POM-V
Prescription Required
Companion Animal
GentaDug 85 mg/ml Solution for Injection for Horses, Cattle, Pigs, Dogs and Cats
Active ingredient: Gentamicin Sulphate
Form
Injection
Species
Cats
Cattle
Dogs
Horses
Pigs
Manufacturer
Bela-Pharm GmbH & Co. KG
VMD MA No.
41816/3000
What it's used for
Cattle: infections of the genital tract. Calves: infections of the respiratory tract, infections of the gastro-intestinal tract, septicaemia, infections of...
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Prescription required
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Clinical information
GentaDug 85 mg/ml Solution for Injection for Horses, Cattle, Pigs, Dogs and Cats — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Cattle: infections of the genital tract.
Calves: infections of the respiratory tract, infections of the gastro-intestinal tract,
septicaemia, infections of the joints, infections of the auditory meatus.
Pigs: infections of the respiratory tract, metritis, mastitis and agalactia (MMA)
complex.
Piglets, weaners: infections of the respiratory tract, enzootic pneumonia, infections
caused by
Dogs, cats: infections of the respiratory tract, infections of the gastro-intestinal tract,
infections of the kidneys, the urinary and the genital tract, septicaemia, infections of
the auditory meatus.
Issued : July 2023
Calves: infections of the respiratory tract, infections of the gastro-intestinal tract,
septicaemia, infections of the joints, infections of the auditory meatus.
Pigs: infections of the respiratory tract, metritis, mastitis and agalactia (MMA)
complex.
Piglets, weaners: infections of the respiratory tract, enzootic pneumonia, infections
caused by
Dogs, cats: infections of the respiratory tract, infections of the gastro-intestinal tract,
infections of the kidneys, the urinary and the genital tract, septicaemia, infections of
the auditory meatus.
Issued : July 2023
Single dose of 11.2 mg gentamicin sulphate (= 6.6 mg gentamicin) per
kg bodyweight, corresponding to 6.6 ml of the veterinary medicinal
product per 50 kg bodyweight given intravenously once daily for 3 - 5
consecutive days.
To ensure a correct dosage, bodyweight should be determined as accurately as
possible. The dosing regimen should not be exceeded. The use of gentamicin in foals
and neonates is not recommended.
Cattle, pigs:
For intramuscular or slow intravenous injection.
5.9 mg gentamicin sulphate (= 3.5 mg gentamicin) per kg bodyweight
corresponding to 3.5 ml of the veterinary medicinal product per 50 kg
bodyweight given twice daily at intervals of 12 hours for 3 to 5 days.
Issued : July 2023
Calves, weaners, piglets in the first months of life:
Initial treatment:
5.9 mg gentamicin sulphate (= 3.5 mg gentamicin) per kg bodyweight
corresponding to 0.7 ml of the veterinary medicinal product per 10 kg
bodyweight
Second and subsequent injections:
2.9 mg gentamicin sulphate (= 1.75 mg gentamicin) per kg bodyweight
corresponding to 0.3 ml of the veterinary medicinal product per 10 kg
bodyweight given twice daily at intervals of 12 hours for 3 to 5 days.
In pigs do not administer more than 1 ml per injection site.
Repeated injections should be made at different injection sites.
For intramuscular, subcutaneous or slow intravenous injection in dogs and cats.
Dogs older than 2 weeks:
6.5 mg gentamicin sulphate (= 3.85 mg gentamicin) per kg bodyweight
corresponding to 0.8 ml of the veterinary medicinal product per 10 kg
bodyweight given twice daily at intervals of 12 hours on the first day,
thereafter once daily at intervals of 24 hours for 3 to 10 days.
Dogs younger than 2 weeks:
Initial treatment:
6.5 mg gentamicin sulphate (= 3.85 mg gentamicin) per kg bodyweight
corresponding to 0.23 ml of the veterinary medicinal product per 3 kg
bodyweight
Second and subsequent injections:
3.25 mg gentamicin sulphate (= 1.925 mg gentamicin) per kg
bodyweight corresponding to 0.12 ml of the veterinary medicinal
product per 3 kg bodyweight given twice daily at intervals of 12 hours
on the first day, thereafter once daily at intervals of 24 hours for 3 to
10 days.
Cats older than 2 weeks:
4.32 mg gentamicin sulphate (= 2.56 mg gentamicin) per kg
bodyweight corresponding to 0.25 ml of the veterinary medicinal
product per 5 kg bodyweight given twice daily at intervals of 12 hours
for 3 to 10 days.
Cats younger than 2 weeks:
Initial treatment:
4.32 mg gentamicin sulphate (= 2.56 mg gentamicin) per kg
bodyweight corresponding to 0.13 ml of the veterinary medicinal
product per 2.5 kg bodyweight
Second and further injections:
2.16 mg gentamicin sulphate (= 1.28 mg gentamicin) per kg
bodyweight corresponding to 0.06 ml of the veterinary medicinal
Issued : July 2023
product per 2.5 kg bodyweight given twice daily at intervals of 12
hours for 3 to 10 days.
If no significant clinical improvement is noted within 3 days of treatment, the initial
diagnosis should be reassessed and the therapy should be changed, if necessary.
In case an extended treatment is required, kidney function should be monitored.
The closure should not be pierced more than 50 times.
kg bodyweight, corresponding to 6.6 ml of the veterinary medicinal
product per 50 kg bodyweight given intravenously once daily for 3 - 5
consecutive days.
To ensure a correct dosage, bodyweight should be determined as accurately as
possible. The dosing regimen should not be exceeded. The use of gentamicin in foals
and neonates is not recommended.
Cattle, pigs:
For intramuscular or slow intravenous injection.
5.9 mg gentamicin sulphate (= 3.5 mg gentamicin) per kg bodyweight
corresponding to 3.5 ml of the veterinary medicinal product per 50 kg
bodyweight given twice daily at intervals of 12 hours for 3 to 5 days.
Issued : July 2023
Calves, weaners, piglets in the first months of life:
Initial treatment:
5.9 mg gentamicin sulphate (= 3.5 mg gentamicin) per kg bodyweight
corresponding to 0.7 ml of the veterinary medicinal product per 10 kg
bodyweight
Second and subsequent injections:
2.9 mg gentamicin sulphate (= 1.75 mg gentamicin) per kg bodyweight
corresponding to 0.3 ml of the veterinary medicinal product per 10 kg
bodyweight given twice daily at intervals of 12 hours for 3 to 5 days.
In pigs do not administer more than 1 ml per injection site.
Repeated injections should be made at different injection sites.
For intramuscular, subcutaneous or slow intravenous injection in dogs and cats.
Dogs older than 2 weeks:
6.5 mg gentamicin sulphate (= 3.85 mg gentamicin) per kg bodyweight
corresponding to 0.8 ml of the veterinary medicinal product per 10 kg
bodyweight given twice daily at intervals of 12 hours on the first day,
thereafter once daily at intervals of 24 hours for 3 to 10 days.
Dogs younger than 2 weeks:
Initial treatment:
6.5 mg gentamicin sulphate (= 3.85 mg gentamicin) per kg bodyweight
corresponding to 0.23 ml of the veterinary medicinal product per 3 kg
bodyweight
Second and subsequent injections:
3.25 mg gentamicin sulphate (= 1.925 mg gentamicin) per kg
bodyweight corresponding to 0.12 ml of the veterinary medicinal
product per 3 kg bodyweight given twice daily at intervals of 12 hours
on the first day, thereafter once daily at intervals of 24 hours for 3 to
10 days.
Cats older than 2 weeks:
4.32 mg gentamicin sulphate (= 2.56 mg gentamicin) per kg
bodyweight corresponding to 0.25 ml of the veterinary medicinal
product per 5 kg bodyweight given twice daily at intervals of 12 hours
for 3 to 10 days.
Cats younger than 2 weeks:
Initial treatment:
4.32 mg gentamicin sulphate (= 2.56 mg gentamicin) per kg
bodyweight corresponding to 0.13 ml of the veterinary medicinal
product per 2.5 kg bodyweight
Second and further injections:
2.16 mg gentamicin sulphate (= 1.28 mg gentamicin) per kg
bodyweight corresponding to 0.06 ml of the veterinary medicinal
Issued : July 2023
product per 2.5 kg bodyweight given twice daily at intervals of 12
hours for 3 to 10 days.
If no significant clinical improvement is noted within 3 days of treatment, the initial
diagnosis should be reassessed and the therapy should be changed, if necessary.
In case an extended treatment is required, kidney function should be monitored.
The closure should not be pierced more than 50 times.
Do not use in animals with impaired renal function.
Do not use in dehydrated animals due to the risk of acute renal failure.
Do not use in animals with disturbances of the vestibular or auditory systems.
Do not use in cases of known hypersensitivity to the active substance or to any of the
excipients.
Do not inject intravenously if used concomitantly with muscle relaxants.
Do not use concomitantly with bacteriostatic antibiotics.
Do not administer concurrently with diuretics and potentially nephrotoxic medicinal
products.
Do not exceed the proposed dosing regimen.
Do not use in dehydrated animals due to the risk of acute renal failure.
Do not use in animals with disturbances of the vestibular or auditory systems.
Do not use in cases of known hypersensitivity to the active substance or to any of the
excipients.
Do not inject intravenously if used concomitantly with muscle relaxants.
Do not use concomitantly with bacteriostatic antibiotics.
Do not administer concurrently with diuretics and potentially nephrotoxic medicinal
products.
Do not exceed the proposed dosing regimen.
Horses (non-food producing horses), cattle, pigs, dogs and cats:
Undetermined frequency
(cannot be estimated from the
available data):
Vestibular disorder
Internal ear disorder
Renal disorders
Proteinuria
Issued : July 2023
May occur when administered for a treatment period exceeding the
recommendations.
Renal disorders may result in proteinuria
nitrogen.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also section “Contact
details” of the package leaflet for respective contact details.
Undetermined frequency
(cannot be estimated from the
available data):
Vestibular disorder
Internal ear disorder
Renal disorders
Proteinuria
Issued : July 2023
May occur when administered for a treatment period exceeding the
recommendations.
Renal disorders may result in proteinuria
nitrogen.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See also section “Contact
details” of the package leaflet for respective contact details.
Within the group of aminoglycosides, complete cross-resistance is often observed.
Special precautions for safe use in the target species:
As gentamicin has a narrow therapeutic margin, to ensure a correct dosage, body
weight should be determined as accurately as possible.
Use of the product should be based on identification and susceptibility testing of the
target pathogen(s). If this is not possible, therapy should be based on
epidemiological information and knowledge of susceptibility of the target pathogens
at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional
antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG
category) should be used for the first line treatment where susceptibility testing
suggests the likely efficacy of this approach.
Because of the risk of occurrence of neuromuscular blockade, the veterinary
medicinal product must be injected slowly when administered intravenously.
In dehydrated animals, fluid balance should be restored before treatment is initiated.
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.
Issued : July 2023
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.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
People with known hypersensitivity to gentamicin, sodium metabisulfite or methyl- or
propyl parahydroxybenzoate should avoid contact with the veterinary medicinal
product.
Special precautions for safe use in the target species:
As gentamicin has a narrow therapeutic margin, to ensure a correct dosage, body
weight should be determined as accurately as possible.
Use of the product should be based on identification and susceptibility testing of the
target pathogen(s). If this is not possible, therapy should be based on
epidemiological information and knowledge of susceptibility of the target pathogens
at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional
antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG
category) should be used for the first line treatment where susceptibility testing
suggests the likely efficacy of this approach.
Because of the risk of occurrence of neuromuscular blockade, the veterinary
medicinal product must be injected slowly when administered intravenously.
In dehydrated animals, fluid balance should be restored before treatment is initiated.
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.
Issued : July 2023
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.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
People with known hypersensitivity to gentamicin, sodium metabisulfite or methyl- or
propyl parahydroxybenzoate should avoid contact with the veterinary medicinal
product.
When treating simultaneously with other pharmaceuticals, they should always be
administered separately to avoid possible inactivation.
Do not use concomitantly with other oto- or nephrotoxic drugs.
Combined therapy with suitable antibiotics (e.g. ß-lactam antibiotics) may lead to a
synergistic effect. Synergistic effects with acylaminopenicillins on Pseudomonas
aeruginosa and with cephalosporins on Klebsiella pneumoniae
Please note that cross allergy to other aminoglycoside antibiotics may occur.
administered separately to avoid possible inactivation.
Do not use concomitantly with other oto- or nephrotoxic drugs.
Combined therapy with suitable antibiotics (e.g. ß-lactam antibiotics) may lead to a
synergistic effect. Synergistic effects with acylaminopenicillins on Pseudomonas
aeruginosa and with cephalosporins on Klebsiella pneumoniae
Please note that cross allergy to other aminoglycoside antibiotics may occur.
This veterinary medicinal product does not require any special storage conditions.
Not authorised for use in horses producing meat or milk for human consumption.
Following intramuscular or intravenous injection:
Cattle: Meat and offal: 214 days
Milk: 7 days
Calves: Meat and offal: 192 days
Pigs, piglets, weaners: Meat and offal: 146 days
Due to accumulation of gentamicin in liver, kidneys and injection site, treatment
should not be repeated during the withdrawal period.
Following intramuscular or intravenous injection:
Cattle: Meat and offal: 214 days
Milk: 7 days
Calves: Meat and offal: 192 days
Pigs, piglets, weaners: Meat and offal: 146 days
Due to accumulation of gentamicin in liver, kidneys and injection site, treatment
should not be repeated during the withdrawal period.
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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Related Conditions
Same active ingredient
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