Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Linezolid
Pfizer Healthcare Ireland
J01XX; J01XX08
Linezolid
100 mg/5ml
Granules for oral suspension
Product subject to prescription which may not be renewed (A)
Other antibacterials; linezolid
Marketed
2001-07-27
Page 1 of 9 2022-0078713, 2022-0075377 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYVOX ® 100 MG/5 ML GRANULES FOR ORAL SUSPENSION Linezolid 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 Zyvox is and what it is used for 2. What you need to know before you take Zyvox 3. How to take Zyvox 4. Possible side effects 5. How to store Zyvox 6. Contents of the pack and other information 1. WHAT ZYVOX IS AND WHAT IT IS USED FOR Zyvox 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 Zyvox is suitable to treat your infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYVOX DO NOT TAKE ZYVOX : • 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 Zyvox passes into breast milk and could affect the baby. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Zyvox. Zyvox may not be suitable for you if you answer YES to any of the following questions. In this case tell your doctor as he/she will need to check your general Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 01 December 2022 CRN00CS50 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zyvox 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), 11.4 mg sodium, no more than 16.8 mg fructose, no more than 43.8 mg sorbitol (E420), 10 mg sodium benzoate (E211), no more than 1 mg ethanol, which is equivalent to 1 mg/5 ml (0.02% w/v). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral suspension. White to yellow-orange granule/powder, may contain white to yellow-orange lumps or white to yellow-orange-brown lumps. Orange flavoured granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nosocomial pneumonia Community acquired pneumonia Zyvox 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 Zyvox 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) Zyvox 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 pat Lesen Sie das vollständige Dokument