Country: European Union
Language: English
Source: EMA (European Medicines Agency)
ibafloxacin
Intervet International BV
QJ01MA96
ibafloxacin
Dogs; Cats
Antibacterials for systemic use
Dogs:Ibaflin is indicated for the treatment of the following conditions in dogs:dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible strains of Staphylococci, Escherichia coli and Proteus mirabilis;acute, uncomplicated urinary-tract infections, caused by susceptible strains of Staphylococci, Proteus species, Enterobacter spp., E. coli and Klebsiella spp.;respiratory-tract infections (upper tract) caused by susceptible strains of Staphylococci, E. coli, and Klebsiella spp.Ibaflin gel is indicated in dogs for the treatment of the following conditions:dermal infections (pyoderma - superficial and deep, wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli and P. mirabilis.Cats:Ibaflin gel is indicated in cats for treatment of the following conditions:dermal infections (soft-tissue infections - wounds, abscesses) caused by susceptible pathogens such as Staphylococcus spp., E. coli, Proteus spp. and Pasteurella spp.;upper respiratory-tract infections caused by susceptible pathogens such as Staphylococcus spp., E. coli, Klebsiella spp. and Pasteurella spp.
Revision: 7
Withdrawn
2000-06-13
B. PACKAGE INSERT 25/35 Medicinal product no longer authorised P ACKAGE INSERT FOR INCLUSION WITH THE I BAFLIN T ABLETS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands NAME AND ADDRESS OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE Intervet GesmbH. Siemensstraße 107 1210 Vienna Austria 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 30 mg tablets for dogs Ibaflin 150 mg tablets for dogs Ibaflin 300 mg tablets for dogs Ibaflin 900 mg tablets for dogs 3. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) Ibaflin 30 mg: ibafloxacin 30 mg Ibaflin 150 mg: ibafloxacin 150 mg Ibaflin 300 mg: ibafloxacin 300 mg Ibaflin 900 mg: ibafloxacin 900 mg 4. INDICATIONS Ibaflin is indicated for the treatment of the following conditions in dogs: Dermal infections (pyoderma – superficial and deep, wounds, abscesses) caused by susceptible strains such as S _taphylococci, E. coli, Proteus mirabilis_ . Acute, uncomplicated urinary tract infections _, _ caused by susceptible strains such as S _taphylococci, _ _Proteus spp., Enterobacter spp., E. coli _ and _ Klebsiella spp. _ Respiratory tract infections (upper tract) _ _ caused by susceptible strains of S _taphylococci, E. coli, _ and _ _ _Klebsiella spp_ . 5. CONTRAINDICATIONS Do not use in dogs during the period of growth as articular cartilage may be affected. This period depends on the breed. For the majority of breeds the use of ibafloxacin is contra-indicated in dogs less than 8 months of age, and in giant breeds less than 18 months. Do not use in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures. 26/35 Medicinal product no longer authorised 6. UNDESIRABLE EFFECTS Diarrhoea, soft faeces, vomiting, dullness and anorexia have been observed with low frequency. These effects Read the complete document
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/35 Medicinal product no longer authorised 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ibaflin 30 mg tablets for dogs Ibaflin 150 mg tablets for dogs Ibaflin 300 mg tablets for dogs Ibaflin 900 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Ibaflin contains: ACTIVE SUBSTANCE(S) Ibafloxacin 30 mg Ibafloxacin 150 mg Ibafloxacin 300 mg Ibafloxacin 900 mg EXCIPIENTS For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE Ibaflin is indicated for the treatment of the following conditions in dogs: Dermal infections (pyoderma – superficial and deep, wounds, abscesses) caused by susceptible strains of _Staphylococci, E. coli, _ and _Proteus mirabilis_ . Acute, uncomplicated urinary tract infections _, _ caused by susceptible strains of _Staphylococci, Proteus _ _spp., Enterobacter spp., E. coli _ and _ Klebsiella spp. _ Respiratory tract infections (upper tract) _ _ caused by susceptible strains of _Staphylococci, E. coli, _ and _ _ _Klebsiella spp_ . 4.3 CONTRAINDICATIONS Do not use in dogs during the period of growth as articular cartilage may be affected. This period depends on the breed. For the majority of breeds the use of ibafloxacin is contra-indicated in dogs less than 8 months of age and in giant breeds less than 18 months. Do not use in combination with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not use in dogs with known quinolone hypersensitivity. 2/35 Medicinal product no longer authorised 4.5 SPECIAL PRECAUTIONS FOR USE Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antibiotic. Ibaflin should only be used based on s Read the complete document