Cefalexin Sandoz

Active ingredient:

Cefalexin monohydrate 27.602 mg/mL equivalent to Cephalexin 25 mg/mL (+5% stability overage);  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Cefalexin monohydrate 27.602 mg/mL (=Cephalexin 25 mg/mL; +5% stability overage)

Dosage:

125 mg/5mL

Pharmaceutical form:

Granules for oral suspension

Composition:

Active: Cefalexin monohydrate 27.602 mg/mL equivalent to Cephalexin 25 mg/mL (+5% stability overage)   Excipient: Apple flavour 648601 Citric acid Guar gum Iron oxide yellow Raspberry flavour 501183 TP0551 Saccharin sodium Simeticone Sodium benzoate Strawberry flavour 052303 BP0551 Sucrose Tutti frutti flavour 051880 AP0551

Units in package:

Bottle, glass, Polyethylene/polypropylene child resistant cap, in carton, 60 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

DSM Sinochem Pharmaceuticals Spain, S.A.

Therapeutic indications:

Cefalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: · bacterial sinusitis caused by streptococci, Streptococcus pneumoniae, and Staphylococcus aureus (methicillin -sensitive only); ·respiratory tract infections caused by S. pneumoniae and Streptococcus pyogenes (penicillin is the usual medicine of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever - cefalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefalexin in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available at present); · otitis media due to S. pneumoniae, Haemophilus influenzae, staphylococci, streptococci, and Moraxella catarrhalis; · skin and skin-structure infections caused by staphylococci and/or streptococci; · bone infections caused by staphylococci and/or Proteus mirabilis; · genitourinary tract infections, including acute prostatitis, caused by Eschericia coli, P. mirabilis, and Klebsiella pneumoniae; · dental infections caused by staphylococci and/or streptococci. Note - Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, Polyethylene/polypropylene child resistant cap, in carton - 60 mL - 36 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Bottle, glass, Polyethylene/polypropylene child resistant cap, in carton - 100 mL - 36 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2000-10-12