SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Marbocare 100 mg/ml Solution for Injection for Cattle and Pigs (UK, IE, FR)

Odimar 100 mg/ml Solution for Injection for Cattle and Pigs (BE, NL, LU, ES, PT, DE, AT)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Marbofloxacin 100.0 mg

Excipients:

Metacresol 2.0 mg

Monothioglycerol 1.0 mg

Disodium edetate 0.1 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.

Clear, yellowish solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle and Pigs.

4.2 Indications for use, specifying the target species

In cattle:

Treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica, Histophilus somniand Mycoplasma bovis

Treatment of acute mastitis caused by E.colistrains sensitive to marbofloxacin during the lactation period.

In pigs:

Treatment of Metritis Mastitis Agalactia syndrome (postpartum dysgalactiae syndrome, PDS) caused by susceptible strains of organisms.

4.3 Contraindications

Do not use in animals with known hypersensitivity to marbofloxacin or to any other quinolone or to any of the excipients

Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).

4.4 Special warnings for each target species

None

4.5 Special precautions for use

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. Efficacy data have shown an insufficient efficacy of the product for the treatment of acute mastitis caused by Gram positive strains.

• People with known hypersensitivity to (fluoro)quinolones should avoid any contact with the product.

• If the product comes into contact with the skin or eyes, rinse with large amounts of water.

• Wash hands after use.

• In case of accidental self-injection or ingestion, seek medical advice immediately and show package leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Intramuscular or subcutaneous injections are well tolerated although transitory inflammatory lesions without clinical impact can occur at the injection site.

Administration by the intramuscular route may cause transient local reactions such as pain and swelling at the injection site and inflammatory lesions which may persist for at least 12 days after injection. No other adverse effect was observed on cattle.

4.7 Use during pregnancy, lactation or lay

Laboratory studies in the rat and rabbit have not produced any evidence of a teratogenic, foetoxic or maternotoxic effect.

Dose of 2 mg/kg body weight:

Safety of the product has been established in pregnant and lactating cows and sows.

Dose of 8 mg/kg body weight:

The safety of the veterinary medicinal product has not been established in the pregnant cow or in suckling calves when used in the cow. Therefore, this dose regimen should be used only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

To ensure administration of the correct dose, body weight should be determined as accurately as possible, to avoid underdosing.

Cattle:

Respiratory infections:

This product may be administered as a single dose given on one day only or as a multiple dose injection given over 3-5 days.

Single dose – Intramuscular use:

The recommended dosage is 8 mg/kg bodyweight (i.e. 2 ml of product /25 kg bodyweight in a single injection). This optimised dosing regimen should be considered as the dosing regimen of choice in the treatment of cattle respiratory disease with the exception of the situations listed below.

Multiple dose – Intramuscular, intravenous or subcutaneous use:

The recommended dosage is 2mg/kg bodyweight (i.e. 1 ml of product/50 kg bodyweightin a single daily injection for 3-5 days). This dosing regimen should be used for treatment of specific cases such as those which require intravenous treatment or infections caused by Mycoplasma bovis).

Acute mastitis:

-Intramuscular or subcutaneous use:

The recommended dosage is 2 mg/kg bodyweight (i.e. 1 ml of product/ 50 kg bodyweightin a single daily injection, for 3 consecutive days.

The first injection may also be given by the intravenous route.

Pigs (sows):

-Intramuscular use:

The recommended dosage is 2 mg/kg bodyweight (i.e. 1 ml of product/ 50 kg bodyweightin a single daily injection, for 3 consecutive days).

It is preferable to inject cattle and pigs in the neck.

If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.

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.

Do not broach the 100mL‑vial more than 25 times and a 250mL‑vial more than 50 times

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively.

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

4.11 Withdrawal periods

	Meat and offal	Milk
Cattle 2mg/kg for 3 to 5 days (IV/IM/SC)	6 days	36 hours
Cattle 8mg/kg on a single occasion (IM)	3 days	72 hours
Pigs	4 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, Fluoroquinolones.

ATC Vet code: QJ01MA93

5.1 Pharmacodynamic properties

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group.It acts by inhibition of DNA gyrase and shows concentration dependant bactericidal activity. It has a broad-spectrum activity against Gram-positive bacteria and Gram-negative bacteria (e.g. Pasteurella multocida, Mannheimia haemolytica,Histophilus somni,E. coli) as well as against mycoplasmas (Mycoplasma bovis).

The marbofloxacin in vitro activity against pathogens isolated in 2004 from bovine respiratory diseases during a clinical field trial in France, Germany, Spain and Belgium, is good: MIC values are comprised between 0.015 and 0.25 µg/ml for M. haemolytica (MIC90 = 0.124 µg/ml; MIC50 = 0.025 µg/ml), between 0.004 and 0.12 µg/ml for P. multocida (MIC90 = 0.022 µg/ml; MIC50 = 0.009 µg/ml) and between 0.015 and 2 µg/ml for Histophilus somni. Strains with MIC ≤ 1 µg/ml are sensitive to marbofloxacin whereas strains with MIC ≥ 4 µg/ml are resistant to marbofloxacin.

Resistance to fluoroquinolones occurs mostly by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump or mutation of enzymes responsible for molecule binding.

5.2 Pharmacokinetic particulars

After subcutaneous or intramuscular administration in cattle and intramuscular administration in pigs at the recommended dose of 2mg/kg body weight, marbofloxacin is readily absorbed and reaches maximal plasma concentrations of 1.5µg/ml within less than 1 hour. Its bioavailability is close to 100%.

After a single intramuscular administration in cattle at the recommended dose of 8 mg/kg body weight, the maximum plasma concentration of marbofloxacin (Cmax) is 7.3 µg/ml reached in = 0.78h (Tmax). Binding to plasma proteins is about 30%. Marbofloxacin is eliminated slowly (t½ β = 15.60 h), predominantly in the active form in urine and faeces.

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 a higher concentration than in plasma.

In cattle, marbofloxacin is eliminated slowly in pre-ruminating calves (t½ β = 5-9h) but faster in ruminant cattle (t½ β = 4-7h) predominantly in the active form in urine (3/4 in pre-ruminating calves, 1/2 in ruminants) and faeces (1/4 in pre-ruminating calves, 1/2 in ruminants).

In pigs, marbofloxacin is eliminated slowly (t½ β = 8-10h) predominantly in the active form in urine (2/3) and faeces (1/3).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium edetate

Metacresol

Monothioglycerol

Gluconolactone

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging (20, 50, 100, 250 ml vials): 28 days. The 10mL vials must be used immediately after the first opening.

6.4. Special precautions for storage

Keep the container in the outer carton in order to protect from light

10 ml vials: Following withdrawal of the required dose, the remainder to the contents of the vial should be discarded.

6.5 Nature and composition of immediate packaging

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

The vials are closed with a fluorinated bromobutyl rubber stopper oversealed with an aluminium cap. Each vial is packaged in a cardboard box.

Not all pack sizes may be marketed.

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.

7. MARKETING AUTHORISATION HOLDER

Animalcare Ltd

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

8. MARKETING AUTHORISATION NUMBERS

Vm:10347/4035

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date:21 December 2012

10. DATE OF REVISION OF THE TEXT

Date:August 2013

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

21 November 2013