Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM PH. EUR.
Brillpharma (Ireland) Limited
J01CF; J01CF05
FLUCLOXACILLIN SODIUM PH. EUR.
125 mg/5ml
Powder for oral solution
Beta-lactamase resistant penicillins; flucloxacillin
Not marketed
2020-07-24
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUCLOXACILLIN 125 MG / 5ML POWDER FOR ORAL SOLUTION, SUGAR FREE flucloxacillin (as sodium). FLUCLOXACILLIN 250 MG / 5ML POWDER FOR ORAL SOLUTION, SUGAR FREE flucloxacillin (as sodium). 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 this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE 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 Page 2 of 8 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 THIS MEDICINE DO NOT TAKE THIS MEDICINE: if you are allergic to the active substance, other penicillin antibiotics (see symptoms in section 4) or any of the other ingredients of this medicine (listed in section 6). Have suffered before from jaundice or liver pr Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 15 July 2021 CRN00C748 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 125 mg/5 ml Powder for Oral Solution, Sugar Free 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml reconstituted solution contains flucloxacillin sodium equivalent to 125 mg flucloxacillin. Excipients with known effect: Aspartame (E951) 5 mg / 5 ml Mannitol (E421) 326.50 mg / 5 ml Sodium 10.61 mg/5 ml. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution Free flowing white granular powder for oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is indicated in the 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 Impetigo Abscesses Infected wounds Carbuncles Infected burns Furunculosis Protection for skin grafts Cellulitis 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. 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. Health Products Regulatory Authority 15 July 2021 CRN00C748 Page 2 of 8 Usual adults dosage (including elderly patients) Oral: - 250 mg four times a day. In serious infections, Olvassa el a teljes dokumentumot