LINEZOLID

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

LINEZOLID

Beszerezhető a:

Accord Healthcare Limited

ATC-kód:

J01XX08

INN (nemzetközi neve):

LINEZOLID

Adagolás:

2 Mg/Ml

Gyógyszerészeti forma:

Solution for Infusion

Recept típusa:

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

Terápiás terület:

linezolid

Engedélyezési státusz:

Authorised

Engedély dátuma:

2017-11-10

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
LINEZOLID 2 MG/ML SOLUTION FOR
INFUSION
Linezolid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
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 or
pharmacist.
- 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Linezolid infusion is and what it is used for
2. What you need to know before you use Linezolid infusion
3. How to use Linezolid infusion
4. Possible side effects
5. How to store Linezolid infusion
6. Contents of the pack and other information 1.
WHAT LINEZOLID INFUSION 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 USE
LINEZOLID INFUSION
YOU SHOULD NOT BE TREATED WITH LINEZOLID INFUSION IF
YOU ARE:
•
allergic (hypersensitive) to linezolid or any of the other
ingredients of this medicine
•
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;
•
you are breastfeeding. This is because it passes into
breast milk and could affect the baby.
WARNINGS AND PRECAUTIONS
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 duri

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid 2 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 2 mg linezolid. 300 ml infusion bags contain 600 mg
linezolid.
Excipients: each 300 ml also contains 13.7 g glucose and 114 mg
sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Isotonic, clear, colourless to yellow solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid 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 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
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.
Linezolid should only be initiated in a hospital environment and after
consultation with a relevant specialist such as a
microbi