Zyvox 2 mg/ml solution for infusion

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

LINEZOLID

から入手可能:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATCコード:

J01XX08

INN（国際名）:

LINEZOLID 2 mg/ml

医薬品形態:

SOLUTION FOR INFUSION

構図:

LINEZOLID 2 mg/ml

処方タイプ:

POM

治療領域:

ANTIBACTERIALS FOR SYSTEMIC USE

認証ステータス:

Authorised

承認日:

2007-02-15

情報リーフレット

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

製品の特徴

1 of 18
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 concomitantly.
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Linezolid should only be initiated in a hospital e