Linezolid 2mg/ml Solution for Infusion

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

linezolid

Available from:

INFOMED FLUIDS

ATC code:

J01XX08

INN (International Name):

linezolid

Dosage:

2mg/ml

Pharmaceutical form:

Solution for infusion

Administration route:

intravenous route

Units in package:

Pack sizes of one, ten or 25 infusion bags

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

INFOMED FLUIDS

Therapeutic group:

Other antibacterials

Therapeutic indications:

It 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 2 mg/ml Solution for Infusion is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among Grampositive bacteria should be taken into consideration. (See section 5.1 for the appropriate organisms).

Authorization status:

Authorised

Authorization date:

2015-04-02

Patient Information leaflet

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DOCUMENT OUTLINE * Page 1 * Page 2

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Linezolid 2 mg/ml Solution for Infusion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml contains 2 mg of linezolid. Each 300 ml infusion
bag contains 600 mg of 
linezolid. 
Excipients with known effect:  
Each 300 ml bag contains approximately 13.7 g of glucose and 114
mg of sodium. 
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Solution for infusion. 
Linezolid 2 mg/ml Solution for Infusion is an isotonic, clear,
colourless to yellowish 
solution, free from visible particles. 
The pH value of the solution for infusion ranges from 4.6 to 5.0
and the solution has 
an osmolality between 270 to 330 mOsm/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 2 mg/ml
Solution for 
Infusion 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