Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Esteve Pharmaceuticals GmbH
J01CF; J01CF05
FLUCLOXACILLIN SODIUM
1000 milligram(s)
Powder for solution for injection/infusion
Beta-lactamase resistant penicillins; flucloxacillin
Not marketed
2019-08-13
May 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUCLOXACILLIN 500MG AND 1000MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION Flucloxacillin sodium 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. The full name of this product is FLUCLOXACILLIN 500 MG OR 1000MG , POWDER FOR SOLUTION FOR INJECTION OR INFUSION , but within the leaflet it will be referred to as FLUCLOXACILLIN . WHAT IS IN THIS LEAFLET 1. What Flucloxacillin is and what it is used for 2. What you need to know before you use Flucloxacillin 3. How to use Flucloxacillin 4. Possible side effects 5. How to store Flucloxacillin 6. Contents of the pack and other information 1. WHAT FLUCLOXACILLIN IS AND WHAT IT IS USED FOR Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that cause them. It belongs to a group of antibiotics called “penicillins”. Flucloxacillin is available in two strengths. Each vial contains 500mg or 1000mg flucloxacillin powder for reconstitution for injection. Flucloxacillin is used for the treatment of a range of bacterial infections including bone infections (osteomyelitis) and infections within the lining of the heart (endocarditis). Flucloxacillin can also be used to prevent infections that can occur during major surgical operations, such as heart (cardiothoracic surgery) or bone, joint and muscle operations (orthopaedic surgery). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUCLOXACILLIN YOU SHOULD NOT BE GIVEN FLUCLOXACILLIN: - if you are allergic to flucloxacillin - if you are allergic to penicillins, cephalo Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 13 July 2023 CRN00DLLP Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 1000 mg powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1000 mg flucloxacillin as flucloxacillin sodium and 2 mmol sodium per vial. 3 PHARMACEUTICAL FORM Powder for solution for injection/infusion Flucloxacillin sodium is supplied as a white or almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. Flucloxacillin is indicated for the treatment of the following infections in adults and children caused by flucloxacillin-sensitive gram positive organisms (see section 5.1.): - Osteomyelitis - Endocarditis Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Flucloxacillin may also be used in the peri-operative prophylaxis for surgical procedures when appropriate, for example cardiothoracic or orthopaedic surgery. Consideration shouldbe 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. The usual adult dosage (including the elderly) is as follows: BY SLOW INTRAVENOUS INJECTION OR BY INFUSION: 250 mg to 1 g every six hours. These doses may be doubled in severe infections. Doses of up to 8 g daily divided in 3 to 4 divided doses have been suggested for osteomyelitis; in endocarditis a dose of 8 g daily in four divided doses in patients weighing up to 85 kg, and 12 g daily in 6 divided doses may be used in those weighing more. DURING SURGICAL PROPHYLAXIS, 1 to 2 g intravenously at induction of anae Olvassa el a teljes dokumentumot