国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Flucloxacillin
Athlone Laboratories Ltd
J01CF; J01CF05
Flucloxacillin
250 mg/5ml
Oral solution
Product subject to prescription which may not be renewed (A)
Beta-lactamase resistant penicillins; flucloxacillin
Marketed
2010-10-08
0023 CCRF23100 IE/H/0916/001/IAIN/0016 PATIENT INFORMATION LEAFLET (RMS) PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUCLOXACILLIN 250MG/5ML ORAL SOLUTION Flucloxacillin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR 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 (chemist). - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Flucloxacillin 250mg/5ml Oral Solution is and what it is used for 2. What you need to know before you take Flucloxacillin 250mg/5ml Oral Solution 3. How to take Flucloxacillin 250mg/5ml Oral Solution 4. Possible side effects 5. How to store Flucloxacillin 250mg/5ml Oral Solution 6. Contents of the pack and other information 1. WHAT FLUCLOXACILLIN 250MG/5ML ORAL SOLUTION IS AND WHAT IT IS USED FOR Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs to a group of antibiotics called “penicillins”. Flucloxacillin is used to treat: • chest infections • throat or nose infections • ear infections • skin and soft tissue infections • heart infections • bone and joint infections • meningitis • digestive system infections • blood infections • kidney, bladder or urethra (the tube which carries urine from the bladder) infections. Flucloxacillin can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN 250MG/5ML ORAL SOLUTION DO NOT TAKE FLUCLOXACILLIN 250MG/5ML ORAL SOLUTION IF: - You are allergic to flucloxacillin or any other penicillin antibiotics (see symptoms in section 4). - You are allergic t 完全なドキュメントを読む
Health Products Regulatory Authority 29 June 2023 CRN00DP3V Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 250mg/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted each 5ml contains 250mg flucloxacillin as flucloxacillin sodium. Excipients with known effect: Each 5ml dose contains 2.96g sucrose. Each 5ml dose contains 24.09mg sodium. Each 5ml dose contains 5mg sodium benzoate. For the 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 β-lactamase-producing_ _ _Staphylococci _and_ Streptococci_. Typical indications include: _Skin and soft tissue infections:_ Boils Infected burns Impetigo Furunculosis Abscesses Protection for skin grafts Infected wounds Cellulitis Carbuncles Infected skin conditions e.g. Ulcers, eczema and acne _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. Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents. Health Products Regulatory Authority 29 June 2023 CRN00DP3V Page 2 of 9 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 Posology The dosage depends on age, weight and renal function of the patient, as well as the severity of the infection. _A 完全なドキュメントを読む