Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
pradofloxacin
Bayer Animal Health GmbH
QJ01MA97
pradofloxacin
Dogs; Cats
Antibacterials for systemic use, Fluoroquinolones
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).
Revision: 8
Authorised
2011-04-12
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 Lestu allt skjalið
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 Lestu allt skjalið