Marfloxin 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)

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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)
12-06-2017
DSU DSU (DSU)
23-06-2022

有效成分:

Marbofloxacin

可用日期:

Krka, d.d., Novo mesto

ATC代码:

QJ01MA93

INN(国际名称):

Marbofloxacin

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:

Cattle, Pigs

治疗领域:

marbofloxacin

疗效迹象:

Antibacterial

授权状态:

Authorised

授权日期:

2011-08-26

产品特点

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marfloxin 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100 mg
EXCIPIENTS:
Disodium edetate
0.10 mg
Monothioglycerol
1 mg
Metacresol
2 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, greenish yellow to brownish yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- treatment of respiratory infections caused by sensitive strains of_
Pasteurella multocida, Mannheimia haemolytica_ and
_Histophilus somni._
- treatment of acute_ E.coli_ mastitis_._
In pigs:
- treatment of Metritis Mastitis Agalactia (MMA) syndrome caused by
susceptible strains of organisms.
4.3 CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
Do not administer in animals with known hypersensitivity to
fluoroquinolones, or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account
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