Zyvox 2 mg/ml solution for infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
01-12-2022
Summary of Product characteristics
(SPC)
01-12-2022
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:
Marketed
Authorization date:
2001-07-27
Patient Information leaflet
Page 1 of 18
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYVOX 2 MG/ML SOLUTION FOR INFUSION
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.
-
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 ARE
TREATED WITH 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 health and your blood
pressure before and during your
treatment or may decide that another treatment is better for you.
Ask your doctor if you are not sure whether these categories
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
01 December 2022
CRN00CS50
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zyvox 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
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 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 concom
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