Marfloxin 20 mg Marbofloxacin 1 blister / 10 tablets /

MARFLOXIN 20MG dog tablets – is an antibiotic used to treat infections caused by marbofloxacin-sensitive bacterial strains.

1. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND OF THE MANUFACTURING AUTHORIZATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DURING THE DATE OF DISPOSAL OF THE MARKETING AUTHORIZATION HOLDER AND OF THE MANUFACTURING AUTHORIZATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Marketing Authorization Holder KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo city Slovenia

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Marfloxin 20 mg tablets for dogs Marbofloxacin

3. STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS (INGREDIENTS)

Each tablet contains 20 mg of marbofloxacin.

Light yellow-brown, round, biconvex, marbled, blunt-edged tablets and darker or lighter dark spots marked on one side.

Tablets can be divided into equal halves.

4. INDICATION (S)

Treatment of infections caused by marbofloxacin-sensitive bacterial strains in dogs:

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

 urinary tract infections (ITU) associated with prostatitis or epididymitis;

 respiratory tract infections.

5. CONTRAINDICATIONS

Do not use in dogs under 12 months of age or under 18 months in very large breeds such as Great Danes, Briard, Bernese, Bouvier and Mastif, where the growth period is longer.

Do not use in cats; for their treatment, 5 mg tablets are available. Do not use in animals with known hypersensitivity to marbofloxacin, other (fluoro) quinolones, or any of the excipients of the product.

6. ADVERSE REACTIONS

Occasionally, mild side effects such as vomiting, soft feces, thirst, or temporary hyperactivity may occur. These clinical signs disappear spontaneously at the end of the treatment and do not require it to be discontinued.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs.

8. DOSAGE FOR EACH SPECIES, ROUTE (S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION

Oral administration.

The recommended dose is 2 mg / kg body weight / day (1 tablet per 40 kg body weight per day) at single dose.

If necessary and only in dogs, the combination of whole tablets and half-tablets of different concentrations (5 mg, 20 mg or 80 mg) allows for adequate dosing.

To avoid underdosing, body weight should be determined as accurately as possible.

Duration of treatment

– In skin and soft tissue infections, the duration of treatment is at least 5 days and, depending on disease progression, may reach 40 days.

– In urinary infections, the duration of treatment is at least 10 days and, depending on disease progression, may reach 28 days.

– In respiratory infections, the duration of treatment is at least 7 days and, depending on disease progression, may reach 21 days.

9. RECOMMENDATIONS ON CORRECT ADMINISTRATION

It’s not necessary.

10. WITHDRAWAL PERIOD

It’s not necessary.

11. SPECIAL PRECAUTIONS FOR STORAGE

Keep out of the reach and sight of children.

Store in the original package in order to protect from light.

This medicinal product does not require any special storage temperature. Do not use after the expiry date which is marked on the carton after EXP.

Shelf-life of half-divided tablets: 5 days.

12. SPECIAL WARNING (S)

Some high dose fluoroquinolones are potentially epileptogenic. In dogs with epilepsy, caution is recommended. However, when given with therapeutic doses, severe side effects in dogs and cats are not expected. In particular, no clinical lesions were observed in the clinical studies at the recommended dose.

In the case of low urinary pH, the effect of marbofloxacin may decrease.

Pyodermitis occurs in particular as a disease secondary to a background disease, therefore, it is preferable to diagnose and treat the animal appropriately.

The drug should be used taking into account official, local antibiotic policies. Fluoroquinolones should be reserved for the treatment of diseases that have responded or are expected to respond inappropriately to other classes of antibiotics. When possible, fuorochinolones should only be used on the basis of the antibiotic. Using the product in addition to the instructions in the SPC may increase the prevalence of fluoroquinolone-resistant bacteria and decrease the efficacy of treatment with other quinolones due to potential cross-resistance.

Studies in laboratory animals (rat, rabbit) have not demonstrated teratogenic, fetotoxic, maternotoxic effects when marbofloxacin is administered. However, specific studies in cats and dogs during gestation and lactation have not been performed. It is only used in accordance with the benefit / risk assessment carried out by the responsible veterinarian.

Fluoroquinolones are known to interact with oral cations (aluminum, calcium, magnesium, iron). In these cases, the bioavailability of marbofloxacin may be reduced.

Concomitant administration of the theophylline-containing products may result in decreased clearance of theophylline.

Overdose can cause acute neurological disorders requiring symptomatic treatment.

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

Persons 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.

After use, wash hands with water.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Ask your veterinarian for information on how to dispose of medicines no longer required. These measures contribute to environmental protection.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

15. OTHER INFORMATION

PVC-Al-OPA / Al blister of 10 tablets.

Blister and 10 tablets or 100 tablets.

Not all pack sizes may be marketed.