Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
linezolid, Quantity: 2 mg/mL
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: citric acid; hydrochloric acid; water for injections; sodium citrate dihydrate; glucose monohydrate; sodium hydroxide
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
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 Leggi il documento completo
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 Leggi il documento completo