Label: GARASOL- gentamicin sulfate injection, solution
- NDC Code(s): 0061-0134-01
- Packager: Merck Sharp & Dohme Corp.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 15, 2023
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DESCRIPTION
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.
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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.
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VETERINARY INDICATIONS
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.
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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:
GARASOL
mLSterile Saline
mL# Doses Dose/Chicken
mL1 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:
GARASOL
mLSterile Saline
mL# Doses Dose/Turkey
mL1 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 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.
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- PRINCIPAL DISPLAY PANEL - 100 mL Vial Label
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INGREDIENTS AND APPEARANCE
GARASOL
gentamicin sulfate injection, solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0061-0134 Route of Administration SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GENTAMICIN SULFATE (UNII: 8X7386QRLV) (gentamicin - UNII:T6Z9V48IKG) gentamicin 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0061-0134-01 100 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA101862 07/27/1983 Labeler - Merck Sharp & Dohme Corp. (001317601) Establishment Name Address ID/FEI Business Operations Vet Pharma Friesoythe GmbH 341934053 MANUFACTURE
