Linezolid Pfizer 2 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Linezolid

Available from:

Pfizer Healthcare Ireland

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:

2015-02-13

Patient Information leaflet

dddZY 2_0 2nd Brand - DCP 10.1
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PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID PFIZER 2 MG/ML SOLUTION FOR INFUSION
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 PFIZER 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 ARE TREATED WITH LINEZOLID PFIZER
DO NOT TAKE LINEZOLID PFIZER:

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.
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 de

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid Pfizer 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 300 ml also contains 13.7 g glucose and 114 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Isotonic, clear, colourless to yellow solution with pH range of
4.4-5.2.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid Pfizer 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
Pfizer 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 Pfizer 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 initiated concomitantly.
Linezolid should only be initiated