GENTAMICIN PIGLET  - gentamicin sulfate injection 
Sparhawk Laboratories, Inc.

----------

GENTAMICIN PIGLET INJECTION

(GENTAMICIN SULFATE, USP)
Piglet Injection - 5 mg/mL

Piglet Injection Veterinary
Antibacterial for Piglets up to 3 days of age

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.

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. Getnamicin 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 of 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 this 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

Gentamicin Piglet Injection, 5 mg/mL is abailable in 100 mL and 250 mL multiple dose vials.

Gentamicin Piglet Injection Label

GENTAMICIN PIGLET 
gentamicin sulfate   injection
Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)58005-663
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN SULFATE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
158005-663-04100 mL In 1 VIALNone
258005-663-05250 mL In 1 VIALNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA200-39407/31/2007

Labeler - Sparhawk Laboratories, Inc. (958829558)
Revised: 04/2010Sparhawk Laboratories, Inc.