GENTAMICIN PIGLET- gentamicin sulfate injection

GENTAMICIN PIGLET by

Drug Labeling and Warnings

GENTAMICIN PIGLET by is a Animal medication manufactured, distributed, or labeled by Sparhawk Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Piglet Injection Veterinary

Antibacterial

For Piglets Up to 3 days of age

For intramuscular use only.

ANADA#: 200-394 Approved by F.D.A

DESCRIPTION

Gentamicin Piglet Injection is a sterile preparation for intramuscular administration in piglets up to 3 days of age. Each milliliter contains gentamicin sulfate, USP equivalent to 5 mg gentamicin base, 2 mg sodium bisulfite, 0.1 mg edetate disodium, 7.46 mg sodium acetate, 3 mg glacial acetic acid; 1.3 mg methylparaben and 0.2 mg propylparaben as preservatives, water for injection q.s.

WARNING

For use in piglets up to 3 days of age only.

Piglets injected with Gentamicin Piglet Injection must not be slaughtered for food for at least forty (40) days following treatment. Use of more than the recommended dose will result in gentamicin tissue residues beyond forty (40) days.

Restricted Drug (California)--use only as directed.

Read accompanying directions carefully.

INDICATIONS

Gentamicin Piglet Injection is recommended for the treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin.

DOSAGE AND ADMINISTRATION

The recommended dose is 1 mL (5 mg) administered intramuscularly. Gentamicin Piglet Injection is not to be used more than once in each piglet. If piglets do not respond to treatment with Gentamicin Piglet Injection, diagnosis should be reevaluated. Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use. Prior to injection, disinfect the injection site and top the vial with a suitable disinfectant, such as 70% alcohol. Use all precautions to prevent contamination of vial contents.

CONTRAINDICATIONS

There are no known contraindications to this drug when used as directed.

PRECAUTIONS

Store between 2o and 30oC (36o and 86oF)

CHEMISTRY

Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin Sulfate, USP is a mixture of sulfate salts of the antibiotics produced in the fermentation. The salts are weakly acidic and freely soluble in water. Gentamicin sulfate, USP is stable in solution for the period of time indicated on the labels by the expiration date.

Gentamicin sulfate, USP contains not less than 500 micrograms of gentamicin base per milligram.

HOW SUPPLIED

Enter section text here

STORAGE AND HANDLING

Store between 2o and 30oC (36oand 86oF)

Protect from freezing.

For intramuscular use only.

TAKE TIME OBSERVE LABEL DIRECTIONS

PRINCIPAL DISPLAY PANEL

Manufactured by
Sparhawk Laboratories, Inc.
Lenexa, KS 66215

G-6639-04                       Rev. 2-09

INGREDIENTS AND APPEARANCE

GENTAMICIN PIGLET 
gentamicin sulfate injection

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 58005-663
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)	GENTAMICIN	5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58005-663-04	100 mL in 1 VIAL
2	NDC: 58005-663-05	250 mL in 1 VIAL
3	NDC: 58005-663-06	500 mL in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200394	07/31/2007

Labeler - Sparhawk Laboratories, Inc. (147979082)