Linezolid 2 mg/ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Baxter Holding B.V.

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:

2017-06-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINEZOLID 2 MG/ML SOLUTION FOR INFUSION
LINEZOLID
The name of your medicine is Linezolid 2 mg/ml solution for infusion,
which will be
referred to as Linezolid throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 take Linezolid.
3. How to take 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
The active substance in Linezolid is Linezolid. 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 ARE TREATED WITH LINEZOLID
DO NOT TAKE 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 may not be suitable for you if you answer
YES
to any of the following
questions. In this case tell your doct

Summary of Product characteristics

Health Products Regulatory Authority
21 September 2021
CRN00CHQR
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
1 ml solution for infusion contains 2 mg Linezolid. 300 ml infusion
bags contain 600 mg Linezolid.
Excipients with known effect:
Each ml of solution contains 0.38 mg of sodium and 50.24 mg of
glucose.
Each 300 ml of solution contains 114 mg of sodium and 15.07 g of
glucose.
For the full list of excipients, see section 6.1_._
3 PHARMACEUTICAL FORM
Solution for infusion.
Isotonic, clear, colourless to yellow solution.
Osmolarity: 285 mOsmol/L- 330 mOsmol/L.
pH between 4.50 and 5.10
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
alternat