Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Athlone Laboratories Ltd
J01CF; J01CF05
FLUCLOXACILLIN SODIUM
125 mg/5ml
Powder for oral solution
Product subject to prescription which may not be renewed (A)
Beta-lactamase resistant penicillins; flucloxacillin
Not marketed
2011-10-14
0015 CCRF23100 PRAC 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUCLOXACILLIN 125MG/5ML ORAL SOLUTION BP Flucloxacillin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET 1. What Flucloxacillin Oral Solution BP is and what it is used for 2. What you need to know before you take Flucloxacillin Oral solution BP 3. How to take Flucloxacillin Oral solution BP 4. Possible side effects 5. How to store Flucloxacillin Oral solution BP 6. Contents of the pack and other information 1. WHAT FLUCLOXACILLIN ORAL SOLUTION BP 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 ORAL SOLUTION BP DO NOT TAKE FLUCLOXACILLIN ORAL SOLUTION IF YOU: - Are allergic to flucloxacillin or any other penicillin or cephalosporin antibiotics (such as amoxicillin or cefaclor - see symptoms listed in section 4) - Are allergic to any of the other ingredients of this medicine (listed in se Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 30 June 2023 CRN00DMDP Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 125mg/5ml Oral Solution BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted as directed each 5 ml contains flucloxacillin 125 mg as flucloxacillin sodium. Excipients with known effect: Contains 18 mg sodium, 3.1 g of sucrose and 5mg sodium benzoate per 5ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. Unreconstituted powder: a pink granular powder with a characteristic odour of pineapple. Reconstituted solution: a pink coloured solution with a characteristic flavour and odour of pineapple 4 CLINICAL PARTICULARS Flucloxacillin is an isoxazolyl penicillin of the β-lactam group of antibiotics which exerts a bactericidal effect upon many Gram-positive organisms including β-lactamase-producing staphylococci and streptococci. 4.1 THERAPEUTIC INDICATIONS Flucloxacillin is indicated for the treatment of infections due to sensitive Gram-positive organisms, including β-lactamase-producing staphylococci and streptococci. Typical indications include: _Skin and soft tissue infections:_ Boils, cellulitis, infected burns, abscesses, infected skin conditions, e.g. ulcer, eczema, and acne, protection for skin grafts, carbuncles, furunculosis, infected wounds, impetigo _Respiratory tract infections:_ Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, otitis media and externa, tonsillitis, quinsy _Other infections caused by flucloxacillin-sensitive organisms:_ Osteomyelitis, urinary tract infection, enteritis, meningitis, endocarditis, septicaemia Flucloxacillin is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery. Parenteral usage is indicated where oral dosage is inappropriate. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMIN Կարդացեք ամբողջական փաստաթուղթը