Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
linezolid, Quantity: 2 mg/mL
Fresenius Kabi Australia Pty Ltd
Linezolid
Injection, intravenous infusion
Excipient Ingredients: sodium citrate; sodium hydroxide; glucose monohydrate; citric acid; hydrochloric acid; water for injections
Intravenous Infusion
30, 20, 1, 10, 50
(S4) Prescription Only Medicine
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.,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: Clear, colourless to yellow solution.; Container Type: Bottle; Container Material: PE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-05-19
CMI for Linezolid Kabi May 2017 1.3.2 - CMI clean Page 1 of 4 LINEZOLID KABI Linezolid CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Linezolid Kabi. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking Linezolid Kabi against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT LINEZOLID KABI IS USED FOR Linezolid Kabi contains the active ingredient, linezolid. 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 Linezolid Kabi for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LINEZOLID KABI HAS BEEN PRESCRIBED FOR YOU OR YOUR CHILD. This medicine is not addictive. BEFORE YOU ARE GIVEN LINEZOLID KABI _WHEN YOU MUST NOT BE GIVEN IT _ LINEZOLID KABI 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 by a carcinoid tumour are taking or have taken in the last two weeks any medicine that is a monoamine oxidase inhibitor (e.g. moclobemide, phenelzine or tranylcypromine to treat depression or selegiline to tre Đọc toàn bộ tài liệu
1 AUSTRALIAN PRODUCT INFORMATION –LINEZOLID KABI (LINEZOLID) SOLUTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Linezolid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Linezolid Kabi 2 mg/mL solution for intravenous infusion. The solution also contains glucose monohydrate, sodium citrate, citric acid, hydrochloric acid/sodium hydroxide and water for injections. 3 PHARMACEUTICAL FORM Each 300 mL infusion bag or bottle contains 600 mg linezolid (i.e. 2 mg/mL) in an isotonic, clear, colourless to yellow solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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. 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. 4.2 D OSE AND METHOD OF ADMINISTRATION Patients who commence treatment on the parenteral formulation may be switched to an oral preparation when clinically indicated. In such circumstances, no dose adjustment is required as linezolid has an oral bioavailability of approximately 100%. The injection should be administered over a period of 30–120 minutes. An oral preparation may be taken with or without food. The maximum recommended duration of treatment is 28 days. An oral preparation of Linezolid Kabi is not available; where clinically indicated, another brand of an oral linezolid dosage form is to be administered. 2 ADULTS AND CHILDREN 12 YEARS OR OLDER The recommended dosage should be administered intravenously or orally twice daily as shown in Table 1. Duration of treatment is variable. It is dependent on the pathogen, the site of infection and its severity, and on the patient’s clinical response. The maximum recommended duration of treatment is 28 days. No increas Đọc toàn bộ tài liệu