Equigent 100 mg/ml Solution for Injection for Horses

Do not use in horses which are intended to produce meat or milk for human
consumption.

Special precautions for use in animals
Gentamicin is well known to induce nephrotoxicity even at therapeutic doses in horses.
There are also isolated reports of ototoxicity with gentamicin. No margin of safety has
been established under the approved dosing regimen. As such, gentamicin has a
narrow margin of safety. The product should therefore only be used based on the
benefit-risk assessment by the responsible veterinary surgeon for each individual horse,
taking into account alternative available treatment.
In order to reduce the nephrotoxic risk, adequate hydration of animals under treatment
should be ensured, and fluid therapy should be instituted, if required.
Close monitoring of horses being treated with gentamicin is strongly advised. This
monitoring includes assessing relevant kidney parameters in blood (e.g. creatinine and
urea) and urinalysis (e.g. gamma glutamyl transferase/creatinine ratio). Therapeutic
blood monitoring of gentamicin concentration is also recommended because of known
individual animal variations in peak and trough gentamicin plasma concentrations.
Where blood monitoring is available, target peak plasma gentamicin concentrations
should be approximately 16–20
Particular caution should be taken when administering gentamicin with other potential
nephrotoxic medicinal products (containing e.g. NSAIDs, furosemide, and other
aminoglycosides).
Safety of gentamicin has not been established in foals and there is a lack of knowledge
of the extra effects of gentamicin on foal kidneys, especially neonates. Current
knowledge suggests that foals, especially neonates, are at a higher risk of gentamicin-
induced nephrotoxicity compared to adults.
Differences between neonatal foal kidneys and adults include a slower clearance of
gentamicin in foals.
As such, no margin of safety has been established in neonatal foals. It is therefore not
recommended to use the product in foals.
Whenever possible, use of the product should be based on susceptibility testing of the
bacteria isolated from the animal. Gentamicin is a narrow-spectrum Gram-negative
bactericidal antimicrobial, without effects on anaerobe bacteria and mycoplasmas.
Gentamicin does not penetrate intracellularly, or into abscesses. Gentamicin is de-
activated in the presence of inflammatory debris, low oxygen environments and low pH.
The dosing regimen must not be exceeded. Use of the product deviating from the
instructions given in the SPC increases the risk of nephrotoxicity, and may increase the
prevalence of bacteria resistant to gentamicin.
Extra caution is advised if using gentamicin in old horses, or with fever, endotoxemia,
sepsis and dehydration.

Unlimited renewal: May 2023
AN: 00113/2023
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Gentamicin may cause hypersensitivity (allergic) reactions following exposure. People
with known hypersensitivity to gentamicin should avoid contact with the product.
Administer the product with caution.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.