Marbodug 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:

Emdoka

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 område:

marbofloxacin

Autorisation status:

Authorised

Autorisation dato:

2013-01-11

Produktets egenskaber

Health Products Regulatory Authority
14 September 2020
CRN009V48
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbodug 100 mg/ml Solution for Injection for Cattle and Pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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EACH ML CONTAINS:
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​
ACTIVE SUBSTANCE:
​
​
Marbofloxacin
​
100.0 mg
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EXCIPIENTS:
​
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Metacresol
2.0 mg
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Monothioglycerol
​
1.0 mg
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Disodium edetate
​
0.1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Pigs (sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
Treatment of respiratory infections caused by sensitive strains of
_Pasteurella multocida_, _Mannheimia haemolytica, Histophilus _
_somni_ and _Mycoplasma bovis_
Treatment of acute mastitis caused by _E. coli_ strains sensitive to
marbofloxacin during the lactation period.
In pigs:
Treatment of Metritis Mastitis Agalactia syndrome (postpartum
dysgalactiae syndrome, PDS) caused by susceptible strains of
organisms.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to marbofloxacin or
to any other quinolone or to any of the excipients
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Efficacy data have shown an insufficient efficacy of the product for
the treatment of acute mastitis caused by Gram positive
strains.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account
when the product is used. Fluoroquinolones should be
reserved for the treatment of clinical conditions which have responded
poorly, or are expected to respond poorly, to other
classes of antimicrobials. Whenever possible, fluoroquinolones should
only be used based on susceptibility testing. Use of the
Health Products Regulatory Authority
14 September 202