Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
aztreonam
Gilead Sciences Pty Ltd
Aztreonam
Registered
CAYSTON CMI v2.0 Page 1 of 5 CONSUMER MEDICINE INFORMATION CAYSTON ® Generic Name: aztreonam for inhalation WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU, OR THE PERSON IN YOUR CARE STARTS TAKING CAYSTON. Also, read it each time you get your CAYSTON prescription refilled, in case something has changed. This leaflet is only a summary and does not take the place of talking with your doctor or pharmacist about your medical condition or your treatment. Talk to your doctor or pharmacist if you have any questions about CAYSTON. Keep this leaflet with the medicine. You may need to read it again. WHAT IS CAYSTON AND HOW DOES IT WORK? CAYSTON is an antibiotic, belonging to a group of medicines called monobactams. CAYSTON is used to help people who have Cystic Fibrosis (CF). CF is a genetic disease that affects a number of organs in the body. The lungs are often clogged with thick, sticky mucus that may lead to chronic airway infections. CAYSTON is not a cure for this disease. CAYSTON is used to fight lung infections caused by bacteria such as _Pseudomonas aeruginosa (P. aeruginosa). _ When you inhale CAYSTON with your Altera TM Nebulizer System, it will enter your lungs and contact the _P. aeruginosa _bacteria that are present. CAYSTON works by decreasing the number of _P. aeruginosa _bacteria living in your lungs to improve your respiratory symptoms and lung function. WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING CAYSTON? TELL YOUR DOCTOR IF: you are allergic to aztreonam or lysine you are allergic to any antibiotics you are pregnant or planning on becoming pregnant you are breast-feeding Tell your doctor or pharmacist about all of your medical conditions. CAYSTON CMI v2.0 Page 2 of 5 Tell your doctor or pharmacist about all the medicines you take, including prescription and non-prescription medicines and dietary supplements. DO NOT TAKE CAYSTON IF: you are allergic to aztreonam or lysine the expiry date (EXP) on the vial or the ampoule has passed the solution of Đọc toàn bộ tài liệu
CAYSTON Product Information v5.0 Page 1 of 19 PRODUCT INFORMATION CAYSTON ® (AZTREONAM FOR INHALATION) NAME OF THE MEDICINE CAYSTON The active substance in CAYSTON is aztreonam. Aztreonam is a monobactam antibiotic. The monobactams are structurally different from beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems) due to a unique monocyclic nucleus. This nucleus contains several side chains; sulfonic acid in the 1- position activates the nucleus, an aminothiazolyl oxime side chain in the 3-position confers specificity for aerobic gram-negative bacteria including _Pseudomonas spp_ ., and a methyl group in the 4-position enhances beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,-3S)-2- methyl-4-oxo-1-sulfo-3-azetidinyl]caramoyl]methylene]amino]oxy]-2-methylpropionic acid. The structural formula is presented below: N N H S N H 2 N N O O OH H 3 C H 3 C O O H CH 3 SO 3 H H Molecular formula: C 13 H 17 N 5 O 8 S 2 . Molecular weight: 435.435 CAS number: 78110-38-0 DESCRIPTION CAYSTON is a white to off-white powder. It is soluble in water and aqueous solutions. CAYSTON is sterile, hygroscopic, and light sensitive. Once reconstituted with the supplied diluent, the pH range is 4.5 to 6.0. A dose of CAYSTON consists of one vial containing lyophilized aztreonam (75 mg) and lysine (46.7 mg) and one ampoule containing diluent (1 mL sterile saline [0.17% w/v sodium chloride]). The formulations contain no preservatives. CAYSTON Product Information v5.0 Page 2 of 19 PHARMACOLOGY PHARMACOKINETICS _ _ _Sputum Concentrations _ Aztreonam concentration in individual patients’ sputum exhibited considerable variability. Ten minutes following a single dose of 75 mg CAYSTON, the mean sputum level in 195 patients with cystic fibrosis (CF) was 726 µg/g, which is approximately 10 times that of the aztreonam MIC 90 for all isolates of _P. aeruginosa_ observed at baseline for patients treated with CAYSTON in the Phase 3 placebo-controlled studies (64 µg/ml). Mean spu Đọc toàn bộ tài liệu