Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Flucloxacillin sodium monohydrate
Wockhardt UK Limited
J01CF; J01CF05
Flucloxacillin sodium monohydrate
1 gram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Beta-lactamase resistant penicillins; flucloxacillin
Marketed
2003-09-19
PACKAGE LEAFLET: INFORMATION FOR THE USER FLUCLOXACILLIN 250MG, 500MG AND 1G POWDER FOR SOLUTION FOR INJECTION OR INFUSION 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 further questions, please ask your doctor or nurse. If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Flucloxacillin 250mg, 500mg and 1g Powder for Solution for Injection or Infusion. In the rest of this leaflet it is called Flucloxacillin Injection. WHAT IS IN_ _THIS LEAFLET: 1. What Flucloxacillin Injection is and what it is used for 2. What you need to know before you use Flucloxacillin Injection 3. How to use Flucloxacillin Injection 4. Possible side effects 5. How to store Flucloxacillin Injection 6. Contents of the pack and other information 1. WHAT FLUCLOXACILLIN INJECTION IS AND WHAT IT IS USED FOR Flucloxacillin belongs to a group of medicines called penicillins, which are antibiotics. These medicines work by killing bacteria that cause infections. Flucloxacillin Injection is used for the treatment of a range of bacterial infections including bone infections (osteomyelitis) and infections within the lining of the heart (endocarditis). It is also used to prevent infections that can occur during major surgical operations such as heart and lung operations (cardiothoracic surgery) and bone, joint and muscle operations (orthopaedic surgery). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUCLOXACILLIN INJECTION_ _ DO NOT USE FLUCLOXACILLIN INJECTION: • If you are allergic to flucloxacillin or any of the other ingredients of this medicine (listed in section 6). • If you_ _are allergic to cephalosporins, penicillin, or any other β-lactam antibiotic. • If you_ _have had jaundice (yellow skin and whites of eyes) or other liver problems when you have been given flucloxacillin prev Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 1g Powder for Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium flucloxacillin monohydrate equivalent to flucloxacillin 1g For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion (Powder for injection or infusion) Flucloxacillin sodium is supplied as a white or almost white crystalline powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flucloxacillin is indicated for the treatment of infections due to penicillinase producing staphylococci and other gram positive organisms susceptible to this anti-infective (see Section 5.1). Indications include: osteomyelitis and endocarditis. Flucloxacillin is also indicated for use as a prophylactic agent during major surgical procedures when appropriate; for example cardiothoracic and orthopaedic surgery. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage depends on the severity and nature of the infection. Method of administration The usual routes of administration for Flucloxacillin 250mg, 500mg and 1g Powder for Solution for Injection or Infusion are by slow intravenous injection and intravenous infusion. Flucloxacillin 250mg and 500mg Powder for Solution for Injection or Infusion may also be administered by intramuscular, intra-articular or intrapleural injection. Flucloxacillin 250mg may also be inhaled by nebuliser. The solutions must be prepared as follows: _ADULTS AND THE ELDERLY_ INTRAVENOUS: Dissolve 250 to 500mg in 5 to 10ml of water for injections or 1g in 15 to 20ml of water for injections. Administer by slow intravenous injection (over three to four minutes). Flucloxacillin may also be added to infusion fluids or injected (suitably diluted) into the drip tube over three to four minutes. Flucloxacillin may be added to most intravenous fluids (eg water for injections, sodium chloride Preberite celoten dokument