Veraflox
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
08-04-2020
Summary of Product characteristics
(SPC)
08-04-2020
Public Assessment Report
(PAR)
18-07-2011
Active ingredient:
pradofloxacin
Available from:
Bayer Animal Health GmbH
ATC code:
QJ01MA97
INN (International Name):
pradofloxacin
Therapeutic group:
Dogs; Cats
Therapeutic area:
Antibacterials for systemic use, Fluoroquinolones
Therapeutic indications:
DogsTreatment 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);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.CatsTreatment 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).
Product summary:
Revision: 8
Authorization status:
Authorised
Authorization date:
2011-04-12
Patient Information leaflet
36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET:
VERAFLOX 15 MG TABLETS FOR DOGS AND CATS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder :
Bayer Animal Health GmbH
D-51368 Leverkusen
Germany
Manufacturer responsible for batch release:
KVP Pharma +Veterinär Produkte GmbH
Projensdorfer Str. 324
D-24106 Kiel
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Veraflox 15 mg tablets for dogs and cats
pradofloxacin
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each tablet contains:
ACTIVE SUBSTANCE:
Pradofloxacin
15 mg
Brownish single-scored tablets with “P15” on one side
The tablet can be divided into equal doses.
4.
INDICATIONS
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. (see section “Special
Warnings”).
Cats:
38
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_
).
5.
CONTRAINDICATIONS
-
Do not use in cases of hypersensitivity to the active substances 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 ma
Read the complete document
Summary of Product characteristics
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Veraflox 15 mg tablets for dogs and cats
Veraflox 60 mg tablets for dogs
Veraflox 120 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Pradofloxacin
15 mg
Pradofloxacin
60 mg
Pradofloxacin
120 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
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.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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. (see section 4.5).
Cats:
3
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_
)
_._
4.3
CONTRAINDICATIONS
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-c
Read the complete document
