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

Powder and solvent for solution for injection.

Qualitative and Quantitative Composition:

		SA 200mg
Lyophilisate vial Active ingredient:
Marbofloxacin		200mg
Disodium Edetate Benzalkonium Chloride Excipient to		20mg 2mg 1000mg
Solvent vial
Water for Injections		20ml

Uses

In dogs: Marbocyl SA is indicated:

‑ in the treatment of infected wounds and subcutaneous abcesses due to Staphylococcus intermedius, Staphylococcus aureus, Escherichia coli, Pasteurella spp. and Pseudomonas spp.

‑ in the treatment of lower urinary tract infections due to Escherichia coli and Proteus spp.

In cats: Marbocyl SA is indicated :

‑ in the treatment of infected wounds and subcutaneous abcesses due to Pasteurella multocida, Staphylococcus intermedius, Staphylococcus aureus, Staphylococcus spp., Enterobacter spp. and Klebsiella spp.

Marbofloxacin is inactive against anaerobic bacteria.

Dosage and administration

Reconstitution: - Before use, reconstitute the lyophilised powder using the solvent (water for injections) provided for the 200mg vial. Using aseptic technique, withdraw 20ml from the vial of solvent and add rapidly to the lyophilised powder. When reconstituted in this way, the solution will contain 10mg marbofloxacin per ml.

In dogs: the recommended doses and durations of treatment are:

For the treatment of infected wounds and subcutaneous abcesses- a single subcutaneous or intravenous injection, at a dosage of 2mg/kg (1ml/5kg), followed the next day by administration of Marbocyl Tablets daily at a dosage of 2mg/kg for 6 days.

For the treatment of lower urinary tract infections - a single subcutaneous or intravenous injection, at a dosage of 2mg/kg (1ml/5kg), followed the next day by administration of Marbocyl Tablets daily at 2mg/kg for at least 10 days and up to 28 days.

In cats: the recommended dose and duration of treatment is:

For the treatment of infected wounds and subcutaneous abscesses 2 mg/kg/day (0.2ml/kg/day), by subcutaneous or intravenous injection followed by subcutaneous injections for a total of 3 to 5 days.

Contra-indications, warnings, etc

Marbofloxacin should not be used in dogs aged less than 12 months or less than 18 months for exceptionally large breeds of dogs, such as Great Danes or Mastiffs with a longer growth period.

Studies carried out with laboratory animals showed no embryotoxic, foetotoxic or teratogenic effects. However, no specific studies have been carried out on pregnant cats or dogs.

The dosage of theophylline must be reduced when used concurrently.

Overdosage may cause acute signs in the form of neurological disorders, hypersalivation or trembling which should be treated symptomatically.

After subcutaneous administration, no undesirable effect is observed up to 2 times the maximum recommended therapeutic dose in dogs or 3 times the maximum recommended dose for cats. After i.v. administration at 4mg/kg, rare mild and transitory side effects have been reported: -ptyalism (excess salivation) - nervous disorders: vocalization, excitation, trembling (myoclonia).

Withdrawal period

Not applicable

Operator warning

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

Pharmaceutical precautions

Protect both lyophilized powder and reconstituted solutions from light. Do not store above 25°C.

Any reconstituted product remaining 28 days after preparation should be discarded.

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 SA is packaged in amber Type II glass vials containing 200mg marbofloxacin in the form of a white freeze dried powder. Colourless Type II glass vials of solvent are supplied which contain 20ml Water for Injections PhEur.

Further information

Pharmacodynamic properties

Marbofloxacin is a synthetic bactericidal anti-infective, belonging to the fluoroquinolone group. It acts by inhibition of DNA gyrase. It is effective against a wide range of Gram positive bacteria (in particular Staphylococcus spp.), Gram negative (Escherichia Coli, Salmonella typhimurium, Campylobacter jejunii, Citrobacter freundii, Enterobacter cloacae, Serratia marcescens, Morganella morganii, Proteus spp, Shigella spp, Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Mannheumia haemolytica, Pasteurella multocida, Klebsiella spp. Haemophilus spp, Moraxella spp, Pseudomonas spp, Brucella canis) as well as Mycoplasma.

Pharmacokinetic properties

After subcutaneous administration at the recommended dose of 2mg/kg to dogs and cats, marbofloxacin is rapidly absorbed with a bioavailability close to 100%. After subcutaneous administration of 2mg/kg in dogs and cats, the maximum plasma concentration achieved is 1.5 microgram/ml. IV administration results in a similar pharmacokinetic profile for Area Under the Time Curve (AUC) and Elimination (T1/2) values).

Marbofloxacin is weakly bound to plasma proteins (< 10% in dogs and cats) and is extensively distributed. In most tissues (skin, muscles, liver, kidney, lungs, bladder, digestive tract), tissue concentrations are higher than in plasma.

Marbofloxacin is slowly eliminated with an elimination half life from 10 to14 h in both species, mainly in the active form in urine (2/3), and faeces (1/3).