Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Anhydrous Cefaclor
Pinewood Laboratories Ltd,
J01DC; J01DC04
Anhydrous Cefaclor
125 mg/5ml
Granules for oral suspension
Product subject to prescription which may not be renewed (A)
Second-generation cephalosporins; cefaclor
Not marketed
1999-05-14
Health Products Regulatory Authority 27 May 2019 CRN0092T6 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pinaclor Granules for Oral Suspension 125mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of the constituted suspension contains Cefaclor monohydrate 131.1mg equivalent to anhydrous Cefaclor 125mg. Excipients: Each 5ml of constituted suspension contains 2.29g of sucrose, 2.695mg of sodium, and 0.625mg of Allura Red AC (E129). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. White to off-white granule powder forming a red suspension on constitution with water, having a strawberry flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefaclor is indicated for the treatment of the following infections due to susceptible microorganisms including _Streptococcus _ _pyogenes_ (group A beta haemolytic streptococci) and _Branhamella catarrhalis._ Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis and as part of the management of sinusitis Otis media Skin and soft tissue infections. Urinary tract infections including pyelonephritis and cystitis. Cefaclor has been found to be effective in both acute and chronic urinary tract infections. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, however, data establishing efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available. Consideration should be given to the local guidance regarding the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cefaclor is administered orally. _Adults:_ The usual adult dosage is 250 mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Doses of 4 g per day have been administered safely to normal subjects for 28 days but the total daily dosage should not exceed this amount. Cefaclor may be adm Прочетете целия документ