Genta-Equine 100 mg/ml Solution for Injection for Horses
Active ingredient: Gentamicin
Form
Injection
Species
Manufacturer
Franklin Pharmaceuticals Ltd
VMD MA No.
33848/4000
What it's used for
For the treatment of infections of the lower respiratory tract in horses caused by aerobic Gramnegative bacteria susceptible to gentamicin.
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Paying less for Gentamicin
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Prescription required
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Genta-Equine 100 mg/ml Solution for Injection for Horses — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.
aerobic Gramnegative bacteria susceptible to gentamicin.
Intravenous use.
Single dose of 6.6 mg/kg body weight given intravenously once daily for 3–5
consecutive days.
To ensure a correct dosage, bodyweight should be determined as accurately as
possible to avoid under- or over-dosing. The dosing regimen must not be
exceeded.
The use of gentamicin in foals and neonates is not recommended.
Do not use in cases of known hypersensitivity to the active substance or to any of
the excipients.
Do not exceed the proposed dosing regimen.
Genta- Equine 100 mg/ml Solution for Injection for Horses.
A local reaction may occur at the injection site, especially in case of repeated
injections in adjacent sites. See Section 4.5 Part A.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated
reports).
consumption.
Revised: December 2025
AN: 02813/2025
i. Special precautions for use in animals
Horses:
Gentamicin is well known to induce nephrotoxicity even at therapeutic doses.
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 μg/ml.
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.
ii. 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
Revised: December 2025
AN: 02813/2025
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.
antibiotics, or with other drugs known to induce either ototoxicity or
nephrotoxicity.
5.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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