GARASOL Dailymed
OTC Animal Generic: gentamicin sulfate is used for the treatment of Bone Diseases, Infectious Central Nervous System Infections Endocarditis Endocarditis, Bacterial Escherichia coli Infections Hypersensitivity Klebsiella Infections Proteus Infections Pseudomonas Infections Respiratory Tract Infections Staphylococcal Infections Peritonitis, Tuberculous Urinary Tract Infections Eye Infections, Bacterial Serratia Infections Skin Diseases, Bacterial Soft Tissue Infections Sepsis
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Injection – 100 mg/mL Anti-Infective for Day-Old Chickens and One- to Three-Day-Old Turkeys
PRODUCT INFORMATION
NADA #101-862, Approved by FDA.
Description Section
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 overa wide range of temperatures and pH.
Veterinary Indications Section
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.
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:
GARASOLmL Sterile SalinemLÂ Â # Doses Dose/ChickenmL 1 99 500 0.2 2 198 1000 0.2 4 396 2000 0.2 10 990 5000 0.2 100 (1 bottle) 9900 50000 0.2
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:
GARASOLmL Sterile SalinemLÂ Â # Doses Dose/TurkeymL 1 19 100 0.2 2 38 200 0.2 4 76 400 0.2 10 190 1000 0.2 100 (1 bottle) 1900 10000 0.2
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 WARNING SECTION
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 Section
HOW SUPPLIED GARASOL Injection, 100 mg/mL, is available in 100-mL multiple-dose vials, NDC 0061-0134-01.
STORAGE AND HANDLING SECTION
Store between 2° and 30°C (36° and 86°F).
Intervet Inc. (d/b/a Merck Animal Health)Madison, NJ 07940.
Made in Germany.
Rev. 02/19
Copyright © 1982, 1996, 2004, 2019Intervet Inc., a subsidiary of Merck & Co.All rights reserved.
182688 R5
Principal Display Panel - 100 Ml Vial Label
100 mg/mL
Sterile
NDC 0061-0134-01
Garasol® (gentamicin injection)Injection
NADA # 101-862,Approved by FDA.
(100 mL)
MERCK Animal Health
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