Each Marbocyl Bolus 50mg Tablet contains:

Marbofloxacin bolus is indicated in the treatment of neonatal gastro-enteritis caused by Escherichia coli, in calves of 25-50kg.

The recommended dosage is 1mg/kg/day (1 bolus per 50kg calf) in a single oral administration per day.

Treatment duration is 3 days.

The bolus can be given manually or with an appropriate applicator.

Do not exceed the recommended duration of treatment (3 days).

When administration is carried out using an applicator, care should be taken to avoid soft tissue injury.

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, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

At the recommended dosage, no undesirable effect is expected. At twice the dosage, a reversible, short term decrease of the intestinal Enterobacteriaceae population can occur, as well as faecal softening, but this is without clinical consequence as the balance of aerobes/anaerobes is not affected.

A greenish coloration of the faeces is sometimes observed, but this is reversible when the treatment is discontinued.

Concurrent administration of oral preparations which contain a high proportion of divalent cations may reduce marbofloxacin activity.

At four times the recommend dosage, a marked, reversible decrease in the intestinal Enterobacteriaceae population was observed. Diarrhoea can occur at higher dosages, as is known to occur for other oral antibiotics administered to neonatal animals. Further administration of marbofloxacin must be stopped and symptomatic treatment instituted.

People with known hypersensitivity to fluoroquinolones should avoid using this product. Wash hands after use.

Meat: 6 days.

The product is not indicated for use in lactating animals.

Do not store above 25°C.

Keep out of reach of children.

For animal treatment only.

Any unused product or waste material should be disposed of in accordance with national requirements.

Marbocyl Bolus is packaged in thermoshaped blister packs made of orange-yellow polyvinylchloride (PVC) and aluminium.

The product is supplied in a box containing 24 and 96 blisters of 6 boluses.

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of DNA gyrase. Fluoroquinolones act by concentration-dependent killing mechanism, so high plasma concentration initially is important (see below). It is effective against a wide range of Gram positive bacteria (in particular Staphylococci) and Gram negative bacteria (Escherichia coli, Salmonella typhimurium, Campylobacter jejunii, Citrobacter freundii, Enterobacter cloacae, Serratia marcescens, Morganella morganii, Proteus spp, Klebsiella spp, Shigella spp, Actinobacillus pleuropneumoniae, Bordetella brochiseptica, Pasteurella haemolytica, Pasteurella multocida, Haemophilus spp, Moraxella spp, Pseudomonas spp, Brucella canis) as well as Mycoplasma (Mycoplasma bovis, Mycoplasma dispar, Mycoplasma hyopneumoniae). The bactericidal activity of marbofloxacin is concentration dependant on Gram–negative strains and time dependant on Gram-positive strains.

After oral administration to calves at the recommended dose of 1mg/kg, marbofloxacin is quite slowly absorbed and its bioavailability is close to 100%. It is weakly bound to plasma proteins (about 30% in calves), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, digestive tract) it achieves higher concentrations than in plasma.

After an oral administration, marbofloxacin is eliminated slowly in calves (t1/2β = 8.50 ± 2.88h) predominately in urine (72-81%) and faeces (5-13%) and in active form.