Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
CIPROFLOXACIN
DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece
J01MA02
CIPROFLOXACIN 2 mg/ml
SOLUTION FOR INFUSION
CIPROFLOXACIN 2 mg/ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2007-04-04
UFEXIL 100MG/50ML, 200MG/100ML, 400MG/200ML (CIPROFLOXACIN) 1. NAME OF THE MEDICINAL PRODUCT UFEXIL 100mg/50ml, UFEXIL 200mg/100ml, UFEXIL 400mg/200ml. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION (IN ACTIVE INGREDIENT) Ciprofloxacin Lactate 2.55 mg equivalent to Ciprofloxacin 2 mg Ciprofloxacin Lactate: C 17 H 18 FN 3 O 3 C 3 H 6 O 3 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carbo- xylic acid lactate. 3. PHARMACEUTICAL FORM Solution for intravenous infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin is indicated for the treatment of infections caused by susceptible organism strains in the following conditions: Lower respiratory tract infections:_ _Caused by _Escherichia coli, Klebsiella _ _pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas _ _aeruginosa_ . It is not effective in pneumonia caused by pneumococcus. Ciprofloxacin is particularly effective against _Pseudomonas aeruginosa _in cystic fibrosis. Prevention of pulmonary anthrax development after possible or certain inhalation of anthrax bacillus seeds. Skin and skin structure infections:_ _Caused by _Escherichia coli, Klebsiella pneumoniae, Enterobacter _ _cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella _ _morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus _ _aureus _ and_ Staphylococcus epidermidis_ (methicillin resistant strains). In the last case, concomitant treatment with another antibiotic (e.g. rifampicin) is suggested, in order to prevent organism resistance to ciprofloxacin. Bone and joint infections: Caused by _Enterobacter cloacae,_ _Serratia marcescens_, _Pseudomonas aeruginosa_ and _Enterobacter spp_. in general. Urinary tract infections: Caused by_ Escherichia coli, Klebsiella pneumoniae, Enterobacter _ _cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Olvassa el a teljes dokumentumot
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT UFEXIL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION (IN ACTIVE INGREDIENT) Ciprofloxacin Lactate 2.55 mg equivalent to Ciprofloxacin 2 mg /ml Ciprofloxacin Lactate: C 17 H 18 FN 3 O 3 C 3 H 6 O 3 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carbo-xylic acid lactate. 3. PHARMACEUTICAL FORM Solution for intravenous infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ciprofloxacin is indicated for the treatment of infections caused by susceptible organism strains in the following conditions: Lower respiratory tract infections:_ _Caused by _Escherichia coli, Klebsiella pneumoniae, _ _Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa_. It is not effective in pneumonia from pneumococcus. Ciprofloxacin is particularly effective against _Pseudomonas _ _aeruginosa _in cystic fibrosis. Prevention of pulmonary anthrax development after possible or certain inhalation of anthrax bacillus seeds. Skin and skin structure infections:_ _Caused by _Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus _ _vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas _ _aeruginosa, Staphylococcus aureus _and_ Staphylococcus epidermidis_ (methicillin resistant strains). In the last case, concomitant treatment with another antibiotic (e.g. rifampicin) is suggested, in order to prevent organism resistance to ciprofloxacin. Bone and joint infections: Caused by _Enterobacter cloacae,_ _Serratia marcescens_, _Pseudomonas aeruginosa_ and _Enterobacter spp_. in general. Urinary tract infections: Caused by_ Escherichia coli, Klebsiella pneumoniae, _ _Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella Olvassa el a teljes dokumentumot