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Indicated for dogs in the treatment of infections caused by bacteria susceptible to marbofloxacin:
Each 1200 mg tablet contains:
Active substance:
Marbofloxacin ………………… 80 mg
Oblong, 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 yet fully reached sexual maturity.
Do not use in cases of hypersensitivity to the active substance or to 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 classes of antibiotics.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used as first-line treatment if susceptibility testing indicates probable 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 information and knowledge of pathogen susceptibility at farm or local/regional level.
Use of a product outside the instructions stated in the summary of product characteristics (SPC) may increase the prevalence of fluoroquinolone-resistant bacteria and reduce the efficacy 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 plenty of water.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label.
Do not use during pregnancy and lactation.
The bioavailability of marbofloxacin may be reduced when administered together with cations such as aluminium, calcium, iron, or magnesium.
When co-administered with theophylline, a reduction in its dose is recommended.
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 per 10,000 treated): vomiting, diarrhea, thirst, temporary hyperactivity.
These adverse reactions are transient and resolve spontaneously, very rarely requiring treatment.
Reporting adverse events is important. It allows continuous monitoring of the safety of the veterinary medicinal product.
If you notice any adverse reactions, even those not listed in this leaflet, or if you believe the medicine was ineffective, please contact your veterinarian first.
You may also report adverse events to the marketing authorization holder using the contact details 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 40 kg body weight.
For skin or soft tissue infections, the treatment duration is at least 5 days. If necessary, it may be extended up to 40 days.
For urinary infections, the treatment duration is at least 10 days. If necessary, it may be extended up to 4 weeks.
For respiratory infections, the treatment duration is minimum 7 days and maximum 21 days.
To ensure correct dosing, body weight should be determined as accurately as possible.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date stated on the label and carton.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Use local collection systems for unused veterinary medicinal products or their waste in accordance with applicable local and national regulations.
These measures help protect the environment.
Ask your veterinarian or pharmacist how to properly dispose of unused medicines.
Veterinary medicinal product subject to prescription.
Cardboard box x 1 blister of OPA-ALU-PVC / ALU x 10 tablets.
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