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Neo-Terramycin 50/50Dosage Form: FOR ANIMAL USE ONLY Neo-Terramycin® 50/50 (neomycin-oxytetracycline) TYPE A MEDICATED ARTICLE (Antibiotic) Active Drug Ingredients:Oxytetracycline (from oxytetracycline dihydrate) equivalent to oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 g/lb Neomycin Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 g/lb CAUTION:For use in manufacturing medicated animal feeds only. CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety. Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected. STORE IN A DRY, COOL PLACE FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS. MIXING AND USE DIRECTIONSThoroughly mix the amount of this Type A Medicated Article according to the directions below with at least an equal amount by weight of feed ingredients prior to blending into a complete feed. Indications for Use Oxytetracycline and Neomycin Amount lb. of Neo Terramycin 50/50 per ton CHICKENS Increased rate of weight gain and improved feed efficiency 10-50 g/ton Feed continuously 0.2-1.0 Control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline 100-200 g/ton Feed continuously for 7-14 days 2-4 Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and E. colisusceptible to oxytetracycline 400 g/ton Feed continuously for 7-14 days 8 Reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline 500 g/ton Feed continuously for 5 days 10 WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Low calcium feeds at 500 g/ton, withdraw 3 days before slaughter. Zero-day withdrawal period for lower use levels. In low calcium feeds withdraw 3 days before slaughter. Do not administer to chickens producing eggs for human consumption. TURKEYS For growing turkeys for increased rate of weight gain and improved feed efficiency 10-50 g/ton Feed continuously 0.2-1.0 Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline 100 g/ton Feed continuously for 7-14 days 2 Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline 200 g/ton Feed continuously for 7-14 days 4 Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline 25 mg/lb of body weight daily Feed continuously for 7-14 days 16.7? WARNING: At 200 g/ton use level or higher, withdraw 5 days before slaughter. Zero-day withdrawal period for lower use levels. Do not administer to turkeys producing eggs for human consumption. SWINE Increased rate of weight gain and improved feed efficiency 10-50 g/ton Feed continuously 0.2-1.0 Treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin 10 mg/lb of body weight daily Feed continuously for 7-14 days 102 For breeding swine for control and treatment of Leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline 10 mg/lb of body weight daily Feed continuously for not more than 14 days 10? WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage. CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE For calves (up to 250 lb) for increased rate of weight gain and improved feed efficiency 0.05-0.1 mg/lb of body weight daily Feed continuously 0.1-0.2? For calves (250-400 lb) for increased rate of weight gain and improved feed efficiency 25 mg/head/day Feed continuously 0.54 For growing cattle (over 400 lb) for increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses 75 mg/head/day Feed continuously 1.54 Prevention and treatment of the early stages of shipping fever complex 0.5-2.0 g/head/day Feed 3-5 days before and after arrival in feedlots 10-404 Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin 10 mg/lb of body weight daily Feed continuously for 7-14 days If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. 1005 For calves (up to 250 lb) for treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin 10 mg/lb of body weight daily Feed continuously for 7-14 days If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. 206 WARNING: A withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. At the 0.5-2.0 g/head/day and 10 mg/lb levels: A milk discard time has not been established for use in lactating dairy cattle; do not use in female dairy cattle 20 months of age or older. At the 10 mg/lb level, withdraw 5 days before slaughter. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues. SHEEP Increased rate of weight gain and improved feed efficiency 10-20 g/ton Feed continuously 0.2-0.4 Treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin 10 mg/lb of body weight daily Feed continuously for 7-14 days If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. 247 WARNING: 5-day withdrawal before slaughter at 10 mg/lb dosage. 1If bird weighs 10 lb, consuming 0.6 lb of complete feed per day 2If pig weighs 100 lb, consuming 4 lb of complete feed per day 3If calf weighs 100 lb, consuming 2 lb of complete starter feed per day 4Include in feed supplement based on consumption of 2 lb of supplement per head per day 5If animal weighs 500 lb, consuming 2 lb of supplement per head per day 6If calf weighs 100 lb, consuming 2 lb of complete starter feed per day 7If lamb weighs 60 lb, consuming 1 lb of supplement per head per day FOR USE IN ANIMAL FEEDS ONLY NOT FOR HUMAN USE RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED Neo-Terramycin is a registered trademark of Pfizer, Inc., licensed to Phibro Animal Health, for Neomycin-Oxytetracycline combination products. SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS USE DIRECTIONS AND WARNINGS Net Weight 50 lb (22.7 kg) NADA #94-975, Approved by FDA 8858000 101-9012-08 Neo-Terramycin 50/50 neomycin-oxytetracycline powder Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 66104-0003 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYTETRACYCLINE HYDROCHLORIDE (OXYTETRACYCLINE) OXYTETRACYCLINE HYDROCHLORIDE 50 g in 0.45 kg NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 50 g in 0.45 kg Inactive Ingredients Ingredient Name Strength MINERAL OIL SODIUM ALUMINIUM SILICATE RICE BRAN Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 66104-0003-1 22.7 kg In 1 BAG None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA94975 01/11/1999 Labeler - Phibro Animal Health (006989008) Revised: 01/2011Phibro Animal Health |
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