Marfloxin 100 mg/ml solution for injection for cattle and pigs

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

即購入

製品の特徴 製品の特徴 (SPC)
12-06-2017
公開評価報告書 公開評価報告書 (PAR)
12-06-2017
DSU DSU (DSU)
23-06-2022

有効成分:

Marbofloxacin

から入手可能:

Krka, d.d., Novo mesto

ATCコード:

QJ01MA93

INN(国際名):

Marbofloxacin

投薬量:

100 milligram(s)/millilitre

医薬品形態:

Solution for injection

処方タイプ:

POM: Prescription Only Medicine as defined in relevant national legislation

治療群:

Cattle, Pigs

治療領域:

marbofloxacin

適応症:

Antibacterial

認証ステータス:

Authorised

承認日:

2011-08-26

製品の特徴

                                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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