treatment make certain that animals maintain adequate water intake. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Albon® S.R. (Sustained Release)

Chickens (broiler and replacements)

Administer 1.875 grams/gallon (0.05 percent) of drinking water for 6 consecutive days.

Oral

Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Concentrated Solution 12.5%

Chickens (broilers and replacements)

Administer 1.875 (0.05 percent) grams of powder per gallon of water in drinking water or as a drench. Administer for 6 consecutive days.

Oral

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks (112 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.05 percent) as regular drinking water. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

DI-METHOX®

Chickens (broilers and replacements)

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

Oral

Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaughter.

Rofenaid® 40

Chickens (broilers and replacements)

1.875 (0.05 percent) grams per gallon. The powder is used to prepare a drench or drinking water.

Oral

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfasol Soluble Powder

Chickens (broilers and replacements)

Administer 1.875 grams per gallon (0.05 percent) of drinking water for 6 consecutive days.

Oral

Do not administer to chickens over 16 weeks (112 days) of age. Administer as sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.05 percent) as regular drinking water. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

DI-METHOX®

Chickens (broilers and replacements)

1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.

Oral

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfamed-G®

Chickens (broilers and replacements)

1.875 (0.05 percent) grams per gallon of drinking water.

Oral

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Chickens that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulforal®

Chickens (broilers)

Sulfadimethoxine, 113.5 grams (0.0125 percent) per ton of feed plus ormetoprim 68.1 grams (0.0075 percent) per ton of feed plus roxarsone, 22.7 grams (0.0025 percent) per ton of feed.

Oral

Withdraw 5 days before slaughter. Feed as sole source of organic arsenic.

Rofenaid® Plus Roxarsone

Chickens (broiler and replacement)

1.875 (0.05%) grams per gallon to prepare a drench or drinking water (contents of packet diluted to 50 gallons of water). Treat for 6 consecutive days.

Oral

Do not administer to chickens over 16 weeks (112 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Sulfadimethoxine Soluble Powder

Chickens (broiler and replacement)

1.875 (0.05 percent) grams of powder per gallon to prepare a drench or drinking water.

Oral

Administer for 6 consecutive days. Do not administer to chickens over 16 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Soluble Powder

Turkeys (growing)

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Oral

Do not administer to turkeys over 24 weeks of age. Use as the sole source of drinking water and sulfonamide medication.Withdraw 5 days before slaughter. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine 12.5% Oral Solution

Turkeys (meat)

0.938 (0.025 percent) grams per gallon. The powder is used to prepare a drench or drinking water.

Oral

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfasol Soluble Powder

Turkeys (meat)

0.938 (0.025 percent) grams of powder per gallon to prepare a drench or drinking water.

Oral

Administer for 6 consecutive days. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. As sulfadimethoxine solution or sulfadimethoxine soluble sodium salt. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfamed-G®

Turkeys (meat)

0.938 (0.025 percent) grams of powder per gallon of drinking water.

Oral

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Albon®

Turkeys (meat-producing)

0.938 (0.025%) grams per gallon to prepare a drench or drinking water (contents of the packet diluted to 100 gallons of water). Treat for 6 consecutive days.

Oral

Do not administer to turkeys over 24 weeks (168 days) of age. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Prepare a fresh stock solution daily. Handle the recommended dilutions (chicken 0.05% and turkeys 0.025%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

Sulfadimethoxine Soluble Powder

Turkeys (meat-producing)

Administer 0.938 grams per gallon (0.025 percent) of drinking water for 6 consecutive days.

Oral

Do not administer to turkeys over 24 weeks (168 days) of age. Use as the sole source of drinking water and sulfonamide medication. Withdraw 5 days before slaughter. If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilution (0.025 percent) as regular drinking water. Turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Prepare a fresh stock solution daily. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

DI-METHOX®

Turkeys (meat-producing)

0.938 (0.025 percent) grams of powder per gallon of drinking water.

Oral

Administer for 6 consecutive days. Do not administer to turkeys over 24 weeks of age. As sole source of drinking water and sulfonamide medication. Withdraw 5 days prior to slaughter. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

Sulfadimethoxine Soluble Powder

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

Oral

Do not feed to turkeys producing eggs for food. Withdraw 5 days before slaughter.

Rofenaid® 40

On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

Oral

For use only by or on the order of a licensed veterinarian.

Bactrovet Oral Suspension 12.5%

It is administered by subcutaneous, intramuscular or intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours thereafter. Continue treatment until the animal is free from symptoms for 48 hours.

Subcutaneous, Intramuscular, Intravenous

For use by or on the order of a licensed veterinarian.

Medacide-SDM Injection 10%

On the first day of treatment, administer 25 milligrams per pound (55 milligrams per kilogram) of body weight. Then follow with a daily dosage of 12.5 milligrams per pound (27.5 milligrams per kilogram) of body weight.

Oral

Continue treatment until patient is asymptomatic for 48 hours, but do not exceed a total of 21 consecutive days. Maintain adequate water intake during the treatment period. Safety in breeding animals has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Primor® Tablets

It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.

Intravenous, Subcutaneous

Federal law restricts this drug to use by or on the order of a veterinarian.

Albon®

12.5 to 25 milligrams per pound body weight.

Oral

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.

Bactrovet Tablets 250 mg

On the first day of treatment administer an oral dose of 25 milligrams per pound of body weight, then follow with a daily dosage of 12.5 milligrams per pound of body weight. Length of treatment will depend upon clinical response. Continue treatment until patient is asymptomatic for 48 hours. Maintain adequate water intake during the treatment period.

Oral

For use only by or on the order of a licensed veterinarian.

Bactrovet Oral Suspension 12.5%

It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.

Intravenous, Subcutaneous

Federal law restricts this drug to use by or on the order of a veterinarian.

Albon®

12.5 to 25 milligrams per pound body weight.

Oral

Administer 25 milligrams per pound body weight for first day followed by 12.5 milligrams per pound body weight per day until the animal is free of symptoms for 48 hours, for use only by or on the order of a licensed veterinarian.

Bactrovet Tablets 250 mg

Fresh-water reared salmonids

50 milligrams of active ingredients per kilogram of body weight per day.

Oral

Administer for 5 consecutive days. Withdraw 42 days before release as stocker fish or slaughter.

Romet®-30

Catfish

50 milligrams of active ingredients per kilogram of body weight per day.

Oral

Administer for 5 consecutive days. Withdraw 3 days before slaughter or release as stocker fish.

Romet®-30

Ducks (including breeding ducks)

Sulfadimethoxine, 227 grams per ton of feed (0.025 percent), and ormetoprim, 136.2 grams per ton of feed (0.015 percent).

Oral

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

Rofenaid® 40

Sulfadimethoxine, 454 grams per ton of feed (0.05 percent), and ormetoprim, 272.4 grams per ton of feed (0.03 percent).

Oral

Feed as 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.

Rofenaid® 40

Chukar partridges

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

Oral

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

Rofenaid® 40

It is administered by intravenous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours until the patient is asymptomatic for 48 hours.

Intravenous, Subcutaneous

Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Albon®

DOSAGE AND ADMINISTRATION: SulfaMed Injection 40% must be administered only by the intravenous route in cattle. Cattle should receive 1 mL of SulfaMed Injection 40% per 16 lb of body weight (55 mg/kg) as an initial dose, followed by 0.5 mL per 16 lb of body weight (27.5 mg/kg) every 24 hours thereafter. Sulfadimethoxine Boluses may be utilized for maintenance therapy in cattle. Representative weights and doses are indicated in the following table: Length of treatment depends on the clinical response. In most cases treatment for 3 - 5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours. DIRECTIONS FOR INTRAVENOUS INJECTION: Equipment Needed: 1. A nose lead and/or halter sufficiently strong enough to effectively restrain or hold the animal's head steady so that the intravenous injection can be made with ease. 2. Hypodermic needles, 16 or 18 gauge and 2 inches long. Only new, sharp and sterile hypodermic needles should be used. Dull needles should be discarded. Extra needles should always be available in case the needle being used should become clogged. 3. Hypodermic syringes, 40- or 50-mL sterile, disposable or reusable glass syringes should be available. 4. Alcohol (70%) or equally effective antiseptic for disinfecting the skin. Preparation of equipment: Glass syringes and regular hypodermic needles should be thoroughly cleaned and washed. Following this, the needles and syringes should be immersed in boiling water for 30 minutes prior to each injection. Regular hypodermic needles should not be used more than 3-4 times as repeated skin puncturing and boiling of the needles causes them to become quite dull. Disposable hypodermic needles and syringes should not be used more than once. Restraint of animal: The cow should preferably be in a stanchion for maximum restraint. If this is not possible, the animal should be restrained in a manner to prevent excessive movement. A nose lead should be applied and the animal's head turned sidewise to stretch the skin and tense the muscles of the neck region (See Figure 1). Locating the jugular vein: Once the animal has been restrained (as above), you will notice a long depression of the skin from below the angle of the jaw to just above the shoulder. This is known as the jugular furrow or jugular groove. The jugular vein is located just under the jugular groove (See Figure 1). Preparation of SulfaMed Injection 40% for injection: The rubber cap of the bottle should be thoroughly cleaned with 70% alcohol or other satisfactory antiseptic. The correct amount of SulfaMed Injection 40% for treatment should be calculated (see dosage directions) and that amount withdrawn into a syringe (See Figure 2). One or two syringefuls of air should be injected into the bottle first to make withdrawing the drug easier. SulfaMed Injection 40% should preferably be at room temperature when filling syringes and when injecting intravenously. Entering the vein: The skin of the injection area should be clean and free of dirt. Cotton saturated with 70% alcohol (or suitable antiseptic) should be used to wipe the injection site. Apply pressure over the jugular vein close to the shoulder. This will reduce the flow of blood to the heart and cause the jugular vein to bulge or enlarge (See Figure 3). When the jugular vein has been "raised", insert the hypodermic needle at a 45° angle through the skin just underneath the jugular vein. The beveled edge of the hypodermic needle should be up (See Figure 4). After the skin has been punctured, the point of the needle should be directed toward the side of the vein and pushed into the center of the vein (See Figure 5). When the needle is in the center of the vein, there will be free flow of blood back through the needle. Release external pressure when you are sure the needle is within the vein. Injecting the SulfaMed Injection 40%: After the needle has been accurately inserted into the jugular vein, firmly attach the syringe containing SulfaMed Injection 40% to the inserted hypodermic needle. Caution; be sure syringe is free of air. Exert firm pressure on the plunger of the syringe to inject the SulfaMed Injection 40% while the barrel is held firmly. The injection should be made moderately slow - never rapidly. If the animal moves, causing resistance in pushing the plunger of the syringe, or if a bubble of the drug is noted under the skin, the needle is no longer within the vein. The needle should be repositioned. When the injection is completed, quickly withdraw the syringe and needle with a quick pull and apply light pressure over the injection site with alcohol and cotton to minimize bleeding from the puncture site. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

INTRAVENOUS

FDA application 200-523

Chickens and Turkeys Treatment Period: 6 consecutive days Recommended Concentrations: Chickens – 0.05%; Turkeys – 0.025% Chickens Add 1 fl oz (30 mL) to 2 gallons of drinking water or 25 fl oz to 50 gallons of drinking water. Turkeys Add 1 fl oz (30 mL) to 4 gallons of drinking water or 25 fl oz to 100 gallons of drinking water. Automatic Proportioners* Stock Solution To make 2 gallons of Stock Solution use: Chickens Add 1 gallon of Sulfadimethoxine Concentrated Solution 12.5% to 1 gallon of water Turkeys Add 2 qts of Sulfadimethoxine Concentrated Solution 12.5% to 6 qts of water *Set proportioner to a feed rate of 1 fl oz (30 mL) of Sulfadimethoxine Stock Solution per gallon of water. Dairy Calves, Dairy Heifers, and Beef Cattle Treatment Period: 5 consecutive days Dosage: Initial dose of 25 mg/lb followed by four maintenance doses of 12.5 mg/lb/day Summer Administration Dosage recommendations for summer are based on an estimated water intake of 1 gallon of water per every 100 lb of body weight per day. Sulfadimethoxine Concentrated Solution 12.5% Daily Drinking Water Supply Initial Dose Maintenance Dose 25 gal 1 pt (16 fl oz) 1 cup (8 fl oz) 50 gal 1 qt (32 fl oz) 1 pt (16 fl oz) 200 gal 1 gal (128 fl oz) 2 qt (64 fl oz) Winter Administration Dosage recommendations for winter are based on an estimated water intake of 1 gallon of water per every 150 lb of body weight per day. Sulfadimethoxine Concentrated Solution 12.5% Daily Drinking Water Supply Initial Dose Maintenance Dose 16 gal 1 pt (16 fl oz) 1 cup (8 fl oz) 33 gal 1 qt (32 fl oz) 1 pt (16 fl oz) 127 gal 1 gal (128 fl oz) 2 qt (64 fl oz) For individual treatment of cattle, Sulfadimethoxine Concentrated Solution 12.5% may be given as a drench. Administer using an initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5 mg/lb/day. One fl oz will medicate one 150-lb animal initially and 1/2 fl oz will medicate one 150-lb animal on maintenance dose.

ORAL

Sulfadimethoxine Concentrated Solution 12.5%

Dosage and Administration Chickens and Turkeys Treatment Period: 6 consecutive days Recommended Concentration: Chickens – 0.05%; Turkeys – 0.025% Chickens Add 1 fl oz (30 mL) to 2 gal of drinking water or 25 fl oz to 50 gal of drinking water. Turkeys Add 1 fl oz (30 mL) to 4 quarts of drinking water or 25 fl oz to 100 gal of drinking water. Automatic Proportioners *Stock Solution – To make 2 gal of stock solution: Chickens Add 1 gal of Sulfadimethoxine Concentrated Solution 12.5% to 1 gal of water. Turkeys Add 2 gal of Sulfadimethoxine Concentrated Solution 12.5% to 6 qt of water *Set proportioner to a feed rate of 1 fl oz of stock solution per gal of water Dairy Calves, Dairy Heifers, and Beef Cattle Treatment Period: 5 consecutive days Dosage: Initial dose of 25 mg/lb followed by four maintenance doses of 12.5 mg/lb/day. Summer Administration Dosage recommendations for summer are based on an estimated water intake of 1 gal of water for every 100 lb of body weight per day. Sulfadimethoxine Concentrated Solution 12.5% Daily Drinking Water Supply Initial Dose Maintenance Dose 25 gal 1 pt (16 fl oz) 1 cup (8 fl oz) 50 gal 1 qt (32 fl oz) 1 pt (16 fl oz) 200 gal 1 gal (128 fl oz) 2 qt (64 fl oz) Winter Administration Dosage recommendations for winter are based on an estimated water intake of 1 gal of water for every 150 lb of body weight per day Sulfadimethoxine Concentrated Solution 12.5% Daily Drinking Water Supply Initial Dose Maintenance Dose 16 gal 1 pt (16 fl oz) 1 cup (8 fl oz) 33 gal 1 qt (32 fl oz) 1 pt (16 fl oz) 127 gal 1 gal (128 fl oz) 2 qt (64 fl oz) For individual treatment of cattle, Sulfadimethoxine Concentrated Solution 12.5% may be given as a drench. Administer using an initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5 mg/lb/day. One fl oz will medicate one 150-lb animal initially and ½ fl oz will dedicate one 150-lb animal on maintenance dose.

ORAL

FDA application 200-030

SULFADIMETHOXINE SOLUBLE POWDER Dosage and Administration: Species Concentration Use of Directions Chickens 0.050% Contents of packet to 50 gal of water Turkeys 0.025% Contents of packet to 100 gal of water Automatic Proportioners: To make stock solution, add contents of 5 packets to 2 gal of water for chickens and to 4 gal of water for turkeys. Set proportioner to feed at a rate of 1 fl oz stock solution per gal of water. Treatment Period: 6 consecutive days Dairy Calves, Dairy Heifers, and Beef Cattle Dosage: 25 mg/lb first day followed by 12.5 mg/lb/day for 4 days Sulfadimethoxine in Water Water Consumption Amount of Stock Solution for Cattle* (Summer)* 1 gal/100 lb body weight** (Winter)* 1 gal/150 lb body weight** First Day Add 1 qt 10 gal 7 gal 2 qt 20 gal 14 gal 1 gal 40 gal 28 gal Next 4 Days Add 1 qt 20 gal 14 gal 2 qt 40 gal 28 gal 1 gal 80 gal 56 gal *Note: Make a cattle stock solution by adding 1 packet of Sulfadimethoxine Soluble Powder to 1 gal of water. *Twenty fl oz of cattle stock solution will medicate 1-600 lb animal initially or 2-600 lb animals on maintenance dose. Contents of packet will medicate 6-600 lb animals initially or 12-600 lb animals on maintenance dose. **This dosage recommendation is based on a water consumption of 1 gal per 100 lb of body weight per day, the expected water consumption rate for summer. Water consumption during cold months (winter) may drop markedly (30%-40%). Accordingly, adjustments must be made in the dilution rates to compensate for this and insure proper drug intake. For treatment of individual cattle, Sulfadimethoxine Soluble Powder stock solution for cattle may be given as a drench. Treatment Period: 5 consecutive days

ORAL

SULFASOL SOLUBLE POWDER

Dosage: 25mg/lb first day followed by 12.5 mg/lb/day for 4 days. Sulfadimethoxine in Water Water Consumption Amount of Stock Solution for Cattle* (Summer) 1 gal/100 lb body wt** (Winter) 1 gal/150 lb body wt** First Day Add 1 qt 2 qt 1 gal 10 gal 20 gal 40 gal 7 gal 14 gal 28 gal Next 4 Days Add 1 qt 2 qt 1 gal 20 gal 40 gal 80 gal 14 gal 28 gal 56 gal *Note: Make a cattle stock solution by adding 1 packet of Sulfadimethoxine Soluble Powder to 1 gal of water. ** This dosage recommendation is based on a water consumption of 1 gal per 100 lb of body weight per day, the expected water consumption rate for summer. Water consumption during cold months (winter) may drop markedly (30-40%). Accordingly, adjustments must be made in the dilution rates to compensate for this and insure proper drug intake. For treatment of individual cattle, Sulfadimethoxine Soluble Powder stock solution for cattle may be given as a drench. Administer using same mg/lb dosage as outlined above. *Twenty fluid ounces of cattle stock solution will medicate one-600 lb animal initially or two-600 lb animals on maintenance dose. Contents of packet will medicate six-600 lb animals initially or twelve-600 lb animals on maintenance dose. Treatment Period - 5 consecutive days

ORAL

Sulfadimethoxine Soluble Powder

Initial Dose: 25 mg/lb (55 mg/kg) of animal body weight. Subsequent Daily Doses: 12.5 mg/lb (27.5 mg/kg) of animal body weight. Dogs and cats should receive 1 teaspoonful of Albon Oral Suspension 5% per 10 lb of body weight (25 mg/lb or 55 mg/kg) as an initial dose, followed by 1/2 teaspoonful per 10 lb of body weight (12.5 mg/lb or 27.5 mg/kg) every 24 hours thereafter. Representative weights and doses are indicated in the following table: Animal Weight Initial Dose 25 mg/lb (55 mg/kg) Subsequent Daily Doses 12.5 mg/lb (27.5 mg/kg) 5 lb (2.2 kg) 1/2 tsp (2 1/2 mL) 1/4 tsp (1 1/4 mL) 10 lb (4.5 kg) 1 tsp (5 mL) 1/2 tsp (2 1/2 mL) 20 lb (9.1 kg) 2 tsp (10 mL) 1 tsp (5 mL) 40 lb (18.2 kg) 4 tsp (20 mL) 2 tsp (10 mL) 80 lb (36.4 kg) 8 tsp (40 mL) 4 tsp (20 mL) Treatment may be initiated with Albon Injection 40% to obtain effective blood levels almost immediately or to facilitate treatment of the fractious animal. Length of treatment depends on the clinical response. In most cases treatment for 3–5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

ORAL

ALBON® (sulfadimethoxine)

Initial Dose: 25 mg/lb (55 mg/kg) of animal body weight. Subsequent Daily Doses: 12.5 mg/lb (27.5 mg/kg) of animal body weight. For ease of administration in animals of varying weights, 3 tablet sizes are provided. The following table indicates how dosage may be adjusted depending on tablet size and body weight. Subsequent doses should be given at 24-hour intervals. Tablet Size Approximate Animal Weight Initial Dose 25 mg/lb (55 mg/kg) Subsequent Daily Doses 12.5 mg/lb (27.5 mg/kg) 125 mg 5 lb (2.2 kg) 1 tablet 1/2 tablet 250 mg 10 lb (4.5 kg) 1 tablet 1/2 tablet 500 mg 20 lb (9.1 kg) 1 tablet 1/2 tablet Treatment may be initiated with Albon Injection 40% to obtain effective blood levels almost immediately or to facilitate treatment of the fractious animal. Length of treatment depends on the clinical response. In most cases treatment for 3–5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

ORAL

ALBON® Tablets

DOSAGE AND ADMINSTRATION: Sulfadimethoxine Injection 40% must be administered only by the intravenous route in cattle. Cattle should receive 1 mL of Sulfadimethoxine Injection 40% per 16 pounds of body weight (55 mg/kg) as an initial dose, followed by 0.5 mL per 16 pounds of body weight (27.5 mg/kg) every 24 hours thereafter. Sulfadimethoxine boluses may be utilized for maintenance therapy in cattle. Representative weights and doses are indicated in the following table: Length of treatment depends on the clinical response. In most cases treatment for 3 to 5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

INTRAVENOUS

FDA application 200-038

EACH mL CONTAINS: 400 mg sulfadimethoxine compounded with 20% propylene glycol, 1% benzyl alcohol, 0.1 mg disodium edetate, 1 mg sodium formaldehyde sulfoxylate, and pH adjusted with sodium hydroxide. DOSAGE: To be administered in amounts to provide 25 mg/lb (55 mg/kg) for initial dose, followed by 12.5 mg/lb (27.5 mg/kg) for maintenance doses every 24 hours. During treatment period, make certain that animals maintain adequate water intake. For detailed dosage recommendations, indications, limitations and precautions, read accompanying booklet.

INTRAVENOUS

FDA application 200-038

Dosage and Administration Species Concentration Use Directions Chickens 0.05% Contents of packet to 50 gallons of water Turkeys 0.025% Contents of packet to 100 gallons of water Automatic proportioners - To make stock solution, add contents of 5 packets to 2 gallons of water for chickens and to 4 gallons of water for turkeys. Set proportioner to feed at rate of 1 fl oz of stock solution per gallon of water. Treatment Period - 6 consecutive days

ORAL

Sulfadimethoxine Soluble Powder

Albon should be administered to cattle so that the initial dose is equivalent to 25 mg/lb of body weight and each subsequent daily dose is equivalent to 12.5 mg/lb of body weight. Length of treatment will depend on clinical response. In most cases, treatment for 3–4 days is adequate. Treatment should not be continued beyond 5 days. The following tables show the dosage and dosage forms to be used for cattle of different weights.

ORAL

ALBON® Boluses

DOSAGE: To be administered in amounts to provide 25 mg/lb (55 mg/kg) for initial dose, followed by 12.5 mg/lb (27.5 mg/kg) for maintenance doses every 24 hours. During treatment period, make certain that animals maintain adequate water intake.

INTRAVENOUS

FDA application 200-038

Intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.

Intravenous

SulfaMed®

Administer medicated feed daily for five consecutive days to provide approximately 50 mg of active ingredients per kg (23 mg/lb) of live body of fish per day.

Oral

ROMET 30 Sulfadimethoxine & OrmetoprimType A Medicated ArticleFor freshwater-reared salmonids (trout and salmon) and catfish