Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Florfenicol
Intervet Ireland Limited
QJ01BA90
Florfenicol
40 milligram(s)/gram
Premix for medicated feeding stuff
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
florfenicol
Antibacterial
Authorised
2007-08-31
Health Products Regulatory Authority 27 February 2018 CRN000WK7 Page 1 of 7 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Nuflor 40 mg/g Premix for Medicated Feeding Stuff for Swine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per gram: ACTIVE SUBSTANCE: QUANTITY: Florfenicol 40 mg EXCIPIENTS: Propylene Glycol (E1520) 10 mg Ground Limestone qs to 1 g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Premix for medicated feeding stuff. White to off-white, free flowing powder with red and/or black grains dispersed throughout. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (Fattening pigs). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and metaphylaxis of swine respiratory disease caused by _Pasteurella multocida _susceptible to florfenicol in infected herds. The presence of the disease in the herd must be established before the product is used. 4.3 CONTRAINDICATIONS Do not administer to boars intended for breeding. Do not use in case of hypersensivity to the active substance or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Animals showing a decreased appetite and/or a poor general condition should be treated by the parenteral route. Health Products Regulatory Authority 27 February 2018 CRN000WK7 Page 2 of 7 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS: The product should be used in conjunction with susceptibility testing and take into account official and local policy relating to the use of antimicrobials. This premix is intended for the manufacturing of solid medicated feed and cannot be used as it is; the incorporation rate of the premix in feed cannot be lower than 5 kg/ton. This premix contains ground limestone, which can lead to a decrease in food consumption and to a phosphorus calcium imbalance in feed intake. Care should therefore be taken to consider the calcium content of the final medicated feed. Treatment should not exceed 5 days. In a field clinical study, within a wee Lugege kogu dokumenti