SUSTAIN III CALF- sulfamethazine sustained release calf tablet, extended release

Sustain III Calf by

Drug Labeling and Warnings

Sustain III Calf by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Second Pharma Company, Ltd., Nanhai Beisha Pharmaceutical Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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).

WARNINGS

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 & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Sulstain III® 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 the 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 an additional 72 hours of therapy, particularly in those more severe cases. The above schedule should be used at each 72-hour interval.

PRECAUTIONS

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.

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUSTAIN III CALF 
sulfamethazine sustained release calf tablet, extended release

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 61133-1333
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfamethazine (UNII: 48U51W007F) (SULFAMETHAZINE - UNII:48U51W007F)	Sulfamethazine	8.02 g  in 8.63 g

Product Characteristics
Color	blue	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	NA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-1333-1	215.75 g in 1 BOTTLE
2	NDC: 61133-1333-2	431.5 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA120615	07/18/1984

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda, Inc.		060492923	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Second Pharma Company, Ltd.		527973171	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Nanhai Beisha Pharmaceutical Co.		527929800	api manufacture