PHARMACOR LINEZOLID linezolid 600 mg film coated tablets bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linezolid, Quantity: 600 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; silicon dioxide; copovidone; sodium stearylfumarate; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

20, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PHARMACOR 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.,PHARMACOR LINEZOLID is active against Gram-positive bacteria only. PHARMACOR 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: White to off white capsule shape film-coated tablet debossed with "LIN 600" on one side, plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-10-15

Patient Information leaflet

PHARMACOR LINEZOLID
_TABLETS_
_ _
_linezolid _ CONSUMER MEDICINE INFORMATION
PHARMACOR LINEZOLID CMI (V-03)
Page
1
of
5
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before
taking
PHARMACOR
LINEZOLID.
This
leaflet
answers
some
common
questions
about
PHARMACOR LINEZOLID. It does
not
contain
all
the
available
information. It does not take the place
of
talking
to
your
or
your
child's
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed
the risks of you or your child taking
PHARMACOR LINEZOLID 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
PHARMACOR
LINEZOLID IS FINISHED.
You may need to read it again.
WHAT PHARMACOR
LINEZOLID IS USED FOR
PHARMACOR
LINEZOLID
contains
the
active
ingredient,
linezolid.
PHARMACOR
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
PHARMACOR
LINEZOLID
for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
PHARMACOR
LINEZOLID
HAS
BEEN
PRESCRIBED
FOR
YOU
OR
YOUR
CHILD.
This medicine is not addictive.
BEFORE TREATMENT WITH
PHARMACOR
LINEZOLID
_WHEN PHARMACOR _
_LINEZOLID MUST NOT BE _
_USED _
PHARMACOR 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 pheochromocytoma (a type
of tumour of the adrenal gland)

have thyrotoxicosis (an overactive
thyroid gland)

have flushing or other symptoms
caused b

Summary of Product characteristics

PHARMACOR LINEZOLID PI (V-03)
Page
1
of
27
AUSTRALIAN PRODUCT INFORMATION – PHARMACOR LINEZOLID (LINEZOLID)
1.
NAME OF THE MEDICINE
Linezolid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg of Linezolid
List of excipients with known effect
'For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.'
3.
PHARMACEUTICAL FORM
Film coated tablets
PHARMACOR LINEZOLID 600 mg tablets
Linezolid 600 mg Film-coated tablets are white to off white capsule
shape film coated tablet
debossed with "LIN 600" on one side, plain on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PHARMACOR 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.
PHARMACOR LINEZOLID is active against Gram-positive bacteria only.
PHARMACOR
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
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_Linezolid _
_solution _
_for _
_injection _
_and _
_granules _
_for _
_oral _
_suspension _
_are _
_unavailable _
_in _
_the _
_PHARMACOR LINEZOLID brand. For intravenous and oral suspension dosing
requirements _
_other brands are available. Information obtained using linezolid
solution for injection and _
_granules _
_for _
_oral _
_suspension _
_formulations _
_have _
_been _
_retained _
_throughout _
_the _
_PI, _
_where _
_appropriate, for continuity and prescriber information. _
PHARMACOR LINEZOLID PI (V-03)
Page
2
of
27
Patients who commence treatment on the parenteral formulation may be
switched to either oral
presentation when clinically indicated. In such circumstances, no dose
adjustment is required as
linezolid tablets has an oral bioavailability of approximately 100%.
The film coated tablets may be taken with or without food.
The maximum r