Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
cefuroxime axetil
Aspen Pharmacare Australia Pty Ltd
Registered
Zinnat-susp-pi-11nov19 AUSTRALIAN PRODUCT INFORMATION ZINNAT (CEFUROXIME AXETIL) GRANULES FOR ORAL SUSPENSION 1 NAME OF THE MEDICINE Cefuroxime axetil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinnat granules for oral suspension contains either 125 mg or 250 mg cefuroxime (as cefuroxime axetil) per 5 mL. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Zinnat granules for oral suspension are presented in bottles and sachets. Multidose bottles: ZINNAT suspension is provided as white to off-white free-flowing granules forming a white to pale yellow suspension upon reconstitution in water. When reconstituted as directed, it provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per 5 mL of suspension. Sachets: ZINNAT suspension is provided as dry, white to off-white, tutti-frutti flavoured granule in laminated sachets. When reconstituted as directed, it provides the equivalent of 125 mg or 250 mg of cefuroxime (as cefuroxime axetil) per dose. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ZINNAT suspension is indicated for the treatment of the following mild to moderately severe infections caused by sensitive bacteria in paediatric patients 3 months to 12 years; tonsillitis and pharyngitis, acute bacterial otitis media. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefuroxime axetil appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx. However, substantial data establishing the efficacy of cefuroxime axetil in the subsequent prevention of rheumatic fever is not available at present. 4.2 D OSE AND METHOD OF ADMINISTRATION Zinnat tablets and Zinnat oral suspension are not bioequivalent and are therefore not substitutable on a mg per mg basis (see Pharmacokinetics). The usual course of therapy with Zinnat suspension is 7 days (with a range of 5 to 10 days). Cefuroxime axetil should be taken w Baca dokumen lengkapnya