Boflox Flavour 20 mg Tablets for Dogs and Cats

Composition

Each tablet contains:

Active substance:

Marbofloxacin 20mg

Excipients:

Qualitative composition of excipients and other constituents

Lactose monohydrate

Cellulose, powdered

Povidone

Crospovidone

Silica, colloidal anhydrous

Calcium behenate

Yeast

Beef flavour

Round beige cross-snap tablets with brown speckles.

The tablets can be divided into halves or quarters.

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Pharmacological properties

4.1 ATCvet code:

QJ01MA93.

4.2 Pharmacodynamics

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group which acts by inhibition of DNA gyrase and Topoisomerase IV. It is effective against a wide range of Gram positive bacteria and Gram negative bacteria. Efficacy was established in particular in:

• Skin and soft tissue infections caused by Staphylococcus spp. (S. aureus and S. intermedius), E. coli, Pasteurella multocida and Pseudomonas aeruginosa

• Urinary tract infections caused by Staphylococcus spp. (S. aureus and S. intermedius), Streptococcus spp, Enterobacteriaceae (E. coli, Proteus spp., Klebsiella spp., Citrobacter freundii, Enterobacter cloacae) and Pseudomonas aeruginosa

• Respiratory tract infections infections caused by Pasteurella multocida, Enterobacteriaceae (E. coli, Klebsiella pneumoniae), Staphylococcus spp. (S. aureus, S. intermedius), Pseudomonas aeruginosa, Bordetella bronchiseptica and Streptococcus spp.

Cases of resistance have been observed in Streptococcus.

Strains from dermal infections in cats and dermal and UTI infections in dogs with MIC < 1µg/ml are sensitive to marbofloxacin (CLSI, 2008) whereas strains with MIC ≥ 4 µg/ml are resistant to marbofloxacin.

Resistance to fluoroquinolones occurs by chromosomal mutation with the following mechanisms: Decrease in bacterial cell wall permeability, expression of genes coding for efflux pump or mutations in genes encoding enzymes responsible for molecule binding. Plasmid-mediated resistance to fluoroquinolones confer only decreased susceptibility of bacteria, however, it can facilitate development of mutations in genes of target enzymes and can be transferred horizontally. Depending on the underlying resistance mechanism cross-resistance to other (fluoro)quinolones and co-resistance to other antimicrobial classes can occur.

Marbofloxacin is not active against anaerobes, yeasts or fungi.

4.3 Pharmacokinetics

After oral administration in dogs and cats 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 (elimination half- life is 14 hours in dogs and 10 hours in cats) predominantly in the active form in urine (2/3) and faeces (1/3).

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Target species

Dogs, cats.

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Indications

Treatment of infections caused by strains of microorganisms susceptible to marbofloxacin. Please see section 4.2.

In dogs:

• skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis)

• urinary tract infections (UTI) associated or not with prostatitis or epididymitis

• respiratory tract infections.

In cats:

• skin and soft tissue infections (wounds, abscesses, phlegmons)

• upper respiratory tract infections.

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Dosage

For oral administration.

The recommended dose rate is 2 mg/kg/d (1 tablet for 10 kg per day) in single daily administration. To ensure a correct dosage body weight should be determined as accurately as possible.

The 20mg tablet can be accurately and easily broken into four equal quarters by pressing with the thumb on the top facing score line.

Duration of treatment:

Dogs:

In skin and soft tissue infections, treatment duration is at least 5 days. Depending on the course of the disease, it may be extended up to 40 days.

In urinary tract infections, treatment duration is at least 10 days. Depending on the course of the disease, it may be extended up to 28 days.

In respiratory infections, treatment duration is at least 7 days Depending on the course of the disease, it may be extended up to 21 days.

Cats:

In skin and soft tissue infections (wounds, abscesses, phlegmons) treatment duration is 3 to 5 days.

In upper respiratory infections, treatment duration is 5 days.

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Contraindications

Do not use in dogs aged less than 12 months, or less than 18 months for exceptionally large breeds of dogs, such as Great Dane, Briard, Bernese, Bouvier and Mastiff, with a longer growth period.

Do not use in cats aged less than 16 weeks.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in cases of resistance against quinolones, since (almost) complete cross- resistance exists against other fluoroquinolones.

Not suitable for infections resulting from strict anaerobes, yeast or fungi.

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Adverse reactions

Dog, cat:

Rare (1 to 10 animals / 10 000 animals treated): Joint pain; Neurological symptoms (ataxia, aggressiveness, convulsion, depression)

Undetermined frequency (cannot be estimated from the available data): Allergic reaction1 (allergic skin reaction2); Vomiting3, soft stool3, modification of thirst3; Hyperactivity2,3

1 Due to histamine release

2 Temporary

3 Mild; cease spontaneously after treatment and do not necessitate cessation of treatment

At the therapeutic recommended dosage, no severe side-effects are to be expected in dogs and cats.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

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 and cats 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. Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may reduce 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.

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

People with known hypersensitivity to (fluoro)quinolones should avoid contact with the veterinary medicinal product.

In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Studies in pregnant rats and rabbits showed no side effects on pregnancy. The safety of the veterinary medicinal product has not been established in dogs and cats during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

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Interactions

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

Do not use in combination with tetracyclines, macrolides because of the potential antagonist effect.

When administered together with theophylline, the half-life and thus the plasma concentration of theophylline increases. Hence, the dose of theophylline should be reduced.

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Overdose

Overdosage may cause cartilage damage in the joints and acute signs in the form of neurological disorders (e.g. salivation, streaming eyes, shivering, myoclonia, seizures), which should be treated symptomatically.

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Special warnings

A low urinary pH could have an inhibitory effect on the activity of marbofloxacin. Pyoderma occurs mostly secondary to an underlying disease, thus, it is advisable to determine the underlying cause and treat the animal accordingly.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

Alu / PA-Alu-PVC blister each of 10 tablets packed in cardboard box.

Pack sizes:

Cardboard box with 10 tablets

Cardboard box with 20 tablets

Cardboard box with 50 tablets

Cardboard box with 100 tablets

Cardboard box with 150 tablets

Cardboard box with 200 tablets

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special temperature storage conditions.

Store the blisters in the original container.

If the tablets are divided, the remaining halves and quarters should be kept in the blister pocket.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years

Shelf life of tablet halves and quarters: 4 days

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

7 MARKETING AUTHORISATION NUMBERS

Vm 36547/5006 Vm 36547/3006

8 DATE OF FIRST AUTHORISATION

20 February 2017

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

November 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

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Registration holder

Industrial Veterinaria SA

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