LINEZOLID KABI linezolid 600 mg/300 mL solution for injection infusion bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linezolid, Quantity: 2 mg/mL

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

Linezolid

Pharmaceutical form:

Injection, intravenous infusion

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

10, 30, 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: Clear, colourless to yellow solution.; Container Type: Bag; Container Material: Plastic; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-05-19

Patient Information leaflet

CMI for Linezolid Kabi
May 2017
1.3.2 - CMI clean
Page 1 of 4
LINEZOLID KABI
Linezolid
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Linezolid Kabi. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
Linezolid Kabi against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT LINEZOLID KABI IS
USED FOR
Linezolid Kabi 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
prescribe Linezolid Kabi for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LINEZOLID
KABI HAS BEEN PRESCRIBED FOR
YOU OR YOUR CHILD.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
LINEZOLID KABI
_WHEN YOU MUST NOT BE GIVEN IT _
LINEZOLID KABI 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. moclobemide,
phenelzine or tranylcypromine
to treat depression or selegiline
to tre

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –LINEZOLID KABI
(LINEZOLID) SOLUTION FOR INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Linezolid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Linezolid Kabi 2 mg/mL solution for intravenous infusion.
The solution also contains glucose monohydrate, sodium citrate, citric
acid, hydrochloric
acid/sodium hydroxide and water for injections.
3
PHARMACEUTICAL FORM
Each 300 mL infusion bag or bottle contains 600 mg linezolid (i.e. 2
mg/mL) in an isotonic,
clear, colourless to yellow solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Patients who commence treatment on the parenteral formulation may be
switched to an oral
preparation when clinically indicated. In such circumstances, no dose
adjustment is required
as linezolid has an oral bioavailability of approximately 100%.
The injection should be administered over a period of 30–120
minutes. An oral preparation
may be taken with or without food.
The maximum recommended duration of treatment is 28 days.
An oral preparation of Linezolid Kabi is not available; where
clinically indicated, another brand
of an oral linezolid dosage form is to be administered.
2
ADULTS AND CHILDREN 12 YEARS OR OLDER
The recommended dosage should be administered intravenously or orally
twice daily as
shown in Table 1. Duration of treatment is variable. It is dependent
on the pathogen, the site
of
infection
and
its
severity,
and
on
the
patient’s
clinical
response.
The
maximum
recommended duration of treatment is 28 days. No increas