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Animal NDC 61133-5485-1 Spectogard Water Soluble Powder

Spectinomycin

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-5485-1
Proprietary Name Spectogard Water Soluble Powder What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Spectinomycin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Bimeda, Inc.
Product Type Prescription Animal Drug
Usage Information
    SpectoGard® Water Soluble Powder(spectinomycin)FOR GROWING CHICKENSAnti-infectiveCAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.NOT FOR USE IN HUMANSKEEP OUT OF REACH OF CHILDRENRestricted Drug (California) - Use only as directedApproved 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.
Active Ingredient(s)
  • Spectinomycin
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA038661 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Spectogard Water Soluble Powder Images

Spectogard Water Soluble Powder Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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, 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.


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.

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.


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).


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.