Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Flucloxacillin
Teva B.V.
J01CF; J01CF05
Flucloxacillin
Powder for solution for injection/infusion
Beta-lactamase resistant penicillins; flucloxacillin
Marketed
1979-01-18
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ FLOXAPEN 250 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION FLOXAPEN 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Floxapen is and what it is used for 2. What you need to know before you use Floxapen 3. How to use Floxapen 4. Possible side effects 5. How to store Floxapen 6. Contents of the pack and other information 1. WHAT FLOXAPEN IS AND WHAT IT IS USED FOR Floxapen is an antibiotic used to treat infections by killing the bacteria that cause them. It belongs to a group of antibiotics called “penicillins”. Floxapen is used to treat a wide range of infections caused by bacteria including the following: • chest infections • throat or nose infections • ear infections • skin and soft tissue infections • heart infections • bone and joint infections • meningitis • infections of the blood • digestive system infections • kidney, bladder or urethra (the tube which carries urine from the bladder) infections Floxapen can also be used to prevent infections following major surgical procedures, particularly in heart or orthopaedic surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN DO NOT USE FLOXAPEN - if you are allergic to flucloxacillin 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-asso Aqra d-dokument sħiħ
Health Products Regulatory Authority 23 June 2023 CRN00DM1Y Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Floxapen 250mg Powder for solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250 mg flucloxacillin (as flucloxacillin sodium). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion A fine white homogeneous sterile powder for solution for injection, infusion or nebuliser solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Floxapen is indicated for the treatment of infections due to β-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:_ - Osteomyelitis, arthritis, urinary tract infection, small intestine and colon infection, meningitis, endocarditis, septicaemia Floxapen is also indicated for prophylaxis in cardiovascular surgery (valve prostheses, artery prostheses) and in orthopedic surgery (arthroplasty, osteosynthesis and arthrotomy) because of the dominant pathogenic potential of staphylococci during such surgical procedures. 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. For instructions on the preparation of solution see section 6.6. For incompatibilities see section 6.2. Intramuscular or intravenous Aqra d-dokument sħiħ