Thursday, September 15, 2016

Aureomycin 100 Granule





Dosage Form: FOR ANIMAL USE ONLY
Aureomycin®

100 Granular

Chlortetracycline

Type A Medicated Article



Active drug ingredient


Chlortetracycline calcium complex equivalent to 100 g chlortetracycline hydrochloride per lb.



Ingredients


Dried Streptomyces aureofaciens Fermentation Product and Calcium Sulfate.



For use in the manufacture of medicated animal feeds.

For use in dry feed only. Not for use in liquid medicated feeds.



Use directions


Mix sufficient Aureomycin 100 Granular Medicated Article to supply desired concentration of chlortetracycline per ton with part of the feed ingredients to make a preblend. Add the remainder of the ingredients and mix thoroughly. For specific use levels, see Indications.



Mixing directions















Level desired

grams per ton
Amount of medicated

article per ton*

*

It is recommended that 1 pound of Aureomycin 100 Granular Type A Medicated Article be diluted with 3 pounds of one of the feed ingredients to form a 4 pound working premix. Use 2 pounds of the working premix to make a preblend (see Use directions) for a Type C feed containing 50 g Aureomycin chlortetracycline / ton of feed.

501/2 lb
1001 lb
2002 lb
4004 lb
5005 lb



















































































































IndicationsChlortetracycline

mg per lb body

wt per day
Cattle
Calves (up to 250 lb): Increased rate of weight gain and improved feed efficiency.0.1
  
Beef Cattle (over 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.0.5
  
Beef and Non-Lactating Dairy Cattle: As an aid in control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline when delivered in a free-choice feed. Free-choice feed must be manufactured under a feed mill license utilizing an FDA approved formulation.0.5-2.0
  
Calves, Beef and Non-Lactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. Feed for not more than 5 days. The appropriate amount of Aureomycin-containing feed supplement may be mixed in the cattle's daily ration or administered as a top-dress. If the Aureomycin-containing feed supplement is administered as a top-dress, it must be spread uniformly on top of the ration and sufficient space must be provided so that all cattle can eat at the same time.10
Swine
Control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.

Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Note: this drug level is equivalent to approximately 400 grams per ton, depending on feed consumption and body weight.)

Feed for not more than 14 days.
10
Turkeys
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 to 14 days.25
Indicationsmg per head

per day
Cattle
Calves (250 to 400 lb): Increased rate of weight gain and improved feed efficiency.25-70
  
Growing Cattle (over 400 lb): Increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses.70
  
Beef Cattle: Control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.350
  
Beef Cattle (under 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.350
Sheep
Breeding Sheep: Reduction in the incidence of (vibrionic) abortions caused by Campylobacter fetus infection susceptible to chlortetracycline.80
IndicationsIn complete feed

Chlortetracycline

g per ton
Swine
Increased rate of weight gain and improved feed efficiency.10-50
  
Reduction in the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline.50-100
  
Breeding Swine: Control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Feed continuously for not more than 14 days.400
Sheep
Increased rate of weight gain and improved feed efficiency.20-50
Ducks
Control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. Feed in complete ration to provide from 8 to 28 mg per pound of body weight per day depending upon age and severity of disease. Feed for not more than 21 days.200-400
Chickens
Increased rate of weight gain and improved feed efficiency.10-50
  
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

Feed continuously for 7 to 14 days.
100-200
  
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline.

Feed continuously for 7 to 14 days.
200-400
  
Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline. Feed for 5 days.500
Turkeys
Increased rate of weight gain and improved feed efficiency.10-50
  
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Feed continuously for 7 to 14 days.200
  
Control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline. Feed continuously for 7 to 14 days.400
  
Turkey Poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline.400
Indicationsmg per g feed
Psittacine birds
Warning: Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals and man. Contact appropriate public health and regulatory officials.
Caution: Aspergilliosis may occur following prolonged treatment.
  
Treatment of psittacine birds (parrots, macaws, cockatoos) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. Feed continuously for 45 days. Each bird should consume an amount of medicated feed equal to one-fifth of its body weight daily. During treatment, parrots, macaws, and cockatoos should be kept individually or in pairs in clean cages.10

Warning


A withdrawal period has not been established for this product in pre-ruminating calves.

Do not use in calves to be processed for veal.

Do not feed to ducks or turkeys producing eggs for human consumption.



NADA 48-761, Approved by FDA



Marketed by

Alpharma Inc.

Bridgewater, New Jersey 08807



Trademarks registered

by Alpharma Inc.


700388 0902



PRINCIPAL DISPLAY PANEL - 50 LB Bag


Aureomycin®

100 Granular


ALPHARMA


GUARANTEED

AUREOMYCIN®

CHLORTETRACYCLINE


Chlortetracycline

Type A Medicated Article


See mixing directions, claims, cautions

and warnings on back


Net wt 50 LB (22.68 kg)


Aureomycin®

100 Granular




PRINCIPAL DISPLAY PANEL - 2000 LB Supersack


Aureomycin®

100 Granular


Chlortetracycline

Type A Medicated Article


Aureomycin is a registered trademark of Alpharma Inc.


Net wt 2000 LB (907 kg)


AHL-543 0812


Lot No.:


Expiration Date:










AUREOMYCIN 
chlortetracycline hydrochloride  granule










Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGNDC Product Code (Source)46573-006
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlortetracycline Hydrochloride (Chlortetracycline)Chlortetracycline Hydrochloride100 g  in 0.45 kg






Inactive Ingredients
Ingredient NameStrength
calcium sulfate 


















Product Characteristics
ColorGRAY (gray to brown)Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
146573-006-0022.68 kg In 1 BAGNone
246573-006-18909.1 kg In 1 SUPERSACKNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA04876101/01/2009


Labeler - Alpharma Inc. Animal Health (070954094)









Establishment
NameAddressID/FEIOperations
Alpharma Inc. Animal Health005300025MANUFACTURE, ANALYSIS, RELABEL, REPACK
Revised: 05/2009Alpharma Inc. Animal Health



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