Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN MAGNESIUM
Actavis Group PTC ehf
J01CF05
FLUCLOXACILLIN MAGNESIUM
250 MG/5ml
Powder for Oral Suspension
Product subject to prescription which may not be renewed (A)
Beta-lactamase resistant penicillins
Authorised
2008-04-04
PACKAGE LEAFLET: INFORMATION FOR THE USER FLOXAPEN SYRUP 125 MG/5 ML POWDER FOR ORAL SUSPENSION FLOXAPEN SYRUP 250 MG/5 ML POWDER FOR ORAL SUSPENSION Flucloxacillin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1 WHAT FLOXAPEN SYRUP IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN SYRUP 3 HOW TO USE FLOXAPEN SYRUP 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE FLOXAPEN SYRUP 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT FLOXAPEN SYRUP IS AND WHAT IT IS USED FOR Floxapen is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs to a group of antibiotics called “penicillins”. Floxapen syrup may be used to treat: • chest infections. • throat or nose infections. • ear infections. • skin and soft tissue infections. • meningitis. • digestive system infections. • kidney, bladder or the urethra (the tube which carries urine from the bladder) infections. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN SYRUP DO NOT USE FLOXAPEN SYRUP: • if you are ALLERGIC to flucloxacillin, penicillin, any other antibiotic or any of the other ingredients of this medicine (listed in section 6). • if you have had an allergic reaction to β-lactam antibiotics (e.g. penicillins, cephalosporins). • if you have a previous history of flucloxacillin associated jaundice/liver dysfunction. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USINGFLOXAPEN SYRUP IF YOU: • have LIVER or KIDNEY problems. • have Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Floxapen Syrup 250mg/5ml Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted as directed each 5 ml contains 250 mg flucloxacillin as Flucloxacillin Magnesium. Excipients with known effect: Contains sucrose 2.8g/5ml This medicinal product contains 10.3mg sodium per dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension A white free flowing powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Floxapen is indicated for the treatment of infections due to -lactamase-producing staphylococci and other sensitive Gram-positive organisms such as streptococci (see section 5.1 for details on sensitive strains). Typical indications include: _SKIN AND SOFT TISSUE INFECTIONS:_ - Boils, abscesses, carbuncles, furunculosis, cellulites, infected burns, infected wounds, impetigo, protection for skin grafts, infected skin conditions e.g. ulcer, eczema, and acne _RESPIRATORY TRACT INFECTIONS:_ - Pneumonia, lung abscess, sinusitis, tonsillitis, quinsy, pharyngitis, empyema, otitis media and externa _OTHER INFECTIONS CAUSED BY FLOXAPEN-SENSITIVE ORGANISMS:_ - Urinary tract infection, small intestine and colon infection, meningitis Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage depends on age, weight and renal function of the patient, as well as the severity and nature of the infection. _Adults and children over 10 years of age:_ Total daily dosage of 1 g to 3 g, administered in three to four equally divided doses. _Children under 10 years of age:_ 25-50 mg/kg/24 hours in three to four equally divided doses. The dosage may be increased if necessary. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Perskaitykite visą dokumentą