País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
LINEZOLID
Generics (UK) Limited
J01XX08
LINEZOLID
2 Mg/Ml
Solution for Infusion
Product subject to prescription which may not be renewed (A)
linezolid
Marketed
2015-11-06
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No . Barcode Info Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Myraid Pro 9.5 pt 9.5 pt Linezolid 2mg_ml_1 Leaflet 1273754 905314 1273754 PL 04569/1630 PA0405/094/001 Synthon BV (Nijmegen - NL) PR1273754 TBC N/A 509864 6 Ireland; United Kingdom 9015_LF_440x480_v1 N/A 02 Nov 17 21:44 1 440 x 480 mm Black 1 / 2 3D Render ID N/A v3/Jul 2017 PACKAGE LEAFLET: INFORMATION FOR THE USER 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, pharmacist or nurse. • 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 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 DO NOT USE 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 Llegiu el document complet
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 Each 1 ml of solution for infusion contains 0.38 mg sodium. Each 300 ml bag solution for infusion contains 114 mg sodium. Each 1 ml of solution for infusion contains 48 mg glucose. Each 300 ml bag solution for infusion contains 14.4 g glucose. 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 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 a Llegiu el document complet