SPECTINOMYCIN- spectinomycin hydrochloride solution 
Bayer HealthCare LLC

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Drug Facts

Active ingredient

EACH mL CONTAINS:

Spectinomycin ............................................. 100 mg (from spectinomycin dihydrochloride pentahydrate)

Sodium Metabisulfite ................................... 0.5 mg

Sodium Citrate Dihydrate ..............................10 mg

Benzyl Alcohol, as preservative.................... 9 mg

Water for Injection ..........................................q.s.

Also contains Citric Acid and may contain Sodium Hydroxide for pH adjustment.

Description

WARNING: For use only in 1-3 day old turkey poults and newly-hatched chicks.

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.

Restricted drug, use only as directed.

To assure sterility, there should be only one entry into the vial.

IMPORTANT: For indications for use and for complete dosage information, directions and precautions to be observed, read attached insert before using this product.

PRODUCT CHARACTERISTICS

SPECTAM® Injectable is a clear, sterile solution of spectinomycin (from spectinomycin dihydrochloride pentahydrate) intended for subcutaneous injection in newly-hatched baby chicks and turkey poults. It is stable under normal conditions of storage and possesses excellent flow characteristics that make possible the use of a fine-gauge needle for injection. Spectinomycin has an extremely low degree of toxicity. Subcutaneous injections of up to 50 mg per poult have caused no detectable ill effects. Doses of 90 mg per poult have produced transient ataxia and coma from which poults recovered in approximately four hours. Under post-mortem examination, no local tissue reaction has been observed following the injection of SPECTAM®.

Uses

INIDICATIONS FOR USE

SPECTAM® (spectinomycin) Injectable is for use in turkey poults and baby chicks as shown below:

Poults-

 
1. As an aid in the control of Chronic Respiratory Disease (CRD) associated with E. coli.
 
2. As an aid in the control of airsacculitis associated with Mycoplasma meleagridis sensitive to spectinomycin.

Chicks-

As an aid in the control of mortality and to lessen severity of infections caused by M. synoviae, S.typhimurium, S. infantis and E. coli.

Dosage and Administration

SPECTAM® Injectable is intended only for subcutaneous injection. The injection should be made under the loose skin on the top of the neck halfway between the head and the base of the neck. Thoroughly clean and sterilize syringes and needles before using (needles and syringes may be sterilized by boiling in water for 15 minutes).

Use all precautions to prevent contamination of contents of bottle. Injection site should be disinfected with a suitable disinfectant such as 70% isopropyl alcohol just prior to injecting SPECTAM®.

DOSAGE

Directions

Poults-

 
1. As an aid in the control of Chronic Respiratory Disease (CRD) associated with E. coli, inject newly-hatched turkey poults with 5 mg of spectinomycin subcutaneously. See dilution table below for 5 mg concentration in saline solution.
 
2. As an aid in the control of airsacculitis associated with Mycoplasma meleagridis sensitive to spectinomycin, inject newly-hatched turkey poults with 0.1 mL (10 mg) of spectinomycin subcutaneously.

Chicks-

As an aid in the control of mortality and to lessen severity of infections caused by M. synoviae, S. typhimurium, S. infantis and E coli, inject newly-hatched chicks subcutaneously with SPECTAM® Injectable diluted with sterile physiological saline solution to provide 2.5 to 5.0 mg of spectinomycin in a 0.2 mL dose. See dilution table below for 2.5 mg or 5.0 mg concentration in saline solution.

Dilution Table to administer SPECTAM® Injectable containing 100 mg/mL.

Caution: For large flock administration only utilizing appropriate equipment with aseptic techniques. Discard any diluted solution remaining.

Dilution Table

Precautions

WARNING

For use only in 1-3 day old turkey poults and newly-hatched chicks.

PRECAUTIONS

To assure sterility, there should be only one entry into the bottle. 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.

Protect from freezing.

Restricted drug, use only as directed. Not for human use.

Storage

Store at controlled room temperature 20º-25 ºC (68º-77º F)

Take Time Observe Label Directions

HOW SUPPLIED

SPECTAM® Injectable, 100 mg/mL, is supplied in 500 mL rubber-stopped glass bottles. Additional information supplied on request.

Bayer, the Bayer Cross and Spectam are registered trademarks of Bayer. Manufactured for Bayer HealthCare Shawnee Mission, KS 66201

Product of China

81667381, R.0 200122.00

Package/Label Principal Display Panel

SPECTAM Injectable 500mL label and onsert
SPECTINOMYCIN 
spectam injectable solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:0859-2383
Route of AdministrationSUBCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPECTINOMYCIN HYDROCHLORIDE (UNII: HWT06H303Z) (SPECTINOMYCIN - UNII:93AKI1U6QF) SPECTINOMYCIN HYDROCHLORIDE100 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0859-2383-01500 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA04004011/13/201408/31/2015
Labeler - Bayer HealthCare LLC (152266193)
Registrant - Bayer HealthCare LLC (152266193)

Revised: 8/2015
 
Bayer HealthCare LLC