Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
linezolid, Quantity: 400 mg
Panpharma Australia Pty Ltd
Linezolid
Injection, solution
Excipient Ingredients: glucose monohydrate; sodium citrate dihydrate; citric acid; hydrochloric acid; sodium hydroxide; water for injections
Intravenous
1 infusion bag, 5 infusion bags, 10 infusion bags
(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: It is a clear, colourless to yellowish solution, free from visible particles.; Container Type: Bag; Container Material: Plastic; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-09-30
LINEZOLID PANPHARMA INJECTION _LINEZOLID _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before taking linezolid. This leaflet answers some common questions about linezolid. It does not contain all the available information. It does not take the place of talking to your child’s doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking linezolid against the expected it will have. ASK YOUR DOCTOR IF YOU HAVE ANY CONCERNS ABOUT YOU OR YOUR CHILD TAKING THIS MEDICINE. KEEP THIS LEAFLET EVEN AFTER YOUR TREATMENT WITH LINEZOLID IS FINISHED. You may need to read it again. WHAT LINEZOLID IS USED FOR Linezolid Panpharma Injection 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 prescribed linezolid for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LINEZOLID HAS BEEN PRESCRIBED FOR YOU OR YOUR CHILD. This medicine is not addictive. BEFORE BEING TREATED WITH LINEZOLID _WHEN LINEZOLID MUST NOT BE _ _GIVEN _ LINEZOLID 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 phaeochromocytoma (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 t Belgenin tamamını okuyun
Product Information Page 1 Linezolid Panpharma Injection (2 mg/mL) ______________________________________________________________________________________________________________________________ PRODUCT INFORMATION Linezolid Panpharma Injection 2 mg/mL NAME OF THE MEDICINE Linezolid Panpharma Injection 2 mg/mL (600 mg/300 mL, 400 mg/200 mL and 200 mg/100 mL) The structure formula of linezolid is shown below: Active ingredient: Linezolid Chemical name: (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- oxazolidinyl]methyl]-acetamide Molecular formula: C 16 H 20 FN 3 O 4 Molecular weight: 337.35 CAS registry number: 165800-03-3 DESCRIPTION Linezolid Panpharma Injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. Linezolid is biologically active and is metabolised to form inactive derivatives. The aqueous solubility of linezolid is approximately 3 mg/mL, independent of pH between pH 3 to 9. Each 1 mL of Linezolid Panpharma Injection contains 2 mg of linezolid in an isotonic, clear, colourless to yellow solution. The injection also contains glucose monohydrate, sodium citrate, citric acid anhydrous, hydrochloric acid, sodium hydroxide and water for injections. ____________________________________________________________________________________ Version 1.0 Product Information Page 2 Linezolid Panpharma Injection (2 mg/mL) ______________________________________________________________________________________________________________________________ PHARMACOLOGY PHARMACODYNAMICS _GENERAL PROPERTIES_ Linezolid is a synthetic, antibacterial agent belonging to a class of antibiotics, the oxazolidinones, with _ in vitro _ activity against Gram-positive aerobic bacteria, some Gram-positive anaerobic bacteria and certain Gram-negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome and prevents the formatio Belgenin tamamını okuyun