ENRO-SLEECOL 100 MG/ML ORAL SOLUTION FOR CHICKENS AND TURKEYS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-04-2016
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Active ingredient:
ENROFLOXACIN
Available from:
Krka, d.d., Novo mesto
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:
2013-09-20
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enro-Sleecol 100 mg/ml oral solution for chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral solution contains:
ACTIVE SUBSTANCE:
Enrofloxacin 100 mg
EXCIPIENT:
Benzyl alcohol 14 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
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._
4.3 CONTRAINDICATIONS
Do not use in birds producing eggs for human consumption.
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.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 15/04/2016_
_CRN 7022042_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of _Mycoplasma _spp. infections may not eradicate the organism.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Before use, header tanks should be emptied, thoroughly cleaned and then filled with a known volume of clean water
before adding the required amount of the product. The resulting mixture should be stirred.
Before use, header tanks should be inspected at regular intervals for presence of dus
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