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Clinical particulars
Target species
Cats
Indications for use, specifying the target species
Treatment of:
acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and Staphylococcus intermedius group (including S. pseudintermedius).
wound infections and abscesses caused by susceptible strains of Pasteurella multocida and the Staphylococcus intermedius group (including S. pseudintermedius).
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Due to lack of data, pradofloxacin should not be used in kittens less than 6 weeks.
Pradofloxacin has no effects on the developing cartilage of kittens 6 weeks of age and older. However the product should not be used in cats with persisting articular cartilage lesions, as these 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
None
Special precautions for use
Special precautions for use in animals
Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.
Official and local antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroqinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for cross-resistance.
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
Due to potential harmful effects, the bottles and the filled syringes must be kept out of sight and reach of children.
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)
Mild transient gastro-intestinal disturbances including vomiting have been observed in rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reported).
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 pregnancy. Pradofloxacin induced eye malformations at foetal and maternal toxic dosages in rats.
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, Veraflox should not be administered concurrently with antacids, sucralfate, multivitamins or dairy products, as absorption of Veraflox 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.
Doses
The recommended dose is 5 mg/kg bodyweight of pradofloxacin once daily. 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)
Pradofloxacin dose (mg/kg bw)
> 0.67 - 1
0.2
5 - 7.5
1 - 1.5
0.3
5 - 7.5
1.5 - 2
0.4
5 - 6.7
2 - 2.5
0.5
5 - 6.3
2.5 - 3
0.6
5 - 6
3 - 3.5
0.7
5 - 5.8
3.5 - 4
0.8
5 - 5.7
4 - 5
1
5 - 6.3
5 - 6
1.2
5 - 6
6 - 7
1.4
5 - 5.8
7 - 8
1.6
5 - 5.7
8 - 9
1.8
5 - 5.6
9 - 10
2
5 - 5.6
To ensure a correct dose, bodyweight should be determined as accurately as possible to avoid under dosing.
To facilitate accurate dosing, the 15 ml bottle of Veraflox oral suspension is supplied together with a 3 ml oral dosing syringe (graduation: 0.1 to 2 ml).
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
Treatment should be reconsidered if no improvement of the clinical condition is observed within 3 days after starting the treatment.
Method of administration
Description: Screenshot 2021-08-02 173639
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.
Withdrawal period(s)
Not applicable