MARFLOXIN 5 MG MARBOFLOXACIN 1 PACK / 100 TABLETS /

Marfloxin 5 mg tablets for cats and dogs

1. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

AND THE MANUFACTURER, IF THEY ARE DIFFERENT

Marketing Authorization Holder and manufacturer responsible for batch release:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Marfloxin 5 mg tablets for cats and dogs

Marbofloxacin

3. CONTENTS OF ACTIVE SUBSTANCE AND EXCIPIENTS

Each tablet contains 5 mg of marbofloxacin.

Light brown-yellow, round, biconvex, marbled tablets with bevelled edges,

with dark and white spots with a dividing line on one side.

The tablet can be divided into two halves.

4. THERAPEUTIC INDICATIONS

Treatment of infections caused by species susceptible to microorganisms

marbofloxacin.

In dogs:

– Infections of the skin and soft tissues (pyoderma of the skin folds, impetigo,

folliculitis, furunculosis, cellulitis);

– Urinary tract infections (UTs), whether or not associated with prostatitis or epididymitis.

– Respiratory tract infections.

In cats:

– Skin and soft tissue infections (wounds, abscesses, phlegmon);

– Infections of the upper respiratory tract.

5. CONTRAINDICATIONS

Do not use in dogs under 12 months of age or less than 18 months of age

Extremely large breeds such as German Dog, French Shepherd (Biard), Mountain Bernez,

Bouvier Bernard and Mastiff, with a prolonged growth period.

Do not use in cats less than 16 weeks of age.

Do not use in case of known hypersensitivity to marbofloxacin or others

(fluorine) quinolones or to any of the excipients.

6. UNDESIRABLE EFFECTS

Occasionally slight mild side effects such as vomiting may occur

stools, changed thirst, or transient increase in activity. These symptoms

disappear spontaneously after treatment and do not require termination.

If you notice any serious side effects or other effects not listed in this leaflet

leaflet, please inform your veterinary surgeon.

7. TARGET SPECIES FOR VMP

Cats and dogs.

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

For oral use.

The recommended dose is 2 mg / kg / day (1 tablet per 2.5 kg per day) taken once. When it is

possible, only in dogs, the use of a combination of whole or half tablets from

different concentrations (5 mg, 20 mg or 80 mg) will allow accurate dosing.

To ensure proper dosing, body mass should be precisely defined to be

avoid taking too little of the medicine.

Duration of treatment:

Dogs:

In skin and soft tissue infections, the duration of treatment is at least 5 days

and depending on the development of the disease, may be prolonged to 40 days.

For urinary tract infections, the duration of treatment is at least 10 days and at least 10 days

Dependence on the development of the disease may be prolonged to 28 days.

For respiratory infections, the duration of treatment is at least 7 days, and

Dependence on the development of the disease may be prolonged to 21 days.

Cats:

In infections of the skin and soft tissues (wounds, abscesses, phlegmons) the duration of

treatment is 3 to 5 days.

For upper respiratory tract infections, the duration of treatment is 5 days.

9. ADVICE ON CORRECT ADMINISTRATION

There is no.

10. WITHDRAWAL PERIOD

Not applicable.

11. SPECIAL STORAGE CONDITIONS

Keep out of the reach and sight of children.

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

This veterinary medicinal product does not require any special temperature conditions

storage.

Do not use the veterinary medicinal product after the expiry date,

indicated on the packaging after ‘EXP’

Shelf life of half a tablet: 5 days.

12. SPECIAL WARNINGS

Special warnings for each species for which the VMP is intended

Low urinary pH may have an inhibitory effect on marbofloxacin activity.

Pyoderma may occur, mainly secondary, with ongoing disease, which is why it is

it is advisable to determine the primary disease to treat the animal.

Special precautions for use in animals:

High doses of certain fluoroquinolones have epileptogenic potential. Recommended

careful use in dogs and cats diagnosed with epilepsy. However, it does not

expect severe adverse drug reactions in dogs and cats when administered

the recommended therapeutic dose. In particular, joint lesions have not been observed in

clinical studies with the recommended dose range.

Formal and local antimicrobial requirements should be respected when taken

uses the veterinary medicinal product. Fluorocinolones should be used for

treatment of clinical conditions that are poorly responded or expected to have a poor response

to other classes of antimicrobial preparations.

Whenever possible, the use of fluoroquinolones should be done after a sensitivity test.

The use of the product beyond the indications given in the SPC may increase the prevalence

of bacteria resistant to (fluoro) quinolones and may reduce the effectiveness of treatment

with other quinolones due to the possibility of cross-resistance.

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

animals:

People with known hypersensitivity to (fluoro) quinolones should avoid contact with

veterinary medicinal product.

In case of accidental ingestion seek medical advice immediately and show the doctor

provide the package leaflet or product label.

Wash hands after use.

Pregnancy and lactation:

Laboratory studies in rats, rabbits do not provide any evidence

teratogenicity, foetotoxicity and maternal toxicity. However, they have not been conducted

specific studies with pregnant or lactating cats and dogs. Therefore, use

these types of animals should be made only after a benefit / risk assessment by the attending physician

veterinarian.

Interaction with other veterinary medicinal products and other forms of interaction:

Fluoroquinolones are known to interact with orally administered cations (aluminum, calcium,

magnesium, iron). In such a case, the bioavailability of marbofloxacin may be

reduced. Concomitant administration of theophylline-containing products may be followed

of the inhibition of theophylline clearance.

Overdose (symptoms, emergency measures, antidotes):

Overdose can cause acute symptoms of neurological disorders that occur

treated symptomatically.

Incompatibilities:

Not applicable.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT

OR ANY RESULTS FROM HIM, IF ANY

Any unused product or waste material must be disposed of

compliance with national requirements.

Ask your veterinarian what to do with unnecessary VMPs. These measures will

help protect the environment.

14. DATE OF REVISION OF THE TEXT

29.01.2013

15. ADDITIONAL INFORMATION

Cold-Pressed Polyvinyl Chloride / Aluminum / Oriented Polyamide / Aluminum –

containing 10 tablets

Letter boxes for use with 10 tablets and 100 tablets.

Not all packs may be placed on the market.

For any information about this veterinary medicinal product, please contact:

with the local representative of the marketing authorization holder.