Label: SPECTOGARD WATER SOLUBLE POWDER- spectinomycin powder, for solution

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated November 20, 2019

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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

    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

    RESIDUE WARNING: DO NOT administer this drug within 5 days of slaughter. DO NOT administer to laying chickens.

  • 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.

    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

    Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted 15°C - 30°C (59°F - 86°F).

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SPECTOGARD WATER SOLUBLE POWDER 
    spectinomycin powder, for solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:61133-5485
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SPECTINOMYCIN (UNII: 93AKI1U6QF) (SPECTINOMYCIN - UNII:93AKI1U6QF) SPECTINOMYCIN500 g  in 1000 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-5485-11000 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03866106/14/2016
    Labeler - Bimeda, Inc. (060492923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bimeda, Inc.060492923manufacture