Baytril Flavour 25 mg/ml Oral Suspension for Cat

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Enrofloxacin

Tilgængelig fra:

Bayer plc

ATC-kode:

QJ01MA90

INN (International Name):

Enrofloxacin

Lægemiddelform:

Oral suspension

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cats

Terapeutisk område:

Antimicrobial

Autorisation status:

Expired

Autorisation dato:

2011-08-19

Produktets egenskaber

Revised: May 2016
AN: 00881/2015
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril flavour 25 mg/ml oral suspension for cat
(all MS except DK, FI, IS, NO, SE and ES)
(The product name will be translated into national languages)
Baytril Sabor 25 mg/ml suspensión oral para gatos (ES)
Lorenax vet. 25 mg/ml oral suspension for cat (DK),
Baytril vet. 25 mg/ml oral suspension for cat (FI, IS, NO and SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the product contains:
ACTIVE SUBSTANCE:
Enrofloxacin
25 mg
EXCIPIENTS:
Ascorbic acid (E300)
0.2 mg
Sorbic acid (E200)
2 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral suspension
White to yellow-white suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cat
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of single or mixed bacterial infections of the
respiratory, alimentary
and urinary tract, skin or wounds caused by the following
enrofloxacin-sensitive
Gram-negative and Gram-positive bacteria:
Staphylococci,_ E. coli, Haemophilus _spp._ _and_ Pasteurella _spp_._
Revised: May 2016
AN: 00881/2015
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use in

Animals with existing impairment of cartilage growth

Animals with a known history of seizures_, _ since enrofloxacin may
cause
CNS stimulation.

Animals with known hypersensitivity to fluoroquinolones or any of the
excipients
For use in pregnant animals see section 4.7 and for interactions with
other medicinal
products see section 4.8
4.4
SPECIAL WARNINGS
Do not use in cases of known resistance to quinolones because of
near-total cross-
resistance
with
these
compounds
and
complete
cross-resistance
with
other
fluoroquinolones.
In animals where product administration is associated with excessive
salivation or
where difficulty administering the required dose is experienced,
administration should
be discontinued and an alternative therapy used.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS