Pays: Malte
Langue: anglais
Source: Medicines Authority
CEFACLOR
Phadisco Limited Yiannou Kranidioti Avenue 185, CY-2234 Latsia, Cyprus
J01DC04
CEFACLOR 125 mg/5ml
GRANULES FOR ORAL SUSPENSION
CEFACLOR 125 mg/5ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2005-11-10
Page 1 of 6 PATIENT INFORMATION LEAFLET 1. MEDICINAL PRODUCT CHARACTERISTICS 1.1 BRAND NAME: C E C L O R ® 1.2 COMPOSITION: Granules for oral suspension. Active ingredient: Cefaclor monohydrate. Excipients: Sodium Lauryl Sulfate, Dimethicone, Erythrosine Aluminium Lake, Methylcellulose 15, Xanthan Gum, Starch Pregelatinised, Artificial Strawberry Flavour, Sucrose. 1.3 PHARMACEUTICAL FORM Granules for oral suspension 1.4 CONTENTS IN ACTIVE INGREDIENT Granules for oral suspension CECLOR ® Granules for oral suspension cefaclor 125mg/5ml Granules for oral suspension cefaclor 250mg/5 ml 1.5 DESCRIPTION – PACKAGING Granules for oral suspension CECLOR ® Granules for oral suspension 125mg/5 ml: 100ml vial Granules for oral suspension 250mg/5 ml: 100ml vial Certain strengths of the pharmaceutical form are not available in some countries. 1.6 THERAPEUTIC CATEGORY Antibiotic 1.7 MANUFACTURING/PACKAGING COMPANY ACS DOBFAR S.P.A Via Laurentina Km 24, 730 00071 Pomezia (RM), Italy 1.8 MARKETING LICENSE HOLDER Phadisco Ltd. 185, Yiannou Kranidioti Avenue, CY-2234 Latsia, Cyprus 2. WHAT YOU SHOULD KNOW ABOUT CECLOR 2.1 GENERAL INFORMATION Cefaclor is a semisynthetic 2 nd generation cephalosporin antibiotic, orally administered. 2.2 INDICATIONS Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Page 2 of 6 OTITIS MEDIA caused by _S. pneumoniae_ , _H. influenzae_ , staphylococci (except for methicillin resistant strains), and _S. pyogenes _ (group A ß-hemolytic streptococci) and _M. catarrhalis_ . ACUTE BRONCHITIS AND ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS caused by _S. pneumoniae_ , _H. influenzae _ (including beta-lactamase producing strains), _H. parainfluenzae_ , _M. catarrhalis _ (including beta-lactamase producing strains), _S. aureus_ , after their susceptibility is confirmed _in vitro_ . PHARYNGITIS AND TONSILLITIS caused by _S. pyogenes _ (group A ß-hemolytic streptococci). (NOTE: Penicillin is generally the first line drug for Lire le document complet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCTS Ceclor 125mg/5ml. Ceclor 250mg/5ml. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of reconstituted 125mg/5ml suspension contains, as the active ingredient, cefaclor monohydrate PhEur, equivalent to 125mg of cefaclor base. Each 5ml of reconstituted 250mg/5ml suspension contains, as the active ingredient, cefaclor monohydrate PhEur, equivalent to 250mg of cefaclor base. 3. PHARMACEUTICAL FORM Granules for oral suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ceclor is indicated for the treatment of the following infections due to susceptible micro organisms: Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of sinusitis Otitis media Skin and soft tissue infections Urinary tract infections, including pyelonephritis and cystitis Ceclor 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ceclor is administered orally. Adults: The usual adult dosage is 250mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Doses of 4g per day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount. Page 2 of 7 Ceclor may be administered in the presence of impaired renal function. Under such conditions, dosage is usually unchanged (see 'Special warning and special precautions for use'). Patients undergoing haemodialysis: Haemodialysis shortens serum half life by 25 30%. In patients undergoing regular haemodialysis, a loading dose of 250mg 1g administered prior to dialysis and a therapeutic dose of 250 500mg ev Lire le document complet