Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Flucloxacillin
Teva B.V.
J01CF; J01CF05
Flucloxacillin
Powder for solution for injection/infusion
Beta-lactamase resistant penicillins; flucloxacillin
Marketed
2012-08-03
_ _ 1 PACKAGE LEAFLET: INFORMATION FOR THE USER FLOXAPEN 1000 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION FLOXAPEN 2000 MG POWDER FOR SOLUTION FOR INJECTION/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 belonging to a class of antibiotics called beta-lactamase resistant penicillins. The active substance is flucloxacillin. Flucloxacillin works by killing bacteria that cause infection. It only works with specific strains of bacteria. Floxapen is used to treat infections such as: - Skin and soft tissue infections - abscesses, cellulites (inflammation of tissue below the skin) - Respiratory tract infections - pneumonia, lung abscess - Bone and joint infections - bone and bone marrow infections (osteomyelitis) - arthritis - Inflammation of the lining of the heart and its valves (endocarditis). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLOXAPEN DO NOT USE FLOXAPEN - if you are allergic to flucloxacillin or other beta-lactam antibiotics (e.g. penicillins, cephalosporins), or any of the other ingredients of this medicine (listed in section 6) - if you have previous history of liver problems from taking flucloxacillin. WARNINGS AND PRECAUTIONS _ _ 2 Talk to your doctor or pharmacist before taking Floxapen - if Læs hele dokumentet
Health Products Regulatory Authority 22 June 2023 CRN00DMCM Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Floxapen 1000 mg powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1000 mg flucloxacillin (as flucloxacillin sodium). Each 1000 mg vial contains approximately 2.2 mmol (51 mg) sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. White to off-white powder for solution for injection or infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucloxacillin is indicated for the treatment of the following infections when caused by susceptible organisms, in particular _Staphylococcus aureus_ (see sections 4.2 and 5.1). _Skin and soft tissue infections_ Abscesses, cellulitis. _Respiratory tract infections_ Lower respiratory tract infections: lung abscess, pneumonia. _Bone and joint infections_ Arthritis, osteomyelitis. Endocarditis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults and adolescents over 12 years of age: _ Total daily dosage of 1 g – 6 g administered in 3-6 divided doses, by i.v. or i.m. injection. In cases of severe infections: Up to 8 g per day administered in three to four infusions (over 20 to 30 min). No intramuscular single bolus injection should exceed 2 g. The maximum dose of 12 g per day should not be exceeded. Paediatric population _Childern under 12 years of age _ 25 to 50 mg/kg/24 hours administered in three to four equally divided doses by i.m. or i.v. injection. In cases of severe infections: Up to 100 mg/kg/24 hours in three to four divided doses. Health Products Regulatory Authority 22 June 2023 CRN00DMCM Page 2 of 8 No single bolus injection or infusion should exceed 33 mg/kg. Children aged 10 to 14 years usually receive a daily dose of 1.5 g to 2 g and children aged 6 to 10 years 0.75 g to 1.5 g, divided into Læs hele dokumentet