ZYVOX linezolid 600mg/300mL injection infusion bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linezolid, Quantity: 2 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

1 bag, 10 bags

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Zyvox 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. Zyvox (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: A clear, colourless to yellow solution free from visible particulates.; Container Type: Bag; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2001-09-24

Patient Information leaflet

ZYVOX
®
Z
Y
V
O
X
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ZYVOX?
Zyvox contains the active ingredient linezolid. It is used in the
treatment of bacterial infections such as pneumonia, skin infections
or
blood infections. For more information, see Section 1. Why am I using
Zyvox? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ZYVOX?
Do not use if you or your child have ever had an allergic reaction to
Zyvox or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding. For more information, see Section 2. What should
I know before I use Zyvox? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Zyvox and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ZYVOX?
Zyvox injection is given by infusion into the blood (known as an
intravenous infusion or "drip") by a doctor or nurse.
Your doctor will give you instruction on how to take Zyvox tablets or
oral suspension. You or your child may be changed from Zyvox
injection to Zyvox tablets or oral suspension to complete the course
of treatment.
More instructions can be found in Section 4. How do I use Zyvox? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ZYVOX?
THINGS YOU
SHOULD DO
•
Tell your doctor if the symptoms of the infection do not improve
within a few days, or if they become
worse; you or your child have severe diarrhoea, a sore white mouth or
tongue; you have vaginal itching
or discharge; or if you are pregnant, or plan to become pregnant.
•
Tell any other doctor or dentist you visit that you or your child are
using Zyvox.
•
For more information on "Things you should do" can be found in Section
5 in the full CMI.
THINGS YOU
SHOULD

Summary of Product characteristics

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AUSTRALIAN
PRODUCT
INFORMATION
–
ZYVOX
® (LINEZOLID)
1.
NAME OF THE MEDICINE
Linezolid.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TABLETS
Each Zyvox tablet contain 600 mg linezolid.
GRANULES FOR ORAL SUSPENSION
Following reconstitution with 123 mL of water, each mL contains 20 mg
of linezolid.
SOLUTION FOR INJECTION
Each 1 mL of Zyvox solution for injection (Zyvox injection) contains 2
mg of linezolid.
EXCIPIENT(S) WITH KNOWN EFFECT
GRANULES FOR ORAL SUSPENSION
Each mL contains 210.6 mg sucrose, 100 mg mannitol (E421) and 7 mg
aspartame (E951),
sodium as sodium citrate dihydrate (3 mg), sodium benzoate (2 mg) and
sodium chloride (2.7
mg). Fructose and sorbitol (E420) are present in mafco magna sweet (12
mg) and sweet-am
powder (6 mg).
SOLUTION FOR INJECTION
Each mL contains 50.24 mg glucose monohydrate and sodium as sodium
citrate dihydrate
(1.64 mg).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
TABLETS
Zyvox 600 mg tablets are white to off-white coated tablet with
“ZYV” debossed on one side
and “600” debossed on the other.
GRANULES FOR ORAL SUSPENSION
Zyvox granules for oral suspension are white to yellow-orange and may
contain white to
yellow-orange-brown lumps. The constituted suspension is white to
yellow-orange and orange
flavoured.
SOLUTION FOR INJECTION
Zyvox injection is in an isotonic, clear, colourless to yellow
solution with pH between 4.4-5.2.
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4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zyvox 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.
Zyvox is active against Gram-positive bacteria only. Zyvox has no
clinical activity against
Gram-negative pathogens. Specific Gram-negative therapy is required if
a concomitant Gra