Thursday, 8 September 2016

Sustain III





Dosage Form: FOR ANIMAL USE ONLY
Sustain III Bolus Antibacterial Sulfamethazine Sustained Release Bolus NADA 120-615, Approved by FDA

DOSAGE AND ADMINISTRATION:  Sustain III Boluses (Sulfamethazine Sustained Release Boluses) are designed to be administered orally to beef cattle and non-lactating dairy cattle (See WARNING).  Sustain III Boluses should be given according to the following dosage schedule:


No. of boluses                                       Animal Body Weight


       1                                                             200 lbs.

      

       1.5                                                          300 lbs.


       2                                                             400 lbs.


       2.5                                                          500 lbs.


       3                                                             600 lbs.


       3.5                                                          700 lbs.


       4                                                             800 lbs.


       4.5                                                          950 lbs.


       5                                                            1,000 lbs.





This bolus may be divided for better approximation of correct dose; however, care should be taken not to crush the bolus.  Care should also be taken to ensure the entire dose has been swallowed by the animal.  Observe animals following administration to ensure boluses are not reguritated.  Lubricate Sustain III before dosing animals.


Sustain III Boluses are designed to provide a therapeutic sulfamethazine level in approximately 6 hours and persist in providing this level for 72 hours (3 days).  After 72 hours, all animals should be re-examined for persistence of observable disease signs.  If signs are present, consult your veterinarian.  It is strongly recommended that a second dose be given to provide for an additional 72 hours of therapy, particularly in those more severe cases.  The dosage schedule should be used at each 72-hour interval.


Fluid intake must be adequate at all times throughout the three-day therapy provided by the sustained release bolus.



Caution



CAUTION:


This drug, like all sulfonamides, may cause toxic reactions and irreparable injury unless administered with adequate and continuous supervision; follow recommended dosages carefully.



Residue Warning


WARNING:  Animals intended for human consumption should not be slaughtered for food for at least 12 days after the last dose.  Exceeding two (2) consecutive doses may cause violative tissue residues to remain beyond the withdrawal time.  Do not use in female dairy cattle 20 months of age or older.  Use of sulfamethazine in this class of cattle may cause milk residues.  Do not use in calves under one (1) month of age or calves being fed an all milk diet.  Use in these classes of calves may cause violative residues to remain beyond the withdrawal time.



Indications and Usage


EACH BOLUS CONTAINS:  Sulfamethazine (formulated in a sustained release base).........................................495 grains (32.1 grams)


Sustain III Boluses (Sulfamethazine Sustained Release Boluses) are intended for oral administration to beef cattle and non-lactating dairy cattle (See WARNING).  Sustain III Boluses are indicated for the treatment of the following diseases when caused by one or more of the following pathogenic organisms sensitive to sulfamethazine:


Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping Fever Complex) (Pasteurella spp.), Colibacillosis (Bacterial Scours) (E. coli), Necrotic pododermatitis (Foot rot), Calf Diptheria (Fusobacterium necrophorum), Acute Metritis (Streptococcus spp).





Package Label Display Panel


Sustain III


Antibacterial Sulfamethazine Sustaine Release Bolus (72 Hours)


FOR ANIMAL USE ONLY


KEEP OUT OF REACH OF CHILDREN


See CAUTION AND WARNING ON SIDE PANEL


NADA 120-615, Approved by FDA


FEEDLOT PACK


NET CONTENTS:  100 BOLUSES










Sustain III 
sulfamethazine  tablet










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)61133-1331
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfamethazine (Sulfamethazine)Sulfamethazine32.1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Colorwhite (32.1 gram cattle bolus/100 carton)Score2 pieces
ShapeOVAL (32.1 gram cattle bolus/100 carton)Size1935mm
FlavorImprint CodeNA
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
161133-1331-2100 BOLUS In 1 CARTONNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12061507/14/1984


Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)
Revised: 01/2010Bimeda, Inc. Division of Cross Vetpharm Group



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