Baytril Max 100 mg/ml Solution for Injection for Cattle

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Enrofloxacin

Tilgængelig fra:

Bayer plc

ATC-kode:

QJ01MA90

INN (International Name):

Enrofloxacin

Lægemiddelform:

Solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle

Terapeutisk område:

Antimicrobial

Autorisation status:

Expired

Autorisation dato:

1999-06-14

Produktets egenskaber

Revised: November 2011
AN: 01356/2011
Page 1 of 6
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
ACTIVE CONSTITUENTS MG PER ML
Enrofloxacin
100
RELEVANT CONSTITUENTS OF THE EXCIPIENTS
Benzyl alcohol
20
n-butyl alcohol
30
For 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.
Indicated for the treatment of local signs (inflammation, milk quality
and
yield) associated with peracute/acute mastitis in lactating dairy
cattle
caused by E. coli, where herd history and previous sensitivity testing
indicate enrofloxacin as the drug of choice.
Revised: November 2011
AN: 01356/2011
Page 2 of 6
4.3
CONTRAINDICATIONS
Baytril Max should not be used for prophylaxis
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Normal sterile precautions should be taken.
The safety of the product has not been established in calves when
administered by the intravenous route and use of this route of
administration in calves is therefore not recommended.
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, fluoroquinolones should only be used based on
susceptibility testing.
Use of the product deviating from the instruct