CEFUROXIME CEFT LIMITED
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
28-04-2024
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Ingredient activ:
CEFUROXIME
Disponibil de la:
Ceft Limited
Dozare:
250 Milligram
Forma farmaceutică:
Tablets
Data de autorizare:
2011-09-30
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime Ceft Limited 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300.72 mg cefuroxime axetil equivalent to 250 mg cefuroxime.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, capsule shaped tablets with ‘A33’ debossed on one side and plain on the other side. The size is 16.0
mm X 6.5 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime Ceft 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 Ceft Limited tablets should be taken
shortly after meals.
The dosage depends on the severity of the infection. For severe infections
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