LINEZOLID

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

LINEZOLID

제공처:

Teva Pharma B.V.

ATC 코드:

J01XX08

INN (국제 이름):

LINEZOLID

복용량:

2 Mg/Ml

약제 형태:

Solution for Infusion

처방전 유형:

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

치료 영역:

linezolid

승인 상태:

Not Marketed

승인 날짜:

2012-03-16

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LINEZOLID 2 MG/ML SOLUTION FOR INFUSION
Linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 yot 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 are given Linezolid
3.
How Linezolid is given
4.
Possible side effects
5.
How to store Linezolid
6.
Contents of the pack and other information
1.
WHAT LINEZOLID 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 GIVEN LINEZOLID
YOU SHOULD NOT BE GIVEN LINEZOLID:

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 may be used to treat depression or Parkinson’s disease.

if you are breast-feeding. This is because it passes into breast milk
and could affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before receiving 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 decide that another treatment is better
for you.
Ask your doctor if you

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 2 mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for infusion contains 2 mg linezolid.
Each 300 ml bag of solution for infusion contains 600 mg linezolid.
Each ml of the solution contains 45.7 mg (i.e. 13710.0 mg/300 ml)
glucose. This should be taken into account in
patients with diabetes mellitus or other conditions associated with
glucose intolerance. Each ml of solution also
contains 0.38 mg (114.0 mg/300 ml) sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear solution, free from visible particles.
pH:
4.6-5.0
Osmolality:
270-330 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia.
Community acquired pneumonia.
Linezolid Teva 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 Teva 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 Teva 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
th