GENTAMICIN SULFATE solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG)

Commercializzato da:

Aspen Veterinary Resources, Ltd.

INN (Nome Internazionale):

GENTAMICIN SULFATE

Composizione:

GENTAMICIN 100 mg in 1 mL

Via di somministrazione:

INTRAUTERINE

Tipo di ricetta:

PRESCRIPTION

Indicazioni terapeutiche:

For intra-uterine use in horses only. Gentamicin Sulfate Solution 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. There are no known contraindications to this drug when used as directed.

Dettagli prodotto:

Gentamicin Sulfate Solution, 100 mg per mL for intrauterine use, is available in 100 mL and 250 mL multiple dose vials.

Stato dell'autorizzazione:

Abbreviated New Animal Drug Application

Scheda tecnica

GENTAMICIN SULFATE- GENTAMICIN SULFATE SOLUTION
ASPEN VETERINARY RESOURCES, LTD.
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GENTAMICIN SULFATE SOLUTION 100 MG/ML
STERILE MULTIPLE DOSE VIAL
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
APPROVED BY FDA UNDER ANADA # 200-395
DESCRIPTION
Each mL of Gentamicin Sulfate Solution contains gentamicin sulfate
veterinary equivalent
to 100 mg gentamicin base; 2.4 mg sodium metabisulfite; 0.8 mg sodium
sulfite,
anhydrous; 0.1 mg edetate disodium; 10 mg benzyl alcohol as
preservative; water for
injection q.s.
CHEMISTRY: GENTAMICIN IS A MIXTURE OF AMINGLYCOSIDE 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.
ANTIBACTERIAL ACTIVITY:_ In Vitro_ antibacterial activity has shown
that gentamicin is
active against most gram-negative and gram-positive bacteria isolated
from domestic
animals.
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.
PHARMACOLOGY: Studies in man indicate that 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.
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.
TOXICITY STUDIES: No toxi