SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

MARBOCYL 2 % SOLUTION FOR INJECTION

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Marbofloxacin 2.0 % w/v

Disodium edetate 0.01 % w/v

Thioglycerol 0.05 % w/v

Metacresol 0.2 % w/v

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Solution for injection

4. CLINICAL PARTICULARS

- Cattle: pre-ruminants up to 100 kg b.w.

- Pigs

4.2 Indications for use, specifying the target species

In cattle and pigs

Indicated in the treatment of respiratory infections caused by susceptible strains of organisms.

4.3 Contra-indications

None

None

4.5 Special precautions for use

i. Special precautions for use in animals

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, or are expected to respond 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.

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

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

No severe side-effects are to be expected at doses up to 5 times the recommended dose in cattle and pigs. In particular no lesions of the articular joints are encountered.

Subcutaneous injection is well tolerated. Transitory inflammatory reactions are sometimes observed at the injection site, but without clinical impact.

Not applicable.

None known

The recommended dosage is 2 mg/kg/day (1 ml/10 kg) in a single daily injection by subcutaneous or intravenous routes in cattle and by intramuscular route in pigs.

Treatment duration is as follows:

- cattle, IV route : 3 to 5 days

- cattle, SC route : 3 days

- pigs, IM route : 3 to 5 days

In order to reduce the risk of particulate contamination of the product, it is recommended that a draw-off needle be used to reduce the number of times the septum is punctured.

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

	MEAT
Preruminating calves (up to 100kg bodyweight)	6 days
Pigs	4 days

The volume of injection should be limited to 10 ml at each site of injection for pigs.

5. PHARMACOLOGICAL PROPERTIES

ATC Vet Code:QJ01MA93

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of DNA gyrase. 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, Enterobacter, Proteus spp, Klebsiella spp, Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Pasteurella haemolytica, Pasteurella multocida, Haemophilus spp, Moraxella spp, Pseudomonas aeruginosa) as well as Mycoplasma (Mycoplasma bovis, Mycoplasma dispar, Mycoplasma hyopneumoniae).

Resistance to Streptococcus spp. may occur.

Pharmacokinetic properties:

After subcutaneous administration in cattle and pigs at the recommended dose of 2 mg/kg, marbofloxacin is readily absorbed and its bioavailability is close to 100 %. It is weakly bound to plasma proteins (less than 10 % in pigs and 30 % in cattle), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, uterus digestive tract) it achieves higher concentrations than in plasma.

In cattle, marbofloxacin is eliminated slowly in pre-ruminating calves (t_1/2β= 5-9 h) predominantly in the active form in urine (3/4) and faeces (1/4).

In pigs, marbofloxacin is eliminated slowly (t_1/2β= 8-10 h) predominantly in the active form in urine (2/3) and faeces (1/3).

Gluconolactone

Water for injection

Mannitol

Nil

2 years

Following withdrawal of the first dose, use the product within 28 days

Discard unused material.

Do not store above 25°C. Protect from light.

6.5 Nature and composition of immediate packaging

Packaged in amber type II glass vials of 10, 20, 50 ml, 100 ml and 250 ml.

The vials are closed with a chlorobutyl rubber stopper oversealed with aluminium caps.

Each vial is packaged in a cardboard box.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste 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.

Manure and slurry containing marbofloxacin should not be spread on the same area of land in successive years.

VETOQUINOL SA

Magny- Vernois

BP 189

70204 LURE Cedex

FRANCE

8. MARKETING AUTHORISATION NUMBER(S)

Vm06462/4005

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date: 25 June 1998/26 June 2003

10. DATE OF REVISION OF THE TEXT

Date: June 2011