LINEZOLID PFIZER

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LINEZOLID

Available from:

Pfizer Healthcare Ireland

ATC code:

J01XX08

INN (International Name):

LINEZOLID

Dosage:

100 MG/5ml

Pharmaceutical form:

Granules for Oral Suspension

Prescription type:

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

Therapeutic area:

linezolid

Authorization status:

Not Marketed

Authorization date:

2015-02-13

Patient Information leaflet

1 of 8
2016-0014743
PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID PFIZER 100 MG/5 ML GRANULES FOR ORAL SUSPENSION
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.
-
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, 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 TAKE 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 doct

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid Pfizer 100 mg/5 ml granules for oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Following reconstitution with 123 ml water, each 5 ml contains 100 mg
linezolid.
Excipients with known effect
Each 5 ml also contains 1052.9 mg sucrose, 500 mg mannitol (E421),
35.0 mg aspartame (E951), 8.5 mg sodium, 12
mg fructose, 36 mg sorbitol (E420), ethanol (alcohol), less than 100
mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to light-yellow, orange flavoured granules.
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 treatmen