ZYVOX linezolid 200mg/100mL 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: hydrochloric acid; sodium citrate dihydrate; water for injections; glucose monohydrate; sodium hydroxide; citric acid

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

Summary of Product characteristics

Version: pfpzyvoa10622
Supersedes: pfpzyvoa10821
Page 1 of 26
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.
Version: pfpzyvoa10622
Supersedes: pfpzyvoa10821
Page 2 of 26
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