Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Ciprofloxacin hydrochloride 291mg equivalent ciprofloxacin 250 mg; ;
Ipca Pharma (NZ) Pty Limited
Ciprofloxacin hydrochloride 291 mg (equivalent ciprofloxacin 250 mg)
250 mg
Film coated tablet
Active: Ciprofloxacin hydrochloride 291mg equivalent ciprofloxacin 250 mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 4000 Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Purified water Sodium starch glycolate Titanium dioxide
Blister pack, PVC/Al (not marketed), 7 tablets
Prescription
Prescription
Dr Reddy's Laboratories Limited
For complicated urinary tract infections or pyelonephritis due to E.coli in paediatric patients aged 1-17 years. The risk-benefit assessment indicates that administration of ciprofloxacin to paediatric patients is appropriate. Treatment should only be initiated after careful benefit/risk evaluation, due to possible adverse events related to joints/surrounding tissues. The use of ciprofloxacin for other indications is not recommended in children.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 7 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C
2004-07-15
NEW ZEALAND DATA SHEET IPCA-CIPROFLOXACIN Page 1 of 19 1. PRODUCT NAME Ipca-Ciprofloxacin 250 mg, 500mg, 750 mg, film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Film-coated tablets Ciprofloxacin 250: 1 tablet contains ciprofloxacin hydrochloride equivalent to 250 mg ciprofloxacin. Ciprofloxacin 500: 1 tablet contains ciprofloxacin hydrochloride equivalent to 500 mg ciprofloxacin. Ciprofloxacin 750: 1 tablet contains ciprofloxacin hydrochloride equivalent to 750 mg ciprofloxacin. 3. PHARMACEUTICAL FORM Film-coated tablet: 250 mg: White to creamish-white, round, biconvex film coated tablets with CPR 250 embossed on one side and ‘BL’ on the other. 500 mg: White to creamish-white caplet shaped film coated tablets with CPR 500 embossed and with scoreline on one side and ‘BL’ on the other. 750 mg: White to creamish-white capsule shaped film coated tablets with CPR 750 embossed on one side and ‘BL’ on the other. Do not halve the tablet. Dose equivalence when the tablet is divided has not been established. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS Uncomplicated and complicated infections caused by ciprofloxacin sensitive pathogens: Infections of the lower respiratory tract. In the treatment of outpatients with pneumonia due to Pneumococcus, ciprofloxacin should not be used as a medicine of first choice. Ciprofloxacin can be regarded as a suitable treatment for pneumonias caused by _Klebsiella_, _Enterobacter_, _Proteus_, _E.coli, Pseudomonas, Haemophilus,_ _ _ _Branhamella, Legionella, and Staphylococcus_. Infections of the kidneys and/or the efferent urinary tract. Infections of the genital organs, including adnexitis, gonorrhoea, prostatitis. NEW ZEALAND DATA SHEET IPCA-CIPROFLOXACIN Page 2 of 19 Infections of the abdominal cavity (e.g. infections of the gastrointestinal tract or of the biliary tract, peritonitis). Infections of the skin and soft tissue. Infections of the bones and joints. Sepsis. Inhalational anthrax (post-exposure): To reduce the incidence or progression Læs hele dokumentet