Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Linezolid
Clonmel Healthcare Ltd
J01XX; J01XX08
Linezolid
2 milligram(s)/millilitre
Solution for infusion
Intravenous use
Pack sizes: 1, 10 infusion bags
Product subject to prescription which may not be renewed (A)
STADA Arzneimittel AG
Antibacterials for systemic use
Other antibacterials; linezolid
Linezolid Clonmel 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 Clonmel 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
Not marketed
2015-10-02
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER LINEZOLID CLONMEL 2MG/ML SOLUTION FOR INFUSION For adults Linezolid READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS GIVEN TO YOU 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 Linezolid Clonmel is and what it is used for 2. What you need to know before you are treated with Linezolid Clonmel 3. How Linezolid Clonmel is given 4. Possible side effects 5. How to store Linezolid Clonmel 6. Contents of the pack and other information 1. WHAT LINEZOLID CLONMEL IS AND WHAT IT IS USED FOR Linezolid Clonmel contains the active substance linezolid and 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 Clonmel is suitable to treat your infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH LINEZOLID CLONMEL DO NOT USE LINEZOLID CLONMEL IF YOU ARE : allergic to linezolid or any of the other ingredients of this medicine (listed in section 6.). taking or have taken within the last 2 weeks any medicines known as monoamine oxidase inhibitors (MAOIs for example phenelzine, isocarboxazid, selegiline, moclobemide). These may be used to treat depression or Parkinson’s disease. you are breast-feeding. This is because it passes into breast milk and could affect the baby. Linezolid Clonmel may not be suitable for you if you answer YES to any of the following questions. In this case tell your docto Read the complete document
Health Products Regulatory Authority 20 January 2020 CRN009FLL Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Linezolid Clonmel 2mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 2 mg linezolid. Each bag with 300 ml solution for infusion contains 600 mg linezolid. Excipients with known effect Each 300 ml also contains 13.7 g glucose and 119.29 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Isotonic, clear, colourless to yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nosocomial pneumonia Community acquired pneumonia Linezolid Clonmel 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 Clonmel 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 Clonmel 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 treatment against Gram negative organisms must be Read the complete document