BAYTRIL MAX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
ENROFLOXACIN
Available from:
Bayer Limited
ATC code:
QJ01MA90
INN (International Name):
ENROFLOXACIN
Dosage:
100 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Enrofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1998-12-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Max 100 mg/ml Solution for Injection for Cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow sterile aqueous solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the treatment of bovine respiratory disease associated with _Mannheimia haemolytica, Pasteurella_
_multocida, Haemophilus somnus _and _Mycoplasma _spp. where clinical experience, supported where possible by
sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
4.3 CONTRAINDICATIONS
Baytril Max should not be used for prophylaxis.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE CONSTITUENTS
mg/ml
Enrofloxacin
100
RELEVANT CONSTITUENTS OF THE EXCIPINETS
Benzyl alcohol
20
n-butyl alcohol
30
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/12/2011_
_CRN 7011652_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Normal sterile precautions should be taken.
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.
Whenever possible, fluoroquinoones should only be used based on susceptibility testing.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the
fluoroquinolones and may decrease the effectiveness of treatment with other quinolo
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