Terramycin 50 description, usages, side effects, indications, overdosage, supplying and lots more!

Terramycin 50

Phibro Animal Health

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Drug Ingredient:

Oxytetracycline (from oxytetracycline dihydrate base) equivalent to

oxytetracycline hydrochloride . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 AT ROOM TEMPERATURE

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 formula ingredients prior to blending into a complete feed.

Indications for Use

Oxytetracycline Amount

lb of
Terramycin 50/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 Escherichia coli susceptible to oxytetracycline

400 g/ton

Feed continuously for 7-14 days

8

Reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli susceptible to oxytetracycline

500 g/ton

Feed continuously for 5 days

10

WARNING: At 500 g/ton level, withdraw 24 hours before slaughter. Zero-day withdrawal period for lower use levels. In lowcalcium 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 Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline

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

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. (Feed 3-5 days before and after arrival in feedlots.)

0.5-2.0 g/head/day

10-404

Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline

10 mg/lb of body weight daily

Feed continuously for 7-14 days

1005

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 Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline

10 mg/lb of body weight daily

Feed continuously for 7-14 days

246

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

2Pig consuming 4 lb of complete feed per 100 lb body weight 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 lamb weighs 60 lb, consuming 1 lb of supplement per head per day

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

NOT FOR HUMAN USE

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS,

USE DIRECTIONS, AND WARNINGS

Terramycin is a registered trademark of Pfizer, Inc.,

licensed to Phibro Animal Health, for Oxytetracycline HCl

Net Weight 50 lb (22.7 kg)

NADA #95-143, Approved by FDA

8842000

101-9009-07

Principal Display Panel

Terramycin 50

oxytetracycline POWDER

Product Information

Product Type Otc type a medicated article animal drug label Item Code (Source) NDC:66104-7200
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Oxytetracycline Hydrochloride OXYTETRACYCLINE ANHYDROUS 50 g

Inactive Ingredients

Ingredient Name Strength
Mineral Oil
CALCIUM CARBONATE
RICE BRAN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66104-7200-0 22.7 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA095143 2010-03-31


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