Monday, September 19, 2016

Spectam Water Soluble Concentrate





Dosage Form: FOR ANIMAL USE ONLY
Spectam Water Soluble Concentrate (spectinomycin) NADA 038-661, Approved by FDA Bimeda, Inc. Division of Cross Vetpharm Group

Indications:




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.


For increased rate of weight gain and improved feed efficiency in floor-raised broiler chickens.  Administer one-half (1/2) gram 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.

Dosage and Administration:


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.


To provide 1/2 g/gal:  Dissolve contents of 1/2 package in 500 gallons of water.  For proportioners, dissolve contents of 1/2 package in 4 gallons of water.  Meter at one (1) oz/gal.



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



Precautions:


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.



Storage and Handling:


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



General Precautions:


Take Time Observe Label Directions


FOR ANIMAL USE ONLY


KEEP OUT OF REACH OF CHILDREN



Package Label.Principle Display Panel:


Spectam Water Soluble Concentrate


(spectinomycin)


Anti-Infective


for growing chickens



Each 1000g contains:  Spectinomycin dihydrochloride pentahydrate equivalent to spectinomycin activity ..... 500.00g



FOR ANIMAL USE ONLY


KEEP OUT OF REACH OF CHILDREN


Restricted Drug (California) - Use Only as Directed


NADA 038-661, Approved by FDA


Net Contents:


1000g (35.27 oz)


Manufactured by:


Bimeda, Inc.


Le Sueur, MN 56058










Spectam Water Soluble Concentrate 
spectinomycin  powder, for solution










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)12487-5485
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
spectinomycin (spectinomycin)spectinomycin500.00 g  in 1000 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
112487-5485-11000 g In 1 JARNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA03866106/17/1969


Labeler - Osborn (043653216)
Revised: 10/2010Osborn



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