Label: SPECTOGARD WATER SOLUBLE POWDER- spectinomycin powder, for solution
- NDC Code(s): 61133-5485-1
- Packager: Bimeda, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated November 20, 2019
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INDICATIONS & USAGE
SpectoGard® Water Soluble Powder
FOR GROWING CHICKENS
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
NADA 038-661, Approved by FDA
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 synovotis 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.
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
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.
To report suspected adverse events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS) contact Bimeda, Inc. at www.bimeda.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
SPECTOGARD WATER SOLUBLE POWDER
spectinomycin powder, for solution
Product 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