Label: SPECTOGARD WATER SOLUBLE POWDER- spectinomycin powder, for solution
- NDC Code(s): 61133-5485-1
- Packager: Bimeda, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
Drug Label Information
Updated December 6, 2023
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INDICATIONS & USAGE
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 & USAGE
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.
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DOSAGE & ADMINISTRATION
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
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PRECAUTIONS
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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INGREDIENTS AND APPEARANCE
SPECTOGARD WATER SOLUBLE POWDER
spectinomycin powder, for solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61133-5485 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SPECTINOMYCIN (UNII: 93AKI1U6QF) (SPECTINOMYCIN - UNII:93AKI1U6QF) SPECTINOMYCIN 500 g in 1000 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-5485-1 1000 g in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA038661 06/14/2016 Labeler - Bimeda, Inc. (060492923) Establishment Name Address ID/FEI Business Operations Bimeda, Inc. 060492923 manufacture