SUSTAIN III- sulfamethazine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sulfamethazine (UNII: 48U51W007F) (SULFAMETHAZINE - UNII:48U51W007F)

Available from:

Bimeda, Inc.

INN (International Name):

Sulfamethazine

Composition:

Sulfamethazine 32.1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

EACH BOLUS CONTAINS: Sulfamethazine (formulated in a sustained release base), 495 grains (32.1 grams). Sustain III Boluses (sulfamethazine) are intended for oral administration to beef cattle and non-lactating dairy cattle (See RESIDUE WARNING Statement ). Sustain 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 Diphtheria (Fusobacterium necrophorum ), Acute Metritis (Streptococcus spp.).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SUSTAIN III - SULFAMETHAZINE TABLET
BIMEDA, INC.
----------
SUSTAIN III® 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
EACH BOLUS CONTAINS: Sulfamethazine (formulated in a sustained release
base),
495 grains (32.1 grams).
Sustain III Boluses (sulfamethazine) are intended for oral
administration to beef cattle
and non-lactating dairy cattle (SEE RESIDUE WARNING STATEMENT).
Sustain 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 Diphtheria (_Fusobacterium necrophorum_), Acute Metritis
(_Streptococcus_spp.).
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.
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.
CONTACT INFORMATION: To report adverse drug events, for technical
as