Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
LINEZOLID
Pfizer Healthcare Ireland
J01XX08
LINEZOLID
100 MG/5ml
Granules for Oral Suspension
Product subject to prescription which may not be renewed (A)
linezolid
Not Marketed
2015-02-13
1 of 8 2016-0014743 PACKAGE LEAFLET: INFORMATION FOR THE USER LINEZOLID PFIZER 100 MG/5 ML GRANULES FOR ORAL SUSPENSION 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Linezolid is and what it is used for 2. What you need to know before you take Linezolid 3. How to take Linezolid 4. Possible side effects 5. How to store Linezolid 6. Contents of the pack and other information 1. WHAT LINEZOLID PFIZER IS AND WHAT IT IS USED FOR Linezolid is an antibiotic of the oxazolidinones group that works by stopping the growth of certain bacteria (germs) that cause infections. It is used to treat pneumonia and some infections in the skin or under the skin. Your doctor will have decided if Linezolid is suitable to treat your infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID PFIZER DO NOT TAKE LINEZOLID PFIZER: if you are allergic to linezolid or any of the other ingredients of this medicine (listed in section 6). if you are taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs: for example phenelzine, isocarboxazid, selegiline, moclobemide). These medications may be used to treat depression or Parkinson’s disease. if you are breast-feeding. This is because Linezolid passes into breast milk and could affect the baby. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Linezolid. Linezolid may not be suitable for you if you answer YES to any of the following questions. In this case tell your doct Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Linezolid Pfizer 100 mg/5 ml granules for oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Following reconstitution with 123 ml water, each 5 ml contains 100 mg linezolid. Excipients with known effect Each 5 ml also contains 1052.9 mg sucrose, 500 mg mannitol (E421), 35.0 mg aspartame (E951), 8.5 mg sodium, 12 mg fructose, 36 mg sorbitol (E420), ethanol (alcohol), less than 100 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. White to light-yellow, orange flavoured granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nosocomial pneumonia Community acquired pneumonia Linezolid Pfizer is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram positive bacteria. In determining whether Linezolid Pfizer is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among Gram positive bacteria should be taken into consideration (see section 5.1 for the appropriate organisms). Linezolid is not active against infections caused by Gram negative pathogens. Specific therapy against Gram negative organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected. Complicated skin and soft tissue infections (see section 4.4) Linezolid Pfizer is indicated in adults for the treatment of complicated skin and soft tissue infections ONLY when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria. Linezolid is not active against infections caused by Gram negative pathogens. Linezolid should only be used in patients with complicated skin and soft tissue infections with known or possible co-infection with Gram negative organisms if there are no alternative treatment options available (see section 4.4). In these circumstances treatmen Läs hela dokumentet