CEFUROXIME GLOB LIMITED
Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Súhrn charakteristických
(SPC)
16-04-2024
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Aktívna zložka:
CEFUROXIME
Dostupné z:
Glob Limited
Dávkovanie:
125 Milligram
Forma lieku:
Tablets
Dátum Autorizácia:
2011-09-30
Súhrn charakteristických
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime Glob Limited 125 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150.36 mg cefuroxime axetil equivalent to 125 mg cefuroxime.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, capsule shaped tablets with ‘A32’ debossed on one side and plain on the other side. The size is 12.5
mm X 5.0 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime Glob Limited is indicated for the treatment of the following mild to moderately severe infections caused by
micro-organisms susceptible to cefuroxime:
•
upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
•
acute bacterial bronchitis, acute exacerbations of chronic bronchitis
•
lower uncomplicated urinary tract infections: cystitis
•
skin and soft tissue infections: furunculosis, pyoderma and impetigo
•
treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in adults and
children above 12 years of age.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ROUTE OF ADMINISTRATION: oral
This medicinal product is available in three strengths:
125 mg, 250 mg and 500 mg
The usual duration of therapy is 7 days (ranging from 5 to 10 days). For treatment of pharyngotonsillitis caused by
_Streptococcus pyogenes _a therapy duration of at least 10 days is indicated. The duration of treatment of early Lyme
disease should be 20 days. In order to achieve optimum absorption cefuroxime Glob Limited tablets should be taken
shortly after meals.
The dosage depends on the severity of the infection. For severe infections
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