Linezolid Clonmel 2mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Clonmel Healthcare Ltd

ATC code:

J01XX; J01XX08

INN (International Name):

Linezolid

Dosage:

2 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous use

Units in package:

Pack sizes: 1, 10 infusion bags

Prescription type:

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

Manufactured by:

STADA Arzneimittel AG

Therapeutic group:

Antibacterials for systemic use

Therapeutic area:

Other antibacterials; linezolid

Therapeutic indications:

Linezolid Clonmel 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 Clonmel 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

Authorization status:

Not marketed

Authorization date:

2015-10-02

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE
USER
LINEZOLID CLONMEL 2MG/ML SOLUTION FOR
INFUSION
For adults
Linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE 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.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if
their
signs of illness are the same as
yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS
LEAFLET
1.
What Linezolid Clonmel is and what it is used
for
2.
What you need to know before you are treated with Linezolid Clonmel
3.
How Linezolid Clonmel is
given
4.
Possible side
effects
5.
How to store Linezolid Clonmel
6.
Contents of the pack and other information
1.
WHAT LINEZOLID CLONMEL IS AND WHAT IT IS USED
FOR
Linezolid Clonmel contains the active substance linezolid and 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 Clonmel is suitable to treat your
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE TREATED WITH LINEZOLID CLONMEL
DO NOT USE LINEZOLID CLONMEL IF YOU
ARE
:

allergic to linezolid or any of the other ingredients of this
medicine (listed in section 6.).

taking or have taken within the last 2 weeks any medicines known as
monoamine oxidase
inhibitors
(MAOIs for example phenelzine, isocarboxazid, selegiline,
moclobemide). These may
be used to
treat
depression or Parkinson’s
disease.

you are breast-feeding. This is because it passes into breast milk and
could affect the
baby.
Linezolid Clonmel may not be suitable for you if you answer YES to any
of the following questions.
In this case tell
your
docto

Summary of Product characteristics

Health Products Regulatory Authority
20 January 2020
CRN009FLL
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid Clonmel 2mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg linezolid. Each bag with 300 ml solution for
infusion contains 600 mg linezolid.
Excipients with known effect
Each 300 ml also contains 13.7 g glucose and 119.29 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Isotonic, clear, colourless to yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid Clonmel 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 Clonmel 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 Clonmel 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