One 40 mg tablet contains: Marbofloxacin 40.0 mg

One 100 mg tablet contains: Marbofloxacin 100.0 mg

For the full list of excipients, see section Pharmaceutical particulars.

Chewable tablet. Clover-shaped scored beige tablet. The tablets can be divided into four equal parts

Dogs

Dogs:

Marbofloxacin is indicated in the treatment of:

Do not use in dogs aged less than 12 months, or less than 18 months for giant breeds of dogs with a longer growth period.

Do not use in cases of hypersensitivity to the active substance, other (fluoro)quinolones or any of the excipients.

A low urinary pH could have an inhibitory effect on the activity of marbofloxacin.

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

The fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals

The fluoroquinolones are also known for their potential neurological side effects. Cautious use is recommended in dogs diagnosed as suffering from epilepsy.

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, use of fluoroquinolones should be 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 effectiveness of treatment with other quinolones due to the potential for cross-resistance.

Official and local antimicrobial policies should be taken into account when the product is used.

People with known hypersensitivity to (fluoro)quinolones or other components of the formulation should avoid contact with the veterinary medicinal product. In case of accidental ingestion seek medical attention and show the package leaflet or the label to the physician. Wash hands after use.

Mild side effects that do not necessitate cessation of treatment such as vomiting, softening of faeces, modification of thirst or transient increase in activity may very rarely occur. These signs cease spontaneously after treatment.

Studies in laboratory animals (rat, rabbit) showed no teratogenicity, embryotoxicity, and maternotoxicity with marbofloxacin at therapeutic doses.

The safety of marbofloxacin has not been assessed in pregnant and lactating dogs. Use only according to the benefit/risk assessment by the responsible veterinarian in pregnant and lactating animals.

Fluoroquinolones are known to interact with orally administered cations (Aluminium, Calcium, Magnesium, Iron). In such cases, the bioavailability may be reduced.

Serum levels of theophylline should be carefully monitored when theophylline and marbofloxacin are used concomitantly, as fluoroquinolones may increase serum levels of theophylline.

For oral administration.

The recommended dose rate is 2 mg/kg/d (40 mg tablet: 1 tablet for 20 kg per day; 100 mg tablet: 1 tablet for 50 kg per day) in single daily administration

Dogs:

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. The chewable tablets may be accepted by dogs or can be administered directly into the mouth of the animals.

Instruction on how to divide the tablet: Put the tablet on an even surface, with its scored side facing down (convex face up). With the tip of the forefinger, exert slight vertical pressure on the middle of the tablet to break it along its width into halves. Then, in order to obtain quarters, exert slight pressure on the middle of one half with the forefinger to break it into two parts

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

Not applicable

Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones. ATCvet code: QJ01MA93

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of DNA gyrase and topoisomerase IV.

It has a broad-spectrum activity in vitro against Gram-positive bacteria (in particular staphylococci and streptococci) and Gram-negative bacteria (Escherichia coli, Enterobacter cloacae, Proteus spp., Klebsiella spp., Shigella spp., Pasteurella spp., Pseudomonas spp.) as well as Mycoplasma spp.

A report on microbiological susceptibility including two European field surveys covering hundreds of canine and feline pathogens sensitive to marbofloxacin was published in 2009

MIC breakpoints have been determined for Enterobacteriaceae and Staphylococcus spp. in dogs and cats (skin, soft tissue, UTI). CLSI, July 2013 as ≤1 μg/ml for sensitive, 2 μg/ml for intermediate and ≥4 μg/ml for resistant bacterial strains to marbofloxacin.

Marbofloxacin is not active against anaerobes, yeasts or fungi.

The activity of marbofloxacin against the target bacterial species is bactericidal concentration dependant.

Resistance to fluoroquinolones occurs by chromosomal mutation with the following mechanisms: decrease in bacterial wall permeability, expression change of genes encoding for efflux pumps or mutations in genes encoding enzymes responsible for molecule binding. Plasmid-mediated resistance to fluoroquinolones, which confers reduced susceptibility, has also been described. Depending on the underlying resistance mechanism cross-resistance to other (fluoro)quinolones and co-resistance to other antimicrobial classes can occur.

After oral administration in dogs at the recommended dose of 2 mg/kg, marbofloxacin is readily absorbed and reaches maximal plasma concentrations of 1.5 μg/ml within 2 hours. Its bioavailability is close to 100%. It is weakly bound to plasma proteins (less than 10%), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, digestive tract) it achieves higher concentrations than in plasma. Marbofloxacin is eliminated slowly (t½ß = 14 h in dogs) predominantly in the active form in urine (2/3) and faeces (1/3).

Lactose monohydrate, Copovidone, Silica, colloidal anhydrous, Croscarmellose sodium, Hydrogenated castor oil, Pig liver powder, Malted yeast, Cellulose microcrystalline.

Not applicable

Shelf-life of the veterinary medicinal product as packaged for sale:

Blister: PVC-TE-PVDC - aluminium heat sealed: 3 years

Blister: PA-AL-PVC - aluminium heat sealed: 3 years

Shelf-life after first opening the immediate packaging: 72 hours

Blister: PVC-TE-PVDC - aluminium heat sealed: Do not store above 30°C

Blister: PA-AL-PVC - aluminium heat sealed: This veterinary medicinal product does not require any special temperature storage conditions.

Tablet portions should be stored in the blister pack

Any tablet portions remaining after 72 hours should be discarded

Keep the blister in the outer carton.

40 mg tablets: (Polyvinyl chloride-Thermo-elast-Polyvinylidene chloride - aluminium heat sealed) containing 8 tablets per blister

Cardboard box of 8 tablets containing 1 blister of 8 tablets

Cardboard box of 16 tablets containing 2 blisters of 8 tablets

Cardboard box of 120 tablets containing 15 blisters of 8 tablets

Cardboard box of 240 tablets containing 30 blisters of 8 tablets.

100 mg tablets: (Polyvinyl chloride-Thermo-elast-Polyvinylidene chloride - aluminium heat sealed) containing 6 tablets per blister.

40 mg and 100 mg tablets: (Polyamide-Aluminium-Polyvinyl chloride - aluminium heat sealed) containing 6 tablets per blister

Cardboard box of 6 tablets containing 1 blister of 6 tablets

Cardboard box of 12 tablets containing 2 blisters of 6 tablets

cardboard box of 120 tablets containing 20 blisters of 6 tablets

Cardboard box of 240 tablets containing 40 blisters of 6 tablets.

Not all pack sizes may be marketed.

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

UK: Vm 15052/4097-4098

7 August 2013

October 2021

Nil