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

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

现在购买

产品特点 产品特点 (SPC)
12-06-2017
公众评估报告 公众评估报告 (PAR)
01-09-2021
DSU DSU (DSU)
08-11-2023

有效成分:

Enrofloxacin

可用日期:

Chanelle Pharmaceuticals Manufacturing Limited

ATC代码:

QJ01MA90

INN(国际名称):

Enrofloxacin

剂量:

100 milligram(s)/millilitre

药物剂型:

Solution for injection

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗组:

Bovine, Porcine

治疗领域:

enrofloxacin

疗效迹象:

Antibacterial

授权状态:

Authorised

授权日期:

2010-07-16

产品特点

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
CATTLE
Treatment of infections of the respiratory tract caused by
enrofloxacin susceptible strains of_ Pasteurella multocida,_
_Mannheimia haemolytica_ and_ Mycoplasma_ spp.
Treatment of infections of the alimentary tract caused by enrofloxacin
susceptible strains of_ Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains
of_ Escherichia coli_.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin
susceptible strains of_ Mycoplasma bovis_ in
cattle less than 2 years old.
PIGS
Treatment of infections of the respiratory tract caused by
enrofloxacin susceptible strains of_ Pasteurella multocida,_
_Mycoplasma_ spp. and_ Actinobacillus pleuropneumoniae_.
Treatment of infections of the urinary tract caused by enrofloxacin
susceptible strains of_ Escherichia coli_.
Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome)
caused by enrofloxacin susceptible strains of
_Escherichia coli_ and_ Klebsiella_ spp.
Treatment of infections of the alimentary tract caused by enrofloxacin
susceptible strains of_ Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains
of_ Escherichia coli_.
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENT:
n-butanol
30
mg
For the full list of excipients, see section 6.1.
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