SUSTAIN III CALF- sulfamethazine sustained release calf tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bimeda, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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 ).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SUSTAIN III CALF- SULFAMETHAZINE SUSTAINED RELEASE CALF TABLET,
EXTENDED
RELEASE
BIMEDA, INC.
----------
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
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_).
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.
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
assistance or
to obtain a copy of the Saf