Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Cefixime
Orchid Europe Limited
J01D
Cefixime
200 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
OTHER BETA-LACTAM ANTIBACTERIALS
Not marketed
2010-10-15
Health Products Regulatory Authority 23 November 2018 CRN008L3F Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefixime 200 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 223.81 mg Cefixime trihydrate equivalent to 200 mg Cefixime (anhydrous) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, circular, biconvex film-coated tablets debossed with ‘C’ on one side and plain surface on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefixime is indicated for the treatment of the following infections when caused by susceptible organisms (see sections 4.4 and 5.1): Acute exacerbations of chronic bronchitis Community-acquired Pneumonia Lower urinary tract infections Pyelonephritis In the treatment of: Otitis media Sinusitis Pharyngitis The use of cefixime should be reserved for infections in which the causative organism is known or suspected to be resistant to other commonly used antibacterial agents or when treatment failure with other commonly used antibacterial agents may carry significant risk. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Health Products Regulatory Authority 23 November 2018 CRN008L3F Page 2 of 11 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults_ The recommended dose for adults is 200-400 mg daily according to the severity of infection,taken as a single dose (400 mg may also be taken as two divided doses) (see section 5.1). _Elderly patients_ Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment (See above and section 4.4). _Adolescents ≥ 12 years of age _ Adolescents ≥ 12 years of agemay be given the same dose as recommended for adults. _Children from 6 months to 11 years of age _ It is recommended that children from 6 months to 11 years of age be given cefixime as an oral suspension b Belgenin tamamını okuyun