LINEZOLID 2 Mg/Ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LINEZOLID

Available from:

Claris Lifesciences (UK) Limited

ATC code:

J01XX08

INN (International Name):

LINEZOLID

Dosage:

2 Mg/Ml

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

Other antibacterials

Authorization status:

Authorised

Authorization date:

2017-06-23

Patient Information leaflet

ARTWORK CODE :
REF. CODE CREATION/BLOCKAGE NOTE:
“CONTROLLED COPY” HOLDER (1) (2) (3) (4) (5)
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BARCODE INFORMATION:
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COLOUR CODE :
BLACK
PANTONE
PANTONE
PANTONE
PANTONE
PANTONE
PANTONE
PANTONE
1400006264
SUPER SUN SHINE
300ML NPVC BAG
UNITED KINGDOM, IRELAND
INJECTABLE
ENGLISH
21212
600X350
60 GSM
Times New roman 9 Pt.
350X600
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 wit

Summary of Product characteristics

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 alternative treatment
options available (see section 4.4).
In these circumstances trea