Indicated for dogs in the treatment of infections caused by bacteria susceptible to marbofloxacin:
Each 300 mg tablet contains:
Active substance:
Marbofloxacin ………………… 20 mg
Round, beige tablets with brown spots, scored on one side.
Do not use in dogs younger than 8 to 18 months, depending on breed size, or in male dogs that have not fully reached sexual maturity.
Do not use in cases of hypersensitivity to the active substance or any of the excipients.
None.
Special precautions for safe use in target species:
When using the product, official and local antimicrobial policies should be considered.
Fluoroquinolones should be reserved for clinical conditions that have responded poorly, or are expected to respond poorly, to other antibiotic classes.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used as first-line treatment if susceptibility testing indicates likely efficacy.
Use of fluoroquinolones should be based, whenever possible, on identification and susceptibility testing of the target pathogen(s).
If this is not possible, treatment should rely on epidemiological data and local or regional knowledge of pathogen susceptibility.
Use of a product outside the instructions in the summary of product characteristics (SPC) may increase the prevalence of fluoroquinolone-resistant bacteria and reduce the effectiveness of other quinolones due to potential cross-resistance.
People with known hypersensitivity to fluoroquinolones should avoid contact with the veterinary medicinal product.
Wash hands after use.
Avoid contact with skin and eyes. In case of accidental contact, rinse thoroughly with water.
If accidentally ingested, seek medical advice immediately and show the package leaflet or label.
Do not use during pregnancy or lactation.
The bioavailability of marbofloxacin may be reduced when administered with cations such as aluminium, calcium, iron, or magnesium.
When co-administered with theophylline, reduce the dose of theophylline.
Very high doses (>2000 mg/kg body weight) may cause acute neurological symptoms.
Symptomatic treatment is required in such cases.
Not applicable.
Not applicable.
Dogs:
Very rare (<1 animal in 10,000 treated): vomiting, diarrhea, thirst, temporary hyperactivity.
These adverse reactions are transient and resolve spontaneously, rarely requiring treatment.
Reporting adverse events is important for ongoing monitoring of the product’s safety.
If you notice any adverse effects, even if not listed in this leaflet, or suspect the medicine was ineffective, contact your veterinarian.
You may also report adverse events to the marketing authorization holder using the contact details provided at the end of this leaflet or via the national reporting system: farmacovigilenta@ansvsa.ro, icbmv@icbmv.ro.
Oral administration, directly into the mouth or with a small amount of food.
The recommended dose is 2 mg marbofloxacin/kg body weight/day, i.e., 1 tablet per 10 kg body weight.
In skin or soft tissue infections: minimum 5 days, up to 40 days if necessary.
In urinary infections: minimum 10 days, up to 4 weeks if necessary.
In respiratory infections: minimum 7 days, up to 21 days.
To ensure correct dosing, body weight should be accurately determined.
This veterinary medicinal product does not require any special storage conditions.
Do not use after the expiry date stated on the label and carton.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste.
Use local systems for returning unused veterinary medicinal products or waste derived from them.
These measures help protect the environment.
Ask your veterinarian or pharmacist how to dispose of medicines no longer required.
Veterinary medicinal product subject to prescription.
Cardboard box x 1 blister OPA-ALU-PVC / ALU x 10 tablets.
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