Introduction

Company name: Vétoquinol UK Ltd

Address: Vétoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

Telephone: 01280 814500

Fax: 01280 825460

Email: office@vetoquinol.co.uk

Website: www.vetoquinol.co.uk

Presentation

Each Marbocyl Bolus contains:

Marbofloxacin	50.00mg
Excipient to	1500mg

Uses

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

Dosage and administration

The recommended dosage is one bolus per calf in a single oral administration per day.

Treatment duration is 3 days.

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

Contra-indications, warnings, etc

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

Withdrawal periods

Meat: 6 days.

The product is not indicated for use in lactating animals.

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

At four times the recommended dosage, a marked decrease in the intestinal Enterobacteriaceae population has been observed but this is reversible. At higher dosages, as is known for other oral antibiotics administered to neonatal animals, symptoms in the form of diarrhoea can occur. Further administration of marbofloxacin must be stopped and the symptoms treated symptomatically.

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

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

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.

Operator warning

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

Pharmaceutical precautions

Do not store above 25°C.

Keep out of reach of children.

For animal treatment only.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

POM-V

Packaging Quantities

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

The product is supplied in a box containing 1,4,8,16,20,40,80 blisters of 6 boluses. Not all pack sizes are marketed.

Further information

Pharmacodynamic properties

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, Cibrobacter freundii, Enterobacter cloacae, Serratia marcescens, Morganella morganii, Proteus spp, Klebsiella spp, Shigella spp, Actinobacillus pleuropneumonia, 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.

Pharmacokinetic properties

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.