LINEZOLID

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

LINEZOLID

Verfügbar ab:

Generics (UK) Limited

ATC-Code:

J01XX08

INN (Internationale Bezeichnung):

LINEZOLID

Dosierung:

2 Mg/Ml

Darreichungsform:

Solution for Infusion

Verschreibungstyp:

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

Therapiebereich:

linezolid

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2015-11-06

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Myraid Pro
9.5 pt
9.5 pt
Linezolid 2mg_ml_1
Leaflet
1273754
905314
1273754
PL 04569/1630
PA0405/094/001
Synthon BV
(Nijmegen - NL)
PR1273754
TBC
N/A
509864
6
Ireland;
United Kingdom
9015_LF_440x480_v1
N/A
02 Nov 17
21:44
1
440 x 480 mm
Black
1 / 2
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N/A
v3/Jul 2017
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 is and what it is used for
2.
What you need to know before you use Linezolid
3.
How to use 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
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
USE LINEZOLID
DO NOT USE 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

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg linezolid. Each 300 ml infusion bag contains 600 mg
linezolid.
Excipient(s) with known effect
Each 1 ml of solution for infusion contains 0.38 mg sodium.
Each 300 ml bag solution for infusion contains 114 mg sodium.
Each 1 ml of solution for infusion contains 48 mg glucose.
Each 300 ml bag solution for infusion contains 14.4 g glucose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Isotonic, clear, colourless to yellow solution.
The pH of the solution is 4.5 - 5.0.
Osmolality is 270 – 330 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 a