SPECTOGARD WATER SOLUBLE POWDER- spectinomycin powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SPECTINOMYCIN (UNII: 93AKI1U6QF) (SPECTINOMYCIN - UNII:93AKI1U6QF)

Available from:

Bimeda, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

SpectoGard® Water Soluble Powder (spectinomycin) FOR GROWING CHICKENS Anti-infective CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. NOT FOR USE IN HUMANS KEEP OUT OF REACH OF CHILDREN Restricted Drug (California) - Use only as directed Approved by FDA under NADA # 038-661 INDICATIONS, DOSAGE AND ADMINISTRATION: As an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO). Administer two (2) grams per gallon of water as the only source of drinking water for the first three days of life and for one day following each vaccination. As an aid in controlling infectious synovitis due to Mycoplasma synoviae in broiler chickens. Administer one (1) gram per gallon of water as the only source of drinking water for the first three to five days of life.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SPECTOGARD WATER SOLUBLE POWDER- SPECTINOMYCIN POWDER, FOR
SOLUTION
BIMEDA, INC.
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SPECTOGARD WATER SOLUBLE POWDER
(SPECTINOMYCIN)
FOR GROWING CHICKENS
_ANTI-INFECTIVE_
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
RESTRICTED DRUG (CALIFORNIA) - USE ONLY AS DIRECTED
Approved by FDA under NADA # 038-661
INDICATIONS, DOSAGE AND ADMINISTRATION:
As an aid in the prevention or control of losses due to CRD associated
with _M._
_gallisepticum_ (PPLO). Administer two (2) grams per gallon of water
as the only source of
drinking water for the first three days of life and for one day
following each vaccination.
As an aid in controlling infectious synovitis due to _Mycoplasma
synoviae_ in broiler
chickens. Administer one (1) gram per gallon of water as the only
source of drinking
water for the first three to five days of life.
DIRECTIONS FOR USE:
To provide 2 g/gal: Dissolve contents in 250 gallons of water. For
proportioners, dissolve
contents of 1/2 package in 1 gallon of water. Meter at 1 oz/gal.
To provide 1 g/gal: Dissolve contents in 500 gallons of water. For
proportioners, dissolve
contents of 1/2 package in 2 gallons of water. Meter at 1 oz/gal.
RESIDUE WARNING: DO NOT administer this drug within 5 days of
slaughter. DO NOT
administer to laying chickens.
PRECAUTION:
Rarely, some individuals who handle spectinomycin develop serious
reactions involving
skin, nails and eyes. Individuals who have experienced rash or other
evidence of allergic
reaction should avoid further contact with spectinomycin.
The Safety Data Sheet (SDS) contains more detailed occupational safety
information. To
report suspected adverse drug events, for technical assistance or to
obtain a copy of
the SDS, contact Bimeda, Inc. at 1888-524-6332. For additional
information about
adverse drug experience reporting for animal drugs, contact FDA at
1-888-FDA-VETS or
online at www.fda.gov/reportanimalae.
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