Marbocyl P 5 mg Tablet for Dogs and Cats

Composition

Each tablet contains:

Active substance:

Marbofloxacin 5mg

Excipients:

Beige brown spotted round tablet.

3

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. It is effective against a wide range of Gram positive bacteria (in particular Staphylococci,Streptococci) and Gram negative bacteria (Escherichia coli, Salmonella typhimurium, Citrobacter freundii, Enterobacter cloacae, Serratia marcescens, Morganella morganii, Proteus spp, Klebsiella spp, Shigella spp, Pasteurella spp, Haemophilus spp, Moraxella spp, Pseudomonas spp, Brucella canis) as well as Mycoplasma spp.

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 (t½ß = 14 h in dogs and 10h in cats) predominantly in the active form in urine (2/3) and faeces (1/3).

3

Target species

Dogs and cats.

3

Indications

In dogs

Marbofloxacin is indicated in the treatment of:

skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis) caused by susceptible strains of organisms.

urinary tract infections (UTI) associated or not with prostatitis caused by susceptible strains of organisms.

respiratory tract infections caused by susceptible strains of organisms.

In cats

Marbofloxacin is indicated in the treatment of skin and soft tissue infections (wounds, abscesses, phlegmons) and upper respiratory tract infections caused by susceptible strains of organisms.

3

Dosage

To ensure a correct dosage, body weight should be determined as accurately as possible.

For oral administration.

The recommended dose rate is 2 mg/kg/d (1 tablet for 2.5 kg per day) in single daily administration.

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 and depending on the course of the disease, it may be extended up to 21 days.

Cats:

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

for upper respiratory infections treatment duration is 5 days.

3

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 Danes, Briard, Bernese, Bouvier and Mastiffs, with a longer growth period.

Do not use in cats aged less than 16 weeks.

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

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

Do not use for infections resulting from strict anaerobes, yeast or fungi.

3

Adverse reactions

Dogs and cats:

Rare (1 to 10 animals / 10 000 animals treated): Vomiting1,2, soft stool1,2, Hyperactivity1,2,3, Excessive thirst1,2, Allergic skin reaction3,4, Neurological disorder (ataxia, convulsion), Joint pain, Aggression, Depression

At the therapeutic recommended dosage, no severe side-effects are to be expected in dogs and cats. In particular, no lesions of the articular joints were encountered in clinical studies at the recommended dose rate

1 Mild

2 These signs cease spontaneously and do not require discontinuation of treatment

3 Transient

4 Due to the release of histamine

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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

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.

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

A low urinary pH could have an inhibitory effect on the activity of marbofloxacin. 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 the effectiveness of treatment with other quinolones due to the potential for cross resistance.

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.

In case of accidental ingestion seek medical attention and show the package leaflet or the label to the physician. Wear gloves when handling or dividing tablets. 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.

3

Use during pregnancy, lactation or lay

Studies in pregnant rats and rabbits showed no side effects on pregnancy. However no specific studies have been carried out in pregnant cats and dogs.

3

Interactions

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

3

Overdose

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

3

Special warnings

None.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Aluminium / aluminium blister strips containing 10 tablets/blister. Cardboard box:

Pack sizes of 10, 20, 30, 40, 50, 100 and 250 tablets.

Not all pack sizes may be marketed.

3

Storage

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

3

Shelf life

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

3

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.

3

Additional information

Vm 08007/5024

8 DATE OF FIRST AUTHORISATION

20 June 2003

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

April 2026

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.

Gavin Hall Approved: 21 April 2026

3

Registration holder

Vetoquinol UK Limited

3