ANADA No.: 200-037
NDC No.: 50989-318-12
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Each mL of GENTAVED 100 contains:
Gentamicin sulfate equivalent to gentamicin base 100 mg
Sodium metabisulfite 2.4 mg
Sodium sulfite, anhydrous 0.8 mg
Edetate disodium 0.1 mg
Benzyl alcohol as preservative 10 mg
Water for injection q.s.
GENTAVED 100 is recommended for the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin. Bacteriologic studies should be conducted to identify the causative organism and to determine its sensitivity to gentamicin sulfate. Sensitivity discs of the drug are available for this purpose.
Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture of sulfate salts of the antibiotics produced in this fermentation. The salts are weakly acidic, freely soluble in water, and stable in solution.
In vitro antibacterial activity has shown that gentamicin is active against most gram-negative and gram-positive bacteria isolated from domestic animals.
1. Gentamicin is active against Pseudomonas aeruginosa, indole-positive and -negative Proteus species, Escherichia coli, Klebsiella species, Enterobacter species, Alcaligenes species, Staphylococcus species, and Streptococcus species. Studies in man indicate that the recommended doses of gentamicin produce serum concentrations bactericidal for most bacteria sensitive to gentamicin within an hour after intramuscular injection; these concentrations last for 6 to 12 hours.
2. Some 30% of the administered dose of gentamicin is bound by serum proteins and released as the drug is excreted. Gentamicin is excreted almost entirely by glomerular filtration. High concentrations of the active form are found in the urine. Fifty to 100% of the gentamicin injected can be recovered unchanged within 24 hours from the urine of patients with normal renal function. A small amount is excreted into the bile.
Dosage and Administration:
The recommended dose is 20 to 25 mL (2.0-2.5 g) of GENTAVED 100 per day for three (3) to five (5) days during estrus. Each dose should be diluted with 200-500 mL of sterile physiological saline before aseptic uterine infusion.
There are not any known contraindications to this drug when used as directed.
Store between 2°-30°C (36°-86°F). Protect from freezing. If hypersensitivity to any of the components develops, or if an overgrowth of nonsusceptible bacteria, fungi, or yeasts occurs, treatment with GENTAVED 100 should be discontinued and appropriate therapy instituted. Although GENTAVED 100 is not spermicidal, treatment should not be given on the day of breeding.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FOR INTRA-UTERINE USE IN HORSES ONLY.
FOR ANIMAL USE ONLY.
NOT FOR HUMAN USE.
KEEP OUR OF REACH OF CHILDREN.
Not for use in horses intended for food.
Toxic effects were not observed in rats given gentamicin sulfate 20 mg/kg/day for 24 days; nor in cats given 10 mg/kg/day for 40 days. Gentamicin sulfate given to dogs at 6 mg/lb./day, six days a week for three weeks, did not cause detectable kidney damage. At higher doses, impairment of equilibrium and renal function were observed in these species. Side Effects: There have not been reports of drug hypersensitivity nor other adverse side effects following the recommended intra-uterine infusion of GENTAVED 100 combined with sterile physiological saline in mares.
Available upon request.
GENTAVED 100 is available in 100 mL and 250 mL multiple dose vials.
VEDCO - 11/10/98.1
GENTAVED 100 (Gentamicin 100mg)