SUSTAIN III CALF BOLUS - sulfamethazine sustained release calf bolus tablet, extended release 
Durvet

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Sustain III® CalfBolus (sulfamethazine)

SUSTAINED RELEASE CALF BOLUS (72 HOURS)

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California)- Use Only as Directed

NADA 120-615, Approved by FDA

EACH BOLUS CONTAINS: Sulfamethazine (Formulated in a sustained release base), 123.8 grains (8.02 grams).

Sustain III® Calf Boluses (Sulfamethazine Sustained Release Boluses) are intended for oral administration to ruminating replacement calves (calves over one (1) month old that are not on an all-milk diet).  Sustain III® Calf 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 (Pasteurella spp.), Colibacillosis (Bacterial Scours) (E. coli) and Calf Diphtheria (Fusobacterium necrophorum).

RESIDUE WARNING: Treated 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 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. 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.

DOSAGE AND ADMINISTRATION: Sustain II®I Calf Boluses (Sulfamethazine Sustained Release Boluses) are designed to be administered orally to ruminating replacement calves (See RESIDUE WARNING Statement). Sustain III® Calf Boluses should be given according to the following dosage schedule:

No. of Boluses                            2                      3                           4                           5                               6

Animal Body Weight            100 lbs.               150 lbs.                  200 lbs.                 250 lbs.                     300 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 the administration to ensure boluses are not regurgitated.  Lubricate bolus before dosing animals. 

Sustain III® Calf 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 a 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 above schedule should be used at each 72-hour interval. 

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

Fluid intake must be adequate at all times throughout the three-day therapy provided by the sustained release bolus. This product has not been shown to be effective for non-ruminating calves.

Store at 20°C - 25°C (68°F - 77°F), with excursions permitted to 15°C - 30°C (59°F - 86°F).

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SUSTAIN III CALF BOLUS 
sulfamethazine sustained release calf bolus tablet, extended release
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:30798-108
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfamethazine (UNII: 48U51W007F) (Sulfamethazine - UNII:48U51W007F) Sulfamethazine8.02 g  in 8.63 g
Product Characteristics
ColorblueScore2 pieces
ShapeOVALSize13mm
FlavorImprint Code NA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30798-108-66215.75 g in 1 BOTTLE
2NDC:30798-108-69431.5 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA12061507/18/198409/06/2017
Labeler - Durvet (056387798)
Registrant - Bimeda, Inc. Division of Cross Vetpharm Group Ltd (060492923)
Establishment
NameAddressID/FEIBusiness Operations
Bimeda, Inc. Division of Cross Vetpharm Group Ltd060492923manufacture
Establishment
NameAddressID/FEIBusiness Operations
Second Pharma Company, Ltd.527973171api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Southwest Synthetic Pharmaceutical Corp., Ltd.544377874api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Nanhai Beisha Pharmaceutical Co.527929800api manufacture

Revised: 9/2017
 
Durvet