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Neo-Terramycin 50/50

Phibro Animal Health

Neo-Terramycin 50/50 (neomycin-oxytetracycline)TYPE A MEDICATED ARTICLE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

(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 DIRECTIONS

Thoroughly 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

16.7¹

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

10²

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

0.1-0.2³

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

Neo-Terramycin 50/50

neomycin-oxytetracycline POWDER

Product Information

Product Type Otc type a medicated article animal drug label Item Code (Source) NDC:66104-0003
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oxytetracycline Hydrochloride OXYTETRACYCLINE ANHYDROUS 50 g
Neomycin Sulfate NEOMYCIN 50 g

Inactive Ingredients

Ingredient Name Strength
Mineral Oil
SODIUM ALUMINIUM SILICATE
RICE BRAN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66104-0003-1 22.7 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA94975 1999-01-11


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