FLOXAMAX 100 MG/ML CONCENTRATE FOR ORAL SOLUTION F

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ENROFLOXACIN

Available from:

SP Veterinaria, S.A.

ATC code:

QJ01MA90

INN (International Name):

ENROFLOXACIN

Dosage:

100 Mg/Ml

Pharmaceutical form:

Oral Solution

Prescription type:

POM

Therapeutic group:

Fowl - Chicken, Fowl - Turkey

Therapeutic area:

Enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2008-03-07

Summary of Product characteristics

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, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by the following bacteria susceptible to enrofloxacin:
CHICKENS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Avibacterium paragallinarum,_
_Pasteurella multocida,_
_Escherichia coli._
TURKEYS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Pasteurella multocida,_
_Escherichia coli._
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/06/2014_
_CRN 7017527_
_page number: 1_
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�