AmTech Spectam Injectable

Manufacturer: Teva Animal Health

Spectinomycin 100 Mg/ml

Anti-infective For Turkey Poults And Newly-hatched Chicks

Sterile Solution

For Subcutaneous Use Only

For Animal Use Only

Keep Out Of Reach Of Children

Not For Human Use

Nada 040-040, Approved By Fda

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 examinations, no local tissue reaction has been observed following the injection of SPECTAM^®.

AmTech Spectam Injectable Indications 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.

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.

To Provide 2.5 Mg Per 0.2 Ml Diluted Dose
mL SPECTAM® Injectable	mL sterile saline	Number of doses	Dose/chick mL
500 (1 bottle)	3500	20,000	0.2
1000 (2 bottles)	7000	40,000	0.2
To Provide 5.0 Mg Per 0.2 Ml Diluted Dose
500 (1 bottle)	1500	10,000	0.2
1000 (2 bottles)	3000	20,000	0.2

Each Ml Contains

Spectinomycin (from spectinomycin dihydrochloride pentahydrate)	100 mg
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.

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.

Important

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

HOW SUPPLIED

SPECTAM^® Injectable, 100 mg/mL, is supplied in 500 mL rubber-stopped glass bottles.

Additional information supplied on request.

Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by IVX Animal Health, Inc., St. Joseph, MO 64503

SPECTAM^® and AmTech^® are registered trademarks of IVX Animal Health, Inc.

NET CONTENTS:	NDC
500 mL	59130-731-03	600105-03 Rev1205

Nac No.

10740603