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

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Marbofloxacin

Tilgængelig fra:

Krka, d.d., Novo mesto

ATC-kode:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosering:

100 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle, Pigs

Terapeutisk område:

marbofloxacin

Terapeutiske indikationer:

Antibacterial

Autorisation status:

Authorised

Autorisation dato:

2011-08-26

Produktets egenskaber

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
wh