diclazuril

Broiler Chickens

For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati) and E. maxima; and for increased rate of weight gain and improved feed efficiency in broiler chickens. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.

Clinacox™ and Flavomycin®

Broiler Chickens

For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. For increased rate of weight gain and improved feed efficiency in broiler chickens.

Clinacox™ and BMD®

Broiler Chickens

For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunette, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.

Feed continuously as the sole ration throughout the growing period. Use as sole source of organic arsenic. Over dose or lack of drug may result in leg weakness. Not for use in hens producing eggs for human food.

Clinacox™ plus 3-Nitro®

Broiler Chickens

As an aid in the control of necrotic enteritis caused or complicated by Clostridium species or other organisms susceptible to bacitracin, for improved rate of weight gain, for improved feed efficiency and improved pigmentation.

Feed throughout growing period. Start at first signs of clinical disease; vary dosage of bacitracin based on severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist. Then reduce bacitracin to prevention level (50 grams per ton). Use as sole source of organic arsenic. Drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdrawal 5 days before slaughter.

3-Nitro® / BMD® / Clinacox™

Broiler Chickens

For increased rate of weight gain, improved feed efficiency, and improved pigmentation.

Feed continuously as the sole ration throughout the growing period. Use as sole source of organic arsenic. Over dose or lack of drug may result in leg weakness. Not for use in hens producing eggs for human food.

Clinacox™ plus 3-Nitro®

Broiler Chicken

For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. For increased rate of weight gain and improved feed efficiency in broiler chickens.

Feed continuously as the sole ration. Do not use in hens producing eggs for human food.

Clinacox™ / Stafac®

Broiler chickens

For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati) and E. maxima; and for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin in broiler chickens. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.

Clinacox® and Stafac®

Growing Turkeys

For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.

Clinacox™ and Flavomycin®

Growing Turkeys

For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for improved feed efficiency in growing turkeys.

Clinacox™ and Flavomycin®

Growing Turkeys

For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis and E. meleagrimitis.

Clinacox™ 0.2%

For the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.

For oral use in horses only. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Protazil®

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati) and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. Growing Turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis and E. meleagrimitis. IMPORTANT: MUST BE THOROUGHLY MIXED INTO POULTRY FEEDS BEFORE USE.

FDA application 140-951

PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets are indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona in horses.

PROTAZIL® (1.56% diclazuril) ANTIPROTOZOAL PELLETS

The effectiveness of diclazuril in inhibiting merozoite production of Sarcocystis neurona and S. falcatula in bovine turbinate cell cultures was studied by Lindsay and Dubey (2000).1 Diclazuril inhibited merozoite production by more than 80% in cultures of S. neurona or S. falcatula treated with 0.1 ng/mL diclazuril and greater than 95% inhibition of merozoite production (IC95) was observed when infected cultures were treated with 1.0 ng/mL diclazuril. The clinical relevance of the in vitro cell culture data has not been determined.

PROTAZIL® (1.56% diclazuril) ANTIPROTOZOAL PELLETS

Use of PROTAZIL® (1.56% diclazuril) Antiprotozoal Pellets is contraindicated in horses with known hypersensitivity to diclazuril.

PROTAZIL® (1.56% diclazuril) ANTIPROTOZOAL PELLETS

For use in horses only. Do not use in horses intended for human consumption. Not for human use. Keep out of reach of children.

PROTAZIL® (1.56% diclazuril) ANTIPROTOZOAL PELLETS

There were no adverse effects noted in the field study which could be ascribed to diclazuril.

PROTAZIL® (1.56% diclazuril) ANTIPROTOZOAL PELLETS

Broiler Chickens

Diclazuril 0.91 grams per ton feed in combination with bacitracin methylene disalicylate 100 to 200 grams per ton of feed plus roxarsone 22.7 to 45.4 grams per ton.

Oral

Feed throughout growing period. Start at first signs of clinical disease; vary dosage of bacitracin based on severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist. Then reduce bacitracin to prevention level (50 grams per ton). Use as sole source of organic arsenic. Drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdrawal 5 days before slaughter.

3-Nitro® / BMD® / Clinacox™

Broiler Chickens

Diclazuril 0.91 grams per ton of feed in combination with bambermycins 1 to 2 grams per ton of feed.

Oral

Clinacox™ and Flavomycin®

Broiler Chickens

0.91 grams diclazuril per ton (1 part per million) with 22.7 to 45.4 grams per ton roxarsone.

Oral

Feed continuously as the sole ration throughout the growing period. Use as sole source of organic arsenic. Over dose or lack of drug may result in leg weakness. Not for use in hens producing eggs for human food.

Clinacox™ plus 3-Nitro®

Broiler Chickens

Diclazuril: 0.91 g/ton (1 ppm) Bacitracin methylene disalicylate: 4 to 50 g/ton

Oral

Clinacox™ and BMD®

Broiler Chickens

Diclazuril: 0.91 g/ton (1 ppm) Virginiamycin: 5 to 15 g/ton

Oral

Feed continuously as the sole ration. Do not use in hens producing eggs for human food.

Clinacox™ / Stafac®

Broiler Chickens

0.91 grams per ton (1 part per million). Feed continuously.

Oral

Clinacox™ 0.2%

Broiler Chicken

Diclazuril: 0.91 g/ton (1 ppm) Virginiamycin: 5 g/ton

Oral

Feed continuously as the sole ration. Do not use in hens producing eggs for human food.

Clinacox™ / Stafac®

Broiler chickens

0.91 grams (1 ppm) diclazuril and 20 grams virginiamycin per ton of Type C medicated feed.Feed as the sole ration.

Oral

Clinacox® and Stafac®

Growing Turkeys

Diclazuril: 0.91 g/ton (1 ppm) Bacitracin Methylene Disalicylate: 4 to 50 g/ton

Oral

Clinacox™ and BMD®

Growing Turkeys

0.91 grams per ton (1 part per million). Feed continuously as the sole ration.

Oral

Clinacox™ 0.2%

Growing Turkeys

Diclazuril: 0.91 g/ton (1 ppm) Bambermycins: 1 to 2 g/ton

Oral

Clinacox™ and Flavomycin®

Administer as a top dress in the daily grain ration at a rate of 1 milligram per kilogram (0.45 milligrams per pound) of body weight for 28 days. The quantity necessary to deliver this dose is 64 mg pellets per kg (29 mg pellets/lb) of body weight.

Oral

For oral use in horses only. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Protazil®

To manufacture a Type C medicated feed directly from the Type A medicated article: Thoroughly mix one pound (1 lb) of CLINACOX (0.2% diclazuril) into each ton of complete feed to provide 0.91 g/ton (1 ppm) of diclazuril (use level). It is recommended that an intermediate mix containing one part CLINACOX and not less than nine parts appropriate feed ingredient be thoroughly mixed before incorporation into the final feed. To manufacture a Type B medicated feed and then a Type C medicated feed: Thoroughly mix 200 lbs of CLINACOX (0.2% diclazuril) with 1800 lbs unmedicated feed to produce 2000 lbs of Type B medicated feed containing 182 g/ton (200 ppm) diclazuril. Thoroughly mix 10 lbs of the resulting Type B medicated feed with 1990 lbs of unmedicated feed to produce 2000 lbs of Type C medicated feed containing 0.91 g/ton (1 ppm) diclazuril. The resulting Type C medicated feed should be fed continuously as the sole ration. CAUTION: Do not feed to breeding turkeys. WITHDRAWAL PERIODS AND RESIDUE WARNINGS No withdrawal period is required when used according to labeling. Do not feed to birds producing eggs for human consumption.

ORAL

FDA application 140-951