Apel 600 mg film-coated tablets

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

LINEZOLID

Pieejams no:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATĶ kods:

J01XX08

SNN (starptautisko nepatentēto nosaukumu):

LINEZOLID 600 mg

Zāļu forma:

FILM-COATED TABLET

Kompozīcija:

LINEZOLID 600 mg

Receptes veids:

POM

Ārstniecības joma:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorizācija statuss:

Authorised

Autorizācija datums:

2019-02-22

Lietošanas instrukcija

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
APEL 600 MG FILM-COATED TABLETS
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.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Apel is and what it is used for
2.
What you need to know before you take Apel
3.
How to take Apel
4.
Possible side effects
5.
How to store Apel
6.
Contents of the pack and other information
1.
WHAT APEL IS AND WHAT IT IS USED FOR
Zoxilid 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 Zoxilid is
suitable to treat your infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE APEL
DO NOT TAKE APEL:
•
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 linezolid passes into
breast milk and could affect the
baby.
Page 2 of 9
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Apel.
Apel 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 befo

Produkta apraksts

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Apel 600 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg linezolid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The film coated tablets are white, oval, biconvex, plain on both sides
with dimensions 18 x 9 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Apel 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)
Apel 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 microbiologist or infectious diseases specialist.
Consideration should be given