MARBOXIL 5 mg

MARBOXIL 5 mg – oral antibiotic for small dogs and cats, based on marbofloxacin. Treats skin, urinary tract, and respiratory infections.

Indications

Indicated for the treatment of infections caused by bacteria susceptible to marbofloxacin:

– skin and soft tissue infections (pyoderma, folliculitis, furunculosis, cellulitis) in dogs and cats;

– urinary tract infections in dogs;

– respiratory tract infections in dogs and cats.

COMPOSITION

Each 75 mg tablet contains:

Active substance:

Marbofloxacin ………………… 5 mg

Round, beige tablets with brown spots, scored on one side.

CONTRAINDICATIONS

Do not use in dogs younger than 8 to 18 months (depending on breed size) and in sexually immature male dogs.

Do not use in cats younger than 6 months.

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

SPECIAL WARNINGS

Special precautions for use in target species:

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

Fluoroquinolones should be reserved for clinical conditions that have responded poorly, or are expected to respond poorly, to other antibiotic classes.

An antibiotic with lower risk of promoting antimicrobial resistance (lower AMEG category) should be used for first-line treatment when susceptibility testing suggests effectiveness.

Use of fluoroquinolones should be based, whenever possible, on pathogen identification and susceptibility testing.

If not possible, treatment should rely on epidemiological information and local/regional knowledge of pathogen susceptibility.

Deviation from the product characteristics summary (SPC) can increase the prevalence of fluoroquinolone-resistant bacteria and reduce the effectiveness of other quinolones due to potential cross-resistance.

Special precautions for the person administering the veterinary medicinal product:

People with known hypersensitivity to fluoroquinolones should avoid contact with the product.

Wash hands after use.

Avoid contact with skin and eyes. In case of contact, rinse thoroughly with water.

If accidentally ingested, seek medical advice immediately and show the label or leaflet.

PREGNANCY AND LACTATION

Do not use during pregnancy or lactation.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

The bioavailability of marbofloxacin may be reduced if administered with cations such as aluminium, calcium, iron, and magnesium.

If co-administered with theophylline, reduce the theophylline dose.

OVERDOSE

Very high doses (>2000 mg/kg body weight) may cause acute neurological symptoms.

Symptomatic treatment is required.

SPECIAL RESTRICTIONS AND CONDITIONS OF USE

Not applicable.

MAJOR INCOMPATIBILITIES

Not applicable.

ADVERSE EVENTS

Dogs:

Very rare (<1 in 10,000 animals treated, including isolated reports): vomiting, diarrhea, thirst, temporary hyperactivity.

These reactions are transient and usually resolve spontaneously, rarely requiring treatment.

Reporting adverse events is important for ongoing product safety monitoring.

If you notice any side effects, even those not listed, or suspect ineffectiveness, consult your veterinarian.

You can also report adverse events to the marketing authorization holder using the contact information at the end of the leaflet or through the national reporting system: farmacovigilenta@ansvsa.ro, icbmv@icbmv.ro.

DOSAGE FOR EACH SPECIES, ADMINISTRATION ROUTES AND METHODS

Oral administration, directly into the mouth or with a small amount of food.

Recommended dose: 2 mg marbofloxacin/kg body weight/day.

Cat, small dog: 1 tablet/2.5 kg body weight.

DURATION OF ADMINISTRATION

Dogs:

Skin or soft tissue infections: minimum 5 days, up to 40 days if necessary.

Urinary infections: minimum 10 days, up to 4 weeks if necessary.

Respiratory infections: between 7 and 21 days.

Cats:

Skin or soft tissue infections: 3–5 days.

Upper respiratory infections: 5 days.

RECOMMENDATIONS FOR CORRECT ADMINISTRATION

Accurate determination of body weight is essential to ensure correct dosing.

SPECIAL STORAGE PRECAUTIONS

This veterinary medicinal product does not require special storage conditions.

Do not use after the expiry date on the label and box. The expiry date refers to the last day of that month.

SPECIAL PRECAUTIONS FOR DISPOSAL

Medicines should not be disposed of via wastewater or household waste.

Use local collection systems for unused veterinary medicinal products or waste materials.

These measures help protect the environment. Ask your veterinarian or pharmacist for proper disposal methods.

CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

PRESENTATION / PACKAGING

Carton box x 1 blister OPA-ALU-PVC / ALU x 10 tablets.


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