Linezolid 2 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

KRKA, d.d., Novo mesto

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:

Marketed

Authorization date:

2017-01-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 2 MG/ML SOLUTION FOR INFUSION
linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINAL PRODUCT IS
GIVEN TO YOU 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 pharmacist or
nurse.
-
If you get any side effects, talk to your doctor or 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 are treated with Linezolid
3.
How Linezolid is given
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 in adults. 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
YOU SHOULD NOT BE TREATED WITH 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 or pharmacist or nurse before you are treated with
Linezolid.
Linezolid 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
your blood pressure before and
during your treatment or may decide t

Summary of Product characteristics

Health Products Regulatory Authority
13 July 2023
CRN00DFT4
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for infusion contains 2 mg linezolid. Each 300 ml
infusion bag contains 600 mg linezolid.
Excipients with known effect:
- Glucose (13.7 g/300 ml)
- Sodium (114 mg/300 ml)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to yellow or to yellowish-brown solution (pH: 4.6
– 5.2, osmolality: 270 mOsmol/kg – 320 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 again