Linezolid 2mg/ml Solution for Infusion

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

LINEZOLID

Boleh didapati daripada:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Kod ATC:

J01XX08

INN (Nama Antarabangsa):

LINEZOLID 2 mg/ml

Borang farmaseutikal:

SOLUTION FOR INFUSION

Komposisi:

LINEZOLID 2 mg/ml

Jenis preskripsi:

POM

Kawasan terapeutik:

ANTIBACTERIALS FOR SYSTEMIC USE

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2017-10-11

Risalah maklumat

1
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 ,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 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 DO NOT TAKE LINEZOLID INFUSION:
•
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 breastfeeding. This is because Linezolid infusion passes
into breast milk and could
affect the baby.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Linezolid
infusion.
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 deci

Ciri produk

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Linezolid 2 mg/ml solution for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2 mg linezolid. Each 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, practically free from
particles, with pH range
of 4.0-5.0 and Osmolarity range of 270-330 mOsmol/l.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nosocomial pneumonia
Community acquired pneumonia
Linezolid infusion 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 infusion 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 infusion 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.
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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 Gr