দেশ: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Cefalexin monohydrate 262.9mg equivalent to cephalexin 250 mg;
Sandoz New Zealand Limited
Cefalexin monohydrate 262.9 mg (=cephalexin 250 mg)
250 mg
Capsule
Active: Cefalexin monohydrate 262.9mg equivalent to cephalexin 250 mg Excipient: Gelatin Magnesium stearate Microcrystalline cellulose Titanium dioxide Water
Blister pack, PVC/PVDC/Al foil 20&100,
Prescription
Prescription
DSM Sinochem Pharmaceuticals Spain, S.A.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil - 20 capsules - 48 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al foil - 100 capsules - 48 months from date of manufacture stored at or below 30°C
2000-10-12
NEW ZEALAND DATA SHEET Page 1 of 10 1 PRODUCT NAME Cefalexin Sandoz _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cefalexin Sandoz capsules contain 250 mg or 500 mg cefalexin Cefalexin Sandoz granules for oral suspension contain 125 mg or 250 mg cefalexin per 5mL when reconstituted Excipient(s) with known effect: n/a For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cefalexin Sandoz capsules, hard 250 mg: Capsule, powder filled, Size 2, orange opaque cap and grey opaque body, approximately 17.5 mm length and 6.3 mm diameter. 500 mg: Capsule, powder filled, Size 0, orange opaque cap and grey opaque body, approximately 21.2 mm length and 7.6 mm diameter. Cefalexin Sandoz granules for oral suspension 125 mg/5 mL: Orange to yellow granules 250 mg/5 mL: Orange to yellow granules 4 CLINICAL PARTICULARS 4.1 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, S. pneumoniae, and Staphylococcus aureus (methicillin-sensitive only); _ _ respiratory tract infections caused by S. pneumoniae and S. 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, H. influenzae, staphylococci, streptococci, and M. catarrhalis; _ _ skin and skin-structure infections caused by staphylococci and/or streptococci; _ _ bone infections caused by staphylococci and/or P. mirabilis; _ _ genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and Klebsiella pneumoniae; _ _ dental infections caused by sta সম্পূর্ণ নথি পড়ুন