LINEZOLID PANPHARMA INJECTION linezolid 400 mg in 200 mL solution for injection infusion bag

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

linezolid, Quantity: 400 mg

Tilgjengelig fra:

Panpharma Australia Pty Ltd

INN (International Name):

Linezolid

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: glucose monohydrate; sodium citrate dihydrate; citric acid; hydrochloric acid; sodium hydroxide; water for injections

Administreringsrute:

Intravenous

Enheter i pakken:

1 infusion bag, 5 infusion bags, 10 infusion bags

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Linezolid is indicated for the treatment of suspected or proven infections due to Gram positive organisms resistant to multiple classes of antibiotics, including methicillin resistant Staphylococcus species and vancomycin resistant Enterococcus species. Linezolid is active against Gram-positive bacteria only. Linezolid has no clinical activity against Gram-negative pathogens. Specific Gram-negative therapy is required if a concomitant Gram-negative pathogen is documented or suspected.

Produkt oppsummering:

Visual Identification: It is a clear, colourless to yellowish solution, free from visible particles.; Container Type: Bag; Container Material: Plastic; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2016-09-30

Informasjon til brukeren

LINEZOLID PANPHARMA INJECTION
_LINEZOLID _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before taking linezolid. This leaflet
answers some common questions
about linezolid. It does not contain all
the available information. It does not
take the place of talking to your
child’s doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you or your child taking linezolid
against the expected it will have.
ASK YOUR DOCTOR IF YOU HAVE ANY
CONCERNS ABOUT YOU OR YOUR CHILD
TAKING THIS MEDICINE.
KEEP THIS LEAFLET EVEN AFTER YOUR
TREATMENT WITH LINEZOLID IS FINISHED.
You may need to read it again.
WHAT LINEZOLID IS USED
FOR
Linezolid Panpharma Injection
contains the active ingredient,
linezolid.
Linezolid 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 prescribed
linezolid for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LINEZOLID HAS
BEEN PRESCRIBED FOR YOU OR YOUR
CHILD.
This medicine is not addictive.
BEFORE BEING TREATED
WITH LINEZOLID
_WHEN LINEZOLID MUST NOT BE _
_GIVEN _
LINEZOLID 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 phaeochromocytoma (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.
moclobemide, phenelzine or
t

Preparatomtale

Product Information
Page 1
Linezolid Panpharma Injection (2 mg/mL)
______________________________________________________________________________________________________________________________
PRODUCT INFORMATION
Linezolid Panpharma Injection
2 mg/mL
NAME OF THE MEDICINE
Linezolid Panpharma Injection 2 mg/mL (600 mg/300 mL, 400 mg/200 mL
and 200
mg/100 mL)
The structure formula of linezolid is shown below:
Active ingredient:
Linezolid
Chemical name:
(S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-
oxazolidinyl]methyl]-acetamide
Molecular formula:
C
16
H
20
FN
3
O
4
Molecular weight:
337.35
CAS registry number:
165800-03-3
DESCRIPTION
Linezolid Panpharma Injection contains linezolid, which is a synthetic
antibacterial
agent of the oxazolidinone class. 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 Panpharma Injection contains 2 mg of linezolid
in an isotonic,
clear, colourless to yellow solution. The injection also contains
glucose monohydrate,
sodium citrate, citric acid anhydrous,
hydrochloric acid, sodium hydroxide and water
for injections.
____________________________________________________________________________________
Version 1.0
Product Information
Page 2
Linezolid Panpharma Injection (2 mg/mL)
______________________________________________________________________________________________________________________________
PHARMACOLOGY
PHARMACODYNAMICS
_GENERAL PROPERTIES_
Linezolid is a synthetic, antibacterial agent belonging to a 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 formatio