Marbim 100 mg/ml Solution for Injection for cattle and pigs

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Marbofloxacin

Dostupné s:

Bimeda Animal Health Limited

ATC kód:

QJ01MA93

INN (Mezinárodní Name):

Marbofloxacin

Dávkování:

100 milligram(s)/millilitre

Léková forma:

Solution for injection

Druh předpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické oblasti:

marbofloxacin

Stav Autorizace:

Authorised

Datum autorizace:

2016-11-11

Charakteristika produktu

Health Products Regulatory Authority
07 January 2022
CRN00C9WX
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbim 100 mg/ml Solution for Injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
​
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Marbofloxacin
​100
​mg
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EXCIPIENTS:
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Metacresol
​2.0
​mg
​
Monothioglycerol
​1.0
​mg
Disodium edetate (E 386)
​0.1
​mg
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​
​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellow solution, free of any particulate matter.
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_ and
_Mycoplasma bovis_.
Treatment of acute mastitis caused by _E. coli_ strains sensitive to
marbofloxacin during the lactation period.
In Pigs (sows):
Treatment of Metritis Mastitis Agalactia syndrome (postpartum
dysgalactia syndrome, PDS) caused by susceptible strains of
organisms.
4.3 CONTRAINDICATIONS
Do not use for bacterial infections with resistance to other
fluoroquinolones (cross resistance).
Do not administer in animals with known hypersensitivity to
marbofloxacin or any other quinolone or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy data showed that the product has insufficient efficacy
for the treatment of acute forms of mastitis induced by
gram positive bacteria.
Health Products Regulatory Authority
07 January 2022
CRN00C9WX
Page 2 of 4
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