avilamycin

Chickens (Broilers)

For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens.

Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.

Inteprity™

Chickens (broiler)

For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E.maxima in broiler chickens.

Feed this complete Type C medicated feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of necrotic enteritis associated with Clostridium perfringens in broiler chickens. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses,equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

Inteprity™ and Coban™

Broiler chickens

For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, in broiler chickens.

Inteprity™ and Coxidin®

Broiler chickens

For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati in broiler chickens.

Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens in broiler chickens. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication.

Inteprity™ and Bio-Cox®

Swine (Weaned Pigs)

For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in groups of weaned pigs

Federal law restricts avilamycin medicated feeds to use under a veterinary feed directive (VFD) and the professional supervision of a licensed veterinarian.

Kavault™

For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in groups of weaned pigs.

Elanco™ AF0374 Kavault™ Avilamycin

For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens.

FDA application 141-439

Withdrawal Period: No withdrawal period is required. User Safety Warnings: Avilamycin may be irritating to the eyes and may cause allergic reactions in those hypersensitive to avilamycin. Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators mixing and handling Inteprity Type A medicated article should use protective clothing, impervious gloves, goggles, and an approved dust mask. Wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water and seek medical attention. If wearing contact lenses, rinse the eyes first, then remove contact lenses and continue to rinse the eyes thoroughly and seek medical attention. If accidental skin contact occurs, wash all exposed areas of skin with soap and water, and seek medical attention if irritation develops. If accidental inhalation occurs, seek medical attention if breathing difficulty occurs. Not for human consumption. If accidental ingestion occurs, call a physician or poison control center. Do not induce vomiting. Keep out of reach of children. The Safety Data Sheet contains more detailed occupational safety information. To report adverse effects in users, to obtain more information, or to obtain a Safety Data Sheet, call 1-800-428-4441.

FDA application 141-439

To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

FDA application 141-439

Chickens (Broilers)

Feed at 13.6 to 40.9 grams per ton of Type C medicated feed (15 to 45 ppm) as the sole ration for 21 consecutive days.

Oral

Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.

Inteprity™

Chickens (broiler)

13.6 to 40.9 grams avilamycin per ton and 90 to 110 grams monensin activity per ton of Type C medicated feed.

Oral

Feed this complete Type C medicated feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of necrotic enteritis associated with Clostridium perfringens in broiler chickens. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Not for broiler breeder replacement chickens. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses,equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal.

Inteprity™ and Coban™

Broiler chickens

13.6 to 40.9 g/ton of avilamycin (as Inteprity™) and 90 to 110 g/ton of monensin (as Coxidin®). Feed this complete Type C medicated feed as the sole ration for 21 consecutive days.

Oral

Inteprity™ and Coxidin®

Broiler chickens

13.6 to 40.9 grams per ton avilamycin, 27 to 45 grams per ton narasin, and 27 to 45 grams nicarbazin per ton of Type C medicated feed.

Oral

Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens in broiler chickens. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. Nicarbazin medicated broilers may show reduced heat tolerance if exposed to high temperature and high humidity. Provide adequate drinking water and ventilation during these periods. Do not allow adult turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Narasin and nicarbazin may only be sourced from Maxiban™, NADA #138-952, which provides these drugs at a 1:1 ratio.

Inteprity™ and Maxiban™

Broiler chickens

13.6 to 40.9 grams avilamycin per ton and 40 to 60 grams salinomycin sodium activity per ton of Type C medicated feed.

Oral

Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens in broiler chickens. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication.

Inteprity™ and Bio-Cox®

Broiler chickens

13.6 to 40.9 g/ton avilamycin and 54 to 90 g/ton narasin per ton of Type C medicated feed.

Oral

Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens in broiler chickens. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. Do not allow adult turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal.

Inteprity™ and Monteban™

Swine (Weaned Pigs)

Feed at 73 grams avilamycin per ton of Type C medicated feed (80 ppm) as the sole ration for 21 consecutive days. The veterinarian may direct feeding for up to a total of 42 consecutive days, based on the clinical assessment.

Oral

Federal law restricts avilamycin medicated feeds to use under a veterinary feed directive (VFD) and the professional supervision of a licensed veterinarian.

Kavault™

Avilamycin is to be fed at 13.6 to 40.9 grams per ton of Type C medicated feed (15 to 45 ppm) as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens.

ORAL

FDA application 141-439