Target species
Cats
Indications for use, specifying the target species
Treatment of:
•acute infections of the upper respiratory tract caused by strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
•wound infections and abscesses caused by strains of Staphylococcus intermedius group (including S. pseudintermedius) and Pasteurella multocida.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in kittens less than 6 weeks.
Pradofloxacin has no effects on the developing cartilage of kittens 6 weeks of age and older. Do not use in cats with persisting articular cartilage lesions, since lesions may worsen during treatment with fluoroquinolones.
Do not use in cats with central nervous system (CNS) disorders, such as epilepsy, as fluoroquinolones could potentially cause seizures in predisposed animals.
Do not use in cats during pregnancy and lactation (see section below: Use during pregnancy, lactation or lay)
Special warnings for each target species
Cross-resistance has been shown between pradofloxacin and other fluoroquinolones. Use of pradofloxacin should be carefully considered when susceptibility testing has shown resistance to fluoroquinolones because its effectiveness may be reduced.
Special precautions for use
Special precautions for safe use in the target species
Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at local/regional level.
Use of the product should be in accordance with official, national and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach. Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance selection should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Pradofloxacin may increase sensitivity of the skin to sunlight. During treatment, animals should therefore not be exposed to excessive sunlight.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to quinolones should avoid any contact with the veterinary medicinal product.
Avoid skin and eye contact with the veterinary medicinal product. Wash hands after use.
In case of accidental contact with the eyes, wash immediately with water.
In case of contact with the skin, rinse off with water.
Do not eat, drink or smoke while handling the veterinary medicinal product.
In case of accidental ingestion, seek medical advise and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Cats.
Rare (1 to 10 animals / 10,000 animals treated): | Digestive tract disorder (e.g. Vomiting)1 |
Use during pregnancy, lactation or lay
The safety of this veterinary medicinal product has not been established during pregnancy and lactation.
Pregnancy:
Do not use during the whole or part of pregnancy. Laboratory studies in rats have shown evidence of pradofloxacin induced eye malformations at foetotoxic and maternotoxic dosages.
Lactation:
Do not use during lactation since there are no data on pradofloxacin in kittens aged less than 6 weeks. Fluoroquinolones are known to cross the placenta and to be distributed into milk.
Fertility:
Pradofloxacin has been shown to have no effects on fertility in breeding animals.
Interaction with other medicinal products and other forms of interaction
Concurrent administration with metal cations such as those contained in antacids or sucralfate made with magnesium hydroxide or aluminium hydroxide, or multivitamins containing iron or zinc, and dairy products containing calcium, has been reported to decrease the bioavailability of fluoroquinolones. Therefore, the veterinary medicinal product should not be administered concurrently with antacids, sucralfate, multivitamins or dairy products, as absorption of the veterinary medicinal product may be decreased.
Further, fluoroquinolones should not be used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in animals with a history of seizures because of potential pharmacodynamic interactions in the CNS. The combination of fluoroquinolones with theophylline could increase the plasma levels of theophylline by altering its metabolism and thus should be avoided. The combined use of fluoroquinolones with digoxin should also be avoided because of potentially increased oral bioavailabilty of digoxin.
Amounts to be administered and administration route
Oral use.
The recommended dose is 5 mg/kg bodyweight of pradofloxacin once daily. To ensure a correct dosage, body weight should be determined as accurately as possible. Due to the graduation of the syringe the resulting dose range is 5 to 7.5 mg/kg bodyweight according to the following table:
Dosing Table
Bodyweight of Cat (kg) | Dose of Oral suspension to be given (ml) |
> 0.67 - 1 | 0.2 |
>1 - 1.5 | 0.3 |
>1.5 - 2 | 0.4 |
>2 - 2.5 | 0.5 |
>2.5 - 3 | 0.6 |
>3 - 3.5 | 0.7 |
>3.5 - 4 | 0.8 |
>4 - 5 | 1 |
>5 - 6 | 1.2 |
>6 - 7 | 1.4 |
>7 - 8 | 1.6 |
>8 - 9 | 1.8 |
>9 - 10 | 2 |
Duration of treatment.
The duration of the treatment depends on the nature and severity of the infection and on the response to treatment. For most infections the following treatment courses will be sufficient:
Indication | Duration of treatment (days) |
Wound infections and abscesses | 7 |
Acute infections of the upper respiratory tract | 5 |
The treatment should be reconsidered if no improvement of the clinical condition is observed within 3 days after starting the treatment.
Method of administration
To facilitate accurate dosing, the 15 ml bottle of Veraflox oral suspension is supplied with a 3 ml oral dosing syringe (graduation: 0.1 to 2 ml).
In order to avoid cross contamination, the same syringe should not be used for different animals. Thus, one syringe should only be used for one animal. After administration, the syringe should be cleaned with tap water and stored in the carton box together with the veterinary medicinal product.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No specific antidotes for pradofloxacin (or other fluoroquinolones) are known, therefore, in case of overdose, symptomatic treatment should be given.
Intermittent vomiting was observed after repeated oral administration of 1.6 times the maximum recommended dose.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance Not applicable.
Withdrawal period(s)
Not applicable