Zyvox 100 mg/5 ml granules for oral suspension

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Linezolid

Tillgänglig från:

Pfizer Healthcare Ireland

ATC-kod:

J01XX; J01XX08

INN (International namn):

Linezolid

Dos:

100 mg/5ml

Läkemedelsform:

Granules for oral suspension

Receptbelagda typ:

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

Terapiområde:

Other antibacterials; linezolid

Bemyndigande status:

Marketed

Tillstånd datum:

2001-07-27

Bipacksedel

Page 1 of 9
2022-0078713, 2022-0075377
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYVOX
® 100 MG/5 ML GRANULES FOR ORAL SUSPENSION
Linezolid
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 Zyvox is and what it is used for
2.
What you need to know before you take Zyvox
3.
How to take Zyvox
4.
Possible side effects
5.
How to store Zyvox
6.
Contents of the pack and other information
1.
WHAT ZYVOX IS AND WHAT IT IS USED FOR
Zyvox 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 Zyvox is suitable to treat your
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYVOX
DO NOT TAKE ZYVOX
:
•
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 Zyvox passes into breast milk and could
affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Zyvox.
Zyvox 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

Produktens egenskaper

Health Products Regulatory Authority
01 December 2022
CRN00CS50
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zyvox 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), 11.4 mg sodium, no more than
16.8 mg fructose, no more than 43.8 mg sorbitol (E420), 10 mg sodium
benzoate (E211), no more than 1 mg ethanol, which is
equivalent to 1 mg/5 ml (0.02% w/v).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to yellow-orange granule/powder, may contain white to
yellow-orange lumps or white to yellow-orange-brown lumps.
Orange flavoured granules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Zyvox 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 Zyvox 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)
Zyvox 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 pat