Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Enrofloxacin

Fáanlegur frá:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC númer:

QJ01MA90

INN (Alþjóðlegt nafn):

Enrofloxacin

Leyfisstaða:

Expired

Vara einkenni

Revised: August 2012
AN: 00396/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs
Floxibac vet 100 mg/ml Solution for Injection for Cattle and Pigs
(Sweden)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100mg
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 and Pigs.
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. or _Mycoplasma_
spp.
Alimentary tract infections caused by _E. coli_.
Enrofloxacin should be used where clinical experience, supported where
possible by sensitivity testing of the causal organism, indicates
enrofloxacin as
the drug of choice.
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
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
Page 1 of 5
Revised: August 2012
AN: 00396/2012
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not exceed the recommended dose.
Repeat injections should be made at different sites.
The safety of the product has not been established in pigs or calves
when
administered by the intravenous route and use of this route of
administration is not recommended in these animal groups.
Official and local antimicrobial policies should be taken into account
when
the product is used.
Fluoroquinolones should be reserved for the treatment of clinical
cond