Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Enrofloxacin
SP Veterinaria, S.A.
QJ01MA90
Enrofloxacin
100 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens, Turkeys
enrofloxacin
Antibacterial
Authorised
2008-03-07
B.1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT FLOXAMAX 100 mg/ml concentrate for oral solution for chickens and turkeys 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Enrofloxacin ……………. 100 mg Excipients: Benzyl alcohol (E1519)………….. 0.014 ml For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Concentrate for oral solution. Clear yellow solution. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Chickens and turkeys 4.2. INDICATIONS FOR USE Treatment of infections caused by the following bacteria susceptible to enrofloxacin: CHICKENS _Mycoplasma gallisepticum, _ _Mycoplasma synoviae, _ _Avibacterium paragallinarum, _ _Pasteurella multocida _ TURKEYS _Mycoplasma gallisepticum, _ _Mycoplasma synoviae, _ _Pasteurella multocida _ _ _ 4.3. CONTRAINDICATIONS Do not use for prophylaxis. Do not use when resistance / cross-resistance to (fluoro)quinolones is known to occur in the flock intended for treatment. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES Treatment of _Mycoplasma spp _infections may not eradicate the organism. 4.5. SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Since enrofloxacin was first authorised for use in poultry, there has been widespread reduction in susceptibility of _E. _ _coli _ to fluoroquinolones and emergence of resistant organisms. Resistance has also been reported in _Mycoplasma synoviae _in the EU. Whenever possible fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given by in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolo Izlasiet visu dokumentu