AN: 00408/2013
2.
100.0 mg
Excipients:
Monothioglycerol
Metacresol
1.0 mg
2.0 mg
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow to amber solution.
4.
CLINICAL PARTICULARS
4.1
Target species
Cattle and Pig
4.2
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4.3
Contraindications
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
Do not use in animals with known hypersensitivity to fluoroquinolones or to
any of the excipients.
4.4
4.5
ii.
4.6
4.8
4.9
5.
PHARMACOLOGICAL PROPERTIES
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Pharmacodynamic properties
Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the
fluoroquinolone group which acts by inhibition of DNA gyrase. It has a
broad-spectrum of activity in-vitro against Gram-negative (Pasteurella
multocida, Mannheimia haemolytica, E. coli), Gram-positive bacteria as
well as Mycoplasma spp.
The marbofloxacin in vitro activity against pathogens isolated in 2004 from
bovine respiratory diseases during a clinical field trial in France, Germany,
Spain and Belgium, is good: MIC values were reported as being 0.015 and
0.25 g/ml for M. haemolytica (MIC90 = 0.124 g/ml; MIC50 = 0.025
g/ml)and between 0.004 and 0.12 g/ml for P. multocida (MIC90 = 0.022
g/ml; MIC50 = 0.009 g/ml).
Strains with MIC1g/ml are sensitive to marbofloxacin whereas strains
with MIC4g/ml are resistant to marbofloxacin.
Resistance to fluoroquinolones occurs by chromosomal mutation with
three mechanisms: decrease of the bacterial wall permeability, expression
of efflux pump or mutation of enzymes responsible for molecule binding.
5.2
Pharmacokinetic properties
After subcutaneous or intramuscular administration in cattle and pigs, at
the recommended dose of 2 mg/kg bodyweight, marbofloxacin is readily
absorbed and reaches peak plasma concentrations of 1.5 g/ml within 1
hour. The bioavailability of marbofloxacin is almost 100%.
Marbofloxacin is weakly bound to plasma proteins (less than 10% in pigs
and 30 % in cattle), extensively distributed and achieves a higher
concentration in most tissues, (liver, kidney, skin, lung, bladder, uterus
and digestive tract) than in plasma
In cattle, marbofloxacin is eliminated slowly in pre-ruminant calves but
faster in ruminant cattle (t1/2 = 5-9 hours and 4 7 hours respectively). In
pre-ruminant calves elimination of the active form is predominantly via
urine, ( urine, faeces). In ruminant cattle the active form is eliminated
equally in urine and faeces.
In pigs, the active form of marbofloxacin is eliminated slowly (t 1/2= 8 10
hours) predominantly urine (2/3) and faeces (1/3).
6.
PHARMACEUTICAL PARTICULARS
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6.1
List of excipients
Monothioglycerol
Metacresol
Disodium Edetate
Gluconolactone
Water for injections
6.2
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product
must not be mixed with other veterinary medicinal products
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7.
8.
Vm 02000/4331
9.
10.
Approved: 14/08/2013
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