Država: Velika Britanija
Jezik: angleščina
Source: VMD (Veterinary Medicines Directorate)
Gentamicin
Franklin Pharmaceuticals Ltd
QJ01GB03
Gentamicin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Horses
Antimicrobial
Authorized
2009-07-07
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 Preberite celoten dokument