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Date: Thursday, March 28, 2024 20:55

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Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.36
Veraflox Tablets
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Pradofloxacin
Product:Veraflox Tablets
Product index: Veraflox Tablets
Incorporating:VERAFLOX® 15 MG TABLETS FOR DOGS AND CATS
VERAFLOX® 60 MG TABLETS FOR DOGS
VERAFLOX® 120 MG TABLETS FOR DOGS
Qualitative and quantitative composition
Each tablet contains:
Active substance:
Pradofloxacin 15mg
Pradofloxacin 60mg
Pradofloxacin 120mg
Pharmaceutical form
Tablets.
Brownish single-scored tablets with "P15" on one side
Brownish single-scored tablets with "P60" on one side
Brownish single-scored tablets with "P120" on one side
The tablet can be divided into equal doses.
Clinical particulars
Target species
Dogs, cats
Indications for use, specifying the target species
Treatment of:
Dogs:
Treatment of:
Wound infections caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius),
Superficial and deep pyoderma caused by susceptible strains of the Staphylococcus intermedius group (including S. pseudintermedius),
Acute urinary tract infections caused by susceptible strains of Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius) and
As adjunctive treatment to mechanical or surgical periodontal therapy in the treatment of severe infections of the gingiva and periodontal tissues caused by susceptible strains of anaerobic organisms, for example Porphyromonas spp. and Prevotella spp.
Cats:
Treatment of acute infections of the upper respiratory tract caused by susceptible strains of Pasteurella multocida, Escherichia coli and the Staphylococcus intermedius group (including S. pseudintermedius).
Contraindications
Dogs:
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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
Cats:
Due to the lack of data, pradofloxacin should not be used in kittens aged less than 6 weeks.
Pradofloxacin has no effects on the developing cartilage of kittens of 6 weeks of age and older. However, the product must 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
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 instructions given in the summary of product characteristics (SPC) may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other fluoroquinolones due to the potential for cross ­resistance.
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
Due to potential harmful effects, the tablets must be kept out of the 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.
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.
Adverse reactions (frequency and seriousness)
Mild transient gastro-intestinal disturbances including vomiting have been observed in rare cases in dogs and cats.
The frequency of adverse reactions is defined using the following convention:
-very common (more than 1 in 10 animals treated displaying adverse reactions)
-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 reports).
Use during pregnancy, lactation or lay
The safety of this veterinary medicinal product has not been established during pregnancy and lactation in cats and dogs.
Pregnancy:
Do not use during pregnancy. Pradofloxacin induced eye malformations at foetal and maternal toxic doses in rats.
Lactation:
Do not use during lactation. Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of fluoroquinolones. 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 ofVeraflox 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 bioavailability of digoxin.
Amounts to be administered and administration route
Oral use.
Doses
The recommended dose is 3 mg/kg bodyweight ofpradofloxacin once daily. Due to the available tablet sizes the resulting dose range is 3 to 4.5 mg/kg bodyweight according to the following tables.
To ensure a correct dose, bodyweight should be determined as accurately as possible to avoid under dosing. When the dose requires a half tablet to be used the remaining portion should be given at the next administration.
Dogs:
Bodyweight of Dog (kg)
Number of Tablets
Pradofloxacin dose (mg/kg bw)
15mg
60mg
120mg
>3.4 - 5
1
3 - 4.4
5 - 7.5
1 1/2
3 - 4.5
7.5 - 10
2
3 - 4
10 - 15
3
3 - 4.5
15 - 20
1
3 - 4
20 - 30
11/2
3 - 4.5
30 - 40
1
3 - 4
40 - 60
11/2
3 - 4.5
60 - 80
2
3 - 4

Cats:

Bodyweight of Cat (kg)
Number of Tablets 15mg
Pradofloxacin dose (mg/kg bw)
>3.4 - 5
1
3 - 4.4
5 - 7.5
11/2
3 - 4.5
7.5 - 10
2
3 - 4
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:
Dogs:
Indication
Duration of treatment (days)
Infections of the skin:
Superficial pyoderma
14 - 21
Deep pyoderma
14 - 35
Wound infections
7
Acute infections of urinary tract
7 - 21
Severe infections of the gingiva and periodontal tissues
7
The treatment should be re-considered if no improvement of the clinical conditions is observed within 3 days, or in cases of superficial pyoderma 7 days, and in cases of deep pyoderma 14 days, after starting the treatment.
Cats:
Indication
Duration of treatment (days)
Acute infections of the upper respiratory tract
5
The treatment should be re-considered if no improvement of the clinical condition is observed within 3 days after starting the treatment.
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 and soft faeces were observed in dogs after repeated oral administration of
2. 7 times the maximum recommended dose.
Infrequent vomiting was observed in cats after repeated oral administration of 2. 7 times the maximum recommended dose.
Withdrawal period(s)
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones.
ATCvet code: QJ01MA97
Pharmacodynamic properties
Mode of Action
The primary mode of action of the fluoroquinolones involves interaction with enzymes essential for major DNA functions such as replication, transcription and recombination. The primary targets for pradofloxacin are the bacterial DNA gyrase and topoisomerase IV enzymes. Reversible association between pradofloxacin and DNA gyrase or DNA topoisomerase IV in the target bacteria results in inhibition of these enzymes and rapid death of the bacterial cell. The rapidity and extent of bacterial killing are directly proportional to the drug concentration.
Antibacterial Spectrum
Although pradofloxacin has in-vitro activity against a wide range of Gram-positive and Gram­negative organisms, including anaerobic bacteria, this veterinary medicinal product should only be used for the approved indications and in accordance with the prudent use recommendations in section 'special precautions for use'.
MIC-Data
Dogs:
Bacterial Species
Number of strains
MIC50 (µg/ml)
MIC90 (µg/ml)
MIC range (µg/ml)
Staphylococcus intermedius group (including S. pseudintermedius)
1097
0.062
0.062
0.002 - 4
Escherichia coli
173
0.031
0.062
0.008 - 16
Porphyromonas spp.
310
0.062
0.125
≤ 0.016 - 0.5
Prevotella spp.
320
0.062
0.25
≤ 0.016 - 1
Cats:
Bacterial species
Number of strains
MIC50 (μg/ml)
MIC90 (μg/ml)
MIC range (μg/ml)
Pasteurella multocida
323
0.016
0.016
0.002 - 0.062
Escherichia coli
135
0.016
4
0.008 - 8
Staphylococcus intermedius group (including S. pseudintermedius)
184
0.062
0.125
0.016 - 8
The bacteria were isolated between 2001 and 2007 from clinical cases in Belgium, France, Germany, Hungary, Poland, Sweden and UK.
Types and Mechanisms of Resistance
Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins. All mechanisms lead to a reduced susceptibility of the bacteria to fluoroquinolones. Cross-resistance within the fluoroquinolone class of antimicrobials is common.
Pharmacokinetic particulars
In laboratory studies the bioavailability of pradofloxacin was reduced in fed dogs and cats compared to fasted animals. However in the clinical studies feeding did not reveal any impact on the treatment effect.
Dogs:
After oral administration of the therapeutic dose to dogs, pradofloxacin is rapidly (T max of 2 hours) and almost completely (approximately 100%) absorbed reaching peak concentrations of 1.6 mg/1.
A linear relationship between pradofloxacin serum concentrations and the administered dose is observed in dogs within a tested dose range of 1 to 9 mg/kg body weight. Long-term daily treatment has no impact on the pharmacokinetic profile, with an accumulation index of 1.1. In vitro plasma protein binding is low (35%). The high volume of distribution (V d) >21/kg bodyweight indicates good tissue penetration. Pradofloxacin concentrations in skin homogenates of dogs exceed those in serum by up to seven times.
Pradofloxacin is eliminated from serum with a terminal half-life of7 hours. Major elimination pathways are glucuronidation as well as renal excretion. Pradofloxacin is cleared from the body at 0.241/h/kg. Approximately 40% of the administered product is excreted unchanged via the kidneys.
Cats:
In cats, absorption of orally administered pradofloxacin at the therapeutic dose is rapid reaching peak concentrations of 1.2 mg/1 within 0.5 hours. The bioavailability of the tablet is at least 70%. Repeated dosing shows no impact on the pharmacokinetic profile (accumulation index = 1.0). In vitro plasma protein binding is low (30%). The high volume of distribution (V d) >41/kg body weight indicates good tissue penetration.
Pradofloxacin is eliminated from serum with a terminal half-life of9 hours. The major elimination pathway in cats is glucuronidation. Pradofloxacin is cleared from the body at 0.28 1/h/kg.
Pharmaceutical particulars
List of excipients
Lactose monohydrate
Cellulose, microcrystalline
Povidone
Magnesium stearate
Silica, colloidal anhydrous
Artificial beef flavour
Croscarmellose sodium
Major incompatibilities
Not applicable
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
Folding cartons containing aluminium blister packs. One blister contains 7 tablets.
The following pack sizes are available:
7 tablets
21 tablets
70 tablets
140 tablets
Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany
Marketing Authorisation Number
Veraflox 15 mg Tablets for Cats and Dogs
UK (Great Britain): Vm 04895/5009
UK (Northern Ireland): EU/2/10/107/001-004
Veraflox 60 mg Tablets for Dogs
UK (Great Britain): Vm 04895/5011
UK (Northern Ireland): EU/2/10/107/005-008
Veraflox 120 mg Tablets for Dogs
UK (Great Britain): Vm 04895/5008
UK (Northern Ireland): EU/2/10/107/009-012
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 12/04/2011
Date oflast renewal: 07/01/2016
Date of revision of the text
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Any other information
Legal category
Legal category: POM-V
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