Supra Sulfa III description, usages, side effects, indications, overdosage, supplying and lots more!

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Supra Sulfa III

Aspen Veterinary Resources
Bimeda Inc., Division of Cross Vetpharm Group




FULL PRESCRIBING INFORMATION

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)

Uses

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.).

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 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: 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.

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

Supra Sulfa III

Supra Sulfa III

Sulfamethazine TABLET, EXTENDED RELEASE

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:46066-123
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SULFAMETHAZINE SULFAMETHAZINE 32.1 g

Product Characteristics

Color Size Imprint Code Shape
white 83 mm NA OVAL

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 2012-03-12


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