Cefalexin Sandoz
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
07-07-2017
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Active ingredient:
Cefalexin monohydrate 262.9mg equivalent to cephalexin 250 mg;
Available from:
Sandoz New Zealand Limited
INN (International Name):
Cefalexin monohydrate 262.9 mg (=cephalexin 250 mg)
Dosage:
250 mg
Pharmaceutical form:
Capsule
Composition:
Active: Cefalexin monohydrate 262.9mg equivalent to cephalexin 250 mg Excipient: Gelatin Magnesium stearate Microcrystalline cellulose Titanium dioxide Water
Units in package:
Blister pack, PVC/PVDC/Al foil 20&100,
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
DSM Sinochem Pharmaceuticals Spain, S.A.
Product summary:
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
Authorization date:
2000-10-12
Summary of Product characteristics
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
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