País: Reino Unido
Idioma: inglés
Fuente: VMD (Veterinary Medicines Directorate)
Gentamicin Sulphate
Bela-Pharm GmbH & Co. KG
QJ01GB03
Gentamicin Sulphate
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Cattle, Dogs, Horses, Pigs
Antimicrobial
Authorized
2023-07-28
Issued : July 2023 AN: 00003/2022 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT GentaDug 85 mg/ml solution for injection for horses, cattle, pigs, dogs and cats. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1.0 ml solution for injection contains: ACTIVE SUBSTANCE: Gentamicin sulphate 85 mg (equivalent to Gentamicin 50 mg) QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCt Methyl parahydroxybenzoate 0.9 mg Propyl parahydroxybenzoate 0.1 mg Sodium metabisulfite Water for injection A clear, colourless to slight yellow solution. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Horses (non-food producing horses), cattle, pigs, dogs and cats. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Treatment of the following infections: Horses: for the treatment of infections of the lower respiratory tract in horses caused by aerobic Gram-negative bacteria. 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 _E. coli_. 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 AN: 00003/2022 Page 2 of 9 3.3 CONTRAINDICATIONS 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 w Leer el documento completo