GentaMed-P for Poultry Injection

(gentamicin sulfate, USP)

Sterile Solution

100 mg/mL

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

ANADA 200-468, Approved by FDA

Description

Each mL of GentaMed™-P for Poultry Injection contains gentamicin sulfate, USP equivalent to 100 mg gentamicin base; 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 sulfate, USP 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.

GentaMed-P for Poultry Injection Indications

Day-old chickens: Chickens: GentaMed™-P for Poultry 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 GentaMed™-P for Poultry Injection diluted with sterile, physiological saline solution to provide 0.2 mg gentamicin in a 0.2 mL dose. This concentration can be provided by diluting GentaMed™-P for Poultry Injection as follows:

Turkeys: Each 1 to 3-day old turkey should be aseptically injected subcutaneously in the neck with GentaMed™-P for Poultry 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 the base of the neck. This concentration can be provided by diluting GentaMed™-P for Poultry 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 WARNING: Chickens injected with GentaMed™-P for Poultry Injection must not be slaughtered for food for at least 5 weeks following treatment. Turkeys injected with GentaMed™-P for Poultry Injection must not be slaughtered for food for at least 9 weeks following treatment.

How Supplied

GentaMed™-P for Poultry Injection 100 mg/mL is available in 100 mL, multiple-dose vials.

STORE AT 20°C - 25°C (68°F - 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing.

FOR SUBCUTANEOUS USE ONLY.

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California) - Use Only as Directed.

™ GentaMed is a Trademark of Bimeda, Inc.

Manufactured for: Bimeda, Inc., Le Sueur, MN 56058

www.bimeda.com

CPN: 1399110.0