Gentamicin Sulfate

Bayer HealthCare LLC

GentaPoult (Gentamicin Sulfate Injection)

FULL PRESCRIBING INFORMATION: CONTENTS*

• Front Panel
• GENTAMICIN SULFATE DESCRIPTION:
• CHEMISTRY:
• INDICATIONS:
• GENTAMICIN SULFATE DOSAGE AND ADMINISTRATION:
• RESIDUE WARNING:
• HOW SUPPLIED:
• STORAGE:
• PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
• PACKAGE/LABEL (ONSERT) LABEL
• PACKAGE/LABEL 12 X 100mL DIE CUT
• PACKAGE/LABEL 6 X 12 X 100mL SHIPPER

FULL PRESCRIBING INFORMATION

Front Panel

NDC 0859-2369-01

GentaPoult®

(Gentamicin Sulfate Injection)

Sterile Injection Veterinary

Anti-Infective for Day-Old Chickens and 1 to 3 Day-Old Turkeys

FOR ANIMAL USE ONLY

NOT FOR HUMAN USE

KEEP OUT OF REACH OF CHILDREN

Net Contents: 100mL (3.4 fl oz)

ANADA 200-147, Approved by FDA

FOR SUBCUTANEOUS USE ONLY

EACH mL CONTAINS: Gentamicin sulfate veterinary equivalent to 100 mg gentamicin base; 3.2 mg sodium metabisulfite, 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.

INDICATIONS: Chickens: GentaPoult® (Gentamicin Sulfate Injection) is recommended for the prevention of early mortality in day-old chickens 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: Inject each day-old chicken subcutaneously in the neck with GentaPoult® (Gentamicin Sulfate Injection) diluted with sterile, physiologic saline solution to provide 0.2 mg gentamicin in a 0.2 mL dose. Turkeys: Inject each 1 to 3 day-old turkey subcutaneously in the neck with GentaPoult® (Gentamicin Sulfate Injection) diluted with sterile, physiologic saline solution to provide 1.0 mg gentamicin in a 0.2 mL dose.

For additional information please see label onsert. Product of China

Restricted Drug (California) - Use Only As Directed PROTECT FROM FREEZING Store at controlled room temperature 20°-25°C (68°-77°F).

Manufactured for Bayer HealthCare LLC, Shawnee Mission, KS 66201 Bayer, the Bayer Cross and GentaPoult are registered trademarks of Bayer.

Bayer 81584842,R.O 200116.00

DESCRIPTION:

Each milliliter of GentaPoult® (Gentamicin Sulfate Injection) contains gentamicin sulfate veterinary equivalent to 100 mg gentamicin base; 3.2 mg sodium metabisulfite; 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 veterinary 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.

INDICATIONS:

Day-old chickens - GentaPoult® (Gentamicin Sulfate 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 GentaPoult® (Gentamicin Sulfate 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 GentaPoult® (Gentamicin Sulfate Injection) as follows:

 Turkeys:

Each 1 to 3 day-old turkey should be aseptically injected subcutaneously in the neck with GentaPoult® (Gentamicin Sulfate Injection) diluted with sterile, physiologic saline solution to provide 1.0 mg gentamicin in a 0.2 mL dose. The dose should be injected under the loose skin on the top of the neck, halfway between the head and base of the neck. This concentration can be provided by diluting GentaPoult® (Gentamicin Sulfate 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:

For use in day-old chickens and 1 to 3 day-old turkeys only. Chickens injected with GentaPoult® (Gentamicin Sulfate Injection) must not be slaughtered for food for at least five (5) weeks following treatment. Turkeys injected with GentaPoult® (Gentamicin Sulfate Injection) must not be slaughtered for food for at least nine (9) weeks following treatment.

HOW SUPPLIED:

GentaPoult® (Gentamicin Sulfate Injection) 100 mg/mL is available in 100 mL vials

STORAGE:

Protect from freezing

Store at controlled room temperature 20°-25°C (68°-77°F).

Manufactured for Bayer HealthCare LLC Shawnee Mission, KS 66201

Product of China

Bayer, the Bayer Cross and GentaPoult are registered trademarks of Bayer.

81584842, R.0

200116.00

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE/LABEL (ONSERT) LABEL

PACKAGE/LABEL 12 X 100mL DIE CUT

PACKAGE/LABEL 6 X 12 X 100mL SHIPPER