Animal NDC 61133-1333-2 Sustain Iii Calf
Sulfamethazine Sustained Release Calf

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-1333-2
Proprietary Name Sustain Iii Calf What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Sulfamethazine Sustained Release Calf What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Bimeda, Inc.
Product Type Prescription Animal Drug
Usage Information
    EACH BOLUS CONTAINS: Sulfamethazine (formulated in a sustained release base), 123.8 grains (8.02 grams).Sustain III Calf Boluses (sulfamethazine) 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 (Fusobacteriulm necrophorum).
Active Ingredient(s)
  • Sulfamethazine
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA120615 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Sustain Iii Calf Images

Sustain Iii Calf Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



Sustain III® Calf Bolus(sulfamethazine)

SUSTAINED RELEASED BOLUS (72 HOURS) Antibacterial 

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. 

NOT FOR HUMAN USE

KEEP OUT OF REACH OF CHILDREN

Approved by FDA under NADA # 120-615


Indications & Usage



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

Sustain III Calf Boluses (sulfamethazine) 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 (Fusobacteriulm 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.


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.


Other



CONTACT INFORMATION: To report adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

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

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.


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).


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.