Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
linezolid, Quantity: 2 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: hydrochloric acid; sodium citrate dihydrate; water for injections; glucose monohydrate; sodium hydroxide; citric acid
Intravenous
1 bag, 10 bags
(S4) Prescription Only Medicine
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..
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
Licence status A
2001-09-24
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 Baca dokumen lengkap