Linezolid Clonmel 600 mg film-coated tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Linezolid

Beszerezhető a:

Clonmel Healthcare Ltd

ATC-kód:

J01XX; J01XX08

INN (nemzetközi neve):

Linezolid

Adagolás:

600 milligram(s)

Gyógyszerészeti forma:

Film-coated tablet

Recept típusa:

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

Terápiás terület:

Other antibacterials; linezolid

Engedélyezési státusz:

Marketed

Engedély dátuma:

2013-08-23

Betegtájékoztató

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LINEZOLID CLONMEL 600MG FILM-COATED TABLETS
Active substance: 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 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 Clonmel is and what it is used for
2.
What you need to know before you take Linezolid Clonmel
3.
How to take Linezolid Clonmel
4.
Possible side effects
5.
How to store Linezolid Clonmel
6.
Contents of the pack and other information
1.
WHAT LINEZOLID CLONMEL IS AND WHAT IT IS USED FOR
Linezolid Clonmel contains the active substance linezolid.
Linezolid Clonmel 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
Clonmel is suitable to treat your
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LINEZOLID CLONMEL
Contact your doctor if you are not sure if you belong to a patient
group described below.
DO NOT TAKE LINEZOLID CLONMEL IF YOU ARE

allergic to linezolid or any of the other ingredients of this medicine
(listed in section 6).

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.

breastfeeding. This is because it passes into breast milk and could
affect the baby.
Linezolid Clonmel must not be used if you answer

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Linezolid Clonmel 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg linezolid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oblong, biconvex, white to off-white film-coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid Clonmel is indicated 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 Clonmel 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 Clonmel is indicated 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
microbiologist or infectious diseases specialist.
CONSIDERATION SHOULD BE GIVEN TO OFFI