SUPRA SULFA III- sulfamethazine tablet, extended release

Supra Sulfa III by

Drug Labeling and Warnings

Supra Sulfa III by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resources, Bimeda Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Supra Sulfa® III

Antibacterial Sulfamethazine

Sustained Release Bolus (72 hours)

See Caution and Warning on Side Panels

Restricted drug ( California) - Use only as Directed

For Animal Use Only

Keep Out of Reach of Children

NADA 120-615, Approved by FDA

NET CONTENTS: 50 Boluses

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

INDICATIONS & USAGE

Supra Sulfa® III Boluses (Sulfamethazine Sustained Release Boluses) are intended for oral administration to beef cattle and non-lactating dairy cattle (See Warning). Supra Sulfa®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) and Acute Metritis (Streptococcus spp.).

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.

DOSAGE & ADMINISTRATION

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

No. of Boluses	Animal Body Wgt.	No. of Boluses	Animal Body Wgt.	No. of Boluses	Animal Body Wgt.
1	200 lbs	2.5	500 lbs	4	800 lbs
1.5	300 lbs	3	600 lbs	4.5	900 lbs
2	400 lbs	3.5	700 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 regurgitated. Lubricate bolus before dosing animals.

Supra Sulfa®III Boluses are designed to provide a therapeutic sulfamethazine level in approximately 6 hours, and persist in providing this level of 72 hours (3 days). After 72 hours, all animals should be reexamined 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 dosage schedule should be used at each 72-hour interval.

RESIDUE WARNING

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 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.

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUPRA SULFA III 
sulfamethazine tablet, extended release

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-123
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFAMETHAZINE (UNII: 48U51W007F) (SULFAMETHAZINE - UNII:48U51W007F)	SULFAMETHAZINE	32.1 g

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	83mm
Flavor		Imprint Code	NA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-123-02	50 in 1 BOX
2	NDC: 46066-123-03	100 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA120615	03/12/2012

Labeler - Aspen Veterinary Resources (627265361)

Registrant - Bimeda Inc. (060492923)

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