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

Calf Bolus
Antibacterial

Sulfamethazine Sustained Release Calf 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: 25 Boluses

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

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

  No. of Boluses  2
 Animal Body Wgt.  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 administration to ensure boluses are not regurgitated. Lubricate bolus before dosing animals.

Supra Sulfa®III Calf 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.

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

Uses

Supra Sulfa® 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). Supra Sulfa®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 Diptheria (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.

Supra Sulfa III

Supra Sulfa III

Sulfamethazine TABLET, EXTENDED RELEASE

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:46066-129
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SULFAMETHAZINE SULFAMETHAZINE 8.02 g

Product Characteristics

Color Size Shape
white 50 mm OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46066-129-01 25 in 1 BOTTLE
2 NDC:46066-129-02 50 in 1 BOTTLE

Marketing Information

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


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