GARASOL- gentamicin sulfate injection, solution

GARASOL by

Drug Labeling and Warnings

GARASOL by is a Animal medication manufactured, distributed, or labeled by Merck Sharp & Dohme Corp., Vet Pharma Friesoythe GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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.

SPL UNCLASSIFIED SECTION

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

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:

GARASOL mL	Sterile Saline mL	# Doses	Dose/Chicken mL
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:

GARASOL mL	Sterile Saline mL	# Doses	Dose/Turkey mL
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 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

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).

SPL UNCLASSIFIED SECTION

Intervet Inc. (d/b/a Merck Animal Health)
Madison, NJ 07940.

Made in Germany.

Rev. 02/19

Copyright © 1982, 1996, 2004, 2019
Intervet 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

INGREDIENTS AND APPEARANCE

GARASOL 
gentamicin sulfate injection, solution

Product 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