SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

MARBOCYL SA 200mg Powder and solvent for solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Lyophilisate vial

Active ingredient:

Marbofloxacin 200mg

Antimicrobial preservatives:

Disodium edetate 20mg

Benzalkonium chloride 2mg

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Powder and solvent for solution for injection.

4. CLINICAL PARTICULARS

‑ DOGS

‑ CATS

4.2 Indications for use, specifying the target species

In dogs, Indicated :

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

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

In cats, Indicated :

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

Marbofloxacin is inactive against anaerobic bacteria.

4.3 Contra-indications

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.

4.4 Special warnings for each target species

None

4.5 Special precautions for use

(i) Special precautions for use in animals

None.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

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

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).

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.

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 abscesses - 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 doses and durations of treatment are:

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.

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

Not Applicable.

5. PHARMACOLOGICAL PROPERTIES

ATC Vet Code: QJ01MA93

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 1.5μg/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).

Disodium edetate dihydrate

Benzalkonium chloride

Mannitol

Sodium hydroxide

Water for injection

None

- 3 years.

- The reconstituted solution should be stored below 25°C and

protected from light. Any reconstituted product remaining 28 days

after preparation should be discarded.

Protect both lyophilised powder and reconstituted solutions from light.

Do not store above 25°C.

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

materials derived from the use of such products

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

Vétoquinol UK Limited

Vetoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

8. MARKETING AUTHORISATION NUMBER(S)

Vm 08007/4079

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

8^th March 1999

8^th March 2004

10. DATE OF REVISION OF THE TEXT

December 2007