Genta-Equine 100 mg/ml Solution for Injection for Horses

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Gentamicin

Saatavilla:

Franklin Pharmaceuticals Ltd

ATC-koodi:

QJ01GB03

INN (Kansainvälinen yleisnimi):

Gentamicin

Lääkemuoto:

Solution for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Horses

Terapeuttinen alue:

Antimicrobial

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2009-07-07

Valmisteyhteenveto

Revised: February 2019
AN: 00524/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Genta-Equine 100 mg/ml Solution for Injection for Horses.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Gentamicin (as gentamicin sulfate)
100 mg
EXCIPIENTS:
Sodium Metabisulfite
1.0 mg
Sodium Methyl parahydroxybenzoate (E219)
0.9 mg
Sodium Propyl parahydroxybenzoate
0.1 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection
A clear, almost colourless liquid, free from undissolved particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses (non food producing horses).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections of the lower respiratory tract in
horses caused by
aerobic Gramnegative bacteria susceptible to gentamicin.
4.3
CONTRAINDICATIONS
Do not use in known cases of renal dysfunction.
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.
4.4
SPECIAL WARNINGS
Do not use in horses which are intended to produce meat or milk for
human
consumption.
Revised: February 2019
AN: 00524/2018
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
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 in