CEPOREX 250 mg/5 MG/5ml Granules for Oral Suspension
Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Αρχείο Π.Χ.Π.
(SPC)
19-04-2024
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Δραστική ουσία:
CEFALEXIN
Διαθέσιμο από:
Glaxo Laboratories Limited
INN (Διεθνής Όνομα):
CEFALEXIN
Δοσολογία:
250 mg/5 MG/5ml
Φαρμακοτεχνική μορφή:
Granules for Oral Suspension
Καθεστώς αδειοδότησης:
Withdrawn
Ημερομηνία της άδειας:
2006-08-30
Αρχείο Π.Χ.Π.
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceporex Granules for Oral Suspension 250 mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted, each 5ml contains Cephalexin .equivalent to 250mg Cephalexin (anhydrous).
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension
Pale orange granules with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceporex is indicated in the management of moderate and serious infections due to micro-organisms sensitive to this
anti-infective, for example beta-haemolytic Streptococci, Staphylococci, _Proteus mirabilis _etc.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Many infections in adults will respond to oral dosage of 1 gram to 2 grams per day in divided doses; however, for most
infections, the following simple scheme will be found satisfactory:
_Adults and children over 12 years: _500mg t.d.s. (three times daily). To aid compliance, especially in ambulatory
patients, the daily dosage may be given in two equal doses, e.g. 1g twice daily in adult with urinary tract infections.
The following additional information should also be considered:
For severe or deep-seated infections, especially when less sensitive organisms are involved, the dosage should be
increased to 1g t.d.s. or 1.5g q.d.s. (four times daily).
For prophylaxis of recurrent urinary tract infections in adults, a dose of 125mg each night is recommended and may be
continued for several months (the 125mg/5ml suspension is suitable for this purpose).
Children:
Ideally, dosage should be calculated on a body-weight basis, particularly in infants. The following dosage
recommendations for children are derived from a normal dosage of 25 to 60mg/kg/day. For chronic, severe or deep-
seated infections, t
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