País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Sulfadiazine ; Trimethoprim
Le Vet Beheer B.V.
QJ01EW10
Sulfadiazine ; Trimethoprim
250, 50 milligram(s)/gram
Oral powder
POM: Prescription Only Medicine as defined in relevant national legislation
sulfadiazine and trimethoprim
Authorised
2019-07-05
Health Products Regulatory Authority 22 July 2019 CRN000VD7 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Equibactin 250 mg/g + 50 mg/g oral powder for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: ACTIVE SUBSTANCES: Sulfadiazine 250 mg Trimethoprim 50 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral powder. White to off-white powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infections in horses caused by micro-organisms susceptible to the combination of trimethoprim and sulfadiazine, such as infections of the upper respiratory tract, the urogenital system and wound infections. 4.3 CONTRAINDICATIONS Do not use in horses with severe liver or kidney disease. Do not use in known cases of hypersensitivity to the active substances or to any of the excipients. Do not use in known cases of resistance to trimethoprim and sulphonamides. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Throughout the treatment, animals should have free access to drinking water to avoid possible crystalluria. In the treatment of new-born animals and animals with liver damage, caution should be exercised. Renal impairment may cause accumulation, increasing the risk of side effects in long term treatment. Use the product cautiously in horses with blood dyscrasias. 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 bacteria at farm level, or at local/regional level. Use of the product should be in accordance with official, national and regional antimicrobial policies. Use of the product deviating from the instru Leer el documento completo