FLUCLOXACILLIN Powder for Oral Solution 250mg/5ml Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
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Active ingredient:
FLUCLOXACILLIN SODIUM
Available from:
Athlone Laboratories Ltd
Dosage:
250mg/5ml Milligram
Pharmaceutical form:
Powder for Oral Solution
Authorization date:
2010-10-08
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flucloxacillin 250mg/5ml Oral Solution BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted each 5ml contains 250mg flucloxacillin as flucloxacillin sodium.
Each 5ml dose contains up to 3.05g sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Solution.
Free flowing pink coloured powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of infections due to sensitive Gram-positive organisms, including infections caused by -lactamase-
producing _Staphylococci._
Typical indications include:
Skin and soft tissue infections:
Boils
Impetigo
Abscesses
Infected wounds
Carbuncles
Infected skin conditions e.g. ulcers, eczema and acne.
Infected burns
Furunculosis
Protection for skin grafts
Cellulitis
_Respiratory tract infections:_
Pneumonia
Pharyngitis
Lung abscess
Tonsillitis
Empyema
Quinsy
Sinusitis
Otitis media and externa
_Other infections caused by Flucloxacillin sensitive organisms:_
Osteomyelitis
Septicaemia
Enteritis
Meningitis
Endocarditis
Urinary-tract infection
Flucloxacillin is also indicated for use as a prophylactic during major surgical procedures such as cardiothoracic and
orthopaedic surgery. Parenteral usage is indicated where oral dosage is inappropriate.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/11/2011_
_CRN 2105473_
_page number: 1_
Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of
antibacterial agents.
Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be
initiated before the results are available.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration
Ora
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