Animal NDC 58005-663-06 Gentamicin Piglet
Gentamicin Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 58005-663-06
Proprietary Name Gentamicin Piglet What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Gentamicin Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Sparhawk Laboratories, Inc.
Product Type Otc Animal Drug
Usage Information
    Gentamicin Piglet Injection is recommended for the treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin.
Active Ingredient(s)
  • Gentamicin Sulfate
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200394 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Gentamicin Piglet Images

Gentamicin Piglet Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



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


Package Label.Principal Display Panel



Manufactured by
Sparhawk Laboratories, Inc.
Lenexa, KS 66215

G-6639-04                       Rev. 2-09



* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.