LINEZOLID MYX linezolid 600 mg/300 mL injection infusion bag

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

linezolid

Fáanlegur frá:

Mayne Pharma International Pty Ltd

INN (Alþjóðlegt nafn):

Linezolid

Leyfisstaða:

Registered

Upplýsingar fylgiseðill

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LINEZOLID MYX™
_linezolid _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before taking Linezolid MYX. This
leaflet answers some common
questions about Linezolid MYX. It
does not contain all the available
information. It does not take the
place of talking to your or child’s
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
Linezolid MYX against the
expected benefits it will have.
ASK THE DOCTOR IF YOU HAVE ANY
CONCERNS ABOUT YOU OR YOUR CHILD
TAKING THIS MEDICINE.
KEEP THIS LEAFLET EVEN AFTER YOUR
TREATMENT WITH LINEZOLID MYX IS
FINISHED.
You may need to read it again.
WHAT LINEZOLID MYX
IS USED FOR
Linezolid MYX contains the active
ingredient, linezolid.
Linezolid MYX is an antibiotic (an
agent used to destroy certain types
of bacteria). It is used in the
treatment of bacterial infections
such as pneumonia, skin infections
or blood infections.
Depending on the type of bacteria,
you may be given additional
medicines.
Your doctor, however, may
prescribe Linezolid MYX for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU OR
YOUR CHILD.
This medicine is not addictive.
BEFORE BEING TREATED
WITH LINEZOLID MYX
_WHEN YOU MUST NOT BE _
_GIVEN IT _
LINEZOLID MYX MUST NOT BE GIVEN
IF YOU OR YOUR CHILD:
•
are allergic to linezolid or any
of the other ingredients listed
at the end of this leaflet.
•
Some of the symptoms of an
allergic reaction may include:
shortness of breath, wheezing
or difficulty breathing,
swelling of the face, lips,
tongue or other parts of the
body, rash, itching or hives on
the skin.
•
have uncontrolled high blood
pressure
•
have pheochromocytoma (a
type of tumour of the adrenal
gland)
•
have thyrotoxicosis (an
overactive thyroid gland)
•
have flushing or other
symptoms caused by a
carcinoid tumour
•
are taking or have taken in the
last two weeks any medicine
that is a monoamine oxidase
inhibitor (e.g.

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Product Information
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LINEZOLID MYX™ INJECTION
NAME OF THE MEDICINE
Non-proprietary name:
Linezolid
Chemical name:
(S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-
oxazolidinyl]methyl]-acetamide
The empirical formula of linezolid is C
16
H
20
FN
3
O
4
and its chemical structure is represented
below:
CAS Number:
CAS-165800-03-3
DESCRIPTION
Linezolid MYX injection contains linezolid, which is a synthetic
antibacterial agent of the
oxazolidinone class with a molecular weight of 337.35. Linezolid is
biologically active and is
metabolised to form inactive derivatives. The aqueous solubility of
linezolid is approximately 3
mg/mL, independent of pH between pH 3 to 9.
Each 1 mL of Linezolid MYX injection contains 2 mg of linezolid in an
isotonic, clear,
colourless to yellow solution. The injection also contains glucose
monohydrate, sodium citrate,
citric acid, hydrochloric acid/sodium hydroxide and water for
injections.
Linezolid MYX injection contains no antimicrobial and is for single
use in one patient on one
occasion only. Discard any remaining residue.
PHARMACOLOGY
PHARMACODYNAMICS
GENERAL PROPERTIES_ _
Linezolid is a synthetic, antibacterial agent belonging to a new class
of antibiotics, the
oxazolidinones, with
_in vitro _
activity against Gram positive aerobic bacteria, some Gram
positive anaerobic bacteria and certain Gram negative bacteria. It
selectively inhibits bacterial
protein synthesis via a mechanism of action different from that of
other antibacterial agents.
Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the
bacterial ribosome and
prevents the formation of a functional 70S initiation complex which is
an essential component
of the bacterial translation process. The results of time-kill studies
have shown linezolid to be
bacteriostatic against enterococci and staphylococci. For
streptococci, linezolid was found to
be bactericidal for the majority of strains.
Product Information
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BREAKPOINTS_ _
The MIC breakpoints in Table 1 separate susceptible from
non-susceptible iso