LINEZOLID 2 Mg/Ml Solution for Infusion

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

LINEZOLID

זמין מ:

Fresenius Kabi Limited

קוד ATC:

J01XX08

INN (שם בינלאומי):

LINEZOLID

כמות:

2 Mg/Ml

טופס פרצבטיות:

Solution for Infusion

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Other antibacterials

מצב אישור:

Authorised

תאריך אישור:

2014-12-05

עלון מידע

_Linezolid 2mg/ml FFX & KP– Package leaflet – June 2015 _
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 (hypersensitive) to linezolid or any of the other ingredients of this 
medicine  

  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;  

  i

מאפייני מוצר

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 Gram
negative organisms must be initiated concomitantly.
Linezolid should only b