Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Enrofloxacin

Mevcut itibaren:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC kodu:

QJ01MA90

INN (International Adı):

Enrofloxacin

Yetkilendirme durumu:

Expired

Ürün özellikleri

Issued 26/05/2010 – AN 00792/2008
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and
Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
50mg
EXCIPIENT:
n-butanol
30mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear light yellow solution free from particulate matter.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, Pigs, Dogs and Cats.
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
Treatment of bacterial infections caused by strains susceptible to
enrofloxacin
Cattle:
Respiratory infections caused by _Pasteurella _spp. or _Mycoplasma
_spp.
Alimentary tract infections caused by_ E_. _coli_.
Pigs:
Respiratory infections caused by of _Pasteurella _spp.,
_Actinobacillus_ spp. or _Mycoplasma_ spp.
Alimentary tract infections caused by _E. coli._
Dogs and Cats:
Treatment of bacterial infections of the alimentary, respiratory and
urogenital tracts, skin, wound
infections and otitis externa.
Enrofloxacin should be used where clinical experience, supported where
possible by sensitivity
testing of the causal organism, indicates enrofloxacin as the drug of
choice.
1/6
Issued 26/05/2010 – AN 00792/2008
4.3
CONTRAINDICATIONS
Do not use when resistance / cross resistance to (Fluoro)quinolones is
known to occur. Refer to
section 4.5. Do not use in the case of known hypersensitivity to
fluoroquinolones or to any of the
excipients.
Dogs under 1 year of age should not be treated with Enrofloxacin as
damage to the articular cartilage
may occur during the period of rapid growth, specifically in large
breeds of dog. As a precaution very
large breeds of dog should not be treated with Enrofloxacin until they
are 18 months of age because of
their longer growth period.
Do not use in cats less than 8 weeks of age.
Do not use for prophylaxis.
4.4
SPECIAL WARNINGS
Cattle, pigs:
None
Cats:
Retinotoxic effects including blindness can occur when th