Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Linezolid
Fresenius Kabi Deutschland GmbH
J01XX; J01XX08
Linezolid
2 milligram(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Other antibacterials; linezolid
Marketed
2014-12-05
_Linezolid 2mg/ml FFX & KP– Package leaflet – V004 _ Package leaflet: Information for the use LINEZOLID 2 MG/ML SOLUTION FOR INFUSION 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 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. WHAT IS IN THIS LEAFLET 1. What Linezolid is and what it is used for 2. What you need to know before you use Linezolid 3. How to use Linezolid 4. Possible side effects 5. How to store Linezolid 6. Contents of the pack and other information 1. WHAT LINEZOLID 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 USE LINEZOLID YOU SHOULD NOT BE TREATED WITH LINEZOLID : • 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 doctor as he/she will need to check your general health and your _Linezolid 2mg/ml FFX & KP– Package leaflet – V004 _ blood pressure before and during y Read the complete document
Health Products Regulatory Authority 03 November 2023 CRN008TK0 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Linezolid 2 mg/ ml solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for infusion contains 2 mg linezolid. Each 300 ml infusion bag contain 600 mg linezolid. Excipients: each 300 ml also contains 13.7 g glucose and 114 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Isotonic, clear, practically free from particles, colourless to yellow solution. pH: 4.4-5.2 Osmolality: 270-330 mOsmol/kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nosocomial pneumonia Community acquired pneumonia Linezolid 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 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 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 Gra Read the complete document