Linezolid 2 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

J01XX; J01XX08

INN (International Name):

Linezolid

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Prescription type:

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

Therapeutic area:

Other antibacterials; linezolid

Authorization status:

Not marketed

Authorization date:

2017-11-10

Patient Information leaflet

1
PT/H/1195/001/IB/013 ver 00, AUG 2023
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 infusion is and what it is used for
2.
What you need to know before you use Linezolid infusion
3.
How to use Linezolid infusion
4.
Possible side effects
5.
How to store Linezolid infusion
6.
Contents of the pack and other information
1.
WHAT LINEZOLID INFUSION IS AND WHAT IT IS USED FOR
Linezolid infusion 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 infusion is
suitable to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LINEZOLID INFUSION DO NOT TAKE LINEZOLID INFUSION:
•
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 breastfeeding. This is because Linezolid infusion passes
into breast milk and could affect the
baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Linezolid
infusion.
Linezolid infusion 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

Summary of Product characteristics

Health Products Regulatory Authority
23 August 2023
CRN00D0CN
Page 1 of 13
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 linezolid. Each 300 ml infusion bags contain 600
mg linezolid.
Excipients with known effect: 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, colourless to yellow solution, practically free from
particles, with pH range of 4.0-5.0 and Osmolarity range of
270-330 mOsmol/l.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid infusion 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 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 infusion 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