国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Linezolid
Generics (UK) Limited
J01XX08
Linezolid
2mg/ml
solution for infusion
Intravenous use
Each box contains 1, 2, 5, 10, 20 or 25 infusion bag
Product subject to prescription which may not be renewed (A)
Other antibacterials
Linezolid is indicated 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 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.
Authorised
2015-11-06
Common Technical Document Linezolid Solution for infusion Module 1 – Section 3.1 Core SmPC, Labelling and Package Leaflet Document number (version): M13.1_03.LII.inj.001.06.Core Page 1 of 20 1.3.1 Package leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER [PRODUCT NAME] <2MG/ML>Linezolid 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, 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. WHAT IS IN THIS LEAFLET: 1. What [product name] is and what it is used for 2. What you need to know before you use [product name] 3. How to use [product name] 4. Possible side effects 5. How to store [product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] contains the active substance linezolid. 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 USE [PRODUCT NAME] DO NOT USE [PRODUCT NAME] - If you are allergic (hypersensitive) to linezolid or any of the other in 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Linezolid 2 mg/ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 2 mg linezolid. Each 300 ml infusion bag contains 600 mg linezolid. Excipient(s) with known effect: this medicinal product contains 14.4 g glucose and 114 mg sodium per bag (300 ml). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Isotonic, clear, colourless to yellow solution. The pH of the solution is 4.5 - 5.0. Osmolality is 270 – 330 mosmol/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nosocomial pneumonia Community acquired pneumonia Linezolid is indicated 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 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 is indicated 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 完全なドキュメントを読む