Garasol Injection (100 mg/mL)

Product Information

(gentamicin injection)

Injection - 100 mg/mL

Anti-Infective for Day-Old Chickens and One- to Three-Day-Old Turkeys

Approved by FDA under NADA # 101-862

Description

Each milliliter of GARASOL Injection contains 100 mg gentamicin base (equivalent to 156 mg gentamicin sulfate); 3.2 mg sodium bisulfite; 0.1 mg edetate disodium; 4.5 mg sodium acetate, anhydrous; 3.0 mg glacial acetic acid; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; water for injection q.s.

CHEMISTRY Gentamicin is a bactericidal aminoglycoside antibiotic derived from Micromonospora purpurea of the Actinomycetes group. It is a powder, readily soluble in water and basic in nature. Gentamicin aqueous solutions do not require refrigeration and are stable over a wide range of temperatures and pH.

Garasol Injection (100 mg/mL) Indications

Day-old chickens - GARASOL Injection is recommended for the prevention of early mortality associated with Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate. Turkeys - As an aid in the prevention of early mortality of 1- to 3-day-old turkeys associated with Arizona paracolon infections susceptible to gentamicin sulfate.

Garasol Injection (100 mg/mL) Dosage And Administration

Chickens: Each day-old chicken should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 0.2 mg gentamicin in a 0.2-mL dose. This concentration can be provided by diluting GARASOL Injection as follows:

Turkeys: Each 1- to 3-day-old turkey should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 1 mg gentamicin in a 0.2-mL dose. The dose should be injected under the loose skin on top of the neck, halfway between the head and base of the neck. This concentration can be provided by diluting GARASOL Injection as follows:

Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use.

Disinfect the injection site and top of the bottle with a suitable disinfectant, such as 70% isopropyl alcohol. Use all precautions to prevent contamination of vial contents.

Residue Warnings For use in day-old chickens and 1- to 3-day-old turkeys only. Chickens injected with GARASOL Injection must not be slaughtered for food for at least 5 weeks following treatment. Turkeys injected with GARASOL Injection must not be slaughtered for food for at least 9 weeks following treatment.

HOW SUPPLIED GARASOL Injection, 100 mg/mL, is available in 100-mL multiple-dose vials, NDC 0061-0134-01.

Store between 2° and 30°C (36° and 86°F). Use within 28 days of first puncture and puncture a maximum of 10 times.

Gentamicin sulfate (active ingred.) made in China.

Formulated in Germany.

Rev. 12/19

342534 R1

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CPN: 1047092.6