Veraflox 120 mg Tablets for Dogs

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.

Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Dogs:
Do not use in dogs during the period of growth as developing articular cartilage may
be affected. The period of growth depends on the breed. For the majority of breeds,
pradofloxacin-containing veterinary medicinal products must not be used in dogs of
less than 12 months of age and in giant breeds less than 18 months.
Do not use in dogs with persisting articular cartilage lesions, since lesions may
worsen during treatment with fluoroquinolones.
Do not use in dogs with central nervous system (CNS) disorders, such as epilepsy,
as fluoroquinolones could possibly cause seizures in predisposed animals.
Do not use in dogs during pregnancy and lactation (see section 3.7).
3.4 Special warnings
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.
3.5 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.
Pyoderma occurs mostly secondary to an underlying disease, thus, it is advisable to
determine the underlying cause and to treat the animal accordingly.
This veterinary medicinal product should only be used in severe cases of periodontal
disease. Mechanical cleaning of teeth and removal of plaque and calculus or
extraction of teeth are prerequisites for a persistent therapeutic effect. In case of
gingivitis and periodontitis, the veterinary medicinal product should only be used as
an adjunct to mechanical or surgical periodontal therapy. Only those dogs for which
periodontal treatment goals cannot be achieved by mechanical treatment alone
should be treated with this veterinary medicinal product.
Pradofloxacin may increase sensitivity of the skin to sunlight. During treatment,
animals should therefore not be exposed to excessive sunlight.
Excretion via kidneys is an important elimination route for pradofloxacin in dogs. As
for other fluoroquinolones, the renal excretion rate of pradofloxacin may be
decreased in dogs with impaired kidney function and, therefore, pradofloxacin should
be used with caution in such animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
People with known hypersensitivity to quinolones should avoid contact with the
veterinary medicinal product.
Avoid skin and eye contact with the veterinary medicinal product. Wash hands after
use.
Do not eat, drink or smoke while handling the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.