GENTAMICIN PIGLET description, usages, side effects, indications, overdosage, supplying and lots more!

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GENTAMICIN PIGLET

Sparhawk Laboratories, Inc.

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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Piglet Injection Veterinary

Antibacterial

For Piglets Up to 3 days of age

For intramuscular use only.

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

GENTAMICIN PIGLET 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.

GENTAMICIN PIGLET 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.

GENTAMICIN PIGLET 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

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

Protect from freezing.

For intramuscular use only.

TAKE TIME OBSERVE LABEL DIRECTIONS

Manufactured by
Sparhawk Laboratories, Inc.
Lenexa, KS 66215

G-6639-04                       Rev. 2-09


GENTAMICIN PIGLET

GENTAMICIN PIGLET

GENTAMICIN PIGLET

GENTAMICIN SULFATE INJECTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:58005-663
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Gentamicin Sulfate GENTAMICIN 5 mg

Packaging

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

Marketing Information

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


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