Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
NEOMYCIN SULFATE, SULFADIAZINE
Cross Vetpharm Group Limited
QJ01RA02
NEOMYCIN SULFATE, SULFADIAZINE
Unknown
Oral Suspension
POM
Bovine
Sulfonamides, combinations with other antibacterials excl. trimethoprim
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bimastat Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pre-ruminant calves. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of diarrhoea in pre-ruminant calves associated with infections caused by organisms known to be, or suspected of being, susceptible to the combination of sulfadiazine and neomycin. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredients. Do not exceed the recommended dosage or the period of treatment. Do not use local anaesthetics of the procaine group during treatment as they are antagonistic to the sulphonamide component. Do not use in calves with functional rumens. Do not use in lactating cows. Do not use in foals and horses. ACTIVE SUBSTANCE Sulfadiazine 150.0 mg/ml Neomycin (as neomycin sulphate) 25.0 mg/ml EXCIPIENTS Methyl parahydroxybenzoate 2.0 mg/ml Propyl parahydroxybenzoate 0.2 mg/ml Carmoisine E122 0.05 mg/ml HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 13/01/2016_ _CRN 7022820_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Concurrent intravenous fluid therapy should be considered in dehydrated calves. Parenteral antibiotic treatment should be considered if a clinical response is not seen after 48 hours treatment. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm Lesen Sie das vollständige Dokument